Medicolegal issues
वक्रतुण्ड महाकाय सूर्यकोटि समप्रभ ।
निर्विघ्नं कुरु मे देव सर्वकार्येषु सर्वदा ॥
O Lord (Ganesha), who has a huge body, curved elephant trunk and whose brilliance is equal to billions of Suns,
May always remove all obstacles from my endeavors.
Om Bhur Bhuva Swaha,
Tat Savitur Varenyam,
Bhargo Devasya Dhimahi,
Dhiyo Yonah Prachodayat.
We meditate on the transcendental Glory of the Supreme Deity, who is inside the heart of the earth, within the life of the sky and inside the soul of Heaven. May He stimulate and illuminate our minds.
Yaa Devi Sarva-Bhutessu Buddhi-Ruupenna Samsthitaa |
Namas-Tasyai Namas-Tasyai Namas-Tasyai Namo Namah ||
To that Devi Who in All Beings is Abiding in the Form of Intelligence,
Salutations to Her, Salutations to Her, Salutations to Her, Salutations again and again.
Contents
Medicolegal issues8
Allied and Healthcare Professions Bill, 20188
Anti-Counterfeiting Trade Agreement10
Ayushman Bharat Yojana10
Basic Principles of Medical Negligence: Need for Protection of Doctors12
BAYH-DOLE ACT13
BIG FINES TO PHARMA INDUSTRY13
BIOMEDICAL WASTE MANAGEMENT14
Biosimilar15
Bolam law and Professional Negligence15
Bolam test15
Books of accounts15
Budget for health sector-IMA reaction.19
Can A Doctor Be Arrested by Police?20
Can you practice medicine ethically in India?24
Clinical Establishment Act- How will it affect the practicing dentist25
CLINICAL ESTABLISHMENT ACT, IMA & MINIMAL STANDARDS26
why the government wants it.26
why the doctors don’t want it.27
Clinical Establishment Act . . . The long story27
Minimal standards of clinical establishment33
CLINICAL ESTABLISHMENTS ACT RULES36
Compulsory license42
Consent42
Consumer Law and Practice42
Controlled drugs45
UNRCPD53
Digital signature53
Drug laws54
EMTALA LAW70
English tort law71
Epidemic act.71
Error of judgement72
Evergreening77
Goldwater rule77
GST AND NURSING HOME AND PATHOLOGY LABS80
GST act and health care80
GST AND PHARMA INDUSTRY81
Guidelines for issuing a Medical Certificate83
Hathi committee85
Hippocrates could not have seen this coming.86
HIPPOCRATIC OATH89
IMA White Paper on Indian Medical Service90
RELEVANT PROVISIONS FOR DOCTORS UNDER INDIAN PENAL CODE, 186093
Can a Doctor be Arrested?105
India—a tale of one country, but stories of many states109
India Needs Punishment Policy for Illegally Sold Medicines110
Indian legal system and mental health111
The constitution of India112
Indian penal code for doctors117
JUDGEMENT ON PNDT ACT122
LAWS IN MEDICINE123
Criminal Liability in Medical Profession128
LAWS APPLICABLE TO HOSPITALS128
Laws Governing to Medicolegal Aspects135
Licenses/Certifications Required for Hospitals136
MEDICAL COUNCIL OF INDIA139
MCI peer group review177
MCI concerned about assault on doctors178
Medical ethics.179
Medical negligence182
Medical Negligence Vs Bad Practice, Which Is Going to Cost You More182
Medico Legal General Medicine187
Criminal Liabilities in Medical Profession187
MENTAL HEALTH ACT 1987193
Mental health bill interview292
Modernizing Code of Medical Ethics297
National digital health blueprint299
NEW MENTAL HEALTH BILL BANS ELECTRIC SHOCKS, GIVES RIGHT TO TREATMENT301
The bill decriminalizes suicide for mentally ill patients.302
NMC act and controversies303
PCPNDT – Medicolegal Secrets304
THE NEW ‘QUIT INDIA’ MOVEMENT?316
Prescription Drug Charges318
Problems with mental health act321
RECORD KEEPING: VARIOUS LAWS.321
Revalidation323
Shakoor v Situ324
Should Code of Medical Ethics be modernized325
SUNSHINE ACT327
Tally for doctors327
The Criminal Justice and Public Order Act of 1994330
THE INDIAN MEDICAL COUNCIL ACT, 1956337
The Jan Aushadi Pariyojana: A primer for Indian doctors352
THE PERSONS WITH DISABILITIES (EQUAL OPPORTUNITIES, PROTECTION OF RIGHTS AND FULL PARTICIPATION) ACT, 1995354
Three vital supreme court decisions385
Clinical Establishment Act.386
Are doctors doing some illegal work to be harassed like this397
A bitter pill?397
List of laws related to doctors in India408
Rights of patients-417
THE CONSUMER PROTECTION ACT, 2019423
NMC ACT492
SUROGACY BILL493
The Food Safety and Standards (Contaminants, toxins and Residues) Regulations, 2011.495
Food Safety and Standards (Prohibition and Restrictions on Sales) Regulations, 2011504
Food Safety and Standards Regulations, 2011- Laboratory And Sample Analysis511
Air (Prevention and Control of Pollution) Act, 1981 No. 14 of 1981512
The Transplantation of Human Organs Act, 1994513
The Pharmacy Act, 1948516
Bio-Medical Waste (Management and Handling) Rules, 1998519
Drugs and Cosmetics Act, 1940521
Prevention of Food Adulteration Act, 1954526
Narcotic Drugs and Psychotropic Substances Act 1985532
Maternity Benefit Act, 1961540
Insecticides Act, 1968542
Rehabilitation Council Act of India Act 1992545
The Pre-Natal Diagnostic Techniques (PNDT) Act & Rules547
Pre-Natal Diagnostic Techniques (Regulation and Prevention of Misuse) Rules, 1996548
Medical Termination of Pregnancy ACT, 1971549
Medicolegal issues
Gone are the days when doctors on graduation could be said to get a license to kill! Rightly or wrongly, the doctors are increasingly coming in conflict with the law. Their actions are now summarily challenged in courts of law, be it for a simple error in giving a medicolegal certificate or an error of judgement under consumer protection act or more stringently a clerical mistake under draconian PNDT act.
The policies are changing resulting in acts as comprehensive as Ayushman Bharat or the recent covid pandemic forcing the medical council of India to formulate a detailed telemedicine guideline.
Also pertinent is for doctors to know the laws and judgments and issues relating to law and pharmaceuticals industry.
it is therefore, of utmost importance that the doctors know at least basics of these bills and acts.
Allied and Healthcare Professions Bill, 2018
Cabinet approves the Allied and Healthcare Professions Bill, 2018 for regulation and standardization of education and services by allied and healthcare professionals
The Union Cabinet chaired by Prime Minister Shri Narendra Modi has approved the Allied and Healthcare Professions Bill, 2018 for regulation and standardization of education and services by allied and healthcare professionals. The Bill provides for setting up of an Allied and Healthcare Council of India and corresponding State Allied and Healthcare Councils which will play the role of a standard-setter and facilitator for professions of Allied and Healthcare.
Details:
1 Establishment of a Central and corresponding State Allied and Healthcare Councils; 15 major professional categories including 53 professions in Allied and Healthcare streams.
2 The Bill provides for Structure, Constitution, Composition and Functions of the Central Council and State Councils, e.g. Framing
Contents
Pertains to policies and standards, Regulation of professional conduct, Creation and maintenance of live Registers, provisions for common entry and exit examinations, etc.
The Central Council will comprise 47 members, of which 14 members shall be ex-officio representing diverse and related roles and functions and remaining 33 shall be non-ex-officio members who mainly represent the 15professional categories.
The State Councils are also envisioned to mirror the Central Council, comprising 7 ex-officio and 21 non-ex officio members and Chairperson to be elected from amongst the non-ex officio members.
Professional Advisory Bodies under Central and State Councils will examine issues independently and provide recommendations relating to specific recognized categories.
The Bill will also have an overriding effect on any other existing law for any of the covered professions.
The State Council will undertake recognition of allied and healthcare institutions.
Offences and Penalties clause have been included in the Bill to check malpractices.
The Bill also empowers the Central and State Governments to make rules.
Central Govt. also has the power to issue directions to the Council, to make regulations and to add or amend the schedule.
Targets:
◦ An Interim Council will be constituted within 6 months of passing of the Act holding charge for a period of two years until the establishment of the Central Council.
◦ The Council at the Centre and the States are to be established as body corporate with a provision to receive funds from various sources.
◦ Councils will also be supported by Central and State Governments respectively through Grant-in-aid as needed. However, if the State Government expresses inability, the Central Government may release some grant for initial years to the State Council.
Major Impact, including employment generation potential:
I Bring all existing allied and healthcare professionals on board during the first few of years from the date of establishment of the Council.
ii Opportunity to create qualified, highly skilled and competent jobs in healthcare by enabling professionalism of the allied and healthcare workforce.
iii High quality, multi-disciplinary care in line with the vision of Ayushman Bharat, moving away from a ‘doctor led’ model to a ‘care accessible and team based’ model.
iv Opportunity to cater to the global demand (shortage) of health care work force which is projected to be about 15 million by the year 2030, asper the WHO Global Workforce, 2030 report.
Expenditure involved:
Total cost implication is expected to be Rupees 95 crores for the first four years. About four-fifth of the total budget (i.e. Rupees 75 crores) is being earmarked for the States while the remaining fund will support the Central Council operations for 4 years and also establish the Central and State Registers.
Number of beneficiaries:
It is estimated that the Allied and Healthcare Professions Bill, 2018 will directly benefit around 8-9 Lakh existing Allied and Healthcare related professionals in the country and several other graduating professionals joining workforce annually and contributing to the health system. However, since this Bill is directed to strengthen the healthcare delivery system at large, it may be said that the entire population of the country and the health sector as a whole will be benefited by this Bill.
Background:
in the current state of healthcare system, there exist many allied and healthcare professionals, who remain unidentified, unregulated and underutilized. Our system is highly focused on efforts towards strengthening limited categories of professionals such as doctors, nurses and frontline workers (like Accredited Social Health Activist or ASHAs, Auxiliary Nurse Midwife or ANMs). However, numerous others have been identified over the years, whose potential can be utilized to improve and increase the access to quality driven services in the rural and hard to reach areas.
Allied and Healthcare Professionals (A&HPs) constitute an important element of the health human resource network, and the skilled and efficient Allied and Healthcare Professionals (A&HPs) can reduce the cost of care and dramatically improve the accessibility to quality driven healthcare services.
Globally, Allied and Healthcare Professionals typically attend undergraduate degree programmed of a minimum of three to four years to begin with and may attain up to PhD level qualification in their respective streams. However, most of Indian institutions offering such courses lack standardization.
Majority of the countries worldwide, have a statutory licensing or regulatory body that is authorized to license and certify the qualifications and competence of such professionals, particularly those involved in direct patient care (such as physiotherapist, nutritionist etc.) or those whose occupation impact patient care directly (such as lab technologists, dosimetrists etc.).
Though such professionals have existed in the Indian healthcare system for many decades, a considerable gap in the allied and healthcare space is because of a lack of a comprehensive regulatory framework and absence of standards for education and training of A&HPs.
The Bill thus seeks to establish a robust regulatory framework which will play the role of a standard-setter and regulator for Allied and Healthcare professions.
Anti-Counterfeiting Trade Agreement
The Anti-Counterfeiting Trade Agreement (ACTA) is a multinational treaty for the purpose of establishing international standards for intellectual property rights enforcement. The agreement aims to establish an international legal framework for targeting counterfeit goods, generic medicines and copyright infringement on the Internet, and would create a new governing body outside existing forums, such as the World Trade Organization, the World Intellectual Property Organization, and the United Nations.
Ayushman Bharat Yojana
Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (AB PM-JAY) is a flagship scheme of the Indian government’s National Health Policy which aims to provide free health coverage at the secondary and tertiary level to its bottom 40% poor and vulnerable population. PM-JAY is the world’s largest and fully state sponsored health assurance scheme which covers a population of the combined size of USA, Mexico and Canada. It was launched in September 2018, under the aegis of Ministry of Health and Family Welfare in India.
The National Health Protection Scheme (NHPS) scheme is formed by subsuming multiple schemes including Rashtriya Swasthya Bima Yojana, Senior citizen health Insurance Scheme (SCHIS), Central Government Health Scheme (CGHS), Employees’ State Insurance Scheme (ESIS), etc. The National Health Policy, 2017 has envisioned Health and Wellness Centres as the foundation of India’s health system which the scheme aims to establish.
The Central Government Health Scheme (CGHS) was started under the Indian Ministry of Health and Family Welfare in 1954 with the objective of providing comprehensive medical care facilities to Central Government employees, pensioners and their dependents residing in CGHS covered cities. This health scheme is now in operation with cities such as Bhubaneswar, Bhopal, Chandigarh, and Bangalore. The dispensary is the backbone of the Scheme. Instructions on these various matters have been issued from, time to time for the guidance of specialists and medical Officers. The Central Government Health Scheme offers health services through Allopathic and Homeopathic systems as well as through traditional Indian forms of medicine such as Ayurveda, Unani, Naturopathy, Yoga and Siddha.
Every year more than 6 crore Indians are pushed into poverty because of catastrophic out of pocket medical expenses. AB PM-JAY was launched on 23 September, 2018 at Ranchi, Jharkhand. The scheme envisions to alleviate the condition of 50 crore poor and vulnerable Indians.
PM-JAY is a health assurance scheme that covers 10.74 crores households across India or approx. 50 crores Indians.
It provides a cover of 5 lakh per family per year for medical treatment in empaneled hospitals, both public and private.
It provides cashless and paperless service to its beneficiaries at the point of service, i.e. the hospital.
E-cards are provided to the eligible beneficiaries based on the deprivation and occupational criteria of Socio-Economic Caste Census 2011 (SECC 2011).
There is no restriction on family size, age or gender.
All previous medical conditions are covered under the scheme.
It covers 3 days of hospitalization and 15 days of post hospitalization, including diagnostic care and expenses on medicines.
The scheme is portable and a beneficiary can avail medical treatment at any PM-JAY empaneled hospital outside their state and anywhere in the country.
So far, 25 States and Union Territories have adopted the PM-JAY scheme, except three states: Odisha, West Bengal and Telangana, and Union territory Delhi By February 2020, more than 12 crore e-cards have been generated and over 86 lakh people have taken benefit under this scheme. The number of public and private hospitals empaneled nationwide stands at 22,000.
The scheme has faced some challenges in its year and a half journey, mainly that of fraudulent medical bills.
There have been media reports of misuse of the Ayushman Bharat scheme by unscrupulous private hospitals through submission of fake medical bills. Under the Scheme, surgeries have been claimed to be performed on persons who had been discharged long ago and dialysis has been shown as performed at hospitals not having kidney transplant facility. There are at least 697 fake cases in Uttarakhand State alone, where fine of Rs one crore has been imposed on hospitals for frauds under the Scheme. However, unlike the earlier RSBY (Rastriya Swasthya Bema Yojana) era, plagued by lax monitoring of insurance fraud, AB-PMJAY involves a robust information technology infrastructure overseeing transactions and locating suspicious surges across the country. Many hospitals have been blacklisted and the constantly evolving fraud-control system will play a major role in streamlining the scheme as it matures. Initial analysis of high-value claims under PMJAY has revealed that a relatively small number of districts and hospitals account for a high number of these, and some hint of an anti-women bias, with male patients getting more coverage. Despite all efforts to curb foul-play, the risk of unscrupulous private entities profiteering from gaming the system is clearly present in AB-PMJAY.
Basic Principles of Medical Negligence: Need for Protection of Doctors
Hon’ble SC in a case of medical negligence decide on 10th February 2010, observed that on scrutiny of the leading cases of medical negligence both in our country and other countries especially United Kingdom, some basic principles emerge in dealing with the cases of medical negligence. [Para 94]
While deciding whether the medical professional is guilty of medical negligence following well known principles must be kept in view:
Negligence is the breach of a duty exercised by omission to do something which a reasonable man, guided by those considerations which ordinarily regulate the conduct of human affairs, would do, or doing something which a prudent and reasonable man would not do.
Negligence is an essential ingredient of the offence. The negligence to be established by the prosecution must be culpable or gross and not the negligence merely based upon an error of judgment.
The medical professional is expected to bring a reasonable degree of skill and knowledge and must exercise a reasonable degree of care. Neither the very highest nor a very low degree of care and competence judged in the light of the particular circumstances of each case is what the law requires.
A medical practitioner would be liable only where his conduct fell below that of the standards of a reasonably competent practitioner in his field.
In the realm of diagnosis and treatment there is scope for genuine difference of opinion and one professional doctor is clearly not negligent merely because his conclusion differs from that of another professional doctor.
The medical professional is often called upon to adopt a procedure which involves higher element of risk, but which he honestly believes as providing greater chances of success for the patient rather than a procedure involving lesser risk but higher chances of failure. Just because a professional looking to the gravity of illness has taken higher element of risk to redeem the patient out of his/her suffering which did not yield the desired result may not amount to negligence.
Negligence cannot be attributed to a doctor so long as he performs his duties with reasonable skill and competence. Merely because the doctor chooses one course of action in preference to the other one available, he would not be liable if the course of action chosen by him was acceptable to the medical profession.
It would not be conducive to the efficiency of the medical profession if no Doctor could administer medicine without a halter round his neck.
It is our bounden duty and obligation of the civil society to ensure that the medical professionals are not unnecessary harassed or humiliated so that they can perform their professional duties without fear and apprehension.
The medical practitioners at times also have to be saved from such a class of complainants who use criminal process as a tool for pressurizing the medical professionals/hospitals particularly private hospitals or clinics for extracting uncalled for compensation. Such malicious proceedings deserve to be discarded against the medical practitioners.
The medical professionals are entitled to get protection so long as they perform their duties with reasonable skill and competence and in the interest of the patients. The interest and welfare of the patients have to be paramount for the medical professionals.
SC observed that in our considered view, the aforementioned principles must be kept in view while deciding the cases of medical negligence. We should not be understood to have held that doctors can never be prosecuted for medical negligence. As long as the doctors have performed their duties and exercised an ordinary degree of professional skill and competence, they cannot be held guilty of medical negligence. It is imperative that the doctors must be able to perform their professional duties with free mind. [Para 95]
When we apply well settled principles enumerated in the preceding paragraphs in dealing with cases of medical negligence, the conclusion becomes irresistible that the appellants have failed to make out any case of medical negligence against the respondents.
When the doctors lose the litigation against them, it is usually not because they were actually negligent. Mostly it is because of other reasons, some of them are as under: 1. Poor medical records 2. Poor communication skills 3. Poor grievance redressal mechanism at their hospital 4. Poor image in the society 5. No self-regulation at individual level or at the level of professional bodies 6. Lack of proper guidance when a legal notice or court notice is received 7. Proper reply is not prepared or proper supporting literature is not submitted 8. Credible expert opinions are not submitted 9. Sometimes extraneous reasons difficult to explain and difficult to prove It is very important for the professional bodies to form a credible team to educate, enlighten & prepare medical practitioners for preventing / facing medical litigation prudently. I find that in spite of so much harassment etc. due to the problem of medical litigations (civil & criminal) over these years, most medical practitioners and most professional bodies are still complacent about this issue.
BAYH-DOLE ACT
The Bayh–Dole Act or Patent and Trademark Law Amendments Act (Pub. L. 96-517, December 12, 1980) is United States legislation dealing with intellectual property arising from federal government-funded research. Sponsored by two senators, Birch Bayh of Indiana and Bob Dole of Kansas, the Act was adopted in 1980, is codified at 94 Stat. 3015, and in 35 U.S.C. § 200-212,[1] and is implemented by 37 C.F.R. 401
BIG FINES TO PHARMA INDUSTRY
On Monday, the Department of Justice announced that drug company GlaxoSmithKline agreed to pay a $3 billion fine, the largest health care fraud fine in the history of the United States. This fine is just the latest in a string of drug company penalties for improper promotion of drugs for “off-label,” or unapproved, uses. Here we take a look at six recent multi-million dollar fines that drug companies have agreed to pay for inappropriately, and in some cases illegally, promoting prescription drugs.
BIOMEDICAL WASTE MANAGEMENT
Q. How to recall color of BMW disposal bins inside Hospital?
Colored Biomedical Waste (BMW) bag disposal as per Indian Bio-Medical Waste Management Rules, 2016.
• R-Red Bin- Recyclable waste(R-R)- Red blood soaked (used) Rubber gloves, Rubber & Plastic tubes & IV sets.
• Y-Yellow Bin- pus(Yellow) soaked Cotton Gauze pieces & dressing, Microbiology Waste (infected pus(Yellow) producing Bacteria), Human anatomical waste (tissues, organs, fetal parts)- infected (pus filled -Yellow), Animal waste, Empty Blood bags, soiled (Yellow) linen & Contaminated Bedsheets, discarded cytotoxic drugs for Burning infective waste in Yellow fire during incarnation.
• W- White Puncture-proof bin – Whole (unbroken) metallic (White) needles, blades & sharp waste.
• Brown Cardboard Box with Blue Marking- Unbroken Broken glass (Nukila Glass in Neela (Blue lining Brown Box)) & Body implants(metallic).
• Black- Black & white paper(non-infectious) waste.
Q. Why BMW disposal is Important?
80% non-infectious, (kitchen waste, paper)
15% is infectious (dressings, anatomical wastes, blood bags)
5% is non-infectious but hazardous, (chemicals, drugs and mercury)
When this 20% of the hospital infectious material is mixed with 80%
Then all the 100% waste becomes hazardous and infectious, hence segregation should be at source.
Q. What is definition of BMW?
Bio-medical Waste (BMW) means any waste, which is generated during the diagnosis, treatment or immunization of human beings or animals or in research activities or in production or testing of biological or in health camps.
Q. Which institutions need to follow BMW rules?
Hospitals, Medical or surgical camps, Nursing homes, Vaccination camps, Clinics, dispensaries, Blood donation camps, Veterinary institutions, First aid rooms of schools, Animal houses, Forensic laboratories, Pathological laboratories, Research labs, Blood banks, Ayush hospitals, Clinical establishments, Research or educational institutions, Health camps.
Bio-medical Waste (Management) Rules, 2016 notified on March 28, 2016 by MoEFCC, Govt. of India under Environmental Protection Act, 1986.
Biosimilar
A biosimilar (also known as follow-on biologic or subsequent entry biologic) is a biologic medical product which is almost an identical copy of an original product that is manufactured by a different company. Biosimilars are officially approved versions of original “innovator” products, and can be manufactured when the original product’s patent expires. Reference to the innovator product is an integral component of the approval.
Bolam law and Professional Negligence
In conducting this inquiry on professional negligence, the Panel must:
develop and evaluate options for a requirement that the standard of care in professional negligence matters (including medical negligence) accords with the generally accepted practice of the relevant profession at the time of the negligent act or omission.
Bolam test
Bolam v Friern Hospital Management Committee [1957] 1 WLR 582 is an English tort law case that lays down the typical rule for assessing the appropriate standard of reasonable care in negligence cases involving skilled professionals (e.g. doctors): the Bolam test. Where the defendant has represented him or herself as having more than average skills and abilities, this test expects standards which must be in accordance with a responsible body of opinion, even if others differ in opinion. In other words, the Bolam test states that “If a doctor reaches the standard of a responsible body of medical opinion, he is not negligent”.
Books of accounts
Your income tax return must include income earned from all sources. This includes income earned from your practice, any rental income, income from fixed deposits and savings accounts and income earned from sale of any shares or property, called capital gains. There are 2 ways to calculate income from your practice. Either consider it like a business activity and deduct actual expenses from actual receipts to calculate its profit and loss and pay tax on it. Or opt for presumptive taxation.
Once your income is calculated from all sources, you can claim reduce your taxable income by claiming deductions under section 80 and pay tax on the remaining income. Start your income tax return here
What is presumptive taxation?
When you opt for presumptive taxation. Your income is ‘presumed’. Actual profit is not calculated. You can assume your profits to be 50% of your receipts. However, only those who have annual receipts of Rs 50lakhs or less can opt for this scheme. If your annual receipts exceed Rs 50lakhs, you must report them and deduct actual business expenses to compute profit (or loss). This profit may be less or more than 50% of receipts. Those who opt for presumptive taxes do not have to compute or report actual profits. Presumptive taxation for doctors has been introduced effective FY 2016-17. This scheme is available to individuals and HUF, if you are incorporated as a company, your profits cannot be presumptive. Also, you must be Resident in India as per the income tax act.
What are the benefits of presumptive taxation?
If you opt for this scheme, you do not have to keep books of accounts and no audit is required. This will help you save Rs. 20,000 easily that you would have to pay as fees to an accountant and auditor. The intent of law is to encourage small taxpayers to file tax returns and make compliance easy for them. But it may be wise to continue to keep at least some record of the transactions of your business.
You are also not required to pay advance tax in instalments; paying your entire tax dues by 15th March of the financial year will suffice. Don’t worry if you fail to do so, pay as soon as you can. Penal interest is applicable on delayed tax payment @ 1% calculated monthly until you file your return.
Do I need to keep accounting records of my practice?
Just like a patient must diligently maintain medical records, accounting records of your practice are also useful and, in some cases, mandatory. The threshold for keeping accounting records is low for doctors. If your annual receipts are more than Rs 1.5lakhs in each of the past 3 years, you should keep some form of financial books. Some records have been prescribed such as –
Cash book – A record of day to day cash receipts and payments. A record that shows cash balance at the end of the day or at best at the end of each month.
Journal – A journal is a log of all day to day transactions accounting transactions.
Ledger – A ledger where all entries flow from the journal, it can be used to prepare the financial statements.
Copies of bills – Photocopies of bills or receipts issued by you which are more than Rs 25
Original bills of expenditure incurred by you which are more than Rs 50
Following are the additional requirements for doctors –
• Daily cash register with details of patients, services rendered, fees received and date of receipt
• Details of stock of drugs, medicines, and other consumables used.
Those who opt for presumptive scheme are exempt from record keeping, but some basic bill book, receipt book, bank statements must be kept for cross-validation.
How to calculate annual receipts?
The term gross receipts are not specifically defined in the income tax laws. However, all your receipts directly because of your profession, must be considered. You may have other receipts such as from authorships, taking lectures, contributing articles, which may not be included in computing your gross receipts. If you have a significantly large number of other receipts – you should seek an expert’s help to sort this. At Clear Tax, our experts can guide you and file your tax returns. Check out our expert assisted plan here
When should I get my accounts audited?
Audit is mandatory in two situations. When your receipts exceed Rs 50lakhs in a financial year. Or when your receipts are under Rs 50 lakhs but your profit is lower than 50% and your total income is more than Rs 2.5Lakhs (i.e. total income is taxable). Basically, when your total income is taxable and profits are less than 50% of gross receipts.
Do I pay lower taxes on digital receipts?
The answer is no. The lower rate of estimated profit of 6% (instead of 8%) for digital receipts is only available to presumptive businesses. So, your assumed profit will be 50% of your total receipts, irrespective of whether they are in cash or digital mode.
Can I submit profits higher than 50% of receipts?
Yes, that is completely possible. You can opt for the presumptive scheme and still declare profits higher than 50% of receipts. But if your receipts are under Rs 50 lakhs and your expenses are lower than 50% of receipts, you’ll end up saving significant tax by opting for this scheme.
My profits are less than 50% of receipts?
If you claim your profits are lower than 50% of receipts, but your total income is taxable, (it exceeds Rs 2.5L) in such a situation, you will have to maintain books of accounts and get them audited as well.
I earn income from a business, besides income from my practice, how do I report?
As a doctor, you may be running another commercial venture, say you are running a medicines shop, or you run a nursing home, where fee is charged for a room etc. In such a case, you may have to report income from these business activities as a business and presumptive rate of tax will not apply. Presumptive tax will only be available to your income earned directly due to your profession. You can report a part of your income (professional income) as presumptive and balance income from a business can be calculated by claiming actual expenses, like running of any other business. In such a case, book keeping and audit rules may apply to the business activity, whereas presumptive activity may be exempt from these.
For how many years do I need to opt for this scheme?
Unlike presumptive businesses, there is no restriction for presumptive taxation for professionals. They can claim it one year and then opt out and then in the following year opt in again.
Which tax return do I need to file?
For presumptive income ITR-4 is applicable. In this form income from one house property, salary income can also be reported. However, if you have any capital gains income or you own more than one house property, you cannot file this form. You will have to file ITR-3.
Start your income tax return here
How is my income tax computed under presumptive scheme?
Rajesh is a doctor and has his own practice in Mumbai. He also works as a consultant in many reputed hospitals. He earned an income of ₹40 lakh in FY2016-17, that is between 1 April 2016 and 31 March 2017. In the normal course of things, without the benefit of presumptive tax, Rajesh’s taxable income (the amount she would need to pay tax on) would be something like this.
Taxable income without using presumptive taxation scheme
Total gross income for the year from consultancy and own practice
₹45 lakh
Work-related expenses that he plans to claim as tax deductions
• Travel & Transport Expense
• Meeting & Conferences Expense
• Communication Expense
• Assistant Salary Expense
₹15 lakh
Total taxable income (gross income – expenses)
₹30 lakh
If there was no presumptive taxation scheme, Rajesh would pay income tax on ₹30 lakh. But by availing the benefit of presumptive taxation, she can show her taxable income to be half of her gross income–that is ₹22.5 lakh.
Taxable income after availing presumptive taxation scheme
Total gross income for the year from consultancy and own practice
₹45 lakh
Presumed taxable income after availing presumptive taxation scheme
₹22.5 lakh
The presumptive taxation scheme allows her to save tax on ₹7.5 lakh. Let’s calculate how much tax she would actually save.
Without presumptive taxation
With presumptive taxation
Taxable income – ₹30 lakh
Taxable income – ₹22.5 lakh
Tax calculation as per slabs for FY16-17
Tax calculation as per slabs for FY16-17
Income
Tax
Income
Tax
Up to ₹2.5 lakh
₹0
Up to ₹2.5 lakh
₹0
From ₹2.5 lakh to ₹5 lakh
₹25,000
From ₹2.5 lakh to ₹5 lakh
₹25,000
From ₹5 lakh to ₹10 lakh
₹1,00,000
From ₹5 lakh to ₹10 lakh
₹1,00,000
From ₹10 lakh to ₹30 lakh
₹6,00,000
From ₹10 lakh to ₹22.5 lakh
₹3,75,000
Total
₹7,25,000
Total
₹5,00,000
As is apparent, by using the presumptive taxation scheme, Rajesh will be able to save ₹2.25 lakh in taxes. That is, he will have to pay ₹2.25 lakh less as income tax. Do note that 3% cess would be added to the taxable income in both cases.
Budget for health sector-IMA reaction.
IMA welcomes certain provisions for health sector in the budget presented today but still lacks the necessary allocations to mitigate the problems faced by the community in regards to have an accessible, affordable, accountable and scientific health care.
Primary figures of allocation to health sector are not at all satisfactory- IMA had demanded minimum 3% of GDP for health.
Also, an integrated & consolidated approach involving sanitation, drugs, nutrition dept under health is not considered.
1-IMA congratulates GOI for accepting IMA demand of setting more govt medical colleges by upgrading district hospitals, especially in unserved areas.
This is a welcome change in policy direction against the policy envisaged in NMC bill of unbridled privatization of medical education.
Now IMA demands that 50% of seats in this govt medical colleges should be reserved for the students of that district with a rider to serve in the same district. This will help in availability of MBBS doctors in rural areas.
IMA will fully cooperate for smooth functioning of this govt medical colleges especially by providing faculty.
2- TB Program-
Budgetary support for TB patients is a welcome move. IMA has been partnering the govt & will continue to do so in END TB program.
3- Ayushman Bharat scheme-
Even though the move to open 1.5 lacks health and wellness centers is a good move, the meagre allocation of 1200 crores translates to only Rs 80000 per center!
Still IMA promises to support this move in a PPP model.
4- NATIONAL HEALTH PROTECTION SCHEME, covering up to 5 lakh per annum per family for secondary and tertiary hospitalization for 10 crore families. But fund allocation for the cause not mentioned.
Taking base of Maharashtra govt similar scheme, GOI will need more than Rs 10000 crores will be needed for payment of premium to provide insurance cover.
More ever this scheme should include all small & medium hospitals so that all beneficiaries are really benefited. The past experience is that such schemes only benefit private insurance companies.
Patient should have the choice of selecting the doctor and hospital for his treatment. 5- Tax reliefs on premiums of health insurance is a welcome move.
Can A Doctor Be Arrested by Police?
Whenever a doctor anticipates that a negligence case can be framed against him from the patient’s side, he gets panicked and indecisive. What should be the immediate steps to avoid police arrest? Can doctors be arrested in all medical negligence cases? What should a doctor know about his rights, if arrested by the police? This article will provide an insight to these questions.
As discussed in our previous article titled “A Quick Revision of Criminal Laws Relevant to Doctors”, doctors must know the provisions in IPC to save doctors from false allegation and legal suits filed by the patient and his family. This article deals with the probable police arrest and its consequences if at all a situation like that arises in any case.
When should the police be informed?
There can be two specific set of situations where a doctor MUST inform the police and where the informing police are ADVISABLE to avoid future complications. A doctor has to inform the police without fail in following circumstances, failing to which might lead to penal consequences for the physician.
Cases of suspected homicide
Cases of suicidal deaths
Unknown, unconscious patient
Death on operation table
Suspected unnatural death
Sudden, unexpected, violent and unexplained death
Instant death after treatment or reaction of medicine
Married lady dying within seven years of marriage due to any reason.
There are few situations where it is advisable to inform the police. Such as
Undiagnosed death within 24 hrs. of admission or especially if there is any suspicion
Any cases of poisoning
Accidental deaths
In cases of hospital deaths if (a) accidents that are not related to medical management like fall from staircase etc. (b) unexpected or rare complications may occur sometimes like a child may vomit, aspirate the content and may die.
In cases of death due to negligence in treatment, there are no specific provisions or legal obligation to inform the police but in order to avoid untoward incidences or allegation of patient’s family, it is better to inform the police.
Brought dead cases: In such cases, if the cause of death is clear and not related to some medico-legal complications then it is not necessary to inform the police. If the cause of death cannot be ascertained, it is desirable to send the body for autopsy examination preferably with the help of the police.
It is advisable to suggest post-mortem in the following circumstances:
Whenever death is sudden, unexpected or unexplained,
Accidental deaths which may be roadside, domestic or industrial,
When the precise cause of death is needed for insurance claim purposes etc.
As a help to arrive at a final diagnosis.
Information to police shall preferably be in writing and the written acknowledgement should be obtained. If the information is telephonic one must note down the name, buckle number and designation of the police.
Can a doctor be arrested?
Doctors have no immunity against arrest (as any other citizen of India) for the various criminal acts as per the provisions of IPC or CPC of India. But whether a doctor can be arrested for the following reason is still debated.
Alleged medical negligence during day to day care of a patient,
Unexplained hospital deaths like Sudden Infant Death Syndrome etc.,
Postoperative complication or failure of operation;
Not attending or refusing a patient (who was not already under his care) who becomes serious or dies and
Not attending a case of a roadside accident.
The Supreme Court directives (Criminal Writ Petition no. 270 of 1988) in a roadside accident include:
The medical aid should be instantaneous. It is the duty of the registered medical practitioner to attend the injured and render medical aid, treatment without waiting for procedural formalities unless the injured person or guardian (in a case of minor) desires otherwise.
The effort to save the person and preserve the life should be the top priority, not only for the doctor but also of the police officer or any other citizen who happens to notice such an accident.
The professional obligation of protecting life extends to every doctor, whether at Government hospital or otherwise.
The obligation being total, absolute and paramount, no statutory or procedural formalities can interfere in discharging this duty.
Whenever better or specific assistance is required, it is the duty of treating doctor to see that the patient reaches the proper expert as early as possible.
Non-compliance of these directives may invite prosecution under provisions of Motor Vehicle Act or IPC (7).
If a FIR is lodged from the side of the patient’s family, a doctor can readily be arrested for not complying with the above guidelines. Therefore, it is wise for the doctor to lodge a FIR from his side beforehand stating the incidence happened whenever he anticipates that a nuisance can be made by the patient’s side. Further, a crisis management committee may be formed that includes doctors, social workers, legal personalities, politicians, press reporters etc. in the district or taluka level. The committee members may meet the police officers and request them for a complete investigation of the incidence and to avoid prosecution till the guilt is proved. The committee can also request the press reporters not to give unnecessary publicity to such cases. Some state government has formed such bodies where the medical negligence case is heard and decided by a group of related experts from the field and administrators.
Legal Rights of an Arrested Person
If in any case a doctor is arrested, the following rights of an arrested person should be kept in mind:
The arrested person shall be communicated to the particulars of offence and the ground for arrest. If the offense is bailable, then the person should be informed and the arrangement for the bail may be made.
The person shall not be subjected to more restraint than necessary to prevent his escape. If there are any offensive weapons belonging to the arrested person, these weapons may be seized.
The arrested person must be produced before a magistrate having jurisdiction in that case. No police officer shall detain in custody an arrested person for more than 24 hours unless a special order from a magistrate is obtained.
Anticipatory Bail: In order to avoid frivolous accusations, there is a provision for anticipatory bail. This may be granted as a protection in offences which are non-bailable. It is a direction to release applicant on bail if there is an arrest. Once granted it remains in force. Pre-requisites for anticipatory bail are: (i) there must be a reasonable apprehension of arrest, (ii) the alleged offence must be non-bailable, and (iii) the registration of FIR is not necessary.
Procedure for Bail: The accused is required to execute his personal bond at the police station with or without surety. The surety may be a close relative, a friend or a neighbor, who is required to undertake to pay the said amount in case of absconding of the accused.
As a precaution doctors can keep the following points in mind to avert a possible police arrest:
Inform police whenever necessary and extend all possible co-operation to the police.
DO NOT PANIC.
Furnish copies of medical records to police, court or relatives whenever demanded. Consent of patient may be taken while providing information to police.
Do not do unlawful and unethical manipulation and tampering of the documents
Follow the legal procedures or provisions. Consult your lawyer before giving any reply.
Have a valid informed consent for the treatment and preserve the documents, records especially in medico-legal, controversial or complicated cases.
Insist for post-mortem examination if the cause of death cannot be ascertained.
Involve medical associations, medico-legal cells, and voluntary organizations whenever a legal problem arises.
Do not neglect the treatment while completing legal formalities especially in serious or emergency situation.
There is a significant disjunction between legal standards and doctors’ awareness of those standards, thereby creating a significant source of liability for doctors, especially in countries like India. Therefore, it is an urgent need to develop legal awareness programs for clinical practitioners based on doctors’ identified needs and preferences.
References:
Tiwari SK, Baldwa M. Medical Negligence. Indian Pediatr 2001; 38: 488-495.
Joshi MK. Doctor and Medical Law. 2nd edition, Ahmedabad, 1995, pp 4-6.
Lele RD. The medical profession and the law: An overview. In: The Medical Profession and the Law, 1st edition, Mumbai, Sajjan Sons, 1992; p 9.
All India Reporter. Supreme Court Section, Nagpur 1989, 76: 2039.
Jhabwala NH. Indian Penal Code, 13th edition, Mumbai, C. Jamnadas & Company 1997; pp 17-18.
Do you think, in most cases, patients and his family exploit the lack of medico-legal knowledge of a doctor to frame false medical negligence case against a doctor?
Can you practice medicine ethically in India?
Can you practice medicine ethically in India? This is a million-dollar question facing every Indian doctor. This is also relevant to thousands of medical students who will become doctors of tomorrow and hundreds of thousands of Indian doctors working abroad, who want to return home but are put off by the character of Indian medical practice.
The problem in Indian medical profession is unique. The vast majority of Indian doctors are working in the private sector or as freelancers. In such a set-up, you are constantly fighting with your colleagues for work in a “market”. Markets are good, but only if properly controlled, and with some oversight from the regulators. The problem of this market is that there are little controls and the regulators (Medical Council of India and State Medical Councils) have largely proved to be ineffective.
In a well-functioning market, patients (the consumers) will know clearly their doctors’ professional skills, qualifications, results, feedback from others, fees etc. They will be able to compare doctors and choose wisely. Regulators will be working effectively and keeping a close eye on the profession for various medical malpractices.
However, the market is not working well. Patients do not have any other information about their doctors. The only thing they pretty much know is how much their doctor is charging. Results are immaterial as patients have no means to verify them anyway and lies and exaggerations are commonplace. In a very fee/charge sensitive environment, General Practitioners (GPs) are hence constantly driving each other down on pricing to attract patients. It then reaches a level where, in a civilized society, it is impossible to live on an earned wage that forces them to look for income elsewhere. The easiest source of that income is commission from laboratories and specialists for referrals. Patients are not aware that this is happening as they seemingly have a choice in deciding which labs or specialists they go to. Whatever little do they know is, that every single lab/specialist (the vast majority) will send their doctor the commission. In that sense, it is immaterial where they go.
From the point of view of specialists or laboratories, no matter how good you are, you need your general practitioner colleagues in medical profession to confirm that to the patients, as patients have no validated tools to be able to verify authenticity of any facts. In this situation, you become the biggest surgeon in town if you give out the biggest cuts to the general practitioners. If you are not so good or a new surgeon in the area, you have to work even harder!
Like the rest of India, there is a lot of black money circulating in the system, as most of the payments to doctors and labs by patients are cash with very few authentic receipts.
So, how can we even begin to solve this? I have following suggestions to make. Needless to say, it needs help from all stakeholders, if we are to even to begin to see a change.
1. Medical Council of India and State Medical Councils should raise awareness about the cut practice and commissions and clearly explain to their members that it is both unethical and illegal to give and take commissions. Money should not play any consideration in whom they refer their patients to or who they advise their patients to go to? When money is involved, patients cannot be sure that their (doctors’) advice is not biased. They (Medical Councils) should even make examples of some doctors by cancelling their privileges to practice. It shouldn’t be too difficult to organize some sting operations!
2. Doctors should start charging their patients more if they can’t survive on their income rather than supplementing it through unfair means. Government and medical councils should educate the public that it costs to study medicine and become a doctor and that it costs to live. This service can’t be provided for free. For free or subsidized healthcare, we should reinforce our state medical sector. Needless to say, we need to work on increasing the reach of insurance sector as well.
3. Results of doctors and feedback from other patients etc. should be validated and made available to patients. In this context, we need mechanisms to ensure doctors engage in continuing medical education (CME) and have systems of auditing their practice.
4. Tax authorities should ask doctors/labs/hospitals to provide their patients with proper receipts. They should close in on the black money being generated by hospitals and labs, which is then dished out to general practitioners through “marketing” channels.
5. Media should keep a spotlight on these issues and monitor the situation periodically.
6. Medical colleges and academicians in these institutions should make these issues a top priority item in medical curriculum.
No doctor wants to work unethically. This is not why we join this noble profession. But doctors also have a life and a family. They also expect to work and live with dignity. It is up to the wider society to provide us with a mechanism, which is sustainable. Currently, we are stuck in a massive waterfall of declining standards, which is constantly dragging us down. Each individual is helpless in fighting this force. Together, we can change it. Are we all ready for it?
Clinical Establishment Act- How will it affect the practicing dentist
The Clinical Establishment Act 2010 became effective in Feb 2012 through an extraordinary gazette notification and is today applicable in 4 states with at least three more poised to adopt the same. There is no doubt that this is a landmark legislation which very few people in the dental profession noticed. One of the reasons is that, dentistry as an important clinical branch of health care has been grossly under represented. The DCI has represented the meeting of the national Council in two of its four meetings through its secretary. The minutes of the meetings are available on the website of the body (1). Scanning through the minutes it is surprising to see that while all the branches have strongly voiced their opinions, dentistry has not spoken out a single sentence (as per the recorded minutes). It must be said that the National Council has made an exhaustive list of the regulations required for starting and running of clinics. In fact, the requirement for a dental clinic is rather well formatted. It is divided into Dental Centre for a single dentist practice and a Dental Hospital for those with inpatient facility. The Dental Hospital requirements are a little difficult to fulfil- at least for the new practitioner starting in a metro city! Dr Anmol Kalha is the member from the Dental Profession and we hope that dentistry is well spoken for. The State Council will be the implementing authority through its district officers. The District registering committee will be nominated by the Collector and will have three members including a senior police officer and a representative from the profession. It is at this level that one can expect problems if any for the practicing dentist. The inspectors are nominated by the District authority.
Since most of the States have yet to adopt the Act, it may be some time before all dentists face the nuts and bolts of regulation. We sincerely hope that it will not be a source of harassment for an already struggling profession. On the other hand, regulating practice may eliminate quackery to a large extent. More importantly it will ensure safety for the public.
I thought I will touch upon a few of the requirements and comment on them so that eminent persons who will eventually represent us will be able to get an idea about how laws are likely to affect the common dental practitioner. I was recently told by someone that impossible guidelines like an OPG in every clinic etc. were suggested. On reading the clinical requirements, it is clear that these were exaggerations. It is titled as Standard No CEA/ Dental Hospital-38 and 39 for Dental Hospitals and Dental Centers respectively. This is unusual because the Code of Ethics Regulation prevents Dental Clinics from being called Hospitals. That may change because the new code of Ethics is almost ready as per information from the DCI.
In any case the new requirements will cover all dental clinics including single person run establishments and exceptions are only for the armed forces. The format available on the website (2) is comprehensive and covers all specialties. The norms for infection control, cleanliness and safety (including bio and radiation safety) are quite rational and practical. However there appears to be some need for pragmatism in the space requirements. It says that for Dental Hospitals 30% of carpet area should be reception and circulation. 30% of carpet area for one Chair is expected to be 6 sq. meters of carpet space (i.e. 18×18= 324 Sq. Ft). In addition, 30% carpet area should be for ancillary purposes including sterilization, toilet etc. This means that a clinic should have a minimum of 1000 Sq. Ft for one chair. For every extra chair there must be an additional 60% or 600 Sq. Ft. I will leave it to the reader to decide if this is practical in a city like Mumbai. It does not say where the patients will be admitted. On the other hand, Dental Centers need only 60 Sq. Ft for a chair and 35 Sq. feet for reception etc. The 60Sq ft will be a little tight if a patient needs to be shifted after a syncope. I do not understand why one needs 5 times more space around a chair in the hospital category! There are several other small glitches including a number of inspections for bio safety, lift safety, drug expiry etc. While I think it is necessary, I am not sure how many dentists will be comfortable with buying Oxygen and other gases and all monitoring systems and equipment. Another difficult task will be the employment of ‘qualified’ assistance (diploma recognized by state dental council) and providing minimum wages according to the labor laws. Some requirements like waste disposal etc. are definitely important. Some others may need tinkering. Some other requirements may worry dentists and doctors. One is expected to put a price list for procedures for patients to see and the rates are decided by the competent authority, not the dentist. I am not sure if this will work for health care.
My biggest issue with the construct of the legislation is the absence of the IDA inputs, whereas the IMA, Ayurveda, Unnani, Yoga and Homeopathy associations (not just councils) are very well represented. How in the world are they going to implement ground level regulation without technical inputs from the dental profession- particularly practicing dentists!
CLINICAL ESTABLISHMENT ACT, IMA & MINIMAL STANDARDS
clinical establishment act- basics
why the government wants it.
The government wants insurance in health sector. The insurance sector is hesitant to enter in an unregulated heath sector. Hence the act
Why the government is making a mistake.
Insurance was introduced in American health care because American health care is inaccessible and very expensive. Indian health care is accessible and cheap. Insurance will make it more expensive, with more paper work for overburdened doctors.
Danielle Ofri on what plagues American medical system, one of the costliest in the world writes that insurance and consumer affair concerns makes American doctors do too much of paper work which is more than the time spent in treating patients. This is what we are trying to imitate. IMA proposes that section of the act which entails reporting data of the patient be withdrawn completely. Other than notifiable communicable diseases, no data will be provided to the government as it will hamper direct patient care, considering our large population.
why the doctors don’t want it.
The government does not provide any support monitory or otherwise to private sector which is catering to 70 % of the population. The conduct of private sector which works on the demands of the market forces which has proved to be the best regulator, has been exemplary. Just ask a passerby whether he will go to paid private service or free government services. He will definitely like to go to private sector.
The market has seen the ill effects of inspector raj. Why the government wants to impose inspector raj when it is talking of deregulation and delicensing in other fields. It will only hamper an efficiently working sector.
Private doctors have their constitutional rights about when and how they want to work and to choose type of work they are comfortable with. To ask any clinician for example a yoga teacher (who seems to be covered in the act as a clinical establishment) to stabilize a heart attack under threat of persecution is asking for trouble. Going by the same analogy will the government ask all the restaurant owners to feed a hungry incomer without any compensation. The whole idea is absurd. Ethically every doctor does his best to help the patient in distress. Wasting time in stabilization can result in accusations from angry and impatient relatives with threats of violence; and in this era of consumer courts, asking for disaster.
There is huge shortage in trained manpower particularly nurses. To ask all hospitals to have trained nurses in small clinics and nursing homes may not be possible.
Minimal standards list is like a list for essay for a competitive exam not taking into consideration that will ultimately will increase in the costs to the patient per se. With a poor Indian population American standard are being enforced. Brings to mind the COBRA, EMTALA AND 250 Yards rule of American health care. All very laudable but is American health care so good. It is prohibitively expensive and inaccessible; appointment can take months to materialize. So dear government, make your own laws, don’t ape America.
The act lays down monitory penalties for noncompliance which are more than the penalties for INDIAN PENAL CODE. Are doctors doing any illegal activities to be harassed like that.
Clinical Establishment Act . . . The long story
The Vedas have long ago stated the fact that in kaliyug the do gooders would be hounded out and the corrupt would flourish. The clinical establishment act seems to fulfils this prophesy not in parts but in full measures
Starting with COBRA and EMTALA in American health care legislation, the Indian government has also initiated its own version of COBRA AND EMTALA. The CLINICAL ESTABLISHMENT ACT. The point is -India is not America.
What would be the disadvantage of the act?
There are stringent and huge monitory penalties for non-registration by any medical professional which are more than many criminal penalties of IPC.
What would the CEA lead to in most of the regions of the country –
1. Healthcare which is already expensive would become more expensive.
2. Healthcare would become inaccessible to most of the Indian poor unless they live in a state which has good public healthcare.
3. Specialists would become more in demand. Their salaries would rocket sky-high
4. Most of the small nursing homes and hospitals especially mission hospitals would have to be closed down.
5. Healthcare would become an industry rather than a service
This Act is a step towards corporatization of healthcare. All small units of healthcare like clinics will not be able to survive if this Act is introduced. It has been made keeping the foreign countries in mind and this is the biggest flaw in it. According to the Act, each clinic should have one nurse and pharmacist each despite the fact that the WHO, in a 2010 report, has revealed that India is grappling with shortage of medical staff.”
“At least 70% of the total health services in the country are provided by clinics and they should not be restricted through the guidelines of this Act. Also, medical facilities in rural areas are already in a bad shape and with the requirements being asked at a medical establishment, it is next to impossible to run a clinic in rural areas. Not only will this be a problem for doctors as it needs high investment but also for the patients who will have to bear high cost.”
It’s worthwhile looking at a statement made by the IMA back in 2010 in this regard:
“The sincerity of the govt. may be appreciated, if it initiate[s] and strives to eradicate the quacks and quackery from our country which has been crippling our society’s health in the guise of providing first-aid care….[putting] corporate hospitals and rural area hospital in same line to accredit-ate is unjustifiable as it favors corporatization of health care and jeopardizing the health services within reach of common man”
Unresolved issues in the Act
While in many ways a regulatory framework is essential, there are still unresolved problems with the Act. Some of them are listed here.
Section 12(2)
It states thus: “The clinical establishment shall undertake to provide; such medical examination and treatment as may be required to stabilize the emergency medical condition of any individual who comes or is brought to such clinical establishment.”
What this boils down to is that all clinical establishments are expected to stabilize a patient in an emergency medical condition before transferred to another hospital.” But one doesn’t have to stretch the imagination to see that its interpretations can vary.
The original Supreme Court directive on this regard was meant for providing life-saving first aid for victims of accidents. It’s quite unrealistic-and potentially unfair to the doctors to extend this to any and all emergency situations.
Lack of provision for extra machinery for additional workload of regulating private clinics
In this backdrop, it’s hard to see how a fair implementation of the Act is possible-affecting not just the doctors but also the patients. For instance, the Act has called for the establishment of the National Council-which is supposed to have a special secretary: the director-general (DG) of health services, Ministry of Health and Family Welfare as an ex-officio member and chairperson.
This implies that important decisions could be delayed if the DG cannot squeeze out more time for this additional task. There are to be no additional appointments at the state level to manage this work. And at the district level, the situation could be potentially worse. For in the districts the chairperson and the secretary of the registering authority are to be the district collector and the district health officer respectively. Needless to say, this increases their workload by a long stretch, causing further delays in getting things done.
Those who wish to appeal against the order of the district health authority must approach the state council
Even if a marginal number of establishments from a state wish to go for an appeal, this would amount to a substantial volume of appeals from within distinct district registering authorities. But the doctors must approach the state capital for matters related to the disputes. That’s on ordeal that could be avoided with a simplified provision.
These are but a few of the issues that one finds in the Act, giving the doctors substantial basis for opposing it.
Such issues point to the necessity for a more involved discussion between the government and the medical fraternity. The key issue here is the provision of adequate healthcare to a huge number of people. And it’s the state’s job to ensure that care-givers, regardless of the size of their institutions are able to provide that in the best possible manner, facing minimal hassles.
I personally have much misgiving to the regulations of the Act in the present form.
1. In a country like India which is very vast and the majority of the population (about 70%) lives in villages, it is going to be very difficult for anybody to set up hospitals in semi-urban and rural areas. The stipulations are going to be very hard to meet that setting up a hospital would hardly be a profitable venture. The other side is that even if hospitals are set up, the cost of care would be quite expensive. Almost all of us have mostly depended on small clinics or nursing homes which are run by a single doctor with the help of a nurse or by a doctor family. In fact, quite a lot of us may have knowingly or unknowingly gone to an unqualified practitioner or quack for our small medical problems. At present I live in a place where almost 95% of the population go to a quack first for treatment. They have bungled up cases where the patient ultimately died. However, nobody has been able to do anything. The only reason being that these guys are the only people who have some knowledge about medicine in remote settings. And they come very cheap. The regulations appear to be giving more importance for corporate multi-specialty hospitals. This is quite protectionist in nature towards encouraging a corporate model which will ensure that healthcare is only available at a premium in the absence of an efficient public health care system.
2. There is enough scientific evidence that family practice and nurse practitioner based primary care is as efficient, and rather more people friendly than specialist doctors in full-fledged hospital set ups.
3. If you consider any of the complex clinical conditions one can think of, the primary level of care is much more important than high tech healthcare. We have examples of countries like Brazil and South Africa, where Family Medicine graduates have major role in healthcare. The present regulations would only increase costs. If you look at the regulations, the first level of treatment is going to be a Level 1 Hospital which needs to have a staffing of at least 6 for a place which do not have inpatient care.
4. Most of our tertiary care centers are burdened with primary care. It is not uncommon for any faculty in our medical colleges who end up complaining that most of the patients that they see could have been easily managed at a Primary Health Centre or even by a Nurse practitioner. The ultimate result is that quite a many of our specialists are over-worked to the extent that they are not able to do justice to the specialized skills they’ve obtained.
If we can think of changes that can be proposed, I would propose the following –
1. Legalizing Nurse-Practioners Care: Nurses should be trained to treat simple illnesses allowed to prescribe medicines. A major need would be to allow a category of health centers which are entirely run by nurses who may or may not supervised by doctors. At least for populations who have poor access to healthcare, they would be a major boon. In fact, such nurse-led primary care centers have already been in existence in the country, mainly facilitated by various congregations of the Catholic Church.
2. Provision for single doctor healthcare centers: We are all very familiar with such single doctor establishments. A 100 square feet room with a familiar friendly face to whom you ran when you had a toothache or a cold. You pay about 50 rupees and then you pay some more for the medicines and some basic investigations. The whole process took not more than half an hour. If the regulations in its present form are accepted and finalized, the family doctor would be history.
Section 55 of the act enlists the ‘Rights of patients’ as follows:
(1) The patients and / or Person authorized by patient shall receive the relevant information about the nature, cause of illness, proposed care, and the expected results of treatment, possible complications and the expected costs.
(2) Confidentiality of treatment and privacy during examination. Examination of female patient should be carried out in presence of female attendant.
(3) Person suffering from HIV/AIDS shall not be denied care.
(4) Complaint register should be made available in Clinical establishment.
(5) List of Specialists along with Qualifications Should be displayed at prominent place in Clinical establishment.
(6) Patient has the right to seek second opinion. All medical and diagnostic reports shall be made available to the patient or authorized person to facilitate second opinion.
(7) Patient and / or Person authorized by patient or guardian if patient is minor has a right to have an access to his / her clinical records during admission to Clinical establishment and Photocopy of indoor papers should be made available on demand after discharge.
(8) Discharge card should be issued to patient mentioning: Diagnosis, clinical findings, results of investigations, treatment given, the patient’s condition at the time of discharge and advice to patient.
(9) Patient has right to choose registered pharmacy or recognized diagnostic center at his / her own responsibility.
(10) Protection ensured by statutory guidelines and legally enabled provisions applicable to Clinical Establishments which are conducting clinical research.
(11) Informed consent prior to potentially hazardous tests / treatment.
Thus, if the intents of the Act are preserved, it is likely to benefit both-the patients and the health care service providers alike.
Cl. 5 empowers the government to develop ‘proper’ as well as minimum standards for healthcare. The latter alone is to be applied in reviewing the state of any facility. In a country with limited information about the nature and quality of healthcare, no national program for development of practice guidelines or medical review criteria (World Bank Report, 2003) in addition to vast regional and social disparities, creating such standards will be quite a difficult task. The RWG acknowledges this (para 37) and being a long-drawn process, recommends delinking it from registration (para 40(x)), a view incorporated in the draft bill.
Cl. 10 designates the District Health Officer (DHO) or Chief Medical Officer (CMO) as the district registering authority for registration of clinical establishments in each district. The DHO/CMO also shoulders responsibilities for the management of government facilities in that district. This leads to a conflict of interest.
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. How will better regulatory standards impact this? Cl. 42-44 allow the government to levy fines for failing to conform and a proviso to cl. 32(3(b)) allows for the institution to be restrained from ‘carrying on’ if there is imminent danger to the health and safety of patients. As mentioned before (vide supra), with the DHO/CMO holding overall responsibility for government facilities in the district, the ensuing conflict of interest makes it quite unlikely that he/she would be willing to take strong action against erring individuals or facilities. Apart from this, the coercive impact is blunted as any fine levied is merely one arm of the government paying another. There may be more severe consequences if a facility is actually forced to shut down for non-compliance. That is however likely to be a rare event; if it is serious enough to scandalize the government or even otherwise jolt it into action, the finger will once again point to the very DHO/CMO who ordered it. Thus, even if better accountability standards are developed and adopted, these constraints are likely to hamper their effective implementation.
The Indian Medical Association (IMA) which has consistently resisted state regulation, not surprisingly, came out against this particular effort also. As it alleges, this is, in a sense, a return to the license-permit raj with registration and inspection becoming potential focal points of corruption.
The Act applies to all “clinical establishments” defined under Section 2 (c). The definition is an unnaturally wide one, and includes hospitals, maternity homes, nursing homes, dispensaries, clinics, sanatoriums and institutions that offers services or facilities requiring diagnosis, treatment or care for illness, injury, deformity, abnormality or pregnancy, in any recognized system of medicine. “Recognized system of medicine” under the Act covers Allopathy, Yoga, Naturopathy, Ayurveda, Homeopathy, Siddha, and Unani systems of medicine, as well as any other system of medicine that may be recognized by the Central government. Every conceivable range of treatment is sought to be included within the parameters of the Act. Under Section 11 of the Act, no person can run a clinical establishment unless it has been duly registered in accordance with the provisions of the Act. A severe monetary penalty is provided under the Act for carrying on an establishment without registration.
This in itself would not be overly onerous, if it was not for the extremely unreasonable standards that the Act mandates every clinical establishment, in every recognized system of medicine, to have. Section 2 (d) of the Act incorporates a very vast definition of ‘emergency medical condition’ (which includes symptoms of sufficient severity, including severe pain, that may cause serious bodily impairment or dysfunction), and imposes on every clinical establishment, the duty to provide facilities ‘to stabilize’ an ‘emergency medical condition’ and to provide such medical treatment necessary to assure within reasonable medical probability, that no material deterioration results during the transfer of the individual from a clinical establishment. What this effectively means is that if a person has a heart attack and is taken to a Yoga center, the Yoga center must provide for the minimum medical treatment necessary to ‘stabilize’ him, in terms of the definition above. Quite clearly, this seems like an unworkable and even an unconstitutional onus to impose.
The above features of the Act curtail the right of medical practitioners to carry on their occupation, under Article 19 (1)(g) of the Constitution of India, 1950. The Act forces clinical establishments to provide services that they may not wish to provide at all. Implicit in the right to carry on an occupation under Article 19 (1)(g) is the right not to carry on a particular occupation. While this obligation is imposed, the Act is completely silent on how these clinical establishments will be remunerated for the services to be provided under the Act. This obligation of the State to improve public health is being transferred to the private establishments, in the guise of regulation.
The Act also seems to suffer from the vice of excessive delegation of non-delegable functions. Section 3 of the Act establishes a ‘National Council’ with the powers of classifying all clinical establishments and developing minimum applicable standards. Under Section 12 of the Act, every clinical establishment must have these prescribed conditions of minimum standards and requirements necessary for registration and continuation. Therefore, the Act purports “to prescribe minimum standards of facilities and services” and to “determine the standards for clinical establishments”. No such prescription of any standards for facilities and services, are however discernible from the text of the Act. Instead, the Act delegates this essential legislative function to the Central Government and the National Council, empowering them to prescribe the necessary standards. To impose a stringent regulatory regime, without prescribing the parameters of the regime and any guideline based on which the delegate can formulate minimum standards, seems to me an abdication of the constitutional duty to lay down the law and an unconstitutional delegation of non-delegable powers to the Executive.
Not unsurprisingly, a lot of medical associations and doctors who have become aware of this legislation, are strongly opposing it. The Act, applicable to the Union Territory of Chandigarh, was recently challenged in the Punjab and Haryana High Court, but the challenge was withdrawn as premature because the Act was yet to come into force through a notification. Nevertheless, what is being argued is that, the conditions that are sought to be imposed under the Act, can only be provided by large scale, multi-specialty hospitals, and therefore in the guise of providing a regulatory framework, the Act will virtually eliminate small and medium-scale clinical establishments, creating a monopoly in favor of large hospitals.
The Act therefore may have the completely opposite effect of the object it seeks to achieve. Instead of improving the standards of public health, it may lead to depriving several millions of people of adequate healthcare facilities, which are provided by individual doctors or small clinical establishments. While the regulation of clinical establishments is important, the Act as it stands today, is discriminatory and vague, and in my opinion, will not meet the strong constitutional objections that will be raised against it in the future.
The bill unleashes license raj with powers of penalties up to 5 lacs. The registering authority can impose fines for noncompliance and if a CE fails to pay the same, it would be recovered as an arrears of land revenue.
The penalties are stringent and for first offence the penalties are more than that in IPC. For first offence it is 1000 INR, then for second offence it is 50000 and for third offence it is 5 lacs. Disobeying any direction or obstruction to inspection entails Rs 5 lac penalty.
The bill unleashes license Raj with draconian powers to the inspectors with little provision for appeal.
Are doctors doing some illegal work to be harassed like this
IMA proposes that the act should not be implemented at all. If at all government is adamant and hell bent it should be such the single doctors’ clinics to be considered for minimal registration only without applying strict rules. The provision should be prospective in implementation and old clinics and hospitals should be excluded.
IMA wants that only those establishment with indoor facilities should be included in the act. Also, till date existing establishments should be exempted from the provisions of the act.
IMA Proposes that the requirements of pharmacist and clinical psychologists in various places should be done away. Pharmacists are not needed as most drugs are formulated and psychologists are mostly non-medical persons masquerading as doctors.
IMA proposes that the ethics and rules are different and should not be intermixed. Stabilizing a patient is ethical and making a rule is like asking an inappropriate person to treat the disease and waste time in referral.
Danielle Ofri on what plagues American medical system, one of the costliest in the world writes that insurance and consumer affair concerns makes American doctors do too much of paper work which is more than the time spent in treating patients. This is what we are trying to imitate. MA proposes that section of the act which entails reporting data of the patient be withdrawn completely. Other than notifiable communicable diseases, no data will be provided to the government as it will hamper direct patient care, considering our large population.
Minimal standards of clinical establishment
IMA proposals are …
The bill unleashes license raj with powers of penalties up to 5 lacs. The registering authority can impose fines for noncompliance and if a CE fails to pay the same, it would be recovered as an arrears of land revenue.
The penalties are stringent and for first offence the penalties are more than that in IPC. For first offence it is 1000 INR, then for second offence it is 50000 and for third offence it is 5 lacs. Disobeying any direction or obstruction to inspection entails Rs 5 lac penalty.
The bill unleashes license Raj with draconian powers to the inspectors with little provision for appeal.
Are doctors doing some illegal work to be harassed like this
IMA proposes that the act should not be implemented at all. If at all government is adamant and hell bent it should be such the single doctors’ clinics to be considered for minimal registration only without applying strict rules. The provision should be prospective in implementation and old clinics and hospitals should be excluded.
IMA wants that only those establishment with indoor facilities should be included in the act. Also, till date existing establishments should be exempted from the provisions of the act.
IMA Proposes that the requirements of pharmacist and clinical psychologists in various places should be done away. Pharmacists are not needed as most drugs are formulated and psychologists are mostly non-medical persons masquerading as doctors.
IMA proposes that the ethics and rules are different and should not be intermixed. Stabilizing a patient is ethical and making a rule is like asking an inappropriate person to treat the disease and waste time in referral. If he dies in time wasted in stabilization in wrong hands who is responsible
Danielle Ofri on what plagues American medical system, one of the costliest in the world writes that insurance and consumer affair concerns makes American doctors do too much of paper work which is more than the time spent in treating patients. This is what we are trying to imitate. MA proposes that section of the act which entails reporting data of the patient be withdrawn completely. Other than notifiable communicable diseases, no data will be provided to the government as it will hamper direct patient care, considering our large population.
Minimal standard of psychiatry clinic.
There are psychiatrists who are using ECT, there are that don’t. A mandatory requirement of ECT Machine with EEG monitoring with boles apparatus is suggested.
An annual maintenance record to equipment is mandatory.
Blood storage unit is mentioned
IMA proposes these be scrapped.
Minimal standards for deaddiction center.
Requirement of MBBS DOCTOR
one nurse head, general nurses and two nurses for ICU/OT/HDU
ONE LAB technician
ECG technician
dietician
physiotherapist
psychologists
medico social worker
driver
ambulance
data entry operators
policy manpower
annual maintenance contracts
laboratory
imaging
pharmacy
sterilization
laundry
kitchen
medical gas
blood bank
ambulance service
IMA PROPOSES THAT All THE ABOVE Be SCRAPPED
PSYCHIATRY SERVICES IN HOSPITAL
MBBS DOCTORS FOR DAY AND ANOTHER FOR NIGHT
NURSING HEAD, NURSES AND TRAINED NURSES FOR ICU, OT AND HDU
PHARMACIST
LAB TECHNICIANS
X RAY TECHNICIAN
ECG TECHNICIAN
DIETICIAN
PHYSIOTHERAPIST
PSYCHOLOGISTS
MEDICO SOCIAL WORKER
MRD OFFICE STAFF
AMBULANCE
DRIVER
DATA ENTRY OPERATOR
HOUSE KEEPING
RAPID RESPONSE TEAM
BLOOD STORAGE UNIT
BOYLES APPARATUS
LABORATORY
IMAGING
KITCHEN
LAUNDRY
MEDICAL GAS
IMA FEELS ALL THESE ARE UNNECESSARY AND BE SCRAPPED. FOR EXAMPLE, ALL PSYCHIATRIC WORKERS USES already sterilized STERIWARE SYRINGES.WHAT IS THE NEED FOR STERILISATION equipment
CLINICAL ESTABLISHMENTS ACT RULES
The Clinical Establishments (Registration and Regulation) Rules, 2010 Draft Rules for the Central Government These rules may be called The Clinical Establishments (Registration and Regulation) Rules (Central Government), 2010 These rules extend to the whole of the States of Arunachal Pradesh, Himachal Pradesh, Mizoram, Sikkim and in any other State which adopts this Act under clause (1) of Article 252 of the Constitution and the Union Territories of Chandigarh, NCT of Delhi, Dadra & Nagar Haveli, Puducherry, Andaman and Nicobar Islands, Daman and Diu and Lakshadweep It shall come into force from the date of notification of these Rules in the Official Gazette. The Rules shall be applicable to various categories of clinical establishments in a phased manner, as may be notified from time to time. Definitions In these rules, unless the context otherwise requires: a) ‘Act means the Clinical Establishments (Registration and Regulation) Act 2010 b) ‘Rules’ means the Clinical Establishments (Registration and Regulation) Rules, 2010 c) ‘Authority1 means the district registering authority set up under Section 10 of the Act. d) ‘Certificate’ means certificate of registration issued under section 30; e) ‘Clinical Establishment’ means (i) a hospital, maternity home, nursing home, dispensary, clinic, sanatorium or an institution by whatever name called that offers services, facilities requiring diagnosis, treatment or care for illness, injury, deformity, abnormality or pregnancy in any recognized system of medicine established and administered or maintained by any person or body of persons, whether incorporated or not; or (ii) a place established as an independent entity or part of an establishment referred to in sub-clause (i), in connection with the diagnosis or treatment of diseases where pathological, bacteriological, genetic, radiological, chemical, biological investigations or other diagnostic or investigative services with the aid of laboratory or other medical equipment, are usually carried on, established and administered or maintained by any person or body of persons, whether incorporated or not, and shall include a clinical establishment owned, controlled or managed by (a) the Government or a department of the Government; (b) a trust, whether public or private; (c) a corporation (including a society) registered under a Central, Provincial or State Act, whether or not owned by the Government; (d) a local authority; and (e) a single doctor, but does not include the clinical establishments owned, controlled or managed by the Armed Forces constituted under the Army Act 1950, the Air Force Act 1950 and the Navy Act 1957. f) ‘Emergency Medical Condition’ means a medical condition manifesting itself by acute symptoms of sufficient severity (including severe pain) of such a nature that the absence of immediate medical attention could reasonably be expected to result in: (i) placing the health of the individual or with respect to a pregnant women, the health of the woman or her unborn child, in serious jeopardy; (ii) serious impairment to bodily functions; or (iii) serious dysfunction of any organ or part of a body
g) ‘National Council’ means the National Council for clinical establishments established under section 3 of the Act h) ‘Prescribed’ means prescribed by rules made under this Act by the Central Government or, as the case may be, the State Government; i) ‘Recognized System of Medicine’ means Allopathy, Yoga, Naturopathy, Ayurveda, Homoeopathy, Siddha and Unani System of medicines or any other system of medicine as may be recognized by the Central Government; j) ‘Register” means the register maintained by the authority, State Government and the Central Government under sections 37, 38 and 39 respectively of this Act containing the number of clinical establishments registered; k) ‘Registration’ means to register under section 11 and the expression registration or registered shall be construed accordingly; I) ‘Schedule’ means the Schedule appended to this Act; m) ‘Standards’ means the conditions that the Central Government may prescribe under section 12, for the registration of clinical establishments from time to time; n) ‘State Government, in relation to a Union Territory’, means the Administrator thereof appointed under article 239 of the Constitution; and o) To stabilize’ (with its grammatical variations and cognate expressions) means, with respect to an emergency medical condition specified in clause (f), to provide such medical treatment of the condition as may be necessary to assure, within reasonable medical probability, that no material deterioration of the condition is likely to result from or occur during the transfer of the individual from a clinical establishment. The words and expressions used herein and not defined but defined in the Act shall have the same meanings respectively assigned to them in the Act. The National Council for Clinical Establishments Establishment of the National Council for Clinical Establishments the Central Government by way of a Notification shall constitute a National Council for Clinical Establishments. The establishment of the National Council shall be as defined in Section 3 of the Act Appointment of Secretary of the National Council by the Central Government The Central Government shall appoint an officer of the rank of Joint Secretary dealing with the subject of Clinical Establishments in the Ministry of Health & Family Welfare as the Secretary, National Council under Section 3 (10) of the Act. The term of office of Secretary of the National Council shall be for a period of 3 years. The Secretary of the council will be responsible for the control & management of the secretariat of the council and supervision of the other employees of the Council and perform such other duties as may be required of him/her by the Council for the purposes of the Act. He shall attend the meetings of the Council. The Central Government will provide the National Council with such other secretarial and other staff as deemed necessary by it under Section 3 (10) of the Act. The powers and duties of the other employees shall be such as may be laid down from time to time in the standing orders as may be framed for the purposes by the National Council. Functions of the National Council for Clinical Establishments the National Council shall: x
(a) Compile and publish a National Register of clinical establishments within two years from the date of the commencement of this Act; (b) Classify the clinical establishments into different categories; (c) Develop the minimum standards and their periodic review; (d) Determine within a period of two years from its establishment, the first set of standards for ensuring proper healthcare by the clinical establishments; (e) Collect the statistics in respect of clinical establishments (f) Perform any other function determined by the Central Government from time to time. Sub – Committees of the National Council The National Council shall at any time constitute sub-committees for such periods, not exceeding two years, for the consideration of particular matters related to : O Categorization of clinical establishments; O Development of minimum standards and personnel for various categories of clinical establishments and their periodic review; O Compilation and publication of a National Register of clinical establishments; O Collection of statistics from clinical establishments and O Any other function determined by the Central Government from time to time. A motion for the appointment of each sub-committee shall define the functions of each subcommittee, number and nature of members to be appointed thereon and timeline for completion of tasks. At the time of formation of each sub-committee, it should be ensured that there is adequate representation from across the country in each committee from experts in the relevant fields across the private sector, public sector and/its organizations, non-governmental sector, professional bodies, academia and research institutions amongst others. The Chairperson of every such sub-committee shall be appointed by the National Council at the time of the appointment of the sub-committee. The proceedings of the meetings of the sub-committees shall be preserved in the form of minutes which shall be authenticated after confirmation by the chairperson of the subcommittees. Any decisions taken by the sub-committee/s shall be placed before the National Council at its next meeting for its consideration and approval. The National Council of Clinical Establishments shall request the State / Union Territory Councils to provide inputs for the consideration of particular matters. If required, the State / Union Territory Council shall at the request of the National Council and / or as determined by the Central Government constitute sub-committee/s consisting of members of the state and UT council and field experts for such period not exceeding one year, for the particular matter. Determination of standards of personnel, facilities and services (including standards for permanent registration); classification of clinical establishments by the National Council The minimum standards of facilities and services and personnel for different categories of Clinical Establishments for permanent registration shall be submitted by the National Council to the Central Government to be notified from time to time under Section 5 (c) (d) read with Section 7, Section 12 (1) (i) (ii) and Section 13 (1) (2), Section 28 of the Act. The Clinical Establishments of different systems of medicines under Section 13 (1) have been classified into the categories as prescribed in CG1 Annexe and the Central Government will have the power to add, delete or modify such categories, as it deems appropriate from time to time, based on the recommendations of the National Council established under this Act. The National Council shall constitute sub-committees having adequate representation from across the country including experts in the relevant fields across the private sector, public sector and/its organizations, non-governmental sector, professional bodies, academia and research institutions amongst others for such period, not exceeding two years, for determination of minimum standards and personnel for different categories of Clinical Establishments under Section 5 (c) (d) read with Section 7, Section 12 (1) (i) (ii) and Section 13 (2) of the Act, in particular, the National Council shall have regard to local conditions while prescribing the standards of personnel, facilities and services for different categories of clinical establishments.
Once the standards are developed, the National Council shall prepare the application form for permanent registration, including format for submission of evidence that different categories of clinical establishments have met the requirements of minimum standards and personnel. The form and format developed shall come into effect after notification by the Central Government. Conduct of business of meetings of the National Council Every meeting of the National Council shall be presided over by the Chairperson Time and Place of and Preparation of Business for Meetings of the National Council The meetings of the National council shall ordinarily be held at Delhi or at such other place in India and on such dates as may be fixed by the Council, The National Council shall meet every month till such time as standards are developed. Thereafter, the Council shall at the minimum meet every three months. Notice of Meeting Notice of every meeting other than a special meeting called shall be issued to each member of the Council not less than 15 days before the date of the meeting. Quorum, Call for Meeting, Minutes One – third of the total number of members of the National Council shall form a quorum and all actions of the Council shall be decided by a majority of the members present and voting. The notice and agenda of every such meeting of the National Council shall ordinarily be given 15 days before the meeting by the Secretary of the National Council. A copy the minutes of each meeting of the National Council shall be submitted to the Chairperson within 7 days of the meeting and after having been approved by him/her shall be sent to each member of the Council within 15 days of the meeting. If no objection to their correctness is received within 10 days of their dispatch, any decisions therein shall be given effect to, provided that the Chairperson may, where in his opinion it is necessary or expedient so to do, direct that action be taken on the decision taken in the meeting. The proceedings of the meetings of the Council shall be preserved in the form of minutes which shall be authenticated after confirmation by the signature of the Chairperson. Allowances for members of the National Council The central government officials who are members of the National Council for Clinical Establishments under sub-section 3 (5) of the Act shall not be paid any allowances. The travel and daily allowance for state government officials shall be paid by the respective States / UTs. The non-official members of the Council shall be paid travel and daily allowance in accordance with the rules of the Central Government for Class I officials as applicable from time to time. Resignation and filling of casual vacancies A member desiring to resign his seat on the National Council shall send his resignation in writing to the Chairperson and every such resignation shall take effect from the date mentioned by him in this behalf or in case no such date is mentioned, from the date of the receipt of his letter by the Chairperson after confirmation from the member concerned about his resignation. When a casual vacancy occurs by reason of death, resignation or otherwise of a member, a report shall be made forthwith by the Chairperson to the Central Government which shall take steps to have the vacancy filled by nomination or election, as the case may be. Disqualification for Appointment of Member A person shall be disqualified for being appointed as a member of the National Council if she/he a) has been convicted and sentenced to imprisonment for an offence which, in the opinion of the Central Government, involves moral turpitude: or b) is an undischarged insolvent; or c) is of unsound mind and stands so declared by a competent court; or
d) has been removed or dismissed from the service of the Government or a Corporation owned or controlled by the Government; or e) has, in the opinion of the Central Government, such financial or other interest in the Council as is likely to affect prejudicially the discharge by him of his functions as a member. Register of Clinical Establishments Every State Government shall maintain a State Register of Clinical Establishments in digital format containing the particulars as prescribed in CG3 Annexe under Section 38 of the Act District Registering Authority Qualification and the terms and conditions for the members of the authority The Central Government prescribes that 3 members of the District Registering Authority under Section 10 sub-section (1) clause (c) shall be nominated by the District Collector /District Magistrate and they shall include one representative from the City Police Commissioner (or his/her nominee) or SP or SSP, (as the case may be); one representative from a reputed Non-Governmental Organization working in the district / State in the area o health and related issues for a minimum period of 3 years and one representative from i professional medical association or body, having jurisdiction in the district or at the state level (as the case may be) The term of office for the representative from the NGO and the professional medica association or body shall be for a period of 3 years. If a casual-vacancy occurs in the office of any other members, whether by reason of death, resignation or inability to discharge, functions owing to illness or any other incapacity, such vacancy shall be filled by the District Collector/District Magistrate by making a fresh appointment and the member so appointed shall hold office for the remaining term of office of the person in whose place s/ he is so appointed. The State Government shall include the members in the District Registration Authority for each District as prescribed by the Central government in clause 52 (d) under section 10 (1) (c) of the Act Procedures under which the powers of the authority may be exercised by the District Health Officer or Chief Medical Officer for the purpose of provisional registration of clinical establishment The district registering authority shall have the power to grant, renew, enforce or cancel registration of any clinical establishment in accordance with the provisions and rules of the Clinical Establishments (Registration and Regulation) Act 2010 as per procedure prescribed under Section 14 (1) (2) (3) (4) (5); Section 15; Section 16 (1) (2); Section 17; Section 19; Section 22; Section 23 (1) (2) (3); Section 24; Section 25; Section 26; Section 29; Section 30 (1) (2) (3) (4); Section 32 (1) (2) (3); Section 33 (1) (2) (3) (4); Section 34 and Section 36. The District Registering Authority shall be responsible for O Grant, renewal, suspension or cancellation of registration for any clinical establishment O Enforcing compliance with the provisions and rules of the Clinical Establishments (Registration and Regulation) Act 2010 O Investigation of complaints of breach to the provisions of this Act or the rules made thereunder and take immediate action; O Preparation and submission of report to the State / Union Territory Council, on a quarterly basis containing details related to number and nature of provisional and permanent registration certificates issued; included those cancelled, suspended or rejected O Reporting to the State / Union Territory Council on a quarterly basis on action taken against non-registered clinical establishments operation in violation of the Act The District Health Officer or the Chief Medical Officer (by whatever name called) shall exercise the powers of the district health authority as per procedure outlined in the Act The Convener of the District Registering Authority may also perform such functions as maybe assigned to him / her by the Chairperson from time to time and the Rules framed by the State government.
Maintenance of records and reporting by clinical establishments Every Clinical Establishment shall maintain medical records of patients treated by it and health information and statistics in respect of national programs and furnish the same to the district authorities in form of quarterly reports. The minimum medical records to be maintained and nature of information to be provided by the Clinical Establishments are prescribed in CG 2 Annexe as per Section 12 (1) (iii) of the Act Copies of all records and statistics shall be kept with the clinical establishment concerned for at least 3 or 5 years or in accordance with any other relevant Act in force at the time under Section 12(1) (iii)). All clinical establishments shall be responsible for submission of information and statistics in time of emergency or disaster or epidemic situation. The Central Government may notify from time to time, the nature of information that needs to be furnished by the Clinical Establishments along with the prescribed interval. Other conditions for registration and continuation of clinical establishment Each category of clinical establishments shall comply with the Standard Treatment Guidelines and maintain electronic medical records of every patient as may be notified by the Central Government from time to time Each category of clinical establishments shall charge the rates for each type of procedure and service within the range of rates to be notified by the central government from time to time, for such procedures and services. Every Clinical Establishment shall display the rates charged for each type of service provided and facilities available, for the benefit of the patients at a prominent place in the local dialect and as well as in English language. The minimum list of services for which rates are to be displayed are given in CG 4 Annexe. In addition to the specific provisions of the Clinical Establishments (Registration & Regulation) Act 2010, all establishments shall comply and maintain information and statistics in keeping with other applicable Acts and Rules which are in force in the country. Every category of clinical establishments, as may be notified by the Central Government from time to time, shall establish mechanisms for review and audit for the purpose of provision of rational practice and service and maintenance of high standards of quality. Each category of clinical establishments, as may be notified by the Central Government shall carry out every prescription audits every 3 months. Each category of clinical establishments, as may be notified by the Central Government from time to time, shall carry out audit to assess the cause of death including treatments given to explore better preventive and management strategies.
CG1 Annexe Classification of Clinical Establishments Classification of Clinical Establishments would be as follows: 1) Rural/Urban 2) Government or Private 3) System of Medicine 4) Type of Establishment Systems of Medicine • Allopathy • Ayurveda • Unani • Siddha • Homeopathy • Yoga & Naturopathy Type of Establishment Providing Out Patient Care • Single practitioner • Polyclinic • Sub-Centre • Physiotherapy Clinic • Occupational Therapy • Infertility • Day Care Centre • Dental clinic • Dispensary • Dialysis Centre • Integrated Counselling and Testing Centre (ICTC) • Wellness/fitness center • Any other Providing In Patient Care • Hospital • Nursing Home • Maternity Home • Primary Health Centre • Community Health Centre • Sanatorium • Any other Providing Testing & Diagnostic Services: Laboratory • Pathology • Hematology • Biochemistry • Microbiology • Genetics • Collection Centre • Any other
Diagnostic and Imaging Centre • X Ray center • Mammography center • Bone Densitometry center • Sonography center • Color Doppler center • CT Scan center • Magnetic Resonance Imaging (MRI) center • Positron Emission Tomography (PET) Scan center • Electro Myo Graph (EMG) centre • Any other
CG2 Annexe RECORDS TO BE MAINTAINED BY CLINCIAL ESTABLISHMENTS The various medical records to be maintained by clinical establishment Outpatient Register • Inpatient Register • Operation Theatre register
• Labor room register • MTP register (if registered under the MTP Act) • Case sheets • Medico legal register • Laboratory Register • Radiology and imaging register • Discharge summary • Medical certificate in duplicate • Complaint register • Birth register (Notified to such medical officer as authorized • Death register by Government in such format as prescribed by Government/ State level authority) • Information in terms of government programmes / areas of work (e.g. maternal health, child health, immunization, family planning, Vector borne disease, NLEP, RNTCP, IDSP. NRHM initiatives-ASHA, JSY) • Number of beds system-wise and specialty-wise in Clinical Establishments providing in patient care (e.g. Genera! Med/Surg Beds; Special Care Beds) • Total Discharges:
CG3 Annexe State / District Register for Clinical Establishment Details of Information Required (A) At State/District level: Total number of establishments by – Category – System of medicine practiced – Type of service provided – Rural / urban / metro – No of beds Number of Clinical Establishments increased or decreased Number of Inspections carried out. Number of Pending applications with reasons Action Taken against non-registered Establishments operating in violation of the Act Complaints received by the State Council under the Act and Action taken pursuant thereto (B) Detailed information Details of each Clinical Establishment by Name Location containing details Rural / Urban / Metropolitan Village / Town Taluka District State Pin code Phone Number Email ID: Ownership Details Name of Owner Educational Qualification Person in Charge of Clinical Establishment Educational Qualification Urban / Rural Designation: Longitude / Latitude: Systems of Medicine offered Type of Establishments by category specified under Section ___ of the ____ rules Nature of Services provided by category specified under Section ___ of the ____ rules Number of beds system-wise and specialty-wise in Clinical Establishments providing in patient care
Total Employees: Total Discharges: Average length of stay (OP / IP) Utilization Statistics Details of Staff with Name, Qualification, Registration number, Number temporary or permanent
CG 4 Annexe Minimum list of services for which rates are to be displayed
Name of the service Type of Service Charges (in Rs.) Room Charges: (includes Room/ Bed charges, Nursing charges, Medical utilities charges) General Services Private rooms: Semi Deluxe – Shared Deluxe with AC Intensive care units: (Charges include the ICU Bed Charges, Medical Utilities, Monitoring and Nursing charges) MICU &ICU NEURO POW Neonatal ICU V Pediatrics ICU OT Charges General Anesthesia Vz Hour General ward Twin/ Triple sharing General Anesthesia 1 Hour General Ward Twin/ Triple sharing Local Anesthesia 1/2 Hour 1 Hour Surgical procedures Charges (Package) (includes Surgeon charges+ Anesthetist charges* Nursing Home Charges and Inpatient Medicine Charges) General Surgical Procedures Ob & Gyn procedures Orthopedic Surgical procedures Cardiac Surgical procedures Doctor Consultation charges: OP Specialist Super Specialist IP Per Visits Emergency Visits Per Visits Emergency care team charges 3 shift per day Diagnostic Charges Common diagnostic Tests X- ray per film Ultra Sound, General and Obstetric care Abdomen Female Pelvic KUB CT Scan: Multi slice/Spiral/CT scan Brain Plain Chest/ Abdomen/ Neck/ Spine MRI 0.5/1/1 .5 (Magnetic Resonance Imaging) Brain Chest Contrast ECG/TMT/ECHO/EMG/EEG Upper Gl Endoscopy/ Lower Gl Endoscopy Lab Investigation: Random Blood sugar Serum Creatinine CBP/ESR/CUE Blood Group Blood for MP LFT
Lipid profile HBSAG/VDRL/HIV Electrolytes T3, T4, TSH Any other items (not included above] Note: Other service charges for Inpatients such as drugs & disposables, investigations and concession, if any, shall be displayed at appropriate places for the benefit of the patient
Compulsory license
A compulsory license provides that the owner of a patent or copyright licenses the use of their rights against payment either set by law or determined through some form of adjudication or arbitration. In essence, under a compulsory license, an individual or company seeking to use another’s intellectual property can do so without seeking the rights holder’s consent, and pays the rights holder a set fee for the license. This is an exception to the general rule under intellectual property laws that the intellectual property owner enjoys exclusive rights that it may license – or decline to license – to others.
Consent
In UK law, only a person with capacity can give consent. There is no proxy consent. When a person loses capacity due to mental disorder (for ex delirium), the doctor can take a decision in the best interest of patient. He takes the wishes of family members as a good practice. If time permits and patient does not agree for a treatment (for ex surgery), he should approach court. Usually trusts legal time does all the work plus advice. You cannot treat physical illnesses of mentally ill under MHA. Of course, Psychiatric treatment is given under Mental health act and no need for court to intervene
Consumer Law and Practice
We are an Association of over 11000 Specialist Consultant doctors and around 1500 small and medium sized hospitals/nursing homes across Mumbai and have chapters in Mangalore, Bangalore, Pune, Nashik, Ratnagiri, and Goa. We are a front-line medical organization and represent the medical profession on several Government Expert Committees. We have a vibrant and dedicated medico-legal cell which assists our members in cases of medical litigation and often reaches out to patients as well by means of Alternate Dispute Redressal. Our mission is to network with the various stake-holders and to make a meaningful difference to our health-care delivery system in our country.
At the outset, we would like to state that we appreciate the sentiments expressed in the above letter and share your concern for the protection of patients from the malpractices and acts of gross medical negligence at the hands of hospitals and doctors. There cannot be two views on aggrieved patients being provided avenues of redressal of their grievances against medical negligence.
Notwithstanding this, it will be prudent to consider whether the inclusion of medical services under the purview of the CPA has served its purpose and is it the best way to address the problem.
To begin with, we need to examine the question: Does it stand to reason that a life and death profession whose main objective is to mend dysfunctional human bodies and heal troubled minds, be equated to business and commercial enterprises engaged in buying and selling transactions. Is it justified to compare doctors with traders? Is it not demeaning for both patients and doctors to be brought down to the level of customers (grahaks) and “sellers “? Is it right to treat at par a complaint against a defective TV set manufacturer with a complaint by a patient against adverse or suboptimal outcome of a treatment? Even as we concede that patients need to have recourse to redressal mechanisms against negligent treatment, do you honestly think that dragging doctors to consumer courts is the right way to do so? Let us examine what the CPA has achieved for aggrieved patients in the 3 decades of its existence.
Yes, some plaintiffs have been awarded compensations, some of them large enough to create a fear psychosis amongst doctors and hospitals. This may be a source of satisfaction for the proponents of the CPA vis-à-vis medical grievances, but this should not be looked at in isolation. At the end of the day, we need to look at the overall scenario and consider the fall-out of this on patient care.
You have stated in your letter that CPA ensures speedy redressal of patient grievances. Let us see how speedy it is. The time frame for the conclusion of cases in the consumer forums was supposed to be 90 days. But the fact of the matter is that the vast majority of cases do not get concluded even in 90 months!! In our experience, a case in a District forum or State Forum takes an average of 5 to 6 years at the least, before it concludes. Cases in the National Forum take far longer and it is not uncommon to get final judgments after 15 to 20 years! We have conclusive data of this. That much for the speedy justice!
What about the cost of obtaining this justice? As per the CPA, a complainant need not hire an advocate to argue his or her case before the Consumer forum. But factually, barring a miniscule minority, all complainants feel the need to appoint an advocate to argue their cases. The average advocates ‘fees are in the range of 1 lakh rupees or more, for the duration of the case, which is a minimum of 5 to 6 years in the lower forums, as mentioned earlier. That much for cheap justice!
Having seen how the CPA has served the patient community, let us see what effect it has had on the healthcare providers and the health care system. As a direct consequence of the CPA the following has happened: (achievements of CPA!)
1. Apprehensive of being dragged to a Consumer court , doctors are now per force , prescribing a whole list of medical investigations, not because they are all necessary to arrive at a diagnosis , but to protect themselves and to cover all remote possibilities and to minimize the possibility of getting implicated by allegations of negligence subsequently.
2. For similar reasons, doctors are now referring patients to a greater number of Specialists in order to document diligence in treatment and to share responsibility, should the outcome of treatment not be as expected.
3. Doctors are reluctant to accept patients who are critically ill and whose prognosis may be equivocal. They are promptly referred to high-end or tertiary care hospitals, though they could well have been treated in a low- cost facility. Apart from implications on cost, this also has implications of delay in commencement of treatment. The homily, that it is better for the doctor to be safe than sorry has never been more faithfully followed. This again is on account of the scare of CPA.
4. The patient-doctor relationship has taken a hit, being severely eroded. A doctor now tends to look upon every patient as a potential plaintiff. He is more concerned with documentation and doing the medicolegally correct thing than the actual medical issues. Mutual trust between patients and doctors has been replaced with mutual suspicion.
5. As a result of all of the above, practicing defensive medicine by doctors is now inevitable. This has a domino effect and has escalated the cost of health care by crores of rupees, a cost which a resource challenged country like ours can ill-afford. Sadly, patients are the worst-affected.
6. More doctors are retiring from practice early or switching over to alternate occupations in order to pre-empt a traumatic litigation experience under the CPA. There is presently a hopelessly skewed doctor-patient ratio in this country. Experienced doctors closing their practices prematurely is a severe loss to society and can only make a bad situation worse.
7. Small and medium hospitals/nursing homes, fearful of the post-CPA scenario are shutting shop, further worsening the hospital beds / population ratio.
8. Bright students now do not find pursuing a medical career attractive, since the profession has become a high risk, low return profession. As a result, the quality of doctors has already started plunging.
9. Owing to the fact that CPA has led to souring of patient-doctor relationship , apart from the risks of litigation , the bigger risk of being subjected to physical abuse is now a reality and is proving to be an effective deterrent for good students from taking up the medical profession, further compounding the situation.
Clearly, including medical services under the CPA has proved to be counter- productive and has neither served the cause of patients nor of the healthcare system and hence ought to be reviewed and reversed.
It is incredible that the set of persons who comprise the Consumer Forum and are supposed to adjudicate on complaints pertaining to medical treatment have zero knowledge on medical matters, being non-technical as far as Medicine is concerned. Yet they are expected to give opinions and judgments on what are often highly specialized, technical medical matters of which they have no knowledge whatsoever. Huge compensations are being awarded often on the basis of perceptions of laypersons or flimsy technical deficiencies or on sympathy factor.
Medicine is a highly complicated science – being related to a complex machine. It has also been described as an inexact science and to give retrospective judgments which have the benefit of hindsight is grossly unfair.
Complaints of medical negligence against doctors and hospitals are essentially complaints of professional incompetence or professional dereliction of duty. Of course, they should be actionable. But this should be determined by professional, technical persons who have knowledge and experience of the subject at hand. In fact, those professionals investigating the complaint should necessarily belong to the same specialization as that of the accused doctors. For example, how can an Orthopedic surgeon opine on deficiencies or otherwise of, say, a coronary artery stenting done by a cardiologist when he may not be even in a position to comment on an ECG with conviction. Only a panel of cardiologists ought to be giving their considered and expert opinion in the matter. The same is true vice versa. Enquiry into a plane crash to establish the cause of the crash is always done by a technical team of aviation experts, even if under judicial supervision. Similarly, how can the reason for complications of a Laparoscopic surgery be judged by non-experts.
This reasoning becomes more important because of the fact that an erroneous judgment has extremely grave consequences for the accused doctors. The fact that a judgment given by a lower Forum is often reversed by a higher forum giving diametrically opposite reasons for acquittal or conviction confirms the arbitrariness of the proceedings.
It is our considered submission that medical complaints should be outside the purview of consumer courts. Instead, they should be directed to Professional Tribunals with Specialty specific experts on it. (Experts could be selected from a pool of senior, retired Specialists of integrity) A judicial officer such as a retired judge could be the guiding light of the Tribunal. This Tribunal should exclusively hear medical cases. It should not be in the nature of legal proceedings but a technical enquiry into the medical facts of the case. It should be an enquiry about professional conduct, by professional experts. Hence lawyers could be dispensed with resulting in reduced cost implications and speedier decisions in a time bound fashion facilitated by the fact that there are no lawyers and hence no adjournments and the like. Tribunals could be appropriately empowered and have the force of Law.
Speedy, seamless enquiry would be appreciated by patients as well as doctors who, in a medical mishap, are described as the second victims.
Medical Councils should restrict themselves to complaints of violation of the Code of Medical Ethics and professional misconduct especially those involving moral turpitude. Medical negligence cases should be placed within the domain of the Tribunal of Experts. Bringing medical services under the purview of CPA has inflicted severe damage to the healthcare system and to patient –doctor relationship as can be seen by the current healthcare scenario.
We have to request you to ponder on our above submissions .We are sure that in view of your profound knowledge and erudition on this subject you will apply the same wisdom and logic which prevents you from writing a similar letter to the Prime Minister to include the legal profession under the purview of the CPA both being liberal professions and not a business or trade. Our Association will be pleased to have further interactions and networking with you and your team at the prestigious and nationally acclaimed National Law School of India University.
Controlled drugs
The Misuse of Drugs Regulations 2001 divide Controlled Drugs (CDs) into five schedules corresponding to their therapeutic usefulness and misuse potential. A number of changes affecting the prescribing, record keeping and destruction of CDs have been introduced as a result of amendments to the Misuse of Drugs Regulations 2001. The Controlled Drugs (Supervision of Management and Use) Regulations 2006 came into effect on 1st January 2007.[1]
Schedule 1 (Controlled Drug license)
Have no recognized medicinal use and include cannabis, coca leaf, lysergic acid diethylamide (LSD) and mescaline.
Production, possession and supply of these drugs are limited to research or other special purposes.
Practitioners and pharmacists may not lawfully possess Schedule 1 drugs except under license.
Includes diamorphine (heroin), morphine, remifentanil, pethidine, secobarbital, glutethimide, amphetamine, and cocaine.
Are subject to safe custody requirements and so must be stored in a locked receptacle, usually in an appropriate CD cabinet or approved safe, which can only be opened by the person in lawful possession of the CD or a person authorized by that person.
A license is required to import or export drugs in Schedule 2.
The drug may be administered to a patient by a doctor or dentist, or by any person acting in accordance with the directions of a doctor or dentist.
A register must be kept for Schedule 2 CDs and this register must comply with the relevant regulations.
The destruction of CDs in Schedule 2 must be appropriately authorized and the person witnessing the destruction must be authorized to do so.
Schedule 3 (Controlled Drugs – no register)
Includes a small number of minor stimulant drugs and other drugs which are less likely to be misused than the drugs in Schedule 2.
Examples are the barbiturates (except secobarbital, now Schedule 2), buprenorphine, diethylpropion, mazindol, meprobamate, midazolam, pentazocine, phentermine, and temazepam.
The government has now placed tramadol in Schedule 3 to the Misuse of Drugs Regulations 2001 but with exemption from the safe custody requirements.[2]
Are exempt from safe custody requirements and can be stored on the open dispensary shelf except for temazepam, buprenorphine and diethylpropion, which must be stored in a locked CD receptacle.
Are subject to the same special handwriting requirements as Schedule 2 CDs.
There is no legal requirement to record transactions in a CD register.
The requirements relating to destruction do not apply unless the CDs are manufactured by the individual.
Invoices must be retained for a minimum of two years.
Schedule 4
Are exempt from safe custody requirements, with destruction requirements only applying to importers, exporters and manufacturers.
Specific CD prescription-writing requirements do not apply.
CD registers do not need to be kept, although records should be kept if such CDs are produced, or if a licensed person imports or exports such drugs:
Part 1: benzodiazepines (except temazepam and midazolam, which are in Schedule 3) and zolpidem, which are subject to minimal control:
Includes most of the benzodiazepines, plus eight other substances including fencamfamin and mesocarb.
Possession is an offence without an appropriate prescription. Possession by practitioners and pharmacists acting in their professional capacities is authorized.
Are subject to full import and export control.
Part 2 includes androgenic and anabolic steroids, clenbuterol, human chorionic gonadotrophin (hCG), non-human chorionic gonadotrophin, somatotropin, somatrem, and somatropin:
Includes most of the anabolic and androgenic steroids such as testosterone, together with clenbuterol (adrenoreceptor stimulant) and growth hormones.
There is no restriction on the possession when it is part of a medicinal product.
A Home Office license is required for the importation and exportation of substances unless the substance is in the form of a medicinal product and is for self-administration by a person.
Schedule 5 (Controlled Drug – invoice)
Includes preparations of certain controlled drugs (e.g., codeine, pholcodine, morphine) which are exempt from full control when present in medicinal products of low strengths, as their risk of misuse is reduced.
No restriction on the import, export, possession, administration or destruction of these preparations and safe custody regulations do not apply.
A practitioner, pharmacist or a person holding an appropriate license may manufacture or compound any CD in Schedule 5.
Therefore, exempt from virtually all CD requirements other than that invoices must be kept for a minimum of two years.
Procedures
Regulations made under the Health Act 2006 require each healthcare organization to appoint an Accountable Officer, responsible for the safe and effective use of CDs in their organization. The Regulations also introduce standard operating procedures (SOPs) for the use and management of CDs. GP practices will need to have an appropriate process in place to agree and adopt SOPs for their use.
An SOP is a document that describes the responsibilities and the procedures, including audit, necessary to manage CDs safely and accountably. The SOPs must include:
Ordering and receipt of CDs.
Assigning responsibilities.
Where the CDs are stored.
Who has access to the CDs?
Security in the storage and transportation of CDs as required by misuse of drugs legislation.
Disposal and destruction of CDs.
The person who is to be alerted if complications arise.
Record keeping, including:
Maintaining relevant CD registers under misuse of drugs legislation
Maintaining a record of the CDs specified in Schedule 2 to the Misuse of Drugs Regulations 2001 that have been returned by patients
The practice SOP should also include:
Responsibilities within the practice team.
Validation by clinical commissioning group (CCG) and date.
Review period – e.g., one, two or three years.
Lead author and named people contributing to the SOP.
Prescriptions for Controlled Drugs
The amendments to the Misuse of Drugs Regulations 2001 that came into force in November 2005 removed the requirement that CD prescriptions should be written in the prescriber’s own handwriting. This means that CD prescriptions can be typewritten, handwritten or computer printed. Only the signature of the prescriber has to be handwritten.
Further changes following amendments to the Misuse of Drugs Regulations came into force in July 2006. These include:
A new requirement that patients or other people collecting medicines on their behalf must sign for them.
Validity of any prescription for Schedule 2, 3 and 4 CDs to be restricted to 28 days.
Strong recommendation that the maximum quantity be limited to 30 days for prescriptions of Schedule 2, 3 and 4 CDs.
Re-emphasis of professional guidance that doctors should prescribe CDs for themselves or family members only in exceptional circumstances.
Doctors are only able to prescribe diamorphine, dipipanone and cocaine to substance misusers for the treatment of addiction if they hold a license issued by the Home Office. All doctors may prescribe such drugs for patients, including substance misusers, for the relief of pain due to organic disease or injury, without a specific license.
Prescriptions for Schedule 4 and 5 CDs are exempt from the specific prescription requirements of the Misuse of Drugs Regulations 2001. However, they must still comply with the general prescription requirements as specified under the Medicines Act.
Emergency supplies of Schedule 2 and 3 CDs, for a specific patient, are not permitted either at the request of the patient or a practitioner. The only exception to this rule is phenobarbital for the treatment of epilepsy.
NHS prescription form
FP10 prescription forms now include a box on the back of the prescription where the signature of the patient or other person collecting a Schedule 2 or 3 CD must be recorded.
The prescriber should include the patient’s NHS number on the prescription form.
The prescriber should sign any script changes. The prescription must contain the following details:
The patient’s full name, address and, where appropriate, age.
The name and form of the drug, even if only one form exists.
The strength of the preparation, where appropriate.
The dose to be taken.
The total quantity of the preparation, or the number of dose units, to be supplied in both words and figures.
Form FP10MDA-S is used for prescribing CDs (mainly methadone) to addicts. It is twice the size of the standard FP10 because it contains space for the pharmacist to record each time an instalment is supplied.
FP10SS forms are designed for use with the prescriber’s computer system. FP10NC are for handwritten prescriptions.
Private prescription form
A special form (FP10PCD) has been introduced for any private prescription of schedule 2 and 3 CDs which will be dispensed in the community.
The prescriber should obtain the patient’s NHS number if possible and enter this number on the prescription form.
The private prescription form includes space for the person collecting the CD to sign the back of the form. Any person collecting Schedule 2 and 3 CDs will be asked to sign the back of the prescription form.
There are two kinds of forms available, personalized (FP10PCDNC) and non-personalized (FP10PCDSS). Personalized forms contain the prescriber’s details already printed.
Prescribing in instalments
Some CDs can be dispensed to substance misusers in instalments, providing they are prescribed using specific NHS prescription forms.
In England, GPs must use the form FP10MDA-S to prescribe in instalments Schedule 2 CDs, buprenorphine (Schedule 3) or diazepam (Schedule 4) for drug addiction. This form must not be used for any other purpose.
The prescription must be dispensed on the date on which it is due. If the client does not collect an instalment when it is due, that supply is no longer valid. The client cannot collect that supply the following day.
If a CD prescription is to be dispensed in instalments (e.g., daily) then the FP10MDA-S must specify:
The number of instalments.
The intervals to be observed between instalments (if necessary, instructions for supplies at weekends or bank holidays should be included).
The total quantity of CD that will provide treatment for a period not exceeding 14 days.
The quantity to be supplied in each instalment.
Current legislation does not allow Schedule 2 and 3 CDs to be prescribed as repeat prescriptions (i.e. to be part of the repeat prescribing or dispensing system)
Ordering, possessing and supplying Controlled Drugs
Doctors, dentists and pharmacists are authorized under the Misuse of Drugs Regulations 2001 to possess, supply and compound CDs in Schedules 2, 3, 4 and 5. They may only supply CDs to those who may lawfully possess them, including patients for whom a drug is prescribed.
Paramedics have more recently been authorized to possess and administer controlled drugs.[4]
Practitioners must not use patient-specific CD prescriptions to replace or top up their bags or practice stock, even if the stock was used for that patient initially.
Practitioners may obtain Schedule 2 and 3 CDs from pharmacies or wholesalers for practice use or stock upon the production of a written requisition. The requisitions must be:
Signed by the prescriber.
State the prescriber’s name and address, and their profession or occupation.
Specify the total quantity of the drug (this does not have to be in words and figures).
Specify the purpose for which it is required – e.g., for practice use.
Suppliers must keep all requisitions for a minimum of two years. A requisition is not required before supplying or obtaining Schedule 4 or 5 CDs.
A practitioner who requires a Schedule 2 or 3 CD urgently and who is unable to supply a signed order can request the drugs to be supplied in an emergency. The practitioner may be supplied with the CD provided he or she gives an undertaking to supply a written, signed requisition within 24 hours. Failure to do this is a criminal offence on the part of the practitioner.
It is the responsibility of the pharmacist or doctor, when receiving a supply of CDs from the wholesaler, to ensure that the correct item is delivered and that all appropriate entries are made in the CD register on the day of supply, or the day following the day of supply.
There is now a requirement for persons asked to supply Schedule 2 CDs on prescription to seek to establish whether the person collecting the drug is the patient, the patient’s representative or a healthcare professional acting in his/her professional capacity on behalf of the patient.
Where the person is the patient or the patient’s representative (e.g., a friend, or a neighbor) the dispenser:
May request evidence of that person’s identity; and
May refuse to supply the drug if he/she is not satisfied as to the identity of that person.
Where the person collecting the prescription is a healthcare professional acting in his/her professional capacity on behalf of the patient, the dispenser:
Must obtain that person’s name and address.
Must, unless he/she is acquainted with that person, request evidence of that person’s identity; but
May supply the drug even if he/she is not satisfied as to the identity of that person.
The new regulations do allow discretion not to ask patients or patient representatives for proof of identity if, for example, they have concerns that to do so may compromise patient confidentiality or deter patients from having their medicine dispensed.
Keeping and storage of Schedule 2 Controlled Drugs and buprenorphine
These CDs must be kept in a locked receptacle. This can be a doctor’s bag with a lock and, if the bag is transported in the doctor’s car, it must be locked and placed in a locked boot. A locked car is not adequate security; the bag must also be locked.
In the surgery, a locked cabinet should ideally be secured to the wall of a room and only opened by the GP or someone authorized by the GP.
Records for Schedule 2 but not Schedules 3, 4 or 5 CDs must be kept in a CD register. All healthcare professionals must keep their own CD register. GPs, pharmacists or other healthcare professionals are personally responsible for keeping the relevant CD registers up-to-date.
Requirements for records
Records for Schedule 2 CDs must be kept in a CD register. This is not a legal requirement for Schedule 3, 4 or 5 CDs.
All healthcare professionals who hold personal CD stock must keep their own CD register, and they are personally responsible for keeping this accurate and up-to-date.
The register must:
Be bound (not loose-leaved) or a computerized system which is in accordance with best practice guidance.
Contain class sections for each individual drug.
Have the name of the drug specified at the top of each page.
Have the entries in chronological order and made on the day of the transaction or the next day.
Have the entries made in ink or otherwise so as to be indelible or in a computerized form in which every such entry is attributable and capable of being audited.
Not have cancellations, obliterations or alterations; corrections must be made by a signed and dated entry in the margin or at the bottom of the page.
Be kept at the premises to which it relates and be available for inspection at any time. A separate register must be kept for each set of premises (e.g., at each branch surgery).
Be kept for a minimum of two years after the date of the last entry, once completed.
Not be used for any other purpose.
For CDs received into stock, the following details must be recorded in the CD register:
The date on which the CD was received.
The name and address of the supplier – e.g., wholesaler, pharmacy.
The quantity received.
The name, form and strength of the CD.
For CDs supplied to patients (via prescriptions), or to practitioners (via requisitions), the following details must be recorded in the CD register:
The date on which the supply was made.
The name and address of the patient or practitioner receiving the CD.
Particulars of the authority of the person who prescribed or ordered the CD.
The quantity supplied.
The name, form and strength in which the CD was supplied.
The Secretary of State for Health can authorize the medical adviser of the CCG or other appointed doctor to ask GPs to produce records and to view stocks. Failure to comply is an offence.
Doctor’s bag
Where a practitioner carries a bag for home visits, etc., containing CDs, a separate CD register should be kept for the CD stock held within that bag. Each doctor is responsible for the receipt and supply of CDs from their own bag.
Restocking of a bag for home visits, etc., from practice stock should be witnessed by another member of the practice staff, as should the appropriate entries into the practice’s CD register.
Where a prescription is written by a doctor following the administration of a CD to a patient, the doctor should endorse the prescription form with the word ‘administered’ and then date it.
Information should also be entered into the patient’s record as soon as practicable.
Destroying Controlled Drugs
NB: professional guidance strongly recommends that any medication returned from patient stocks should not be re-issued or used to treat other patients.
There is no current legal requirement that ‘patient-returned’ Schedule 2 and 3 CDs should be destroyed in the presence of an authorized witness, but it is strongly recommended that doctors and pharmacists have the destruction of these returns witnessed by another member of staff (preferably by a registered healthcare professional) and make a record of the destruction in a separate book set aside for this purpose.
Those healthcare professionals and service providers required by law to maintain a CD register are not allowed to destroy expired Schedule 2 (or 1) CDs from their stock without destruction being witnessed by an authorized person.
When a CD is destroyed, details of the drug must be entered into the CD register. This should include: the name of the drug, form, strength and quantity, the date it was destroyed, and the signature of the authorized person who witnessed the destruction and that of the professional destroying it (i.e. two signatures).
The list of those authorized to witness the destruction of CDs includes:
A CCG chief pharmacist or pharmaceutical prescribing adviser who reports directly to the chief executive or to a director of the CCG.
A registered medical practitioner who has been appointed to the CCG Professional Executive Committee or equivalent.
The CCG board executive member with responsibility for clinical governance or risk management.
Medical director of a CCG.
UNRCPD
Convention on the Rights of Persons with Disabilities
The Convention on the Rights of Persons with Disabilities is an international human rights treaty of the United Nations intended to protect the rights and dignity of persons with disabilities. Parties to the Convention are required to promote, protect, and ensure the full enjoyment of human rights by persons with disabilities and ensure that they enjoy full equality under the law. The Convention has served as the major catalyst in the global movement from viewing persons with disabilities as objects of charity, medical treatment and social protection towards viewing them as full and equal members of society, with human rights. It is also the only UN human rights instrument with an explicit sustainable development dimension. The Convention was the first human rights treaty of the third millennium.
Digital signature
It is a common tendency among Doctors tend to allow their names and signatures to be used by labs, ultrasound centers and imaging centers for a fee, where these labs or radiological centers put a stamp of a doctor or digital sign for any investigations carried out. Doctors also give these digital sign or stamp very often to their corporate hospital desk or in Government set up hospitals or medical colleges without charging anything where doctor’s stamp is used by resident doctors or nursing staff for ordering some investigations or giving fitness or sickness certificate or on discharge certificate or during referral of patient to other place or for ordering something or even for Death certificates. They pre-sign lab reports, fitness certificates, sickness certificates without actually having seen the patient or the specimen to be tested, leaving the data to be filled in by another person. This “selling” of signatures is not only a professional misconduct liable to disciplinary proceedings before the medical council, but is also breaking the law punishable under the Indian Penal Code under Section 191 “Giving false evidence”, Section 192 “Fabricating false evidence”. And if this document is presented in the Court during any stage of the judicial proceeding, the punishment is imprisonment for up to seven years along with fine, as per Section 193 “Punishment for false evidence”. The Supreme Court in the case of Martin F D’ Souza vs Mohd Ishfaq in 2009 also had said, “No prescription should ordinarily be given without actual examination.” In the same judgement, the Apex Court also advised against telephonic consultations stating “The tendency to give prescription over the telephone, except in an acute emergency, should be avoided.” Actions have been taken by the State Medical Councils, the Maharashtra Medical Council and Delhi Medical Council, in such instances. For doctors, the interests of the patient are above all. Ethical earning is a part of ethical medicine. The MCI Code of Ethics Regulations has clearly banned fee splitting including any other rebates and commissions (Regulation 6.4.1). “A physician shall not directly or indirectly, participate in or be a party to act of division, transference, assignment, subordination, rebating, splitting or refunding of any fee for medical, surgical or other treatment. “These are unethical practices. And the money earned by way of these practices is unethical earning. Recently, the Medical Council of India has issued a directive stating that “All lab reports are to be signed/countersigned by persons registered with MCI/State Medical Council”. Doctors, even MBBS doctors, should be very careful about giving their signatures, either on paper or even electronic or digital signatures, allowing them to be used in any such establishment. It is vulnerable to misuse, as is also your name. Doctors are required to inform the police if their stamp is lost. Please keep the record of the complaint with the own file. We should keep our signature safe and should not allow it to be used by others, digital or stamp signature means we ourselves have seen the patient personally present there, so it should not be given others to use it in our absence as it applies our own presence there.
Drug laws
Although we think of some drugs being legal, and others being illegal, many drugs are somewhere in between. Some substances are legal, but there are laws restricting their use or sale. Others are illegal to use, possess or produce.
New psychoactive substances (synthetics) – including synthetic cannabis
A range of terms have been used to describe new psychoactive substances (NPS), including new and emerging drugs (NEDs), synthetics, legal highs, herbal highs, party pills, herbal ecstasy, bath salts, drug analogues and synthetic cannabis.
The laws surrounding NPS are complex, constantly changing and differ between states/territories, but in general they are increasingly becoming stronger.
In Queensland, New South Wales, and South Australia there is now a ‘blanket ban’ on possessing or selling any substance that has a psychoactive effect other than alcohol, tobacco and food.
In other states and territories in Australia specific NPS substances are banned and new ones are regularly added to the list. This means that a drug that was legal to sell or possess today, may be illegal tomorrow. The substances banned differ between these states/territories (G. Barnes, personal communication, April 23, 2014).
See below for an outline of laws relating to individual drugs in Australia. For more detailed information contact a legal aid service in your state or territory.
Legal and restricted drugs
Alcohol
There are laws that govern how alcohol may be used. These laws may differ depending on the state, territory or local area. For example, in some areas local by-laws make it illegal to drink alcohol in public places such as beaches, parks and streets.
It is an offence for a person who is under 18 years of age to buy, receive or drink alcohol on licensed premises, unless they are with a parent or guardian.
In some states in Australia, it is also an offence to supply a person under 18 years of age with alcohol in a private home, unless the young person’s parent or guardian has given permission and the alcohol is supplied in a responsible manner. This is known as secondary supply.
It is illegal to drive under the influence of alcohol.
Penalties for breaking these laws can include fines, imprisonment and disqualification from driving.
Employers have legal obligations in relation to health and safety of their workers and people who visit their workplace. Find out more about the responsibilities of employers and employees.
Amphetamines
Use of amphetamines is restricted. They can only be prescribed by a medical practitioner for medical reasons.
Federal and state laws provide penalties for possessing, using, making, selling or driving under the influence of amphetamines without a prescription from an authorized person. There are also laws against forging or alerting a prescription or making false representation to obtain amphetamines or a prescription for them. Laws have been introduced that prevent the sale and possession of ice pipes in some states and territories.
Benzodiazepines
Using benzodiazepines without a prescription from a doctor, or selling or giving them to someone else, is illegal. There are also laws against forging or altering a prescription or making false representation to obtain benzodiazepines or a prescription for them.2
In 2014, in response to concerns about the use and harms associated with the benzodiazepine, alprazolam (Xanax®), it was rescheduled under the Pharmaceutical Benefits Scheme (PBS) as a Schedule 8 drug. Doctors must now follow additional state and territory laws when prescribing alprazolam and must notify, or receive approval from, the appropriate health authority.1
Betel nut
The active ingredient in betel nut is arecoline, which is a Schedule 4 poison (prescription only medicine) and therefore is illegal to possess or sell without proper authority.
Buprenorphine
Using buprenorphine without a prescription from a doctor, or selling or giving it to someone else, is illegal. There are also laws against forging or altering a prescription or making false representation to obtain buprenorphine or a prescription for it.2
Cognitive enhancers (smart drugs)
Modafinil is a Schedule 4 substance that can only be prescribed by a doctor or dentist in the ordinary course of their professions.
Methylphenidate is a Schedule 8 drug which means doctors must follow state and territory laws when prescribing it and must notify, or receive approval from, the appropriate health authority.
Using modafinil or methylphenidate without a prescription from a doctor, or selling or giving them to someone else, is illegal. There are also laws against forging or altering a prescription or making false representation to obtain pharmaceuticals or a prescription for them.2
Inhalants
Inhalant use is not a criminal offence in any Australian state or territory.
In recent years, some Australian states and territories have revised police powers to intervene in inhalant use in two main ways. Police are authorized to:
Take away inhalants and related equipment
Pick up young people who are misusing inhalants, and release them into the care of a responsible person, or a place of safety.
It is also illegal in some states and territories for shopkeepers to sell products to someone if they believe they are to be used for inhaling.
Ketamine
Legally produced ketamine is a restricted substance and only a doctor or vet may prescribe or administer it. All other ketamine is illegal in Australia.
Federal and state laws provide penalties for the illegal use, possession, production, selling or driving under the influence of ketamine. Penalties can include fines, imprisonment and disqualification from driving.
Kava
The import, advertising and sale of kava in Australia are strictly controlled. Kava is listed as a controlled substance under the Customs (Prohibited Imports) Regulations Act.
As of 26 June 2007, commercial importations of kava are no longer allowed, except for medical or scientific purposes.
Passengers coming into Australia, who are over the age of 18 years, are allowed to bring 2 kg of kava without a license or permit, provided it is in their accompanied baggage.
Khat
It is illegal to import khat into Australia for personal use. Khat can only be imported for medical and/or scientific use. Importing khat without a permit is subject to fines or prosecution. For more information visit the Australian Government’s Department of Health website.
Oxycodone
Under the Pharmaceutical Benefits Scheme (PBS), oxycodone is a Schedule 8 drug. Doctors must follow state and territory laws when prescribing oxycodone and must notify, or receive approval from, the appropriate health authority.
Using oxycodone without a prescription from a doctor, or selling or giving them to someone else, is illegal. There are also laws against forging or altering a prescription or making false representation to obtain oxycodone or a prescription for them from a health professional.
Methadone
Using methadone without a prescription from a doctor, or selling or giving it to someone else, is illegal. There are also laws against forging or altering a prescription or making false representation to obtain methadone or a prescription for the drug. It is also illegal to inject methadone.4
Tobacco
Federal and state laws make it an offence to sell or supply tobacco products to people under 18 years of age. It is also illegal for anyone under 18 years to purchase tobacco products.
There are laws that regulate and restrict how tobacco products are advertised, promoted and packaged.
There are also laws and regulations that restrict smoking in public areas such as shopping centers, cafes and workplaces. Most states and territories have laws that ban smoking in cars with children.
Illegal drugs
The following drugs are some of the drugs that are illegal in Australia. Federal and state laws provide penalties for possessing, using, making or selling them, or driving under their influence.
Cannabis, including some synthetic cannabinoids
Cocaine
Ecstasy (MDMA)
GHB (gamma hydroxybutyrate)
Heroin
Ice (crystal methamphetamine)
LSD (lysergic acid diethylamide)
PCP (phencyclidine)
PMA (paramethoxyamphetamine) and PMMA (paramethoxymethamphetamine).
There are also laws that prevent the sale and possession of bongs and other smoking equipment in some states and territories. (For example, Victoria has passed legislation that will ban the sale of cannabis water pipes (bongs) from January 2012.)
Ice (crystal methamphetamine)
Use of methamphetamine (ice) is against the law. Federal and state laws provide penalties for possessing, using, making, selling, importing or exporting, or driving under the influence of methamphetamine. The importation or exportation and the procuring of precursor drugs (such as pseudoephedrine) with the intention of manufacturing a controlled drug, is also against the law. Laws have been introduced that prevent the sale and possession of ice pipes in some states and territories.
Drug laws in Australia distinguish between those who use drugs and those who supply or traffic drugs.
The Federal Customs Act covers the importing of drugs, and each state has its own laws governing the manufacture, possession, distribution and use of drugs, both legal and illegal.
The Drugs, Poisons and Controlled Substances Act (DPCSA) includes these major drug offences:
Use includes smoking, inhaling of fumes, or otherwise introducing a drug of dependence, into a person’s body (including another person’s body).
Possession is the most common offence. Possession means having control or custody of a drug. Knowledge of such possession must be proven in court. Possession applies both to drugs found on the person or their property, unless it is proven the drugs do not belong to that person.
Cultivation is the act of sowing, planting, growing, tending, nurturing or harvesting a narcotic plant.
Trafficking is a very serious offence. It includes the preparing of a drug of dependence for trafficking; manufacturing a drug of dependence; or selling, exchanging, agreeing to sell, offering for sale or having in possession for sale, a drug of dependence. If this is done in commercial quantities, the penalties are extremely severe.
It is illegal to drive under the influence of drugs. Breaking this law carries penalties including disqualification from driving, heavy fines and/or imprisonment.
Some states have introduced random roadside testing for cannabis and amphetamines.
Penalties for breaking laws in relation to alcohol and other drugs may include fines, imprisonment and disqualification from driving
Drugs and the Criminal Law
The number of people dealt with for drug offences in 1998 was 153,200 and of these, 127,840 were found guilty, cautioned, given a fiscal fine or dealt with by compounding for drug offences in 1998.
Offences mainly involved cannabis (76%), followed by amphetamine (12%), heroin (9%) and cocaine (4%), with little change in the type of drug from 1997. More info: UK Drug Report 2000 – The Drug Situation in the UK)
Drugs law in the UK is inconsistent, with some quite harmful substances freely available, and others prohibited. The focus of this publication is on illegally produced drugs, rather than prescribed medicines.
History of drugs law
The main piece of legislation dealing with drugs is the Misuse of Drugs Act 1971, which consolidated most previous drugs legislation.
In 1908 the sale of opium was restricted to people known to a pharmacist. Cocaine, heroin and morphine were first subject to legal control in 1917, cannabis in 1925, amphetamines in 1964, and LSD in 1966.
Since 1971 major subsequent drugs legislation has included the Intoxicating Substances Act 1985 controlling the sale of solvents to people under 18, and the Drugs Trafficking Offences Act 1986, allowing for the confiscation of profits from drug dealing, and creating new offences concerned with the laundering of drug money.
Drugs law in context
Drugs law operates within the wider context of criminal law. Rules governing detention and questioning in police stations, court procedure and other basic legal principles all apply to drugs cases.
The most important legislation governing arrest, detention, questioning and prosecution of offences is the Police and Criminal Evidence Act 1984 (PACE).
A general rule concerning all criminal cases is that a person has to have a “guilty mind” if they are to be convicted.
If someone is carrying controlled drugs without knowing it, they should, if believed, be found not guilty of possession.
Knowing that criminal offences are being committed by another person will not normally amount to being guilty unless assistance is given to the law breaker in some way.
The Misuse of Drugs Act 1971
Classification of drugs
The Misuse of Drugs Act (MDA) is the major Act controlling drugs. It divides drugs into categories (A, B and C) depending on how dangerous the drugs were thought to be at the time of legislation.
The home secretary can usually add new drugs on to those controlled under the original 1971 Act without referring to Parliament.
Class A drugs include: Cocaine, coca leaf, dicanol, heroin, LSD, mescalin, methadone, morphine, opium, PCP, pethadine, poppy straw, psilocybin, STP, ecstasy and cannabinol except where it is contained in cannabis or cannabis resin. Class B drugs become class A drugs if they are prepared for injection.
Class B drugs include: Amphetamine, codeine in concentrations above 2.5%, DF118, ritalin and barbiturates.
Class C drugs include: Methaqualone, cannabis, benzodiazepines (valium etc).
See: Cannabis reclassified (Jan 2004)
Drug classification and sentence
Under the MDA, offences involving different classes of drugs attract different penalties. Class A drugs offences involving heroin, for example, are taken more seriously than offences involving class B or C drugs.
The table set out below show maximum penalties for different types of offences. Note: Maximum sentences are seldom imposed and average sentences for offences are much lower, depending on the individual circumstances of the case.
Some class C drugs are legal to possess. The Misuse of Drugs schedules determine whether a drug may be prescribed or not, and impose duties relating to record keeping, manufacturing, storage, and distribution of drugs. Temazepam, for example, is a Class C drug, listed under schedule 4. It may be possessed, provided it is in a medicinal form.
Chart 2 – Schedules
There are 5 Schedules.
Schedule 1
Schedule 1 drugs are considered to have no legitimate therapeutic use, and cannot be prescribed by doctors, or dispensed by chemists. Possession is only legitimate with a Home Office license.
These are issued only to doctors and scientists engaged in research. Schedule 1 drugs include cannabis and LSD.
Schedules 2 & 3
These schedules cover many controlled drugs considered to have medical therapeutic uses. Drugs in the Schedules may be possessed by doctors, pharmacists, scientific research institutes, sisters and acting sisters employed in hospitals and nursing homes, and various scientific analysts.
A patient who has been prescribed scheduled drugs by a doctor my legitimately be in possession, provided that the drugs are administered in accordance with doctor’s directions.
Someone who “abused” prescribed drugs could be in unlawful possession, provided that the intention to abuse could be proved.
Schedule 2 includes heroin, morphine, pethadine, amphetamine and cocaine.
Schedule 3 includes diethylpropion and other mild slimming aids.
Schedule 4
This Schedule includes many benzodiazepines such as Diazepam, Lorazepam and Temazepam. Any person listed under Schedules 2 and 3 may possess these drugs.
In addition, any person may possess any Schedule 4 drug, provided it is a medicinal product. However, supply by an unauthorized person is illegal.
Schedule 5
This schedule covers compound preparations like cough mixtures and anti- diarrhea medicines that contain tiny amounts of controlled drugs like morphine or cocaine.
Some schedule 5 drugs are sold over the counter, and they may be possessed legally without a prescription. Regulations may stipulate the proportion of, for example, morphine, that may be contained in a preparation, which mush not easily be recoverable.
Possession of Illegal Drugs
Possession means having drugs in your physical possession or having control of drugs. If you leave drugs in a suitcase in a left luggage office, you do not possess drugs physically, but legally, you still have control of the drugs.
Legal possession of drugs involves knowledge.
A left luggage attendant holding a suitcase belonging to someone else may not know that the suitcase contains drugs, and will therefore not legally be in possession.
Intention is very important. Not everyone in possession of drugs will be guilty of an offence. Conveying a drug to someone who is entitled to have the drugs in their possession is not an offence. Nor is taking possession in order to destroy them.
A teacher, for example, confiscating cannabis could flush it down the loo. If, however, the teacher held onto the drugs, and did not destroy them, and offence of possession would be committed.
Common types of possession
Simple possession
In order to prove possession, the prosecution have to identify the drug precisely – cannabis resin or amphetamine sulphate, for example. Normally, this is done by sending drugs away for scientific analysis.
If you identify a drug to the police – for example, “this is lorazepam” – they may be able to use your identification as evidence, on the basis that you have behaved as it is Lorazepam.
If you have already tried the drugs, it could be said that you have formed an opinion about the nature of the drug, even though you are not a scientific expert (Bird v Adams 1972, Wells 1976). Each case must be judged on the facts.
If you are in possession of, for example, a quantity of white powder which you think is cocaine, you may be charged with possession of cocaine, even if, on analysis, it turns out to be amphetamine sulphate.
The prosecution must prove that you had physical custody of the drugs, or controlled them in some way, and that you knew or suspected that drugs were present, and that they were illegal. Seeing someone else use a drug, or being close to drugs does not amount to possession (Searle 1971, Bland 1988).
Joint possession
If you own a pool of drugs with other people – cannabis for example, then handing a joint round the group does not amount to supply. Each person draws from a common pool, and therefore each person has control (Searle 1971).
Someone offering a cannabis smoke to another person not already in possession of the drug could be said to be supplying even if the joint is not handed over permanently. However, it would be difficult for anyone to act independently in controlling the drug (Moore 1979).
Traces
At one time you could argue in court that minute quantities of drugs were not “usable”. The courts have decided that “usability” is not relevant to drugs possession cases (Boyesen 1980).
There are some problems in prosecutions involving traces. Accurate analysis and identification of minute quantities of drugs may be difficult. Knowledge may also be a problem. Someone in possession of, for example, cannabis in a jacket pocket may not know that the drug is present.
Used syringes and needles may contain traces of illegal drugs. People using needle exchanges should check with local drugs agencies about the attitude of local police, who may agree not to prosecute in certain circumstances. The public interest may be taken into account by the police, who are able to exercise considerable discretion in enforcing the law (R v Metropolitan Police Commissioner 1968).
Traces of drugs found in urine or blood cannot be used as evidence to support a charge of possession of drugs.
(Hambleton v Callinan 1968.) But many people found in possession of traces may be tempted to admit past possession of drugs to the police.
Past possession
Traces of drugs can be used as evidence of past possession.
Such prosecutions can be regarded as oppressive (Pragiola 1977). More often, prosecutions for past possession use statements and admissions from suspects who have admitted taking illegal drugs in the past. The courts can rely on admissions of guilt by defendants in drugs cases with little corroborative evidence.
An occupier who saw people injecting heroin or freebasing cocaine on their premises would be under no legal obligation to stop them, provided they did not actively assist them. But the same occupier would have to stop the consumption of cannabis.
Occupiers of premises
The MDA places special obligations on occupiers of premises, who may not knowingly allow drugs production or supply. The law in this area is under review, and may change to make it an offence if an occupier does not stop the use of any illicit drug.
Premises
Premises can mean anything from a house to a boat or caravan which is not moving. An open field does not count as “premises”.
Responsibility for premises lies with occupiers, not owners. A person who is in a position to invite or exclude visitors, holds the key, or takes responsibility for premises will count as an occupier (Tao 1976).
People sharing houses or flats are in a difficult position. If one person uses cannabis with the knowledge of others, then the co- tenants could be prosecuted for allowing the premises to be used for smoking cannabis.
Knowledge
“Knowing” that drugs are being used, supplied or produced on premises mean deliberately or recklessly disregarding the obvious.
Supply of Drugs
Supply of drugs, or “trafficking” is a serious offence. It does not necessarily mean large scale dealing for profit. Simply handing certain controlled drugs to another person can count as supply, and may attract heavy penalties.
Possession with intent to supply
This is one of the most common “trafficking” offences. Possession with intent to supply includes all the elements of simple possession, and additional evidence about intent.
The prosecution may try to establish intent to supply in various ways. In some cases, the quantity of drugs involved is obviously too large for personal use.
In other cases, intent to supply can be established through statements and admissions made by suspects.
Evidence of drug paraphernalia such as scales, packaging and cutting equipment may be used as part of the prosecution. Police evidence on patters of drug use may be called. This evidence may be contested by calling more sympathetic experts for the defense.
Where a person has left drugs with a friend for safekeeping, anticipating that they be handed back on demand, the friend looking after the drugs is guilty of supply if the drugs are handed back, or they intend to hand them back. (Maginnis 1987)
Supply
“Supply” means different things in different cases. Sometimes, the courts concentrate on the physical transfer of drugs from one person to another (Delgado 1984).
At other times, the courts look at whether the person receiving the drugs has benefitted (Dempsey 1986).
Some drugs supply cases involve evidence from police observation, in which drugs are not fully identified.
Suspected suppliers may make admissions to the police, along with the people buying the drugs. Sometimes, purchases of drugs are persuaded to give evidence against contacts who supplied them.
When several friends pool money to buy drugs, then the person making the actual purchase and delivering the drugs will be supplying, even if all considered themselves to be jointly involved in the purchase (Buckley and Lane 1979).
Injecting someone with their own heroin is not a supplying offence, assuming that the drugs never leave the control of the person taking them, and the person injecting them is simply assisting (Harris 1969).
Sometimes, people who are not supplying drugs are charged with “being concerned” in supply. This means some kind of identifiable assistance such as telephoning a contact or similar helpful act.
Supplying intoxicating substances
The intoxicating Substances Act covers the supply of substances other than controlled drugs, such as solvents and lighter fuel.
Supply is illegal is the substance or its fumes are to be used to intoxicate a young person under 18.
A supplier must know or suspect that the young person concerned is under 18. People under 18 who supply to one another should not be prosecuted unless they are selling substances as part of a business.
Production of Controlled Drugs
Production of controlled drugs can mean illegal manufacture of drugs such as amphetamine sulphate and LSD for large sale distribution. It can also mean the cultivation of cannabis.
Although there is a special offence of “cultivating” cannabis, most people are now charged with production of the drug.
“Production” can be seen as a trafficking offence, or as a smaller scale offence, depending on the circumstances.
Knowledge is important. Someone who could establish that they did not know that the plant they were tending was cannabis would be not guilty of the offence (Champ 1979).
Admissions are also important. A person simply possessing psilocybin mushrooms is not committing an offence, as psilocybin mushrooms grow naturally within the UK. If a mushroom grower admits growing mushrooms for the purposes of using psilocybin (the active ingredient of the mushrooms), they are likely to be prosecuted.
Import / Export
The law on the importation and export of drugs is complex. The most important piece of legislation is the Customs and Excise Management Act 1979 (CEMA). Much of the legislation is directed at commercial traffickers, and is technical in nature. Importing and exporting controlled drugs are normally considered trafficking offences.
Import
The simplest offence is going through Customs carrying undeclared controlled drugs. But people quite remote from the physical act of passing through customs may be considered to be “concerned” with fraudulent evasion or attempted evasion of a prohibition or restriction.
Someone sent an unsolicited package of drugs by a friend abroad could be prosecuted if they decided to hold on to the drugs, even though they had not known of the existence of the package when it passed through customs.
Assistance given to an importer of drugs after entry to the UK could also lead to a charge.
Export
Similar conditions apply to the export of controlled drugs. Export of drugs can also be seen as a trafficking offence.
People travelling abroad can take certain drugs out of the country without making special arrangements.
Controlled drugs such as tranquilizes (Schedule 4) can be exported, provided they are in medicinal form, along with medicines containing very small proportions of controlled drugs such as codeine and morphine (Schedule 5).
People prescribed other controlled drugs such as methadone who need to travel with the drug should check to see if they need a license to export. In practice, different groups of people are treated differently by the criminal justice system.
A pensioner without a license needing to travel with controlled drugs would probably not be challenged while someone of suspect appearance getting treatment for an addiction might well be challenged, it is important to check with the country being visited that it is not against their law to import the drug.
Paraphernalia
Possession of drug taking apparatus is not illegal, provided that it is clean. Many objects used for drug taking may contain traces of illegal drugs, and of course, possession of drug taking apparatus could be used to support a charge of some kind, although other evidence would have to be available.
Supply and distribution of drug-taking kits such as pipes and so on is illegal under the Drug Trafficking offences Act 1986 (DTOA).
However, many items used by drug takers can be used for other purposes. A shop selling such goods as decorative novelty items would probably avoid prosecution.
Hypodermic needles and syringes are specifically exempt from the legislation, even if suppliers believe that they are likely to be used in the administration of illegal drugs (DTOA).
Forfeiture
Drugs found by the police are normally destroyed, by order of the court.
In suspected drugs trafficking cases, the courts and investigating officers enjoy wide powers to seek out financial information, and to assess the profits made form suspected drug trafficking under the DTOA.
The DTOA is a complex piece of legislation designed to make life difficult for large scale dealers. It imposes a duty on bank officials and other people whom they suspect of laundering and depositing drug money. Relatives and friends of suspected drugs traffickers are often caught up in the investigative proceedings.
Where someone has been convicted of a drugs trafficking offence in Crown Court (supply, intent to supply, importation etc.), the court must make enquiries to assess and recover proceeds of drug dealing.
In practice, often occur very soon after arrest. The court can make a restraint order preventing any person dealing in realizable property except as directed by the court.
Drug Trafficking
In making an assessment of drug proceeds, the courts rely on a retrospective assessment of police and customs officers, who look into financial dealings up to six years before the institution of criminal proceedings.
The burden of proof is on the defense (i.e., the convicted trafficker) to show that property and good during that period were acquired legitimately.
Evidence can be produced by the prosecution about the standard of living, lifestyle and so on.
Proceeding under the DTOA are very complicated. Husbands and wives of drug trafficking suspects may have their property frozen while matters are investigating. It is possible to apply to the court for a restraint order to be varied. Full legal advice and representation is essential.
Drugs Act 2005, Tough Choices and the Drug Interventions Program me (DIP)
Test on Arrest – The Drugs Act 2005 introduced new powers compelling police in certain, high-drug crime areas to test people arrested for certain “trigger” offences for the presence of Class A drugs. Failing to complete the drug test is a criminal offence in itself and can result in a fine, up to 3 months in prison or both.
Required Assessment – If an individual test positive for recent drug use of heroin, cocaine or crack, they will be compelled to attend one or two appointments with a drug worker, whether or not they are charged with the crime they were originally arrested for. Non-attendance is a criminal offence and can result in a fine, up to 3 months in prison, or both.
Restrictions on Bail – If charged with the offence for which you have tested positive (or any offence put to you during that period of detention), a court considering bail will be obliged to take your positive test into consideration. The test could be used as a reason to remand you in custody (for fear of further offending), or alternatively will mean the court must put a condition on your bail compelling you to attend the Drug Interventions Programme. Non-attendance at these appointments could result in your bail being revoked.
You have the right to appeal against any drug test. The on-site police tests are about 95% accurate. Many legally prescribed or over-the-counter opiates will produce a false positive. NB, methadone and buprenorphine (subutex) are not known to produce false positives.
If you do test positive, you have the right to say nothing in the Required Assessment. However, if you are charged with the offence, non-compliance with the Required Assessment could be considered during a bail hearing.
Home Office: Guidance for the Implementation of the DIP provisions of the Drugs Act 2005
Police and Criminal Evidence Act
The Police and Criminal Evidence Act 1984 (PACE) sets out police powers to stop, search and arrest, conditions of detention in police stations, and codes of practice governing treatment of prisoners.
Is a most important piece of legislation dealing with police powers to stop, search, arrest and detain ordinary citizens, and affects almost every aspect of detention procedure.
The police now have to keep detailed records about people detained. Custody officers have been introduced to deal with detainees.
Continued detention must be reviewed periodically, and there is a strict limit to the maximum period of detention before charge.
Police arrest people in order to hold them while they investigate offences and gain evidence for the prosecution. The length of time people can be held depends on the kind of offence police suspect they have committed. Under PACE, drugs offences are divided into:
arrestable offences, such as possession of illegal drugs
serious arrestable offences, such as supply of illegal drugs, importation and production.
Police Powers to Search
Important new addition (added 9/4/96): New anti-terrorist provisions were rushed through Parliament on Wednesday 3rd April, which will give the police power to search people without having to give reasonable cause for suspicion, and also allows them to search shoes and socks without taking the suspect to a police station.
Although designed as anti-terrorist provisions, they are likely to be used as power to conduct random drug searches.
It is not yet known when this extra provision will be implemented, although it is likely to be in the near future. Police can stop and question people whenever they wish. They are supposed to ask questions in order to decide whether or not grounds exist for a search.
A satisfactory explanation for “suspicious” behavior, should, according to police codes of practice, make a search unnecessary.
Police often try to get consent for search by describing a search as “just routine”. In fact, routine searches are illegal unless they are done with consent.
Searches with consent may be more thorough than those without, as there are rules governing conduct of searches without consent.
Searches without consent may only be done on “reasonable suspicion”. Grounds for “reasonable suspicion” may be based on furtive or other unusual behavior, time or place of activity, and tip offs. Belonging to a particular ethnic group, unusual dress, or police knowledge of previous convictions are not reasonable grounds.
Before searching someone against their will, police must:
identify themselves, giving their name and police station
explain grounds for suspicion
explain exactly what they are looking for
inform the person searched that a copy of the record of the search will be available if requested within a year
A public search should only be a superficial inspection of outer clothing. A more detailed search should be done by a police officer of the same sex. Searches for drugs may involve a detailed search at a police station.
Special legal provisions for drugs searches allow the police to take suspects to a police station without a formal arrest (Misuse of Drugs Act s23).
Intimate searches
Intimate searches of body orifices can be authorized in writing by a police superintendent who suspects that a Class A drug (such as cocaine or heroin) has been concealed with criminal intent.
The search must be conducted by a doctor or nurse in a hospital or clinic (Police and Criminal Evidence Act s55). An intimate search in relation to cannabis (a Class B drug) would be illegal.
Search of premises
Police have extensive powers to enter and search premises. Police can search at any time with consent. But with consent, they can only enter and search:
following an arrest for an arrestable offence
to execute a warrant (an authority from a court)
to arrest someone for a serious offence or an offence that is visibly taking place (e.g. visible drug taking) or are in hot pursuit
to prevent a breach of the peace (could be violence threatened from a house)
to protect life and limb
to recapture someone at large (such as an escaped prisoner)
or if the premises are in the immediate vicinity of a “serious arrestable offence” (such as robbery, supply of drugs, serious wounding).
Police can enter by force if they feel that delay in entering will lead to disposal of evidence (drugs, for example).
Evidence acquired during an unlawful search is admissible in court. Inviting police onto premises may imply consent to unforeseen actions.
An invitation onto premises to discuss, say, the loss of a bicycle, could become a drugs search if police become suspicious.
When police search premises, they often search individuals, even visitors, on the premises.
Usually they have the legal power to do so. They often ask questions which may amount to an interrogation. Police should supply occupiers of search premises with a paper that outlines their rights.
Special rules apply to search of people with confidential personal counselling and welfare responsibilities. Under PACE, some categories of confidential material are not available to police. But staff taking work home with them may find that files that would have been legally protected at work are unprotected at home.
Drug Offences and Rights in Custody
People suspected of “arrestable offences” are entitled to
have a friend or relative informed of their arrest
consult a duty solicitor or other solicitor for advice
consult police codes of practice
Many people detained sign a form saying they do not want to see a solicitor, which is usually a mistake. However, solicitors are often reluctant to deal with minor drugs offences. After 24 hours, people suspected of minor offences must either be charged or released.
Serious arrestable offences
People suspected of serious arrestable offences may be
held up to 36 hours without having anyone informed
held up to 36 hours without access to legal advice (on authority of a superintendent)
After 36 hours, access to a solicitor is guaranteed. Continued detention can be authorized by a magistrate in a series of stages up to a maximum of 96 hours
After 96 hours, people suspected of minor offences must either be charged or released
The police are trained in interrogation and are aware that some drug users are disoriented. They may play on this. Most people are prepared to do almost anything to get out of the police station – even to sign false statements admitting guilt.
The best approach to questioning in custody, is to insist that a solicitor is called. (See our ‘Rights on arrest’ page for more info.)
Although silence will probably lead to longer detention and perhaps some harassment, there are strict limits on detention, and eventually the police will have to release or make a charge.
Young people under 17 should not be questioned without an appropriate adult being present – a parent, or social worker.
Interviews taken without an appropriate adult present are never admissible in court. In dealing with the police it is useful to have a degree of self-awareness. Insisting on theoretical rights can be difficult without support, information and insight into how the police are likely to react.
Right to silence
Many drug users are convicted of offences because of verbal and written admissions made to the police.
Sometimes such admissions form part of the “facts” of a case, and may determine whether a person is charged with, say possession, or possession with intent to supply. Past possession charges are usually brought on the basis of admissions made to the police.
If you are in doubt about your rights, or what you should say, then insist on seeing a solicitor, and say nothing until you have spoken with them.
What is said during questioning will be of critical importance even without a formal caution. Everyone held in custody has the right to see the Duty Solicitor, for free legal advice.
Rules on detention
Many people held in police stations are not under arrest at all. They are said to be “helping police with their enquiries”. If they try to leave, however, they often find themselves under arrest.
Some people are not sure whether or not they are under arrest. If they cannot leave the station on request, they should insist that they are arrested and booked in by the custody officer.
Arrest means being under forcible detention and this would start the PACE “clock”. Under PACE, most important rules governing detention apply only if the person is under arrest.
Generally speaking, it is an advantage to have been arrested. Strict time limits to detention apply and it is possible to sue in cases of wrongful arrest.
A custody officer is responsible for the welfare of prisoners. The officer is independent of the investigation. Anyone booked into a police station should make sure that the arrival time is logged correctly. The custody officer has a special duty to call a doctor if it is known or suspected that a detainee has been using drugs (Police and Criminal Evidence Act Codes of Practice s66).
Helping someone under arrest
The best way to help someone who has been arrested is to get a solicitor involved immediately. All help at a police station is covered under non means tested legal aid.
If in doubt, it is always advisable to speak to a solicitor. You can receive advice from a solicitor free of charge at the police station.
EMTALA LAW
In 1986, the U.S. federal government passed the Emergency Medical Treatment and Labor Act (EMTALA). This act requires any hospital that accepts payments from Medicare to provide care to any patient who arrives in its emergency department for treatment, regardless of the patient’s citizenship, legal status in the United States or ability to pay for the services. EMTALA applies to ambulance and hospital care.
EMTALA was developed to combat “patient dumping,” the practice of refusing to treat people who did not have the ability to pay for healthcare services. It guarantees those with insufficient means will not be turned away from emergency medical care. Most US hospitals participate in Medicare so that in effect the law covers virtually all hospitals.
EMTALA is contained within the Consolidated Omnibus Budget Reconciliation Act (COBRA) and falls under the auspices of CMS, the Center for Medicare Services.
Legal Duties of Hospitals Under the EMTALA Law
1.Medical Screening Exams: Anyone arriving at a hospital emergency department must receive medical screening examinations to determine whether they are in a medical emergency. The law also says these must be done regardless of the financial or insurance status of the patient, in order of priority based only on medical need. EMTALA has legal definitions of “emergency medical condition” and of the term “stabilized.” Further, the CMS says this requirement applies to any facility that provides emergency services, not just to designated emergency rooms. If the medical screening exam finds that there is no emergency medical condition, they are not required to provide further treatment.
2.Stabilize or Transfer: If an emergency medical condition exists, the patient’s condition must be treated to stabilize it or to make a transfer to an appropriate facility. The emergency room cannot simply send a patient home with a condition that is expected to deteriorate further. The patient has to be informed of any transfers and give consent. A patient sent home in an unstable condition or sent to a hospital that doesn’t have the facilities to treat their condition could have legal recourse under EMTALA.
3.Hospitals are Required to Take Transfers for Specialized Services: This addresses the practice of reverse-dumping, where hospitals with specialized units, such as a burn unit, only accept patients with the ability to pay. Under EMTALA, they must take any appropriate transfer. However, the law gives them an escape clause. They must accept the transfer if they have the capacity. If they don’t have any open beds or they are already on ambulance diversion, they don’t have to take a transfer. However, if they tell a hospital requesting a transfer that they are full but the patient gets sent to them anyway (dumping) they must treat the patient when he arrives. They can report the sending hospital for an EMTALA violation later.
EMTALA Does Not Provide Free Care
While hospitals are required to examine and treat patients under EMTALA, their services are not free. They may bill the patient and sue them for unpaid bills. They do not need to provide outpatient care after discharge, but they must refer them to clinics and programs that may provide them at a reduced cost or for free. Hospitals can’t refuse to treat patients presenting under EMTALA who already owe them money.
English tort law
English tort law is the law governing implicit civil responsibilities that people have to one another, as opposed to those responsibilities laid out in contracts. It provides legal remedies, often the payment of money, to those who have been damaged by someone else’s failure to meet these implicit responsibilities. Other countries’ tort laws can work quite differently.
It is to be distinguished from criminal law, which is often thought of as dealing with an individual’s responsibility to the state, where a court has the power to restrict people’s freedoms. Often an act can result in both a criminal and a civil case, for example if someone injures a pedestrian while driving dangerously the state may prosecute them for dangerous driving, whilst the pedestrian might bring a tort case against them failing in their responsibility to not knowingly put other people at risk. The law of tort covers several areas such as negligence, each individual tort has a certain number of requirements needed to be met.
Epidemic act.
1. This Act has been amended in its application to–
(1) The Punjab by the Epidemic Diseases (Punjab Amendment) Act, 1944 (Punjab Act 3 of 1944); in East Punjab by East Punjab by East Punjab Act 1 of 1947;
(2) The C.P. and Berar by the C.P.and Berar Epidemic Diseases (Amendment) Act, 1945 (C.P.and Berar Act 4 of 1945.).
An Act to provide for the better prevention of the spread of Dangerous Epidemic Diseases.
WHEAREAS it is expedient to provide for the better prevention of the spread of dangerous epidemic disease;
It is hereby enacted as follows: –
2. To take special measures and prescribe regulations as to dangerous epidemic diseases.
(1) When at any time the 1[State Government] is satisfied that 2[ the State ] or any part thereof is visited by, or threatened with, an outbreak of any dangerous epidemic disease, the 1[State Government, if 3[ it] thinks that the ordinary provisions of the law for the time being in force are in sufficient for the purpose, may take, or require or empower any person to take, such measures and, by public notice, prescribe such temporary regulations to be observed by the public or by any person or class of persons as 3[it] shall deem necessary to prevent the outbreak of such disease or the spread thereof, and may determine in what manner and by whom any expenses incurred (including compensation if any) shall be defrayed.
(2) In particular and without prejudice to the generality of the foregoing provisions, the {Subs.by the A.O.1937, for” G.G.in C.”} [State Government] may take measures and prescribe regulations for–
(b) The inspection of persons travelling by railway or otherwise, and the segregation, in hospital, temporary accommodation or otherwise, of persons suspected by the inspecting officer of being infected with any such disease.
1. Subs. For the words “Provincial Government” by A.L.O., 1950
2. Subs., for the words “the Province”, by A.L.O., 1950. 3. Subs., for the words “he”, by A.L.O., 1950. 4. Paragraph (a) omitted, by A.L.O., 1950.
5. Sub-section (3) repealed by the Devolution Act, 1920 (33 of 1920). S. 2 and Sch. 1.
2A. Power of Central Government.
1[2A. Power of Central Government.
When the Central Government is satisfied that Indian or any part thereof is visited by, or threatened with, an outbreak of any dangerous epidemic disease and that the ordinary provisions of the law for the time being in force are insufficient to prevent the outbreak of such disease or the spread thereof, the Central Government may take measures and prescribe regulations for the inspection of any ship or vessel leaving or arriving at any port in 2[the territories to which this Act extends] and for such detention thereof, or of any person intending to sail therein, or arriving thereby, as may be necessary.]
1. Subs. by the A.O.1937, for s.2A ins. by Act 38 of 1920, s.2 and Sch.I.
2. Subs. by the Adaptation of Laws (No.2) Order, 1956 for” a Part A State or a Part C State”.
3. Penalty.
Any person disobeying any regulation or order made under this Act shall be deemed to have committed an offence punishable under section 188 of the Indian Penal Code. (45 of 1860).
4. Protection to persons acting under Act.
No suit or other legal proceeding shall lie against any person for anything done or in good faith intended to be done under this Act.
Error of judgement
Supreme Court held that an error of judgement is not amount to Criminal Negligence. Huge relief for doctors as Supreme Court quashed criminal case registered against doctor on the allegations of negligence.
In a very recent judgement pronounced by Hon’ble Supreme Court of India on 6 April 2014 in Criminal Appeal No. 636 of 2017 titled “Dr. Sou Jayshree Ujwal Ingole vs State of Maharashtra & Anr.” Hon’ble court quashed the criminal proceedings against the appellant doctor thereby holding that an error of judgement is not amount to criminal negligence.
The appellant doctor filed appeal before Hon’ble Supreme Court of India against order dated 18 June 2014 passed by Hon’ble High Court of Mumbai, Nagpur bench whereby the petition filed by the appellant doctor under section 482 of the Code of Criminal Procedure for quashing of the criminal proceedings/FIR, was dismissed by Hon’ble High Court.
The Hon’ble Supreme Court referred to its earlier decision titled “Jacob Mathew versus State of Punjab and Anr.” reported at (2005) 6 SCC 1 and reiterated the principles laid down in the said judgement and held that an error of judgement does not amount to criminal negligence and set aside the order and judgement passed by Hon’ble High Court and quashed the entire criminal proceedings against the appellant doctor.
Shekhar Gupta (Advocate) and Dr K K Aggarwal (National President IMA)
Judgment:
Dr. Jayshree Ujwal Ingole vs State Of Maharashtra & Anr on 6 April, 2017
Bench: Madan B. Lokur, Deepak Gupta
IN THE SUPREME COURT OF INDIA, CRIMINAL APPELLATE JURISDICTION, CRIMINAL APPEAL NO. 636 OF 2017, Arising out of SLP (Crl.) No. 7186 of 2014]
Dr. Sou Jayshree Ujwal Ingole Appellant(s) vs State of Maharashtra & Anr. . . . Respondent(s)
J U D G M E N T
Deepak Gupta, J.
2. The appellant herein is a doctor and has challenged the Order dated 18.06.2014 passed by the High Court of Judicature of Bombay, Nagpur Bench in Criminal Application (APL) No. 354 of 2012, whereby the petition filed by the appellant under Section 482 CrPC for quashing the criminal proceedings initiated against her under Section 304-A IPC was dismissed.
3. Briefly stated the facts of the case are that one Shrikrishna Gawai (hereinafter referred to as the ‘deceased’) was admitted on account of injuries suffered in a road accident, in the Irvin Hospital, Amravati on 29.08.1997 for medical treatment. It is the admitted case of the parties that the deceased was suffering from Hemophilia, a disease in which there is impairment of blood clotting. Therefore, special attention was required to be paid during the treatment of the patient. It is not disputed that one Dr. Manohar Mohod was on duty as an Emergency Medical Officer. On 29.08.1997 the patient was treated both by the appellant and Dr. Mohod. On 30 & 31.08.1997, the deceased was attended upon by Dr. Dhirendra Wagh. Thereafter also, the deceased remained in the Hospital under the treatment of the appellant and Dr. Mohod.
4. Dr. Mohod, the Emergency Medical Officer attended upon the deceased on 05.09.1997 at 9.00 p.m. and found that he was suffering from abdominal pain and, thereafter, a call was sent to the appellant, who was Surgeon on Call. It is not disputed that the appellant went to the Hospital on being called. She attended upon the deceased and made a note that a Physician be called. Thereafter, she left the Hospital. In the morning on 06.09.1997, the condition of the deceased worsened and he died.
5. The main allegation against the appellant is that after having called for a Physician, she did not wait in the hospital and did not attend upon the patient, especially when the patient was suffering from Hemophilia. The Physician, Dr. Avinash Choudhary, who is accused No. 1, did not turn up in the hospital. Even next morning on 06.09.1997, when Dr. Mohod again attended upon the deceased, the Physician Dr. Choudhary was not present and, unfortunately, the patient died. Thereafter, a complaint was lodged in the police station, wherein it was alleged by the brother of the deceased that the deceased died as a result of negligence of the three doctors. The complaint was investigated as Crime No. 317 of 1997 which was initially filed against Dr. Avinash Choudhary only but, later on, the names of the appellant Dr. Jayshree Ujwal Ingole and Dr. Manohar Mohod were also included.
6. A separate Departmental Enquiry was also carried out and, in that enquiry, all the three doctors were held negligent in performing their duties. Dr. Mohod was debarred from an annual increment as penalty; the appellant Dr. Jayshree Ingole was permanently prohibited from entering Irvin Hospital, Amravati, and Dr. Avinash Choudhary was transferred. It would be pertinent to mention that Dr. Mohod was discharged in the criminal case on the ground that no case of negligence was made out against him.
7. The appellant herein filed a petition for quashing the charge against her, but this petition was rejected by the learned Single Judge of the High Court of Bombay at Nagpur mainly on the ground that the question whether inaction of the appellant in leaving the deceased at about 11.00 p.m. and not waiting for the Physician to turn up, amounted to a rash and negligent act on her behalf, would be decided during trial.
8. We have heard learned counsel for the parties. Learned counsel for the appellant has placed reliance on the judgment of this Court in Jacob Mathew v. State of Punjab & Anr.[1], wherein this Court held that the court should be circumspect before instituting criminal proceedings against a medical professional.
This Court has held that negligence comprises of (i) a legal duty to exercise due care on the part of the party complained of; (ii) breach of the said duty; and (iii) consequential damage.
It was held that in cases where negligence is alleged against professionals like doctors the court should be careful before instituting criminal proceedings. It is not possible for any doctor to assure or guarantee that the result of treatment would invariably be positive. The only assurance which a professional can give is that he is professionally competent, has requisite skill and has undertaken the task entrusted to him with reasonable care. It would be pertinent to quote the following relevant observations made in Jacob Mathew’s case (supra):
26. No sensible professional would intentionally commit an act or omission which would result in loss or injury to the patient as the professional reputation of the person is at stake. A single failure may cost him dear in his career. Even in civil jurisdiction, the rule of res ipsa loquitur is not of universal application and has to be applied with extreme care and caution to the cases of professional negligence and in particular that of the doctors. Else it would be counter-productive. Simply because a patient has not favorably responded to a treatment given by a physician or a surgery has failed, the doctor cannot be held liable per se by applying the doctrine of res ipsa loquitur.
28. A medical practitioner faced with an emergency ordinarily tries his best to redeem the patient out of his suffering. He does not gain anything by acting with negligence or by omitting to do an act. Obviously, therefore, it will be for the complainant to clearly make out a case of negligence before a medical practitioner is charged with or proceeded against criminally. A surgeon with shaky hands under fear of legal action cannot perform a successful operation and a quivering physician cannot administer the end-dose of medicine to his patient.
29. If the hands be trembling with the dangling fear of facing a criminal prosecution in the event of failure for whatever reason — whether attributable to himself or not, neither can a surgeon successfully wield his life-saving scalpel to perform an essential surgery, nor can a physician successfully administer the life-saving dose of medicine. Discretion being the better part of velour, a medical professional would feel better advised to leave a terminal patient to his own fate in the case of emergency where the chance of success may be 10% (or so), rather than taking the risk of making a last ditch effort towards saving the subject and facing a criminal prosecution if his effort fails. Such timidity forced upon a doctor would be a disservice to society.
30. The purpose of holding a professional liable for his act or omission, if negligent, is to make life safer and to eliminate the possibility of recurrence of negligence in future. The human body and medical science, both are too complex to be easily understood. To hold in favor of existence of negligence, associated with the action or inaction of a medical professional, requires an in-depth understanding of the working of a professional as also the nature of the job and of errors committed by chance, which do not necessarily involve the element of culpability.
After discussing the entire law on the subject, this Court concluded as follows:
“48. We sum up our conclusions as under:
(1) Negligence is the breach of a duty caused by omission to do something which a reasonable man guided by those considerations which ordinarily regulate the conduct of human affairs would do, or doing something which a prudent and reasonable man would not do. The definition of negligence as given in Law of Torts, Ratanlal & Dhirajlal (edited by Justice G.P. Singh), referred to hereinabove, holds good. Negligence becomes actionable on account of injury resulting from the act or omission amounting to negligence attributable to the person sued. The essential components of negligence are three: “duty”, “breach” and “resulting damage”.
(2) Negligence in the context of the medical profession necessarily calls for a treatment with a difference. To infer rashness or negligence on the part of a professional, in particular a doctor, additional considerations apply. A case of occupational negligence is different from one of professional negligence. A simple lack of care, an error of judgment or an accident, is not proof of negligence on the part of a medical professional. So long as a doctor follows a practice acceptable to the medical profession of that day, he cannot be held liable for negligence merely because a better alternative course or method of treatment was also available or simply because a more skilled doctor would not have chosen to follow or resort to that practice or procedure which the accused followed. When it comes to the failure of taking precautions, what has to be seen is whether those precautions were taken which the ordinary experience of men has found to be sufficient; a failure to use special or extraordinary precautions which might have prevented the particular happening cannot be the standard for judging the alleged negligence. So also, the standard of care, while assessing the practice as adopted, is judged in the light of knowledge available at the time of the incident, and not at the date of trial. Similarly, when the charge of negligence arises out of failure to use some particular equipment, the charge would fail if the equipment was not generally available at that particular time (that is, the time of the incident) at which it is suggested it should have been used.
(3) A professional may be held liable for negligence on one of the two findings: either he was not possessed of the requisite skill which he professed to have possessed, or, he did not exercise, with reasonable competence in the given case, the skill which he did possess. The standard to be applied for judging, whether the person charged has been negligent or not, would be that of an ordinary competent person exercising ordinary skill in that profession. It is not possible for every professional to possess the highest level of expertise or skills in that branch which he practices. A highly skilled professional may be possessed of better qualities, but that cannot be made the basis or the yardstick for judging the performance of the professional proceeded against on indictment of negligence.
(4) The test for determining medical negligence as laid down in Bolam vs. Friern Hospital Management Committee (1957) 1 WLR 582 at p. 586 holds good in its applicability in India.
(5) The jurisprudential concept of negligence differs in civil and criminal law. What may be negligence in civil law may not necessarily be negligence in criminal law. For negligence to amount to an offence, the element of mens rea must be shown to exist. For an act to amount to criminal negligence, the degree of negligence should be much higher i.e. gross or of a very high degree. Negligence which is neither gross nor of a higher degree may
provide a ground for action in civil law but cannot form the basis for prosecution.
(6) The word “gross” has not been used in Section 304-A IPC, yet it is settled that in criminal law negligence or recklessness, to be so held, must be of such a high degree as to be “gross”. The expression “rash or negligent act” as occurring in Section 304-A IPC has to be read as qualified by the word “grossly”.
(7) To prosecute a medical professional for negligence under criminal law it must be shown that the accused did something or failed to do something which in the given facts and circumstances no medical professional in his ordinary senses and prudence would have done or failed to do. The hazard taken by the accused doctor should be of such a nature that the injury which resulted was most likely imminent.
(8) Res ipsa loquitur is only a rule of evidence and operates in the domain of civil law, especially in cases of torts and helps in determining the onus of proof in actions relating to negligence. It cannot be pressed in service for determining per se the liability for negligence within the domain of criminal law. Res ipsa loquitur has, if at all, a limited application in trial on a charge of criminal negligence.”
9. Applying the law laid down in Jacob Mathew’s case (supra), we are of the view that this is not a case where the appellant should face trial especially when 20 years have already elapsed. The only allegation against the appellant is that she left the patient. We must remember that the appellant was a Surgeon on Call. She came to the hospital when she was called and examined the patient. As per her judgment, she could find no evidence of bleeding or injury and, therefore, she had noted that a Physician be called. Thereafter, she left the hospital at about 11.00 p.m. True it is that she did not wait for the Physician to come, but it can be assumed that she would have expected that the Physician would come soon. This may be an error in judgment but is definitely not a rash and negligent act contemplated under Section 304-A IPC.
It is nobody’s case that she was called again by the Nursing staff on duty. If the condition of the patient had worsened between 11.00 p.m. and 5.00 a.m., the next morning, the Nursing staff could have again called for the appellant, but they did not do so. Next morning, the doctor on Emergency Duty, Dr. Mohod attended upon the patient but, unfortunately, he died.
10. In the facts and circumstance of this case, it cannot be said that the appellant is guilty of criminal negligence. At best it is an error of judgment.
11. In view of the above discussion, we are of the view that no case of committing a rash and negligent act contemplated under Section 304-A IPC is made out against the appellant. Her case is similar to that of Dr. Mohod who has been discharged. We, accordingly, allow the appeal, set aside the judgment dated 18.06.2014, passed by the learned Single Judge of the High Court of Bombay, Nagpur Bench in Criminal Application (APL) No.354 of 2012 and quash the criminal proceedings initiated against the appellant vide order dated 28.02.2001, passed by the Judicial Magistrate, First Class, Court No.6, Amravati in Regular Criminal Case No. 310 of 1999 in FIR Crime No.317 of 1997. Pending application(s), if any, stand(s) disposed of.
Evergreening
Evergreening is any of various legal, business and technological strategies by which producers extend their patents over products that are about to expire, in order to retain royalties from them, by either taking out new patents (for example over associated delivery systems, or new pharmaceutical mixtures), or by buying out, or frustrating competitors, for longer periods of time than would normally be permissible under the law.
Evergreening is not a formal concept of patent law; it is best understood as a social idea used to refer to the myriad ways in which pharmaceutical patent owners use the law and related regulatory processes to extend their high rent-earning intellectual property rights particularly over highly profitable (either in total sales volume or price per unit) “blockbuster” drugs.
Thus, while the courts are an instrument frequently used by pharmaceutical brand name manufacturers to prolong their patent royalties, evergreening is rarely mentioned explicitly by judges in patent protection cases. The term usually refers to threats made to competitors about a brand-name manufacturer’s tactical use of pharmaceutical patents (including over uses, delivery systems and even packaging), not to extension of any particular patent over an active product ingredient.
The evergreening process has caused some controversy in the pharmaceutical industry. In this context, evergreening may be used by manufacturers of a particular drug to restrict or prevent competition from manufacturers of generic equivalents to that drug.
Goldwater rule
Dr Brendel is a consultant to the American Psychiatric Association (APA) Ethics Committee as well as Director of the Master of Bioethics degree program at the Harvard Medical School Centre for Bioethics, a practicing clinical and forensic psychiatrist at Massachusetts General Hospital, and an Assistant Professor of Psychiatry at Harvard Medical School.
On November 8, 2016, voters elected Donald J. Trump the 45th President of the United States. Trump’s supporters saw strength in his anti-establishment rhetoric, unorthodox public persona, and channeling of resentment of the political status quo. His detractors felt otherwise. Post-inauguration, President Trump continued to behave the way he had as Candidate Trump. Those who supported the President rallied behind him. Those who never did or could no longer support the new President continued the critique.
Some mental health professionals (including Dr Glass), troubled by the new normal, went to the New York Times, without examining the President, without his consent, and based only on the limited knowledge from publicly available data about the President, to publicly air their opinion that the “grave emotional instability indicated by Mr. Trump’s speech and actions makes him incapable of serving safely as president.”
A small number of psychiatrists have been critical of our profession’s restraint regarding public comments by psychiatrists about the mental health of the 45th President. I am the unnamed colleague mentioned in Dr Glass’s article and therefore appreciate the request from Psychiatric Times to offer this critical engagement of the Dr Glass’s critique of the Goldwater Rule, the ethics position of the American Psychiatric Association that prohibits psychiatrists from volunteering public professional opinions about individuals in the public eye.
Precisely in response to questions about the role of psychiatrists in the situation that a psychiatrist, in good faith, believes a public individual poses a threat to the country or national security, the APA Ethics Committee, to which I serve as a consultant, in March of this year clarified the APA’s longstanding Goldwater Rule. One misconception about the APA’s position was that it only applied to rendering a psychiatric diagnosis of a public figure.
However, the Goldwater rule has, since its inception, referred broadly to “professional opinions,” not just to diagnosis. The March 2017 Ethics Committee Opinion sought to clarify the meaning of “professional opinion” and reaffirm the rationale for the APA position. It was not an expansion of the decades-old APA position, and it is not a gag rule. It does, however keep medical diagnosis in a medical setting and out of the media.
At the core of Goldwater doctrine are the fundamental considerations that psychiatrists do their work and formulate psychiatric opinions with respect for persons (including permission and privacy) and through established methods, including examination, history-taking, and collateral inquiry. Dr Glass attempts to obfuscate this ethical underpinning of the Goldwater position, in part, by drawing an artificial distinction between the professional role of the psychiatrist in clinical and non-clinical settings. However, the sound principles of ethics and professionalism apply regardless of whether an encounter is what he would define as clinical or non-clinical.
A first consideration behind Goldwater is the fundamental ethical principle of respect for persons. In order to respect persons, psychiatric evaluation of an individual occurs with consent or other authorization and with clear parameters of expectations regarding privacy of the encounter and assessment. Respect for persons in the setting of rendering professional judgments does not require that an individual establish a clinical relationship. Even absent an examination, making professional judgments about an individual’s mental health is intrusive and can have negative consequences. We need not look further than Barry Goldwater to see that these conclusions, even when “non-clinical,” can be harmful.
A second justification for the Goldwater Rule involves the methods of the profession: psychiatric evaluation and diagnosis is a medical endeavor that occurs in the context of an evaluation, based on thorough history taking, examination, and collateral information. Psychiatric opinions based on insufficient data and/ or method, whether they include diagnoses, compromise both the integrity of the individual psychiatrist and the profession. This behavior also has the potential to lead patients to question the rigor and confidentiality of their own care, or discourage those suffering from mental illness from seeking help for the same reasons.
It is simply not the case that there are separate standards for “clinical” and “non-clinical” contexts. Rendering an opinion, as a psychiatrist, is a medical opinion in any context. The difference is that when it occurs in the media based on observation from afar, or what the author considers a “non-clinical” context, the opinion is given without the rigor and methodology that justifies its conclusions. It is conjecture, albeit based on general psychiatric knowledge and accumulated experience, masquerading as medical truth about a particular individual. The statement, in other words, seeks validation by proxy of the professional qualifications and general psychiatric knowledge of the speaker as a substitute for the actual work and expertise of the profession required to justify the conclusion. And the public nature of the statement draws attention to the speaker rather than focusing on the medical interest of the subject of the statement.
The ethical psychiatrist’s conduct in the media is no different from the ethical conduct of any other physician. In the example of an orthopedist offered by the author, the orthopedist may consult to the media with clear articulation of the parameters that he or she has not examined the particular individual, does not have permission to speak about the particular individual, but will offer general information about types of injuries or other conditions and their care. Alternatively, if a diagnosis is publicly known, the orthopedist may discuss, in general, the features of the condition, its treatment, and expected course. The Goldwater position permits, even encourages, the same from psychiatrists in order to educate the public about psychiatric illnesses and their treatment.
The Goldwater position also aims to prevent stigma by delineating the bounds of professional norms and creating separation between the discourse of capacity to govern and the diagnosis of a mental illness. Linking capacity to govern, a political and legal determination, with mental illness per se stigmatizes mental illness by erroneously characterizing the mere presence of psychiatric symptoms as incompatible with performance of one’s responsibilities for governance. Especially for those in the public eye, this linkage may perpetuate a chilling effect on seeking treatment for mental health concerns. Instead, public education that psychiatric symptoms are treatable, common, and even expected in some situations has the potential to destigmatize treatment-seeking.
Uncoupling the public discourse of capacity to govern from the rubric of mental illness further allows the determination of fitness to govern to remain squarely where it constitutionally belongs, in the government itself. In the case of the president, the 25th Amendment provides a framework for addressing concerns of presidential fitness. Within this framework, if a psychiatrist has actual knowledge or serious concern about the mental health and fitness of a president, the appropriate audience with whom to share this concern is not the New York Times or other media outlet, but privately with the medical or other government personnel whose role it is to evaluate the health and fitness of the President to continue in that role.
The difference in the audience and public nature of the professional opinion separates politics from medicine, and gives the psychiatrist who feels strongly about the ability of the president to govern an appropriate forum to voice his medical concerns. As Dr Glass states, there are indeed two interests at stake in this discussion: the issue of the profession’s public image and members’ rights to follow their conscience. Taking the discussion out of the media and into the medical realm addresses both of these considerations.
The key to Goldwater is that psychiatrists should not be rendering professional opinions on their own account in the press or on TV without license and inconsistent with the methods of the profession. Goldwater has always intended to protect the integrity of psychiatric practice by highlighting the perils of proceeding publicly, without license, and with insufficient data in making assessments about the mental health of public figures. It is not meant to and does not exclude psychiatrists from important work in the public interest.
GST AND NURSING HOME AND PATHOLOGY LABS
Dhirajlal Rambhia KVO Merau Kutchh Health Care Services by a clinical establishment, an authorised medical practitioner or para-medic is exempted under GST. Under this exemption, all treatment or diagnosis or care for any illness, injury, deformity, abnormality or pregnancy by a clinical establishment is covered. Authorized medical practitioners in any recognized branch of medicine like private medical practitioners (doctors), physiotherapists are also exempted from service tax. The term para-medico is not defined in the Act.
However, it has been clarified in the Education Guide that Paramedics are trained health care professionals, for example nursing staff, physiotherapists, technicians, lab assistants, etc. Services by them in a clinical establishment would be in the capacity of employee and not provided in independent capacity and will thus be considered as services by such clinical establishment.
Similar services in independent capacity are also exempted. Such treatment or care of patient could be in any recognized system of medicines in India like Allopathy, Naturopathy, Ayurveda, Homoeopathy, or Unani. These systems of medicines are recognized in terms of cl. 2(h) of the Clinical Establishments Act, 2010. Any other system of medicine that may be recognized by the Central Government is also been entitled for this exemption. However, it does not include hair transplant or cosmetic or plastic surgery, except that such surgery is undertaken to restore or reconstruct anatomy or functions of body affected due to congenital defects, developmental abnormalities, injury or trauma; The clinical establishment would mean any hospital, nursing home, clinic, sanatorium or any other institution by whatever name called. It could be a place established as a part of an establishment or any private diagnostic center like x- ray clinic, pathological laboratory or any diagnostic or investigative center.
GST act and health care
Question on GST act: I am a practicing Clinical Doctor. I purchase medicines from suppliers and in the process pay them GST (previously called as VAT) on the bills received from them. I then dispense medicines to my patients and issue them receipts including consultation dispensing fees. It goes without saying that the cost of medicines so dispensed to medicines includes the GST component too. Am I covered under the GST Act? To what extent are healthcare services covered under the GST Act? Are healthcare products covered under the GST Act? How are products different from services as per the GST Act? Do I have to register for a GST number under the GST Act, 2016? Can I recover ‘input tax credit’ (as paid to supplier’s vis-a-vis when collected from patients while dispensing medicines to them) under the GST Act?
Answer: 1. Healthcare services are exempt from GST under the GST Act, 2016. Healthcare products are not exempted, however. Healthcare products are chargeable. 2. Healthcare services include services rendered for treatment at a healthcare facility. Healthcare products include medicines, instruments, machines, equipment’s, infrastructure, etc. 3. When a Doctor dispenses medicines, they form part of healthcare services (as per the GST Act) and for a reasonable period of time (as per IMC Rules, 2002), they are nevertheless ‘healthcare services’ as a whole and are therefore not chargeable to GST. Please note that ‘services’ are defined under the GST Act, but ‘reasonable period’ is not defined by either the GST Act, 2016 or the Indian Medical Council Rules, 2002. 4. Dispensing is not same as selling. Selling is not same as dispensing. When a Doctor charges a fee for services rendered that includes fees medicines as a whole, it is a service (as per GST Act) and called dispensing (as per IMC Rules). It is not called as selling medicines. This is exempted under the GST Act. 5.. However, if a Doctor charges for medicines/other healthcare products solely, these are chargeable for GST. 5. There is no need for Doctors to register under the GST if they are providing only healthcare services. 6. If they are selling, then only one needs to register. Anyways, a Doctor cannot sell medicines unless he is involved in a trade of medicines/healthcare products. 7. In short, GST does not change anything for practicing Doctors. GST is Goods & Services Tax, and replaces many taxes like VAT, etc. as they were in use previously. 8. Input tax credit can be availed by Doctors if they are involved in a trade of medicines/healthcare products, not while dispensing medicines to their patients. –
GST AND PHARMA INDUSTRY
The long-awaited Goods and Services tax (GST) Bill has been passed by both houses of India. There will be significant improvement in Indian Pharmaceutical industry’s supply chain efficiency as well as a decline in manufacturing cost of Pharmaceutical products.
The long-awaited Goods and Services tax (GST) Bill has been passed by both houses of India. There will be significant improvement in Indian Pharmaceutical industry’s supply chain efficiency as well as a decline in manufacturing cost of Pharmaceutical products.
Post GST, Pharmaceutical industry’s traditional cost and distribution model will get replaced by supply chain efficiencies. The central tax subsumed under GST and interstate transactions between two dealers will become tax neutral. This will lead to decrease in cost which can be added to margins.
GST will also have positive effect on warehousing strategy. There are many of the pharmaceutical companies maintaining their warehouses in different states in order to avoid Central Sales Tax (CST) of different states. Post GST, manufacturers can set their warehouses at their strategic locations and consolidation of warehouses will take place across the sector.
There are various negative impacts on industry post GST. The medicines which are taxed at 5 per cent in some of the states will witness increment of another 13 per cent. In addition, it will impact free-drug samples, bonus schemes and the expired material return system followed by companies from the sector. Overall, on the Pharmaceutical sector impact will be neutralized.
The Goods and Services tax (GST) is one of the India’s biggest indirect tax renovations. It is expected to be beneficial for Indian drug makers in long run as its objective is to simplify tax structure and bring operational efficiency. However, the details such as the application of the rates to Pharma is not known and we think that the government will stress on the fact that essential medicines should have minimum taxes. However, GST is welcomed as it creates a level playing field for pharmaceutical companies and will eventually benefit the consumers. Considering the health care and Pharma industry, it is expected that the new GST regulation would benefit the consumers by making affordable health care. The whole industry is waiting for the details of tax rates, exemptions and legislative framework for implementation that is to be finalized by the GST Council.
It is believed that information technology will play a crucial role in its effective execution and hence it is necessary to have durable infrastructure to ensure seamless compliance and tax administration but analysts warned that there will be very less effect on inflationary impact of GST on prices of medicines in the short run of one or two years. Also, the impact on pricing of drugs will be neutral up to 12% tax rate and beyond that there will be inflationary effect to some extent. The main concern is the rate of GST must be kept at a competitive level in order to have no increase in prices of drugs and medicines.
GST may also have impact on companies to clean up their supply chain in order to save taxes. GST will be a win-win situation for both pharmaceutical companies and consumers. The simplification of supply chain and improved operating environment will alone add 2% to the size of the Pharma market and even a 2% reduction in production or distribution cost of medicines will add the profits up to 20%. It is the single biggest benefit in the arm for the pharmaceutical industry and it creates competitive advantage for those who move early. The Indian pharmaceutical industry has the domestic turnover of over $15 billion and has been witnessing high growth in the past decade but it is still facing problems like cumbersome taxation, heavy competition and increasing price controls and the new GST regulation will overcome such problems. The main drawback of the GST is that it is still not clear that whether the healthcare sector as well as life-saving drugs and medical devices will be continues to be exempted from the taxes after the implementation of the Act.
GST to benefit pharma industry, but pricing remains a concern
GST is expected to be a win-win situation for drug makers as it will not only simplify tax structure but also create a level-playing field for pharmaceutical companies
The goods and services tax (GST), India’s biggest indirect tax reform, is expected to be beneficial for Indian drug makers in the medium to long run as it aims to simplify tax structure and bring operational efficiency. However, concerns about drug prices, exemptions and compliance remain.
“The details such as what rate is applicable to pharma is not known, but we think the government will be conscious of the fact that essential medicines should have minimum taxes,” said D.G. Shah, secretary general of Indian Pharmaceutical Alliance, the industry lobby group that represents large domestic Indian drug makers.
Shah welcomed GST saying that it creates a level playing field for pharmaceutical companies and will eventually benefit consumers.
“As far as the health care and pharma industry is concerned, it is expected that the new GST legislation would benefit the consumers by making affordable health care a reality,” said Ramesh Swaminathan, chief financial officer and executive director of Lupin Ltd, India’s third largest drug maker.
Swaminathan said his company is waiting for details such as tax rates, exemptions and legislative framework for implementation that needs to be finalized by the GST Council.
“We believe that IT will play a crucial role in its effective execution, therefore it is necessary to have robust infrastructure to ensure seamless compliance and tax administration,” Swaminathan said.
Analysts warned that there could be mild inflationary impact of GST on prices of medicines in the short term of one-two years. “Up to 12% tax rate, the impact on pricing of drugs will be neutral. Beyond that, there will be some inflationary effect,” said an analyst tracking the sector who didn’t want to be named citing his company’s policy.
“The concern is that the rate of GST should be kept at a competitive level so that there is no increase in prices of drugs and medicines,” said Utkarsh Palnitkar, partner and head-pharmaceuticals and life sciences at KPMG in India
GST may also require companies to clean up their supply chain, to save taxes.
“Most likely, there will be a need to move to a hub-and-spoke model with primary and secondary hubs across states which could also necessitate an overhaul in the way companies choose their warehousing network with cities like Chandigarh, Lucknow, Guwahati and Nagpur emerging as primary hubs in addition to the metros,” said Palnitkar of KPMG.
Most analysts have pointed out that despite initial issues of tax rate and compliance, in the long run GST will be a win-win situation for both pharmaceutical companies and consumers.
“The simplification of supply chain and improved operating environment will alone add 2% to the size of the pharma market,” Sujay Shetty, leader of the pharma and life sciences at PWC India.
Even a 2% reduction in production or distribution cost will add to the profits by over 20%. It could be the single biggest shot in the arm for the pharmaceutical industry and create competitive advantage for those who move early,” said Manish Panchal, practice head-chemicals, life science and supply chain, and Siddharth Paradkar, principal-logistics and supply chain, at Tata Strategic Management Group in their latest report.
The Indian pharmaceutical industry, with a domestic turnover of over $15 billion, has been witnessing high growth over the past decade. But it is facing problems like cumbersome taxation, heavy competition and increasing price controls.
Guidelines for issuing a Medical Certificate
(a) Medical certificates are legal documents. Medical practitioners who deliberately issue a false, misleading or inaccurate certificate could face disciplinary action under the Indian Medical Council (Professional Conduct, Etiquette and Ethics), Regulations, 2002.
b) The certificate should be legible, written on the doctor’s letterhead and should not contain abbreviations or medical jargon.
The certificate should be based on facts known to the doctor. The certificate may include information provided by the patients but any medical statements must be based upon the doctor’s own observations or must indicate the factual basis of those statements.
C) The certificate should: –
1. Indicate the date on which the examination took place
2. Indicate the degree of incapacity of the patient as appropriate
3. Indicate the date on which the doctor considers the patient is likely to be able to return to work
4. Be addressed to the party requiring the certificates evidence of illness e.g. employer, insurer, magistrate Indicate the date the Certificate was written and signed.
5. Name, signature, qualifications and registered number of the consulting Registered Medical practitioners
6. The nature and probable duration of the illness should also be specified.
7. This certificate must be accompanied by a brief resume of the case giving the nature of the illness, its symptoms, causes and duration.
8. The medical certificate under normal circumstances, as a rule, should be prospective in nature i.e. it may specify the anticipated period of absence from duty necessitated because of the ailment of the patient. However, there may be medical conditions which enable the medical practitioner to certify that a period of illness occurred prior to the date of examination.
9. Medical practitioners need to give careful consideration to the circumstances before issuing a certificate certifying an illness prior to the date of examination, particularly in relation to patients with a minor short illness which is not demonstrable on the day of examination and should add supplementary remarks, where appropriate, to explain the circumstances which warranted the issuances of certificate retrospective in nature.
10. It is further observed that under no circumstances, a medical certificate should certify period of absence from duty, for a duration of more than 15 days. In case the medical condition of the patient is of such a nature that it may require further absence from duty, then in such case a fresh medical certificate may be issued.
11. Record of issuing medical certificate-Documentation should include: Patient to put signature/ thumb impression on the medical certificate. Identification marks to be mentioned on medical certificate That a medical certificate has been issued
12. An official serially numbered certificate should be utilized. The original medical certificate is given to the patient to provide the documentary evidence for the employer. The duplicate copy will remain in the Medical certificate book
We can deny it …. only patient can apply for the certificate. Patient’s consent is essential to issue a certificate.
You can also say that…… you would like to examine again before you issue a certificate again because …… there is a possibility of change in diagnosis…… hence request the family to bring the patient
Finally, if you have to issue
Request the medical board of your hospital to help you. A board can issue
Certificate can also be issued about the past and mentioning…… that *I have not examined him or seen in the past two years* hence *the treating psychiatrist needs to examine the patient before a final certificate is issued*
*very important note for all psychiatrist*
Never issue a mentally normalcy certificate ……. first time when you assess a person for some vague reason.
Please use negative language…. when issuing a negative or normalcy certificate …… for example, *on detailed examination dated …. I couldn’t find a signs and symptoms of severe mental disorder* for confirmation patient needs to be admitted inpatient and evaluated for a period of 2 to 3 weeks
Signatures or thumb impression of patient are essential on body of certificate which should never be affixed involuntarily and hence certificate cannot be issued against consent of the patient.
Hathi committee
1.1 Health is a fundamental human right. The Constitution of India directs the State to regard the improvement of public health as among its primary duties. The Five-Year Plants have been providing the framework within which the Centre and States have developed their health services infrastructure and programmes. Since the attainment of Independence considerable progress has been achieved in the promotion of health status of the people – as reflected in the eradication/control of diseases like small-pox, malaria etc., reduction in mortality rate, rise in life expectancy, creation of a fairly extensive network of health care institutions and the availability of a large stocks of medical and health personnel.
1.2 The National Health Policy of 1983 marks a significant step in the national endeavor to improve public health. It reiterates India’s commitment to the goal of “Health for all by the year 2000 A.D.” through the universal provision of comprehensive primary health care service. The attainment of this goal requires an accelerated development of all inputs to the health care system, including essential and lifesaving drugs and vaccines of proven quality. Drugs alone are not sufficient to provide health care. However, if rationally used, they do play an important role in protecting, maintaining and restoring the health of the people and in controlling population. The Indian Pharmaceutical Industry has, therefore, a vital role in serving the basic health needs of the people.
1.3 The Report of the Hathi Committee (1975) is an important landmark in the development of the Indian Pharmaceutical Industry. The Hathi Committee emphasized the achievement of self-sufficiency in medicines and of abundant availability at reasonable prices of essential medicines. Since 1975, the Indian Pharmaceutical Industry has grown to be the most diversified and vertically integrated pharmaceutical industry in the entire Third World. The country has achieved self-sufficiency in formulations and also in a large number of bulk drugs. In 1984-85, imports of formulations were only Rs.10.17 crores or about 0.5% of the total formulation production in the country and imports of 49 bulk drugs were negligible. Technologies for the production of several bulk drugs, including antibiotics like Ampicillin, Amoxycillin, Erythromycin, Anti-infectives like Sulphamethaxazole and Trimethoprim., anti-TB drugs like Ethambuto Cardio Vascular drugs like Methyl Dopa; Analgesics like Ibuprofen and Isopropyl antipyrine; anti – amoebics like Metronidazole and Tinidazole, anti-cancer drugs like Vinblastine, Vincristire and Cisplatin were indigenously developed. The trade balance in pharmaceuticals is also improving as a result of increasing exports. In 1984-85, exports of drugs and formulations were Rs.217.49 crores while imports were Rs.215.62 crores. A wide range of bulk drugs and formulations are being exported to several countries, including the U.S. and the West European countries. Some Indian firms have also set up production facilities in other countries and are also engaged in the sale of turnkey plants and technical services. The diverse production and technological capabilities developed by the Indian Pharmaceutical Industry are valuable assets in achieving the goals of the National Health Policy and in fully harnessing the export potential.
1.4 While these achievements are impressive by themselves, there are many areas where the industry has to reorient itself if it has to effectively serve the health needs of the people. The present production pattern does not adequately reflect the genuine requirements of the health care needs of the country. The proliferation of formulations and packs without adequate therapeutic rationale is a matter of concern. While many firms in the organized as well as small scale sector have excellent internal testing facilities and a good record of quality control and adoption of good manufacturing practices, the same cannot be said of a large number of firms manufacturing formulations. The present institutional and statutory arrangements for enforcing quality control for registration of new formulations, for monitoring adverse reactions and for dissemination of unbiased information about the safety and efficacy of products marketed in the country are far from being adequate.
1.5 Abundant availability on a continuous basis, at reasonable prices, of essential, lifesaving and prophylactic medicines of good quality, is the corner stone of the new measures. It shall be the endeavor of the Government to ensure that the above objective, which is in consonance with the Government’s Policy of reaching Healthcare facilities to the common masses and with that of ensuring Health for all by the year 2000 A.D., is achieved. In order to sub serve this objective, changes have been brought about in the system of price control of drugs as well as in the licensing and approval procedures. Experience gained in the implementation of the Drugs (Prices Control) Order, 1979 has clearly shown that the pricing system needs to be simplified and rationalized, if the benefits of the price control are to be effectively realized by the consumer, particularly the weaker sections of the society for safeguarding whose interests the Government is committed. The span of price control at present is impracticably large covering 347 bulk drugs and over 4,000 formulations marketed in about 20,000 packs. It is proposed to reduce to a considerable extent this span of control and to make the price control system less cumbersome but more effective.
1.6 As prices of drugs are also determined by the cost effectiveness of domestic production, it is imperative to impart a technological and productivity thrust to the Indian Pharmaceutical Industry which would also enable it to harness export opportunities. The objective of ensuring abundant availability of medicines at reasonable prices, will be best served by promoting competition and economic scales of production and also by removing unnecessary barriers to growth. To this end, licensing and approval procedures have been simplified and greater flexibility given in order to those of essential and lifesaving drugs. The validity of this premise has already been established by the experience, in recent years, with the market prices of bulk is produced by a good number of manufacturers. At the same time, FERA companies will continue to be regulated by Government to ensure that their operations are in consonance with the national objectives and priorities.
1.7 It is against this backdrop that the Government has reviewed the functioning of the Drug Policy and now restructured the Policy in the light of the experience gained and keeping in mind the objective of achieving “Health for All by the Year 2000 A.D.”
Hippocrates could not have seen this coming.
A man was brought to Apollo Gleneagles Hospital in Kolkata from a road traffic accident with severe injuries. Unable to afford the cost of care there, he was moved to the Government tertiary care hospital IPGMER where he died within 4 hours of being moved. This piece of news resulted in the government and much of media alleging Apollo had tried to extort money from the patient’s family before letting him be discharged. In February this year, the CMRI Hospital, in another part of the city, was vandalized by local goons and doctors and other staff attacked. Shortly after the Apollo incident, in Medica, another private hospital in the city, a patient had a myocardial infarct, and despite efforts to treat him, died. The dominant media made no effort to explain any other viewpoint, or even the real reason for the death save the most titillating and damning (of the doctors and the hospitals). Any viewpoint of the hospitals or the attending doctors were silenced or not heard at all in the media brouhaha about standards and costs of care in private hospitals. There is much ongoing talk about the allegedly immoral methods employed by these hospitals to extract money from patients.
Doctors are killing people and understand only money.
Private hospitals are fleecing patients
Suddenly doctor-bashing is in fashion and doctors and private hospitals are under attack. Long beleaguered out of their ‘god’ status in this country, a doctor now is the new enemy. As with almost everything, there is a kernel of truth in the perception, but what is missing is a proper understanding of where the blame should lie.
In an unprecedented move to address grievances against private hospitals, the state government is set to rid patients of the liability to pay for treatment, through the amended Clinical Establishments Act. It has also sought to relax penalty provisions against patient parties charged with ransacking of hospital premises. It is a measure of the trust deficit in the doctor-patient relationship that the average man is ready and eager to believe the political rhetoric and lap up the populist mantra.
Access to healthcare facilities and decent schools are essential parts of civilized society and for many years now, political parties and governments in India, and particularly in West Bengal, have abrogated their responsibility to provide adequate healthcare to the people. Instead of improving cover and standards of public healthcare, the government and politicians – across all parties – have consistently tried to deflect public opinion by trying to portray private hospitals as the culprits, out to fleece people. There is little merit in comparing West Bengal or Calcutta with Chennai/Mumbai/Delhi. In the latter, there are government hospitals, which, if not comparable to private hospitals in plushness, offer quality medical care. It has long not been the case in West Bengal. Private hospitals have thus come up to fill that lacunae. But in West Bengal, people have started to feel private healthcare is an essential service, which, however unpopular the view, they are not. That onus should rest on public healthcare. The sense of entitlement they feel is targeted towards private hospitals when it should be against the government. And because people have started to feel private healthcare is a right, they are agitated when it becomes too expensive to afford. Politicians, however, over the years have fanned those feelings to hide their own inadequacies or indeed near-criminal lack of accountability that has almost become the hallmark of politics in the state.
We must understand that no healthcare is free – government hospitals are funded by the tax-payer’s money and are actually more expensive – if you factor in the enormous numbers of redundant staff employed and the consequent disguised unemployment – than a section of private healthcare. Understand also that the public healthcare system is not being brought under the purview of the law, for reasons quite unfathomable to the sane mind, displaying a blatant disregard for even common fair-play, as well as, if you think about it, an utter devaluation of human lives who are dependent on public healthcare. The people desperate enough to avail public healthcare seem not to deserve any of the compensation and quality guaranties.
There already were in place several ways in which patient grievances could be settled, the most logical one being to complain to the medical council who deliberate on the allegations, consult specialists in the field for a proper decision. The patient could go to the consumer court or complain to the government. The police had no role to play in any of these deliberations, and came only if there was criminal negligence. A private complaint could not be entertained unless the complainant could produce prima facie evidence before the court in the form of a credible opinion given by another ‘competent’ doctor and as the complaint got escalated, it would always involve medical experts to provide unbiased and proficient opinion. It can never be possible to cap medical costs despite complications and suggesting that it can be, speaks of a total lack of perspective about what proper medical care entails. Real issues which should be taken up with the corporate hospitals are not being taken up as they are not going to find popularity.
There is heavy irony and it should not be lost, that the current bill, with its layperson’s commission adjudicating on medical matters and deciding criminal negligence ‘shall not be bound by code of civil procedures but have the same power as vested in a civil court under the civil court procedure’. The Bengal government and the commission ‘shall be protected from prosecution, suit or any other legal proceeding’, and ‘no civil court shall have jurisdiction’ over the commission. So, in essence the government is bypassing the judiciary with a commission who are neither independent, nor from the judicial system (who by definition would be independent) and are certainly not competent to judge medical criminal negligence cases.
Despite the Supreme Court ruling that all complaints need to first be referred to a competent doctor or committee of doctors specialized in the field related to which the negligence is attributed, the amended Bill deliberately, in a blasé fashion subverts due process of law and provides blanket power to a commission not professionally competent to make any assessment of the medical situation to pronounce judgment. This is a clear pathway for corruption to make immediate inroads. It will also mean that smaller hospitals, which cannot afford to pay the hefty compensations necessitated by this law, will close down, making the patients – who cannot afford corporate hospital care but don’t want to go to government hospitals either – the ultimate loser.
“A consequence of encouraging litigation for loss is to persuade the public that all loss encountered in a medical context is the result of the failure of somebody in the system to provide the level of care to which the patient feels entitled” (actual statement by the Supreme Court). The effect on the doctor-patient relationship is already plumbing depths in this miasma of complete breakdown of trust and will not be to the benefit of the patient in the long run. Doctors, who surprisingly, are humans too, and have families for whom they need to protect themselves, will tend to practice defensive medicine, ordering more tests, which will hike up expenses even more. They will stop taking in emergency patients because of the fear of reprisals if anything goes wrong, and by its very nature, there are huge risks involved in any emergency medical care. Patients sometimes die, despite best efforts. If that is always going to be viewed as the hospital’s (note: private hospitals) unscrupulousness and the doctor’s criminal negligence, it is not level playing field, I am afraid. Many who have been trained abroad and wanted to come back with a genuine wish to work here are already planning to leave the state, and sometimes, even the country.
Also, and I am never sure why nobody thinks along those lines, but if lawyers, architects, interior designers and heck, even beauticians charge hefty fees, it is supposed to be a sign of their professional standing. I know women who would not think twice before spending Rs 3000 to colour their hair, complain about doctors’ fees. I know people who go to lawyers who charge by the tens of thousands for a fifteen-minute hearing in court, and then they sometimes even lose – but the lawyer is not held by his collar or thrashed because he has lost the case. I know interior designers who charge the earth, and that is a feather in my very expensive cap if I can employ him or her. I am never sure why medicine makes patients feel so democratic.
Meanwhile, our politicians and media will dance around issues when it suits them, but go out of country or state or to these very same private hospitals for their own treatments.
HIPPOCRATIC OATH
I swear by Apollo, the healer, Asclepius, Hygeia, and Panacea, and I take to witness all the gods, all the goddesses, to keep according to my ability and my judgment, the following Oath and agreement:
To consider dear to me, as my parents, him who taught me this art; to live in common with him and, if necessary, to share my goods with him; To look upon his children as my own brothers, to teach them this art; and that by my teaching, I will impart a knowledge of this art to my own sons, and to my teacher’s sons, and to disciples bound by an indenture and oath according to the medical laws, and no others.
I will prescribe regimens for the good of my patients according to my ability and my judgment and never do harm to anyone.
I will give no deadly medicine to any one if asked, nor suggest any such counsel; and similarly, I will not give a woman a pessary to cause an abortion.
But I will preserve the purity of my life and my arts.
I will not cut for stone, even for patients in whom the disease is manifest; I will leave this operation to be performed by practitioners, specialists in this art.
In every house where I come, I will enter only for the good of my patients, keeping myself far from all intentional ill-doing and all seduction and especially from the pleasures of love with women or men, be they free or slaves.
All that may come to my knowledge in the exercise of my profession or in daily commerce with men, which ought not to be spread abroad, I will keep secret and will never reveal.
If I keep this oath faithfully, may I enjoy my life and practice my art, respected by all humanity and in all times; but if I swerve from it or violate it, may the reverse be my life.
Hippocrates wrote an oath for Physicians circa 350-370 BC. Medicine in those times was considered a holy service meant to heal the sick and not a profession. With time medicine became a profession and monetary benefit for the work done became an accepted norm. Doctors came under normal laws of the land. The application of the Consumer Protection Acts to Medicare redefined the status of doctors to ordinary vendors/service providers and their demi-god status was taken away. Patients were no longer patients but consumers.
Of late, doctors are being labelled as criminals, cheats, swindlers and what not. Doctors are on media trial almost daily for botched up surgeries, financial frauds, seeking commissions/incentives from drug companies/labs and misconduct, amongst other things. The reputation pendulum of doctors has swung from being good-doers to evil devils.
It is time we introspect our current status in society. Are we in social service or are we business professionals? In case our role is service of the humanity, why are governments shifting healthcare services to the private sector? Why are doctors not trained and looked after by the government? Why is medical education so expensive?
In case we are business professional, why does the society expect us to perform social service? Why are doctors penalized in case a complication occurs while treating a patient, but no other professional is? All professions have some bad sheep but that does not mean all are the same. Most doctors follow the ethical standards they are expected to follow. Some don’t! One should reason why they don’t! Is there some pressure on them from their employers to over reach and cheat? Do they have some business targets to meet? Or is it the general influence of the society, which is rife with corruption?
Most medical councils require qualified doctors to undertake the Hippocratic oath before being allowed to practice medicine. The oath burdens them with a social and ethical responsibility. Seeking monetary benefit is against the clause enshrined in the Hippocrates oath on maintaining conscience and dignity. The relevance of the Hippocratic oath is today’s world is questionable. The society needs to clear this confused status of doctors! Why this hypocrisy about the Hippocratic oath!
The society must decide whether the doctors must take the Hippocratic oath or just be professionals
IMA White Paper on Indian Medical Service
Historical perspective
The Indian Medical Service owes its origin to the East India Company formed by the British. It was on December 31, 1600 that Queen Elizabeth granted a charter to the Association of Merchant Adventures of London to trade with the East, which gave birth to the East India Company. As a matter of fact the establishment of the company was a result of a huge struggle amongst the nation for the control of lucrative spice trade, in which to begin with the Venetians, then the Portuguese, the Spaniards, the Dutch, the French and finally the British came to be drawn into the treasure hunt.
For the said trade, the First Fleet of the East India Company under the command of Captain James Lancaster, in December, 1600 sailed out. Each of the four ships in the fleet carried ‘Surgeons’ and a ‘barber’. They came to be designated as ‘Ship Surgeons’. This was also the voyage, which resulted in experiment on lemon juice as a cure for scurvy.
With the establishment of trading posts around India, more surgeons and physicians found employment not only with Europeans but also in the service of wealthy natives. These men of medicine included Nicholas Manucci, a Venetian, born in 1639, who served Dara Shikoh before studying medicine in Lahore where he served Shah Alam from 1678 to 1682. An Armenian named Sikandar Baigh served as Surgeon to Suleman Shikoh, son of Dara Shikoh and there are records of several Dutch and French physicians in courts across India.
Surgeons were also availed for diplomatic missions to various courts and they were found to be very effective. Operationally speaking, the Indian Medical Service (IMS) was a military medical service in British India, which also was attributed some civilian functions. It has served during the two world wars and remained in existence until the independence of India in 1947. Many of its officers who were both British and Indian served in civilian hospitals as well.
The East India Company in 1614 introduced a hierarchy in their establishment with the appointment of a Surgeon General. The first to be appointed to the said post was John Woodall. However, he was accused of financial embezzlement in respect of pay from apprentices as a result of which he was retrenched in 1642.
There are many anecdotes of which one of the important depictions is of Gabriel Boughton who is reported to have saved Shahjahan’s daughter Princes Jahanara from injuries due to burns. In reward he was given Duty Free Trading Rights and it is said that it was the very document, which was availed by the East India Company to procure Rights for itself from the ruler in Surat.
Historically speaking the First sign of organization came into being with the establishment of the Bengal Medical Service on 20th October, 1763, with fixed grades, rules for promotion and services. On the similar lines Madras Medical Services and Bombay Medical Services came to be established in 1764. It was due to increased military actions that compelled the separation of ‘Military Surgeons’ from the ‘Civil Surgeons’.
As a matter of rule each non-native military regiment had a surgeon and as a result of which the strength of the medical service grew. A census record of 1854 reveals that the Bengal Medical Service had a strength of 382, while Madras Medical Service had 217 people and Bombay Medical Service had a strength of 181. The medical services of these three Presidencies were united into a single Indian Medical Service after 1857, which was in vogue till 1947.
The personnel under the medical services contributed to the foundation of other departments as well under the organization of the Govt. Dr William O’Shaughnessy, while serving as Professor of Chemistry at Calcutta conducted the first experiment for the introduction of electric telegraph in India and was designated as Director General of Telegraphs in 1852. In 1861, Dr James Rankin was appointed as Director General of Post Offices in India. Dr John Royale represented the East India Company as a Reporter on their economic products as the great exhibition of 1851 and the first four appointments of Conservator of Forest were also filled by the Medical Officers under the medical services of the presidencies.
In 1858, when the Crown took over the Government of India, and in the context of several epoch-making developments that were occurring in the art of medicine the Indian medical service entered upon a new phase of the history. The General Hospitals were built in the presidency towns and several smaller hospitals and the dispensaries came to be established in the Districts. In 1835, a medical college was founded at Calcutta and another one at Madras. A decade later another medical college was instituted at Bombay. From 1853 onwards, several medical schools were laid out, which mandated the services of the medical officers working under the presidential medical services to be availed for teaching at the initiated medical schools till they had trained graduates to succeed them.
The Indian Medical Service always primarily remained a military service so as to provide medical officers for duty with the Indian Army in the time of War. During the 1914-1918 First World War, the service was represented in France, Palestine, Asia Minor, Persia, China, East and West Africa. Ninety-two Retired officers rejoined for duty and well over 1000 temporary commissions came to be granted. Likewise during the Second World War, more than 1000 filled medical units were mobilized over and above, the hospital accommodation for 11000 officers and 1.50 lakh other ranks arranged for in India. In the course of all these, members of the Indian Medical Service earned ‘Victoria Cross’ for five times. And one of the recipients of the same Dr John Alexander Sinton was later conferred the fellowship of Royal Society in his researches for the problems of Malaria.
It is a matter of record that in the legislative council in Delhi in 1918 a motion was brought forward by an Indian Member of the council to disband the Indian Medical Services primarily on the ground that India was a poor country and could not afford to maintain such a service.
The defense that was put forth by the then Surgeon General Dr Edwards gives a significant insight into the utility of the Indian Medical Service at that point of time. The text of the defense put across by him is as under:
“I need not dwell, on the fact that this resolution is tantamount to the abolition of the distinguished service to which I have the honor to belong, but before proceedings with my reply I wish to say few words concerning the work which has been done by this service in recent year and which is still being done, for I do not think that this council is fully aware of the extraordinary value of the Indian Medical Service not only to India but to the world at large. This service has worked out the life history of the malarial parasite, a discovery which has revolutionized our ideas concerning malaria and which, among other things, has enabled the Panama Canal to be successfully built. It has reduced the mortality of cholera by 2/3rd and Shorn amoebic dysentery of most of its terrors. It has worked out the method of transmission of bubonic plague, work which points the way to the ultimate eradication of that disease. Enlarge prostate, that terrible and fatal concomitant of old age, can now be overcome, thanks to the member of Indian Medical Service, while in the domain of eye surgery more specifically with regard to cataract and glaucoma the work of the service is recognized throughout the scientific world.”
The resolution so moved did not succeed and the Indian Medical Service continued for nearly three decades thereafter with significant work and contribution in research and the unending problems of public health resulting in several achievements as a result of which it stands the scrutiny at the bar of history. Great names attached with it are Ronald Ross, Leonard Rogers, Rickard Christophers, Robert McCarrison, Henry Shortt and many others.
In the year 1943, the Government of India, decided for a review of the whole medical position and also to seek suggestions for future improvements. In fact, it was aimed that evolving a model like that of National Health Service, however, the disease burden that was observed was too huge. It was stated in the report that in India that nearly 10 crores suffer every year from malaria. Five lakh deaths from tuberculosis every year and a further 25 lakh active cases required treatment, cholera, small pox and plague add to the said disease burden. The other diseases of topic namely leprosy, filaria, hookworm, guinea-worm saddle the country with innumerable chronic sufferers. To combat adequately, this magnitude of disease burden and many other problems involved and to provide a comprehensive health service for whole of the population would require a staff of 2.5 lakh doctors, 7.50 lakh nurses along with a great army of associate medical workers. The Indian Medical Service which served India, so well almost for last 300 years definitely had prepared a way for the same, but when power was transferred in 1947, the Indian Medical Services stood abolished.
The foundation of the service
The Bengal Medical Service was founded by orders passed dated 20th October, 1763, whereby the individual medical officers then serving in the Bengal Presidency were, with effect from 1st January, 1764 combined into a regular medical establishment with fixed grades and definite rules for promotion from grade to grade. The Madras and Bombay medical services appeared to have come into existence at about the same time as the Bengal Service.
A list of Bengal Medical Service in 1774, preserved in the Calcutta record office gives a strength of total 69 viz. 18 surgeons, including the Surgeon General and Surgeons Majors, 7 Subordinate Surgeons and 44 Assistant Surgeons.
A list compiled by Surgeon General Denial Campbell in 1777 comprises 64 names that include 22 Surgeons and 42 Assistant Surgeons. Another list compiled for the Governor General Warren Hastings in 1777 gives 27 Surgeons and 45 Assistant Surgeons totaling to 72. Of these, 11 surgeons and 13 Civil Assistant Surgeons are shown in the civil employment as against 15 surgeons and 32 Assistant Surgeons on Military Duty, while one man noted as dead is not shown under either head.
The First Maratha War occurred in 1780-81, the Second Mysore War in 1781, with Campaign against the Raja of Banaras was undertaken in the same year. Five battalions under Col PD Pearse marched from Bengal to Madras towards the end of 1780. Six battalions with artillery and cavalierly were detached to Bombay from 1778 to 1784. All these troops required extra medical officers, and vacancies caused in this campaign required to be filled up. To indent on the court of Directors at home for more medical officers was of little use, as new men from home even if recruited in sufficient numbers could not arrive for more than a year after the requisition for their services was sent home. The Indian govt. accordingly appointed a large number of men, recruited locally to the Bengal medical service. They were obtained chiefly from two sources. Firstly, the surgeons of the India men trading between England and India and secondly, subalterns or free adventurers who had some medical training in some cases had practiced medicine at Home, before coming to India.
Rules regarding medical personnel in military employment holding collateral civil charges and vice versa were laid down in Bengal Gazette of 12th March, 1836. Practically the same rules continued to be in force till 1947, when the services were disbanded. No officer civil or military was at liberty to decline such collateral charges.
In the early settlement of the East India Company in India, the question of rank was not of much importance. The President or Agent stood first next to the President, then came the members of his council. The governing body consisted of four members. The Agent, the Accountant, the Store Keeper, the Purser Marine; fifth rank was the Secretary. The surgeon was sixth after the Secretary, they came the Steward and after him the General Body of Merchants, Writers, and Apprentices. The writers as the name employees were the clerks. But from this small body of commercial servants has developed the finest Governing Body in the World, the Indian Civil Service.
As such, the chronology of events in a sequential manner brings out as to how the Indian Medical Service came to be created by the East India Company to begin with and then how it came to be structured in a definitive manner with stipulated rules and regulations in respect of ‘Rank, Pay, Leave, Duties and Responsibilities’ and other cogent official matters.
Taking into consideration the successes and the effectiveness that got accrued to the said service during a period spanning nearly three centuries, it can be safely deduced that it needs to be revived afresh by suitable incorporations therein in terms of the contemporary and long-term perceived requirements.
RELEVANT PROVISIONS FOR DOCTORS UNDER INDIAN PENAL CODE, 1860
According to the provisions of Indian Penal Code 1860 (IPC) any act of commission or omission is not a crime unless it is accompanied by a guilty mind (MENS REA).
The acts are not punishable only because it led to some mischievous results unless associated with intention or mental attitude of the person.
Most of the times doctor’s treatment is in good faith, with the consent of the patient and hence most of the provisions of IPC are not applicable to the doctors unless or until there is rashness or gross negligence.
The following Sections of IPC are related to medical professionals:
Sec. 29: Deals with documents
29. “Document”. –The word “document” denotes any matter expressed or described upon any substance by means of letters, figures or marks, or by more than one of those means, intended to be used, or which may be used, as evidence of that matter.
Explanation 1: It is immaterial by what means or upon what substance the letters, figures or marks are formed, or whether the evidence is intended for, or may be used in, a Court of Justice, or not.
Illustrations
A writing expressing the terms of a contract, which may be used as evidence of the contract, is a document.
A cheque upon a banker is a document.
A power-of-attorney is a document.
A map or plan which is intended to be used or which may be used as evidence, is a document.
A writing containing directions or instructions is a document.
Explanation 2.: Whatever is expressed by means of letters, figures or marks as explained by mercantile or other usage, shall be deemed to be expressed by such letters, figures or marks within the meaning of this section, although the same may not be actually expressed.
Illustration
A write his name on the back of a bill of exchange payable to his order. The meaning of the endorsement as explained by mercantile usage, is that the bill is to be paid to the holder. The endorsement is a document, and must be construed in the same manner as if the words “pay to the holder” or words to that effect had been written over the signature.
Sec. 52: Describes “good faith”
“Good faith”: Nothing is said to be done or believed in “good faith” which is done or believed without due care and attention.
Sec. 90: Related to consent: Consent known to be given under fear or misconception:
A consent is not such a consent as is intended by any section of this Code, if the consent is given by a person under fear of injury, or under a misconception of fact, and if the person doing the act knows, or has reason to believe, that the consent was given in consequence of such fear or misconception; or Consent of insane person.
Consent of insane person- if the consent is given by a person who, from unsoundness of mind, or intoxication, is unable to understand the nature and consequence of that to which he gives his consent; or Consent of child.
Consent of child. – unless the contrary appears from the context, if the consent is given by a person who is under twelve years of age.
Sec. 176: Failure to inform police whenever essential
176. Omission to give notice or information to public servant by person legally bound to give it: Whoever, being legally bound to give any notice or to furnish information on any subject to any public servant, as such, intentionally omits to give such notice or to furnish such information in the manner and at the time required by law, shall be punished with simple imprisonment for a term which may extend to one month, or with fine which may extend to five hundred rupees, or with both; or, if the notice or information required to be given respects the commission of an offence, or is required for the purpose of preventing the commission of an offence, or in order to the apprehension of an offender, with simple imprisonment for a term which may extend to six months, or with fine which may extend to one thousand rupees, or with both; [or, if the notice or information required to be given is required by an order passed under sub-section (1) of section 565 of the Code of Criminal Procedure, 1898 (5 of 1898), with imprisonment of either description for a term which may extend to six months, or with fine which may extend to one thousand rupees, or with both.]
Sec. 269-271: Related to spread of infectious disease and disobedience of a quarantine rule.
269. Negligent act likely to spread infection of disease dangerous to life: Whoever unlawfully or negligently does any act which is, and which he knows or has reason to believe to be, likely to spread the infection of any disease dangerous to life, shall be punished with imprisonment of either description for a term which may extend to six months, or with fine, or with both.
270. Malignant act likely to spread infection of disease dangerous to life:
Whoever malignantly does any act which is, and which he knows or has reason to believe to be, likely to spread the infection of any disease dangerous to life, shall be punished with imprisonment of either description for a term which may extend to two years, or with fine, or with both.
271. Disobedience to quarantine rule: Whoever knowingly disobeys any rule made and promulgated for putting any vessel into a state of quarantine, or for regulating the intercourse of vessels in a state of quarantine with the shore or with other vessels, for regulating the intercourse between places where an infectious disease prevails and other places, shall be punished with imprisonment of either description for a term which may extend to six months, or with fine, or with both.
Sec. 272-273: Related to adulteration of food and drinks.
272. Adulteration of food or drink intended for sale: Whoever adulterates any article of food or drink, so as to make such article noxious as food or drink, intending to sell such article as food or drink, or knowing it to be likely that the same will be sold as food or drink, shall be punished with imprisonment of either description for a term which may extend to six months, or with fine which may extend to one thousand rupees, or with both.
273. Sale of noxious food or drink: Whoever sells, or offers or exposes for sale, as food or drink, any article which has been rendered or has become noxious, or is in a state unfit for food or drink, knowing or having reason to believe that the same is noxious as food or drink, shall be punished with imprisonment of either description for a term which may extend to six months, or with fine which may extend to one thousand rupees, or with both.
Sec. 274-276: Related to adulteration of drugs.
274. Adulteration of drugs: Whoever adulterates any drug or medical preparation in such a manner as to lessen the efficacy or change the operation of such drug or medical preparation, or to make it noxious, intending that it shall be sold or used for, or knowing it to be likely that it will be sold or used for, any medicinal purpose, as it had not undergone such adulteration, shall be punished with imprisonment of either description for a term which may extend to six months, or with fine which may extend to one thousand rupees, or with both.
275. Sale of adulterated drugs.–Whoever, knowing any drug or medical preparation to have been adulterated in such a manner as to lessen its efficacy, to change its operation, or to render it noxious, sells the same, or offers or exposes it for sale, or issues it from any dispensary for medicinal purposes as unadulterated, or causes it to be used for medicinal purposes by any person not knowing of the adulteration, shall be punished with imprisonment of either description for a term which may extend to six months, or with fine which may extend to one thousand rupees, or with both.
276. Sale of drug as a different drug or preparation: Whoever knowingly sells, or offers or exposes for sale, or issues from a dispensary for medicinal purposes, any drug or medical preparation, as a different drug or medical preparation, shall be punished with imprisonment of either description for a term which may extend to six months, or with fine which may extend to one thousand rupees, or with both.
Sec. 304-A: Deals with death caused by a negligent act.
Causing death by negligence: Whoever causes the death of any person by doing any rash or negligent act not amounting to culpable homicide shall be punished with imprisonment of either description for a term which may extend to two years, or with fine, or with both.]
Sec. 306-309: Related with abatement of suicide.
306. Abetment of suicide: If any person commits suicide, whoever abets the commission of such suicide, shall be punished with imprisonment of either description for a term which may extend to ten years, and shall also be liable to fine.
307. Attempt to murder: Whoever does any act with such intention or knowledge, and under such circumstances that, if he by that act caused death, he would be guilty of murder, shall be punished with imprisonment of either description for a term which may extend to ten years, and shall also be liable to fine; and, if hurt is caused to any person by such act, the offender shall be liable either to [imprisonment for life], or to such punishment as is herein before mentioned.
Attempts by life-convicts.
Attempts by life-convicts: [When any person offending under this section is under sentence of [imprisonment for life], he may, if hurt is caused, be punished with death.]
(a) A shoot at Z with intention to kill him, under such circumstances that, if death ensued A would be guilty of murder. A is liable to punishment under this section
(b) A, with the intention of causing the death of a child of tender years, exposes it in a desert place A has committed the offence defined by this section, though the death of the child does not ensue.
(c) A, intending to murder Z, buys a gun and loads it. A has not yet committed the offence. A fire the gun at Z. He has committed the offence defined in this section, and, if by such firing he wounds Z, he is liable to the punishment provided by the latter part of 3*[the first paragraph of] this section.
(d) A, intending to murder Z by poison, purchases poison and mixes the same with food which remains in A’s keeping; A has not yet committed the offence in this section. A place the food on Z’s table or delivers it to Z’s servants to place it on Z’s table. A has committed the offence defined in this section.
308. Attempt to commit culpable homicide: Whoever does any act with such intention or knowledge and under such circumstances that, if he by that act caused death, he would be guilty of culpable homicide not amounting to murder, shall be punished with imprisonment of either description for a term which may extend to three years, or with fine, or with both; and, if hurt is caused to any person by such act, shall be punished with imprisonment of either description for a term which may extend to seven years, or with fine, or with both.
Illustration
A, on grave and sudden provocation, fires a pistol at Z, under such circumstances that if he there by caused death he would be guilty of culpable homicide not amounting to murder. A has committed the offence defined in this section.
309. Attempt to commit suicide. –Whoever attempts to commit suicide and does any act towards the commission of such offence, shall be punished with simple imprisonment for a term which may extend to one year 1*[or with fine, or with both.]
Sec. 312-314: Related to causing mis-carriage, abortion and hiding such facts.
312. Causing miscarriage.–Whoever voluntarily causes a woman with child to miscarry, shall if such miscarriage be not caused in good faith for the purpose of saving the life of the woman, be punished with imprisonment of either description for a term which may extend to three years, or with fine, or with both; and, if the woman be quick with child, shall be punished with imprisonment of either description for a term which may extend to seven years, and shall also be liable to fine.
Explanation. -A woman who causes herself to miscarry, is within
the meaning of this section.
313. Causing miscarriage without woman’s consent.—Whoever commits the offence defined in the last preceding section without the consent of the woman, whether the woman is quick with child or not, shall be punished with [imprisonment for life], or with imprisonment of either description for a term which may extend to ten years, and shall also be liable to fine.
314. Death caused by act done with intent to cause miscarriage:
Whoever, with intent to cause the miscarriage of a woman with child, does any act which causes the death of such woman, shall be punished with imprisonment of either description for a term which may extend to ten years, and shall also be liable to fine; if act done without woman’s consent, if act done without woman’s consent and if the act is done without the consent of the woman, shall be punished either with [imprisonment for life], or with the punishment above mentioned.
Explanation. -It is not essential to this offence that the offender should know that the act is likely to cause death.
Sec. 315-316: Deals with act to prevent child being born alive or to cause it to die after birth.
Section 315: Act done with intent to prevent child being born alive or to cause it to die after birth: Whoever before the birth of any child does any act with the intention of thereby preventing that child from being born alive or causing it to die after its birth, and does by such act prevent that child from being born alive, or causes it to die after its birth, shall, if such act be not caused in good faith for the purpose of saving the life of the mother, be punished with imprisonment of either description for a term which may extend to ten years, or with fine, or with both.
Section 316: Causing death of quick unborn child by act amounting to culpable homicide: Whoever does any act under such circumstances, that if he thereby caused death he would be guilty of culpable homicide, and does by such act cause the death of a quick unborn child, shall be punished with imprisonment of either description for a term which may extend to ten years, and shall also be liable to fine.
Illustration
A, knowing that he is likely to cause the death of a pregnant woman, does an act which, if it caused the death of the woman, would amount to culpable homicide. The woman is injured, but does not die; but the death of an unborn quick child with which she is pregnant is thereby caused. A is guilty of the offence defined in this section.
Sec. 319-322: Related to causing hurt, grievous hurt, loss of vision, loss of hearing or disfigurement.
319. Hurt: Whoever causes bodily pain, disease or infirmity to any person is said to cause hurt.
320. Grievous hurt: The following kinds of hurt only are designated as “grievous”: –
First, Emasculation.
Secondly, Permanent privation of the sight of either eye.
Thirdly, Permanent privation of the hearing of either ear.
Fourthly, Privation of any member or joint.
Fifthly, Destruction or permanent impairing of the powers of any member or joint.
Sixthly, Permanent disfiguration of the head or face.
Seventhly, Fracture or dislocation of a bone or tooth.
Eighthly, any hurt which endangers life or which causes the sufferer to be during the space of twenty days in severe bodily pain, or unable to follow his ordinary pursuits.
321. Voluntarily causing hurt: Whoever does any act with the intention of thereby causing hurt to any person, or with the knowledge that he is likely thereby to cause hurt to any person, and does thereby cause hurt to any person, is said “voluntarily to cause hurt”.
322. Voluntarily causing grievous hurt: Whoever voluntarily causes hurt, if the hurt which he intends to cause or knows himself to be likely to cause is grievous hurt, and if the hurt which he causes is grievous hurt, is said “voluntarily to cause grievous hurt”.
Explanation – A person is not said voluntarily to cause grievous hurt except when he both causes grievous hurt and intends or knows himself to be likely to cause grievous hurt. But he is said voluntarily to cause grievous hurt, if intending or knowing himself to be likely to cause grievous hurt of one kind, he actually causes grievous hurt of another kind.
Illustration
A, intending of knowing himself to be likely permanently to disfigure Z’s face, gives Z a blow which does not permanently disfigure Z’s face, but which causes Z to suffer severe bodily pain for the space of twenty days. A has voluntarily caused grievous hurt.
Sec. 336-338: Deals with causing hurt by rash or negligent act.
336. Act endangering life or personal safety of others: Whoever does any act so rashly or negligently as to endanger human life or the personal safety others, shall be punished with imprisonment of either description for a term which may extend to three months or with fine which may extend to two hundred and fifty rupees, or with both.
337. Causing hurt by act endangering life or personal safety of Others: Whoever causes hurt to any person by doing any act so rashly or negligently as to endanger human life, or the personal safety of others, shall be punished with imprisonment of either description for a term which may extend to six months, or with fine which may extend to five hundred rupees, or with both.
338. Causing grievous hurt by act endangering life or personal safety of others.–Whoever causes grievous hurt to any person by doing any act so rashly or negligently as to endanger human life, or the personal safety of others, shall be punished with imprisonment of either description for a term which may extend to two years, or with fine which may extend to one thousand rupees, or with both.
Of wrongful restraint and wrongful confinement.
Sec. 340-342: Related to wrongful confinement.
Section 340: Wrongful confinement: Whoever wrongfully restrains any person in such a manner as to prevent that person from proceeding beyond certain circumscribing limits, is said “wrongfully to confine” that person.
Illustrations
(a) A causes Z to go within a walled space, and locks Z. Z is thus prevented from proceeding in any direction beyond the circumscribing line of wall. A wrongfully confines z.
(b) A places man with firearms at the outlets of a building, and tells Z that they will fire at Z if Z attempts leave the building. A wrongfully confines Z.
341. Punishment for wrongful restraint: Whoever wrongfully restrains any person shall be punished with simple imprisonment for a term which may extend to one month, or with fine which may extend to five hundred rupees, or with both.
342. Punishment for wrongful confinement: Whoever wrongfully confines any person shall be punished with simple imprisonment of either description for a term which may extend to one year, or with fine which may extend to one thousand rupees, or with both.
Sec. 491: Related to breach of contract.
Breach of contract to attend on and supply wants of helpless Person: Whoever, being bound by a lawful contract to attend on or to supply the wants of any person who, by reason of youth, or of unsoundness of mind, or of a disease or bodily weakness, is helpless or incapable of providing for his own safety or of supplying his own wants, voluntarily omits so to do, shall be punished with imprisonment of either description for a term which may extend to three months, or with fine which may extend to two hundred rupees, or with both.
Sec. 499: Related to defamation.
Defamation: Whoever by words either spoken or intended to be read, or by signs or by visible representations, makes or publishes any imputation concerning any person intending to harm, or knowing or having reason to believe that such imputation will harm, the reputation of such person, is said, except in the cases hereinafter excepted, to defame that person.
Explanation 1- It may amount to defamation to impute anything to a deceased person, if the imputation would harm the reputation of that person if living, and is intended to be hurtful to the fillings of his family or other near relatives.
Explanation 2 – It may amount to defamation to make an imputation concerning a company or an association or collection of persons as such.
Explanation 3- An imputation in the form of an alternative or expressed ironically, may amount to defamation.
Explanation 4- No imputation is said to harm a person’s reputation, unless that imputation directly or indirectly, in the estimation of others, lowers the moral or intellectual character of that person, or lowers the character of that person in respect of his caste or of his calling, or lowers the credit of that person, or causes it to be believed that the body of that person is in a loathsome state, or in a state generally considered as disgraceful.
Illustrations
(a) A says- “Z is an honest man; he never stole B’s watch”, intending to cause it to be believed that Z did steal B’s watch. This is defamation, unless it falls within one of the exceptions.
(b) A is asked who stole B’s watch. A point to Z, intending to cause it to be believed that Z stole B’s watch. This is defamation, unless it falls within one of the exceptions.
(c) A draws a picture of Z running away with B’s watch, intending it to be believed that Z stole B’s watch. This is defamation, unless it falls within one of the exceptions.
First Exception- Imputation of truth which public good requires to be made or published- It is not defamation to impute anything which is true concerning any person, if it be for the public good that the imputation should be made or published. Whether or not it is for the public good is a question of fact.
Second Exception- Public conduct of public servants. -It is not defamation to express in good faith any opinion whatever respecting the conduct of a public servant in the discharge of his public functions, or respecting his character, so far as his character appears in that conduct, and no further.
Third Exception- Conduct of any person touching any public question. -It is not defamation to express in good faith any opinion whatever respecting the conduct of any person touching any public question, and respecting his character, so far as his character appears in that conduct, and no further.
Illustration
It is not defamation in A to express in good faith any opinion whatever resenting Z’s conduct in petitioning Government on a public question, in signing a requisition for a meeting on a public question, in presiding or attending at such meeting, in forming or joining any society which invites the public support, in voting or canvassing for a particular candidate for any situation in the efficient discharge of the duties of which the public is interested.
Fourth Exception- Publication of reports of proceedings of courts- It is not defamation to publish a substantially true report of the proceedings of a Court of Justice, or of the result of any such proceedings.
Explanation. -A Justice of the Peace or other officer holding an enquiry in open Court preliminary to a trial in a Court of Justice, is a Court within the meaning of the above section.
Fifth Exception- Merits of case decided in Court or conduct of witnesses and others concerned. It is not defamation to express in good faith any opinion whatever respecting the merits of any case, civil or criminal, which has been decided by a Court of Justice, or respecting the conduct of any person as a party, witness or agent, in any such case, or respecting the character of such person, as far as his character appears in that conduct, and no further.
Illustrations
(a) A says- “I think Z’s evidence on that trial is so contradictory that he must be stupid or dishonest.” A is within this exception if he says this in good faith, inasmuch as the opinion which he expresses respects Z’s character as it appears in Z’s conduct as a witness, and no farther.
(b) But if A says-“I do not believe what Z asserted at that trial because I know him to be a man without veracity”; A is not within this exception, inasmuch as the opinion which expresses of Z’s character, is an opinion not founded on Z’s conduct as a witness.
Sixth Exception- Merits of public performance.-It is not defamation to express in good faith any opinion respecting the merits of any performance which its author has submitted to the judgment of the public, or respecting the character of the author so far as his character appears in such performance, and no farther.
Explanation- A performance may be submitted to the judgment of the public expressly or by acts on the part of the author which imply such submission to the judgment of the public.
Illustrations
(a) A person who publishes a book, submits that book to the judgment of the public.
(b) A person who makes a speech in public, submits that speech to the judgment of the public.
(c) An actor or singer who appears on a public stage, submits his acting or singing to the judgment of the public.
(d) A says of a book published by Z- “Z’s book is foolish; Z must be a weak man. Z’s book is indecent; Z must be a man of impure mind.” A is within the exception, if he says this in good faith, inasmuch as the opinion which he expresses of Z respects Z’s character only so far as it appears in Z’s book, and no further.
(e) But if A says- “I am not surprised that Z’s book is foolish and indecent, for he is a weak man and a libertine.” A is not within this exception, inasmuch as the opinion which he expresses of Z’s character is an opinion not founded on Z’s book.
Seventh Exception- Censure passed in good faith by person having lawful authority over another.-It is not defamation in a person having over another any authority, either conferred by law or arising out of a lawful contract made with that other, to pass in good faith any censure on the conduct of that other in matters to which such lawful authority relates.
Illustration
A Judge censuring in good faith the conduct of a witness, or of an officer of the Court; a head of a department censuring in good faith those who are under his orders; a parent censuring in good faith a child in the presence of other children; a schoolmaster, whose authority is derived from a parent, censuring in good faith a pupil in the presence of other pupils; a master censuring a servant in good faith for remissness in service; a banker censuring in good faith the cashier of his bank for the conduct of such cashier as such cashier are within this exception.
Eighth Exception- Accusation preferred in good faith to authorized person – It is not defamation to prefer in good faith an accusation against any person to any of those who have lawful authority over that person with respect to the subject-matter of accusation.
Illustration
If A in good faith accuses Z before a Magistrate; if A in good faith complains of the conduct of Z, a servant, to Z’s master; if A in good faith complains of the conduct of Z, a child, to Z’s father-A is within this exception.
Ninth Exception- Imputation made in good faith by person for protection of his or other’s interests.-It is not defamation to make an imputation on the character of another provided that the imputation be made in good faith for the protection of the interest of the person making it, or of any other person, or for the public good.
Illustrations
(a) A, a shopkeeper, says to B, who manages his business- “Sell nothing to Z unless he pays you ready money, for I have no opinion of his honesty.” A is within the exception, if he has made this imputation on Z in good faith for the protection of his own interests.
(b) A, a Magistrate, in making a report to his own superior officer, casts an imputation on the character of Z. Here, if the imputation is made in good faith, and for the public good, A is within the exception.
Tenth Exception: Caution intended for good of person to whom conveyed or for public good- It is not defamation to convey a caution, in good faith, to one person against another, provided that such caution be intended for the good of the person to whom it is conveyed, or of some person in whom that person is interested, or for the public good.
Section 304 and 304-A
There is lot of discrepancy while applying these sections in cases of professional negligence by doctors. Most of the times the police authorities register the cases of professional negligence deaths under Sec. 304 of IPC. According to this Section the offence is non-bailable. This causes lot of hardship, bad reputation and mental agony to the doctors. In fact, the police should register the cases of deaths due to medical negligence under Sec. 304-A of IPC, in which the offence is bailable and the doctor can be released on bail. The judgment has been passed by Bombay High Court in Criminal Revision application no. 282 of 1996 (Dr. Mrs. Mrudula S. Deshpandevs State of Maharashtra) dated 28th November 1998(3). The basic difference is that in Sec. 304 there is intentional act of negligence while in 304-A the act is never done with the intention to cause death.
Grievous hurt
Sec. 319-322 of IPC are related to causing grievous hurt for example loss of limbs, loss of vision, loss of hearing or disfigurement etc. Sec. 336-338 deal with causing grievous hurt by rash or negligent act.
Examples: (1) While giving IV fluids suppose there is leakage of fluid in surrounding tissue resulting in spasm of vessels and subsequent necrosis of limbs. (2) A surgical procedure is done on eye, limbs, face etc. without adequate aseptic precautions resulting in local infection. This may lead to loss of eyes, limb or disfigurement of face, (3) An unqualified doctor performing surgical procedure which results in permanent damage to eyes, limbs, hearing etc.
Wrongful confinement (Sec. 340-342 of IPC)
A patient cannot be detained on the grounds of non-payment of hospital charges. This may constitute the offense of wrongful confinement under Sec. 340-342 of IPC. Doctors can take advance or fee from the patient before starting the treatment.
If a police officer is keeping the doctor in detention, in cases of bailable offenses, he is liable for the offense of wrongful confinement under these Sections of IPC.
Definitions
Crime or offence means any act or omission which is contrary to any law or statute for the time being in force.
Summons is the process of court asking the opposite party to appear and answer the allegation preferred by the party who has brought action.
Warrant means an order issued by the court, magistrate or a competent judicial authority, directing a police officer to make arrest, seize or search or to do any other work incidental to administration of justice.
A Warrant case is related to an offence punishable with death, life imprisonment or imprisonment for more than two years. Example: If a doctor helps a pregnant woman in getting rid of the child or to cause its death after its birth.
Cases other than warrant cases are Summons cases. If a doctor acts negligently by using infected syringe or instrument resulting in an infection to an uninfected patient exemplifies a Summons case.
Cognizable offences are those in which a police officer may arrest without warrant, according of Schedule I of Criminal Procedure Code (CPC).
Non-cognizable offences are those in which a police officer can’t arrest without a warrant, e.g. a doctor knowingly disobeying a quarantine rule is liable to be punished with imprisonment up to 6 months or fine.
Bailable Offences are those in which bail can be granted by any law for the time being in force. In such cases bail is matter of right. The court can’t refuse bail and the police has no right to keep the doctor in custody. If any police officer puts a doctor in detention in such cases, he is liable for the offense of wrongful confinement under Sec. 340-342 of IPC (4).
Non-Bailable offences are offences other than the bailable or an offence in which bail can’t be granted. These are the serious offences in which a person may be convicted and imprisoned for term extending more than ten years. For example, offences under transplantation of Human Organ Act 1994.
Presumption of innocence: Law presumes that a person is innocent till his guilt is proved. The onus of proof is on prosecution (5).
Mistake of law: “Ignorentiajuris non excusat, means ignorance of law or mistake of law (existence or mistaken understanding) is not excusable. Erroneous or wrong conclusion of law is not a valid defense. For example, if a doctor carries out prenatal test intended to abort a female fetus, can’t avoid prosecution by saying that I was unaware of any law which punishes such act.
Mistake of fact is a situation where a person not intending to do unlawful act, does so because of wrong conclusion or understanding of fact. The guilty mind was never there while doing the act. The person may not be held responsible in such cases.
Res Judicata: This doctrine of law means “the things have been decided”. According to this principle, once the case is completed between two parties, it cannot be tried again between the same parties. Suppose a patient sues a hospital for any wrong, damages or malpractice and the things are decided, he cannot subsequently sue the doctor again separately for the same negligence.
Res Ipsa Loquitur is a situation of gross negligence or rashness. The things are so obvious that they “speak for themselves”. Most of the time there is no need for any proof of negligence in such cases. Common examples include giving blood transfusion to wrong patient, or operating on wrong side of the body or wrong patient.
Consent in Criminal Law (Sec. 90 IPC)
A valid consent must be given voluntarily, by an adult who is not of unsound mind. The consent must be given after reasonable understanding and without any misrepresentation or hiding of the facts. Thus, the consent should be an informed consent, preferably in writing and in presence of witnesses. All components of valid consent are applicable even for the consent in criminal law. According to criminal law, it is an offence to cause injury to any person even with his consent. No person has right to give consent to suffer death or grievous hurt. This point has to be kept in mind specially during cases of organ transplantation. The donor may have given consent under family, social or financial pressures. In cases of dead donors if there is no expressed will, the body is the property of the heirs and their consent is required.
Criminal Liability
A person who commits a wrongful act, shall be liable for it. The crimes are public wrongs and aim of criminal proceeding is to punish the wrong doer. The law imposes liability on him who fails to perform duty. The wrongful act may be (a) Intentional or willful wrong this usually doesn’t apply in medical practice as no doctor has intention to cause harm to his patient, (b) negligent act – the doctor fails to take proper care, precaution and is just indifferent to the consequences of his act. Lack of skill proportional to risk undertaken also amounts to negligence; (c) wrongs of strict liability created by some special statutes like transplantation of human organ act (1994) (6).
When to Inform Police
A doctor has to inform the police in following circumstances (personal communication Dr. JayatNavrange). Failure to inform police in such cases may result in penal consequences. Police must be informed in (i) cases of suspected homicide, (ii) cases of suicidal deaths, (iii) unknown, unconscious patient, (iv) death on operation table, (v) suspected unnatural death, (vi) sudden, unexpected, violent and unexplained death, (vii) instant death after treatment or reaction of medicine, and a (viii) married lady dying within seven years of marriage due to any reason.
It is advisable to inform police in following circumstances (i) undiagnosed death within 24 hrs. of admission or specially if there is any suspicion, (ii) any cases of poisoning, (iii) accidental deaths, and (iv) in cases of hospital deaths if (a) accidents not related to medical management like fall from staircase etc., though there is no legal obligation on doctor, it is advisable to inform the police, (b) unexpected or rare complications may occur sometimes, e.g. a child may vomit, aspirate the content and may die. This is very unpredictable and it is not obligatory on part of the doctor to inform such deaths. But it is better if we inform the police because sometimes patient’s relatives may allege negligence in such cases. In cases of death due to negligence in treatment there are no specific provisions to inform the police but in order to avoid untoward incidences it is better to inform the police.
“Brought dead cases”: In such cases, if the cause of death is apparent and there are no reasonable grounds to suspect some medico-legal complications then it is not necessary to inform the police. If the cause of death can’t be ascertained in any case then it is desirable to send the body for post-mortem examination preferably with the help of the police. It is advisable to suggest post-mortem in the following circumstances: (i) whenever death is sudden, unexpected or unexplained, (ii) accidental deaths which may be roadside, domestic or industrial, (iii) when precise cause of death is needed for insurance claim purposes etc., and (iv) as a help to arrive at final diagnosis.
Information to police shall preferably be in writing and the written acknowledgement should be obtained. If the information is telephonic one must note down name, buckle number and designation of the police.
Can a Doctor be Arrested?
Doctors have no immunity against arrest (as any other citizen of India) for the various criminal acts as per the provisions of IPC or CPC of India.
Illegal organ trading, unlawful sex determination etc. are non-bailable offenses. But the question is whether a doctor be arrested for:
(a) alleged medical negligence during day to day care of a patient,
(b) unexplained hospital deaths like SIDS etc.,
(c) postoperative complication or failure of operation;
(d) not attending or refusing a patient (who was not already under his care) who becomes serious or dies and
(f) not attending a case of roadside accident.
Recently, the chairman of a hospital was arrested for not complying with the Supreme Court directives in a roadside accident. In this particular case the patient died while being shifted to other hospital. The Supreme Court directives (criminal writ petition no. 270 of 1988) in a roadside accident include:
• The medical aid should be instantaneous. It is the duty of the registered medical practitioner to attend the injured and render medical aid, treatment without waiting for procedural formalities unless the injured person or guardian (in case of minor) desires otherwise.
• The effort to save the person and preserve the life, should be top priority, not only of the doctor but also of the police officer or any other citizen who happens to notice such an accident.
• The professional obligation of protecting life extends to every doctor, whether at Government hospital or otherwise.
• The obligation being total, absolute and paramount, no statutory or procedural formalities can interfere in discharging this duty.
• Whenever better or specific assistance is required, it is the duty of treating doctor to see that the patient reaches the proper expert as early as possible.
• Non-compliance of these directives may invite prosecution under provisions of Motor Vehicle Act or IPC (7).
If FIR is lodged by patient or relatives then the police may arrest the doctor. Hence better approach in cases where we feel that the patients or relatives may create nuisance will be as follows:
1. The doctor should lodge a FIR that a particular incidence has happened in my hospital.
2. A crisis management committee may be formed at each Taluka or District level. The committee shall include doctors, social workers, legal personalities, politicians, press reporters etc. The committee members may meet the police officers and request them for complete investigation of the incidence and to avoid prosecution till the guilt is proved. The committee can also request the press reporters not to give unnecessary publicity to such cases. The Government of Kerala (G.R. no. 3231/SS-B4/92/Home dated 20.09.1993) has issued the following instructions if there are any cases of criminal negligence against a private practitioner, doctor or private hospital. According to G.R. the investigating Deputy Superintendent of Police shall refer the case to a panel of Superintendent of Police, commissioner of Police, District Medical Officer or Principal of Medical College. Still if the views differ, the opinion of an apex body consisting of Director of Health Services and expert in that particular specialty may be taken. The affected doctor is also free to approach the apex body with appeals
Legal Rights of an Arrested Person
The arrested person shall be communicated with the particulars of offence and the ground for arrest. If the offense is bailable, then the person should be informed and the arrangement for the bail may be made. If the police officer refuses to release such person on bail, he will be liable for damages for wrongful confinement. Sometimes a police officer may register an offense under Sec. 304 of IPC instead of 304-A in order to detain the accused doctor. In such cases officer may have to face serious consequences. The person shall not be subjected to more restraint than necessary to prevent his escape. If there are any offensive weapons belonging to the arrested person, these weapons may be seized. The arrested person must be produced before a magistrate having jurisdiction in that case. No police officer shall detain in custody an arrested person for more than 24 hours unless a special order from a magistrate is obtained.
Anticipatory Bail: In order to avoid frivolous accusations, there is provision of anticipatory bail. This may be granted as a protection in offences which are non-bailable. It is direction to release applicant on bail, if there is arrest. Once granted it remains in force. Pre-requisites for anticipatory bail are: (i) there must be reasonable apprehension of arrest, (ii) the alleged offence must be non-bailable, and (iii) the registration of FIR is not necessary.
Procedure for Bail: The accused is required to execute his personal bond at the police station with or without surety. The surety may be a close relative, a friend or a neighbor, who is required to undertake to pay the said amount in case of absconding of the accused.
Do’s and Don’ts
Inform police whenever necessary.
Extend all possible co-operation to the police.
Furnish copies of medical records to police, court or relatives whenever demanded. Consent of patient may be taken while providing information to police.
Follow the legal procedures or provisions.
Have a valid informed consent for the treatment (10).
Preserve the documents, records specially in medico-legal, controversial or complicated cases.
Insist for post-mortem examination if the cause of death can’t be ascertained.
Involve medical associations, medico-legal cells, voluntary organizations whenever legal problem arises.
Consult your lawyer before giving any reply.
Don’t become panicky.
Don’t manipulate or tamper with the documents.
Don’t do unlawful or unethical acts.
Don’t issue false or bogus certificates. Certificate was issued on request is no defense.
Don’t neglect the treatment while completing legal formalities specially in serious or emergency situation.
The Supreme Court in the case of medical negligence held as under:
“Jacob Mathew vs State of Punjab & OTHERS”:
Negligence is the breach of a duty caused by omission to do something which a reasonable man guided by those considerations which ordinarily regulate the conduct of human affairs would do, or doing something which a prudent and reasonable man would not do. The definition of negligence as given in Law of Torts, Ratanlal & Dhirajlal (edited by Justice G.P. Singh), referred to hereinabove, holds good. Negligence becomes actionable on account of injury resulting from the act or omission amounting to negligence attributable to the person sued. The essential components of negligence are three: ‘duty’, ‘breach’ and ‘resulting damage’.
Negligence in the context of medical profession necessarily calls for a treatment with a difference. To infer rashness or negligence on the part of a professional, in particular a doctor, additional considerations apply. A case of occupational negligence is different from one of professional negligence. A simple lack of care, an error of judgment or an accident, is not proof of negligence on the part of a medical professional. So long as a doctor follows a practice acceptable to the medical profession of that day, he cannot be held liable for negligence merely because a better alternative course or method of treatment was also available or simply because a more skilled doctor would not have chosen to follow or resort to that practice or procedure which the accused followed. When it comes to the failure of taking precautions what has to be seen is whether those precautions were taken which the ordinary experience of men has found to be sufficient; a failure to use special or extraordinary precautions which might have prevented the particular happening cannot be the standard for judging the alleged negligence. So also, the standard of care, while assessing the practice as adopted, is judged in the light of knowledge available at the time of the incident, and not at the date of trial. Similarly, when the charge of negligence arises out of failure to use some particular equipment, the charge would fail if the equipment was not generally available at that particular time (that is, the time of the incident) at which it is suggested it should have been used.
A professional may be held liable for negligence on one of the two findings: either he was not possessed of the requisite skill which he professed to have possessed, or, he did not exercise, with reasonable competence in the given case, the skill which he did possess. The standard to be applied for judging, whether the person charged has been negligent or not, would be that of an ordinary competent person exercising ordinary skill in that profession. It is not possible for every professional to possess the highest level of expertise or skills in that branch which he practices. A highly skilled professional may be possessed of better qualities, but that cannot be made the basis or the yardstick for judging the performance of the professional proceeded against on indictment of negligence.
The test for determining medical negligence as laid down in Bolam’s case [1957] 1 W.L.R. 582, 586 holds good in its applicability in India.
The jurisprudential concept of negligence differs in civil and criminal law. What may be negligence in civil law may not necessarily be negligence in criminal law. For negligence to amount to an offence, the element of men’s rea must be shown to exist. For an act to amount to criminal negligence, the degree of negligence should be much higher i.e. gross or of a very high degree. Negligence which is neither gross nor of a higher degree may provide a ground for action in civil law but cannot form the basis for prosecution.
The word ‘gross’ has not been used in Section 304A of IPC, yet it is settled that in criminal law negligence or recklessness, to be so held, must be of such a high degree as to be ‘gross’. The expression ‘rash or negligent act’ as occurring in Section 304A of the IPC has to be read as qualified by the word ‘grossly’.
To prosecute a medical professional for negligence under criminal law it must be shown that the accused did something or failed to do something which in the given facts and circumstances no medical professional in his ordinary senses and prudence would have done or failed to do. The hazard taken by the accused doctor should be of such a nature that the injury which resulted was most likely imminent.
Res ipsa loquitur is only a rule of evidence and operates in the domain of civil law specially in cases of torts and helps in determining the onus of proof in actions relating to negligence. It cannot be pressed in service for determining per se the liability for negligence within the domain of criminal law. Res ipsa loquitur has, if at all, a limited application in trial on a charge of criminal negligence.
“Martin D’Souza vs Mohammed Isfaq”
The bench of Justices Markandeya Katju & R M Lodha ruled that “courts must first refer complaints of medical negligence to a competent doctor or a panel of experts in the field before issuing notice to the allegedly negligent doctor. This is necessary to avoid harassment to doctors who may not be ultimately found to be negligent. We further warn the police officials not to arrest or harass doctors unless the facts clearly come within the parameter laid down in Jacob Mathew’s case, otherwise the policemen will themselves have to face legal action”.
Fake doctors:
Those arrested have been booked under sections 419 and 420 of the Indian Penal Code and sections 33 and 36 of the Maharashtra Medical Practitioners Act.
India—a tale of one country, but stories of many states
Colonialism leaves disfiguring scars among those who are colonized. Few countries inflicted such deep wounds as Britain did during its centuries-long colonial rule of India. Understanding the history of colonialism and its consequences is therefore essential if one is to understand the predicaments of nations today. This week, The Lancet publishes the most comprehensive assessment yet of India’s present health predicaments. But India’s contemporary challenges in alleviating its burden of disease must first be examined in the context of Britain’s colonial legacy.
That legacy, in the words of former UN diplomat and now Indian politician Shashi Tharoor, is a “monstrous crime” (Inglorious Empire, Hurst, 2016). The East India Company, Britain’s initial instrument of domination, was established in 1600 during the reign of Elizabeth I. British rule was decisively inaugurated in 1757 after the Battle of Plassey. Thereafter, as Tharoor painstakingly documents, “Britain’s rise for 200 years was financed by its depredations in India”. In 1700, India made up 27% of the world economy. But Britain’s tyranny, subjugation, oppression, racism, and extortion led to “the first great de-industrialization of the modern world”. Britain systematically extracted India’s wealth. Successive British Governments destroyed India’s industry, trade, and shipbuilding. Britain’s “colonial holocaust” led to the needless deaths of some 30–35 million Indians (which Tharoor compares to the cruelties of Mao and Stalin). The argument that Britain’s enlightened despotism bestowed political unity, parliamentary democracy, rule of law, a free press, and a world-class railway system is thoroughly disproven by Tharoor, and several generations of Indian scholars. Most importantly, as one confronts today’s burden of disease and disability in India, Britain showed little interest in building even the most rudimentary elements of a health or scientific research system during its period of colonial rule. The full extent of this history must be appreciated if one is to understand the health needs of the Indian people today.
In 1946, the Bhore Committee set out a proposal for a national programme of health services in India. Over the past 70 years these reforms were never implemented. For the first time, an Indian-led team of authors have now estimated disease burden and risk factor trends for all states in India covering the period 1990 to 2016. The study underscores the fact that India is undergoing a rapid epidemiological transition with a shift in burden to non-communicable diseases (NCDs) and injuries. However, huge variations in disease burden exist across states, with communicable, maternal, neonatal, and nutritional diseases still high in many states and NCDs and injuries increasing in every state, highlighting major health inequalities.
Earlier this year, a study published in The Lancet analyzed access to and quality of health care among and within countries using a new metric, the Healthcare Access and Quality (HAQ) index. Despite India’s HAQ index increasing from 31 in 1990 to 45 in 2015, India still ranked a woeful 154th among 195 countries. In another Lancet study, which analyzed progress towards universal health coverage (UHC) as one of the Sustainable Development Goal indicators, India again underperformed relative to other countries, many of which were far less developed.
The authors note two factors that will further challenge India’s health system in the coming decades: urbanization and ageing of the population. Both of these transitions will add to and exacerbate the major risk factors for disease burden highlighted in this study, which include child and maternal malnutrition, unsafe water and sanitation, air pollution, and metabolic and behavioral risk factors for cardiovascular disease and diabetes. Targeted actions alongside broader (intersectoral) and longer-term policy responses will be required across all states.
Encouragingly, a flourishing era of innovation in the way health care is being designed and delivered is being invested in and led by the states themselves. For example, Kerala, Tamil Nadu, and the Punjab are strengthening health systems in pilot projects for UHC. However, these state level actions should not diminish the responsibility of the federal government for increasing public investment in health care. We are disappointed by the lack of ambition of President Modi’s Government to invest only 2·5% of its GDP into health care by 2025, when the global average for countries is about 6%. The rise in India’s economic fortunes and its aspiration to progress to the same level as its neighbor, China, is something of an embarrassment, given how improvements to health trail so far behind. Until the federal government in India takes health as seriously as many other nations do, India will not fulfil either its national or global potential.
India Needs Punishment Policy for Illegally Sold Medicines
Selling or marketing spurious medicine is a black-market industry of thousand crores in our country. So many medicines are sold openly in the market over the counter without prescription of doctors. Not only this, such medicines should be given by licensed registered pharmacist in chemist shop but in our country, one can get it everywhere and now online at our home. Medicines are sold openly by advertisement in printed.
Medicines are sold openly by advertisement in printed media, electronic media and social media openly, anybody can get any medicine including habit forming sleeping pills and narcotics leading to drug addiction and every other bad effect. Every second person suggests some medicine to other as if a doctor.
Many homoeopathic, ayurvedic and allopathic medicines are advertised completely on fake studies and promises and almost all leading TV channels and all best newspapers and magazines of India. Many medicines are sold on the belief that these medicines do not cause any side effect as Ayurvedic, Homeopathy medicines are desi and never cause any abnormal reaction. A quick recovery for increasing height, sex desire and satisfaction, a color change from black to a fair, reducing weight, treating diabetes, asthma, arthritis cancer, epilepsy etc. are marketed badly by big advertisements or push through marketing persons or via MR through doctors. Vitamins, liver tonics, enzymes, anti-diarrheal, cough syrups, antacids, laxative painkillers etc. are sold openly in different combinations in all pathies which are not recommended pharmacologically. Many banned and discarded medicines are openly sold and marketed in Indian drug market.
MCI gag order to doctors to write generic medicines will further vitiate the black market as now Uneducated medicine sellers as most chemist shops does not have pharmacist will give highly profitable less reliable brand for generic compound to patient after doctor’s prescription. Many such medicines are manufactured by many fake and unregistered companies but as our drug regulating agencies, police, general and health administration or judiciary is easily bribed so this industry of corruption is running full swing.
But the situation is just reverse in USA, UK, Germany, France, Australia etc. all developed and many developing nations where every medicine is given to any patient on the prescription of a doctor and that too by a registered pharmacist only. Audit of every medicine is must as that of a currency an if anybody violate or disobey such rule strict punishment is awarded.
Recently an Indian who went to America and got its natural citizenship too was jailed for 5 yrs. rigorously with a withdrawal of citizenship as he was exporting Viagra like drugs from china and selling it in a different part of America as Sex enhancing pill. He exported this drug from china as a beauty product and then changed its wrapper and all details and sold it in the market under different parts of USA where nobody can sell any medicine if not cleared by FDI and medicines can be sold from a registered pharmacy only. They do not allow to import any medicine which is manufactured there only beauty products, tea etc. can be imported after a valid license so he adapted this way to earn money.
Same way about 2 yrs. back, well-known pharma company has to pay hundred million for importing few not up to standard medicine to the USA for settlement of the case out of Court with the USA Government. But in India, that company easily sold all those medicines due to bribe to politicians and drug controlling authorities.
This is a lesson for a country like us. Our Government and law enforcing agency should have zero tolerance for selling medicines as any careless handling of this serious chemical may damage our body badly or may cause death. Therefore to sell medicines without doctor prescription and selling these by unregistered so called pharmacist at chemist shops or online or shops without drug license or manufacturing and marketing of spurious medicines and running fake drug companies are heinous crime and should be punished as in the USA heavily, to save human life as no compromise with health should be allowed.
Indian legal system and mental health
Although there was a rich tradition of legal system in Ancient India, the present judicial system of the country derives largely from the British system and is based on English Common Law, a system of law based on recorded judicial precedents. Earlier legislations in respect of mental health were primarily concerned with custodial aspects of persons with mental illness and protection of the society. Indian laws are also concerned with determination of competency, diminished responsibility and/or welfare of the society. United Nations Convention for Rights of Persons with Disabilities (UNCRPD) was adopted in 2006, which marks a paradigm shift in respect of disabilities (including disability due to mental illness) from a social welfare concern to a human right issue. The new paradigm is based on presumption of legal capacity, equality and dignity. Following ratification of the convention by India in 2008, it became obligatory to revise all the disability laws to bring them in harmony with the UNCRPD. Therefore, the Mental Health Act – 1987 and Persons with Disability Act – 1995 are under process of revision and draft bills have been prepared. Human right activists’ groups are pressing for provisions for legal capacity for persons with mental illness in absolute terms, whereas the psychiatrists are in favor of retaining provisions for involuntary hospitalization in special circumstances.
Indian Legal Systems refers to the system of law operative in India. In the ancient days, there was a distinct tradition of law, which had a historically independent school of legal theory and practice. Law as a matter of religious prescriptions and philosophical discourse has an illustrious history in India.[1] The Arthashastra dating from 400 BC and the Manusmriti from 100 AD were influential treatises in India, texts that were considered authoritative legal guidance.[2] Manu’s central philosophy was tolerance and pluralism and was cited across Southeast Asia.[2] During the Islamic rule, Sharia law came to India, but that was applicable mainly to the Muslim population. When India became part of the British Empire, there was a break in the tradition, and Hindu and Islamic laws were supplanted by the common law. As a result, the present judicial system of the country derives largely from the British system and has little correlation to the institutions of the pre-British era.[2] Much of the contemporary Indian Laws are largely based on English Common Law, a system of law based on recorded judicial precedents and shows substantial European and American influence and many of the legislations introduced by the British are still operative. Therefore, the roots of most of the legislations in respect of persons with mental disorders (PMI) can be traced to the British periods.
There is a dynamic relationship between the concept of mental illness, the treatment of the mentally ill and the law.[3] As Rappeport has noted, for the psychiatrists the court is “another house … with its different motives, goals and rules of conduct.”[4] While the psychiatrist is concerned primarily with the diagnosis of mental disorders and the welfare of the patient, the court is often mainly concerned with determination of competency, dangerousness, diminished responsibility and/or the welfare of society.[5] Therefore, in India also, most of the earlier legislations in respect of PMI were concerned with these aspects. However, legislations drafted after eighties tend to give some stress on the rights of PMI also.
The constitution of India
The constitution of India provides under Article 21 that no person shall be deprived of his life or personal liberty except according to procedures established by law. It has been held that right to life and personal liberty under this article includes “facilities for reading, writing and expressing oneself in diverse forms, freely moving about and mixing and comingling with fellow human beings.” [6]
According to the Representation of People Act, 1950 (sec 16), a person is disqualified for registration in an electoral roll if he is of unsound mind and stand so declared by a competent court. Therefore, the person so disqualified cannot hold public offices under the Constitution like President, Vice-President, Ministers or Member of Parliament and State Legislatures.
Indian laws regulating treatment of persons with mental disorders
Relationship between psychiatry and law most often comes into play at the time of treatment of PMI. Treatment of PMI often involves curtailment of personal liberty of psychiatric patients. Most of the countries in the World have laws regulating treatment of psychiatric patients. Though there are elaborate descriptions of various forms of mental disorders in various treatises in Ayurveda,[7] the care of mentally ill in the asylums in India is a British innovation.[8] After the takeover of the administration of India by the British crown in 1858, a large number of laws were enacted in quick succession for controlling the care and treatment of mentally ill persons in British India.[9] These laws were
• The Lunacy (Supreme Courts) Act, 1858
• The Lunacy (District Courts) Act, 1858
• The Indian Lunatic Asylum Act, 1858 (with amendments passed in 1886 and 1889)
• The Military Lunatic Acts, 1877.
These Acts gave guidelines for establishment of mental asylums and procedure to admit mental patients. The British scene existing in the middle of the 19th century served as the background of lunacy legislations in that period in India. The various Acts of 1858 naturally reflected the legalistic frame for the management of the mentally ill.[10] During the first decade of the 20th century, public awareness about the pitiable conditions of mental hospitals accentuated as a part of the growing political awareness and nationalistic views spearheaded by the Indian intelligentsia.[9] As a result, the Indian Lunacy Act, 1912 was enacted. The 1912 Act guided the destiny of Psychiatry in India.[10] Lunatic asylums (named mental hospitals in 1922) were now regulated and supervised by a central authority. Procedure of admission and certification in this respect was clearly defined. The provision of voluntary admission was introduced. Still, the main stress was on preventing the society from dangerousness of mentally ills and taking care that no sane person is admitted in these asylums. Psychiatrists were appointed as full-time officers in these hospitals. Provisions of judicial inquisitions for mentally ill persons were also given in the Act. After the Second World War, Universal Declaration of Human Rights was adopted by the UN General Assembly. Indian Psychiatric Society submitted a draft Mental Health Bill in 1950 to replace the outmoded ILA-1912. Mental Health Act (MHA-87) was finally enacted in 1987 after a long and protracted course. Main features of the Act are as follows.
• Definition of mental illness in a progressive way and introducing modern concept of their treatment with stress on care and treatment rather than on custody.
• Establishment of Central/State Mental Health Authority to regulate and supervise the psychiatric hospitals/nursing homes and to advise Central/State Governments on Mental Health matters.
• Admission in special circumstances in psychiatric hospital/nursing homes. Provisions of voluntary admission and admission on the reception orders were retained.
• Role of Police and Magistrate to deal with cases of wandering PMI and PMI cruelly treated.
• Protection of human rights of PMI.
• Guardianship and Management of properties of PMI.
• Provisions of penalties in case of breach of provisions of the Act.
Though having many positive features, the MHA-1987 has been the target of criticism right since its inception. It is alleged to be concerned mainly with the legal procedure of licensing, regulating admissions and guardianship matters of PMI. Human right issues and mental health care delivery are not properly addressed in this Act.[11] Because of a large number of very complicated procedures, defects and absurdities in the Act and also in the Rules made under the Act, it can never be implemented properly.[12] Human right activists have questioned the constitutional validity of the MHA, 1987 because it involves curtailment of personal liberty without the provision of proper review by any judicial body.[13] MHA-87 is currently under process of amendment to make it United Nations Convention for Rights of Persons With Disabilities (UNCRPD) compliant.
Persons with disability (equal opportunities, protection of rights, full participation) Act, 1995 (PDA-95)
PDA-95 was enacted in 1995 to remove discriminations in the sharing of developmental benefits vis-à-vis non-disabled persons and to prevent abuse and exploitations of persons with disability (PWD). It provided for barrier-free environment and spelled out responsibilities for the government to plan strategies for comprehensive development programmes, to special provision for integration of PWD into the social mainstream. Under PDA-95, mental retardation and mental illness are categorized as conditions of disabilities. Thus, the PMI are entitled to benefits available to PWD as provided under the Act. There is a provision of 3% reservation in government jobs, but it is not available to the PMI. This Act is also currently under revision in light of the UNCRPD-2006.
National trust Act-1999
This Act was enacted in the year 1999 for the welfare of persons with autism, cerebral palsy, mental retardation and multiple disabilities to enable and empower them to live as independently and as close to the community to which they belong and to facilitate the realization of equal opportunities and protection of rights. The Act provides for many welfare measures. This Act is also under revision to make it UNCRPD-2006 compliant and make it more comprehensive. Management of properties of PMI is supposed to be covered under the amended Act.
United Nations convention for rights of persons with disabilities-2006 and Indian laws
UNCRPD was adopted in December, 2006. It was ratified by the Parliament of India in May, 2008. Countries that have signed and ratified the UNCRPD are required to bring their laws and policies in harmony with it. Therefore, all the disabilities laws in India are currently under process of revision. The convention marks a paradigm shift in respect of disabilities from a social welfare concern to a human right issue. The new paradigm is based on presumption of legal capacity, equality and dignity. According to article 2 of the convention, PWD will enjoy legal capacity on an equal basis for all aspects of life. Article 3 calls the state to take appropriate measures to provide access to support by PWD to exercise the legal capacity. Article 4 calls for safeguards to prevent abuses of the system of support required by PWD. There is no explicit prohibition of forced interventions in the UNCRPD, but neither does the Convention permit compulsory mental health care.
The process of amendment in MHA-87 was set in motion and a draft Mental Health Care Bill – 2011 (MHCB) has been prepared. MHCB provides for replacement of licensing of mental health establishments to registration and establishment of Mental Health Review Commission with its state panels. Admission processes have been drastically changed. The most salient feature of MHCB is that it enshrines duties on the government to establish and provide mental health services to all citizens and take appropriate measures in this respect. There are elaborate provisions in respect of human rights of the PMI and it has a separate chapter for the purpose.
PDA-95 is also under revision and a draft “The Rights of Persons with Disabilities Bill, 2011 (RPWD Bill) has been submitted to the Ministry of Social Justice and Empowerment (MSJE). Sec 18 of the proposed bill states that PWD will enjoy legal capacity on equal basis with others in all aspects of life and any law, rule, bye-law, custom or practice prescribing disqualification on ground of disability will become unenforceable. PWD have the right to access support necessary to exercise the legal capacity, but they are free to alter, modify or dismantle any support system. Concept of plenary guardianship has been abolished and replaced with limited guardianship. PMI has been provided 1% quota out of the proposed 7% reservation for PWD in government jobs.
Provisions of MHC Bill and RPWD Bill are in conflict of each other. The drafting team of the RPWD was dominated by human right activists. A section of human right activist is in favor of complete legal capacity to all PMI and want a complete ban on involuntary institutionalization and even dismantling of all psychiatric hospitals. They feel that in the MHCB, there is no assumption of universal capacity, and no plan to provide support to people in making informed choices regarding their own affairs.[15] They have even called for outright repeal of MHA-87 and matter to be covered by a revised and comprehensive RPWD Bill under the purview of MSJE.
Indian contract laws
According to Indian Contract Act, 1872, any person of sound mind can make a contract. Section 12 of the Act stipulates that a person is said to be of sound mind for the purpose of making a contract, if, at the time when he makes it, he is capable of understanding it and of forming a rational judgment as to its effect upon his interest. A person, who is usually of unsound mind, but occasionally of sound mind, may make a contract when he is of sound mind. A person, who is usually of sound mind, but occasionally of unsound mind, may not make a contract when he is of unsound mind. It means a PMI who is currently free of the psychotic symptoms can make a contract, whereas a person who is currently intoxicated or delirious cannot make a contract.
Marriage and divorce
Under Hindu Marriage Act, 1955, conditions in respect of mental disorders, which must be fulfilled before the marriage is solemnized under the Act, are as follows.
2 Neither party is incapable of giving a valid consent as a consequence of unsoundness of mind.
3 Even if capable of giving consent, must not suffer from mental disorders of such a kind or to such an extent as to be unfit for marriage and the procreation of children.
4 Must not suffer from recurrent attacks of insanity.
The expression “mental disorder” means mental illness, arrested or incomplete development of mind, psychopathic disorder or any other disorder or disability of mind and includes schizophrenia. The expression “psychopathic disorder” means a persistent disorder or disability of the mind (whether or not including sub-normality of intelligence) which results in abnormally aggressive or seriously irresponsible conduct on the part of the other party, and whether or not it requires or is susceptible to medical treatment.
Marriages in contravention to the provision in respect of mental disorders come under voidable category. Voidable marriages (sec 12) are those which may be annulled by a decree of nullity on the given grounds but may continue to be legal till the time it is annulled by a competent court.
According to the section 13 of the Act, divorce or judicial separation can be obtained if the person has been incurably of unsound mind, or has been suffering continuously or intermittently from mental disorder of such a kind and to such an extent that the petitioner cannot reasonably be expected to live with the respondent.
The expression “incurably” of unsound mind cannot be so widely interpreted as to cover feeble minded persons or persons of dull intellect who understand the nature and consequences of the act and are therefore able to control them and their affairs, and their reaction in the normal way (A.I.R. 1969 Guj-48 and 78 CLT 1994 561). When there was sufficient evidence for the court to conclude that the slight mental disorder of the wife was not of such a kind and to such an extent that the husband could not reasonably be expected to live with her, divorce could not be granted (A.I.R., 1982 CAL 138). Each case of schizophrenia has to be considered on its own merits.[16]
Under Special Marriage Act, 1954, the grounds for marriage, divorce and judicial separation are practically the same as those in the Hindu Marriage Act, 1955. The Special Marriage Act, 1954 is meant for any person in India and Indian nationals abroad, irrespective of the faith that the individual may profess. A marriage solemnized in any other form can be registered under this Act.
Under the prevalent Muslim Law, marriage is a type of contract. Therefore, a Muslim who is of sound mind and has attained puberty is qualified to marry. However, if the guardian of a person of unsound mind considers such a marriage to be in his interest and in the interest of society and is willing to take up all the monetary obligations of the marriage, then such a marriage can be performed. Talaq (divorce) under Muslim Law has to be for a reasonable cause and must be preceded by attempts for reconciliation by two arbiters. According to Muslim Marriage Act, 1939, a woman married under Muslim Law is entitled to obtain a decree of divorce if her husband has been insane for a period of 2 years.
Under Christian Law, marriage is voidable, if either party was a lunatic or idiot. Christians can obtain divorce under Indian Divorce Act. 1869 (as amended in 2001) on grounds of unsoundness of mind provided: (i) it must be incurable (ii) it must be present for at least 2 years immediately preceding the petition. Divorce is not admissible on ground of mental illness under the Parsi Marriage and Divorce Act, 1936. However, divorce can be obtained if the defendant at the time of marriage was of unsound mind, provided the plaintiff was ignorant of the fact and the defendant has been of unsound mind for a period of 2 years upwards and immediately preceding the application.
TESTAMENTARY CAPACITY
Testamentary capacity is the legal status of being capable of executing a Will, a legal declaration of the intention of a testator with respect to his property, which he desires to be carried into effect after his death. Indian Succession Act, 1925 (sec 59), stipulates among other things:
• Any person of sound mind can make a Will.
• Persons, who are ordinarily insane, may make a Will during an interval while they are of sound mind.
• No person can make a Will while he is in such a state of mind, whether arising from intoxication or from illness or from any other cause, so that he does not know what he is doing.
Testamentary capacity requires a person’s full sense and mental sanity to have confirmed and signed the Will after understanding what his assets comprised and what he is doing by making a Will. He understands in full mental capacity to whom he is naming the assets to and how are they related to him and what repercussions it may have later.[17]
CRIMINAL LIABILITY
Indian Penal Code, 1860 states that “Nothing is an offence, which is done by a person who, at the time of doing it, by reason of unsoundness of mind, is incapable of knowing the nature of the act, or that he is doing what is either wrong or contrary to law.” McNaghten Rules define the criminal responsibility of mentally ill in our courts and it has been incorporated in the sec 84.[18] It has been held by the Supreme Court that the law presumes every person of age of discretion to be sane and defense on ground of insanity needs to be proved. If defense is established on ground of insanity, such persons are committed to the Psychiatric Hospitals as per sec 471 (i) of the Cr.P.C., 1973. There have been instances of lesser sentence on account of mental illness. Where the feeling of life unbearable on account of domestic quarrels, a woman (accused) jumped into a well with her children, it was held that the only sentence that could be passed was the lesser sentence of imprisonment for life (AIR 1953 MB 61).
Sec 89, IPC provides protection for any action done in good faith for the benefit of a person of unsound mind by or by consent of the guardian or other person having lawful charge of that person. Sec 305, Indian Penal Code (IPC) provides for punishment of death or imprisonment of life for abetment of suicide by an insane person.
CONCLUSION
Important legal provisions in respect of the PMI in the Indian legal system have been discussed. As most of the laws were either framed during the colonial period or their origin can be traced to the period, British influence is clearly visible. Laws in respect of the PMI are presently on crossroad as most of them are under revision to bring them harmony with the UNCRPD-2006. Human right activists are pressing for legal capacity to PMI in absolute terms, whereas psychiatrists are in favor of retaining provision for involuntary hospitalization in special circumstances. It must be emphasized that the ultimate aim of any legal provision should be the welfare of the PMI and the society at large.
Indian mental health policy
The union health ministry launched the country’s first ever mental health policy to provide access to good quality treatment to mentally ill people with the focus on those living in poverty.
The policy, launched by Union Health Minister Harsh Vardhan, is backed up by the “Mental Health Action Plan 365” which spells out the specific roles to be played by the Centre, the state governments, local bodies and civil society organizations.
The government also came out with two booklets providing training modules for general physicians or the common man.
“Universal access to mental health care is a specific goal of the government. It would find substantial articulation in the evolving National Health Policy and National Health Assurance Mission (NHAM),” Harsh Vardhan told the media after the launch.
The minister also said that Oct 10, which is observed as the world mental health day, would now also be observed as the national mental health day.
Apart from this, “mental health institutes across the country would be remodeled on the lines of the National Institute of Mental Health and Neuro Sciences (NIMHANS), Bangalore”, Harsh Vardhan said.
The new mental health policy’s objective is to provide universal access to mental health care by enhancing understanding of mental health and strengthening leadership in the mental health sector at all levels.
Among the major stakeholders identified for actualizing the objectives of the policy are the union government, local bodies like municipalities, schools and colleges and the private corporate sector.
“It will have a pro-poor orientation because only the creamy layer of society presently has access to mental healthcare in India,” Harsh Vardhan said.
The minister added that the government would try and introduce the mental health bill in parliament in the next session. “This time a policy group worked dedicatedly to develop its recommendations. I thank them for recognizing that the vast majority of the mentally ill people in India live in villages and there is literally no care available for them,” he said.
“The World Health Organization has predicted that about 20 percent of India’s population would suffer from some form of mental illness by 2020. The country has only about 3,500 psychiatrists. Therefore, the government is confronted with the problem of lowering this gap significantly over the next decade,” he added.
Indian penal code for doctors
Ignorance of the law is never an excuse especially when it comes to the medical profession, the doctors are under tremendous pressure to perform at the best of their ability and follow the lawsuit in general as their performance reflects if the patient would be cured or saved. They have certain civil and criminal responsibilities.
But, the double-edged sword of treatment burden, death of a patient, and medical errors are always hanging above the head of doctors. The doctors have to outperform and exceed their expectations but the truth lies within that the death can never be controlled by anyone.
If found guilty, doctors are criminally liable under these circumstances:
A] Evidence and Record:
Section number
Actual Act
Explanation
174
Non-attendance in the obedience of an order from a doctor
A doctor is legally bound to appear in court or in front of the magistrate if he/she is in relation with that case. Failure to do so could be found guilty under this section.
175
Failure to produce the document by the legally bounded person
A doctor is bound to produce all documents (e.g. medical reports or treatment record) in case of the medico-legal case. Failure to do so can result in the offence of laws under this section.
176
Omission to provide notice or information to public servant by legally bounded person
A doctor is bound to inform police about the medico legal, murder case, or a rape case which is admitted in their dispensary or hospital. If he/she fails to do so they are then liable under this section
187
Not assisting the public servant when bound by the law to provide the required assistance
A doctor if he/she fails to treat a patient or public servant allotted to him, then the doctor is guilty under this section.
192
Fabricating false evidence
A doctor or a medical professional in any circumstance produces false evidence, makes a false entry in the book, false statement, then he is criminally liable under this act.
197
Issuing or signing a false certificate
A doctor in any way is not allowed to issue or sign a certificate which is intentionally constructed for a false manner.
470
Forged document or electronic record
A document which is made partly or completely by forgery is legally not allowed in the court of law and such acts will be liable under this section
471
Using a forged document as a genuine document
Doctors at any cost are not allowed to utilize forged documents like an original document for whatever reason, in such cases he/she is liable under this section
B] Laws on Public Health, Safety and Drugs:
Section number
Actual Act
Explanation
269
Negligence resulting in the spread of infectious diseases
The medical professionals are liable to follow strict standards which are set for treating patients under the guidelines and protocols especially for dangerous diseases like AIDS, Hepatitis etc.
270
Malignancy resulting into the spread of infectious diseases
The medical professionals are not allowed to act malignantly in any case, such acts would be strictly taken into action under this section
274
Drug Adulteration
The medical professionals aren’t allowed to adulterate any medical preparation which arbitrarily affects the efficiency and safety of the drug rendering it useless. If found guilty, such professionals are liable under this act.
276
Sale of drugs as a different drug or preparation
The medical practitioners aren’t allowed to retail drugs with their own formulation. All drugs which are liable to sale should be duly approved by the regulatory authorities. If found liable such individuals would have to face stern action under this section.
278
Making the work atmosphere unreliable to work
The medical practitioner caught violating the norms of the general practice that intoxicates the work environment on a large scale are liable under this act.
284
Negligence while handling a poisonous substance
If the medical practitioner, due to any unforeseen reason is involved in providing a poisonous or toxic substance to the patient which can endanger the life, such practitioners are liable under this section.
287
Negligence in handling medical devices
The medical practitioner needs to be very careful while handling medical devices, if any sort of negligence occurs in any circumstance it could lead to serious complications under this section.
C] Laws in relation to endangering life:
Section number
Actual Act
Explanation
336
Endangering the life or personal safety of others
Act performed with negligent intentions which proceeds to endanger their life or personal safety.
337
Hurting life or personal safety of others
A procedure performed which harms human life or personal safety.
338
Hurting grievously or personal safety of others
An act which is responsible for grievously hurting someone which proceeds to endanger their life or personal safety
D] Laws in relation to indoor patients:
Section number
Actual Act
Explanation
340
Wrongful confinement
A medical practitioner is not allowed to wrongfully restrain a person from his/her rights in a manner as to limit the medical proceedings further. It is totally unlawful to confine a person, withhold discharge for any given reason or withhold handing of the dead body due to payment disputes.
E] Laws governing death due to negligence:
Section number
Actual Act
Explanation
304-A
Causing death due to negligence
The medical practitioner who is found guilty of causing death due to medical negligence can be punished with imprisonment of either description for a term which may extend to two years, or with fine, or both. In this section, the Supreme Court of India is of the view that the situation should be very carefully analyzed while imposing criminal offences on doctors under this section.
Finally, it needs to be remembered that establishing a strong doctor-patient relationship could assist in many ways. In any case, more time you spend with your patient in your consulting room, it might reduce your time in the courtroom.
Is Consumer protection Bill 2018 going to disturb my practice?
_Objections and Consideration of CP Bill 2018.
1. Raised pecuniary jurisdictions of District, State & National Commissions, but cleverly removed ‘amount of compensation claimed’ from all the jurisdictions.
*Compensation removed and Consideration* inserted which means that the fine would be higher and easy for implementation even by a local district body. Making us more vulnerable.
2. Appellant can file complaint in his district, where he/she is residing, jurisdiction changes causing more inconvenience to the doctor.
Doctors would have to travel to maybe other district wherein the *complainant can have influence*, sympathy and use non judiciary means for extraction of fine amount.
3. 50% of the fine amount to be deposited in court before going to higher court for appeal.
If the fine is 1 crore, a doctor has to *deposit 50 lakhs cheque for being eligible* for filing and fighting against in higher state Court. I simply can’t imagine the situation if at all it arises.
4. Imposing a penalty of 10000 on frivolous complaints removed.
Increasing the possibility of *false accusations to extract, trouble harass doctor. *
5. Mediation Cell has been introduced. The commission might transfer the dispute to mediation cell for negotiation.
Once we appear for that, it will be *assumed that we are guilty and ready for negotiation*. Money and influence game begin. With the current attitude towards doctors, this mediation cell comprising of non-Medico’s would be a disaster.
6.. Punitive restrictions on doctors for
misleading endorsement of any product. -Whenever a doctor makes a research and make some innovation if he/she endorses the product and somebody, NGO file application against it, then not only fine, penalty but *even the registration could be challenged. *
God bless the Indian citizens who want research and innovative ideas and solutions from us.
7. All this would be in the hands of non-judicial person who will pass judgement, verdicts.
*Incapable of logical thinking and deficiency of judiciary* prerogatives these lay persons will have an out leash in declaring consideration amounts which won’t be capped at 20 lakhs as before in CPA, but now *up to and not limited to 1 Crore. *
JUDGEMENT ON PNDT ACT
HIGHLIGHTS FROM THE JUDGEMENT19. At this stage, the counsel for the petitioner in W.P.(C) No.6968/2011(IRIA) contended that PNDT Act was concerned with the misuse of the techniques of ultrasound for sex determination but has ended up, permitting all MBBS Doctors to conduct ultrasound. However, on enquiry, whether prior thereto, there was any bar on MBBS Doctors doing ultrasound or reporting on ultra sound procedure, no reply was forthcoming.
29………we fail to understand what difference it makes, whether the sonologist or imaging specialist i.e. a person who can use and operate an ultrasound machine, is a mere MBBS or has a Post Graduate qualification in medicine or has experience of one year or has undergone six months training. The PNDT Act does not owe its enactment to the poor or useless or inaccurate diagnostic reports of ultrasound tests and resultant need to prescribe the qualifications of persons who can operate, use, read and report the outcome of the said diagnostic procedure.
34. We are therefore unable to comprehend the purport of the impugned provisions prescribing the qualification of persons who can use and operate the ultrasound machines and like. It is not as if prior to the coming into force of the PNDT Act the ultrasound machines were in the hands of persons other than „Doctors‟. Even in diagnostic centers where „technicians‟ were operating the ultrasound machines, they were under the control and supervision of „Doctors‟ and it was the „Doctors‟ who were preparing and signing the reports of ultrasound diagnosis/test. It was the „Doctors‟ only who were misusing the same for sex determination, as is evident from reports in the news media of the stray cases detected of violation of the Act.
37.We are of the opinion that for the purposes of prevention of sex determination through ultrasound machines or other radiological techniques, it matters not whether the ultrasound machine is in the hands of an MBBS or an MBBS with six months training or an MBBS with one year experience who has cleared the competency test or in the hands of MD radiologist / obstetrics. The qualification of MBBS itself is a highly sought-after qualification, to secure which one has to first appear in a competitive examination for admission to a medical college and thereafter has to undergo the rigors of passing the MBBS examination. By no stretch of imagination can it be said that an MBBS qualified person lacks education or understanding to be not able to comprehend the fatal consequence of female feticide as a result of sex determination or the morality behind the same. In our opinion, to understand the said aspects, the one-year experience or passing the competency test or undergoing the six months training or acquiring the post-graduate qualification, add no further to the person
42.We may at the outset notice the difference in the stand qua the interpretation of Section 2(p) between the petitioner in WP(C) No. 6968/2011(IRIA) and the petitioners in the other two petitions. While according to petitioner in WP(C) No. 6968/2011, which represents Doctors with postgraduate degrees in radio-diagnosis, it is only the Doctors with postgraduate degrees in radio-diagnosis who are competent to install, use, operate and report on diagnosis with ultrasound machines and have been doing so in the past and the PNDT Act has for the first time entitled even those without postgraduate degrees i.e. mere MBBS to do so, the petitioners in other two petitions who represent the general body of Doctors, not necessarily holding postgraduate degree in radio-diagnosis, controvert. However, since we have not been shown and have ourselves not been able to find any bar under the MCI Act or any other law/rule/regulation, to using/operating ultrasound machine save with a postgraduate degree in radio diagnosis, we proceed to interpret Section 2(p) literally.
44. The contention of the petitioners in WP(C)No. 2721/2014 and WP(C) No. 3184/2014 also is that qualification of MBBS or any medical qualification recognized under the MCI Act is enough to operate/use an ultrasound machine. ………If MCI, which is the specialist body in the field of medicine, is of the opinion that persons having MBBS qualification are entitled to practice medicine with use of ultrasound machine, we need look no further…………………………………………….Suffice it is to state that literally, Section 2(p) enables a person who possesses any one of the medical qualification recognized by MCI to be a sonologist or imaging specialist
98. We accordingly dispose of these petitions with the following declarations / directions:
(I) that Section 2(p) of the PNDT Act defining a Sonologist or Imaging Specialist, is bad to the extent it includes persons possessing a postgraduate qualification in ultrasonography or imaging techniques – because there is no such qualification recognized by MCI (Final Interpretation: Every MBBS is a sonologist and six months training is not required)
………………………(vi) Rule 3(3)(1)(b) of the PNDT Rules (as it stands after the amendment with effect from 9th January, 2014) is ultra vires the PNDT Act to the extent it requires a person desirous of setting up a Genetic Clinic / Ultrasound Clinic / Imaging Centre to undergo six months training imparted in the manner prescribed in the Six Months Training Rules.(Final Interpretation: Every MBBS is a sonologist. Six months training is optional)
………………………. Dr. Sonal Randhawa (Secretary-SSOI)
LAWS IN MEDICINE
The modern version of Hippocratic Oath (called the declaration of Geneva), devised by the WHO
after the second world war and accepted by international medical fraternity as the international code of medical ethics, draws heavily upon the ancient oath, been guiding and regulating the conduct
of doctors for centuries.
During the Ashoka period (270 BC), the state showed
interest in the public works and provision of medical care
and as a law. He founded hospitals all over his empire with
medical attendance at state expense.4 Ethics is described in
the Charaka—Samhita, in details and Ayurvedic physicians
of ancient India has a well-defined medical ethics”.5
The colonial power brought with them their own
physicians and barber surgeons. In the mid-19th century, as
the medicine got recognized in England, it slowly started
having its impact in India too. After 1857, the main factors
that shaped colonial health policy in India were their concern
for troops and European civil population.6
The process of establishment of healthcare system
also necessitated creation of legislative framework for
practitioners of medicine. In the earlier period of rule, the
physicians and surgeons brought by the East India company
and after 1857 by the British Government, needed some
discipline and regulations. Lt Colonel DG. Crawfords ‘A
history of Indian medical services, 1600-1913’ narrates
several instances of in-discipline, insubordination,
malpractice, etc. by such doctors and the punishments
(including deportation) mated out to them. It also narrates
the regulation devised by the East India Company for the
hospitals established by them.
After the enactment of the law, establishing General
Medical Council in 1857 in England, the British doctors
employed in India were registered with the GMC and came
under its disciplinary regulation. As the number of doctors
qualified in Indian medical colleges increased, creation of
laws for them became necessary.
As a part of criminal procedures and for other purposes,
the colonial government had, in 1871, enacted Coroner’s
act applicable to Bombay and Calcutta. It defined the
role of medical professionals in the work of conducting
autopsy and inquests. However, the laws for the creation
of indigenous medical councils took many more years for
enactment. Mean-while, the laws were enacted for the
prevention of the spread of dangerous epidemic disease,
for the segregation and medical treatment of pauper, etc.
The epidemic disease act was first enacted in 1807 and is
still in force with amendments, while the Lepers Act 1898
was repealed and substituted by another law in early 1980s.
Grant Medical College Society in 1880 passed a Bombay
Medical Act and established the medical council. The draft
rule of this act included the appointment of a registrar,
maintenance of name in register and penalty for doing wrong
things. The Bombay Presidency enacted Bombay Medical
Act in 1912. Medical acts in some other provinces soon
followed. The Bengal Medical Act and Madras Medical
Registration Act were enacted in 1914.
These provincial acts were immediately followed by the
Indian Medical Degree Act, passed by the Indian Legislative
Council and approved by the Governor General in 1916.
The Medical Council of India, a national level statutory
body for the doctors of modern medicine, was constituted
after the enactment of Indian Medical Council Act 1933. The
first legal recognition and registration for the Indian systems
of medicine came when the Bombay Medical Practioners Act
was passed in 1938.
Post 1947 Developments
The independence in 1947 inaugurated a new phase of
development of organized health care services creating more
entitlement for the people. Along with that, the state also
embarked on enactment of new laws, modification of the
colonial laws and judiciary developed case laws to consolidate
people’s entitlement of health care and to extent the rights.
At the time of independence and the first few years of
planning, the task confronting the country was to create
physical and institutional infrastructure for the rapid
development or modernization of India.
With time, the parliament has passed a large number
of bills and acts to strengthen the healthcare delivery in
India.
Laws Applicable to Medical Practice and Hospitals in India
International Journal of Research Foundation of Hospital & Healthcare Administration, July-December 2013;1(1):19-24
21
JRFHHA
Prerequisites of Medical Practice
A duly qualified medical professional, i.e. a doctor has a
right to seek to practice medicine, surgery and dentistry
by registering himself with the medical council of the state
of which he is resident, by following the procedure as
prescribed under the medical act of the state.
The state medical council has the power to warn, refuse
to register/remove from the name of a doctor who has been
sentenced by any court for any nonbailable offence or found
to be guilty of infamous conduct in any professional respect.
The state medical council has also the power to re-enter the
name of the doctor in the register.
The provision regarding offences and professional
misconduct which may be brought before the appropriate
medical council (state/medical Council of India) have been
stated in the Indian Medical council (Professional conduct,
etiquette and ethics) Regulation 2002. No action against a
medical practitioner can be taken unless an opportunity has
been given to him to be heard in person or through an advocate.7
Emergency Healthcare and Laws
The supreme court has been emphatic in declaring that the
fundamental right to life covered within its scope the right to
emergency healthcare. The landmark judgment that marked
this momentous event is that of Parmanand Katara V, Union
of India (Supreme Court 1989). In this case, a scooter rider
severely injured in a road accident was refused for admission
when taken to nearest hospital on the excuse that hospital
was not competent to handle medicolegal cases. The supreme
court, in its judgment, pronounced that the obligation of
medical professionals to provide treatment in cases of
emergencies overrode the professional freedom to refuse
patients. According to the right to emergency treatment, the
status of a fundamental right under Article 21 (fundamental
right of life), the court categorically stated that ‘Article 21
of constitution casts the obligation on the state to preserve
life. Interestingly, the supreme court went on to say that not
only government hospitals but also ‘every doctor whether
at a government hospital or otherwise has the professional
obligation to extend his/her service with due expertise for
protecting life.
In another case (Paschim Banga Khet Majdoor Samity
vs State of West Bengal, Supreme Court, 1996), a person
suffering from head injuries from a train accident was
refused treatment at various hospital on excuse that they
lacked the adequate facilities and infrastructure to provide
treatment. In this case, supreme court further developed
the right to emergency treatment, and went on to state
that the failure on the part of government hospital to
provide timely medical treatment to a person in need of
such treatment results in violation of his/her right to life
guaranteed under Article 21.
Criminal Liability in Medical Profession
Criminal law tries to mold the individual behavior in a
socially accepted manner. It tries to enforce the rules of
social mortality to a great extent. Criminal law defines certain
types of human conduct as offences and prescribes the
punishment for them. Remission by doctors in their duties
and obligations and lapses left by them may give to criminal
liabilities, the liabilities of being prosecuted in a criminal
court and awarded punishment as per provision of law.
The criminal law operates on a doctor in somewhat a
different manner than an ordinary person. This is because it
allows a doctor to cause injury to the patient for preventing
a greater harm. The crucial area of criminal law for a doctor
are offences affecting life. These offences are mainly murder,
simply hurt, grievous hurt and miscarriage or abortion. A doctor
may be charged for any of these offences in general. However,
the criminal law arms a doctor with three formidable defenses
namely: (1) informed consent, (2) necessity and (3) good faith.
Various criminal liabilities in medical practice related
to different sections of Indian Penal Code, the code of
criminal procedure and different acts like MTP, PCPNDT,
Transplantation of Human Organ Act, etc.
LAWS APPLICABLE TO HOSPITALS
Laws Governing the Commissioning of Hospital
These are the laws to ensure that the hospital facilities are
created after due process of registration, the facilities created
are safe for the public using them, have at least the minimum
essential infrastructure for the type and volume of workload
anticipated, and are subject to periodic inspections to ensure
compliance. These are listed in Table 1 below:
Table 1: Laws governing the commissioning of hospital8
1. Atomic Energy Act 1962
2. Delhi Lift Rules 1942, Bombay Lift Act 1939
3. Draft Delhi Lifts and Escalators Bill 2007
4. Companies Act 1956
5. Indian Electricity Rules 1956
6. Delhi Electricity Regulatory Commission (Grant of consent
for captive power plants) Regulations 2002
7. Delhi Fire Prevention and Fire Safety Act 1986, and Fire
Safety Rule 1987
8. Delhi Nursing Home Registration Act 1953
9. Electricity Act 1998
10. Electricity Rules 1956
11. Indian Telegraph Act 1885
12. National Building Act 2005
13. Radiation Protection Certificate from BARC
14. Society Registration Act
15. Urban Land Act 1976
16. Indian Boilers Act 1923
17. The Clinical Establishment (Registration and Regulation)
Bill 2007
Madhav Madhusudan Singh et al
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Laws Governing to the Qualification/Practice and
Conduct of Professionals
These are the regulations to ensure that staff employed in
the hospital for delivery of healthcare are qualified and
authorized to perform certain specified technical jobs within
specified limits of competence and in accordance with
standard codes of conduct and ethics, their credential is
verifiable from the registering councils and in case of any
professional misconduct the councils can take appropriate
action against them. These laws are listed in Table 2.
Table 2: Laws governing to the qualification/practice and
conduct of professionals
1. The Indian Medical Council Act 1956
2. Indian Medical Council (Professional Conduct, Etiquette,
and Ethics Regulations 2002)
3. Indian Medical degree Act 1916
4. Indian Nursing Council Act 1947
5. Delhi Nursing Council Act 1997
6. The Dentist’s Act 1948
7. AICTE Rules for Technicians 1987
8. The Paramedical and Physiotherapy Central Councils
Bill 2007
9. The Pharmacy Act 1948
10. The Apprenticeship Act 1961
Laws Governing to Sale, Storage of Drugs and
Safe Medication
These are laws to control the usage of drugs, chemicals,
blood, blood products, prevent misuse of dangerous
drugs, regulate the sale of drugs through licenses, prevent
adulteration of drugs and provide for punitive action against
the offenders. These are listed in Table 3.
Table 3: Laws governing to sale, storage of drugs and safe medication
1. Blood Bank Regulation Under Drugs and Cosmetics
(2nd Amendment) Rules 1999
2. Drugs and Cosmetics Act 1940 and Amendment Act 1982
3. Excise permit to store the spirit, Central Excise Act 1944
4. IPC Section 274 (Adulteration of drugs), Sec 275 (Sale of
Adulterated drug), Sec 276 (Sale of drug as different drug
or preparation), Sec 284 (negligent conduct with regard to
poisonous substances)
5. Narcotics and Psychotropic Substances Act
6. Pharmacy Act 1948
7. Sales of Good Act 1930
8. The Drug and Cosmetics Rule 1945
9. The Drugs Control Act 1950
10. VAT Act/Central Sales Tax Act 1956
Laws Governing Management of Patients
These are the laws for setting standards and norms for
conduct of medical professional practice, regulating/
prohibiting performance of certain procedure, prevention
of unfair practices and control of public health problems/
epidemic disease. They deal with the management of
emergencies, medicolegal cases and all aspects related there
to including dying declaration, and conduct of autopsy and
the types of professional negligence. These laws are listed
in Table 4.
Table 4: Laws governing management of patients
1. Birth and Deaths and Marriage Registration Act 1886
2. Drugs and Magic Remedies (Objectionable) Advertisement
Act
3. Guardians and Wards Act 1890
4. Indian Lunacy Act 1912
5. Law of Contract Section 13 (for consent)
6. Lepers’ Act
7. PNDT Act 1994 and Preconception and Prenatal Diagnostic
Tech (prohibition of sex selection) Rules 1996 (Amendment
Act 2002)
8. The Epidemic Disease Act 1897
9. Transplantation of Human Organ Act 1994, Rules 1995
10. The Medical Termination of Pregnancy Act 1971
11. Medical Termination of Pregnancy Rules 2003
12. The Mental Health Act 1987
Laws Governing Environmental Safety
These are the laws aimed at protection of environment
through prevention of air, water, surface, noise pollution and
punishment of offenders. These laws are listed in Table 5.
Table 5: Laws governing environment safety
1. Air (prevention and control of pollution) Act 1981
2. Biomedical Waste Management Handling Rules 1998
(Amended on 2000)
3. Environment Protection Act and Rule1986, 1996
4. NOC from Pollution Control Board
5. Noise Pollution Control Rule 2000
6. Public Health Bye Law 1959
7. Water (prevention and control of pollution) Act 1974
8. Delhi Municipal Corporation (malaria and another mosquito
borne diseases) Bye Law 1975
9. The Cigarettes and Other Tobacco Products (prohibition
of advertisement and regulation of trade and commerce,
production, supply and distribution) Bill 2003
10. Prohibition of Smoking in Public Places Rules 2008
11. IPC Section 278 (making atmosphere noxious to health),
Sec 269 (negligent act likely to spread infection or disease
dangerous to life, unlawfully or negligently)
Laws Governing Employment and
Management of Manpower
This group deals with the laws regulating the employment
of manpower, their salaries and benefits, service rules and
system of redressal of grievances and disputes. These laws
are listed in Table 6.
Laws Applicable to Medical Practice and Hospitals in India
International Journal of Research Foundation of Hospital & Healthcare Administration, July-December 2013;1(1):19-24
23
JRFHHA
Table 8: Laws governing the safety of patients, public and staff
within the hospital premises
1. The Radiation Surveillance Procedures for the Medical
Application of Radiation 1989, Radiation Protection Rules
1971
2. AERB Safety Code no. AERB/SC/Med-2(rev-1) 2001
3. Arms Act 1950
4. Boilers Act 1923
5. Explosive Act 1884 (for diesel storage)
6. Gas Cylinder Rules 2004
7. Insecticide Act 1968
8. IPC Section 336 (act endangering life or personal safety of
others), Sec 337 (causing hurt by act endangering life or
personal safety of others), Sec 338 (causing grievous hurt
by act endangering the life and personal safety of others).
9. NOC from chief fire officer
10. Periodic fitness certificate for operation of lifts
11. Petroleum Act and Storage Rules 2002
12. Prevention of Food Adulteration Act 1954
13. The Indian Fatal Accidents Act 1955
14. The Tamil Nadu Medicare Service Persons and Medicare
Service Institutions (prevention of violence and damage or
loss to property) Act 2008
Laws Governing Professional Training
and Research
There are the laws meant to regulate the standards of
professional education and training of doctors, nurses,
technician and controlling research activities. These laws
are listed in Table 9.
Table 9: Laws governing professional training and research
1. MCI rules for MBBS, PG and internship training
2. National board of examination rules for DNB training
3. ICMR rules governing medical research
4. NCI rules for nursing training
5. Ethical Guidelines for Biomedical Research on Human
Subjects, 2000
Laws Governing the Business Aspects
Some rules are applicable to hospital in relation to its
business aspects. These are listed in Table 10.
Table 10: Laws governing the business aspects
1. Cable Television Network Act 1995
2. Charitable and Religious Trusts Act 1920
3. Contracts Act 1982
4. Copyright Act 1982
5. Custom Act 1962
6. FEMA 1999
7. Gift Tax Act 1958
8. Income Tax Act 1961
9. Insurance Act 1938
10. Sales of Good Act 1930
Table 6: Laws governing to employment and management
of manpower
1. Bombay Labor Welfare Fund Act 1953
2. Citizenship Act 1955
3. Delhi Shops and Establishment Act 1954
4. Employee Provident Fund and Miscellaneous Provision
Act 1952
5. Employment Exchange (compulsory notification of vacancies)
Act 1959
6. Equal Remuneration Act 1976
7. ESI Act 1948
8. ESI Rules 1950
9. Indian Trades Union Act 1926
10. Industrial Dispute Act 1947
11. Maternity Benefits Act 1961
12. Minimum Wages Act 1948
13. Negotiable Instrument Act 1881
14. Payment of Bonus Act 1956
15. Payment of Gratuity Act 1972
16. Payment of Wedges Act 1936
17. Persons with Disabilities Act 1995
18. PPF Act 1968
19. SC and ST ACT 1989
20. Shops and Factories Act (for national holiday)
21. TDS Act
22. The Essential Service Maintenance Act 1981
23. The Payment of Gratuity Act 1972
24. Workmen’s Compensation Act 1923
Laws Governing to Medicolegal Aspects
These are the laws governing the doctor-patient relationship,
legal consequences of breach of contract and medicolegal
aspects of negligence of duty. These laws are listed in
Table 7.
Table 7: Laws governing to medicolegal aspects
1. Consumer Protection Act 1986
2. Indian Evidence Act
3. Law of privileged communication
4. Law of torts
5. IPC Section 52 (good faith), Sec 80 (accident in doing
lawful act), Sec 89 (for insane & children), Sec 90
(consent under fear), Sec 92 (good faith/consent), Sec 93
(communication in good faith).
Laws Governing the Safety of Patients, Public
and Staff within the Hospital Premises
These laws deal with safety of facilities and services against
any accidental hazards that may endanger the lives and the
liability of management for any violation. These laws are
listed in Table 8.
Madhav Madhusudan Singh et al
24
Licenses/Certifications Required for Hospitals
A hospital administrator should be aware about the licenses
that are essentially required and to renew them as and when
required. These are as listed in Table 11.
Table 11: Licenses/certifications required for hospitals
Sr. no. Licenses/certifications Frequency
1. Registration under societies
registration act
Initially
2. Inspection for electrical installation/
substation
Initially
3. NOC from local municipal office for
any bye laws
Initially
4. License for storage of petrol/diesel
on form XV under the petroleum
rules 2002
2 yearly
5. Income tax exemption certificate 3 yearly
6. NOC from Delhi fire services Before
implementation
7. Registration for operation of X-ray
installation with AERB
Every 2 years
8. Drug License for medical store,
IPD pharmacy, OPD pharmacy
Every 5 years
9. License to operate blood bank under
rule 122G of drug and cosmetic act
Every 5 years
10. Registration under PNDT Act 1994 Every 5 years
11. Income tax registration/PAN Once only
12. Registration for VAT/Sales tax Once only
13. Registration for EPF Once only
14. Registration for ESI coverage of
employee
Once only
15. Registration under rule 34, sub rule
(6) of MTP Act 1971
One time
registration
16. Registration under Delhi nursing
Home Act 1953
Yearly
17. Indemnity insurance policy Yearly
18. Standard re and special perils
policy
Yearly
19. Authorization for generation of
BMW under BMW handling rule
1996
Yearly renewal
20. License for operating lift under
Sect 5 and 6 and Rules 4 and 5
(inspector of lift, state govt)
Yearly renewal
Periodic Reports and Returns as
Legal Commitment
A hospital administrator should be aware about the reports
and returns that are essentially required by different
agencies with fixed periodicity. Some of these are listed
in Table 12.
Table 12: Periodic reports and return as legal commitment
for hospitals
Sr. no. Periodic reports and return for
hospitals
Frequency
1. Biomedical waste generation Annual
2. Income Tax Annual return
3. Units processed in blood bank Monthly
4. MTP reports Monthly
5. PNDT report (prenatal USG
done)
Monthly
6. Employees provident fund Monthly/annual
7. ESI act Monthly/annual
8. VAT Monthly/quarterly online
9. Registration of births and deaths on every occurrence
10. Post-polio paralysis case on every occurrence
11. Communicable disease report on every occurrence
12. Radiologist registration under
PNDT
On induction of a new
radiologist
13. USG machine registration
under PNDT
On induction of each
machine
14. Needle stick injuries on occurrence
15. TLD Badges for monitoring the
dosage received
Quarterly
16. TDS Quarterly
CONCLUSION
The health legislations are very few as compared to the size
and problems in the health care sector. There is a need for
having a comprehensive health care act, framed in order to
gear the entire health care sector to the objectives laid down
in the different policy in India. Most of the common medico
legal situations arise out on noncompliance with these rules
and regulations. If a hospital or doctor acquaints well with
these rules and regulations and follow them sincerely, he/
she would be on the right side of the law.
MCI code of ethics
(AMENDED UPTO DECEMBER 2010)
(Published in Part III, Section 4 of the Gazette of India, dated 6th April,2002)
MEDICAL COUNCIL OF INDIA
NOTIFICATION
New Delhi, dated 11th March, 2002
Click here to view / read this Regulation
No. MCI-211(2)/2001/Registration. In exercise of the powers conferred under section 20A read with
section 33(m) of the Indian Medical Council Act, 1956 (102 of 1956), the Medical Council of India, with
the previous approval of the Central Government, hereby makes the following regulations relating to
the Professional Conduct, Etiquette and Ethics f or registered medical practitioners, namely: –
Short Title and Commencement:
1. These Regulations may be called the Indian Medical Council (Professional conduct, Etiquette
and Ethics) Regulations, 2002.
2. They shall come into force on the date of their publication in the Official Gazette.
CHAPTER I
1. CODE OF MEDICAL ETHICS
A. Declaration:
Each applicant, at the time of making an application for registration under the provisions of the Act,
shall be provided a copy of the declaration and shall submit a duly signed Declaration as provided
in Appendix 1. The applicant shall also certify that he/she had read and agreed to abide by the same.
B. Duties and responsibilities of the Physician in general:
1.1 Character of Physician (Doctors with qualification of MBBS or MBBS with post graduate degree/
diploma or with equivalent qualification in any medical discipline):
1.1.1 A physician shall uphold the dignity and honor of his profession.
1.1.2 The prime object of the medical profession is to render service to humanity; reward or financial
gain is a subordinate consideration. Who – so-ever chooses his profession, assumes the obligation to?
conduct himself in accordance with its ideals. A physician should be an upright man, instructed in the
art of healings. He shall keep himself pure in character and be diligent in caring for the sick; he should
be modest, sober, patient, prompt in discharging his duty without anxiety; conducting himself with
propriety in his profession and in all the actions of his life.
1.1.3 No person other than a doctor having qualification recognized by Medical Council of India and
registered with Medical Council of India/State Medical Council (s) is allowed to practice Modern system
of Medicine or Surgery. A person obtaining qualification in any other system of Medicine is not allowed
to practice Modern system of Medicine in any form.
1.2 Maintaining good medical practice:
1.2.1 The Principal objective of the medical profession is to render service to humanity with full
respect for the dignity of profession and man. Physicians should merit the confidence of patients
entrusted to their care, rendering to each a full measure of service and devotion. Physicians should try
continuously to improve medical knowledge and skills and should make available to their patients and
colleagues the benefits of their professional attainments. The physician should practice methods of
healing founded on scientific basis and should not associate profession ally with anyone who violates
this principle. The honored ideals of the medical profession imply that the responsibilities of the
physician extend not only to individuals but also to society.
1.2.2 Membership in Medical Society: For the advancement of his profession, a physician should
affiliate with associations and societies of allopathic medical professions and involve actively in the
functioning of such bodies.
1.2.3 A Physician should participate in professional meetings as part of Continuing Medica l Education
programmers, for at least 30 hours every five years, organized by reputed professional academic
bodies or any other authorized organizations. The compliance of this requirement shall be informed
regularly to Medical Council of India or the State Medical Councils as the case may be.
1.3 Maintenance of medical records:
1.3.1 Every physician shall maintain the medical records pertaining to his / her indoor patients for a
period of 3 years from the date of commencement of the treatment in a standard proforma laid down
by the Medical Council of India and attached as Appendix 3.
1.3.2. If any request is made for medical records either by the patients / authorized attendant or legal
authorities involved, the same may be duly acknowledged and documents shall be issued within the
period of 72 hours.
1.3.3 A Registered medical practitioner shall maintain a Register of Medical Certificates giving full
details of certificates issued. When issuing a medical certificate, he / she shall always enter the
identification marks of the patient and keep a copy of the certificate. He / She shall not omit to record
the signature and/or thumb mark, address and at least one identification mark of the patient on the
medical certificates or report. The medical certificate shall be prepared as in Appendix 2.
1.3.4 Efforts shall be made to computerize medical records for quick retrieval.
1.4 Display of registration numbers:
1.4.1 Every physician shall display the registration number accord ed to him by the State Medical
Council / Medical Council of India in his clinic and in all his prescriptions, certificates, money receipts
given to his patients.
1.4.2 Physicians shall display as suffix to their names only recognized medical degrees or such
certificates/diplomas and memberships/honors which confer professional knowledge or recognizes
any exemplary qualification/achievements.
1.5 Use of Generic names of drugs: Every physician should, as far as possible, prescribe drugs with
generic names and he / she shall ensure that there is a rational prescription and use of drugs.
1.6 Highest Quality Assurance in patient care: Every physician should aid in safeguarding the
profession against admission to it of those who are deficient in moral character or education. Physician
shall not employ in connection with his professional practice any attendant who is neither registered
nor enlisted under the Medical Acts in force and shall not permit such persons to attend, treat or
perform operations upon patients wherever professional discretion or skill is required.
1.7 Exposure of Unethical Conduct: A Physician should expose, without fear or favor, incompetent
or corrupt, dishonest or unethical conduct on the part of members of the profession.
1.8 Payment of Professional Services: The physician, engaged in the practice of medicine shall
give priority to the interests of patients. The personal financial interests of a physician should not
conflict with the medical interests of patients. A physician should announce his fees before rendering
service and not after the operation or treatment is under way. Remuneration received for such
services should be in the form and amount specifically announced to the patient at the time the
service is rendered. It is unethical to enter into a contract of “no cure no payment”. Physician
rendering service on behalf of the state shall refrain from anticipating or accepting any consideration.
1.9 Evasion of Legal Restrictions: The physician shall observe the laws of the country in regulating
the practice of medicine and shall also not assist others to evade such laws. He should be cooperative
in observance and enforcement of sanitary laws and regulations in the interest of public health. A
physician should observe the provisions of the State Acts like Drugs and Cosmetics Act, 1940;
Pharmacy Act, 1948; Narcotic Drugs and Psychotropic substances Act, 1985; Medical Termination of
Pregnancy Act, 1971; Transplantation of Human Organ Act, 1994; Mental Health Act, 1987;
Environmental Protection Act, 1986; Pre –natal Sex Determination Test Act, 1994; Drugs and Magic
Remedies (Objectionable Advertisement) Act, 1954; Persons with Disabilities (Equal Opportunities and
Full Participation) Act, 1995 and Bio -Medical Waste (Management and Handlin g) Rules, 1998 and such
other Acts, Rules, Regulations made by the Central/State Governments or local Administrative Bodies
or any other relevant Act relating to the protection and promotion of public health.
CHAPTER 2
2. DUTIES OF PHYSICIANS TO THEIR PATIENTS
2.1 Obligations to the Sick
2.1.1 Though a physician is not bound to treat each and every person asking his services, he should
not only be ever ready to respond to the calls of the sick and the injured, but should be mindful of the
high character of his mission and the responsibility he discharges in the course of his professional
duties. In his treatment, he should never forget that the health and the lives of those entrusted to his
care depend on his skill and attention. A physician should endeavor to add to the comfort of the sick
by making his visits at the hour indicated to the patients. A physician advising a patient to seek
service of another physician is acceptable, however, in case of emergency a physician must treat the
patient. No physician shall arbitrarily refuse treatment to a patient. However, for good reason, when a
patient is suffering from an ailment which is not within the range of experience of the treating
physician, the physician may refuse treatment and refer the patient to another physician.
2.1.2 Medical practitioner having any incapacity detrimental to the patient or which can affect his
performance vis-à-vis the patient is not permitted to practice his profession
2.2 Patience, Delicacy and Secrecy: Patience and delicacy should characterize the physician.
Confidences concerning individual or domestic life entrusted by patients to a physician and defects in
the disposition or character of patients observed during medical attendance should never be revealed
unless their revelation is required by the laws of the State. Sometimes, however, a physician must
determine whether his duty to society requires him to employ knowledge, obtained through confidence
as a physician, to protect a healthy person against a communicable disease to which he is about to be
exposed. In such instance, the physician should act as he would wish another to act toward one of his
own family in like circumstances.
2.3 Prognosis: The physician should neither exaggerate nor minimize the gravity of a patient’s
condition. He should ensure himself that the patient, his relatives or his responsible friends have such
knowledge of the patient’s condition as will serve the best interests of the patient and the family.
2.4 The Patient must not be neglected: A physician is free to choose whom he will serve. He
should, however, respond to any request for his assistance in an emergency. Once having undertaken
a case, the physician should not neglect the patient, nor should he withdraw from the case without
giving adequate notice to the patient and his family. Provisionally or fully registered medical
practitioner shall not willfully commit an act of negligence that may deprive his patient or patients
from necessary medical care.
2.5 Engagement for an Obstetric case: When a physician who has been engaged to attend an
obstetric case is absent and another is sent for and delivery accomplished, the acting physician is
entitled to his professional fees, but should secure the patient’s consent to resign on the arrival of the
physician engaged.
CHAPTER 3
3.. DUTIES OF PHYSICIAN IN CONSULTATION
3.1 Unnecessary consultations should be avoided:
3.1.1 However in case of serious illness and in doubtful or difficult conditions, the physician should
request consultation, but under any circumstances such consultation should be justifiable and in the
interest of the patient only and not for any other consideration.
3.1.2 Consulting pathologists /radiologists or asking for any other diagnostic Lab investigation should
be done judiciously and not in a routine manner.
3.2 Consultation for Patient’s Benefit: In every consultation, the benefit to the patient is of
foremost importance. All physicians engaged in the case should be frank with the patient and his
attendants.
3.3 Punctuality in Consultation: Utmost punctuality should be observed by a physician in making
themselves available for consultations.
3.4 Statement to Patient after Consultation:
3.4.1 All statements to the patient or his representatives should take place in the presence of the
consulting physicians, except as otherwise agreed. The disclosure of the opinion to the patient or his
relatives or friends shall rest with the medical attendant.
3.4.2 Differences of opinion should not be divulged unnecessarily but t when there is irreconcilable
difference of opinion the circumstances should be frankly and impartially explained to the patient or
his relatives or friends. It would be opened to them to seek further advice as they so desire.
3.5 Treatment after Consultation: No decision should restrain the attending physician from making
such subsequent variations in the treatment if any unexpected change occurs, but at the next
consultation, reasons for the variations should be discussed/explained. The same privilege, with its
obligations, belongs to the consultant when sent for in an emergency during the absence of attending
physician. The attending physician may prescribe medicine at any time for the patient, whereas the
consultant may prescribe only in case of emergency or as an expert when called for.
3.6 Patients Referred to Specialists: When a patient is referred to a specialist by the attending
physician, a case summary of the patient should be given to the specialist, who should communicate
his opinion in writing to the attending physician.
3.7 Fees and other charges:
3.7.1 A physician shall clearly display his fees and other charges on the board of his chamber and/or
the hospitals he is visiting. Prescription should also make clear if the Physician himself dispensed any
medicine.
3.7.2 A physician shall write his name and designation in full along with registration particulars in his
prescription letter head.
Note: In Government hospital where the patient –load is heavy, the name of the prescribing doctor
must be written below his/her signature.
CHAPTER 4
4. RESPONSIBILITIES OF PHYSICIANS TO EACH OTHER
A physician should consider it as a pleasure and privilege to render gratuitous service to all physicians
and their immediate family dependents.
4.2 Conduct in consultation: In consultations, no insincerity, rivalry or envy should be indulged in.
All due respect should be observed towards the physician in -charge of the case and no statement or
remark be made, which would impair the confidence reposed in him. For this purpose, no discussion
should be carried on in the presence of the patient or his representatives.
4.3 Consultant not to take charge of the case: When a physician has been called for consultation,
the Consultant should normally not take charge of the case, especially on the solicitation of the patient
or friends. The Consultant shall not criticize the referring physician. He / she shall discuss the
diagnosis treatment plan with the referring physician.
4.4 Appointment of Substitute: Whenever a physician requests another physician to attend his
patients during his temporary absence from his practice, professional courtesy requires the acceptance
of such appointment only when he has the capacity to discharge the additional responsibility along
with his / her other duties. The physician acting under such an appointment should give the utmost
consideration to the interests and reputation of the absent physician and all such patients should be
restored to the care of the latter upon his/her return.
4.5 Visiting another Physician’s Case: When it becomes the duty of a physician occupying an
official position to see and report upon an illness or injury, he should communicate to the physician in
attendance so as to give him an option of being present. The medical officer / physician occupying an
official position should avoid remarks upon the diagnosis or the treatment that has been adopted.
CHAPTER 5
5 DUTIES OF PHYSICIAN TO THE PUBLIC AND TO THE PARAMEDICAL PROFESSION
5.1 Physicians as Citizens: Physicians, as good citizens, possessed of special training should
disseminate advice on public health issues. They should play their part in enforcing the laws of the
community and in sustaining the institutions that advance the interests of humanity. The y should
particularly co-operate with the authorities in the administration of sanitary/public health laws and
regulations.
5.2 Public and Community Health: Physicians, especially those engaged in public health work,
should enlighten the public concerning quarantine regulations and measures for the prevention of
epidemic and communicable diseases. At all times the physician should notify the constituted public
health authorities of every case of communicable disease under his care, in accordance with the laws,
rules and regulations of the health authorities. When an epidemic occurs, a physician should not
abandon his duty for fear of contracting the disease himself.
5.3 Pharmacists / Nurses: Physicians should recognize and promote the practice of different
paramedical services such as, pharmacy and nursing as professions and should seek their cooperation
wherever required.
CHAPTER 6
6. UNETHICAL ACTS:
A physician shall not aid or abet or commit any of the following acts which shall be construed as
unethical –
6.1 Advertising:
6.1.1 Soliciting of patients directly or indirectly, by a physician, by a group of physicians or by
institutions or organizations is unethical. A physician shall not make use of him / her (or his / her
name) as subject of any for m or manner of advertising or publicity through any mode either alone or
in conjunction with others which is of such a character as to invite attention to him or to his
professional position, skill, qualification, achievements, attainments, specialties, an appointment,
associations, affiliations or honors and/or of such character as would ordinarily result in his self
aggrandizement. A physician shall not give to any person, whether for compensation or otherwise, any
approval, recommendation, endorsement, certificate, report or statement with respect of any drug,
medicine, nostrum remedy, surgical, or therapeutic article, apparatus or appliance or any commercial
product or article with respect of any property, quality or use thereof or any test, demonstration or
trial thereof, for use in connection with his name, signature, or photograph in any form or manner of
advertising through any mode nor shall he boast of cases, operations, cures or remedies or permit the
publication of report thereof through any mode. A medical practitioner is however permitted to make a
formal announcement in press regarding the following:
1. On starting practice.
2. On change of type of practice.
3. On changing address.
4. On temporary absence from duty.
5. On resumption of another practice.
6. On succeeding to another practice.
7. Public declaration of charges.
6.1.2 Printing of self-photograph, or any such material of publicity in the letter head or on sign board
of the consulting room or any such clinical establishment shall be regarded as acts of self-advertisement and unethical conduct on the part of the physician. However, printing of sketches,
diagrams, picture of human system shall not be treated as unethical.
6.2 Patent and Copy rights: A physician may patent surgical instruments, appliance s and medicine
or Copyright applications, methods and procedures. However, it shall be unethical if the benefits of
such patents or copyrights are not made available in situations where the interest of large population
is involved.
6.3 Running an open shop (Dispensing of Drugs and Appliances by Physicians): – A physician
should not run an open shop for sale of medicine for dispensing prescriptions prescribed by doctors
other than himself or for sale of medical or surgical appliances. It is not unethical for a physician to
prescribe or supply drugs, remedies or appliances as long as there is no exploitation of the patient.
Drugs prescribed by a physician or brought from the market for a patient should explicitly state the
proprietary formulae as well as generic name of the drug.
6.4 Rebates and Commission:
6.4.1 A physician shall not give, solicit, or receive nor shall he offer to give solicit or receive, any gift,
gratuity, commission or bonus in consideration of or return for the referring, recommending o r
procuring of any patient for medical, surgical or other treatment. A physician shall not directly or
indirectly, participate in or be a party to act of division, transference, assignment, subordination,
rebating, splitting or refunding of any fee for medical, surgical or other treatment.
6.4.2 Provisions of para 6.4.1 shall apply with equal force to the referring, recommending or
procuring by a physician or any person, specimen or material for diagnostic purposes or other study /
work. Nothing in this section, however, shall prohibit payment of salaries by a qualified physician to
other duly qualified person rendering medical care under his supervision.
6.5 Secret Remedies: The prescribing or dispensing by a physician of secret remedial agents of
which he does not know the composition, or the manufacture or promotion of their use is unethical
and as such prohibited. All the drugs prescribed by a physician should always carry a proprietary
formula and clear name.
6.6 Human Rights: The physician shall not aid or abet torture nor shall he be a party to either
infliction of mental or physical trauma or concealment of torture inflicted by some other person or
agency in clear violation of human rights.
6.7 Euthanasia: Practicing euthanasia shall constitute unethical conduct. However, on specific
occasion, the question of withdrawing supporting devices to sustain cardio -pulmonary function even
after brain death, shall be decided only by a team of doctors and not merely by the treating physician
alone. A team of doctors shall declare withdrawal of support system. Such team shall consist of the
doctor in charge of the patient, Chief Medical Officer / Medical Officer in charge of the hospital and a
doctor nominated by the in -charge of the hospital from the hospital staff or in accordance with the
provisions of the Transplantation of Human Organ Act, 1994.
CHAPTER 7
7. MISCONDUCT:
The following acts of commission or omission on the part of a physician shall constitute professional
misconduct rendering him/her liable for disciplinary action
7.1 Violation of the Regulations: If he/she commits any violation of these Regulations.
7.2 If he/she does not maintain the medical records of his/her indoor patients for a period of three
years as per regulation 1.3 and refuses to provide the same within 72 hours when the patient or
his/her authorized representative makes a request for it as per the regulation 1.3.2.
7.3 If he/she does not display the registration number accorded to him/her by the State Medical
Council or the Medical Council of India in his clinic, prescriptions and certificates etc. issued by him or
violates the provisions of regulation 1.4.2.
7.4 Adultery or Improper Conduct: Abuse of professional position by committing adultery or
improper conduct with a patient or by maintaining an improper association with a patient will render a
Physician liable for disciplinary action as provided under the Indian Medical Council Act, 1956 or the
concerned State Medical Council Act.
7.5 Conviction by Court of Law: Conviction by a Court of Law for offences involving moral turpitude
/ Criminal acts.
7.6 Sex Determination Tests: On no account sex determination test shall be undertaken with the
intent to terminate the life of a female fetus developing in her mother’s womb, unless there are other
absolute indications for termination of pregnancy as specified in the Medical Termination of Pregnancy
Act, 1971. Any act of termination of pregnancy of normal female fetus amounting to female feticide
shall be regarded as professional misconduct on the part of the physician leading to penal erasure
besides rendering him liable to criminal proceedings as per the provisions of this Act.
7.7 Signing Professional Certificates, Reports and other Documents: Registered medical
practitioners are in certain cases bound by law to give, or may from time to time be called upon or
requested to give certificates, notification, reports and other documents of similar character signed by
them in their professional capacity for subsequent use in the courts or for administrative purposes etc.
Such documents, among others, include the ones given at Appendix –4. Any registered practitioner
who is shown to have signed or given under his name and authority any such certificate, notification,
report or document of a similar character which is untrue, misleading or improper, is liable to have his
name deleted from the Register.
7.8 A registered medical practitioner shall not contravene the provisions of the Drugs and Cosmetics
Act and regulations made there under. Accordingly,
1. Prescribing steroids/ psychotropic drugs when there is no absolute medical indication;
2. selling Schedule ‘H’ & ‘L’ drugs and poisons to the public except to his patient;
in contravention of the above provisions shall constitute gross professional misconduct on the part of
the physician.
7.9 Performing or enabling unqualified person to perform an abortion or any illegal operation for which
there is no medical, surgical or psychological indication.
7.10 A registered medical practitioner shall not issue certificates of efficiency in modern medicine to
unqualified or non-medical person.
(Note: The foregoing does not restrict the proper training and instruction of Bonafede students,
midwives, dispensers, surgical attendants, or skilled mechanical and technical assistants and therapy
assistants under the personal supervision of physicians.)
7.11 A physician should not contribute to the lay press articles and give interviews regarding diseases
and treatments which may have the effect of advertising himself or soliciting practices; but is open to
write to the lay press under his own name on matters of public health, hygienic living or to deliver
public lectures, give talks on the radio/TV/internet chat for the same purpose and send announcement
of the same to lay press.
7.12 An institution run by a physician for a particular purpose such as a maternity home, nursing
home, private hospital, rehabilitation center or any type of training institution etc. may be advertised
in the lay press, but such advertisements should not contain anything more than the name of the
institution, type of patients admitted, type of training and other facilities offered and the fees.
7.13 It is improper for a physician to use an unusually large sign board and write on it anything other
than his name, qualifications obtained from a University or a statutory body, titles and name of his
specialty, registration number including the name of the State Medical Council under which
registered. The same should be the contents of his prescription papers. It is improper to affix a sign –
board on a chemist’s shop or in places where he does not reside or work.
7.14 The registered medical practitioner shall not disclose the secrets of a patient that have been
learnt in the exercise of his / her profession except –
1. in a court of law under orders of the Presiding Judge;
2. in circumstances where there is a serious and identified risk to a specific person and / or
community; and
3. notifiable diseases.
In case of communicable / notifiable diseases, concerned public health authorities should be informed
immediately.
7.15 The registered medical practitioner shall not refuse on religious grounds alone to give assistance
in or conduct of sterility, birth control, circumcision and medical termination of Pregnancy when there
is medical indication, unless the medical practitioner feels himself/herself incompetent to do so.
7.16 Before performing an operation the physician should obtain in writing the consent from the
husband or wife, parent or guardian in the case of minor, or the patient himself as the case may be.
In an operation which may result in sterility the consent of both husband and wife is needed.
7.17 A registered medical practitioner shall not publish photographs or case reports of his / her
patients without their permission, in any medical or other journal in a manner by which their identity
could be made out. If the identity is not to be disclosed, the consent is not needed.
7.18 In the case of running of a nursing home by a physician and employing assistants to help him /
her, the ultimate responsibility rests on the physician.
7.19 A Physician shall not use touts or agents for procuring patients.
7.20 A Physician shall not claim to be specialist unless he has a special qualification in that branch.
7.21 No act of invitro fertilization or artificial insemination shall be undertaken without the informed
consent of the female patient and her spouse as well as the donor. Such consent shall be obtained in
writing only after the patient is provided, at her own level of comprehension, with sufficient
information about the purpose, methods, risks, inconveniences, disappointments of the procedure and
possible risks and hazards.
7.22 Research: Clinical drug trials or other research involving patients or volunteers as per the
guidelines of ICMR can be undertaken, provided ethical considerations are borne in mind. Violation of
existing ICMR guidelines in this regard shall constitute misconduct. Consent ta ken from the patient for
trial of drug or therapy which is not as per the guidelines shall also be construed as misconduct.
7.23 If a physician posted in rural area is found absent on more than two occasions during inspection
by the Head of the District Health Authority or the Chairman, Zila Parishad, the same shall be
construed as a misconduct if it is recommended to the Medical Council of India/State Medical Council
by the State Government for action under these Regulations.
7.24 If a physician posted in a medical college/institution both as teaching faculty or otherwise shall
remain in hospital/college during the assigned duty hours. If they are found absent on more than two
occasions during this period, the same shall be construed as a misconduct if it is certified by the
Principal/Medical Superintendent and forwarded through the State Government to Medical Council of
India/State Medical Council for action under these Regulations.
CHAPTER 8
8. PUNISHMENT AND DISCIPLINARY ACTION
8.1 It must be clearly understood that the instances of offences and of Professional misconduct which
are given above do not constitute and are not intended to constitute a complete list of the infamous
acts which calls for disciplinary action, and that by issuing this notice the Medical Council of India and
or State Medical Councils are in no way precluded from considering and dealing with any other form of
professional misconduct on the part of a registered practitioner. Circumstances may and do arise from
time to time in relation to which there may occur questions of professional misconduct which do not
come within any of these categories. Every care should be taken that the code is not violated in letter
or spirit. In such instances as in all others, the Medica l Council of India and/or State Medical Councils
have to consider and decide upon the facts brought before the Medical Council of India and/or State
Medical Councils.
8.2 It is made clear that any complaint with regard to professional misconduct can be brought before
the appropriate Medical Council for Disciplinary action. Upon receipt of any complaint of professional
misconduct, the appropriate Medical Council would hold an enquiry and give opportunity to the
registered medical practitioner to be heard in person or by pleader. If the medical practitioner is found
to be guilty of committing professional misconduct, the appropriate Medical Council may award such
punishment as deemed necessary or may direct the removal altogether or for a specified period, from
the register of the name of the delinquent registered practitioner. Deletion from the Register shall be
widely publicized in local press as well as in the publications of different Medical Associations/
Societies/Bodies.
8.3 In case the punishment of removal from the register is for a limited period, the appropriate
Council may also direct that the name so removed shall be restored in the register after the expiry of
the period for which the name was ordered to be removed.
8.4 Decision on complaint against delinquent physician shall be taken within a time limit of 6 months.
8.5 During the pendency of the complaint the appropriate Council may restrain the physician from
performing the procedure or practice which is under scrutiny.
8.6 Professional incompetence shall be judged by peer group as per guidelines prescribed by Medical
Council of India.
APPENDIX – 1
DECLARATION
At the time of registration, each applicant shall be given a copy of the following declaration by the
Registrar concerned and the applicant shall read and agree to abide by the same:
a. I solemnly pledge myself to consecrate my life to service of humanity.
b. Even under threat, I will not use my medical knowledge contrary to the laws of
Humanity.
c. I will maintain the utmost respect for human life from the time of conception.
d. I will not permit considerations of religion, nationality, race, party politics or social
standing to intervene between my duty and my patient.
e. I will practice my profession with conscience and dignity.
f. The health of my patient will be my first consideration.
g. I will respect the secrets which are confined in me.
h. I will give to my teachers the respect and gratitude which is their due.
i. I will maintain by all means in my power, the honor and noble traditions of medical
profession.
j. I will treat my colleagues with all respect and dignity.
k. I shall abide by the code of medical ethics as enunciated in the Indian Medical Council
(Professional Conduct, Etiquette and Ethics) Regulations 2002.
I make these promises solemnly, freely and upon my honor.
MCI Guidelines
(AMENDED UPTO DECEMBER 2010)
(Published in Part III, Section 4 of the Gazette of India, dated 6th April,2002)
MEDICAL COUNCIL OF INDIA
NOTIFICATION
New Delhi, dated 11th March, 2002
No. MCI-211(2)/2001/Registration. In exercise of the powers conferred under section 20A read with section 33(m) of the Indian Medical Council Act, 1956 (102 of 1956), the Medical Council of India, with the previous approval of the Central Government, hereby makes the following regulations relating to the Professional Conduct, Etiquette and Ethics for registered medical practitioners, namely:-
Short Title and Commencement:
1.These Regulations may be called the Indian Medical Council (Professional conduct, Etiquette and Ethics) Regulations, 2002.
2.They shall come into force on the date of their publication in the Official Gazette.
CHAPTER I
1. CODE OF MEDICAL ETHICS
A. Declaration:
Each applicant, at the time of making an application for registration under the provisions of the Act, shall be provided a copy of the declaration and shall submit a duly signed Declaration as provided in Appendix 1. The applicant shall also certify that he/she had read and agreed to abide by the same.
B. Duties and responsibilities of the Physician in general:
1.1 Character of Physician (Doctors with qualification of MBBS or MBBS with post graduate degree/ diploma or with equivalent qualification in any medical discipline):
1.1.1 A physician shall uphold the dignity and honor of his profession.
1.1.2 The prime object of the medical profession is to render service to humanity; reward or financial gain is a subordinate consideration. Who- so-ever chooses his profession, assumes the obligation to conduct himself in accordance with its ideals? A physician should be an upright man, instructed in the art of healings. He shall keep himself pure in character and be diligent in caring for the sick; he should be modest, sober, patient, prompt in discharging his duty without anxiety; conducting himself with propriety in his profession and in all the actions of his life.
1.1.3 No person other than a doctor having qualification recognized by Medical Council of India and registered with Medical Council of India/State Medical Council (s) is allowed to practice Modern system of Medicine or Surgery. A person obtaining qualification in any other system of Medicine is not allowed to practice Modern system of Medicine in any form.
1.2 Maintaining good medical practice:
1.2.1 The Principal objective of the medical profession is to render service to humanity with full respect for the dignity of profession and man. Physicians should merit the confidence of patients entrusted to their care, rendering to each a full measure of service and devotion. Physicians should try continuously to improve medical knowledge and skills and should make available to their patients and colleagues the benefits of their professional attainments. The physician should practice methods of healing founded on scientific basis and should not associate professionally with anyone who violates this principle. The honored ideals of the medical profession imply that the responsibilities of the physician extend not only to individuals but also to society.
1.2.2 Membership in Medical Society: For the advancement of his profession, a physician should affiliate with associations and societies of allopathic medical professions and involve actively in the functioning of such bodies.
1.2.3 A Physician should participate in professional meetings as part of Continuing Medical Education programmes, for at least 30 hours every five years, organized by reputed professional academic bodies or any other authorized organizations. The compliance of this requirement shall be informed regularly to Medical Council of India or the State Medical Councils as the case may be.
1.3 Maintenance of medical records:
1.3.1 Every physician shall maintain the medical records pertaining to his / her indoor patients for a period of 3 years from the date of commencement of the treatment in a standard proforma laid down by the Medical Council of India and attached as Appendix 3.
1.3.2. If any request is made for medical records either by the patients / authorized attendant or legal authorities involved, the same may be duly acknowledged and documents shall be issued within the period of 72 hours.
1.3.3 A Registered medical practitioner shall maintain a Register of Medical Certificates giving full details of certificates issued. When issuing a medical certificate, he / she shall always enter the identification marks of the patient and keep a copy of the certificate. He / She shall not omit to record the signature and/or thumb mark, address and at least one identification mark of the patient on the medical certificates or report. The medical certificate shall be prepared as in Appendix 2.
1.3.4 Efforts shall be made to computerize medical records for quick retrieval.
1.4 Display of registration numbers:
1.4.1 Every physician shall display the registration number accorded to him by the State Medical Council / Medical Council of India in his clinic and in all his prescriptions, certificates, money receipts given to his patients.
1.4.2 Physicians shall display as suffix to their names only recognized medical degrees or such certificates/diplomas and memberships/honors which confer professional knowledge or recognizes any exemplary qualification/achievements.
1.5 Use of Generic names of drugs: Every physician should, as far as possible, prescribe drugs with generic names and he / she shall ensure that there is a rational prescription and use of drugs.
1.6 Highest Quality Assurance in patient care: Every physician should aid in safeguarding the profession against admission to it of those who are deficient in moral character or education. Physician shall not employ in connection with his professional practice any attendant who is neither registered nor enlisted under the Medical Acts in force and shall not permit such persons to attend, treat or perform operations upon patients wherever professional discretion or skill is required.
1.7 Exposure of Unethical Conduct: A Physician should expose, without fear or favor, incompetent or corrupt, dishonest or unethical conduct on the part of members of the profession.
1.8 Payment of Professional Services: The physician, engaged in the practice of medicine shall give priority to the interests of patients. The personal financial interests of a physician should not conflict with the medical interests of patients. A physician should announce his fees before rendering service and not after the operation or treatment is under way. Remuneration received for such services should be in the form and amount specifically announced to the patient at the time the service is rendered. It is unethical to enter into a contract of “no cure no payment”. Physician rendering service on behalf of the state shall refrain from anticipating or accepting any consideration.
1.9 Evasion of Legal Restrictions: The physician shall observe the laws of the country in regulating the practice of medicine and shall also not assist others to evade such laws. He should be cooperative in observance and enforcement of sanitary laws and regulations in the interest of public health. A physician should observe the provisions of the State Acts like Drugs and Cosmetics Act, 1940; Pharmacy Act, 1948; Narcotic Drugs and Psychotropic substances Act, 1985; Medical Termination of Pregnancy Act, 1971; Transplantation of Human Organ Act, 1994; Mental Health Act, 1987; Environmental Protection Act, 1986; Pre–natal Sex Determination Test Act, 1994; Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954; Persons with Disabilities (Equal Opportunities and Full Participation) Act, 1995 and Bio-Medical Waste (Management and Handling) Rules, 1998 and such other Acts, Rules, Regulations made by the Central/State Governments or local Administrative Bodies or any other relevant Act relating to the protection and promotion of public health.
CHAPTER 2
2. DUTIES OF PHYSICIANS TO THEIR PATIENTS
2.1 Obligations to the Sick
2.1.1 Though a physician is not bound to treat each and every person asking his services, he should not only be ever ready to respond to the calls of the sick and the injured, but should be mindful of the high character of his mission and the responsibility he discharges in the course of his professional duties. In his treatment, he should never forget that the health and the lives of those entrusted to his care depend on his skill and attention. A physician should endeavor to add to the comfort of the sick by making his visits at the hour indicated to the patients. A physician advising a patient to seek service of another physician is acceptable, however, in case of emergency a physician must treat the patient. No physician shall arbitrarily refuse treatment to a patient. However, for good reason, when a patient is suffering from an ailment which is not within the range of experience of the treating physician, the physician may refuse treatment and refer the patient to another physician.
2.1.2 Medical practitioner having any incapacity detrimental to the patient or which can affect his performance vis-à-vis the patient is not permitted to practice his profession
2.2 Patience, Delicacy and Secrecy: Patience and delicacy should characterize the physician. Confidences concerning individual or domestic life entrusted by patients to a physician and defects in the disposition or character of patients observed during medical attendance should never be revealed unless their revelation is required by the laws of the State. Sometimes, however, a physician must determine whether his duty to society requires him to employ knowledge, obtained through confidence as a physician, to protect a healthy person against a communicable disease to which he is about to be exposed. In such instance, the physician should act as he would wish another to act toward one of his own family in like circumstances.
2.3 Prognosis: The physician should neither exaggerate nor minimize the gravity of a patient’s condition. He should ensure himself that the patient, his relatives or his responsible friends have such knowledge of the patient’s condition as will serve the best interests of the patient and the family.
2.4 The Patient must not be neglected: A physician is free to choose whom he will serve. He should, however, respond to any request for his assistance in an emergency. Once having undertaken a case, the physician should not neglect the patient, nor should he withdraw from the case without giving adequate notice to the patient and his family. Provisionally or fully registered medical practitioner shall not willfully commit an act of negligence that may deprive his patient or patients from necessary medical care.
2.5 Engagement for an Obstetric case: When a physician who has been engaged to attend an obstetric case is absent and another is sent for and delivery accomplished, the acting physician is entitled to his professional fees, but should secure the patient’s consent to resign on the arrival of the physician engaged.
CHAPTER 3
3.. DUTIES OF PHYSICIAN IN CONSULTATION
3.1 Unnecessary consultations should be avoided:
3.1.1 However in case of serious illness and in doubtful or difficult conditions, the physician should request consultation, but under any circumstances such consultation should be justifiable and in the interest of the patient only and not for any other consideration.
3.1.2 Consulting pathologists /radiologists or asking for any other diagnostic Lab investigation should be done judiciously and not in a routine manner.
3.2 Consultation for Patient’s Benefit: In every consultation, the benefit to the patient is of foremost importance. All physicians engaged in the case should be frank with the patient and his attendants.
3.3 Punctuality in Consultation: Utmost punctuality should be observed by a physician in making themselves available for consultations.
3.4 Statement to Patient after Consultation:
3.4.1 All statements to the patient or his representatives should take place in the presence of the consulting physicians, except as otherwise agreed. The disclosure of the opinion to the patient or his relatives or friends shall rest with the medical attendant.
3.4.2 Differences of opinion should not be divulged unnecessarily but when there is irreconcilable difference of opinion the circumstances should be frankly and impartially explained to the patient or his relatives or friends. It would be opened to them to seek further advice as they so desire.
3.5 Treatment after Consultation: No decision should restrain the attending physician from making such subsequent variations in the treatment if any unexpected change occurs, but at the next consultation, reasons for the variations should be discussed/explained. The same privilege, with its obligations, belongs to the consultant when sent for in an emergency during the absence of attending physician. The attending physician may prescribe medicine at any time for the patient, whereas the consultant may prescribe only in case of emergency or as an expert when called for.
3.6 Patients Referred to Specialists: When a patient is referred to a specialist by the attending physician, a case summary of the patient should be given to the specialist, who should communicate his opinion in writing to the attending physician.
3.7 Fees and other charges:
3.7.1 A physician shall clearly display his fees and other charges on the board of his chamber and/or the hospitals he is visiting. Prescription should also make clear if the Physician himself dispensed any medicine.
3.7.2 A physician shall write his name and designation in full along with registration particulars in his prescription letter head.
Note: In Government hospital where the patient–load is heavy, the name of the prescribing doctor must be written below his/her signature.
CHAPTER 4
4. RESPONSIBILITIES OF PHYSICIANS TO EACH OTHER
A physician should consider it as a pleasure and privilege to render gratuitous service to all physicians and their immediate family dependents.
4.2 Conduct in consultation: In consultations, no insincerity, rivalry or envy should be indulged in. All due respect should be observed towards the physician in-charge of the case and no statement or remark be made, which would impair the confidence reposed in him. For this purpose, no discussion should be carried on in the presence of the patient or his representatives.
4.3 Consultant not to take charge of the case: When a physician has been called for consultation, the Consultant should normally not take charge of the case, especially on the solicitation of the patient or friends. The Consultant shall not criticize the referring physician. He / she shall discuss the diagnosis treatment plan with the referring physician.
4.4 Appointment of Substitute: Whenever a physician requests another physician to attend his patients during his temporary absence from his practice, professional courtesy requires the acceptance of such appointment only when he has the capacity to discharge the additional responsibility along with his / her other duties. The physician acting under such an appointment should give the utmost consideration to the interests and reputation of the absent physician and all such patients should be restored to the care of the latter upon his/her return.
4.5 Visiting another Physician’s Case: When it becomes the duty of a physician occupying an official position to see and report upon an illness or injury, he should communicate to the physician in attendance so as to give him an option of being present. The medical officer / physician occupying an official position should avoid remarks upon the diagnosis or the treatment that has been adopted.
CHAPTER 5
5 DUTIES OF PHYSICIAN TO THE PUBLIC AND TO THE PARAMEDICAL PROFESSION
5.1 Physicians as Citizens: Physicians, as good citizens, possessed of special training should disseminate advice on public health issues. They should play their part in enforcing the laws of the community and in sustaining the institutions that advance the interests of humanity. They should particularly co-operate with the authorities in the administration of sanitary/public health laws and regulations.
5.2 Public and Community Health: Physicians, especially those engaged in public health work, should enlighten the public concerning quarantine regulations and measures for the prevention of epidemic and communicable diseases. At all times the physician should notify the constituted public health authorities of every case of communicable disease under his care, in accordance with the laws, rules and regulations of the health authorities. When an epidemic occurs, a physician should not abandon his duty for fear of contracting the disease himself.
5.3 Pharmacists / Nurses: Physicians should recognize and promote the practice of different paramedical services such as, pharmacy and nursing as professions and should seek their cooperation wherever required.
CHAPTER 6
6. UNETHICAL ACTS:
A physician shall not aid or abet or commit any of the following acts which shall be construed as unethical –
6.1 Advertising:
6.1.1 Soliciting of patients directly or indirectly, by a physician, by a group of physicians or by institutions or organizations is unethical. A physician shall not make use of him / her (or his / her name) as subject of any form or manner of advertising or publicity through any mode either alone or in conjunction with others which is of such a character as to invite attention to him or to his professional position, skill, qualification, achievements, attainments, specialties, appointments, associations, affiliations or honors and/or of such character as would ordinarily result in his self-aggrandizement. A physician shall not give to any person, whether for compensation or otherwise, any approval, recommendation, endorsement, certificate, report or statement with respect of any drug, medicine, nostrum remedy, surgical, or therapeutic article, apparatus or appliance or any commercial product or article with respect of any property, quality or use thereof or any test, demonstration or trial thereof, for use in connection with his name, signature, or photograph in any form or manner of advertising through any mode nor shall he boast of cases, operations, cures or remedies or permit the publication of report thereof through any mode. A medical practitioner is however permitted to make a formal announcement in press regarding the following:
1.On starting practice.
2.On change of type of practice.
3.On changing address.
4.On temporary absence from duty.
5.On resumption of another practice.
6.On succeeding to another practice.
7.Public declaration of charges.
6.1.2 Printing of self-photograph, or any such material of publicity in the letter head or on sign board of the consulting room or any such clinical establishment shall be regarded as acts of self-advertisement and unethical conduct on the part of the physician. However, printing of sketches, diagrams, picture of human system shall not be treated as unethical.
6.2 Patent and Copy rights: A physician may patent surgical instruments, appliances and medicine or Copyright applications, methods and procedures. However, it shall be unethical if the benefits of such patents or copyrights are not made available in situations where the interest of large population is involved.
6.3 Running an open shop (Dispensing of Drugs and Appliances by Physicians): – A physician should not run an open shop for sale of medicine for dispensing prescriptions prescribed by doctors other than himself or for sale of medical or surgical appliances. It is not unethical for a physician to prescribe or supply drugs, remedies or appliances as long as there is no exploitation of the patient. Drugs prescribed by a physician or brought from the market for a patient should explicitly state the proprietary formulae as well as generic name of the drug.
6.4 Rebates and Commission:
6.4.1 A physician shall not give, solicit, or receive nor shall he offer to give solicit or receive, any gift, gratuity, commission or bonus in consideration of or return for the referring, recommending or procuring of any patient for medical, surgical or other treatment. A physician shall not directly or indirectly, participate in or be a party to act of division, transference, assignment, subordination, rebating, splitting or refunding of any fee for medical, surgical or other treatment.
6.4.2 Provisions of para 6.4.1 shall apply with equal force to the referring, recommending or procuring by a physician or any person, specimen or material for diagnostic purposes or other study / work. Nothing in this section, however, shall prohibit payment of salaries by a qualified physician to other duly qualified person rendering medical care under his supervision.
6.5 Secret Remedies: The prescribing or dispensing by a physician of secret remedial agents of which he does not know the composition, or the manufacture or promotion of their use is unethical and as such prohibited. All the drugs prescribed by a physician should always carry a proprietary formula and clear name.
6.6 Human Rights: The physician shall not aid or abet torture nor shall he be a party to either infliction of mental or physical trauma or concealment of torture inflicted by some other person or agency in clear violation of human rights.
6.7 Euthanasia: Practicing euthanasia shall constitute unethical conduct. However, on specific occasion, the question of withdrawing supporting devices to sustain cardio-pulmonary function even after brain death, shall be decided only by a team of doctors and not merely by the treating physician alone. A team of doctors shall declare withdrawal of support system. Such team shall consist of the doctor in charge of the patient, Chief Medical Officer / Medical Officer in charge of the hospital and a doctor nominated by the in-charge of the hospital from the hospital staff or in accordance with the provisions of the Transplantation of Human Organ Act, 1994.
CHAPTER 7
7. MISCONDUCT:
The following acts of commission or omission on the part of a physician shall constitute professional misconduct rendering him/her liable for disciplinary action
7.1 Violation of the Regulations: If he/she commits any violation of these Regulations.
7.2 If he/she does not maintain the medical records of his/her indoor patients for a period of three years as per regulation 1.3 and refuses to provide the same within 72 hours when the patient or his/her authorized representative makes a request for it as per the regulation 1.3.2.
7.3 If he/she does not display the registration number accorded to him/her by the State Medical Council or the Medical Council of India in his clinic, prescriptions and certificates etc. issued by him or violates the provisions of regulation 1.4.2.
7.4 Adultery or Improper Conduct: Abuse of professional position by committing adultery or improper conduct with a patient or by maintaining an improper association with a patient will render a Physician liable for disciplinary action as provided under the Indian Medical Council Act, 1956 or the concerned State Medical Council Act.
7.5 Conviction by Court of Law: Conviction by a Court of Law for offences involving moral turpitude / Criminal acts.
7.6 Sex Determination Tests: On no account sex determination test shall be undertaken with the intent to terminate the life of a female fetus developing in her mother’s womb, unless there are other absolute indications for termination of pregnancy as specified in the Medical Termination of Pregnancy Act, 1971. Any act of termination of pregnancy of normal female fetus amounting to female feticide shall be regarded as professional misconduct on the part of the physician leading to penal erasure besides rendering him liable to criminal proceedings as per the provisions of this Act.
7.7 Signing Professional Certificates, Reports and other Documents: Registered medical practitioners are in certain cases bound by law to give, or may from time to time be called upon or requested to give certificates, notification, reports and other documents of similar character signed by them in their professional capacity for subsequent use in the courts or for administrative purposes etc. Such documents, among others, include the ones given at Appendix –4. Any registered practitioner who is shown to have signed or given under his name and authority any such certificate, notification, report or document of a similar character which is untrue, misleading or improper, is liable to have his name deleted from the Register.
7.8 A registered medical practitioner shall not contravene the provisions of the Drugs and Cosmetics Act and regulations made there under. Accordingly,
1.Prescribing steroids/ psychotropic drugs when there is no absolute medical indication;
2.selling Schedule ‘H’ & ‘L’ drugs and poisons to the public except to his patient;
in contravention of the above provisions shall constitute gross professional misconduct on the part of the physician.
7.9 Performing or enabling unqualified person to perform an abortion or any illegal operation for which there is no medical, surgical or psychological indication.
7.10 A registered medical practitioner shall not issue certificates of efficiency in modern medicine to unqualified or non-medical person.
(Note: The foregoing does not restrict the proper training and instruction of Bonafede students, midwives, dispensers, surgical attendants, or skilled mechanical and technical assistants and therapy assistants under the personal supervision of physicians.)
7.11 A physician should not contribute to the lay press articles and give interviews regarding diseases and treatments which may have the effect of advertising himself or soliciting practices; but is open to write to the lay press under his own name on matters of public health, hygienic living or to deliver public lectures, give talks on the radio/TV/internet chat for the same purpose and send announcement of the same to lay press.
7.12 An institution run by a physician for a particular purpose such as a maternity home, nursing home, private hospital, rehabilitation center or any type of training institution etc. may be advertised in the lay press, but such advertisements should not contain anything more than the name of the institution, type of patients admitted, type of training and other facilities offered and the fees.
7.13 It is improper for a physician to use an unusually large sign board and write on it anything other than his name, qualifications obtained from a University or a statutory body, titles and name of his specialty, registration number including the name of the State Medical Council under which registered. The same should be the contents of his prescription papers. It is improper to affix a sign-board on a chemist’s shop or in places where he does not reside or work.
7.14 The registered medical practitioner shall not disclose the secrets of a patient that have been learnt in the exercise of his / her profession except –
1.in a court of law under orders of the Presiding Judge;
2.in circumstances where there is a serious and identified risk to a specific person and / or community; and
3.notifiable diseases.
In case of communicable / notifiable diseases, concerned public health authorities should be informed immediately.
7.15 The registered medical practitioner shall not refuse on religious grounds alone to give assistance in or conduct of sterility, birth control, circumcision and medical termination of Pregnancy when there is medical indication, unless the medical practitioner feels himself/herself incompetent to do so.
7.16 Before performing an operation the physician should obtain in writing the consent from the husband or wife, parent or guardian in the case of minor, or the patient himself as the case may be. In an operation which may result in sterility the consent of both husband and wife is needed.
7.17 A registered medical practitioner shall not publish photographs or case reports of his / her patients without their permission, in any medical or other journal in a manner by which their identity could be made out. If the identity is not to be disclosed, the consent is not needed.
7.18 In the case of running of a nursing home by a physician and employing assistants to help him / her, the ultimate responsibility rests on the physician.
7.19 A Physician shall not use touts or agents for procuring patients.
7.20 A Physician shall not claim to be specialist unless he has a special qualification in that branch.
7.21 No act of invitro fertilization or artificial insemination shall be undertaken without the informed consent of the female patient and her spouse as well as the donor. Such consent shall be obtained in writing only after the patient is provided, at her own level of comprehension, with sufficient information about the purpose, methods, risks, inconveniences, disappointments of the procedure and possible risks and hazards.
7.22 Research: Clinical drug trials or other research involving patients or volunteers as per the guidelines of ICMR can be undertaken, provided ethical considerations are borne in mind. Violation of existing ICMR guidelines in this regard shall constitute misconduct. Consent taken from the patient for trial of drug or therapy which is not as per the guidelines shall also be construed as misconduct.
7.23 If a physician posted in rural area is found absent on more than two occasions during inspection by the Head of the District Health Authority or the Chairman, Zila Parishad, the same shall be construed as a misconduct if it is recommended to the Medical Council of India/State Medical Council by the State Government for action under these Regulations.
7.24 If a physician posted in a medical college/institution both as teaching faculty or otherwise shall remain in hospital/college during the assigned duty hours. If they are found absent on more than two occasions during this period, the same shall be construed as a misconduct if it is certified by the Principal/Medical Superintendent and forwarded through the State Government to Medical Council of India/State Medical Council for action under these Regulations.
CHAPTER 8
8. PUNISHMENT AND DISCIPLINARY ACTION
8.1 It must be clearly understood that the instances of offences and of Professional misconduct which are given above do not constitute and are not intended to constitute a complete list of the infamous acts which calls for disciplinary action, and that by issuing this notice the Medical Council of India and or State Medical Councils are in no way precluded from considering and dealing with any other form of professional misconduct on the part of a registered practitioner. Circumstances may and do arise from time to time in relation to which there may occur questions of professional misconduct which do not come within any of these categories. Every care should be taken that the code is not violated in letter or spirit. In such instances as in all others, the Medical Council of India and/or State Medical Councils have to consider and decide upon the facts brought before the Medical Council of India and/or State Medical Councils.
8.2 It is made clear that any complaint with regard to professional misconduct can be brought before the appropriate Medical Council for Disciplinary action. Upon receipt of any complaint of professional misconduct, the appropriate Medical Council would hold an enquiry and give opportunity to the registered medical practitioner to be heard in person or by pleader. If the medical practitioner is found to be guilty of committing professional misconduct, the appropriate Medical Council may award such punishment as deemed necessary or may direct the removal altogether or for a specified period, from the register of the name of the delinquent registered practitioner. Deletion from the Register shall be widely publicized in local press as well as in the publications of different Medical Associations/ Societies/Bodies.
8.3 In case the punishment of removal from the register is for a limited period, the appropriate Council may also direct that the name so removed shall be restored in the register after the expiry of the period for which the name was ordered to be removed.
8.4 Decision on complaint against delinquent physician shall be taken within a time limit of 6 months.
8.5 During the pendency of the complaint the appropriate Council may restrain the physician from performing the procedure or practice which is under scrutiny.
8.6 Professional incompetence shall be judged by peer group as per guidelines prescribed by Medical Council of India.
APPENDIX – 1
DECLARATION
At the time of registration, each applicant shall be given a copy of the following declaration by the Registrar concerned and the applicant shall read and agree to abide by the same:
1.I solemnly pledge myself to consecrate my life to service of humanity.
2.Even under threat, I will not use my medical knowledge contrary to the laws of Humanity.
3.I will maintain the utmost respect for human life from the time of conception.
4.I will not permit considerations of religion, nationality, race, party politics or social standing to intervene between my duty and my patient.
5.I will practice my profession with conscience and dignity.
6.The health of my patient will be my first consideration.
7.I will respect the secrets which are confined in me.
8.I will give to my teachers the respect and gratitude which is their due.
9.I will maintain by all means in my power, the honor and noble traditions of medical profession.
10.I will treat my colleagues with all respect and dignity.
11.I shall abide by the code of medical ethics as enunciated in the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations 2002.
I make these promises solemnly, freely and upon my honor.
Signature ………………………………………………
Name ………………………………………………………
Place ………………………………………………………
Address
………………………………………………
……………………… ………………………
……………………… ………………………
Date …………………
APPENDIX – 2
FORM OF CERTIFICATE RECOMMENDED
FOR LEAVE OR EXTENSION OR COMMUNICATION
OF LEAVE AND FOR FITNESS
Signature of patient
or thumb impression ___________________________________________
To be filled in by the applicant in the presence of the Government Medical Attendant, or Medical Practitioner.
Identification marks: –
1.__________________________
2.__________________________
I, Dr. _____________________________________ after careful examination of the case certify hereby that _______________ whose signature is given above is suffering from __________________ and I consider that a period of absence from duty of ____________________ with effect from __________________ is absolutely necessary for the restoration of his health.
I, Dr. ________________________ after careful examination of the case certify hereby that ______________________ on restoration of health is now fit to join service.
Place ___________________ Signature of Medical attendant.
Date ________________Registration No. ___________________
(Medical Council of India / State Medical Council of ………….…. State)
Note: – The nature and probable duration of the illness should also be specified. This certificate must be accompanied by a brief resume of the case giving the nature of the illness, its symptoms, causes and duration.
APPENDIX-3
FORMAT FOR MEDICAL RECORD
(see regulation 3.1)
Name of the patient:
Age:
Sex:
Address:
Occupation:
Date of 1st visit:
Clinical note (summary) of the case:
Prov.: Diagnosis:
Investigations advised with reports:
Diagnosis after investigation:
Advice:
Follow up
Date:
Observations:
Signature in full ………………………….
Name of Treating Physician
APPENDIX –4
LIST OF CERTIFICATES, REPORTS, NOTIFICATIONS ETC. ISSUED BY DOCTORS FOR THE PURPOSES OF VARIOUS ACTS / ADMINISTRATIVE REQUIREMENTS
1.Under the acts relating to birth, death or disposal of the dead.
2.Under the Acts relating to Lunacy and Mental Deficiency and under the Mental illness Act and the rules made thereunder.
3.Under the Vaccination Acts and the regulations made thereunder.
4.Under the Factory Acts and the regulations made thereunder.
5.Under the Education Acts.
6.Under the Public Health Acts and the orders made thereunder.
7.Under the Workmen’s Compensation Act and Persons with Disability Act.
8.Under the Acts and orders relating to the notification of infectious diseases.
9.Under the Employee’s State Insurance Act.
10.In connection with sick benefit insurance and friendly societies.
11.Under the Merchant Shipping Act.
12.For procuring / issuing of passports.
13.For excusing attendance in courts of Justice, in public services, in public offices or in ordinary employment.
14.In connection with Civil and Military matters.
15.In connection with matters under the control of Department of Pensions.
16.In connection with quarantine rules.
17.For procuring driving license.
(DR. M. SACHDEVA)
SECRETARY
MEDICAL COUNCIL OF INDIA
(Published in Part III, Section 4 of the Gazette of India, dated 22nd February, 2003)
MEDICAL COUNCIL OF INDIA
NOTIFICATION
No.MCI-211(2)2002-Regn.- In exercise of the powers conferred under section 20A read with section 33(m) of the Indian Medical Council Act, 1956 (102 of 1956), the Medical Council of India, with the previous approval of the Central Government, hereby makes the following amendments to the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002, namely:-
Short Title and Commencement: (i) These Regulations may be called the Indian Medical Council (Professional conduct, Etiquette and Ethics) (Amendment) Regulations, 2003.
(ii) They shall come into force on the date of their publication in the Official Gazette.
(2) In the Indian Medical Council (Professional conduct, Etiquette and Ethics) Regulations, 2002, the regulations, 7.23 and 7.24 appearing under Chapter 7, shall be omitted.
(Published in Part III, Section 4 of the Gazette of India, Extraordinary dated 27th May, 2004)
MEDICAL COUNCIL OF INDIA
NOTIFICATION
New Delhi, dated 11th March, 2002
No. MCI-211(2)/2004-(Ethical). – In exercise of the powers conferred under section 20A read with section 33(m) of the Indian Medical Council Act, 1956 (102 of 1956), the Medical Council of India, with the previous approval of the Central Government, hereby makes the following amendments to the Indian Medical Council (Professional conduct, Etiquette and Ethics) Regulations, 2002, namely:-
(1) Short Title and Commencement: (i) These Regulations may be called the Indian Medical Council (Professional conduct, Etiquette and Ethics) (Amendment) Regulations, 2004.
(2) In the Indian Medical Council (Professional conduct, Etiquette and Ethics) Regulations, 2002, after the regulation 8.6 appearing under Chapter 8, the following regulations, shall be added:
“8.7 Where either on a request or otherwise the Medical Council of India is informed that any complaint against a delinquent physician has not been decided by a State Medical Council within a period of six months from the date of receipt of complaint by it and further the MCI has reason to believe that there is no justified reason for not deciding the complaint within the said prescribed period, the Medical Council of India may-
(i) Impress upon the concerned State Medical council to conclude and decide the complaint within a time bound schedule;
(ii) May decide to withdraw the said complaint pending with the concerned State Medical Council straightaway or after the expiry of the period which had been stipulated by the MCI in accordance with para(i) above, to itself and refer the same to the Ethical Committee of the Council for its expeditious disposal in a period of not more than six months from the receipt of the complaint in the office of the Medical Council of India.”
“8.8 Any person aggrieved by the decision of the State Medical Council on any complaint against a delinquent physician, shall have the right to file an appeal to the MCI within a period of 60 days from the date of receipt of the order passed by the said Medical Council:
Provided that the MCI may, if it is satisfied that the appellant was prevented by sufficient cause from presenting the appeal within the aforesaid period of 60 days, allow it to be presented within a further period of 60 days.
MEDICAL COUNCIL OF INDIA
NOTIFICATION
New Delhi, the 10th December 2009
No. MCI-211(1)/2009 (Ethics)/55667.-In exercise of the powers conferred by Section 33 of the Indian Medical Council Act, 1956 (102 of 1956), the Medical Council of India with the previous sanction of the Central Government, hereby makes the following Regulations to amend the “Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002:-
1. (i) These Regulations may be called the “Indian Medical council (Professional Conduct, Etiquette and Ethics) (Amendment) Regulations, 2009 Part I”.
(ii) They shall come into force from the date of their publication in the Official Gazette.
2. In the “Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002”, the following additions/medications/decisions/substitutions, shall be, as indicated therein: –
3. The following clause shall be added after clause 6.7:-
“6.8 Code of conduct for doctor and professional association of doctors in their relationship with pharmaceutical and allied health sector industry.
6.8.1 In dealing with pharmaceutical and allied health sector industry, a medical practitioner shall follow and adhere to the stipulations given below: –
(a) Gifts: A medical practitioner shall not receive any gift from any pharmaceutical or allied healthcare industry and their sales people or representatives.
(b) Travel facilities: A medical practitioner shall not accept any travel facility inside the country or outside, including rail, air, ship, cruise tickets, paid vacations, etc., from any pharmaceutical or allied healthcare industry or their representatives for self and family members for vacation or for attending conference, seminars, workshops, CME programme etc. as a delegate.
(c) Hospitality: A medical practitioner shall not accept individually any hospitality like hotel accommodation for self and family members under any pretext.
(d) Cash or monetary grants: A medical practitioner hall not receive any cash or monetary grants from any pharmaceutical and allied healthcare industry for individual purpose in individual capacity under any pretext. Funding for medical research, study etc., can only be received through approved institutions by modalities laid down by law/rules/guidelines adopted by such approved institutions, in a transparent manner. It shall always be fully disclosed.
(e) Medical Research: A medical practitioner may carry out, participate in, work in research projects funded by pharmaceutical and allied healthcare industries. A medical practitioner is obliged to know that the fulfillment of the following items (1) to (vii) will be an imperative for undertaking any research assignment/project funded by industry-for being proper and ethical. Thus, in accepting such a position a medical practitioner shall: –
(i) Ensure that the particular research proposal(s) has the due permission from the competent concerned authorities;
(ii) Ensure that such a research project(s) has the clearance of national/state/institutional ethics committee/bodies;
(iii) Ensure that it fulfills all the legal requirements prescribed for medical research;
(iv) Ensure that the source and amount of funding is publicly disclosed at the beginning itself;
(v) Ensure that proper care and facilities are provided to human volunteers, if they are necessary for the research projects);
(vi) Ensure that undue animal experimentations are not done and when these are necessary, they are done in a scientific and a humane way;
(vii) Ensure that while accepting such an assignment a medical practitioner shall have the freedom to publish the results of the research in the greater interest of the society by inserting such a clause in the MoU or any other document/agreement for any such assignment.
(f) Maintaining Professional Autonomy: In dealing with pharmaceutical and allied healthcare industry a medical practitioner shall always ensure that there shall never be any compromise either with his/her own professional autonomy and/or with the autonomy and freedom of the medical institution.
(g) Affiliation: A medical practitioner may work for pharmaceutical and allied healthcare industries in advisory capacities, as consultants, as researchers, as treating doctors or in any other professional capacity. In doing so, a medical practitioner shall always:
(i) Ensure that his professional integrity and freedom are maintained:
(ii) Ensure that patient’s interest is not compromised in any way;
(iii) Ensure that such affiliation is within the law;
(iv) Ensure that such affiliations/employments are fully transparent and disclosed.
(h) Endorsement: A medical practitioner shall not endorse any drug or product of the industry publicly. Any study conducted on the efficacy or otherwise of such products shall be presented to and/or through appropriate scientific bodies or published in appropriate scientific journals in a proper way”.
(Lt. Col. (Retd.) Dr. A.R.N. Setalvad)
Secretary
Medical Council of India
Foot Note: The Principal Regulations namely, “Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002” were published in Part III, Section (4) of the Gazette of India on the 6th April, 2002, and amende vide MCI notification, dated 22-2-2003 and 26-5-2004.
MCI peer group review
As per Rule 8.6, professional incompetence of a professional duly registered with the State Medical Council upon fulfilling the precondition of the eligibility of having acquired recognized medical qualifications from a university and duly incorporated in the concerned schedule appended to the Indian Medical Council Act, 1956, shall be judged by peer group as per guidelines prescribed by MCI. However, these guidelines have never been made. Taking serious note of this, national president of Indian Medical Association (IMA) had written to MCI to frame the guidelines. A study group led by the chairman of the academic committee, MCI was set up by MCI president one and half month back to chart out draft guidelines under Rule 8.6 in response to IMA presidents’ letter. The draft guidelines, titled as ‘Guidelines governing the assessment of professional incompetence’ by a peer group under Rule 8.6 of Code of Medical Ethics Regulation 2002 as amended from time to time will come into the force from the date of its notification by MCI. The guidelines shall be applicable for any medical trial jurisdiction at the institutional (medical colleges approved by MCI) or at any council level. They shall not cover a criminal aspect of professional negligence. Professional incompetence, professional misconduct and professional incapacitation by and large are used interchangeably because all the three within their fold include failure on part of the professional to take reasonable steps to safeguard the life and health of the person under his care. In a move to bring more clarity to which action of a medico can be attributed to professional incompetence, the draft has clearly defined it. It says ‘professional incompetence’ is failure to exercise due care and diligence in professional responsibilities due to lack of knowledge, skill or judgment while professional incapacity means inability to carry out professional activities and responsibilities/obligations due to a physical or mental illness that may limit the capacity of a professional person to fulfil his/her professional responsibilities temporarily or permanently. It also defined professional negligence for which the guidelines will not be applicable. As per the draft, an act or omission (failure to act when there is a duty to act) which a reasonable man in the circumstances would do or an act of commission (wrong doing) by a medical professional, which a reasonable man in the circumstances would not do constitutes professional negligence. It further says a peer group at institutional (medical college) /clinical establishment/state medical council/MCI will be constituted to judge the professional incompetency of a registered medical practitioner in a time-bound manner. The peer group shall be a three-member committee with a chairman, one IMA nominee, and one professional subject expert. The peer group on receipt of any complaint shall examine the allegation in a time-bound manner, preferably within two weeks and forward its reasoned-out speaking order following the principle of natural justice and based on “Bolam’s Test” to the institutional head, clinical establishment head /chairman of the ethics committee of the state medical council/chairman of the ethics committee of MCI as the case may be. Bolam Test evolved out of the judgment in the case of Bolam v Friern Hospital Management Committee [1957] 1 WLR 582 is used to assess the standard of care when deciding medical negligence. The MCI will soon hold a meeting to deliberate and finalise the draft guidelines. The IMA which pushed for the guidelines has also convened a central working committee meeting on September 23 to discuss and pass it.
MCI concerned about assault on doctors
• Members supported the concern for assault on Resident doctors and the following Resolutions were proposed
27A Privileges of persons who are enrolled on Indian Medical Register/State Medical Register or under training in Medical Institutes recognized under this Act, whether at undergraduate, intern or postgraduate level.
Notwithstanding anything contained in this or any other Act, no court shall take cognizance of any offence, alleged to have been committed by any doctor registered in Indian Medical Register/State Medical Register, maintained by this Act or State Medical Act for time being in force, or against any medical student who is whether undergraduate, intern or postgraduate, who is under training in medical colleges and hospitals permitted by this Act during their professional duties, training or studies, except with the previous sanction of State or Central Government.
It was further proposed that it would be best if Maharashtra Doctors Protection Act is included in IPC-
We all, the members at MCI are intended to provide best of the medical services to all the citizens of our country, India. In current scenario of attack on medical fraternity, we feel that it is very difficult to provide best of the medical services to our citizens by medical fraternity with fearful mind. For this, we pass a resolution and recommend Central Govt. to:
“Include Maharashtra Ordinance No. V. of 2009, Gazette Notification dt. 30th March, 2009 in Indian Penal Code (IPC)”
• It was further made known to the House about Section 197 of the Code of Criminal Procedure, 1973 and stated that the House may recommend to the Central Government to amend Section 197 of the Cr.P.C. Medical practitioners all over the country should also be sensitized to the legal recourse available to them.
• It was recommended that state Authorities be approached to advertise legal protection available to doctors.
• It was recommended to Include in MSR that every ward/casualty etc. should have a certain number of security guards.
• MCI should take a very strong stand on violence against doctors. It was proposed that there should be a Grievance Cell in every college where doctors can raise their voice. Communication skills of doctors be enhanced. Relevant MCI Regulations be amended to include a clause for the purpose.
• A press release be issued regarding concern on violence against the doctors. MCI Should write to Govt. of India to pass a Central Act (Uniform) – Cognizable and non-bailable Act. The Ethics Committee in the Council should discuss about such provision/legal recourses etc. available at their State Council’s Meetings (sensitization programme).
• The House expressed their concern on the recent incidents of violence against doctors and was of the opinion that only amendments in MSR will not fetch dividends contemplated. It is necessary to issue advisory and a meeting of all the Health Secretaries of all the States on this issue be convened by the MCI.
• Violence against doctors is an international phenomenon. It was pointed out that this issue was even discussed in World Medical Association to find the ways and means to curb the problem. Proposed for draft resolution regarding Anti Violence Committee/Regulation in every college.
Medical ethics.
Medical ethics is a path illuminated by principles to guide members of the medical profession in their dealings with each other and with their patients. Here, I concern myself with the doctor-doctor relationship, which is under severe stress. I refer to negative professional criticism of one’s colleagues, a practice which damages the profession and its reputation in the larger community.
Like other members of society, doctors are caught in the pursuit of money and prestige. Like any other economic enterprise, medical practice too is vulnerable to groupism and power struggles. As a result, doctors can knowingly or unknowingly behave in a manner that detrimentally affects the position of their colleagues. They must respond to this problem by re-establishing ethical principles, because self-regulation is better than forced external controls through laws.
Various codes, both ancient and modern, have spoken on the doctor-doctor relationship, identifying the duty to one’s colleagues as well one’s duty to the community at large. Both ancient India and ancient Greece speak in general terms of honor and moderation. “Your speech must be soft, pleasant, virtuous, truthful, useful and moderate… must be mindful in whatever you do,” warns Sushruta Samhita. “Even when you are learned and proficient, do not show off.” Hippocrates’ oath declares: “Now if I keep this oath and break it not, may I enjoy honour, in my life and art, among all men for all time; but if I transgress… may the opposite befall me.” The World Medical Association’s Declaration of Geneva calls for all doctors to accept that “My colleagues will be my brothers… I will maintain by all means in my power, the honor and the noble traditions of medical profession.” The code of the Indian Medical Association is explicit: “The medical profession should safeguard the public and itself against physicians deficient in moral character or professional competence. Physicians should observe all laws, uphold the dignity and honor of the profession and accept its self-imposed discipline. They should expose without hesitation, the illegal or unethical conduct of fellow members of the profession.”
Positive criticism can be made in an environment which invites criticism, when doctors seek peer review, when professional associations appoint ombudsmen — all with the intention of analyzing current medical practice and using people’s suggestions for self-improvement.
It is perfectly appropriate to quote a misdeed if the purpose is to change the quality of professional practice. Sometimes, the context deserves a suitable example — such as referring to the Lentin Commission’s findings against doctors’ misdeeds. It is also necessary when one must object to unethical work, such as reckless and unauthorized experiments in xeno-transplantation. Criticism may be used to warn against possible misadventure, such as criticizing attempts at human cloning; or potentially dangerous human trials of drugs for investigators’ personal gains. It can be used to expose inhuman trials, and the doctors and organizations associated with such activities, such as the use of an anti-malarial drug to chemically cauterize the uterine endometrium. Criticism of irrational practice is also essential, whether of drug utilization, prescriptions, investigations or other interventions. It may also be necessary to publicly oppose irrational statements made by medical professionals.
All these are attempts to change medical practice for the better. They do not amount to negative criticism. In negative professional criticism, on the other hand, fault finding serves no other purpose than to express ill will, affect the interests of others, and tarnish the image of one’s professional colleagues. There are many situations in which doctors can get entrapped in professional criticism. The following are some commonly noticed situations where professional criticism is most likely to occur.
One can be called to express one’s views about a colleague or subordinate during the course of a medical audit, or in a professional enquiry in a medical board or because of a consumer complaint. During a peer review procedure — editing a manuscript, conducting post examinations — one can be tempted to make comments on one’s colleagues. The doctor must take due care to express the opinion confidentially, without a confrontationist attitude, and in a way that does not malign the colleague. The purpose of expressing one’s opinion is to correct the problem, not enter into an enmity.
Another situation can arise when a patient comes to you for a second opinion or specialist advice or for an alternative/complementary form of treatment. Such visits are often misused to vent one’s individual bias about the competence of other practitioners or schools of treatment. Reserve such comments for professional discussions in academic fora. The consumer has come to you to get the best advice. Do not give him the worst of our profession — the habit of criticizing others. This will only result in the patient losing faith in the profession.
If there is a difference of opinion over the diagnosis, or when the patient has been referred by a general practitioner to a specialist, do not criticize the other professional to establish your superiority. The patient has been referred to you because you are believed to be more competent in that subject. Desist from using him or her as a medium to spread criticism of fellow professionals.
When your patient sees another doctor during an emergency, or because you are otherwise not available, do not criticize the other professional’s decisions. Be thankful to the doctor for having taken care of your case in your absence.
An honest comment offered in good faith, to promote the patient’s best interests, may be justifiable. However, even this can become inappropriate criticism. Think before you speak out loud. Think again before writing such reports, ask a friend to review what you intend to report in writing to save yourself from inadvertent criticism. Remember, comments which are gratuitous, unsustainable and aim at undermining trust in a colleague’s knowledge or skill are unethical.
There is also a need to foster healthy criticism. Promote academic debates among your peers. Utilize forums such as CMEs and medical journals to air your professional opinions.
It is your professional obligation to inform the appropriate authority about a colleague whose professional conduct, fitness to practice and professional performance appears to be deficient. Unfortunately, the majority of professionals turn a Nelson’s eye to such behavior, even while they slander their colleagues informally.
If a patient comes to you with evidence of another doctor’s serious medical negligence, do not get caught in the web. Advise the patient to approach a medical activist, voluntary group, professional organization or medico-legal expert for better guidance. Do not jump to conclusions and pass judgements based on a one-sided version of the story. Understand that you are not an expert in these issues. Should you wish to become an advisor on such issues, become an activist, pursue your interests of cleansing the profession and getting justice to the needy. May God bless you.
If negligence in the profession is continuous and on-going and you feel strongly charged to correct the ills, nothing stops you from discharging your social, ethical, moral and professional responsibility of reporting such matters to the concerned for grievance redressal. You can become a party to action in consumer health fora, the courts, or local health authorities. You can bring the negligence to the knowledge of professional bodies and medical councils and be actively involved without the fear of indulging in professional criticism. It is always better that medical activists come from inside the profession, for they understand the problems of medicine better.
On May 11, 2000, the Committee on Economic, Social and Cultural Rights adopted a General Comment on the right to the highest attainable standard of health.
The General Comment deals with a state’s obligations to maintain the health of its population “to the highest attainable standard” by specifying the universal obligatory core components for every country’s health system. Every state will be obliged to meet, or aim for, not only defined standards of availability, accessibility, acceptability, and quality of healthcare but also the essential prerequisites for health – a healthy environment, clean water, and adequate food and housing. Another important innovation will be the introduction of a system of benchmarks and indicators with which to monitor progress in the development of states’ health services.
Article 12 of the Covenant says states recognize the right of everyone to the enjoyment of the highest attainable standard of physical and mental health. Parties agreed to take steps to reduce stillbirth and infant mortality rates, and to work towards the healthy development of the child, as well as improving all aspects of environmental and industrial hygiene, the prevention, treatment and control of epidemics, and the creation of conditions which would assure medical services and medical attention in the event of sickness.
States were obliged to guarantee that the right to health would be exercised without discrimination. They also had obligations to take deliberate, concrete and targeted steps toward the full realization of the right to health.
Addressing violations of the right to health, the general comment said it was important to distinguish the inability from the unwillingness of a State to comply with the obligations of Article 12. If resource constraints rendered it impossible for a State to comply fully with its Covenant obligations, it had the burden of justifying that every effort had nevertheless been made to use all available resources at its disposal, the document stated.
The general comment recognized that implementation at the national level would vary from one State to another. It pointed out, however, that the Covenant clearly imposed a duty on each State to take whatever steps were necessary to ensure that everyone had access to health facilities, goods and services so that they could enjoy, as soon as possible, the highest attainable standard of physical and mental health.
In pointing out the obligations of actors other than States parties, the document stated that the United Nations agencies and programmers, particularly the World Health Organization (WHO), were of particular importance. States parties, when formulating and implementing their right to health national strategies, should avail themselves of WHO’s technical assistance and cooperation.
The Covenant has been ratified by 130 countries and is the leading legal source for the international human right to health. Every state signatory is required to make ‘periodic reports’ to the Committee at five-year intervals.
Medical negligence
Gratuitously advices shall not be considered liable when the actions are within the established medical procedures
Any doctor who is qualified by medical council and renders emergency care or treatment to a person suffering or appearing to suffer from cardiac arrest, which may include the use of an automated external defibrillator, in good faith and without compensation, shall be immune from civil liability for any personal injury as a result of care or treatment or as a result of any act or failure to act in providing or arranging further medical treatment where the person acts as an ordinary prudent person would have acted under the same or similar circumstances, except damages that may result for the gross negligence of the person rendering emergency care. This immunity shall extend to the licensed physician.
If a doctor passes the scene of an accident in which some person has been injured and is in need of urgent medical attention he would not be held to have been negligent if he does not render assistance, as no doctor/patient relationship has been established and in consequences the doctor owes the patient no legal duty.
If, however, the doctor goes to the assistance of a person who is injured in an accident, a doctor /patient relationship is at once established. When any physician gratuitously advises medical personnel at the scene of an emergency episode by direct voice contact, to render medical assistance based upon information received by voice or biotelemetry equipment, the actions ordered taken by the physician to sustain life or reduce disability shall not be considered liable when the actions are within the established medical procedures.
A doctor has a duty to exercise reasonable skill and care regardless of whether or not his services are being given gratuitously. A national health policy is required to be formulated to render emergency treatment to a person.
If such a practitioner fails to attend an emergency call and a complaint is made against him it may well be that some disciplinary action will be taken against him by the health authority/medical council.
Medical Negligence Vs Bad Practice, Which Is Going to Cost You More
In our previous medico-legal articles we have used the term “medical negligence” and “malpractice” several times. In general, these two terms have been used interchangeably, whereas, in legal aspect they have a subtle difference in the definition of these two terms. A knowledge of this difference may often lessen the legal burden for an accused doctor. A medical negligence in not always intentional and always tried at civil court whereas malpractice cases can come under criminal negligence and can land you up in a criminal court. Definition of Negligence, Malpractice and standard of care Negligence is a failure to exercise the care that a reasonably prudent person would exercise in like circumstances. In tort law, negligence applies to harm caused by carelessness, not intentional harm. Malpractice is a type of negligence; it is often called “professional negligence”. It occurs when a licensed professional (like a doctor, lawyer or accountant) fails to provide services as per the standards set by the governing body (“standard of care”), subsequently causing harm to the plaintiff. Standard of care means an ordinary competent person exercising ordinary skill in that particular profession. There is no medical definition for standard of care, although the term is firmly established by law and is defined as “the caution that a reasonable person in similar circumstances would exercise in providing care to a patient.” The same “standard of care” is applicable to hospitals as to individual physicians with the difference that liability of the hospital is a corporate liability and the hospital is accountable and responsible for an act of negligence of its staff. The Difference between the Two These two terms are often used interchangeably but as per legal concepts, though they are related, have different meanings. Medical malpractice is a subcategory of negligence. The two terms are connected by a third: negligence is a category in between medical malpractice and medical negligence. The key word in all three of these categories is “intent”. That word alone defines the three categories in vastly different ways. Medical negligence is the lack of action by a medical professional, often “without intent”; negligence can be done either with or without intent, and medical malpractice is done “with intent to harm”. How negligence or malpractice are proved Cases of negligence or malpractice are generally difficult to prove, as it is taken that no medical practitioner has a “harmful” intent towards a patient. To win a favorable judgment, a clear causal relationship must be established between the negligent act and the injury caused. There are four elements to proving both negligence and malpractice: Duty: The defendant had a duty or an obligation to the plaintiff. General duties to be discharged by doctors are: A duty of care in deciding whether to undertake the case A duty of care in deciding what treatment to give A duty of care in the administration of that treatment Breach: The defendant breached this duty. When a medical practitioner commits a breach of duty, the immunity he enjoys, turns to be a cause for calling judicial interference, giving a right of action for negligence to the patient in the last resort. Causation: The harm suffered by the plaintiff was a direct result of this breach of duty. Damages: The damages being sought are directly related to the harm caused. Special damages: Directly correlated to the injury or harm and have a specific money amount that can be established (e.g., via medical bills) General damages: More difficult to put a monetary figure to emotional damages e.g., pain and emotional suffering. Punitive damages: Imposed by the court in rare cases when the negligence was gross (extreme). This is rare because negligence, by its nature, is unintentional. Although these elements are of similar nature in the both negligence and malpractice categories, they are distinguished on the basis of the keyword “intent”. Civil versus criminal It is claimed that negligence is negligence and jurisprudentially no clear distinction can be drawn between negligence under civil law and negligence under criminal law. In general, it is the amount of damage incurred which is determinative of the extent of liability in tort; but in criminal law, it is not the amount of damage but the amount of degree of negligence that is determinative of liability. There is no absolute immunity against criminal prosecution and therefore, if a need arises, following guidelines are to be followed. A private complaint may not be entertained unless the complainant has produced prima facie evidence before the Court in the form of a credible opinion given by another competent doctor to support the charge of rashness or negligence on the part of the accused doctor. The investigating officer should, before proceeding against the doctor accused of rash or negligent act or omission, obtain an independent and competent medical opinion preferably from a doctor in government service qualified in that branch of medical practice who can normally be expected to give an impartial and unbiased opinion applying Bolam’s test (A test that arose from English tort law, which is used to assess medical negligence) to the facts collected in the investigations. A doctor accused of rashness or negligence, may not be arrested in a routine manner. A physician should preferably be booked under bailable IPC 304A (Unintentional medical negligence) rather than non-bailable IPC 304 (Intentional negligence), as physicians are supposed to treat their patient in “good faith”. Examples To exemplify the difference between negligence and medical malpractice, it is beneficial to exemplify the category of general professional negligence as well, as negligence is the central aspect of the spectrum between the two respective sides. An example of negligence would be in the case of a driver who texts while at the wheel. Because the driver is distracted with his cell phone, they do not see the car that is driving ahead of them, and they cause an accident. In this case, negligence of attention to the road caused the accident, thus, the driver became a danger to others. His negligence and lack of attention would be proven as the cause. While negligence may or may not be attached by intent, medical negligence is negligence in the medical field without intent. Common examples are A failure of diagnostic revision Failure to warn patients of the risk of treatment Failure to treat a patient Wrongful diagnosis If a medical practitioner takes reasonable care and follows the laid down standard of care, he cannot be held liable. Following are the reasons for which a doctor cannot be sued for medical negligence: Difference in opinion Error in judgment Patient not getting cured despite correct treatment Operation not being successful without any negligence on the part of surgeon On the other hand, with the mistakes of medical negligence in mind, medical malpractice includes the opposite of mistake: a bad (mal) or wrongful “intent”. In medical negligence the doctor simply fails to do something that should have been done, on the contrary, doctors who commit malpractice, perform their job in a way that is not the accepted standard of care leading to serious injury or death. Examples of medical malpractice are those in which the doctor does not perform their duties to the legal medical standards. Such acts include: Wrongful death Mistake during childbirth Error in anesthesia Surgical errors due to the negligence of not abiding by the “standard of care” laid down by recent guidelines. General factors that protect from medical negligence Factors likely to prevent an initiation of litigation against doctors are listed below: Creating an environment that engenders trust. An environment where patient feels like being cared, heard, and respected by the doctor and his staff is essential to building a trust on their recommendations. Doctors having a valid insight regarding their own abilities and limitation. Handling the patient as per his credibility and an appropriate referral as and when needed can save them from an untoward event. Clear and adequate communication between patient, staff, and doctors: Good maintenance of medical records Encouraging patients to maintain their own medical records Encouraging patients to bring written lists of their concerns, medications, and issues they wish to discuss Giving written instructions to patients regarding recommended treatment Sending letters to patients summarizing the results of the patient visit, with copies of letter to consultants (To be mostly done by hospital administration) “A stitch in time saves nine”, this adage is a good reminder that how a proper preventive preparation can save physicians from landing into litigation trouble in future. Doctors who truly care for their patients will not ever want to treat them inappropriately, and will not want to harm them by exceeding their capability or giving them the unrealistic outcome of the treatment. They will always ensure the bridge of communication is always clear between him and patient. At the end, the saying of Francis Peabody is so true, “The secret of the care of the patient is caring for the patient”. References Tiwari S., Tiwari M., Baldwa M., Kuthe A., Textbook on Medicolegal Issues, IAP, 2007. Strauss, Dirk C., and J. Meirion Thomas. “What does the medical profession mean by “standard of care?”.” Journal of Clinical Oncology 27.32 (2009): e192-e193. Medical Malpractice VS. Negligence: What’s the Difference? by Evan Bassett on Fri, Nov 29, 2013, Bassett Law Offices LocaliRussell, et al. “Relation between malpractice claims and adverse events due to negligence: results of the Harvard Medical Practice Study III.” New England Journal of Medicine 325.4 (1991): 245-251. Which specialty, according to you, suffers from the greatest number of medical negligence trial Medical negligence” and “malpractice”
“Medical negligence” and “malpractice” are used frequently. In general, these two terms have been used interchangeably, whereas, in legal aspect they have a subtle difference in the definition of these two terms. A knowledge of this difference may often lessen the legal burden for an accused doctor. A medical negligence in not always intentional and always tried at civil court whereas malpractice cases can come under criminal negligence and can land you up in a criminal court. Definition of Negligence, Malpractice and standard of care Negligence is a failure to exercise the care that a reasonably prudent person would exercise in like circumstances. In tort law, negligence applies to harm caused by carelessness, not intentional harm. Malpractice is a type of negligence; it is often called “professional negligence”. It occurs when a licensed professional (like a doctor, lawyer or accountant) fails to provide services as per the standards set by the governing body (“standard of care”), subsequently causing harm to the plaintiff. Standard of care means an ordinary competent person exercising ordinary skill in that particular profession. There is no medical definition for standard of care, although the term is firmly established by law and is defined as “the caution that a reasonable person in similar circumstances would exercise in providing care to a patient.” The same “standard of care” is applicable to hospitals as to individual physicians with the difference that liability of the hospital is a corporate liability and the hospital is accountable and responsible for an act of negligence of its staff. The Difference between the Two These two terms are often used interchangeably but as per legal concepts, though they are related, have different meanings. Medical malpractice is a subcategory of negligence. The two terms are connected by a third: negligence is a category in between medical malpractice and medical negligence. The key word in all three of these categories is “intent”. That word alone defines the three categories in vastly different ways. Medical negligence is the lack of action by a medical professional, often “without intent”; negligence can be done either with or without intent, and medical malpractice is done “with intent to harm”. How negligence or malpractice are proved Cases of negligence or malpractice are generally difficult to prove, as it is taken that no medical practitioner has a “harmful” intent towards a patient. To win a favorable judgment, a clear causal relationship must be established between the negligent act and the injury caused. There are four elements to proving both negligence and malpractice: Duty: The defendant had a duty or an obligation to the plaintiff. General duties to be discharged by doctors are: A duty of care in deciding whether to undertake the case A duty of care in deciding what treatment to give A duty of care in the administration of that treatment Breach: The defendant breached this duty. When a medical practitioner commits a breach of duty, the immunity he enjoys, turns to be a cause for calling judicial interference, giving a right of action for negligence to the patient in the last resort. Causation: The harm suffered by the plaintiff was a direct result of this breach of duty. Damages: The damages being sought are directly related to the harm caused. Special damages: Directly correlated to the injury or harm and have a specific money amount that can be established (e.g., via medical bills) General damages: More difficult to put a monetary figure to emotional damages e.g., pain and emotional suffering. Punitive damages: Imposed by the court in rare cases when the negligence was gross (extreme). This is rare because negligence, by its nature, is unintentional. Although these elements are of similar nature in the both negligence and malpractice categories, they are distinguished on the basis of the keyword “intent”. Civil versus criminal It is claimed that negligence is negligence and jurisprudentially no clear distinction can be drawn between negligence under civil law and negligence under criminal law. In general, it is the amount of damage incurred which is determinative of the extent of liability in tort; but in criminal law, it is not the amount of damage but the amount of degree of negligence that is determinative of liability. There is no absolute immunity against criminal prosecution and therefore, if a need arises, following guidelines are to be followed. A private complaint may not be entertained unless the complainant has produced prima facie evidence before the Court in the form of a credible opinion given by another competent doctor to support the charge of rashness or negligence on the part of the accused doctor. The investigating officer should, before proceeding against the doctor accused of rash or negligent act or omission, obtain an independent and competent medical opinion preferably from a doctor in government service qualified in that branch of medical practice who can normally be expected to give an impartial and unbiased opinion applying Bolam’s test (A test that arose from English tort law, which is used to assess medical negligence) to the facts collected in the investigations. A doctor accused of rashness or negligence, may not be arrested in a routine manner. A physician should preferably be booked under bailable IPC 304A (Unintentional medical negligence) rather than non-bailable IPC 304 (Intentional negligence), as physicians are supposed to treat their patient in “good faith”. Examples To exemplify the difference between negligence and medical malpractice, it is beneficial to exemplify the category of general professional negligence as well, as negligence is the central aspect of the spectrum between the two respective sides. An example of negligence would be in the case of a driver who texts while at the wheel. Because the driver is distracted with his cell phone, they do not see the car that is driving ahead of them, and they cause an accident. In this case, negligence of attention to the road caused the accident, thus, the driver became a danger to others. His negligence and lack of attention would be proven as the cause. While negligence may or may not be attached by intent, medical negligence is negligence in the medical field without intent. Common examples are A failure of diagnostic revision Failure to warn patients of the risk of treatment Failure to treat a patient Wrongful diagnosis If a medical practitioner takes reasonable care and follows the laid down standard of care, he cannot be held liable. Following are the reasons for which a doctor cannot be sued for medical negligence: Difference in opinion Error in judgment Patient not getting cured despite correct treatment Operation not being successful without any negligence on the part of surgeon On the other hand, with the mistakes of medical negligence in mind, medical malpractice includes the opposite of mistake: a bad (mal) or wrongful “intent”. In medical negligence the doctor simply fails to do something that should have been done, on the contrary, doctors who commit malpractice, perform their job in a way that is not the accepted standard of care leading to serious injury or death. Examples of medical malpractice are those in which the doctor does not perform their duties to the legal medical standards. Such acts include: Wrongful death Mistake during childbirth Error in anesthesia Surgical errors due to the negligence of not abiding by the “standard of care” laid down by recent guidelines. General factors that protect from medical negligence Factors likely to prevent an initiation of litigation against doctors are listed below: Creating an environment that engenders trust. An environment where patient feels like being cared, heard, and respected by the doctor and his staff is essential to building a trust on their recommendations. Doctors having a valid insight regarding their own abilities and limitation. Handling the patient as per his credibility and an appropriate referral as and when needed can save them from an untoward event. Clear and adequate communication between patient, staff, and doctors: Good maintenance of medical records Encouraging patients to maintain their own medical records Encouraging patients to bring written lists of their concerns, medications, and issues they wish to discuss Giving written instructions to patients regarding recommended treatment Sending letters to patients summarizing the results of the patient visit, with copies of letter to consultants (To be mostly done by hospital administration) “A stitch in time saves nine”, this adage is a good reminder that how a proper preventive preparation can save physicians from landing into litigation trouble in future. Doctors who truly care for their patients will not ever want to treat them inappropriately, and will not want to harm them by exceeding their capability or giving them the unrealistic outcome of the treatment. They will always ensure the bridge of communication is always clear between him and patient. At the end, the saying of Francis Peabody is so true, “The secret of the care of the patient is caring for the patient”. References Tiwari S., Tiwari M., Baldwa M., Kuthe A., Textbook on Medicolegal Issues, IAP, 2007. Strauss, Dirk C., and J. Meirion Thomas. “What does the medical profession mean by “standard of care?”.” Journal of Clinical Oncology 27.32 (2009): e192-e193. Medical Malpractice VS. Negligence: What’s the Difference? by Evan Bassett on Fri, Nov 29, 2013, Bassett Law Offices Localio, A. Russell, et al. “Relation between malpractice claims and adverse events due to negligence: results of the Harvard Medical Practice Study III.” New England Journal of Medicine 325.4 (1991): 245-251. Which specialty, according to you, suffers from the greatest number of medical negligence trials? *Disclaimer: The legal information provided in this article in the form of case examples, solutions are, at best, of a general nature to provide an outline and cannot substitute for the advice of a licensed legal professional. Nothing in this article should be construed as an attempt to offer or render a legal opinion or otherwise engage in the practice of law. ls?
Medico Legal General Medicine
Criminal Liabilities in Medical Profession
Ignorance of the law is never an excuse especially when it comes to the medical profession, the doctors are under tremendous pressure to perform at the best of their ability and follow the lawsuit in general as their performance reflects if the patient would be cured or saved. They have certain civil and criminal responsibilities.
But, the double-edged sword of treatment burden, death of a patient, and medical errors are always hanging above the head of doctors. The doctors have to outperform and exceed their expectations but the truth lies within that the death can never be controlled by anyone.
If found guilty, doctors are criminally liable under these circumstances:
A] Evidence and Record:
Section number
Actual Act
Explanation
174
Non-attendance in the obedience of an order from a doctor
A doctor is legally bound to appear in court or in front of the magistrate if he/she is in relation with that case. Failure to do so could be found guilty under this section.
175
Failure to produce the document by the legally bounded person
A doctor is bound to produce all documents (e.g. medical reports or treatment record) in case of the medico-legal case. Failure to do so can result in the offence of laws under this section.
176
Omission to provide notice or information to public servant by legally bounded person
A doctor is bound to inform police about the medico legal, murder case, or a rape case which is admitted in their dispensary or hospital. If he/she fails to do so they are then liable under this section
187
Not assisting the public servant when bound by the law to provide the required assistance
A doctor if he/she fails to treat a patient or public servant allotted to him, then the doctor is guilty under this section.
192
Fabricating false evidence
A doctor or a medical professional in any circumstance produces false evidence, makes a false entry in the book, false statement, then he is criminally liable under this act.
197
Issuing or signing a false certificate
A doctor in any way is not allowed to issue or sign a certificate which is intentionally constructed for a false manner.
470
Forged document or electronic record
A document which is made partly or completely by forgery is legally not allowed in the court of law and such acts will be liable under this section
471
Using a forged document as a genuine document
Doctors at any cost are not allowed to utilize forged documents like an original document for whatever reason, in such cases he/she is liable under this section
B] Laws on Public Health, Safety and Drugs:
Section number
Actual Act
Explanation
269
Negligence resulting in the spread of infectious diseases
The medical professionals are liable to follow strict standards which are set for treating patients under the guidelines and protocols especially for dangerous diseases like AIDS, Hepatitis etc.
270
Malignancy resulting into the spread of infectious diseases
The medical professionals are not allowed to act malignantly in any case, such acts would be strictly taken into action under this section
274
Drug Adulteration
The medical professionals aren’t allowed to adulterate any medical preparation which arbitrarily affects the efficiency and safety of the drug rendering it useless. If found guilty, such professionals are liable under this act.
276
Sale of drugs as a different drug or preparation
The medical practitioners aren’t allowed to retail drugs with their own formulation. All drugs which are liable to sale should be duly approved by the regulatory authorities. If found liable such individuals would have to face stern action under this section.
278
Making the work atmosphere unreliable to work
The medical practitioner caught violating the norms of the general practice that intoxicates the work environment on a large scale are liable under this act.
284
Negligence while handling a poisonous substance
If the medical practitioner, due to any unforeseen reason is involved in providing a poisonous or toxic substance to the patient which can endanger the life, such practitioners are liable under this section.
287
Negligence in handling medical devices
The medical practitioner needs to be very careful while handling medical devices, if any sort of negligence occurs in any circumstance it could lead to serious complications under this section.
C] Laws in relation to endangering life:
Section number
Actual Act
Explanation
336
Endangering the life or personal safety of others
Act performed with negligent intentions which proceeds to endanger their life or personal safety.
337
Hurting life or personal safety of others
A procedure performed which harms human life or personal safety.
338
Hurting grievously or personal safety of others
An act which is responsible for grievously hurting someone which proceeds to endanger their life or personal safety
D] Laws in relation to indoor patients:
Section number
Actual Act
Explanation
340
Wrongful confinement
A medical practitioner is not allowed to wrongfully restrain a person from his/her rights in a manner as to limit the medical proceedings further. It is totally unlawful to confine a person, withhold discharge for any given reason or withhold handing of the dead body due to payment disputes.
E] Laws governing death due to negligence:
Section number
Actual Act
Explanation
304-A
Causing death due to negligence
The medical practitioner who is found guilty of causing death due to medical negligence can be punished with imprisonment of either description for a term which may extend to two years, or with fine, or both. In this section, the Supreme Court of India is of the view that the situation should be very carefully analyzed while imposing criminal offences on doctors under this section.
Finally, it needs to be remembered that establishing a strong doctor-patient relationship could assist in many ways. In any case, more time you spend with your patient in your consulting room, it might reduce your time in the courtroom.
Do you think, criminal liabilities be included in the medical curriculum for avoiding lawsuits?
Medico legal Judgement in favor of doctors
Finally, a Loud Voice in favor of Doctors. Most medicolegal
complaints are personality based rather than issue based.
While we do our technical and moral best to treat us
patients, we must develop the art of sympathetic and deft
handling of patients’ relatives so that they are constantly
informed and should see that we are doing our best. When there is
a doubt in their mind OR there is a lack of adequate
communication from the doctor then medicolegal complains arise in
the face of an adverse event.
NEW DELHI: The Supreme Court has held that doctors cannot be
“unnecessarily harassed” by patients or their claimants to
extract compensation for death or disability due to alleged
medical negligence.
A bench of Justices Dalveer Bhandari and H S Bedi said on
Wednesday that it was the bounden duty of society to ensure that
doctors perform their duties without apprehension of malicious
prosecution though the interests of the patients should be
paramount.
“The medical practitioners at times also have to be saved from
such a class of complainants who use criminal process as a tool
for pressurizing the medical professionals/hospitals,
particularly private hospitals or clinics, for extracting
uncalled for compensation. Such malicious proceedings deserve to
be discarded against the medical practitioners,” Justices
Bhandari writing the judgement said.
The apex court made the remarks while dismissing the Rs. 45-lakh
compensation claim of Kusum Latha, widow of R K Sharma, Senior
Operations Manager in Indian Oil Corporation’s Marketing Division
who, according to the claimants, died due to negligence committed?
by the doctors of Batra Hospital and Medical Research Centre.
Sharma died on October 11, 1990, of ‘pyogenic meningitis’ after
doctors at the hospital performed a surgery to remove an
encapsulated malignant tumor in the left adrenal on the
abdominal side which involved a complicated procedure. Kusum
Latha moved the National Consumer Disputes Redredssal Commission
(NCDRC) with a plea for Rs. 45 lakh compensation charging that the
death occurred due to medical negligence. The Commission, after
examining various records, dismissed the widow’s plea, after
which she moved the apex court. The apex court too, after perusal
of the records and hearing the parties, noted that in the present
case Kusum Latha could not establish the charge of negligence.
Citing a number of its earlier judgements, the apex court said
medical professionals are entitled to protection so long as they
perform their duties with reasonable skill and competence and in
the interest of patients. “The interest and welfare of the
patients have to be paramount for medical professionals. Doctors
in complicated cases have to take a chance even if the rate of
survival is low.”
The professionals should be held liable for his act or omission
but courts, at the same time, have to be extremely careful to
ensure that professionals are not unnecessarily harassed and they
are able to carry out their professional duties without fear, the
apex court said.
According to the apex court, the normal human tendency is to pick
fault whenever there is a death in the family for which the
doctor cannot be made a scapegoat. “It is a matter of common
knowledge that after some unfortunate event, there is a marked
tendency to look for a human factor to blame for an untoward
event, a tendency which is closely linked with the desire to
punish. Things have gone wrong and, therefore, somebody must be
found to answer for it.
“A professional deserves total protection. The Indian Penal Code
has taken care to ensure that people who act in good faith should
not be punished. Sections 88, 92 and 370 of the Indian Penal Code
give adequate protection to the professional and particularly
medical professionals,” the bench said.
The apex court said to prosecute a medical professional for
negligence under criminal law it must be shown that the accused
did something or failed to do something which in the given facts
and circumstances no medical professional in his ordinary senses
and prudence would have done or failed to do.
However, it clarified that “We should not be understood to have
held that doctors can never be prosecuted for medical negligence.
As long as the doctors have performed their duties and exercised
an ordinary degree of professional skill and competence, they
cannot be held guilty of medical negligence
MENTAL HEALTH ACT 1987
THE MENTAL HEALTH ACT, 1987
(No. 14 of 1987)1
[22nd May, 1987]
An Act to consolidate and amend the law relating to the treatment and care of mentally
ill persons, to make better provision with respect to their properly and affairs and for
matters connected therewith or incidental thereto.
STATEMENT OF OBJECTS AND REASONS OF ACT 14 of 19872
1. The attitude of the society towards persons afflicted with mental illness has
changed considerably and it is now realized that no stigma should be attached to
such illness as it is curable, particularly, when diagnosed at an early stage. Thus the
mentally ill persons are to be treated like any other sick persons and the
environment around them should be made as normal as possible.
2. The experience of the working of Indian Lunacy Act, 1912 (4 of 1912) has
revealed that it has become out-moded. With the rapid advance of medical science
and the understanding of the nature of malady, it has become necessary to have
fresh legislation with provisions for treatment of mentally ill persons in accordance
with the new approach.
3. It is considered necessary –
i. to regulate admission to psychiatric hospitals or psychiatric nursing homes
of mentally ill-persons who do not have sufficient understanding to seek
treatment on a voluntary basis, and to protect the rights of such persons
while being detained;
ii. To protect society from the presence of mentally ill persons who have
become or might become a danger or nuisance to others;
iii. To protect citizens from being detained in psychiatric hospitals or
psychiatric nursing homes without sufficient cause;
iv. To regulate responsibility for maintenance charges of mentally ill persons
who are admitted to psychiatric hospitals or psychiatric nursing homes;
v. To provide facilities for establishing guardianship or custody of mentally ill
persons who are incapable of managing their own affairs;
vi. To provide for the establishment of Central Authority and State Authorities
for Mental Health Services;
vii. To regulate the powers of the Government for establishing, licensing and
controlling psychiatric hospitals and psychiatric nursing homes for mentally
ill persons;
viii. To provide for legal aid to mentally ill persons at State expense in certain
cases.
4. The main object of the Bill is to implement the aforesaid proposals.
COMMENTS
It is well settled that when the language of the statute is clear and admits of no ambiguity,
recourse to the Statement of Objects and Reasons for the purpose of construing a
statutory provision is not permissible. Court must strive to so interpret the statute as to
protect and advance the object and purpose of the enactment. Any narrow or technical
interpretation of the provisions would defeat the legislative policy. The Court must,
therefore, keep the legislative policy in mind in applying the provisions of the Act to the
facts of the case2.
The law is well settled that though the Statement of objects and Reasons accompanying a
legislative bill could not be used to determine the true meaning and effect of the
substantive provisions of a statute, it was permissible to refer to the same for the purpose
of understanding the background, the antecedent state of affairs, the surrounding
circumstances in relation to the statute, and the evil which the statute sought to remedy3.
PREAMBLE – It is established law that preamble discloses the primary intention of the
statute but does override the express provisions of the statute4. Although a preamble of a
statute is a key to interpretation of the provisions of the Act, but the intention of
Legislature is not necessarily to be gathered from the preamble taken by itself, but to be
gathered from the provisions of the Act. Where the language of the Act is clear, the
preamble cannot be a guide, but where the object or meaning of the provisions of the Act
is not clear then an aid from the preamble can be taken into consideration for purpose of
explaining the provisions of the Act5.
It is now well settled that the preamble of a statutory instrument cannot control the
express clear language and sweep of the operating provisions of such an instrument. Nor
can the express language of a statutory provision be curtailed or read down in the light of?
the preamble in the absence of any ambiguity in the enacted provisions6.
Be it enacted by Parliament in the Thirty-eighth Year of the Republic of India as follows:
CHAPTER 1
PRELIMINARY
1. SHORT TITLE, EXTENT AND COMMENCEMENT –
1. This Act may be called the Mental Health Act, 1987.
2. It extends to the whole of India
3. It shall come into force on such date1 as the Central Government may, by
notification, appoint and different dates may be appointed for different
States and for different provisions of this Act, and any reference in any
provision to the commencement of this Act in a State shall be construed as
a reference to the coming into force of that provision in that state.
COMMENTS
The Act repeals the Indian Lunacy Act, 1912 (4 of 1912), and the Lunacy Act, 1977
(Jammu and Kashmir Act 25 of 1977). The provisions of the Indian Lunacy Act 1912 and
the Amending Act which compendiously called Lunacy Act, 1912-1926 were not
absolutely exhaustiv2.
S.O. 43 (E), DATED 11TH JANUARY, 1993 – In exercise of the powers conferred by
sub-section (3) of Sec. 1 of the Mental Health Act, 1987 (14 of 1987), the Central
Government hereby appoints the Ist day of April, 1993 as the date on which the said Act
shall come into force in all the States and Union Territories.
RULE OF INTERPRETATION. – It is an accepted proposition of law that Acts must be
construed as a whole. Guidance with regard to the meaning of a particular word or phrase
may be found in other words and phrases in the same section or in other sections although
the utility of an extensive consideration of other parts of the same statute will vary from
case to case3.
In interpreting the provisions, the exercise undertaken by the Court is to make explicit the
intention of the Legislature which enacted the legislation. It is not for the Court to reframe
the legislation for the very good reason that the powers to “legislate” have not been
conferred on the Court4.
In order to sustain the presumption of constitutionality of a legislative measure, the Court
can take into consideration matters of common knowledge, matters of common report, the
history of the times and also assume every state of fact which can be conceived existing at
the time of the legislation5.
The principle of the interpretation that no word used by the Legislature in a legislation is
useless, cannot be fitted into the situation where the question relates to the interpretation
of an agreement. An agreement is not to be culled out from ambiguity6.
INTERPRETATION OF STATUTE-DUTY OF THE COURT – It is well settled that the
Courts should read different provisions of an Act in a manner that no part thereof is held
to be superfluous or surplus and that where language of statute leads to manifest
contradictions the Court must construe them on the basis of which the said provisions can
survive1.
GENERALIA SPECIALIBUS NON DEROGANT- It is well-known proposition of law that
when a matter falls under any specific provision, then it must be governed by that
provision and not by the general provision (Generalia specialibus non derogant)2.
CONSTRUCTION OF WORK- It is settled view that in determining the meaning or
connotation of words and expressions describing an article one should be construed in the
sense in which they are understood. The reason is that it is they who are concerned with it
and, it is the sense in which they understand it which constitutes the definitive index of the
legislative intention3.
2. DEFINITIONS
In this Act, unless the context otherwise requires –
a. “cost of maintenance”. In relation to a mentally ill person admitted in a
psychiatric hospital or psychiatric nursing home, shall mean the cost of
such items as the State Government may, by general or special order,
specify in this behalf;
b. “District Court” means, in any area for which there is a city Civil Court,
that Court, and in any other area the principal Civil Court of original
jurisdiction, and includes any other Civil Court which the State
Government may, by notification, specify as the Court competent to deal
with all or any of the matters specified in this Act:
c. “Inspecting Officer” means a person authorized by the State Government or
by the licensing authority to inspect any psychiatric hospital or psychiatric
nursing home;
d. “license” means a license granted under Sec.8;
e. “licensee” means the holder of a license;
f. “licensed psychiatric hospital” or “licensed psychiatric nursing home”
means a psychiatric hospital or psychiatric nursing home, as the case may
be, licensed, or deemed to be licensed, under this Act;
g. “licensing authority” means such officer or authority as may be specified by
the State Government to be the licensing authority to the purposes of this
Act;
h. “Magistrate” means –
1. in relation to a metropolitan area within the meaning of Cl (k) of
Sec. 2 of the Code of Criminal Procedure, 1973 (2 of 1974), a
Metropolitan Magistrate;
2. in relation to any other area, the Chief Judicial Magistrate, Sub-
Divisional Judicial Magistrate or such other Judicial Magistrate of
the first class as the State Government may, by notification,
empower to perform the functions of a Magistrate under this Act:
i. “medical officer” means a gazette medical officer in the service of
Government and includes a medical practitioner declared, by a general or
special order of the State Government, to be a medical officer for the
purposes of this Act;
j. “medical officer in charge” in relation to any psychiatric hospital or
psychiatric nursing home, means the medical officer who, for the time
being, is in charge of that hospital or nursing home;
k. “medical practitioner” means a person who possesses a recognized medical
qualification as defined –
i. in Cl (h) of Sec 2 of the Indian Medical Council Act, 1956 (102 of
1956), and whose name has been entered in the State Medical
Register, as defined in Cl. (k) of that section;
ii. in Cl (h) of sub-section (1) of Sec. 2 of the Indian Medicine Central
Council Act, 1970 (48 of 1970), and whose name has been entered
in a State Register of Indian Medicine, as defined in cl (j) of subsection
(1) of that section; and
iii. in Cl. (g) of sub-section (1) of Sec. 2 of the Homoeopathy Central
Council Act, 1973 (59 of 1973), and whose name has been entered
in a State Register of Homoeopathy, as defined in Cl. (I) of subsection
1) of that section;
l. “Mentally ill person” means a person who is in need of treatment by person
of any mental disorder other than mental retardation;
m. “mentally ill prisoner” means a mentally ill person for whose detention in,
or removal to, a psychiatric hospital, psychiatric nursing home, jail or other
place of safe custody, an order referred to in Sec. 27 has been made;
n. “minor” means a person who has not completed the age of eighteen years;
o. “notification means a notification published in the Official Gazette;
p. “prescribed” means prescribed by rules made under this Act;
q. “psychiatric hospital” or “psychiatric nursing home” means a hospital, or as
the case may be, a nursing home established or maintained by the
Government or any other person for the treatment and care of mentally ill
persons and includes a convalescent home established or maintained by the
Government or any other person for such mentally ill persons; but does not
include any general hospital or general nursing home established or
maintained by the Government and which provides also for psychiatric
services;
r. “psychiatrist” means a medical practitioner possessing a post-graduate
degree or diploma in psychiatry, recognized by the Medical Council of
India, constituted under Indian Medical Council Act, 1856 (102 of 1956),
and includes, in relation to any State, any medical officer who, having
regard to his knowledge and experience in psychiatry, has been declared by
the Government of that State to be a psychiatrist for the purposes of this
Act;
s.” reception order” means an order made under the provision of this Act for
the admission and detention of a mentally ill person in a psychiatric
Hospital or psychiatric nursing home;
t.” relative” includes any person related to the mentally ill person by blood,
marriage or adoption;
u. “State Government” in relation to a Union territory, means the
Administrator thereof.
COMMENTS
This section defines the various expressions occurring in the Act.
INTERPRETATION OF SECOTION – The Court can merely interpret the section; it
cannot re-write, recast or redesign the section1.
RELATIVE – MEANING OF -certainly the word “relative” used in Sec. 3 of the Lunacy
Act (since repealed by this Act) has to be understood in a legal sense and it has to be
understood in the setting where that word is used in the provisions of the statute,
particularly, the provision enabling a relative to entertain a petition under Sec. 63 of the
Lunacy Act2.
CHAPTER II
MENTAL HEALTH AUTHORITIES
3. CENTRAL AUTHORITY FOR MENTAL HEALTH SERVICES.
. The Central Government shall establish an authority for mental health with
such designation as it may deem fit.
a. The Authority established under sub-section (1) shall be subject to the
superintendence, direction and control of the Central Government.
b. The authority established under sub-section (1) shall –
0. be in charge of regulation, development, direction and coordination
with respect to Mental Health Services under the Central
Government and all other matters which, under this Act, are the
concern of the Central Government or any officer or authority
subordinate to the Central Government.
1. Supervise the psychiatric hospitals and psychiatric nursing homes
and other Mental Health Service Agencies (including places in
which mentally ill persons may be kept or detained) under the?
control of the Central Government.
2. Advise the Central Government on all matters relating to mental
health; and
3. Discharge such other functions with respect to matters relating to
mental health as the Central Government may require.
EXPLANATION – For the purposes of this section and Sec.4 “Mental Health
Services” include, in addition to psychiatric hospitals and psychiatric nursing
homes, observation wards, day-care centers, in patient treatment in general
hospitals, ambulatory treatment facilities and other facilities, convalescent homes
and half-way-homes for mentally ill persons.
COMMENT
This section empowers the Central Government to establish Central Authority for
Mental Health Services.
EXPLANATION- It is now well settled that an explanation added to a statutory provision
is not a substantive provision in any sense of the term but as the plain meaning of the word?
itself shows it is merely meant to explain or clarify certain ambiguities which may have
crept in the statutory provision1.
4. STATE AUTHORITY FOR MENTAL HEALTH SERVICES –
. The State Government shall establish an authority for mental with such
designation as it may deem fit.
a. The Authority established under sub – section (1) shall be subject to the
superintendence, direction and control of the State Government.
b. The Authority established under sub – section (1) shall –
0. be in charge of regulation, development and co-ordination with
respect to Mental Health Service under the State Government and
all other matters which, under this Act, the concern of the state
Government or any officer or authority subordination to the State
Government:
1. supervise the psychiatric hospitals and psychiatric nursing homes
and other Mental health Services Agencies (including places in
which mentally ill persons may be kept or detained) under the
control of the State Government:
2. advise the State Government on all matters relating to mental health
; and
3. discharge such other functions with respect to matters relating to
mental health as the State Government may require.
COMMENT
This section empowers the State Government to established State authority for
Mental Health services.
CHAPTER III
PSYCHIATRIC HOSPITALS AND PSYCHIATRIC NURSING HOMES
5. ESTABLISHED OR MAINTENANCE OF PSYCHIATRIC
HOSPITALSAND PSYCHIATRIC NURSING HOMES –
. The Central Government may, in any part of India, or the state government
may, within the limits of its jurisdiction, established or maintain psychiatric
hospitals or psychiatric nursing homes for the admission, and
care of mentally ill persons at such places as it thinks fit; and separate
psychiatric hospitals and psychiatric nursing homes may be established or
maintained for, –
a. those who are under the age of sixteen years;
b. those who are addicted to alcohol or other drugs which lead
to behavioral changes in a person’s;
c. those who have been convicted of any offence; and
d. those belonging to such other or category of persons as may
be prescribed.
a. Where a psychiatric hospital or psychiatric nursing home is established or
maintained by the Central Government, any reference in this Act to the
State Government shall, in relation to such hospital or nursing home, be
construed as a reference to the Central Government.
COMMENT
This section empowers the Central Government or the State Government to
established or maintain psychiatric nursing homes.
6. ESTABLISHMENT OR MAINTENANCE OF PSYCHIATRIC
HOSPITALS OR PSYCHIATRIC NURSING HOMES ONLY WITH
LICENCE.
. On and after the commencement of this Act, no person shall establish or
maintain a psychiatric hospital or psychiatric nursing home unless he holds
a valid license granted to him under this Act:
Provided that a psychiatric hospital or psychiatric nursing home (whether
called asylum or by any other name) licensed by the central government or
any state Government and maintained as such immediately before the
commencement of this Act may continue to be maintained, and shall be
deemed to be a licensed psychiatric hospital or licensed psychiatric nursing
home, as the case may be, under this Act, –
a. for a period of three months from such commencement,
b. if an application made in accordance with Sec. 7 for a
license is pending on the expiry of the period specified in
CI. (a) till the disposal of such application.
a. Nothing contained in sub-section (1) shall apply to a psychiatric hospital or
psychiatric nursing home established or maintained by a Central
Government or a State Government.
COMMENT
This section prohibits establishment or maintenance of any psychiatric hospital or
psychiatric nursing home by any person, unless he holds a valid license granted to
him under the Act.
7. APPLICATION FOR LICENCE. –
. Every person, who holds, at the commencement of this Act, a valid license
authorizing that person to establish or maintain any psychiatric hospital or
psychiatric nursing home, shall, if the said person intends to establish or
continue the maintenance of such hospital or nursing home after the expiry
of the period referred to in Cl. (a) of the proviso to sub-section (1) of Sec.
6, make at least one month before the expiry of such period, an application
to the licensing authority for the grant of a fresh license for the
establishment or maintenance of such hospital or nursing home, as the case
may be.
a. A person, who intends to establish or maintain, after the commencement of
this Act, a psychiatric hospital or psychiatric nursing home, shall, unless the
said person already holds a valid license, make an application to the license
authority for the grant of a license.
b. Every application under sub-section (1) or sub-section (2) shall be in such
form and be accompanied by such fee as may be prescribed.
COMMENT
This section provides for application for license for establishment or maintenance
of psychiatric hospital or psychiatric nursing homes.
8. GRANT OR REFUSAL OF LICENCE –
On receipt of an application under Sec.7, the licensing authority shall make such
inquiries as it may deem fit and where it is satisfied that –
. the establishment or maintenance of the psychiatric hospital or psychiatric
nursing home or the continuance of the maintenance of any such hospital or
nursing home established before the commencement of this Act is
necessary;
a. the applicant is in a position to provide the minimum facilities prescribed
for the admission, treatment and care of mentally ill persons; and
b. The psychiatric hospital or psychiatric nursing home, will be under the
charge of medical officer who is a psychiatrist.
it shall grant a license to the applicant in the prescribed form, and where it is not so
satisfied, the licensing authority shall, by order, refuse to grant the license applied
for:
Provided that, before making any order refusing to grant a license, the licensing
authority shall give to the applicant a reasonable opportunity of being heard and
every order of refusal to grant a license shall set out there in the reasons for such
refusal and such reasons shall be communicated to the applicant in such manner as
may be prescribed.
COMMENT
This section empowers the licensing authority to grant or refuse license for
establishment or maintenance of psychiatric hospital or psychiatric nursing homes.
9. DURATION AND RENEWAL OF LICENCE –
. A license shall not be transferable or heritable.
a. Where a licensee is unable to function as such for any reason or where a
licensee dies, the licensee or, as the case may be, the legal representative of
such licensee shall forthwith report the matter in the prescribed manner to
the licensing authority and notwithstanding anything contained in subsection
(I), the psychiatric hospital or psychiatric nursing home concerned
may continue to be maintained and shall be deemed to be a licensed
psychiatric hospital or licensed psychiatric nursing home, as the case may
be –
0. for a period of three months from the date of such report or in the
case of the death of the licensee from the date of his death, or
1. if an application made in accordance with sub-section (3) for a
license is pending on the expiry of the period specified in Cl. (a), till
the disposal of such application.
b. The legal representative of the licensee referred to in sub-section (2) shall,
if he intends to continue the maintenance of the psychiatric hospital or
psychiatric nursing home after the expiry of the period referee to in subsection
(2), make, at least one month before the expiry of such period, an
application to the licensing authority for the grant of a fresh license for the
maintenance of such hospital or nursing home, as the case may be, and the
provisions of Sec. 8 shall apply in relation to such application as they apply
in relation to an application made under Sec.7
c. Every license shall, unless revoked earlier under Sec. 11, be valid for a
period of five years from the date on which it is granted.
d. A license may be renewed from time to time, on an application made in
that behalf to the licensing authority, in such form and accompanied by
such fee, as may be prescribed, and every such application shall be made
not less than one year before the date on which the period of validity of the
license is due to expire:
Provided that the renewal of a license shall not be refused unless the licensing
authority is satisfied that –
e. the licensee is not in a position to provide in a psychiatric hospital or
psychiatric nursing home, the minimum facilities prescribed for the
admission, treatment and care therein mentally ill persons; or
f. the licensee is not in a position to provide a medical officer which is a
psychiatrist to take charge of the psychiatric hospital or psychiatric nursing
home, or
g. the licensee has contravened any of the provisions of this Act or any rule
made thereunder.
COMMENT
This section empowers the licensing authority to grant or refuse license for
establishment or maintenance of the psychiatric hospital or psychiatric nursing
home, under certain circumstances.
10. PSYCHIATRIC HOSPITAL AND PSYCHIATRIC NURSING HOME TO
BE MAIN TRAINED IN ACCORDANCE WITH PRESCRIBED
CONDITIONS –
Every psychiatric hospital or psychiatric nursing home shall be maintained in such
manner and object to such condition as may be prescribed.
COMMENT
This section lays down that every psychiatric hospital/nursing home shall be
maintained properly according to the prescribed conditions.
11. REVOCATION OF LICENCE –
. The licensing authority may, without prejudice to any other penalty that
may be imposed on the licensee, by order in writing, revoke the license if it
is satisfied that –
0. the psychiatric hospital or psychiatric nursing home is not being
maintained by the licensee in accordance with the provisions of this
Act or the rules made thereunder; or
1. the maintenance of the psychiatric hospital or psychiatric nursing
home is being carried on in a manner detrimental to the moral,
mental or physical well-being of other in-patients thereof:
Provided that no such order shall be made except after giving the licensee a
reasonable opportunity of being heard, and every such order shall set out
therein the grounds for the revocation of the license and such grounds shall
be communicated to the licensee in such manner as may be prescribed.
a. Every order made under sub-section (1) shall contain a direction that the
in-patients of the psychiatric hospital or psychiatric nursing home shall be
transferred to such other psychiatric hospital or psychiatric nursing home as
may be specified in that order and it shall also contain such provisions
(including provisions by way of directions) as to the care and custody of
such in-patients pending such transfer. Every order made under sub-section
(1) shall take effect –
0. where no appeal has been preferred against such order under Sec.
12, immediately on the expiry of the period prescribed for such
appeal; and
1. where such appeal has been preferred and the same has been
dismissed, from the date of the order of such dismissal.
COMMENT
This section empowers the licensing authority to revoke the license in case the
psychiatric hospital or nursing home is not maintained properly or its maintenance
is detrimental to the well-being of the in-patients thereof.
12. Appeal –
. Any person aggrieved by an order of the licensing authority refusing to
grant or renew a license, or revoking a license, may, in such manner and
within such period as may be prescribed, prefer an appeal to the State
Government:
Provided that the State Government may entertain an appeal preferred after
the expiry of the prescribed period if it is satisfied that the appellant was
prevented by sufficient cause from preferring the appeal in time.
a. Every appeal under sub-section (1) shall be made in such form and
accompanied by such fee as may be prescribed.
COMMENT
This section makes provision for preferring an appeal to the State Government by
any aggrieved person against the order of the licensing authority refusing to grant
or renew a license, or revoking a license for establishment or maintenance of the
psychiatric hospital/nursing home.
13. INSPECTION OF PSYCHIATRIC HOSPITALS AND PSYCHIATRIC
NURSING HOME AND VISISTING OF PATIENTS-
. An Inspecting Officer may, at any time, enter and inspect any psychiatric
hospital or psychiatric nursing home and require the production of any
records, which are required to be kept in accordance with the rules made in
this behalf, for inspection: Provided that any personal records of a patient
so, inspected shall be kept confidential except for the purposes of subsection
(3).
a. The Inspecting Officer may interview in private any patient receiving
treatment and care therein –
0. for the purpose of inquiring into any complaint made by or on
behalf of such patient as to the treatment and care.
1. in any case, where the Inspecting Officer has reason to believe that
any in-patient is not receiving proper treatment and care.
b. Where the Inspecting Officer is satisfied that any in-patient in a psychiatric
hospital or psychiatric nursing home is not receiving proper treatment and
care, he may report the matter to the licensing authority and thereupon the
licensing authority may issue such direction as it may deem fit to the
medical officer-in-charge of the licensee of the psychiatric hospital, or, as
the case may be, the psychiatric nursing home and every such medical
officer-in-charge or licensee shall be bound to comply with such directions.
COMMENT
This section empowers an Inspecting Officer to inspect psychiatric hospitals /
nursing homes, records thereof and to visit and interview patients receiving
treatment and care therein.
14. TREATMENT OF OUT- PATIENT –
Provision shall be made in every psychiatric hospital or psychiatric nursing homes
for such facilities as may be prescribed for the treatment of every mentally ill –
persons, patients or who, for the time being, is not undergoing treatment as in –
patients.
COMMENT
This section makes, provision for the treatment of mentally ill persons in the
psychiatric hospital / nursing home, as an out – patients, in case his condition dies
not warrant his admission or an in – patient.
CHAPTER IV
ADMISSION AND DETENTION IN PSYCHIATRIC HOSPITAL OR
PSYCHIATRIC
NURSING HOME
PART I
ADMISION ON VOLUNTARY BASIS
15. REQUEST BY MAJOR FOR ADMISION AS VOLUNTARY PATIENTS
Any persons (not being a minor), who considers himself to be a mentally ill person
and desires to be admitted to any psychiatric nursing home for treatment, may
request the medical officer in charge for being admitted as a voluntary patient.
COMMENT
This section makes provision for admission to a psychiatric hospital / nursing home
for Treatment as a voluntary patient on request by a major mentally ill person.
16. REQUEST BY GUARDIAN FOR ADMISSION OF A WARD Where
the guardian of a minor considers such minor to be a mentally ill person and
desires to admit such minor in any psychiatric hospital or psychiatric nursing home
for treatment, he may request the medical officer-in-charge for admitting such
minor as a voluntary patient.
COMMENT
This section makes provision for admission of a minor mentally ill person to a
psychiatric hospital/nursing home for treatment as a voluntary patient, on request
by guardian of such minor.
17. ADMISSION OF, AND REGULATION WITH RESPECT
TO, VOLUNTARY PATIENTS-
. On receipt of a request under Sec.15 or Sec.16, the medical officer-in charge
shall make such inquiry as he may deem fit within a period not
exceeding twenty- four hours and if satisfied that the applicant or, as the
case may be, the minor requires treatment as an in – patients in the
psychiatric hospital or psychiatric nursing home, he may admit therein such
application or, as the case may be, minor as a voluntary patient.
a. Every voluntary patient admitted to a psychiatric hospital or psychiatric
nursing home shall be bound to abide by such regulations as may be made
by the medical officer – in – charge or the licensee of the psychiatric
hospital or psychiatric nursing home.
This section deals with the matter relating to admission of, and regulation with
respect to voluntary patients.
18. DISCHARGE OF VOLUNTARY PATIENTS –
. The medical officer-in-charge of a psychiatric hospital or psychiatric
nursing home shall, on a request made in that behalf –
0. by any voluntary patient; and
1. by the guardian of the patient, if he is a minor voluntary patient,
discharge, subject to the provisions of sub-section (3) and within
twenty-four hours of the receipt of such request, the patient from
the psychiatric hospital or psychiatric nursing home.
a. Where a minor voluntary patient who is admitted as an in-patient in any
psychiatric hospital or psychiatric nursing home attains majority, the
medical officer-in-charge of such hospital or nursing home, shall, as soon
as may be, intimate the patient that he has attained majority and that unless
a request for his continuance as an in-patient is made by him within a
period of one month of such intimation, he shall be discharged, and if,
before the expiry of the said period, no request is made to the medical
officer-in-charge for his continuance as an in-patient, he shall, subject to
the provisions of sub-section (3), be discharged on the expiry of the said
period.
b. Notwithstanding anything contained in sub-section (1) or sub-section (2)
where the medical officer-in charge of a psychiatric hospital or psychiatric
nursing home is satisfied that the discharge of a voluntary patient under
sub-section (1) or sub-section (2) will not be in the interest of such
voluntary patient, he shall, within seventy-two hours of the receipt of a
request under sub-section (1), or, if no request under sub-section (2) has
been made by the voluntary patient before the expiry of the period
mentioned in that sub-section within seventy-two hours of such expiry
constitute a Board consisting of two medical officers and seek its opinion
as to whether such voluntary patient needs further treatment and if the
Board is of the opinion that such voluntary patient needs further treatment
in the psychiatric hospital or psychiatric nursing home the medical officer
shall not discharge the voluntary patient, but continue his treatment for a
period not exceeding ninety days at a time.
COMMENT
This section lays down the procedure for discharge of voluntary patient from the
psychiatric hospital or psychiatric nursing home.
PART II
ADMISSION UNDER SPECIAL CIRCUMSTANCES
19. ADMISSION OF MENTALLY ILL PERSONS UNDER CERTAIN
SPECIAL Circumstances
mentally ill persons who does not, or is unable to, express his willingness for
admission as a voluntary patient, may be admitted and kept as an in-patient in a
psychiatric nursing hospital or psychiatric nursing home on an application made in
that behalf by a relative or a friend of the mentally ill persons if the medical
officers-in-charge is satisfied that in the interest of the mentally ill persons it is
necessary so to do:
COMMENT
This section deals with the matters relating to admission of, and regulation with
respect to voluntary patients.
20. DISCHARGE OF VOLUNTARY PATIENTS-
. The medical officers-in-charge of a psychiatric hospital or psychiatric
nursing home shall, on a request made in that behalf
0. by any voluntary patients; and
1. by the guardian of the patient, if he is a minor voluntary patient,
discharge, subject to the provisions of sub-section (3) and within
twenty-four hours of the receipt of such request, patients from the
psychiatric hospitals or psychiatric nursing home.
a. where a minor voluntary patient who is admitted as an in-patient in any
psychiatric hospital or psychiatric nursing home attains majority, the
medical officer-in- charge of such hospital or nursing home shall, as soon
as may be, intimate the patient that he has attained majority and that unless
a request for his continuance as an in-patient is made by him within a
period of one month of such intimation, he shall be discharged, and if,
before the expiry of the said period, no request is made to the medical
officer-in-charge for his continuance as an in-patient, he shall, subject to
the provisions of sub-section (3), be discharged on the expiry of the said
period.
b. Notwithstanding anything contained in sub-section (1) or sub-section (2),
where the medical officers-in-charge of a psychiatric hospital or psychiatric
nursing home is satisfied that the discharge of a voluntary patients under
sub-section (1) or sub-section (2) will not be in the interest of such
voluntary patient, he shall, within seventy-two hours of the receipt of a
request under sub-section (1) or, if no request under sub-section (2) has
been made by the voluntary patient before the expiry of the period
mentioned in that sub-section within seventy-two hours of such expiry
constitute a Board consisting of two medical officers and seek its opinion
as to whether such voluntary patient needs further treatment and if the
Board is of the opinion that such voluntary patient needs further treatment
in the psychiatric hospital or psychiatric nursing home the medical officer
shall not discharge the voluntary patient, but continue his treatment for a
period not exceeding ninety days at a time.
COMMENT
This section lays down the procedure for discharge of voluntary patient from the
psychiatric hospital or psychiatric nursing home.
PART II
ADMISSION UNDER SPECIAL CIRCUMSTANCES
21. ADMISSION OF MENTALLY ILL PERSONS UNDER CERTAIN
SPECIAL CIRCUMSTANCES-
. Any mentally ill person who does not, or is unable to, express his
willingness for admission as a voluntary patient, may be admitted and kept
as an in-patient in a psychiatric hospital or psychiatric nursing home on an
application made in that behalf by a relative or a friend of the mentally ill
person if the medical officer-in-charge is satisfied that in the interests of the
mentally ill person it is necessary so to do;
Provided that no person so admitted as an in-patient shall be kept in the
psychiatric hospital or psychiatric nursing home as an in-patient for a
period exceeding ninety days except in accordance with the other
provisions of the Act.
a. Every application under sub-section (1) shall be in the prescribed form and
be accompanied by two medical certificates, from two medical practitioners
of whom one shall be a medical practitioner in the service of Government,
to the effect that the condition of such mentally ill person is such that he
should be kept under observation and treatment as an in-patient in a
psychiatric hospital or psychiatric nursing home;
Provided that the medical officer, in charge of the psychiatric hospital or
psychiatric nursing home concerned may, if satisfied that it is proper so to
do, cause a mentally ill person to be examined by two medical practitioners
working in the hospital or in the nursing home instead of requiring such
certificates.
b. Any mentally ill person admitted under sub-section (1) or his relative or
friend may apply to the Magistrate for his discharge and the Magistrate
may, after giving notice to the person at whose instance he was admitted to
the psychiatric hospital or psychiatric nursing home and after making such
inquiry as he may deem fit either allow or dismiss the application.
c. The provisions of the foregoing sub-section shall be without prejudice to
the powers exercisable by a Magistrate before whom the case of a mentally
ill person is brought, whether under this section or under any other
provision of this Act, to pass a reception order, if he is satisfied that it is
necessary so to do in accordance with the relevant provision of this Act.
COMMENT
This section makes provision for admission of mentally ill persons to a psychiatric
hospital/nursing home, under special circumstances. No person shall however be
kept there as in-patient for a period exceeding ninety days, except in accordance
with the other provisions of this Act.
PART III
RECEPTION ORDERS
22. APPLICATION FOR RECEPTION ORDER
. An application for a reception order may be made by –
0. the medical officer-in-charge of a psychiatric hospital or psychiatric
nursing home, or
1. by the husband, wife or any other relative of the mentally ill person.
a. Where a medical officer-in-charge of a psychiatric hospital or psychiatric
nursing home in which a mentally ill- person is undergoing treatment under
a temporary treatment order is satisfied that –
0. the mentally ill person is suffering from mental disorder of such a
nature and degree that his treatment in the psychiatric hospital or as
the case may be, psychiatric nursing home is required to be
continued for more than six months, or
1. It is necessary in the interests of the health and personal safety of
the mentally ill person or for the protection of others that such
person shall be detained in a psychiatric hospital or psychiatric
nursing home.
He may make an application to the Magistrate within the local limits of
whose jurisdiction the psychiatric hospital or, as the case may be,
psychiatric nursing home is situated, for the detention of such mentally ill person
under a reception order in such psychiatric hospital or psychiatric
nursing home, as the case may be.
b. Subject to the provisions of sub-section (5), the husband or wife of a
person who is alleged to be mentally ill or, where there is no husband or
wife, or where the husband or wife is prevented by reason of any illness or
absence from India or otherwise from making the application, any other
relative of such person may make an application to the Magistrate within
the local limits of whose jurisdiction the said person ordinarily resides, for
the detention of the alleged mentally ill-person under a reception order in a
psychiatric hospital or psychiatric nursing home.
c. Where the husband or wife of the alleged mentally ill person is not the
applicant, the application shall contain the reasons for the application not
being made by the husband or wife and shall indicate the relationship of the
applicant with the alleged mentally ill person and the circumstances under
which the application is being made.
d. No person –
0. who is a minor, or
1. who, within fourteen days before the date of the application, has
not seen the alleged mentally ill person, shall make an application
under this section.
e. Every application under sub-section (3) shall be made in the prescribed
form and shall be signed and verified in the prescribed manner and shall
state whether any previous application had been made for inquiry into the
mental condition of the alleged mentally ill person and shall be
accompanied by two medical certificates from two medical practitioners of
whom one shall be a medical practitioner in the service of Government.
COMMENT
This section details the procedure for disposal of application for reception order.
23. FORM AND CONTENTS OF MEDICAL CERTIFICATES –
Every medical certificate referred to in sub-section (6) of Sec. 20 shall contain a
statement –
. that each of the medical practitioner referred to in that sub-section has
independently examined the alleged mentally ill person and has formed his
opinion on the basis of his own observations and from the particulars
communicated to him;
a. that in the opinion of each such medical practitioner the alleged mentally ill
person is suffering from mental disorder of such a nature and degree as to
warrant the detention of such person in a psychiatric hospital or psychiatric
nursing home and that such detention is necessary in the interests of the
health and personal safety of that person or for the protection of others.
COMMENTS
The section prescribes form and contents of medical certificates.
24. PROCEDURE UPON APPLICATION FOR RECEPTION ORDER
. on receipt of an application under sub-section (2) of Sec. 20, the
Magistrate may make a reception order, if he is satisfied that –
0. the mentally ill person is suffering from mental disorder of such a
nature and degree that it is necessary to detain him in a psychiatric
hospital or psychiatric nursing home for treatment; or
1. it is necessary in the interests of the mental and personal safety of
the mentally ill person or for the protection of others that he should
be so detained, and a temporary treatment order would not be
adequate in the circumstances of the case and it is necessary to
make a reception order.
a. On receipt of an application under sub-section
b. of Section.20, the Magistrate shall consider the statements made in the
application and the evidence of mental illness as disclosed by the medical
certificates.
c. If the Magistrate considers that there are sufficient grounds for proceeding
further, he shall personally examine the alleged mentally ill person unless,
for reasons to be recorded in writing, he thinks that it is not necessary or
expedient to do so.
d. If the Magistrate is satisfied that a reception order may properly be made
forthwith, he may make such order, and if the Magistrate is not so satisfied,
he shall fix a date for further consideration of the application and may make
such inquiries concerning the alleged mentally ill-person as he thinks fit.
e. The notice of the date fixed under sub-section (4) shall be given to the
applicant and to any other person to whom, in the opinion of the
Magistrate such notice shall be given.
f. If the Magistrate fixes a date under sub-section (4) for further
consideration of the application, he may make such order as he thinks fit,
for the proper care and custody of the alleged mentally ill person pending
disposal of the application.
g. On the date fixed under sub-section (4), or on such further date as may be
fixed by the Magistrate, he shall proceed to consider the application in
camera, in the presence of –
0. the applicant:
1. the alleged mentally ill person (unless the Magistrate in his
discretion otherwise directs);
2. the person who may be appointed by the alleged mentally ill person
to represent him; and
3. Such other person as the Magistrate thinks fit.
and if the magistrate is satisfied that the alleged mentally ill person,
in relation to whom the application is made, is so mentally ill that in
the interests of the health and personal safety of that person or for
the protection of others it is necessary to detail him in a psychiatric
hospital or psychiatric nursing home for treatment, he may pass a
reception order for that purpose and if he is not so satisfied, he shall
dismiss the application and any such order may provide for the
payment of the costs of the inquiry by the applicant personally or
from out of the estate of the mentally ill person, as the Magistrate
may deem appropriate.
h. If any application is dismissed under sub-section (7), the Magistrate shall
record the reasons for such dismissal and a copy of the order shall be
furnished to the applicant.
COMMENT
This section lays down the procedure for disposal of application for a reception
order.
B- Reception orders on production of mentally ill Persons before Magistrate
25. POWERS AND DUTIES OF POLICE OFFICERS IN RESPECT OF
CERTAIN MENTALLY ILL PERSONS –
. Every officer in charge of a police station –
0. may take or cause to be taken into protection any person found
wandering at large within the limits of his station whom he has
reason to believe to be so mentally ill as to be incapable of taking
care of himself, and
1. shall take or cause to be taken into protection any person within the
limits of his station whom he has reason to believe to be dangerous
by reason of mental illness.
a. No person taken into protection under sub-section (1) shall be detained by
the police without being informed, as soon as may be, of the grounds for
taking him into such protection, or where, in the opinion of the officer
taking the person into protection, such person is not capable of
understanding those grounds, without his relatives or friends, if any, being
informed of such grounds.
b. Every person who is taken into protection and detained under this section
shall be produced before the nearest Magistrate within a period of twenty-four
hours of taking him into such protection excluding the time necessary
for the journey from the place where he was taken into such protection of
the Court of the Magistrate and shall not be detained beyond the said
period without the authority of the Magistrate.
COMMENT
This section empowers the police officer in charge of a police station to take action
in respect of certain mentally ill persons.
26. PROCEDURE ON PRODUCTION OF MENTALLY ILL PERSON-
. If a person is produced before the Magistrate under sub-section (3) of
Sec.23, and if in his opinion, there are sufficient grounds for proceeding
further, the Magistrate shall –
0. examine the person to assess his capacity to understand.
1. Cause him to be examined by a medical officer, and
2. Make such inquiries in relation to such person as he may deem
necessary.
a. After the completion of the proceeding under sub-section (1), the
Magistrate may pass a reception order authorizing the detention of the said
person as an in-patient in a psychiatric hospital or psychiatric nursing home
–
0. if the medical officer certifies such person to be a mentally ill
person, and
1. if the Magistrate is satisfied that the said person is a mentally ill
person and that in the interest of the health and personal safety of
that person or for the protection of others, it is necessary to pass
such order.
Provided that if any relative or friend of the mentally ill person desires that the
mentally ill person be sent to any particular licensed psychiatric hospital or licensed
psychiatric nursing home for treatment therein and undertakes in writing to the
satisfaction of the Magistrate to pay the cost of maintenance of the mentally ill
person in such hospital or nursing home, the Magistrate shall, if the medical officer
in charge of such hospital or nursing home consents, make a reception order for
the admission of the mentally ill person into that hospital or nursing home and
detention therein;
Provided further that if any relative or friend of the mentally ill person enters into a
bond, with or without sureties for such amount as the Magistrate may determine,
undertaking that such mentally ill person will be properly taken care of and shall be
prevented from doing any injury to himself or to others, the Magistrate may,
instead of making a reception order, hand him over to the care of such relative or
friend.
COMMENT
This section lays down procedure on production of mentally ill person before a
Magistrate.
27. ORDER IN CASE OF MENTALLY ILL PERSON CRUELLY TREATED
OR NOT UNDER PROPER CARE AND CONTROL –
. Very officer in charge of a police station is mentally ill and is not under
proper care and control, or is mentally ill person, shall forthwith report the
fact to the Magistrate within the local limits of whose jurisdiction the
mentally ill person resides.
a. Any private person who has reason to believe that any person is mentally ill
and is not under proper care and control, or is ill-treated or neglected by
any relative or other person having charge of such mentally ill person, may
report the fact to the Magistrate within the local limits of whose
jurisdiction the mentally ill person resides.
b. If it appears to the Magistrate, on the report of a police officer or on the
report or information derived from any other person, or otherwise that any
mentally ill person within the local limits of his jurisdiction is not under
proper care and control, or is ill-treated or neglected by any relative or
other person having the charge of such mentally ill person, the Magistrate
may cause the mentally ill person to be produced before him, and summon
such relative or other person who is, or who ought to be in charge of, such
mentally ill person.
c. If such relative or any other person is legally bound to maintain the
mentally ill person, the Magistrate may, by order, require the relative or the
other person to take proper care of such mentally ill person and where such
relative or other person willfully neglects to comply with the said order, he
shall be punishable with fine which may extend to two thousand rupees.
d. If there is no person legally bound to maintain the mentally ill person, or if
the person legally bound to maintain the mentally ill person refuses or
neglects to maintain such person, or if, for any other reason, the Magistrate
thinks fit so to do, he may cause the mentally ill person to be produced
before him and, without prejudice to any action that may be taken under
sub -section (4), proceed in the manner provided in Sec.24 as if such
person had been produced before him under sub-section (3) of Sec. 23.
COMMENT
In case the Magistrate, within the local limits of whose jurisdiction the mentally ill
person resides, comes to know that the said mentally ill person is being ill-treated,
neglected or cruelly treated, he is empowered under this section, to pass orders
requiring the relative or other person to take care of such mentally ill person. This
section also makes provision for punishment in case of non-compliance of the
aforesaid orders.
C – Further provisions regarding admission and detention of certain mentally ill
persons.
28. ADMISSION AS IN-PATIENT AFTER INQUISITION –
If any District Court holding an inquisition under Chapter VI regarding any person
who is found to be mentally ill is of opinion that it is necessary so to do in the?
interests of such person, it may, by order, direct that such person shall be admitted
and kept as an in-patient in a psychiatric hospital or psychiatric nursing home and
every such order may be varied from time to time or revoked by the District court.
COMMENT
This section provides for admission of mentally ill person as in-patient in a
psychiatric hospital or psychiatric nursing home.
29. ADMISSION AND DETENTION OF MENTALLY ILL PPRISONER –
An order under Sec. 30 of the Prisoners Act, 1900 (3 of 1900) or under Sec. 144
of the Air Force Act, 111950 (45 of 1950), or under Sec. 145 of the Army Act
1950 (46 of 1950), or under Sec. 143 or Sec. 144 of the Navy Act, 1957 (62 of
1957), or under Sec. 330 or Sec. 335 of the Code of Criminal Procedure 1973 (2
of 1974), directing the reception of a mentally ill prisoner into any psychiatric
hospital or psychiatric nursing home, shall be sufficient authority for the admission
of such person in such hospital or, as the case may be, such nursing home or any
other psychiatric hospital or psychiatric nursing home to which such person may be
lawfully transferred for detention therein.
COMMENT
This section provides for admission of mentally ill prisoner into any psychiatric
hospital or psychiatric nursing home.
30. DETENTION OF ALLEGED MENTALLY ILL PERSON PENDING
REPORT BY MEDICAL OFFICER –
. When any person alleged to be a mentally ill person appears or is brought
before a Magistrate under Sec. 23 or Sec. 25, the Magistrate may, by order
in writing, authorize the detention of the alleged mentally ill person under
proper medical custody in an observation ward of a general hospital or
general nursing home or psychiatric hospital of psychiatric nursing home or
in any other suitable place for such period not exceeding ten days as the
Magistrate may consider necessary for enabling any medical officer to
determine whether a medical certificate in respect of that alleged mentally
ill person may properly be given under Cl. (a) of sub-section (2) of Sec.24.
a. The Magistrate may, from time to time, for the purpose mentioned in subsection
(1), by order in writing, authorize such further detention of the
alleged mentally ill person for periods not exceeding 10 day at a time as he
may deem necessary:
Provided that no person shall be authorized to be detained under this sub-section
for a continuous period exceeding thirty days in the aggregate.
COMMENTS
This section provides for detention of the alleged mentally ill person under proper
medical custody pending receipt of medical report. The period of such detention
should not exceed a period of ten days at a time and thirty days in the aggregate.
SCOPE OF THE SECTION – The provision which the Magistrate could probably
have thought of to justify his action is Sec. 16 of the Lunacy Act (since repealed by
this Act). No other provision gives him the power of detention before adjudging a
person as lunatic. Section 16(1) confers jurisdiction on a Magistrate to deal with a
person who is alleged to be lunatic when he is brought before the Magistrate under
the provisions of Sec. 13 of Sec.15. Such a person can be detained by an order of
the Magistrate, “for such time not exceeding 10 days as may be, in his opinion
necessary to enable the medical officer to determine whether such alleged lunatic is
a person in respect of whom a medical certificate may be properly given”. The
proviso to sub-section (2) imposes a ban on the Magistrate against extension of the
period of detention beyond a total period of 30 days1.
31. DETENTION OF MENTALLY ILL PERSON PENDING HIS REMOVAL
TO PSYCHIATRIC HOSPITAL OR PSYCHIATRIC NURSING HOME –
Whenever any reception order is made by a Magistrate under Sec. 22, Sec. 234 or
Sec. 25, he may by reasons to be recorded in writing, direct that he mentally ill
person in respect of whom the order is made may be detained for such period not
exceeding thirty days in such place as he may deem appropriate. Pending the
removal of such person to a psychiatric hospital or psychiatric nursing home.
COMMENT
This section empowers a Magistrate to issue directions for detention of mentally ill
person for a period not exceeding thirty days in an appropriate place, pending this
removal to psychiatric hospital or psychiatric nursing home;
D – Miscellaneous provision in relation to orders under this chapter.
32. TIME AND MANNER OF MEDICAL EXAMINATIO OF MENTALLY
ILL PATIENT –
Where any other order under this Chapter is required to be made on the basis of a
medical certificate, such order shall not be made unless the person who has signed
the medical certificate, or where such order is required to be made on the basis of
two medical certificates, the signatory of the respective certificates, has certified
that he has personally examined the alleged mentally ill person –
. in the case of an order made on an application, not earlier than ten clears
days immediately before the date on which such application is made; and
a. in any other case, not earlier than ten clear days immediately before the
date of such order;
Provided that where a reception order is required to be made on the basis of two
medical certificates such order shall not be made unless the certificates show that
the signatory of each certificate examined the alleged mentally ill person
independently of the signatory of the other certificate.
COMMENT
This section prescribes the time and manner of medical examination of mentally ill
person.
33. AUTHORITY FOR RECEPTION ORDER –
– A reception order made under this Chapter shall be sufficient authority –
. for the applicant or any person authorized by him, or
a. in the case of a reception order made otherwise than on an application, for
the person authorized so to do by the authority making this order.
To take the mentally ill person to the place mentioned in such order or for his
admission and treatment as an in-patient in the psychiatric hospital or psychiatric
nursing home specified in the order or, as the case may be, for his admission and
detention, therein or in any psychiatric hospital or psychiatric nursing home to
which he may be removed in accordance with the provisions of this Act, and the
medical officer-in-charge shall be bound to comply with such order:
Provided that in any case where the medical officer-in-charge finds
accommodation in the psychiatric hospital or psychiatric nursing home inadequate,
he shall, after according admission, intimate that fact to the Magistrate or the
District Court which passed the order and thereupon the Magistrate or the District
Court, as the case may be, shall pass such order as he or it may deem fit:
Provided further that every reception order shall cease to have effect –
b. on the expiry of thirty days from the date on which it was made, unless
within that period, the mentally ill person has been admitted to the place
mentioned therein, and
c. on the discharge, in accordance with the provisions of this Act, of the
mentally ill person,
COMMENT
This section makes provision for sufficient authority for a reception order. It shall
however, cease to have effect on the expiry of thirty days from the date of the order
or on the discharge of the mentally ill person.
34. COPY OF RECEPTION ORDER TO BE SENT TO MEDICAL OFFICERIN-
CHARGE –
Every Magistrate or District Court making a reception order shall forthwith send a
certified copy thereof together with copies of the requisite medical certificates and
the statement of particulars to the medical officer in charge of the psychiatric
hospital or psychiatric nursing home to which the mentally ill person is to be
admitted.
COMMENT
This section makes provision for supply of certified copy of reception order to
medical officer in charge of psychiatric hospital or psychiatric nursing home.
35. RESTRICTION AS TO PSYCHIATRIC HOSPITALS AND
PSYCHIATRIC NURSING HOMES INTO WHICH RECEPTION ORDER
MAY DIRECT ADMISSION
No Magistrate or District Court shall pass a reception order for the admission as
an in-patient to, or for the detention of any mentally ill person, as an in-patient to,
or for the detention of any mentally ill person, in any psychiatric hospital or
psychiatric nursing home outside the State in which the Magistrate or the District
Court exercises jurisdiction:
Provided that an order for admission or detention into or in a psychiatric hospital
or psychiatric nursing home situated in any other State may be passed if the State
Government has by general or special order and after obtaining the consent of the
Government of such other State, authorized the Magistrate or the District Court in
that behalf.
COMMENT
This section imposes restriction to the passage of reception order for admission or
detention of any mentally ill person, as an in-patient in any psychiatric hospital or
psychiatric nursing home outside the State, unless the State Government has by
general or special order authorized for the same.
36. AMMENDMENT OF ORDER OR DOCUMENT
If, after the admission of any mentally ill person to any psychiatric hospital or
psychiatric nursing home under a reception order, it appears that the order under
which he was admitted or detained or any of the documents on the basis of which
such order was made defective or incorrect, the same may, at any time thereafter
be amended with the permission of the Magistrate or the District Court, by the
person or persons who signed the same and upon such amendment being made, the
order shall have effect and shall be deemed always to have had effect as if it had
been originally made as so amended, or, as the case be, the documents upon which
it was made had been originally furnished, also amended.
COMMENT
This section makes provision for amendment of order or document in case it is
detected that any of the documents on the basis of which such order was made is
defective or incorrect.
37. POWER TO APPOINT SUBSTITUTE FOR PERSON UPON WHOSE
APPLICATION RECEPTION ORDER HAS BEEN MADE –
. Subject to the provisions of this section the Magistrate may, by order in
writing (hereinafter referred to the orders of substitution), transfer the
duties and responsibilities under this Act, of the person on whose
application a reception order was made, to any other person who is willing
to undertake the same and such other person shall thereupon be deemed for
the purposes of this Act to be the person on whose application the
reception order was made and all references in this Act to the latter person
shall be construed accordingly:
Provided that no such order of substitution shall absolve the person upon
whose application the reception order was made or, if he is dead, his legal
representatives, from any liability incurred before the date of the order of
substitution.
a. Before making any order of substitution, the Magistrate shall send a notice
to the person on whose application the reception order was made if he is
alive, and to any relative of the mentally ill person who, in the opinion of
the Magistrate, shall have notice.
b. The notice under sub-section (2) shall specify the name of the person in
whose favor it is proposed to make the order of substitution and the date
(which shall be not less than twenty days from the date of issue of the
notice) on which objections, if any, to the making of such order shall be
considered.
c. On the date specified under sub-section (3), or on any subsequent date to
which the proceedings may be adjourned, the Magistrate shall consider any
objection made by any person to whom notice was sent or by any other
relative of the mentally ill person, and shall receive all such evidence as may
be produced by or on behalf of any such person or relative and after
making such inquiry as the Magistrate may deem fit make or refrain from
making the order of substitution:
Provided that, if the person on whose application the reception order was
made is dead and any other person is willing and is, in the opinion of the
Magistrate, fit to undertake the duties and responsibilities under this Act of
the former person, the Magistrate shall, subject to the provisions contained
in the proviso to sub-section (1), make an order to that effect.
d. In making any substitution order under this section, the Magistrate shall
give preference to the person who is the nearest relative of the mentally ill
person, unless, for reasons to be recorded in writing the Magistrate
considers that giving such preference will not be in the interests of the
mentally ill person.
e. The Magistrate may make such order for the payment of the costs of an
inquiry under this section by any person or from out of the estate of the
mentally ill person as he thinks fit.
f. Any notice under sub-section (2) may be sent by post to the last known
address of the person for whom it is intended.
COMMENTS
This section empowers Magistrate to appoint substitute for a person upon whose
application reception order has been made.
Proviso – A proviso to a section is not independent of the section calling for independent
of the section calling for independent consideration or construction detached from the
construction to be placed on the main section as it is merely subsidiary to the main section
and is to be construed in the light of the section itself1.
It is settled that a proviso cannot expand or limit the clear meaning of the main provision2.
38. OFFICERS COMPETENT TO EXERCISE POWERAS AND DISCHARGE
FUNCTIONS OF MAGISTRATE UNDER CERTAIN SECTIONS –
– In any area where a Commissioner of Police has been appointed, all the powers
and functions of the Magistrate under Secs. 23,24,25 and 28 may be exercised or
discharged by the Commissioner of Police and all the functions of an officer-in charge
of a police station under this Act may be discharged by any police officer
not below the rank of an Inspector.
COMMENTS
Under the provisions of this section all the powers and functions of the Magistrate
under Secs. 23,24,25 and 28 may be exercised or discharged by the Commissioner
of Police in the area where the said office is appointed.
COMMISSIONER, IF INCLUDES “DEPUTY” OR “ASSISTANT” – It is clear
that in the present case the Deputy Commissioner who acted in the matter had no
power under Sec.17 of the Lunacy Act (since repealed by this Act). In any case, no
such power could be conferred upon him even by the State Government. Because
Lunacy Act, (since repealed by this Act) has not recognized conferment of such
power upon any Deputy or Assistant to the Commissioner1.
CHAPTER V
IN SPECTION, DISCHARGE, LEAVE OF ABSENCE AND REMOVAL
OF MENTALLY ILL PERSONS
PART I
INSPECTION
39. APPOINTMENT OF VISITORS –
. The State Government or the Central Government, as the case may be,
shall appoint for every psychiatric hospital and every psychiatric nursing
home, not less than five visitors, of whom at least one shall be a medical
officer, preferably a psychiatrist and two social workers.
a. The head of the Medical Services of the State or his nominee preferably a
psychiatrist be an ex officio visitor of all the psychiatrist hospital and
psychiatric nursing homes in the State.
b. The qualifications of persons to be appointed as visitors under sub-section
(1) and the terms and conditions of their appointment shall be such as may
be prescribed.
COMMENT
This section makes provision for appointment of visitors for every psychiatric
hospital/nursing home. The number of visitors should not be less than five, of
whom at least one should be a psychiatrist or at least a medical officer and two
social workers.
40. MONTHLY INSPECTION BY VISITORS –
Not less than three visitors shall at least once in every month, make a joint
inspection of every part of the psychiatric hospital or psychiatric nursing home in
respect of which they have been appointed and examine every minor admitted as a
voluntary patient under Sec 17 and, as far as circumstances will permit, every other
mentally ill person admitted therein and the order for the admission of and
subsequent to the joint inspection immediately preceding, and shall enter in a book
kept for that purpose such remarks as they deem appropriate in regard to the
management and condition of such hospital or nursing home and of the in-patient
thereof:
Provided that the visitors shall not be entitled to inspect any personal records of an
in-patient which in the opinion of the medical officer-in-charge are confidential in
nature:
Provided further that if any of the visitors does not participate in the joint
inspection of the psychiatric hospital or psychiatric nursing home in respect of
which he was appointed a visitor for three consecutive months, he shall cease to
hold office as such visitor.
COMMENT
This section provides for monthly joint inspection by not less than three visitors of
the psychiatric hospital/nursing home, for which they have been appointed, and for
recording their remarks in respect of the management and condition of such
hospital or nursing home and of the in-patients thereof visitors are not empowered
to inspect personal records of in-patients.
41. INSPECTION OF MENTALLY ILL PRISONERS –
. Notwithstanding anything contained in Sec. 38, where any person is
detained under the provisions of Sec. 144 of the Air Force Act, 1950 (45
of 19150), or Sec. 145 of the Army Act, 1950 (46 of 1950), or Sec. 143 or
Sec. 144 of the Navy Act 1957 (62 of 19957) or Sec. 330 or Sec. 335 of
the Code of Criminal Procedure 1973 (2 of 1974) –
0. the Inspector-General of Prisons, where such person is detained in a
jail; and
1. all or any three of the visitors including at least one social worker
appointed under sub-section (1) of Sec. 37, where such person is
detained, in a psychiatric hospital or psychiatric nursing home.
Shall, once in every three months visit such person at the place where he is
detained, in order to assess the state of mind of such person and make a
report thereon to the authority under whose order such person is so
detained.
a. The State Government may empower any of its officers to discharge all or
any of the functions of the Inspector-General of Prisons under Sub-section
(1).
b. The medical officer in charge of a psychiatric hospital or psychiatric
nursing home wherein any person referred to in sub-section (1) is detained,
shall once in every six months, make a special report regarding the mental
and physical condition of such person to the authority under whose order
such person is detained.
c. Every person who is detained in jail under the provisions of various Acts
referred to in sub-section (1) shall be visited at least once in every three
months by a psychiatrist, or where a psychiatrist is not available, by a
medical officer empowered by the state Government in this behalf and such
psychiatrist or, as the case may be, such medical officer shall make a special
report regarding the mental and physical condition of such person to the
authority under whose order such person is detained.
COMMENT
This section makes provision for inspection of mentally ill prisoners.
PART II
DISCHARGE
42. ORDER OF DISCHARGE BY MEDICAL OFFICER-IN-CHARGE –
Notwithstanding anything contained in Chapter IV., the medical officer-in-charge
of a psychiatric hospital or psychiatric nursing home may, on the recommendation
of two medical practitioners one of whom shall preferably be a psychiatrist, by
order in writing, direct the discharge of any person other than a voluntary patient
detained or undergoing treatment therein as an in-patient, and such person shall
thereupon be discharged from the psychiatric hospital or psychiatric nursing home:
Provided that no order under this sub-section shall be made in respect of a
mentally ill prisoner otherwise than as provided in Sec.30 of the Prisoner Act,
1900 (3 of 1900), or in any other relevant law.
(2) Where any order of discharge is made under sub-section (1) in respect of a
person who had been detained or is undergoing treatment as in-patient in
pursuance of an order off any authority, a copy of such hospital/nursing home.
43. DISCHARGE OF MENTALLY ILL PERSONS ON APPLICATION –
Any person detained in a psychiatric hospital or psychiatric nursing home under an
order and in pursuance of an application made under this Act, shall be discharged
on an application made in that behalf to the medical officer in charge by the person
on whose application the order was made;
Provided that no person shall be discharged under this section if the medical officer
in charge certifies in writing that the person is dangerous and unfit to be at large.
COMMENT
This section lays down that mentally ill persons be discharged on application, from
a psychiatric hospital/nursing home and that no person be discharged unless the
medical officer certifies for the same.
44. ORDER OF DISCHARGE ON THE UNDERTAKING OF RELATIVES OR
FRIENDS ETC., FOR DUE CARE OF MENTALLY ILL PERSON
. Where any relative of friend of a mentally ill person detained in a
psychiatric hospital or psychiatric nursing home under Sec. 22, Sec. 24 or
Sec. 25 desires that such person shall be delivered over to his care and
custody, he may make an application to the medical officer-in-charge who
shall forward it together with his remarks thereon to the authority under
whose orders the mentally ill person is detained.
a. where an application is received under sub-section (1), the authority shall,
on such relative or friend furnishing a bond, with or without sureties, for
such amounts as such authority may specify in this behalf, undertaking to
take proper care of such mentally ill person, and ensuring that the mentally
ill person shall be prevented from causing injury to himself or to others,
make an order of discharge and thereupon the mentally ill person shall be
discharged.
COMMENT
The section makes provision for discharge of mentally ill person from the
psychiatric hospital or psychiatric nursing home on the undertaking of relatives or
friends for due care of such mentally ill person.
45. DISCHARGE OF PERSON ON HIS REQUEST –
. Any person (not being a mentally ill prisoner) detained in pursuance of an
order made under this Act who feels that he has recovered from his mental
illness, may make an application to the Magistrate, where necessary under
the provisions of this Act, for his discharge from the psychiatric hospital or
psychiatric nursing home.
a. An application made under sub-section (1) shall be supported by a
certificate either from the medical officer in charge of the psychiatric
hospital or psychiatric nursing home where the applicant is undergoing
treatment or from a psychiatrist;
b. The Magistrate may, after making such inquiry as he may deem fit, pass an
order discharging the person or dismissing the application.
COMMENT
This section makes provision for the discharge of mentally ill person from
psychiatric hospital or psychiatric nursing home, on his request. This section does
not apply to a mentally ill prisoner.
46. DISCHARGE OF PERSON SUBSEQUENTLY FOUND ON INQUISITION
TO BE OF SOUND MIND –
If any person detained in a psychiatric hospital or psychiatric nursing home in
pursuance of a reception order made under this Act is subsequently found, on an
inquisition held in accordance with the provisions of Chapter VI, to be of sound
mind or capable of taking care of himself and managing his affairs, the medical
officer-in-charge shall forthwith, on the production of a copy of such finding duly
certified by the District Court, discharge such person from such hospital or nursing
home.
COMMENT
This section deals with the matter relating to discharge of person, detained in a
psychiatric hospital or psychiatric nursing home, subsequently found to be of
sound mind.
PART III
LEAVE OF ABSENCE
47. LEAVE OF ABSENCE
. An application for leave of absence on behalf of any mentally ill person (not
being a mentally ill prisoner) undergoing treatment as an in-patient in any
psychiatric hospital or psychiatric nursing home may be made to the
medical officer-in charge,
0. in the case of a person who was admitted on the application of the
husband or wife, by the husband or wife of such mentally ill person,
or where by reason of mental or physical illness, absence from India
or otherwise, the husband or wife is not in a position to make such
application, by any other relative of the mentally ill person duly
authorized by the husband or wife, or
1. in the case of any other person, by the person on whose application
the mentally ill person was admitted.
Provided that no application under this sub-section shall be made by a
person who has not attained the age of majority.
a. Every application under sub-section (1) shall be accompanied by a bond,
with or without sureties for such amount as the medical officer-in-charge
may specify, undertaking –
0. to take proper care of the mentally ill person,
1. to prevent the mentally ill person from causing injury to himself or
to others, and
2. to bring back the mentally ill person to the psychiatric hospital, or,
as the case may be, psychiatric nursing home, on the expiry of the
period of leave.
b. On receipt of an application under sub -section (1), the medical officers-in charge
may grant leave of absence to the mentally ill persons for such
period as the medical officers-in-charge may deem necessary and subject to
such condition as may, in the interests of the protection of others, be
specified in the order:
Provided that the total number of days for which leave of absence may be
granted to a patient under this sub-section shall not exceed sixty days.
c. Where the mentally ill persons is not brought back to the psychiatric
hospital or psychiatric nursing home on the expiry of the leave granted to
him under this section the medical officer-in-charge shall forthwith report
that fact to the Magistrate within the local limits of whose jurisdiction such
hospital or nursing home is situated and the Magistrate may, after making
such inquiry as he may deem fit, make an order directing him to be brought
back to the psychiatric hospital or psychiatric nursing home, as the case
may be,
48. GRANT OF LEAVE OF ABSENCE BY MAGISTRATE –
. Where the medical officer-in-charge refuses to grant leave of absence to a
mentally ill person under Sec. 45, the applicant may apply to the Magistrate
within the local limits of whose jurisdiction the psychiatric hospital or
psychiatric nursing home wherein the mentally ill person is detained is
situate, for the grant of leave of absence to the mentally ill person and the
Magistrate may if he is satisfied that it is necessary so to do, and on the
applicant entering into a bond in accordance with the provisions of subsection
(2), by order grant leave of absence to the mentally ill person for
such period and subject to such conditions as may be specified in the order.
a. Every bond referred to in sub-section (1) shall be with or without sureties
and for such amount as the Magistrate may decide and shall contain the
undertaking referred to in sub-section (2) of sect.45.
b. The Magistrate shall forward a copy of the order to the medical officer-in charge
and on receipt of such order the medical officer-in-charge shall
entrust the mentally ill person to the person on whose application the leave
of absence was granted under this section.
COMMENT
Sections 45 and 46 deal with the matter relating to grant of leave of
absence. Under Sec. 45 the medical officer is empowered to grant leave of
absence. In case he refuses to grant leave of absence to a mentally ill
person, Magistrate is empowered under Sec. 46 to grant leave of absence.
PART IV
REMOVAL
49. REMOVAL OF MENTALLY ILL PERSON FROM ONE PSYCHIATRIC
HOSPITAL OR PSYCHIATRIC NURSING HOME TO ANY OTHER
PSYCHIATRIC HOSPITAL OR PSYCHIATRIC NURSING HOME.
. Any mentally ill person other than a voluntary patient referred to in Sec. 15
or Sec. 16 may, subject to any general or special order of the State
Government, be removed from any psychiatric hospital or psychiatric
nursing home to any other psychiatric hospital or psychiatric nursing home
within the State, or to any other psychiatric hospital or psychiatric nursing
home in any other State with the consent of the Government of that other
State:
Provided that no mentally ill person admitted to a psychiatric hospital or
psychiatric nursing home under an order made in pursuance of an
application made under the Act shall be so removed unless intimation
thereof has been given to the applicant.
a. The State Government may make such general or special order as it thinks
fit directing the removal of any mentally ill prisoner from the place where
he is for the time being detained, to any psychiatric hospital, psychiatric
nursing home, jail or other place of safe custody in the State or to any
psychiatric hospital, psychiatric nursing home, jail or another place of safe
custody in any other State with the consent of the Government of that
other State.
COMMENT
This section permits removal of any mentally ill person from one psychiatric
hospital or psychiatric nursing home to another within the State or even to any
other State with the consent of the Government of that other State.
The provisions of this section however do not apply to a voluntary patient.
50. ADMISSION, DETENTION AND RETAKING IN CERTAIN CASES –
Every person brought into a psychiatric hospital or psychiatric nursing home under
any order made under this Act, may be detained or, as the case may be, admitted
as an in-patient therein until he is removed or is discharged under any law, and in
case of his escape from such hospital or nursing home he may, by virtue of such
order, be retaken by any police officer or by the medical officer-in-charge or any
officer or servant of such hospital or nursing home, or by any other person
authorized in that behalf by the medical officer-in-charge and conveyed to, and
received and detained or, as the case may be, kept as an in-patient in such hospital
or nursing home;
Provided that in the case of a mentally ill person (not being a mentally ill prisoner)
the power to retake as aforesaid under this section shall not be exercisable after the
expiry of a period of one month from the date of his escape.
COMMENT
This section deals with the matter relating to admission, detention or retaking of
certain mentally ill persons. This section does not apply to a mentally ill prisoner.
51. APPEAL FROM ORDERS OF MAGISTRATE
Any person aggrieved by any order of a Magistrate, passed under any of the
foregoing provisions may, within sixty days from the date of the order, appeal
against that order to the District Court within the local limits of whose jurisdiction
the Magistrate exercised the powers, and decision of the District Court on such
appeal shall be final.
COMMENT
This section empowers any person aggrieved by any order of a Magistrate to
appeal against it to the District Court.
JUDICIAL INQUISITION REGADING ALLEGED MENTALLY ILL
PERSION POSSESSING PROPERTY, CUSTODY OF HIS PERSION AND
MANAGEMENT OF HIS PROPERTY
52. APPLICATION FOR JUDICIAL INQUISITION
. Where an alleged mentally ill person is possessed of property, an
application for holding an inquisition into the mental condition of such
person may be made either –
0. by any of his relatives, or
1. by a public curator appointed under the Indian Succession Act,
1925 (39 of 1925) or
2. by the Advocate-General of the State in which the alleged mentally
ill person resides, or
3. where the property of the alleged mentally ill person comprises land
or interest in land, or where the property or part thereof is of such a
nature as can lawfully be entrusted for management to a Court of
Wards established under any law for the time being in force in the
State, by the Collector of the District in which such land is situate,
to the District Court within the local limits of whose jurisdiction the
alleged mentally ill person resides.
a. On receipt of an application under sub-section (1), the District Court shall,
by personal service or by such other mode of service as it may deem fit,
serve a notice on the alleged mentally ill person to attend at such place and
at such time as may be specified in the notice or shall, in like manner, serve
a notice on the person having the custody of the alleged mentally person to
produce such person at the said place and at the said time, for being
examined by the District Court or by any other person from whom the
District Court may call for a report concerning the mentally ill person:
Provided that, if the alleged mentally ill person is a woman, who according
to the custom prevailing in the area where she resides or according to the
religion to which she belongs, ought not to be compelled to appear in
public, the District Court may cause her to be examined by issuing a
commission as provided in the Code of Civil Procedure, 1908 (5 of 1908).
b. A copy of the notice under sub-section (2) shall also be served upon the
applicant and upon any relative of the alleged mentally ill person or other
person who, in the opinion of the District Court, shall have notice of
judicial inquisition to be held by it.
c. For the purpose of holding the inquisition applied for, the District Court
may appoint two or more persons to act as assessors.
COMMENTS
JURISDICTION – The Lunacy (Supreme Courts) Act, 1958, gives power to those Courts
to direct an inquiry as to “any person subject to the jurisdiction of the Court”. The
preamble of the Lunacy (Districts Courts) Act of the same year states that it is expedient
to make better provisions for the case of the states of lunatics “not subject to the
jurisdiction of the Supreme Courts of adjudicature”. In 1981 the Allahabad high court
decided that, under its own letters patent, it had no original jurisdiction in respect of the
persons and estates of lunatics who were natives of India. In the course of that case, the
Court ascertained from the Registrar of the original side of the Calcutta High Court that at
that date its powers in the matters of lunacy as the successor and inheritor of the powers
of the old Supreme Court were, as regards natives of India, only exercised within the
limits of the town of Calcutta itself, and that in other respects the procedure directed by
the Lunacy (District Court) Act, 1958, was followed in Lower Bengal. The Court
expressed the view that this practice was correct. The Lunacy Act, 19121 repealed both
the Acts of 1958, but made no alteration in the law with regard to the matter now under
consideration. For a person to come under that chapter he must be not subject to the
jurisdiction of a High Court, and must be resident within the jurisdiction of a District
Court. The question of jurisdiction was considered in Anila Bala Chowdhurani V.
Dhirendra Nath Saha2 where it was held that the jurisdiction of the Pabna District Court
was ousted because the alleged lunatic (an Indian) resided both at Pabna and at Calcutta,
but it is clear from that case that, but for his residence at Calcutta, the Pabna District
Court would have had jurisdiction and the original side of the Calcutta High Court would
not. In in re Taruchandra Ghosh,3 the Court held that, under Cl. 17 of the Charter, the
Court had power to appoint a guardian of an Indian infant resident outside the original
jurisdiction. The order was made ex parte on the father’s application, it being stated there
was no opposition. The attention of the Court was not drawn to 13 Geo. 3, c. 63, nor to
the cases referred to above. Moreover, the language of Cl.25 of the Charter of 1774 as
regards infants, differs from its language as regards lunatics. The original side of the
Calcutta High Court has no jurisdiction to direct an inquisition or appoint a guardian of
person or property in the case of an Indian not resident in Calcutta4.
WHAT HAS TO BE FOUND UNDER THE ACT – What has to be found under the Act
is that the person is of unsound mind and that the unsoundness of mind is such as to make
him incapable of managing his affairs. A person who is incapable of managing his affairs is
not necessarily of unsound mind and a person of unsound mind may not be incapable of
managing his affairs. The Court must hold that both unsoundness of mind and incapacity
to manage his affairs are present and that the latter is due to the former5.
DUTY OF THE COURT – It has, at the very outset to be realized that an order declaring
a person to be of unsound mind and incapable on that account of managing his affairs is an
order of a very serious character. It has the effect of disqualifying him from using his own
property in the manner he desires and placing a drastic check on his rights and privileges
which as a normal individual, he would be entitled to enjoy. In Teka Devi V. Gopal Das6,
it was observed that:
“It is, therefore, the duty of the Court before proceeding further, the determine judicially
whether the person alleged to be incapable of managing himself or his affairs, is really a
lunatic in this sense. Secondly, it must be remembered that this finding has got very far-reaching
consequences and must be given after very great care and deliberation. It may
have the immediate effect of putting a human being
d. Act 4 of 1912 repealed by Act 14 of 1987.
e. I.L.R. 48 of Cal.577
f. I.L.R. 57 Cal 535.
g. In the matter of Phanindra Chandra Set,35 C.W.N. 1045 at pp 1046-
47: A.I.R. 1932 Cal.91.
h. Sesha Ammal V.Venkatanarasimha Bhattachariar 67 M.L.J 797 at p.798;
A.I.R. 1935 Mad.91
i. A.I.R. 1930 Lah.209.
Being under restraint. It might deprive him for a time, or forever of the possession
and management of his property. It will be prima facie evidence of his lunacy, and
may be read in proof of it in other proceedings. The Legislature has, therefore, laid
down an elaborate procedure for conducting an enquiry into this matter, and this
procedure must be strictly followed. The Court cannot and ought not to deal
lightheartedly with this important question, and it should not consider itself
relieved of its responsibility by the mere circumstance that some or all the relatives
of the person concerned have declared that he is lunatic”.
The above is undoubtedly an accurate statement of the policy underlying the
precaution enjoined by the Legislature in the various provisions of the Act as a
preliminary condition to the final exercise of jurisdiction by the Court in declaring a
person as a lunatic1.
The smallest attention to the words of the Indian Lunacy Act2 whether they be the
words of Sec. 62 or the words of Sec. 38 shows this that the Legislature
appreciates that to have an inquisition into the state of health, the state of mind, the
state of property and general capacity of a person is a thing which affects that
person so prejudicially that it ought not to be taken except it be first ordered upon
a careful consideration of evidence3. It was said in a case reported in Muhammad
Yaqub V. Nazir Ahmad4: “It is true that nothing is contained in the Act itself to
direct or guide a Judge as to how he shall consider applications for an inquisition
and probably no rules exist for dealing with the matter; but ordinary commonsense
would appear to dictate to a tribunal before whom such an application comes that
care should be exercised in a painful matter of this kind, namely, an enquiry into a
man’s or woman’s state of mind; specially in the case of people in conformable
circumstances who merely wish to lead a quiet life care should be exercised that
they are not suddenly flung without sufficient reason into an elaborate inquisition
which after all is nothing more or less than a trial involving sometimes the history
of a person’s life back for many years, medical evidence, and all sorts of family
witnesses”.
INQUISITION – The Lunacy Act does not contain any procedure or permit any
procedure by which a man today can be declared to be a lunatic ten years ago in
the past5.
JURISDICTION OF THE LUNACY COURT – The jurisdiction of the Lunacy Court
depends on normal residence of the alleged lunatic and not on his temporary residence
except in the cases of the High Courts of Calcutta, Madras and Bombay where different
rules are applicable under the Charters and Letter Patent. The principles of residence are
clearly laid down by a Bench of three learned Judges consisting of Sir Ashutosh
Mookerjee, Acting Chief Justice, and Fletcher and Richardson, JJ. In Anila Bala
Choudhurani V. Dhirendra Natha Saha1. That decision is an authority on the proposition
that Sec. 38 of the Lunacy Act does not define the test to be applied to determine whether
a person is or is not subject to the jurisdiction of the High Court for the purpose of judicial
inquisition as to lunacy. But the proceedings are directed primarily against the person and
only secondarily against his property. Such authority over the person may, unless
otherwise directed by statute, be ordinarily exercised in the case of residents within the
local limits of the jurisdiction of the Court. No doubt it may also be exercised over nonresidents,
if there is statutory provision to that effect. The third proposition laid down by
this decision is that before a District Court can institute inquisition of a person possessed
of property and alleged to be a lunatic it must be established not merely that such person is
residing within the jurisdiction of that Court but also that he is not subject to the
jurisdiction of any of the High Courts mentioned in Sec. 37 of the Lunacy Act. Therefore,
in a case where an alleged lunatic is subject to the jurisdiction of a High Court under Sec.
37, the District Court has no jurisdiction under Sec. 62, even though the person may
reside within the local limits of the jurisdiction of the District Court. In other words, the
jurisdiction of the High Court and District Court are not concurrent, but the jurisdiction of
the High Court excludes that of the District Court; although if the alleged lunatic resides in
two districts, the jurisdiction of the two Courts are concurrent and not mutually
exclusive2.
PROOF OF INSANITY- The question of insanity requires a most careful examination and
it is difficult to think that bare assertion by witnesses unsupported by any details of the
cause, the course and the treatment of the malady ought to be accepted as satisfactory
proof3.
NOTICE – DIRECTING AN INQUISITION – The notice contemplated by Sec. 40 is a
notice to be drawn up after there has been an order directing an inquisition. It is notice of
such order and of the time and place at which the inquisition is to be held. It is notice of
the petition. The notice prescribed is a notice that the Court has determined to hold an
inquisition. So far as the alleged lunatic concerned, it is a most important notice. It is a
notice which tells him that he is in such a serious position that Court has determined to
enquire into his state of mind and that his liberty and his right to manage his own affairs is
now in peril by virtue of a considered judgement of a District Judge. There is nothing in
the Lunacy Act about general notices. There is a definite provision in the Lunacy Act for
notice to the lunatics and to such relatives or other persons as the District Judge may think
it desirable to give notice to. Under the Guardians and Wards Act the provision for notice
to the minor is a provision about general notice, that is to say, the notice has to be affixed
in the Court-house and a copy has to be affixed to the permanent place of residence of the
minor4.
53. ISSUES ON WHICH FINDING SHOULD BE GIVEN BY DISTRICT
COURT AFTER INQUISITION –
On completion of the inquisition, the District Court shall record its findings on –
. whether the alleged mentally ill person is in fact mentally ill or not, and
a. Where such person is mentally ill, whether he is incapable of taking care of
himself and managing his property, or incapable of managing his property
only.
COMMENT
This section empowers District Court to record its findings on certain issues.
54. PROVISION FOR APPOINTING GUARDIAN OF MENTALLY ILL
PERSON AND FOR MANAGER OF PROPERTY –
. Where the District Court records a finding that the alleged mentally ill
person is in fact mentally ill and is incapable of taking care of himself and of
managing his property, it shall make an order for the appointment of a
guarding under Sec. 53 to take care of his person and of a manager under
Sec. 54 for the management of his property.
a. Where the District Court records a finding that the alleged mentally ill
person is in fact mentally ill and is incapable of managing his property but
capable of taking care of himself, it shall make an order under Sec.54
regarding the management of his property.
b. Where the District Court records a finding that the alleged mentally ill
person is not mentally ill; it shall dismiss the application.
c. Where the District Court deems fit, it may appoint under sub-section (1)
the same person to be the guardian and manager.
COMMENT
This section makes provision for appointment of guardian of mentally ill person
and for manager or property.
55. APPOINTMENT OF GUARDIAN OF MENTALLY ILL PERSON –
. Where the mentally ill person is incapable of taking care of himself, the
District Court or, where a direction has been issued under sub-section (2)
of Sec.54, the Collector of the District, may appoint any suitable person to
be his guardian.
a. In the discharge of his functions under sub-section (1), the Collector shall
be subject to the supervision and control of the State Government or of any
authority appointed by it in that behalf
COMMENT
This section empowers the District Court or the Collector to appoint guardian of
mentally ill person.
56. APPOINTMENT OF MANAGER FOR MANAGEMENT OF PROPERTY
OF MENTALLY ILL PERSON –
. Where the property of the mentally ill person who is incapable of managing
it is such as can be taken charge of by a Court of Wards under any law for
the time being in force, the District Court shall authorize the Court of
Wards to take charge of such property, and thereupon notwithstanding
anything contained in such law, the Court of Wards shall assume the
management of such property in accordance with that law.
a. Where the property of the mentally ill person consists in whole or in part of
land or of any interest in land which cannot be taken charge of by the Court
of Wards, the District Court may, after obtaining the consent of the
Collector of the District in which the land is situate, direct the Collector to
take charge of the person and such part of the property or interest therein
of the mentally ill person as cannot be taken charge of by the Court of
Wards.
b. Where the management of the property of the mentally ill person cannot be
entrusted to the Court of Wards or to the Collector under sub-section (1)
or sub-Section (2), as the case may be, the District Court shall appoint any
suitable person to be the manager of such property.
COMMENTS
APPOINTMENT OF MANGER – There is no prohibition in the Gwalior law and the
Indian Lunacy Act (since repealed by this Act), against appointment or re-appointment of
persons already acting as managers of the estate of a person during his minority who later
on became a lunatic/mentally ill person either before or after attainment of majority1.
Since the vendor did not obtain any order from the competent Court under the Lunacy Act
(since repealed by this Act), to have him appointed as Manager of the joint family to
alienate the property, the sale is per se illegal. The sale, therefore, appears to be to defeat
the statutory right of the appellant2.
57. APPOINTMENT OF MANAGER BY COLLECTOR –
Where the property of a mentally ill person has been entrusted to the Collector by
the District Court under sub-section (2) of Sec. 54, he may, subject to the control
of the State Government or of any authority appointed by it in that behalf, appoint
any suitable person for the management of the property of the mentally ill person.
COMMENT
This section empowers the Collector to appoint manager of the property of a
mentally ill person.
58. MANAGER OF PROPERTY TO EXECUTE BOND –
Every person who is appointed as the manager of the property of a mentally ill
person by the District Court or by the Collector shall, if so, required by the
appointing authority, enter into a bond for such sum, in such form and with such
sureties as that authority may specify, to account for all receipts from the property
of the mentally ill person.
COMMENT
This section requires the manager of property to execute bond.
59. APPOINTMENT AND REMUNERATION OF GUARDIANS AND
MANAGERS –
. No person, who is the legal heir of a mentally ill person shall be appointed
under Sec. 53, 54 or 55 to be the guardian of such mentally ill person or, as
the case may be, the manager of his property unless the District Court or,
as the case may be, the Collector, for reasons to be recorded in writing,
considers that such appointment is for the benefit of the mentally ill person.
a. The guardian of a mentally ill person or the manager of the property or
both appointed under this Act shall be paid, from out of the property of the
mentally ill person, such allowance as the appointing authority may
determine.
COMMENT
This section deals with appointment and remuneration of guardians and managers.
60. DUTIES OF GUARDIAN AND MANAGER –
. Every person appointed as a guardian of a mentally ill person or manager
of his property, or of both, under this Act shall have the care of the
mentally ill person or his property or of both, and be responsible for the
maintenance of the mentally ill person and of such members of his family as
are dependent on him.
a. Where the person appointed as guardian of a mentally ill person is different
from the person appointed as the manager of his property, the manager of
his property shall pay to the guardian of the mentally ill person such
allowance as may be fixed by the authority appointing the guardian for the
maintenance of the mentally ill person and of such members of his family as
are dependent on him.
COMMENT
“FAMILY” – A married daughter living with her husband and separate from her
father is not entitled to a separate maintenance being allowed to her against her
father’s estate, when that estate is taken charge of by the Court under the
provisions of Lunatic Act (since repealed by this Act).
The word “family” includes persons living with the lunatic/mentally ill person as
members of his family, that is to say, persons actually depending upon him for them
maintenance1.
In the instant case, under the relevant Medical Rules, the father was a member of
the family of his son and was wholly dependent on him and the 2nd respondent
was thus fully entitled to reimbursement for the expenses incurred on the treatment
of his father and other travelling expenses2.
61. POWERS OF MANAGER –
. Every manager under this Act shall, subject to the provisions of this Act,
exercise the same powers in regard to the management of the property of
the mentally ill person in respect of which he is appointed as manager, as
the mentally ill person would have exercised as owner of the property had
he not been mentally ill and shall realize all claims due to the estate of the
mentally ill person and pay all debts and discharge all liabilities legally due
from that estate:
Provided that the manager shall not mortgage, create any charge on, or,
transfer by sale, gift, exchange or otherwise, any immoveable property of
the mentally ill person or lease out any such property for a period
exceeding five years, unless he obtains the permission of the District Court
in that behalf.
a. The District Court may, on an application made by the manager, grant him
permission to mortgage, Create a charge on, or, transfer by sale, gift,
exchange or otherwise, any immoveable property of the mentally ill person
or to lease out any such property for a period exceeding five years, subject
to such conditions or restrictions as that Court may think fit to impose.
b. The District Court shall cause notice of every application for permission to
be served on any relative or friend of the mentally ill person and after
considering objections, if any, received from the relative or friend and after
making such inquiries as it may deem necessary, grant or refuse permission
having regard to the interests of the mentally ill person.
COMMENT
A manager is empowered to exercise the same powers in regard to the
management of the property of the mentally ill person as the mentally ill person
would have exercised as owner of the property had he not been ill.
The manager shall, however, not mortgage, create any charge on, or, transfer by
sale, gift etc. any immoveable property without the prior permission of the District
Court.
62. 60. MANAGER TO FURNISH INVENTORY AND ANNUAL ACCOUNTS –
. Every manager appointed under this Act shall, within a period of six
months from the date of his appointment, deliver to the authority, which
appointed him, an inventory of the immoveable property belonging to the
mentally ill person and of all assets and other moveable property received
on behalf of the mentally ill person, together with a statement of all claims
due to and all debts and liabilities due by, such mentally ill person.
a. Every such manager shall also furnish to the said appointing authority
within a period of three months of the close of every financial year, an
account of the property and assets in his charge, the sums received and
disbursed on account of the mentally ill person and the balance remaining
with him.
COMMENT
Under this section manager has to furnish inventory and annual accounts in respect
of the property of the mentally ill person to the appointing authority.
63. MANAGER’S POWER TO EXECUTE CONVEYANCES UNDER
ORDERS OF DISTRICT COURT –
Every manager appointed under this Act, may, in the name and on behalf of the
mentally ill person –
. execute all such conveyance and instruments of transfers by way of sale,
mortgage or otherwise of property of the mentally ill person as may be
permitted by the District Court; and
a. Subject to the orders of the District Court, exercise all powers vested in
that behalf in the mentally ill person, in his individual capacity or in his
capacity as a trustee or as a guardian.
COMMENT
This section empowers the manager to execute conveyances in the name and on
behalf of the mentally ill person, under the orders of the District Court.
64. MANAGER TO PERFORM CONTRACTS DIRECTED BY DISTRICT
COURT –
Where the mentally ill person had, before his mental illness, contracted to sell or
otherwise dispose of his property or any portion thereof, and if such contract is, in
the opinion of the District Court, of such a nature as ought to be performed, the
District Court may direct the manager appointed under this Act to perform such
contract and to do such other acts in fulfilment of the contract as the Court
considers necessary and thereupon the manager shall be bound to act accordingly.
COMMENT
This section empowers the manager to perform contracts on behalf of the mentally
ill person as per directions of the District Court.
65. DISPOSAL OF BUSINESS PREMISES –
Where a mentally ill person had been engaged in business before he became
mentally ill, the District Court may, if it appears to be for the benefit of the
mentally ill person to dispose of his business premises, direct the manager
appointed under this Act in relation to the property of such person to sell and
dispose of such premises and to apply the sale proceeds thereof in such manner as
the District Court may direct and thereupon the manager shall be bound to act
accordingly.
COMMENT
The District Court is empowered to direct disposal of business premises of a
mentally ill person, who was engaged in business prior to becoming mentally ill, for
the benefit of the said ill person.
66. MANAGER MAY DISPOSE OF LEASES –
Where a mentally ill person is entitled to a lease or under lease, and it appears to
the manager appointed under this Act in relation to the property of such person
that it would be for the benefit of the mentally ill person to dispose of such leas or
under lease, such manager may, after obtaining the orders of the District Court,
surrender, assign or otherwise dispose of such lease or under lease to such person
for such consideration and upon such terms and conditions as the Court may
direct.
COMMENT
This section empowers manager of a mentally ill person to dispose of lease for the
benefit of the mentally ill person, after obtaining the orders of the District Court.
67. POWER TO MAKE ORDER CONCERNING ANY MATTER
CONNECTED WITH MENTALLY ILL PERSON –
The District Court may, on an application made to mentally ill person or his
property, make such order, subject to the provisions of this Chapter, in relation to
that matter as in the circumstances it thinks fit.
COMMENT
This section empowers the District Court to pass order concerning any matter
connected with mentally ill person.
68. PROCEEDING IF ACCURACY OF INVENTORY OR ACCOUNTS IS
IMPUGNED –
If any relative of the mentally ill person or the collector impugns, by a petition to
the District Court, the accuracy of the inventory or statement referred to in subsection
(1), or, as the case may be, any annual account referred to in sub-section
(2) of Sec.60, the Court may summon the manager and summarily inquire into the
matter and make such order thereon as it think fit.
Provided that the District Court may, in its discretion, refer such petition to any
Court subordinate to it, or to the Collector in any case where the manager was
appointed by the Collector and the petition is not presented by the Collector.
COMMENT
This section lays down the procedure for disposal of petition challenging accuracy
of inventory or account.
69. PAYMENT INTO PUBLIC TREASURY AND INVESTMENT OF
PROCEEDS OF ESTATE –
All sums received by a manager on account of any estate in excess of what may be
required for the current expenses of the mentally ill person or for the management
of his property, shall be paid into the public treasury on account of the estate, and
shall be invested from time to time in any of the securities specified in Sec.20 of
the Indian Trusts Act, 1882 (2 of 1982), unless the authority which appointed him,
for reasons to be recorded in writing, directs that, in the interests of the mentally ill
person such sums be otherwise invested or applied.
COMMENT
A manager of mentally ill person is required under this section, to make payment
into public treasury on account of estate.
70. RELATIVE MAY SUE FOR ACCOUNT –
Any relative of a mentally ill person may, with the leave of the District Court, sue
for an account from any manager appointed under this Act, or from any such
person after his removal from office or trust, or from his legal representative in the
case of his death, in respect of any property then or formerly under his
management or of any sum of money or other property received by him on account
of such property.
COMMENT
This section empowers relative of a mentally ill person, with the leave to the
District Court, to sue for account from any manager.
71. REMOVAL OF MANAGERS AND GUARDIANS-
. The manager of the property of a mentally ill person may, for sufficient
cause and for reasons to be recorded in writing, be removed by the
authority which appointed him and such authority may appoint a new
manager in his place.
a. Any manager removed under sub-section (1) shall be bound to deliver the
charge of all property of the mentally ill person to the new manager and to
account for all moneys received or disbursed by him.
b. The District Court may, for sufficient cause, remove any guardian of a
mentally ill person and appoint in his place a new guardian.
COMMENT
This section makes provision for removal of managers and guardians of a mentally
ill person
72. DISSOLUTION AND DISPOSAL OF PROPERTY OF PARTNERSHIP ON
A MEMBER BECOMING MENTALLY ILL –
. Where a person, being a member of a partnership firm, is found to be
mentally ill, the District Court may, on the application of any other partner
for the dissolution of partnership or on the application of any person who
appears to that Court to be entitled to seek such dissolution, dissolve the
partnership.
a. Upon the dissolution under sub-section (1), or otherwise, in due course of
law, of a partnership firm to which that sub-section applies, the manager
appointed under this Act may, in the name and on behalf of the mentally ill
person, join with the other partners in disposing of the partnership property
upon such terms, and shall do all such acts for carrying into effect the
dissolution of the partnership, as the District Court may direct.
COMMENT
This section makes provision for dissolution and disposal of property of
partnership firm when a member becomes mentally ill.
73. POWER TO APPLY PROPERTY FOR MAINTENANCE OF MENTALLY
ILL PERSON WITHOUT APPOINTING MANAGER IN CERTAIN
CASES
. Notwithstanding anything contained in the foregoing provisions, the
District Court may, instead of appointing a manager of the estate, order
that in the case of cash, the cash and in the case of any other property the
produce thereof, shall be realized and paid or delivered to such person as
may be appointed by the District Court in this behalf, to be applied for the
maintenance of the mentally ill person and of such members of his family as
are dependent on him.
a. A receipt given by the person appointed under sub-section (1) shall be valid
discharge to any person who pays money or delivers any property of the
mentally ill person to the person so appointed.
COMMENT
This section empowers the District Court to order for application/utilization of
cash and the produce of other property for maintenance of mentally ill person
without appointing a manager of the estate.
74. POWER TO ORDER TRANSFER OF STOCK, SECURITIES OR SHARES
BELONGING TO MENTALLY ILL PERSON IN CERTAIN CASES –
Where any stock or Government securities or any share in a company (transferable
within India or the dividends of which are payable therein) is or are standing in the
name of, or vested in, a mentally ill person beneficially entitled thereto, or in the
manager appointed under this Act or in a trustee for him, and the manager dies
intestate, or himself becomes mentally ill, or is out of the jurisdiction of the District
Court, or it is uncertain whether the manager is living or dead, or he neglects or
refuses to transfer the stock, securities or shares, or to receive and pay over
thereof the dividends to a new manager appointed in his place, within fourteen
days after being required by the Court to do so, then the District Court may direct
the company or Government concerned to make such transfer, or to transfer the
same, and to receive and pay over the dividends in such manner as it may direct.
COMMENT
This section empowers the District Court to pass order for transfer of stock,
securities or share belonging to mentally ill person, when the manager dies or
himself becomes mentally ill or neglects or refuses to transfer stock, securities, etc.
75. POWER TO ORDER TRANSFER OF STOCK, SECURITIES OR SHARES
OF MENTALLY ILL PERSON RESIDING OUT OF INDIA Where
any stock or Government securities or share in a company is or are standing
in the name of, or vested in, any person residing out of India, the District Court
upon being satisfied that such person has been declared to be mentally ill and that
his personal estate has been vested in a person appointed for the management
thereof, according to the law of the place where he is residing, may direct the
company or Government concerned to make such transfer of the stock, securities
or shares or of any part thereof, to or into the name of the person so appointed or
otherwise, and also to receive and pay over the dividends and proceeds, as the
District Court thinks fit.
COMMENT
This section empowers the District Court to issue directions for transfer of stock,
securities or shares of mentally ill person residing out of India.
76. POWER TO APPLY PROPERTY FOR MENTALLY ILL PERSON’S
MAINTENANCE IN CASE OF TEMPORARY MENTAL ILLNESS –
If it appears to the District Court that the mental illness of a mentally ill person is
in its nature temporary, and that it is expedient to make provision for a temporary
period, for his maintenance for the maintenance of such members of his family as
are dependent on him, the District Court may, in like manner as under Sec. 71,
direct his property or a sufficient part thereof to be applied for the purpose
specified therein.
COMMENT
The District Court is empowered, under this section, to apply property of the
mentally ill person for his maintenance in case of temporary mental illness.
77. ACTION TAKEN IN RESPECT OF MENTALLY ILL PERSON TO BE
SET ASIDE IF DISTRICT COURT FINDS THAT HIS MENTAL ILLNESS
HAS CEASED –
. Where District Court has reason to believe that any person who was found
to be mentally ill after inquisition under this Chapter has ceased to be
mentally ill, it may direct any Court subordinate to it to inquire whether
such person has ceased to be mentally ill.
a. An inquiry under sub-section (1) shall, so far as may be, conducted in the
same manner as an inquisition conducted under this Chapter.
b. If after an inquiry under this section, it is found that the mental illness of a
person has ceased, the District Court shall order all actions taken in respect
of the mentally ill person under this Act to be set aside on such terms and
conditions as that Court thinks fit to impose.
COMMENT
This section makes provision for setting aside the action taken in respect of
mentally ill person if the District Court finds that his mental illness has ceased.
78. APPEALS –
An appeal shall lie to the High Court from every order made by a District Court
under this Chapter.
COMMENT
This section makes provision for appeal in High Court from every order of the
District Court.
79. POWER OF DISTRICT COURT TO MAKE REGULATIONS –
The District Court may, from time to time, make regulations for the purpose of
carrying out the provisions of this Chapter.
COMMENT
This section empowers the District Court to make regulations for carrying out the
provisions of this Chapter.
CHAPTER VII
LIABILITY TO MEET COST OF MAINTENANCE OF MENTALLY ILL
PERSONS DETAINED IN PSYCHIATRIC HOSPITAL OR
PSYCHIATRIC NURSING HOME
80. COST OF MAINTENANCE TO BE BORNE BY GOVERNMENT IN
CERTAIN CASES –
The cost of maintenance of a mentally ill person detained as an in-patient in any
psychiatric hospital or psychiatric nursing home shall, unless otherwise provided
for by any law for the time being in force, be borne by the Government of the State
wherein the authority which passed the order in relation to the mentally ill person
is subordinate, if –
. that authority which made the order has not taken an undertaking from any
person to bear the cost of maintenance of such mentally ill person, and
a. no provision for bearing the cost of maintenance of such a District Court
under this Chapter.
COMMENT
This section makes provisions for maintenance of mentally ill person at
Government cost, in certain cases.
81. APPLICATION TO DISTRICT COURT FOR PAYMENT OF COST OF
MAINTENANCE OUT OF ESTATE OF MENTALLY ILL PERSON OR
FROM A PERSON LEGALLY BOUND TO MAINTAIN HIM –
. Where any mentally ill person detained in a psychiatric hospital or
psychiatric nursing home has an estate or where any person legally bound
to maintain such person has the means to maintain such person, the
Government liable to pay the cost of maintenance of such person under
Sec. 78 or any local authority liable to bear the cost of maintenance of such
mentally ill person under any law for the time being in force, may make an
application to the District Court within whose jurisdiction the estate of the
mentally ill person is situated or the person legally bound to maintain the
mentally ill person and having the means therefor resides, for an order
authorizing it to apply the estate of the mentally ill person to the cost of
maintenance or, as the case may be, directing the person legally bound to
maintain the mentally ill person and having the means therefor to bear the
cost of maintenance of such mentally ill person.
a. An order made by the District Court under sub-section (1) shall be
enforced in the same manner, shall have the same force and effect and be
subject to appeal, as a decree made by such Court in a suit in respect of the
property or person mentioned therein.
COMMENT
When a mentally ill person has an estate or any person legally bound to maintain
such person has means to maintain such ill person, application may be preferred to
the District Court for payment of cost of maintenance of mentally ill person.
82. PERSONS LEGALLY BOUND TO MAINTAIN MENTALLY ILL
PERSON NOT ABSOLBED FROM SUCH LIABILITY –
Nothing contained in the foregoing provisions shall be deemed to absolve a person
legally bound to maintain a mentally ill person from maintaining such mentally ill
person.
COMMENT
The provisions of the Act do not absolve person legally bound to maintain mentally
ill person from maintaining such ill person.
CHAPTER VIII
PROTECTION OF HUMAN RIGHTS OF MENTALLY ILL PERSONS
83.
0. No mentally ill person shall be subjected during treatment to any
indignity (whether physical or mental) or cruelty.
1. No mentally ill person under treatment shall be used for purposes of
research, unless –
a. such research is of direct benefit to him for purposes of diagnosis or
treatment, or
b. Such person, being a voluntary patient, has given his
consent in writing or where such person (whether or not a
voluntary patient) is incompetent, by reason of minority or
otherwise, to give valid consent, the guardian or other
person competent to give consent on his behalf, has given
his consent in writing, for such research.
2. Subject to any rules made in this behalf under Sec.94 for the
purpose of preventing vexatious or defamatory communications or
communications prejudicial to the treatment of mentally ill persons,
no letters or other communications sent by or to a mentally ill
persons under treatment shall be intercepted, detained or destroyed.
COMMENT
PENALTIES AND PROCEDURE
84. PENALTY FOR ESTABLISHMENT OR MAINTENANCE OF
PSYCHIATRIC HOSPITAL OR PSYCHIATRIC NURSING HOME IN
CONTRAVENTION OF CHAPTER III –
. Any person who establishes or maintains a psychiatric hospital or
psychiatric nursing home in contravention of the provisions of Chapter III
shall, on conviction, be punishable with imprisonment for a term which
may extend to three months, or with fine which may extend to two hundred
rupees, or with both, and in the case of a second or subsequent offence,
with imprisonment for a term which may extend to six months, or with fine
which may extend to one thousand rupees, or with both.
a. Whoever, after conviction under sub-section (1) continues to maintain a
psychiatric hospital or psychiatric nursing home in contravention of the
provisions of Chapter III shall, on conviction, be punishable with fine
which may extend to one hundred rupees, for every day after the first day
during which the contravention is continued.
COMMENT
This section makes provision for penalty for establishment or maintenance of
psychiatric hospital/nursing home in contravention of the provisions of Chapter III.
85. PENALTY FOR IMPROPER RECEPTION OF MENTALLY ILL PERSON
–
Any person who receives or detains or keeps a mentally ill person in a psychiatric
hospital or psychiatric nursing home otherwise than in accordance with the
provision of this Act, shall, on conviction, be punishable with imprisonment for a
term which may extend to two years or with fine which may extend to one
thousand rupees, or with both.
COMMENT
This section makes provision for penalty for improper reception of mentally ill
person.
86. PENALTY FOR CONTRAVENTION OF SOECS. 60 AND 69 –
Any manager appointed under this Act to manage the property of a mentally ill
person who contravenes the provisions of Sec. 60 or sub-section (2) of Sec. 69,
shall, on conviction, be punishable with fine which may extend to two thousand
rupees and may be detained in a civil prison till he complies with the said
provisions.
COMMENT
This section makes provision for penalty for contravention of the provisions of
Secs. 60 and 69.
87. GENERAL PROVISION FOR PUNISHMENT OF OTHER OFFENCES –
Any person who contravenes any of the provisions of this Act or of any rule or
regulation made thereunder, for the contravention of which no penalty is expressly
provided, in this Act, shall, on conviction, be punishable with imprisonment for a
term which may extend to six months, or with fine which may extend to five
hundred rupees, or with both.
COMMENT
This section makes general provision for punishment of other offences.
88. OFFENCES BY COMPANIES –
. Where an offence under this Act has been committed by a company, every
person who, at the time of offence was committed, was in charge of, and
was responsible to, the company for the conduct of the business of the
company, as well as the company, shall be deemed to be guilty of the
offence and shall be liable to be proceeded against and punished
accordingly:
a. Notwithstanding anything contained in sub-section (1), where an offence
under this Act has been committed by a company and it is proved that the
offence has been committed with the consent or connivance of, or is
attributable to any neglect on the part of, any director, manager, secretary
or other officer of the company, such director, manager, secretary or other
officer shall also be deemed to be guilty of that offence and shall be liable
to be proceeded against and punished accordingly.
EXPLANATION – For the purposes of this section –
b. “company” means a body corporate and includes a firm or other association
of individuals; and
c. “director”, in relation to a firm, means a partner in the firm. COMMENTS
This section deals with the offences under this Act committed by
companies.
PENAL PROVISION – Penal provision is to be construed rigidly1.
89. SANCTION FOR PROSECUTIONS
–
Notwithstanding anything contained in the Code of Criminal Procedure, 1973 (2 of
1974), no Court shall take cognizance of any offence punishable under Sec. 82,
except with the previous sanction of the licensing authority.
COMMENT
Under this section previous sanction of the licensing authority has to be obtained
for prosecutions.
90. PROVISION AS TO BONDS –
The provisions of Chapter XXXIII of the Code of Criminal Procedure, 1973 (2 of
1974) shall, as far as may be apply to bonds taken under this Act.
COMMENT
This section makes provision as to bonds taken under this Act.
91. SREPORT BY MEDICAL OFFICER –
The medical officer in-charge of a psychiatric hospital or psychiatric nursing home
shall, as soon as may be, after any mentally ill person detained therein has been
discharged make a report in respect of his mental and physical condition to the
authority under whose orders such person had been so detained.
COMMENT
This section requires the medical officer to make a report about the mental and
physical condition of the discharged person to the authority under whose orders
the mentally ill person was detained in the psychiatric hospital/nursing home.
92. PENSION, ETC. OF MENTALLY ILL PERSON PAYABLE BY
GOVERNMENT –
. Where any sum is payable in respect of pay, pension, gratuity or any
allowance to any person by any Government and the person to whom the
sum is payable is certified by a Magistrate under this Act to be a mentally ill
person, the officer under whose authority such sum would be payable, may
pay to the person having charge of the mentally ill person so much of the
said sum as he thinks fit, having regard to the cost of maintenance of such
person and may pay to such member of the family of the mentally ill person
as are dependent on him for maintenance, the surplus, if any, or such part
thereof as he thinks fit, having regard to the cost of maintenance of such
members.
a. Where there is any further surplus amount available out of the funds
specified in sub-section (1) after making payments as provided in that subsection,
the Government shall hold the same to be dealt with as follows
namely:
0. where the mentally ill person is certified to have ceased to be
mentally ill person by the District Court within the local limits of
whose jurisdiction such person resides or is kept or detains, the
whole of the surplus amount shall be paid back to that person;
1. Where the mentally ill person dies before payment, the whole of
the surplus amount shall be paid over to those of his heirs who are
legally entitled to receive the same:
2. Where the mentally ill person dies during his mental illness without
leaving any person legally entitled to succeed to his estate, the
whole of the surplus amount shall, with the prior permission of the
District Court, be utilized for such charitable purpose as may be
approved by the District Court.
b. The Central Government or the State Government, as the case may be,
shall be discharged of all liability in respect of any amount paid in
accordance with this section.
COMMENT
This section makes provision for payment of pay, pension, gratuity, etc. of
mentally ill person payable by Government.
93. LEGAL AID TO MENTALLY ILL PERSON AT STATE EXPENSE IN
CERTAIN CASES –
. Where a mentally ill person is not represented by a legal practitioner in any
proceeding under this Act before a District Court or a Magistrate and it
appears to the District Court or Magistrate that such person has not
sufficient means to engage a legal practitioner, the District Court or
Magistrate shall assign a legal practitioner to represent him at the expense
of the State.
a. Where a mentally ill person having sufficient means to engage a legal
practitioner is not represented by a legal practitioner in any proceeding
under this Act before a District Court or a Magistrate and it appears to the
District Court or Magistrate, having regard to all the circumstances of the
case, that such person ought to be represented by a legal practitioner, the
District Court, or Magistrate may assign a legal practitioner to represent
him and direct the State to bear the expenses with respect thereto and
recover the same from out of the property of such person.
b. The High Court may, with the previous approval of the State Government,
make rules providing for-
0. the mode of selecting legal practitioners for the purpose of Subsection
(1) and (2);
1. the facilities to be allowed to such legal practitioners;
2. the fees payable to such legal practitioners by the Government and
generally, for carrying out the purpose of sub-sections (1) and (2).
EXPLANATION – In this section “legal practitioner” shall have the meaning
assigned to it in Cl. (I) of Sec. 2 of the Advocates Act, 1961 (25 of 1961).
COMMENTS
This section provides for legal and to mentally ill person at State expense in certain
cases.
EXPLANATION – It is now well settled that an explanation added to a statutory provision
is not a substantive provision in any sense of the term but as the plain meaning of the word?
itself shows it is merely meant to explain or clarify certain ambiguities which may have
crept in the statutory provision1.
94. PROTECTION OF ACTION TAKEN IN GOOD FAITH –
. No suit, prosecution or other legal proceeding shall lie against any person
for anything which is in good faith done or intended to be done in
pursuance of this Act or any rules, regulations or orders made thereunder.
a. No suit or other legal proceeding shall lie against the Government for any
damage caused or likely to be caused for anything which is in good faith
done or intended to be done in pursuance of this Act or any rules,
regulations or orders made thereunder.
COMMENT
This section grants immunity from legal proceedings to persons for anything done
or intended to be done under this Act in good faith.
95. CONSTRUCTION OF REFERENCE TO CERTAIN LAWS, ETC.
. Any reference in this Act to a law which is not in force in any area shall, in
relation to that area, be construed as a reference to the corresponding law,
if any, in force in that area.
a. Any reference in this Act to any officer or authority shall, in relation to any
area in which there is no offer or authority with the same designation, be
construed as a reference to such officer or authority as may be specified by
the Central Government by notification.
COMMENTS
This section provides for construction of reference to certain laws. – In construing
social welfare legislation, the Courts should adopt a beneficent rule of construction
and in any event, that construction should be preferred which fulfils the policy of
the legislation. Construction to be adopted should be more beneficial to the
purposes in favor of and in
SOCIAL WELFARE LEGISLATION whose interest the Act has been passed1.
96. POWER OF CENTRAL GOVERNMENT AND STATE GOVERNMENT
TO MAKE RULES –
. The Central Government may, by notification, make rules providing for the
qualifications of persons who may be appointed as Mental Health Authority
under Sec. 3 and the terms and conditions subject to which they may be
appointed under that section and all other matters relating to such
authority.
a. Subject to the provisions of sub-section (1), the State Government, with
the previous approval of the Central Government may, by notification,
make rules for carrying out the provisions of this Act:
Provided that the first rules shall be made by the Central Government by
notification.
b. In particular, and without prejudice to the generality of the foregoing
power, rules made under sub-section (2) may provide for all or any of the
following maters, namely:
0. the qualifications of persons who may be appointed as Mental
Health Authority and the terms and conditions subject to which
they may be appointed under Sec. 4 and all other matters relating to
such authority;
1. The class or category of persons for whom separate psychiatric
hospitals and psychiatric nursing homes may be established and
maintained under Cl (d) of sub-section (1) of Sec. 5;
2. The form in which, –
. an application, may be made for grant or renewal of a
license and the fee payable in respect thereof under Sec. 7
or as the case may be, Sec. 9;
a. a license may be granted for the establishment or
maintenance of a psychiatric hospital or a psychiatric
nursing home under Sec.8;
b. an application may be made for a reception order under Sec.
20
3. the manner in which an order refusing to grant, or revoking, a
license shall be communicated under Sec. 8 or, as the case may be
Sec. 11;
4. the manner in which a report may be made to the licensing authority
under sub-section (2) of Sec.9;
5. the minimum facilities referred to in the proviso to sub-section (5)
of Sec. 9 including –
. psychiatrist-patient ratio;
a. other medical or para-medical staff;
b. space requirement;
c. treatment facilities; and
d. equipment:
6. the manner in which and the conditions subject to which a
psychiatric hospital or psychiatric nursing home shall be maintained
under sec. 10.
7. The form and manner in which and the period within which an
appeal against any order refusing to grant or renew a license or
revoking a license shall be preferred and the fee payable in respect
thereof under sec.12;
8. The manner in which records shall be maintained under subsection
(1) of sec.13.
9. The facilities to be provided under Sec. 14 of the treatment of a
mentally ill person as an out-patient;
10. The manner in which application for a reception order shall be
signed and verified under sub-section (6) of Sec. 20;
11. The qualification of persons who may be appointed as visitors and
the terms and conditions on which they may be appointed, under
Sec.37 and their functions.
12. Prevention of vexatious or defamatory communications and other
matters referred to in sub-section (3) of Sec.81;
13. Any other matter which is required to be, or may be, prescribed.
COMMENTS
This section empowers the Central Government and State Government to
make rules for carrying out the purposes of the legislation.
RULES OF CONSTRUCTION – It is well-settled canon of construction that the rules
made under a statute must be treated exactly as if they were in the Act and are of the same
effect as if contained in the Act. There is another principle equally fundamental to the rules
of construction, namely, that the rules shall be consistent with the provision of the Act1.
97. RULES MADE BY CENTRAL GOVERNMENT OR THE STATE
GOVERNMENT TO BE LAID BEFORE THE LEGISLATURE –
. Every rule made by the Central Government under this Act shall be laid, as
soon as may be after it is made, before each House of Parliament, while it is
in session, for a total period of thirty days which may be comprised in one
session or in two or more successive sessions, and if, before the expiry of
the session immediately following the session or the successive sessions
aforesaid, both Houses agree in making any modification in the rule or both
Houses agree that the rule should not be made, the rule shall thereafter
have effect only if such modified form or be of no effect, as the case may
be; so, however, that any such modification or annulment shall be without
prejudice to the validity of anything previously done under that rule.
a. Every rule made by the State Government under this Act shall be laid, as
soon as may be after it is made, before the State Legislature.
COMMENT
This section provides that the rules framed by the Central Government or
the State Government shall be laid before each Houses of Parliament or the
State Legislature, as the case may be.
98. EFFECT OF ACT ON OTHER LAWS –
The provisions of this Act shall have effect notwithstanding anything inconsistent
therewith contained in any other law for the time being in force and to the extent
of such inconsistency that other law shall be deemed to have no effect.
COMMENT
This section lays down that the provisions of this Act shall have effect on other
laws.
99. POWER TO REMOVE DIFFICULTY –
If any difficulty arises in giving effect to the provisions of this Act in any State, the
State Government may, by order, do anything not inconsistent with such
provisions which appears to it to be necessary or expedient for the purpose of
removing the difficulty.
Provided that no order shall be made under this section in relation to any State
after the expiry of two years from the date on which this Act comes into force in
that State.
COMMENT
This section empowers the State Government to remove difficulty.
100. REPEAL AND SAVING –
. The Indian Lunacy Act, 1912 (4 of 1912) and the Lunacy Act, 1977
[Jammu and Kashmir Act 25 of 1977 (1920 AD)] are hereby repealed.
a. Notwithstanding such repeal, anything done or any action taken under
either of the said Acts shall, in so far as such thing or action is not
inconsistent with the provisions of this Act, be deemed to have been done
or taken under the corresponding provisions of this Act and shall continue
in force until superseded by anything done or any action taken under this
Act.
COMMENT
EFFECT OF IMPLIED REPEAL – If there is a repugnancy between the two pieces of
legislation, to such an extent that both cannot stand together and operate simultaneously,
the latter will have the effect of impliedly repealing theformer1.
SAVING PROVISION – EFFECT OF – While giving effect to a saving provision, when it
provides that something which is done or issued under the repealed provision must be
treated as having been treated or issued under the newly enacted provision, an earlier
order can be saved only if such a direction or an order could be effectively and validly
made under the new provisions of law, which had repealed the earlier provisions2.
THE STATE MENTAL HEALTH RULES 1990
G.S.R. 1005 (E), DATED 29TH DECEMBER 19901 – In exercise of the powers
conferred by the proviso to sub-section (2) of Sec. 94 of the Mental Health Act
1987 (14 of 1987), read with Sec. 22 of the General Clauses Act, 1897 (10 of
1897 (10 of 1897) the Central Government hereby makes the following rules
namely:
CHAPTER I
PRELIMINARY
b. SHORT TITLE AND COMMENCEMENT –
0. These rules may be called the State Mental Health Rules, 1990.
1. They shall come into force in a State on the date of commencement
of the Act in the State.
c. DEFINITIONS
– In these rules unless the context otherwise requires –
0. “Act” means the Mental Health Act, 1987 (14 of 1987);
1. “applicant” means the person who makes an application to the
licensing authority for grant of a license;
2. “authority” means the State Mental Health Authority constituted
under Sec. 4 of the Act;
3. “Chairman” means the Chairman nominated under rule 5;
4. “Form” means Form annexed to these rules;
5. “license” means license granted under Sec. 8 of the Act;
6. “member” means a member of the Authority appointed under rule
3;
7. “membership” means membership of the Authority established
under Sec. 4 of the Act;
8. “non-official member” means a member appointed under sub-rule
(2) of rule 3;
9. “official member” means a member appointed under sub-rule (1) of
rule 3;
10. “secretary” means Secretary to the Authority appointed under rule
13;
11. words and expressions used herein and not defined but defined in
the Act shall respectively have the meanings assigned to them in the
Act.
COMMENT
“MEANS – EXPRESSION OF. – The expression “means” in a definition clause renders
the definition exhaustive of the matter defined. Where an interpretation clause defines a
word to mean a particular thing, the definition is explanatory and prima face restrictive2.
CHAPTER II
STATE MENTAL HEALTH AUTHORITY
d. CONSTITUTION OF THE AUTHORITY – The Authority shall consist
of the following members, namely;
0. Official Members:
. Secretary, Department of Health;
a. Joint Secretary, Department of Health dealing with Mental
Health;
b. Director of Health Services;
c. Medical Superintendent, Government Mental Hospital or
Head of the Department of Psychiatry, Government Medical
College and Hospital.
1. Non-official Members:
Three members including one social worker, one Clinical Psychologist and
one Medical Psychiatrist, who in the opinion of the State Government,
have special interest in the field of Mental Health.
COMMENT
This rule provides for constitution of the Authority for purpose of the
rules.
e. DISQUALIFICATION – A person shall be disqualified for being
appointed as a member or shall be removed from membership by the State
Government, if he –
0. has been convicted and sentenced to imprisonment for an offence
which in the opinion of the State Government involves moral?
turpitude; or
1. is an undischarged insolvent; or
2. is of unsound mind and stands so declared by a competent court; or
3. has been removed or dismissed from the service of the Government
or a body corporate owned or controlled by the Government.
f. CHAIRMAN –
0. The State Government may nominate any official member to act as
the Chairman of the Authority.
1. The Chairman shall cease to hold office when he ceases to be a
member of the Authority.
g. TERM OF OFFICE OF MEMBERS –
0. Every official member shall hold office as such member so long as
he holds the office by virtue of which he was so appointed.
1. Every non-official member shall hold office for a period of three
years from the date of his appointment and shall be eligible for reappointment.
2. A non-official member may at any time resign from membership of
the Authority by forwarding his letter of resignation to the
Chairman and such resignation shall take effect only from the date
on which it is accepted.
3. Where a vacancy occurs by resignation of a non-official member
under sub-section (3) or otherwise, the State Government shall fill
the vacancy by appointing from amongst category of persons
referred to in sub-rule (2) of rule 3 and the person so appointed,
shall hold office for the remainder of the term of office of the
member in whose place he was so appointed.
4. Where the term of office of any non-official member is about to
expire, the State Government may appoint a successor at any time
within three months before the expiry of the term of such member
but the successor shall not assume duty until the term of the
member expires.
CHAPTER III
PROCEEDING OF THE AUTHORITY
h. MEETINGS OF THE AUTHORITY –
0. The Authority shall ordinarily meet once in every six months at
such time and place as may be fixed by the Chairman: Provided that
the Chairman –
. may call a special meeting at any time to deal with any
urgent matter requiring the attention of the Authority.
a. shall call a special meeting if he receives a requisition in
writing signed by not less than four members and stating the
purposes for which they desire the meeting to be called.
1. The first meeting of the Authority to be held in any calendar year
shall be the annual meeting for that year.
COMMENT
PROVISO. – It is a cardinal rule of interpretation that a proviso to a particular provision of
a statute only embraces the field, which is covered by the main provision. It carves out an
exception to the main provision to which it has been enacted by the proviso and to no
other. The proper function of a proviso is to except and deal with a case which would
otherwise fall within the general language of the main enactment, and its effect is to
confine to that case. Where the language of the main enactment is explicit and
unambiguous, the proviso can have no repercussion on the interpretation of the main
enactment, so as to exclude from it, by implication what clearly falls within its express
terms. The scope of the proviso, therefore, is to carve out an exception to the main
enactment and it excludes something which otherwise would have been within the rule. It
has to operate in the same field and if the language of the main enactment is clear, the
proviso cannot be torn apart from the main enactment nor can it be used to nullify by
implication what the enactment clearly says nor set at naught the real object of the main
enactment, unless the words of the proviso are such that it is its necessary effect1.
i. SUBJECTS FOR SPECIAL MEETING – Where a meeting referred to in
the proviso to sub-rule (1) of rule 7 has been convened, only the subjects
for the considerations of which the meeting was convened, shall be
discussed.
j. SUBJECTS FOR THE ANNUAL MEETING – At the Annual Meeting of
the Authority, the following subjects shall be considered and disposed of
namely;
0. Review of the progress of implementation of the various provisions
of the Mental Health Act during the preceding one year;
1. Other business brought forward with the consent of the Chairman
or where he is absent with the consent of the Officer presiding at
the meeting.
k. PROCEDURE FOR HOLDING MEETINGS –
0. Every notice calling for meeting of the Authority shall –
. specify the place, date and hour of the meeting;
a. be served upon every member of the Authority not less than
twenty-one clear days in the case of annual meeting and
fifteen clear days in the case of other meetings before the
day appointed for the meeting.
1. The Secretary shall prepare and circulate to the members along with
the notice of the meeting, an agenda for the meeting showing the
business to be transacted.
2. A member who wishes to move a resolution on any matter included
in the agenda, shall give notice thereof to the Secretary not less
than seven days before the date fixed for the meeting.
3. A member who wishes to move any motion not included in the
agenda shall give notice thereof to the Secretary not less than
fourteen days before the date fixed for the meeting.
COMMENT
This rule lays down the procedure for holding the meetings.
l. PROCEEDINGS OF THE AUTHORITY –
0. The Chairman or in his absence any member authorized by him,
shall preside at the meetings of the Authority.
1. The quorum for the meeting of the Authority shall be four
members.
2. If within half an hour from the time appointed for holding a meeting
of the Authority, quorum is not present, the meeting shall be
adjourned to the same day in the following week at the same time
and place and the presiding officer of such meeting shall inform the
members, present and send notice to other members.
3. If at the adjourned meeting also, quorum is not present within half
an hour from the time appointed for holding the meeting the
members present shall constitute the quorum.
4. In the adjourned meeting if the Chairman is not present and no
member has been authorized to preside at such meeting, the
members present shall elect a member to preside at the meeting.
5. Each member including the Chairman shall have one vote. In the
case of an equality of votes, the Chairman or any member presiding
over such meeting, shall in addition, have a casting vote.
6. All decisions of the meeting of the Authority shall be taken by a
majority of the members present and voting.
m. APPROVAL BY CIRCULATION – Any business which may be necessary
for the Authority to transact except such as may be placed before the
annual meeting, may be carried out by circulation among all members and
any resolution so circulated and approved by a majority of members shall
be valid and binding as if such resolution had been passed at the meeting of
the Authority.
n. SECRETARY TO THE AUTHORITY –
0. The Chairman shall cause to be appointed a Secretary to the
Authority from amongst persons possessing post-graduate degree
in Psychiatric and having three years’ experience in the field of
psychiatry.
1. The Secretary shall be a full-time or part-time servant of the
Authority and shall function as the Administrative Officer of the
Authority.
2. The Secretary shall be responsible for the control and management
of office accounts and correspondence.
3. The Secretary shall attend and take notes of the proceedings of the
meeting of the Authority.
4. The Secretary shall cause to be appointed such members of the
ministerial and non-ministerial staff which are essential for efficient
functioning of the Authority.
5. The Secretary shall exercise such other powers and discharge such
other functions as may be authorized in writing by the Chairman for
the efficient functioning of the Authority.
o. FORWARDING OF COPIES OF THE PROCEEDINGS OF THE
AUTHORITY TO THE STATE GOVERNMENT –
The Secretary shall forward copies of the proceedings of the Authority to
the State Government periodically.
CHAPTER IV
LICENCE
p. APPLICATION FOR LICENCE –
0. Every application for a license under sub-section (1) or sub-section
(2) of Sec. 7 of the Act shall be –
1. made to the licensing authority in Form I or Form II as the case
maybe;
2. accompanied by a fee of rupees two hundred in the form of a bank
draft drawn in favor of the licensing authority.
q. GRANT OF LICENCE – If the licensing authority is satisfied that the
applicant fulfils the conditions laid down in Cls. (a), (b) and (c) of Sec. 8 of
the Act, it shall grant the license in Form III.
r. REFUSAL OF LICENCE AND MANNER OF COMMUNICATING
THE ORDER –
0. If the licensing authority is satisfied that the applicant does not fulfil
the conditions laid down in Sec. 8 of the Act, it may, after giving
the applicant a reasonable opportunity of being heard against the
proposed refusal of license, by order setting out the reasons therein,
refuse to grant the license.
1. Every order refusing to grant a license under Sec. 8 shall be
communicated to the applicant by sending a copy of the order by
registered post to the address given in the application.
2. A copy of the order shall also be conspicuously displayed on the
notice-board of the licensing authority.
s. APPLICATION FOR RENEWAL – Every application for renewal of a
license under sub-section (5) of Sec. 9 of the Act shall be –
0. made to the licensing authority in Form IV.
1. Accompanied by a fee of rupees one hundred in the form of a bank
draft drawn in favor of the licensing authority.
t. REFUSAL OF LICENCE –
0. If the licensing authority is satisfied that the conditions mentioned
in the proviso to sub-section (5) of Sec. 9 of the Act are not
attracted, it shall renew the license.
1. If the licensing authority is of the opinion that the license should
not be renewed in view of the fact the conditions mentioned in the
proviso to sub-section (4) of Sec. 9 are attracted, it may, after
giving the applicant a reasonable opportunity of being heard against
the proposed refusal of renewal of the license by order setting out
the reasons therein, refuse to renew the license.
2. Every order refusing to renew the license under the proviso to subsection
(5) of Sec. 9 shall be communicated to the applicant by
sending a copy of the order by registered post to the address given
in the application for renewal.
u. MANNER AND CONDITIONS OF MAINTAINING PSYCHIATRIC
HOSPITALS OR PSYCHATRIC NURSING HOMES – Every
Psychiatric hospital or nursing home shall be maintained subject to the
condition that, –
0. such hospital or nursing home is located only in an area approved
by the local authority;
1. such hospital or nursing home is located in a building constructed
with the approval of the local authority;
2. the building, where such hospital or nursing home is situated, has
sufficient ventilation and is free from any pollution which may be
detrimental to the patients admitted in such hospital or nursing
home;
3. such hospital or nursing home has enough beds to accommodate
the patient;
4. the nurses and other staff employed in such hospital or nursing
home is duly qualified and competent to handle the work assigned
to them;
5. the supervising officer-in-charge of such hospital or nursing home is
a person duly qualified having a post-graduate qualification in
Psychiatry recognized by the Medical Council of India.
v. TIME FOR APPEAL
0. any person aggrieved by the order of the licensing authority
refusing to grant or renew a license or revoking a license, may
prefer an appeal to the State Government within sixty days of the
communication of such order: Provided that the State
Government may entertain an appeal preferred after the expiry of
the period specified in sub-rule (1) if it is satisfied that the
applicant was prevented by sufficient cause from preferring the
appeal in time.
1. The appeal shall be in “Form V” and shall be sent to the State
Government by registered post or by appearing in person before
and delivering the same to the Secretary to State Government,
Department of Health or any other officer nominated by him in this
behalf.
2. Every appeal shall be accompanied with a fee of rupees five
hundred.
CHAPTER V
PSYCHIATRIC HOSPITAL AND NURSING HOME
w. MINIMUM FACILITIES FOR TREATMENT OF OUT-PATIENTS –
The minimum facilities required for every psychiatric hospital or psychiatric
nursing home for treatment of patients mentioned in Sec. 14 of the Act
shall be as follows:
0. Staff for 10 bedded hospital or nursing home –
. One full time qualified Psychiatrist.
a. One Mental Health Professional Assistant (Clinical)
Psychologist or Psychiatrist Social Worker.
b. Staff Nurses in the nurse: patient ratio 1:3
c. Attenders in the attender: patient ratio 1:5
1. Physical features – Adequate floor space depending on the number
of beds shall be provided.
2. Support/facilities – The minimum support/facilities shall be as
under: –
. Provision for emergency care for out-patient and for
handling medical emergencies for out-patients and inpatients;
a. A well-equipped Electro Convulsive Therapy facility;
b. Psychodiagnostics facilities;
c. Provision for recreational/rehabilitation activities; and
d. Facilities for regular out-patient care.
x. REVOCATION OF LICENCE –
0. Where the licensing authority is satisfied that the license of any
psychiatric hospital or nursing home is required to be revoked in
pursuance of Cl. (a) or (b) of sub-section (1) of Sec. 11 of the Act,
it may, after giving the licensee a reasonable opportunity of being
heard against the proposed revocation by order setting out the
grounds therein, revoke the license.
1. Every order revoking the license under sub-rule (1) shall be
communicated to the licensee by sending a copy of the order by
registered post to the address given in the application.
2. A copy of the order shall also be conspicuously displayed on the
notice-board of the office of the licensing authority and in the
psychiatric hospital or nursing home.
y. MAINTENANCE OF RECORDS –
Every Psychiatric hospital or a psychiatric nursing home shall maintain the
records of the treatment of patient in Form VI.
CHAPTER VI
MISCELLANEOUS
z. ADMISSION AND DETENTION IN PSYCHIATRIC HOSPITAL OR
PSYCHIATRIC NURSING HOME –
0. Application by Medical Officer-in-charge –
. The application for reception order may be made by the
Medical Officer-in-charge of a Psychiatric hospital or
Psychiatric nursing home in “Form VII” or
a. by the husband, wife or any other relative of the mentally ill
person in “Form VIII”.
1. Application from husband or wife:
. Every application by the husband or wife, relative or friend
of a person who is alleged to be mentally ill shall be
accompanied by necessary medical certificates;
a. Such application shall be signed either by the husband or
wife or relative or friend as the case may be, and verified by
two independent witnesses;
b. The name, address, occupation and other details of all the
applicants and the attesting witnesses shall be clearly given
in such application.
aa. THE QUALIFICATION AND FUNCTIONS OF THE VISITORS –
0. The qualifications of persons to be appointed as visitors under Sec.
37 of the Act shall be as follows:
. A degree in Medicine with post-graduate degree in
psychiatry awarded by any University in India recognized by
the Medical Council of India and having at least ten years’
standing in the profession, who has held/is holding the post
of Medical Superintendent/Professor in Psychiatric hospital
or psychiatric wing of a hospital; or
a. Experience as a social worker/clinical
psychologist/psychiatric nurse connected with any mental
hospital for a period of not less than ten years.
1. The visitors appointed by the Government under Sec. 37 of the Act
shall be responsible for –
. review of admission and discharge of patients;
a. inspection of the wards, outdoor patient department and
kitchen;
b. facilities to be provided;
c. suggestion for improvement; and
d. functioning as liaison officer between the Government and
hospital.
bb. LEAVE OF ABSENCE –
Every application by relative or any other person on behalf of the patient
for leave of absence under Sec. 45 of the Act shall be made in “Form IX”.
cc. INTERCEPTION OF THE LETTERS AND OTHER
COMMUNICATIONS ADDRESSED TO THE MENTALLY ILL
PERSONS –
No letter of other communication addressed to a mentally ill person
intended for delivery either through the postal department or otherwise
shall be intercepted, detained or destroyed except under following
circumstances, namely –
0. any letter or other communication intended for delivery to a
mentally ill person shall be opened only if the person having the
supervisory control over the hospital or nursing home is of the
opinion that such letter or communication contains any information
or material which if communicated to such patient will be
detrimental to his health; or
1. that the interception, detention or destruction of any letter or
communication intend to be delivered to the mentally ill person is
necessary in the interests of the public or the State.
FORM I
(See rule 15)
To
The………………………Officer,
Government……………………….
…………………………….………
Dear Sir/Madam,
I/We intend to establish/maintain a Psychiatric Hospital/Psychiatric Nursing
Home in respect of which I am/we are holding a valid license for the
establishment/maintenance of such hospital/nursing home. The details of the
hospital/nursing home are given below:
2. Name of Applicant
3. Details of license with reference to the name of the Authority issuing the
license and date.
4. Age……………….
5. Professional experience in Psychiatry
6. Permanent address of the applicant
7. Location of the proposed Hospital/Nursing Home.
8. Address of the proposed Nursing Home/Hospital
9. Proposed accommodations:
. Number of rooms
a. Number of beds
Facilities provided:
10. Out-patient
11. Emergency services
12. In-patient facilities
13. Occupational and recreational facilities
14. ECT facilities
15. X-ray facilities
16. Psychological testing facilities
17. Investigation and laboratory facilities
18. Treatment facilities.
Staff Pattern:
19. Number of Doctors
20. Number of Nurses
21. Number of Attenders
22. Others.
I am sending herewith a bank draft for Rs………………. Drawn in favor of
………………… as license fee.
I hereby undertake to abide by the rules and regulations of the Mental Health
Authority.
I request you to consider my application and grant the license for
establishment/maintenance of Psychiatric Hospital/nursing home.
Yours faithfully,
Signature………………………………….
Name ……………………………………
Date …………………………………….
FORM II
(See Rule 16)
APPLICATION FOR ESTABLISHMENT OF PSYCHIATRIC
HOSPITAL/NURSING HOME UNDER SUB SECTION (2) OF SEC. 7
To
The………………….
Government………………………….
………………………………………..
Dear Sir/Madam,
I/We intend to establish a Psychiatric Nursing Home/Psychiatric Hospital at
…………….. (mention the place). I am herewith giving you the details.
1. Name of the Applicant
2. Qualification of Medical officer to be in charge of Nursing Home/Hospital
(Certificate to be attached).
3. Age ………………….
4. Professional experience in Psychiatry
5. Permanent Address of the applicant
6. Location of the proposed Hospital/Nursing Home
7. Address of the proposed Nursing Home/Hospital
8. Proposed accommodation:
a. Number rooms,
b. Number of beds.
Facilities provided:
i. Out-patient
j. Emergency services
k. In-patient facilities
l. Occupational and recreational facilities
m. ECT facilities
n. X-ray facilities
o. Psychological testing facilities
p. Investigation and laboratory facilities
q. Treatment facilities
Staff Pattern:
r. Number of Doctors
s. Number of Nurses
t. Number of Attenders
u. Others.
I am herewith sending a bank draft for Rs…………………. drawn in favor of
…………………….. as license fee.
I hereby undertake to abide by the rules and regulations of the Mental Health Authority. I
request you to consider my application and grant license.
Yours faithfully,
Signature…………………………………
Date
………………………………………
FORM III
(See rule 16)
GRANT OF LICENCE FOR ESTABLISHMENT OF PSYCHIATRIC
HOSPITAL/NURSING HOME
I…………. being the licensing authority under the Mental Health Act, 1987, after
considering the application received under Sec. 7 and satisfying the requirements provided
for in Sec. 8 and the other provisions of the Mental Health Act, 1987 (Central Act 14 of
1987) and the rules made thereunder, hereby grant the license for
establishment/maintenance of a psychiatric hospital or nursing home in favor of
……………………. (the applicant).
2. The license shall be valid for the period commencing from……………… and ending
with………………. The license shall be subject to the conditions laid down in the Mental
Health Act, 1987 (14 of 1987) and the rules made thereunder.
Licensing Authority
Place……………
Date ………………
FORM IV
(See rule 18)
APPLICATION FOR RENEWAL OF LICENCE
SEAL
From
Dr……………………
………………………
………………………
To
District Health Officer
……………………
……………………
Sir,
Subject: Renewal of License No…………………dated…………. I request you
to kindly renew my license No………… dated the…………for the next 5 years. I
am providing the facilities as prescribed by the Act and the rules framed
thereunder. I have herewith attached a demand draft for Rs. 100 only.
Thanking you.
Yours faithfully
Signature…………………………….
Name ………………………….
Place…………………
Date………………….
FORM V
(See rule 21)
APPLICATION FOR APPEAL
To,
The Appellate Authority
Government ……………………
…………………………………
Sir,
I, Dr……………………………. of……………………………. had
applied for license for establishing a Psychiatric Nursing Home/Hospital
at……………………. (copy of the earlier application to be attached). My
application was rejected by the licensing authority as per his/her letter
No.————– Dated ————————- with the following:
1.
2.
3.
(copy enclosed)
The above reason(s) appear to be not valid. I request you to
reconsider my application. My justifications are:
4.
5.
6.
I am willing to appear before you for a personal hearing, if necessary. I am
herewith enclosing a draft for Rs. 500.
Thanking you.
Yours faithfully,
Signature………………………….
Name ……………………………
Place…………………
Date…………………
FORM VI
(See rule 24)
PROFORMA OF CASE RECORD
Name of the hospital/nursing home……………………. Patient’s
name………………………. Age……………. Sex……………. Date of
admission…………………………. date of discharge………. Mode of
admission………………………………Voluntary.
Reception order.
Complaints (report from relative/other sources)
Mental State Examination
Physical Examination
Laboratory investigations
Provisional diagnosis.
Initial treatment
Treatment and Progress notes
Clinical State and side effect Treatment
Date
Final diagnosis
Condition at discharge
Follow-up recommendations.
FORM VII
(See rule 25)
APPLICATION FOR RECEPTION ORDER
(By Medical Officer-in charge of a Psychiatric Hospital)
From
Dr……………….
To
*The Magistrate
………………………….
………………………….
Sir,
Subj: Reception order for………………………………. son/daughter of
……………………I, Dr……………………maintain psychiatric hospital/nursing
home at…………………………………. Under license No…………….
dated………………
I request you to issue reception order in respect of Sh/Smt………
son/daughter of…………… who is being treated at my hospital as a voluntary
patient and is not willing to continue. He/she has the following symptoms and/or
signs.
1.
2.
3.
4.
5.
He/She requires to be in the hospital for treatment/personal safety/others
Protection.
Thanking you.
Yours sincerely
Place………………………..
Signature…………………………….
Date:…………
Name………………………………..
o “Magistrate” means –
1. in relation to a metropolitan area within the meaning of Cl.(k) of
Sec. 2 of the Code of Criminal Procedure. 1973, a Metropolitan
Magistrate.
2. In relation to any other area, the Chief Judicial Magistrate, Sub-
Divisional Judicial Magistrate or such other Judicial Magistrate of
the first class as the State Government may, by notification,
empower to perform the functions of a Magistrate under this Act.
FORM VIII
(See rule 25)
APPLICATION FOR RECEPTION ORDER
(By relative or other)
To
…………………………
………………………..
……………………….
Sir,
Subject: Admission of ………………..son/daughter of………..into psychiatry
hospital/nursing home as in-patient.
I……………….son/daughter of……………..residing
at……………………………………request you kindly arrange for admission in
respect of Sh/Smt………………………………………………………. Aged
……………. Years ………………..son/daugher of………………………. An inpatient
To……………..(name of the hospital) or any other hospital/nursing home.
He/She has the following suggestive of mental illness.
1.
2.
3.
4.
5.
I, who is ……………..(relationship) of Sh./Smt…………………………… have an
income ……………..Rs………… and agree to pay the charges of treatment, if any of the
institution. I state that, I have/ have not made any such regard to the mental condition of
………………….as required. I herewith enclose the two medical certificates needed for
the purpose.
Witnesses:
Yours faithfully,
1. Name………………….
Signature…………………………
address………………….
Name in Capital…………….
2.Occupation……………………….
FORM IX
(See rule 27)
APPLICATION FOR LEAVE OF ABSENCE
(By relative or others)
To
Dr. —————————-
………………………..
Sir,
Subject: Request for leave of absence of
Sh/Smt……………..aged…………………..years Admitted on
………………………….to your Institute.
I request that Sh/Smt……………..son/daughter of……………. Be delivered to
my care and custody on leave of absence.
I hereby bind myself that on the said Sh/Smt…………………………………
being made over to my care and custody, I will have him here/properly taken
care of and prevent from doing injury to himself or to others.
Yours faithfully,
Signature…………………………..
Name …………………………..
THE CENTRAL MENTAL HEALTH AUTHORITY RULES 1990
G.S.R. 1004 (E) DATED 20TH DECEMBER 1990.1 – In exercise of the powers
conferred by sub-section (1) of Sec. 94 of the Mental Health Act, 1987, (14 of 1987), read
with Sec. 22 of the General Clauses Act, 1897 (10 of 1897), the Central Government
hereby makes the following rules, namely:
CHAPTER I
PRELIMINARY
1. SHORT TITLE AND COMMENCEMENT
–
1. These rules may be called the Central Mental Health Authority Rules,
1990.
2. They shall come into force on the date of commencement of the Act.
2. DEFINITIONS
– In these rules unless the context otherwise requires –
a. “Act” means the Mental Health Act, 1987 (14 of 1987);
b. “Authority” means the Central Mental Health Authority established
under Sec. 3 of the Act;
c. “Chairman” means the Chairman nominated under rule 5;
d. “Member” means member of the Authority appointed under rule 3.
e. “Membership” means the membership of the Authority established
under rule 3.
f. “Non-Official Member” means a member appointed under sub-rule
(2) of rule3;
g. “Official Member” means a member appointed under sub-rule (1) of
rule3;
h. “Secretary” means the Secretary to the Authority appointed under
rule 13;
i. words and expressions used herein and not defined but defined in
the Act shall respectively have the meaning assigned to them in the
Act.
CHAPTER II
CEMTRAL MENTAL HEALTH AUTHORITY
3. CONSTITUTION OF THE AUTHORITY
– The Authority shall consist of the following members, namely;
0. Official Member –
a. Secretary or Additional Secretary, Ministry of Health and Family
Welfare, Government of India.
b. Joint Secretary, Ministry of Health and Family Welfare dealing with
Mental Health.
c. Additional Director-General of Health Services dealing with Mental
Health.
d. Director, Central Institute of Psychiatry ,Ranchi.
e. Director, National Institute of Mental Health and Neuro Sciences,
Bangalore.
f. Medical Superintendent, Hospital for Mental diseases, Shahdara,
Delhi.
1. Non-Official Members- Three members including one social Worker, one
clinical psychologist and one Medical psychiatric who, in the opinion of the
central Government, have special interest in the field of Mental Health.
COMMENT
This rule provides that the Authority under this rule shall consist of certain official and
non-official members mentioned therein.
4. DISQUALIFICATION
– A persons shall be disqualification for being appointed as a member or shall be
removed from membership by the Central Government if he, –
. has been convicted and sentenced to imprisonment for an offence which in
the opinion of the Central Government involves moral turpitude; or
a. is an undischarged insolvent; or
b. is of unsound mind and stands so declared by a competent court, or
c. has been removed or dismissed from the Government or a body corporate
owned or controlled by the Government.
5. CHAIRMAN –
0. The Central Government may nominate any official member to act as the
Chairman of the Authority.
1. The Chairman shall cease to hold office when he ceases to be a member of
the Authority.
6. TERM OF OFFICE OF MEMBERS
–
0. Every official member shall hold office as such member so long as he holds
the office by virtue of which he was appointed.
1. Every non-official member shall hold office for a period of three years from
the date of his appointment and shall be eligible for re-appointment.
2. A non-official member may at any time resign from membership of the
Authority by forwarding his letter of resignation to the Chairman and such
resignation shall take effect only from the date on which it is accepted.
3. Where a vacancy occurs by resignation of a non-official member under sub rule
(3) or otherwise, the Central Government shall fill the vacancy by
appointing from amongst category of persons referred to in sub-clause (2)
of rule 3 and the person so appointed, shall hold office for the remainder of
the term of office of the member in whose place he was so appointed.
4. Where the term of office of any non-official member is about to expire the
Central Government may appointment a successor at any time within three
months before the expiry of the term of such member but the successor
shall not assume office until the term of the member expires.
CHAPTER III
PROCEEDINGS OF THE AUTHORITY
7. MEETINGS OF THE AUTHORITY –
0. The authority shall ordinarily meet once in every six months at such time
and place as may be fixed by the Chairman. Provided that the Chairman –
i. may call a special meeting at any time to deal with any urgent matter requiring the
attention of the Authority.
ii. Shall call a special meeting if he receives a requisition in writing
signed by not less than four members and stating the purpose for
which they desire the meeting to be called.
1. The first meeting of the Authority to be held in any calendar year shall be
the annual meeting for that year.
8. SUBJECTS FOR SPECIAL MEETING Where
a meeting referred to in the proviso to sub-rule (1) of rule 7 has been convened,
only the subjects for the consideration of which the meeting was convened, shall be
discussed.
9. SUBJECTS FOR THE ANNUAL MEETING
– At the Annual Meeting of the Authority, the following subjects shall be
considered and disposed of namely; –
0. review of the progress of implementation of the various provisions of
Mental Health Act during the preceding one year.
1. Other business on the agenda; and
2. Any other business brought forward with the consent of the Chairman or
where he is absent, with the consent of officer presiding at the meeting.
10. PROCEDURE FOR HOLDING MEETINGS
–
0. Every notice calling for a meeting of the authority shall –
. specify the place, date and hour of the meeting:
a. be served upon every member of the Authority not less than
twenty-one clear days in the case of annual meeting and fifteen clears
days in the case of other meetings before the day appointed for the
meeting.
1. The Secretary shall prepare and circulate to the members along with the
notice of the meeting an agenda for such meeting showing the business to
be transacted.
2. A member who wishes to move a resolution on any matter included in the
agenda shall give notice thereof to the Secretary not less than seven days
before the date fixed for the meeting.
3. A member who wishes to move any motion not included in the agenda shall
give notice to the Secretary not less than fourteen days before the date
fixed for the meeting.
COMMENT
This rule lays down the procedure for holding the meeting.
11. PROCEEDINGS OF THE AUTHORITY
0. The Chairman or in his absence any member authorized by him shall preside
at the meetings of the Authority.
1. The quorum for the meeting of the Authority shall be four members.
2. If within half an hour from time appointed for holding a meeting of the
Authority quorum is not present, the meeting shall be adjourned to the
same day in the following week at the same time and place and the
presiding officer of such meeting shall inform the members present and
send notice to other members.
3. If at the adjourned meeting also, quorum is not present within half an hour
from the time appointed for holding the meeting, the members present shall
constitute the quorum.
4. In the adjourned meeting if the Chairman is not present and no member has
been authorized to preside at such meeting, the members present shall elect
a member to preside at the meeting.
5. Each member including the Chairman shall have one vote. In the case of an
equality of votes, the Chairman or any member presiding over such meeting
shall in addition, have a casting vote.
6. All decisions of the meeting of the Authority shall be taken by a majority of
the members present and voting.
12. APPROVAL BY CIRCULATION
– Any business which may be necessary for the Authority to transact except as such may
be placed before the annual meeting, may be circulated and approved by a majority of
members, shall be valid and binding as if such resolution had been passed at the meeting of
the Authority.
13. SECRETARY TO THE AUTHORITY
–
0. The Chairman shall cause to be appointed a Secretary to the Authority
from amongst persons possessing post-graduate degree in psychiatry and
having three years’ experience in the field of psychiatry.
1. The Secretary shall be a full-time or part-time servant of the Authority and
shall function as the Administrative Officer of the Authority.
2. The Secretary shall be responsible for the control and management of office
accounts and correspondence.
3. The Secretary shall cause to be appointed such members of the ministerial
and non-ministerial staff which are essential for the efficient functioning of
the Authority.
4. The Secretary shall exercise such other powers and discharge such other
functions as may be authorized in writing by the Chairman for the efficient
functioning of the Authority.
14. FORWARDING OF COPIES OF THE PROCEEDINGS OF THE
AUTHORITY TO THE CENTRAL GOVERNMENT
– The Secretary shall forward copies of the proceedings of the Authority to the
Central Government periodically.
Mental health bill interview
Sagarika Ghose: Hi there. We are focusing in this show on a subject that concerns us all, mental illness. Currently 130 million Indians are diagnosed with some form of mental illness, including depression, bipolarity and schizophrenia, 90 per cent of these cases remain untreated. The government has come up with new Mental Health Bill 2012. But activists say that the bill doesn’t protect the rights of the mentally ill. Mental illness is growing in India, will the new mental health care bill help us deal with this challenge. Joining us Harsh Mander, social activist, someone who has written extensively on this new mental health care bill and someone who approves of this particular bill. Dr Nimesh Desai, psychiatrist and director the Department of Psychiatry and the Medical Superintendent at the Institute of Human Behavior and Allied Sciences. Joining us Vandana Gopikumar founder of the Banyan, it is a group that extends mental healthcare to the poor. Akhileshwar Sahay founder of Whole Mind India foundation, you have been adviser to the Delhi metro rail and you are someone who has suffered from bipolar disorder. Javed Abidi convener of disabled group, someone who is a critic of the new mental health care bill. Let’s kick it off with you Dr Desai, the scale of India’s mental problem, 130 million Indians diagnosed with some mental disorder, 90 per cent of them remaining untreated. Does this new mental bill address India’s mental health problem?
Dr Nimesh Desai: I would say briefly as you quoted quite correctly the number of people requiring treatment and those who do not get treatment. The bill attempts to do that and I think we will have to wait and see how well it does that. While the concerns of the Human rights activists and our lawyer friend about protecting the rights of the people with mental illness adequately and doing whatever we want to do correctly is.. The urgency is also about getting people into treatment, necessarily not hospitalization but getting people to treatment, and getting treatment to people who need it. Organizations like Banyan, and a number of organizations which are actively engaged with getting treatment to people. And that balance of getting treatment to people and protecting the rights while doing so is a very delicate one. And so, the need is possibly for a more continuing dialogue to ensure that we get the treatment and help to those who need it, especially the homeless mentally ill, on the streets, and the homebound mentally ill. We are talking about people with illness and how have various degrees of capacity to consent for treatment. We are not talking about depression, anxiety.
Sagarika Ghose: That is a very important point, getting the healthcare even to those who necessarily give their consent. I’m sure it is a very controversial issue though, and I am sure Javed will point to that. But let me put it to Harsh Mander, you have written that the mental healthcare bill 2012 is an exceptional state led attempt to correct many of the historical wrongs with personal with mental health illness have long been subjected to. Why do you believe this bill is such a step forward?
Harsh Mander: You know the way we have treated persons with mental illness in reality and through law is really shocking, I mean, right up to 1987 it was called the lunacy act. And I have seen even up to 1990s, in mental hospitals patients were chained, you know, given electric shock treatment, without consent, without anesthesia. People were abandoned for many years. I think what is important about this bill is that it protects, it treats with dignity people with mental illness, and I think that is very important. It tries to reverse this whole history of very savage abuse and prejudice and stigma. The most law has been against the person with mental illness; even up to the constitution it is debarring the right of the person with mental illness, so I think there is a reversal there. I will just make two quick points about my concerns…
Sagarika Ghose: Harsh just a minute, let me get Javed to respond to the point that the bill addressed the right of the mentally ill, and actually provides them a kind of dignity which hasn’t been provided before. Now, I know, you have a lot of objections about that bill, why don’t you voice them. We will put them to Harsh and then we will let him come on the reservations as well.
Javed Abidi: Well number of issues that we need to get straight. The first is that in 1995 the nation passed the disabilities act of 1995 where the nation said, for the first time said, that people with mental illness are as much as people with disabilities as anyone else. In spite of that the issue continues to remain under the Health Ministry, in spite of that the Ministry of Social Justice has not taken cognizance of the issue.
Sagarika Ghose: Let’s address the substance of the issue on the bill and the mentally ill people. Because if we get into the bureaucrats then it can be long procedure. How do you feel that this bill doesn’t protect the right of the mentally ill?
Javed Abidi: How it doesn’t protect the rights of the people with mentally illness is that it gives them rights with the left hand and takes them away with the right hand. The issue of legal capacity is still not very clear in this particular bill.
Sagarika Ghose: The involuntary admission, that someone can be admitted to a mental institute without their consent.
Javed Abidi: Without their consent and the bill supposedly talks about advanced directives, but then it also says that the advance directive can be taken away by a family member or a psychiatrist.
Sagarika Ghose: This could be misused by a family member; it could be misused by a psychiatrist.
Javed Abidi: Obviously, and then the point is that what is the point of having and advanced directive. I mean, have you ever headed such a thing that I will make a will and, in my wisdom, I don’t leave anything for my brother or sister…
Sagarika Ghose: You make a declaration that in the event of a mental illness this is how I would like to be treated.
Javed Abidi: This is how I would like to be treated or this is how I would not like to be treated. Now that is my legal capacity. If I don’t have the right to make that decision and if in spite of my advance directive, that advance directive can be taken away by a mental health professional by making an appeal to so called mental health authority.
Sagarika Ghose: Right and just to bring you to the other point I know you have been raising is bias towards the private sector.
Javed Abidi: Absolutely, and let me very quickly concise that in less than one minute. We are talking in post CRPD era. The entire world is talking about de-institutionalization, all the nations are struggling with that. And we are prompting institutionalization, in last 10 years more than 500 institutions have come up.
Sagarika Ghose: So, are you saying we don’t need institutions?
Javed Abidi: No, we certainly don’t need institutions.
Sagarika Ghose: But we need mental healthcare facilities.
Javed Abidi: We need mental healthcare facilities, more than that we need community based…
Sagarika Ghose: Right, all your objections in fact have been made into a kind of chart. The activist has objected to the fact that involuntary admissions are provided under this bill. It provides for a prior declaration of part of an individual on how they would like to be treated if they become mentally ill. It is bias towards the private sector. It doesn’t completely ban electric shocks. It promotes medicines and not therapy, and it is bias towards psychiatrists, and against patients. And it also maintains status quo on mental asylums. These are the king of broad problems that activist have pointed out in this bill. Now you are someone, Akhileshwar Sahay, who has suffered from the bipolar disorder, do you believe that at the end of the day it is family and it is people around a mentally ill person, who are the most important.
Akhileshwar Sahay: See, Sagarika, let me be very upfront. If I’m sitting here with you, it is because of my wife. For me doctor, family, therapist, exercise, everything is important. But two things for me as a patient are very important, if I have to be productive, ‘A’ my families support, ‘B’ my doctor. Because for bipolar, schizophrenia these are certain developing diseases where not taking medicines is an invitation to madness and death.
Sagarika Ghose: So, you must take medicines otherwise you will become a lunatic or you will kill yourself.
Akhileshwar Sahay: I have seen my friends, particularly younger friends who say they can manage without medicines. They try it they land in trouble; they land in the same institutes that we are talking about.
Sagarika Ghose: Let me just get in Vandana, Vandana, you know, the point Akhileshwar is making is that the end of the day the mentally ill person, someone who is suffering bipolarity, someone suffering from schizophrenia the most important person is the family. Now, illustrate to us the limits of law, you can have so many enlightened legislations, at the end of the day if there is no awareness there is no family support there is very little that the law can do.
Vandana Gopikumar: Well, Sagarika, over the past 20 years, I have catered to the needs of about 6000 people with mental health issues, both homeless and people with low socio-economic groups. Now the one thing I have heard from every single family is that, you know, the reason I haven’t sought treatment earlier because there was no one that offered medicines. So, in our country out of 640 districts we have only 123 covered by the district medical health programme. I think the most important thing that this legation aims to do, is to fix that. Especially in a mental health context, you know, with a single lens. Rights is a lot broader, if you look at access to care, access to healthcare. I think in our country where significant proportion of people live below poverty line this will be the single most bone that it offers Indian citizens.
Sagarika Ghose: So, what you are saying is that it provides for more mental healthcare facilities across the board. And the question of rights should not come here…
Vandana Gopikumar: It should be continuing care not just medical care, it should be social care, access to employment. It mandates living in the community. And it says in the exceptional circumstances where admission into an institution is inevitable in the best interest of the person, then well let’s try and facilitate it.
Sagarika Ghose: Vandana let me just get Javed quickly to respond to this.
Javed Abidi: No first of all nobody is saying that every single word or every single paragraph in this bill is all wrong. There are certain parts which are extremely good, which are progressive. So far whatever Akhileshwar has said and what ever Vandana has said I don’t seem to have a disagreement.
Sagarika Ghose: Then what exactly is your disagreement then?
Javed Abidi: The disagreement is… my question to Akhileshwar would be that when he talks of his wife, or when he talks of his family who logically would be his nominated representative…
Sagarika Ghose: Does he want to give them that kind of power that they can commit him to a mental institution without his consent.
Javed Abidi: No, Sagarika, you see, he will have to trust someone. And logically in his case that will be his wife that is not my question or objection. My question as his well-wisher is that tomorrow god forbid you don’t want a situation where some psychiatrist or a social worker can come and take away that right from his wife. So Akhileshwar in his wisdom makes her the nominated person and then tomorrow because of a disagreement with a psychiatrist or with someone, somebody takes away that right.
Sagarika Ghose: And then the mentally ill person is at the mercy of whoever exercises that right. Dr Nimesh Desai you heard Javed Abidi saying that this bill is actually very dangerous because someone could use the rights of the primary care giver and then take away the rights of the mentally ill person and send that mentally ill person without consent to a place where he or she may not want to go.
Dr Nimesh Desai: I agree with him about the potential danger for sure, I also agree with Javed Abidi about the finer details but important ones about the advance directives, specially the right of the establishment to withdraw advance directive or to change it. So there needs to be a little more emphasis, little more minute study on that. About the social justice being more relevant… what I want to say our friend Javed and to the audience is two or three positive things. One, I hope, Javed, will agree, in the last 10 or 12 years there have been a few or more than a few very good successful ethically monitored, legally approved outreach models, non-institutional, about getting access to care. That has happened and let’s build on that… the other thing I want to talk about is what Vandana said…
Javed Abidi: Again, to that extent I would agree with Dr Desai, but is it not a fact that in the last one decade alone more than 400 such private establishments have come up across the urban landscape of India. And not all of them are good success stories.
Sagarika Ghose: There is a dangerous aspect of profiteering by the private sector and the in fact abusing the rights of these mentally ill patients. So, you want to quickly come in.
Akhileshwar Sahay: Yes, Sagarika, in 1946 India had only 10,000 psychiatric beds, with all the government, private sector taken together. So, all government, private, NGO sector taken together in last 60 years we have only doubled the beds, from 10,000 to 20,000.
Sagarika Ghose: So, there is still not enough care.
Javed Abidi: So why are you talking about beds, why are you not talking about community healthcare? Now this bill says you not be chained, but in the next instant it says you will be restrained.
Sagarika Ghose: Let me get in a word from you, the fact is are we looking at mental health in a patient doctor framework. We need to look at it in family, community…
Akhileshwar Sahay: Then if we’re telling that, that means we are not reading the act. This act says that institutionalization is the last resort. And two things which are there in this act, to me it is as revolutionary as the RTI act. One the same advance directive, I can choose my nominee. Number two, if it is taken away, I have mental health commission, and it is time bound. Within 21 days mental health commission has to give its verdict.
Sagarika Ghose: Let me put to Harsh Mander, is there a danger that this bill leads to profiteering. Large number of these mental health institutions coming up; the mentally ill who can be always cared by perhaps by family, perhaps by community, for them being forcibly or their right being taken away, moved to these facilities simply to makeup these bottom lines…
Harsh Mander: That is the one concern that I really share. You know this bill talks about the right of every person and mental health to affordable care from the public system. I think it has to be free care by the public system… but the whole thing about involuntary care, there are moments in mental illness when you need to be given treatment, you know this absolutist position that nobody should ever have the right to decide if you refuse treatment, in such moments when you need to be taken care of.
Sagarika Ghose: Let me bring in Vandana, Vandana respond to the broader point the fact is that the mentally ill can’t be a reason for a rise of an industry.
Vandana Gopikumar: If you read the legislation carefully, you will see very clearly what is mandated is care in the community, in fact there are regulations and bodies the ones Akhileshwar referred to, that makes sure that people have right to appeal in case there is a wrong doing.
Javed Abidi: How much the establishment of these so-called mental health facilities is being promoted and how is it is being given to the private sector. It says you can apply on a piece of paper, without inspection you will be given registration, provisional registration. Within 10 days…
Sagarika Ghose: The government is promoting mental health facilities, it is promoting medicines, it is promoting an industry.
Javed Abidi: Without inspection. And if you are caught the only penalty is Rs 50,000. So, I mean, any person or nay organization can setup a so-called mental institution without any inspection, without any registration.
Sagarika Ghose: I’m going to give you the last word, someone who has suffered from mental illness, your last word on this bill.
Akhileshwar Sahay: The bigger issue for me is accessibility to Medicare, rehabilitation…
Sagarika Ghose: The mental transformation that this bill makes in not stigmatizing, not discriminating against the mentally ill. The numbers of mentally ill are rising; the stress is causing mental illness to rise. This is very important that mentally we all have a transformation of how we view the mentally ill… but does this bill address their rights, some believe it is an industry and some believe they provide facility. Thank you very much indeed, Harsh Mander, Dr Nimesh Desai,
Modernizing Code of Medical Ethics
Last month the American Medical Association wrapped up its annual meeting in Chicago, where it has reached the final stages of modernizing its 167-year-old Code of Medical Ethics, last updated more than 50 years ago. The central role of ethics in medicine is reflected in the fact that, at the AMA’s first meeting in 1847, it treated the establishment of a code of ethics as one of its two principal orders of business. Much in medicine has changed since 1847, but this founding document, which most physicians and patients have never seen, still offers important insights that deserve to be reaffirmed.
Spanning 15 pages, the 1847 Code of Ethics addressed just three fundamental concerns: the duties physicians and patients owe each other, physicians’ duties to each other and the profession at large, and the reciprocal duties of the profession and the public. This structure, focused on moral duties, evinces an important feature of the authors’ view of medicine. Namely, medicine is essentially a moral enterprise, grounded in mutual responsibilities, in which patients, physicians, and the public unite to serve the interests of the suffering.
In fact, the preamble to the 1847 Code of Ethics states explicitly that medical ethics “must rest on the basis of religion and morality.” Ethics is not merely a matter of consensus, and the boundaries of professional ethics are not outlined by what a particular patient or physician might happen to agree to. The fact that an employment contract or informed consent form has been signed is insufficient. Professional ethics requires loyalty to ideals that transcend any particular person or group of people. Like taking an oath, it rests on the presumption that professionals serve something higher than themselves.
The preamble to the 1847 Code also acknowledges that, in framing their code of ethics, the authors have “the inestimable advantage of deducing its rules from the conduct of many eminent physicians who have adorned the profession by their learning and piety.” It explicitly holds up the example of the “Father of Medicine,” Hippocrates, by whose conduct and writing the duties of a physician “have never been more beautifully exemplified.” The Code’s authors emphasize that these ideals are not only aspirational but achievable, having been exemplified by “many.”
The first chapter stresses the physician’s duty to answer the call of the sick, which is all the deeper and more enduring “because there is no tribunal other than the physician’s own conscience to adjudge penalties for neglect.” In other words, the Code entrusts the ethics of medical practice not to lawmakers, the courts, or hospital executives, but to the conscience of each physician. We can detect and punish violators, the Code’s authors are saying, but it is impossible to legislate goodness, whose flame must ultimately burn nowhere else but in the hearts of professionals themselves.
The first chapter also states explicitly that physicians should never abandon a patient because a case is deemed incurable. In an era obsessed with improving measurable outcomes such as length of stay and cost of care, many of today’s healthcare leaders need a reminder that a physician’s contribution cannot be fully assayed in terms of cures. Incurable does not mean hopeless, and it is always possible to care well even for those who are dying. The authors state that physicians should strive to be “ministers of hope and comfort to the sick.”
In our day of shifting insurance contracts and medical super-specialization, physicians and patients are often strangers to one another. The second chapter of the Code stresses that, as much as possible, patients should entrust their family’s care to one physician, enabling a relationship to build over time. Simply knowing a patient’s vital signs, physical examination findings, and laboratory test results is not enough. The Code’s authors recognize that good medicine requires physicians to know their patients’ life circumstances, including the families and communities of which they are a part.
In stressing that physicians should be devoted to ends beyond self, the Code also invokes gratitude on the part of patients. The services physicians render, it says, “are of such a character that no mere pecuniary acknowledgment can repay them.” What transpires between patients and physicians, in other words, is not primarily an economic exchange. Simply tending to the elements of a legal contract would not completely fulfill it. To the contrary, the intimacy and dedication at the core of a good patient-physician relationship should inspire enduring gratitude.
Today we tend to see medicine as a scientific enterprise, placing our hopes in the advancement of knowledge and technology. But in the second chapter, the Code of Ethics argues that “no scientific attainments can compensate for want of moral principles.” Everyone holds out the hope of cures for cancer and Alzheimer’s disease, but good medicine is not merely good science. Science helps us understand how to relieve suffering, but it does not explain why should want to relieve suffering in the first place. For that, we must look to ethics and such extra-scientific virtues as compassion.
Today we take for granted the mass marketing of healthcare. But the 1847 Code regards advertising as “derogatory to the dignity of the profession.” There is an important difference between advertising and educating, and the two are not always easy to distinguish from one another. One aims primarily at inducing a customer to spend money, while the other seeks mainly to serve the needs of a patient. To advertise is to make a plea for customer’s business, thereby placing the relationship on a primarily economic footing, while educating treats the dignity of the patient as primary.
This helps to explain why the Code tends to avoid terms such as payment, preferring instead the seemingly awkward formulation of “pecuniary acknowledgment.” In our day, healthcare reform has come to be understood to be about paying for healthcare, focusing primarily on questions such as who pays and how much. To the authors of the AMA’s first Code of Ethics, however, medicine is not a commodity that can be delivered from the back of a truck like a refrigerator. At its best, it much more closely resembles a friendship, a relationship that can never be bought and sold.
The third chapter of the Code declares that there is no profession that more freely dispenses charitable services than medicine. A profession is defined in part by the fact that its members aspire to something beyond money, suggesting that physicians should naturally put tending to patients ahead of the money that the provision of services might or might not generate. In fact, the opportunity to care for a patient pro bono, for good, constitutes one of the most self-defining and reinforcing activities in which professionals can engage.
In our own day, federal and state programs have led many physicians to expect to be compensated for all the care they provide. But the Code calls upon physicians always to care for individuals in indigent circumstances “cheerfully and freely.” It regards the care of the indigent not as an unfortunate burden that physicians must grin and bear, but as a positive opportunity. It is not enough merely to provide such care. It must also be done from the professional’s own free will and even cheerfully, because it is in doing so that professionals give life to what they really believe in.
Some might suppose that a medical code of ethics dating back 167 years could not possibly speak to contemporary physicians and patients. After all, such a code predates the discovery of x-rays, antibiotics, and the structure of DNA. Yet even as medical science evolves at an ever-quickening pace, the core of professional ethics remains essentially unchanged, in large part because goodness is grounded in human character. It is impossible to be a good doctor without first being a good person. As the AMA seeks to “modernize” its Code of Ethics, it would do well to return to the enduring insights of its founders.
National digital health blueprint
The national Health Policy 2017 outlines a robust framework for achieving Health for All through the adoption of the basic principles of accessibility, quality and affordability, and by leveraging the power of information and communication technologies to strengthen the healthcare delivery systems.
The historic and landmark launch of Ayushman Bharat Scheme, which is operational through a robust lT Platform, ensures cashless and paperless services covering a population of 5OO million. Health schemes such as Maternal & Child Health, NIKSHAY and others are also benefitting the patien15 with the right service delivered at the right time Leveraging the technological interventions
Digital health interventions strengthen outcorrie5 of every health service delivery programme in the country. With increased ease of use, acceptance by masses and adaptation by service providers, digital health interventions can be powerful game changers in accelerating the transformation of health agenda and in enhancing the health outcomes of the entire population of the nation.
The integration of various efforts in the ecosystem of digital health is essential for a holistic pursuit of the goals of National Health Policy 2017 and the SDGS relating to health Accordingly, the Government of India has initiated efforts for establishing a comprehensive, ‘.nation wise integrated Digital Health ecosystem through an architectural framework namely, the National Digital Health Blueprint (NDH B).
The blueprint is completely aligned with the vision of our Hon’ble Prime Minister, of India, shri Narendra Modi Ji, to provide health services to every Indian citizen. The successful implementation of NDHB would immensely benefit all Indians by lowering of out of pocket expenses and realization of Universal Health Coverage.
I appreciate the contribution of Sh. Satyanarayana and the members of Committee for their exceptional work in developing this blueprint. I request all the stakeholders to implement the blueprint and pave the way for transforming India into a Digital healthcare economy.
(Dr Harsh Vardhan)
Preface
The National Health Policy 2017 (NHP 2017) envisages the goal of attainment of the highest level of health and well‐being for all at all ages, through increasing access, improving quality and lowering the cost of healthcare delivery. The key principles of NHP 2017 include universality, citizen‐ centricity, quality of care and accountability for performance. The policy lays significant emphasis on leveraging digital technologies for enhancing the efficiency and effectiveness of delivery of all the healthcare services.
While the efforts in deploying technology for healthcare have been continuous and widespread, the benefits have been localized and fragmented. The citizen cannot access his/her health records speedily nor store them conveniently. In the absence of an integrated system, the service providers tend to create isolated medical records enhancing the burden on the citizen significantly. Health service providers in the public and private sectors do not have an aggregated and complete view of the data for providing efficient health services to the citizens. Governments, central and state alike, do not have reliable and complete data for policy analysis and evidence‐based interventions.
The need of the hour is to elevate the existing systems from providing disparate electronic services to integrated digital services. While setting specific goals for the health sector in alignment with SDG’s to be achieved over the next 5 years in vital areas such as life expectancy, IMR, MMR, TFR, immunization, malnutrition and disease control, the NHP 2017 has also prescribed such specific goals for adoption of digital technologies. These include establishing registries for all diseases of public importance and most significantly, ‘establishing Federated National Health Information Architecture, to roll‐out and link systems across public and private health providers at state and national levels and across different healthcare systems like modern medicine and AYUSH systems consistent with Metadata and Data Standards (MDDS) & Electronic Health Record (EHR)’. The policy also envisages leveraging ‘the potential of digital health for 2‐way systemic linkages between primary, secondary and tertiary care to ensure continuity of care’.
Against the above background, the committee constituted by the Health Ministry to create an implementation framework for the National Health Stack (NHS) proposed by NITI Aayog, has come up with the National Digital Health Blueprint, after surveying the global best practices in adoption of digital technologies holistically. The blueprint is not merely an ‘architectural document’. It has specific details of the building blocks required to fulfil the vision of NHP 2017 as also the institutional mechanism and an action plan for realizing digital health in a comprehensive and holistic manner. The key features of the blueprint include a federated architecture, a set of architectural principles, a 5‐layered system of architectural building blocks, Unique Health Identifier (UHID), privacy and consent management, national portability, EHR, applicable standards and regulations, health analytics and above all, multiple access channels like call centers, India Digital Health portal and MyHealth App.
The mandate of the National Digital Health Mission recommended in this report is a balanced combination of designing, developing and realizing certain pure‐play technology building blocks and the essential domain (Health) building blocks.
With a view to leverage the vast amount of knowledge and experience available in the society in this area, the Ministry undertook 2 specific exercises after the committee submitted its draft report. The draft of the NDHB Report was placed in the public domain on 15th July 2019, inviting the members of public, professionals and organizations to give their comments and suggestions by 4th August 2019. In addition, the Ministry conducted a consultation with the stakeholders on 6th August 2019.
The response to the invitation has been overwhelming. Over 300 comments and suggestions have been received from 70 organizations and individuals. The committee has analyzed all the comments and suggestions at its 11th meeting held on 5th September 2019 and decided to incorporate all the suggestions found useful in enriching the blueprint.
The major comments and suggestions have been in relation to elaborating and / or bringing clarity in the areas of federated architecture, privacy, consent management, data protection, role of the state governments, involving NGOs, capacity building and change management, and the implementation timelines. There have been numerous suggestions in operational areas, which are relevant and useful during the implementation phase, and may be passed on to the proposed National Digital Health Mission on its constitution.
The report has improved vastly due to the consultation processes, as several of the suggestions have made a qualitative difference to the usability, feasibility and acceptability of the report. The committee gratefully acknowledges the interest shown by the respondents in providing very valuable inputs. The NDHB is to be considered as a living document. There is scope for further improvement over the next few years.
The National Digital Health Blueprint keeps the overall vision of NHP 2017 in perspective and recommends a pragmatic agenda to start with, adopting the principle of ‘Think Big, Start Small, Scale Fast’. It forms the foundation on which the edifice of an entire National Digital Health Eco‐system can be built in a phased manner.
I wish to acknowledge the contribution made by all the members of the Committee and several other experts who have enriched the discussions.
J Satyanarayana (Chairman of the Committee)
NEW MENTAL HEALTH BILL BANS ELECTRIC SHOCKS, GIVES RIGHT TO TREATMENT
New Delhi: The right of mentally-ill patients to decide their mode of treatment, decriminalizing suicide for them and a ban on electric shock treatment without anesthesia are some of the progressive provisions of the new mental health bill proposed by the Indian government.
“The bill was passed by the union cabinet last week,” Health Secretary K Desiraju told IANS.
Once passed by the parliament, the bill will repeal the Mental Health Act, 1987.
If passed, it will make access to mental healthcare a right for all. Also, such services would be affordable, of good quality and available without discrimination.
An estimated 10-12 million or one to two per cent of the population suffers from severe mental disorders such as schizophrenia and bipolar disorder and nearly 50 million or five per cent from common mental disorders such as depression and anxiety, yielding an overall estimate of 6.5 per cent of the population.
Keeping in mind the rising number of people suffering from mental ailments, the new bill aims at introducing progressive and far-sighted steps for patients, a senior health official told IANS.
“If a person has given an advance directive to the state that he or she should not be admitted to a facility without consent, it will be heeded to,” the official said.
This was proposed keeping in mind that a person can be branded mentally ill by family members in property or marital disputes.
The official said the 1987 Act had vested extraordinary powers in treating psychiatrists. The bill now states that an individual can himself or herself take a call on the treatment.
Psychiatrists, however, feel that by giving powers to a mentally-ill patient to decide on the course of treatment would put him at risk.
“A patient in a psychotic phase or a mentally-ill person doesn’t have the judgmental capacity to decide what is good or bad for him or her. So, trusting that person to make the correct choice in such circumstances might be risky,” Dr Samir Malhotra, head of the department of psychiatry at the Max hospitals, told IANS.
He further said that the bill would significantly reduce the powers of the doctors in deciding the patients’ well-being.
The bill also provides the right to confidentiality and protection from cruel, inhuman and degrading treatment, in addition to the right to live in a community. Legal aid will also be extended to them.
It bans the electric-convulsive therapy or the electric shock treatment without anesthesia and restricts psychosurgery.
Under the provisions of the bill, the government has an obligation to provide halfway homes, community caring centers and other shelters for mentally-ill people. Halfway homes, common in the western world, are for those patients who have recovered but need 24-hour monitoring and rehabilitation.
It also envisages a mental health review commission, which will review all admissions in mental health institutions beyond 30 days.
The commission would be a quasi-judicial body to oversee the functioning of mental health facilities and protect the rights of persons with mental illness in these facilities.
The bill also proposes to provide free care to all homeless, destitute and poor people suffering from mental disorders.
Trying to address the needs of the families, caregivers and those of homeless mentally ill people, the new legislation provides for setting up central and state mental health authorities, which would act as administrative bodies.
The bill decriminalizes suicide for mentally ill patients.
Reacting to this provision, Dr Malhotra said: “In certain circumstances it can help, as police action is sometimes cumbersome, but it can also not be denied that criminalizing suicide had acted as a deterrent in some cases”.
Under the Indian Penal Code, suicide is a criminal act and a person can be jailed for at least one to three years.
The Indian government had launched the National Mental Health Programme (NMHP) in 1982, keeping in view the heavy burden of mental illness in the community, and the absolute inadequacy of mental healthcare infrastructure in the country to deal with it.
According to eminent psychologist Aruna Broota, many Indian mental facilities and institutions are in a pathetic state and need to show a sympathetic attitude towards these people.
“The situation is slightly better in south India than in north India, but generally the condition of these facilities is very bad,” she told IANS.
“One can have as many fancy bills and laws you want. But ultimately, it is us the society that has to accept that mental disorder is like any disease and we need to accept this,” she added.
NMC act and controversies
Lot of controversies have been heard of about scrapping of MCI and introduction of NMC. Introduction of NMC is just not about the change of name but the whole system. There are many wrong self-created misconceptions that has been deliberately circulated through social media to form public opinion based not upon facts but upon some misleading documents and ready to post letters. One of the wrong perceptions that NMC will be controlled by Non-Medicos. In reality out of the total 20 members, 13 are from medical fraternity including the 5 most important persons (Chairman and 4 Presidents of the Boards). What is wrong if there is representation from Allied fields like Health Research, Pharmaceutical, Civil Society, Finance & Law. Only there will be one or two bureaucrats from MOHFW. Another point raised is about the selection procedure of the members of NMC. It’s true that none of the members in NMC will be elected democratically but will be selected by a High-Powered Selection & Search committee. Everything that is democratic like the present MCI need not be taken as granted that it will function optimally without corruption. All the members of Parliament and that of the State Assemblies are also elected democratically, but does that mean that all of them are honest and efficient. In fact, when people are selected, there are more chances of getting efficient people rather than in election where only numbers matter. Profiteering by allowing private colleges to charge fees as per their whim was another allegation against NMC. The truth is that NMC will prescribe norms for determination of fees for a proportion of seats not exceeding 40% in private medical colleges. My further contention is that under the present MCI was there any norm for fee fixation for any proportion of seats in private medical institutes. Govt. control on medical associations is another baseless allegation against the proposed NMC Bill whereas in reality nothing has been mentioned about this aspect in the bill. Last but not the least is the objection regarding National Licentiate Examination. Let us first try to understand why it is needed to the same extent as NEET. If NEET is implemented in proper spirit, it will filter out the undeserved students from getting admitted in Private Medical Institutes in India, But the story does not end there. It is true that the exit exam in each Term is governed by the respective Universities but many universities least bother about how students write their theory exams. In many private medical colleges, the college authority themselves arrange full scale malpractice in theory exam. What can be expected from such students passing out from such medical colleges. When students will have to mandatorily sit in a centrally controlled uniform Medical Licentiate Exam, it will in the long run change their mindset that there is no use in clearing university exam by unfair means as those students are going to get exposed in the Medical Licentiate Exam. Moreover, merit list will be prepared based on the results of this exam for PG admissions and those not featuring in merit list but having the minimum qualifying marks w NMC
The Health Ministry has moved a Cabinet note on the Bill seeking to replace apex medical education regulator Medical Council of India (MCI) with a new and transparent body, the National Medical Commission (NMC). The note was moved this Wednesday after a Group of Ministers (GoM) headed by Finance Minister approved the draft Bill enabling forward movement in the area of medical education reform which began last year with the introduction of National Eligibility-cum-Entrance Test (NEET) for undergraduate and postgraduate admissions. The National Medical Commission (NMC) Bill, 2017, sent for inter-ministerial consultations now, seeks to subsume the MCI in the commission which will have four autonomous boards tasked with conducting undergraduate and postgraduate education, assessing and rating medical institutions, registering practitioners and enforcing medical ethics. A revolutionary aspect of this Bill is an exit examination which all MBBS graduates will have to clear to get practicing licenses. Called the National Licentiate Examination, it will be compulsory for medical graduates to clear for the purpose of grant of license to practice and enrolment in Medical Register(s). The idea is to test the quality of the medical graduate. This exam will also be used as NEET for postgraduate admissions, once the law takes force. As of today, CBSE conducts NEET UG and NEET PG for the purpose of medical admissions. The new Bill contains an important diversion (from the original draft a NITI Aayog expert panel prepared earlier this year) the GoM is learnt to have allowed in respect of the manner of selection of NMC members. The original NMC Bill which a NITI Aayog committee headed by its vice-chairman drafted, argued against elections to pick members of the commission. This argument was in sync with the 92nd report of the Parliamentary Standing Committee on Health, which, while recommending the scrapping of MCI, castigated the MCI for electing its members. The committee said: “MCI system where the regulated elect the regulators is flawed.” The new NMC Bill cleared by the GoM is learnt to have proposed an increase in the strength of commission members from 19 (originally suggested by NITI Aayog) to 29. The new Bill then says nine of the 29 NMC members can come through an election and the rest will be selected. This change, sources said, followed overwhelming opinion in favor of some elected component in the NMC. The Bill seeks to replace the Indian Medical Council Act, 1956, after the parliamentary committee on health concluded that the MCI had become a corrupt body and had failed to fulfil its mandate. It was originally drafted by a committee set up by PM and comprising, Additional Principal Secretary to the PM; NITI Aayog CEO; and, then Health Secretary. The PM had referred the Bill to a GoM for broader consultations in one of the Cabinet meetings earlier this year. The National Medical Commission (NMC) Bill, 2017, provides for an exit exam which MBBS graduates will have to clear to get practicing licenses Once the law takes force, this exam will also be used as NEET for postgraduate admissions. CBSE currently conducts NEET UG and NEET PG GoM allows elected component in NMC. Nine of the 29 proposed members will be elected, while the rest will be selected will be given the License to Practice Modern Medicine in India.
PCPNDT – Medicolegal Secrets
(written By Dr Vivekanshu )
Man & Machines
“Terror of Making Error” among Doctors under PNDT
“Doctors must play with Machines by the specific Country’s Rules”
Q. What is PCPNDT?
PCPNDT=Pre conception & Prenatal Diagnostic Techniques (Prohibition of sex selection) Act 1994.1
Q. What does PNDT Law regulate?
• PNDT Law regulates “Testing & Telling”
• Law regulates fetal testing, but does not prohibit testing, what is prohibited is disclosure of sex of fetus.
Q. What is difference between legal terms in PNDT act- “Permitted, Regulated, Authorized, Registered & Prohibited”?
• Permitted – Name, Place, Person, indication, method, duration
• Regulated – Permitted to kill in specific non-medical indications (population control)
• Prohibited- Punishment for doing act not permitted.
• Registered – Document what you do, when & why.
• Authorized- Take Documented Permit License authored by
o Legal Limiting body,
o for limited period,
o by limited doctors,
o using limited technology,
o for limited indications,
o in limited population,
o at limited place,
o in limited surroundings.
Q. How PNDT “Rules changed with Time” for Permitted, Registered, Regulated, Prohibited, Authorized?
• Before 1971- Abortion is illegal as per IPC
• 1971- Abortion is legal- to control population
• 1994- Sex selective Abortion (Amniocentesis) is illegal.1
• 2003- Sex selection (with USG), Genetic studies) for abortion is illegal.2
• 2016- IVF for sex selective reproduction is illegal
Q. Why Doctors need to be legally controlled, regulated & prohibited?
• Magical Medical technology – Playing with God
(Technology needs money, to make more money “Money attracts Money”)
Technology for prolonging Life & Looks
• Implants & Transplants – Major Revenue generators.
• Implants in joints, bones, teeth, breast, face, genitalia
• Transplant- kidney, liver, heart, lung, cornea, bone-marrow, genitalia
Technology for continuing Lineage- generation (Inheritance of money)
• Sex Selection in choosing male child
• Pre- implantation genetic diagnostics- Perfect child
• Infertility – Assisted reproduction – IVF
• Intrauterine insemination -Surrogacy in infertile couples
• Wanting Child in single parent family
Technology for getting rid of unwanted pregnancy
• Unwanted fetus – feticide
• Unwanted Female fetus – Female feticide
• Wanted “Designer” child
Q. How to easy recall Forms in PNDT?
Maintain “ABC” in Your USG center
• Form ‘A’- Application for registration of an USG center
• Form ‘B’- Batch displayed of registration certificate
• Form ‘C’- Cancelled- Rejection of application for renewal of registration
Maintenance of Records – Form D-G
• Form ‘D’- DNA Diagnosis in family – Genetic Counselling centers
• Form ‘E’- Examining DNA for abnormalities- Genetic Laboratories
• Form ‘F’- foetus USG- Detail address of foetus family
• Form ‘G’ – Gravida –Pregnant consent form
Q. What are “added” powers for AA (Appropriate Authority) in PCPNDT amendments in 2003?
Sonography- “11 S”- Sex selection PCPNDT amendments – 2003
AA can
• Suspect PCPNDT violation on complaint received
• Sting Operation with decoy clients for Sonography
• Suspend the Sonography registration
• Summon the Sonography owner
• Suo motto cognizance
• Show Cause Notice for temporary suspension of registration
• Search warrant of Sonography centre,
• Seizure of Sonography
• Seal the Sonography machine
• Sale & purchase monitoring of Sonography
• Scrutinizing Records- Form F – Sonography
• Statement Recording from accused and co accused
Q. What is misuse of “License Raj” related to PNDT?
PNDT officers victimize doctors – Many complaints made by doctors to Govt
• Allegation of Extortion of money from Gynecologists, for renewing license.
• Allegation to Blackmail Radiologists to seize the USG.
Doctors suffer
• IRREPAIRABLE LOSS,
• Financial HARDSHIPS
• Penal erasure
• DEFAMATION
• Outcaste from medical community
• Harassment of doctors by AA in PCPNDT- Undemocratic & violation of article 21 of constitution
Q. Who Acts in GOOD FAITH as AA under PNDT?
• Doctor
• CMO
• Police
• Magistrate
• IAS
• Judge
Q. What are Acts in GOOD FAITH?
Definition of “Good faith”- A thing shall be deemed to be done in good faith, where it is in fact done honestly whether it is done negligently or not.”
• Absence of “personal malice” may be relevant fact in dealing with the plea of good faith, but its significance or importance can’t be exaggerated.
Q. What are specific sections of Protection of Legal Action taken by AA in Good faith?
• PCPNDT- Section 9 & 31
• MTP – Section 8
• HOTA- Section 23
• Registration of Births and Deaths Act- Section 28
• Mental health act amendment -2017
• MCI Act- section 31
• No suit, prosecution, or other legal proceeding shall lie against any officer for anything which is in good faith done or intended to be done under this Act.
Q. Does it require to be Expert Specialist to become AA in PNDT?
• Good faith gives immunity – RMP can do surgery in good faith in emergency situation to save a life, as per law:
– No Qualification is asked
– No experience questioned
– No expertise expected
• Unlike acts done by doctors working AA in MTP, PNDT & HOTA, Doctor should have minimum qualifications as Expert Specialist, experience & expertise, before he does abortion, does USG, does amniocentesis, does transplant. So, doctor has to do MCh in transplant surgery of the specific organ, before he can be authorized by doing transplant. But any govt MBBS doctor can be appointed by Govt in AA- legal bodies to regulate illegal acts of abortion, transplantation.
Q. Why PNDT Crime is called a Racket or Scam in News?
• Daily USG for sex determination is a continuing offence
• Section 178 (c) CrPC deals with a situation where an offence is continuing one, and continues to be committed in more local areas than one.
• A continuing offence means that if an act or omission on the part of the accused constitutes an offence and if that act or omission continues from day to day, then a fresh offence is committed every day on which the act or omission continues.
Q. What is difference between legal Act, Bill & Rules?
An act is an official copy of a statute or regulation that is initially presented in the form of a bill and after being verified it is passed in the process of a legislature. An act is enforced in a legal manner. In context to an act, rules define the guidelines that must be followed for the successful implementation of the act.
A bill is the draft of a legislative proposal, which passes through various stages in order to become an act. It can be viewed as one of the sources of law. The acts are used for the creation of new laws or changing an existing law. The process of an act to become a law may vary from one country to the other.
Act is legal framework to define & regulate the illegal secret acts of criminals in specific field, by specific technology, done by specific person, on specific population, for making money illegally.
Rules are the procedures laid down for the authority taking action against the criminal doing the specific act. Rules can be enforced at any level. For example, a teacher might form a rule stating that every student in her class needs to show her homework every day. The rules of these types are not rigid and depends upon the enforcing entity that how strict it is and what steps it has taken to ensure the proper implementation of the rules.
Q. How do court analyses Criminal Act in Law?
• Culprit
• Victim
• Date, time & Place of crime
• Intention for crime
• Damage & loss to victim
• Eye witness & Documentary Evidence of crime
Q. How PNDT act is configured?
• Illegal Act- Selective Child killing
• Crime – Selective Child making, kills unwanted gender
• Tools of crime – USG, Echo, Amniocentesis, CT, MRI
• Alleged Criminal – Gynecologists, Radiologists, Cardiologist, Sonologists, Veterinary Doctors.
• Govt Hospital CMO/ District Magistrates – Appropriate Authority (AA)
• IAS officer team – Authorizing committee
• Legal Cell – Advisory Committee advises AA
Q. How to easy recall the facts about “Gender specific Medicolegal Crimes”?
• W- What’s the crime- Sexual assault, Induction of sex selective Abortion.
• W- Who did it
• W- Where- Place of crime
• W- When- time & Date
• W- Why did the crime- Intention
• W- Whom- To Whom- Women
• W- Who is killed- Would be a Woman (female foetus)
• W- Witness of crime- pregnant Woman- Hostile
Q. Why Hospital owner is arrested in illegal organ transplant rackets & illegal abortion & sex determination, although he has done no illegal abortion by himself?
• Owner of place of illegal work
• Allowed occurrence of repeated crimes
• Maximum money sharing in the deal
• Mastermind in procuring patients
Q. What are Dilemma’s related to PNDT act?
“Dilemma of AA – to report or not.”
“Dilemma of Police- to arrest or not (Cognizable)”
“Dilemma of Court – to bail out or not (non-bailable & Non-compoundable)”
• Role of AA, Police & court is to save life of female foetus.
• In human body related crimes- attempt to murder, physical torture, sexual assaults etc., police can immediately arrest the suspect without warrant, to prevent destruction of evidence or further attempts to harm victim & witnesses.
• Duty of Police is to maintain law & order in society, by stopping further crime by arresting the suspected criminal (Doctor/ nurse).
But to justify arrest, police need documentary evidence by an independent witness, so MLR by AA needed.
• Arrested Doctor/nurse can be bailed out in hours by court & can attempt to kill the female foetus again.
• So, to decide whether the accused can be bailed out or not, court needs expert opinion whether the criminal act was an attempt to diagnose gender for aborting female foetus.
Q. Why shouldn’t Police register FIR in PNDT?
As per PNDT rules. FIR should not be filed for any act of violation of PNDT. Instead, the Police should work with AA to file a court case against the alleged doctor, as per the complaint by victim.
Q. Is decoy “sting operation” by AA legally permitted?
• AA can conduct decoy operation to generate evidence, when intelligence has been gathered about a centre or a facility that is conducting or aiding illegal sex selection.
Ref: – SOP Guidelines for AA in PCPNDT by MOHFW – Aug 2016.
Q. What are doctor’s Dilemma in PNDT act?
• Presumption about doctors alleged to be guilty -Section 24 – PCPNDT
• Presumption by AA that every doctor doing USG is guilty of sex determination, until proven otherwise.
• Burden of proof is not on the prosecution.
• It’s the Doctor, who has to prove that he is not guilty just like in Rape & Dowry deaths.
• Offence under the PCPNDT act is cognizable, non bailable & non compoundable
PNDT Offence: cognizable, non-bailable & non-compoundable
Cognizable – offence in which police can arrest without warrant from magistrate.
How to recall list of Cognizable Offences allegedly done by doctors?
10 R’s mnemonic of Cognizable Offences for easy recall
• Rape
• Ragging students
• Ragging wife by in-laws for dowry – causing death- 304B
• Rioting
• Robbery
• Recognizing sex of foetus (PCPNDT violation)
• Removing life (murder) – 302 IPC
• Removing organs (HOTA violation)
• Removing foetus (female feticide)- MTP violation
• Rash act of killing – 304 A – Negligence
Q. What is the Problem with the PNDT act?
• PNDT Act is still Toothless piece of legislation for quacks in villages
Q. What are Bottle necks & Clutches for doctors in PCPNDT ACT?
• Pregnant needs Prenatal investigation for foetal well being
• Prohibition of Female feticide
• Prohibition of sale of sex identification device- Sonography
• Prohibition of Advertisement of sex selection
• Prevention of misuse of sex selection
• Punishment for sex selection by prosecuting only doctors
• Penalties to doctors – Penal Erasure of registration to practice
• Permission to detect foetal anomalies
• Pro-life & Pro-choice issues
• Public Display of Signboard- No foetal sex detection
• Public Obligation of reporting PCPNDT violation
• Patrilineal inheritance in society
• Prescription for doing prenatal procedures- USG
• Portable USG can’t be shifted out from registered premises
• Protection of doctors against violence by patients is lacking in act
• Presumption by AA that every doctor doing USG does sex determination, until proven otherwise
• Paperwork – documentation of Form F, consent
• Preservation of Records
Q. What the Doctor Wants in PNDT act?
• Protection from getting arrested
• Prevention of legal hassle
• Progression in clinical Practice & career
• Permission to independent decision making in critical situations in emergency
• Doctors want to become Whistle-blowers & inform AA, if any pregnant asks for foetal sex.
• But AA has no power to take any legal action against pregnant lady.
• Police do not take any action against pregnant, has no legal provisions for preventing abortion & MTP allows pregnant to seek abortion for controlling family size.
Q. How PNDT is misused against doctors- False allegations by pregnant mother’s family?
• Extortion of money from doctor
• Blackmail for Disclosure of gender of unborn foetus
• Alleged Negligence in prenatal care
Q. How PNDT is misused against doctors – False allegations by pregnant?
• Dowry – son preference
• Dowry Prohibition act, 1961
• Dowry Harassment- 498A
• Dowry Death- 304B
• Domestic violence act
• Discrimination by family members
• Disclosure of gender of unborn foetus
• Discard the Pregnant, forcing her to abort
Q. What are the usual allegations framed by Patient’s lawyer against Doctor doing illegal abortion causing PNDT violation?
• अस्पताल के डॉक्टरों ने मेरे ससुराल वालो से पैसे लेकर सोनोग्राफी से मेरे गर्भ में जुड़वाँ भ्रूण कि लिंग का पता किया, जब पता चला के एक भ्रूण लड़की है, तो मुझसे दहेज़ की मांग की, मेरे मायके वालो ने मना किया तो मुझे जबरदस्ती गैर-कानूनी कब्जे में अस्पताल रखा, जबरदस्ती खाली कागज़ पर मेरे हस्ताक्षर कराये, फर्जी दस्तावेज़ बनाकर मुझे एनेस्थेटिस्ट ने बेहोश कर के, गायेनेकोलोगिस्ट ने मेरा गर्भपात कर दिया.
Q. How above alleged complaint is dissected in legal format of IPC by court?
• 120 (B) IPC- अपराध को अंजाम देने के लिए साझा साजिश
• 34 IPC– दो या दो से अधिक व्यक्ति अपराध संयुक्त रूप
• (342) IPC= गैर-कानूनी कब्जे में रखना
• (468) IPC – धोखाधड़ी के उद्देश्य से जालसाजी
• (471) IPC-फर्जी दस्तावेज को असली की तरह इस्तेमाल करना
• 498A- IPC= Demanding Dowry & Domestic Violence
• Section 5 in MTP act- illegal abortion
• Section 23 in PNDT – illegal sex determination
Q. Why Doctors gets maximum allegations of misuse of PNDT?
“Documentary evidence of meeting the patient”
• Registration of patient
• Documentation of consultation
• Medical Investigation report like USG or amniocentesis mentions name of doctor reported & patient examined
• CCTV camera in public places
Q. What becomes the Evidence of Crime in PNDT?
• Documentary evidence (link between accused doctor & victim patient & unborn foetus)
– Hospital Registration form
– Prescription
– USG report & Forms
– Receipt of payment to Hospital
– Discharge summary
• All are missing in quacks doing female feticide, so AA fails to prove the crime in quacks & raids genuine doctors to complete monthly targets & finds faults in documents
Q. Why Doctors doing USG are presumed guilty simply on allegation by anyone?
Presumption about doctors alleged to be guilty -Section 24 – PCPNDT
• Presumption by AA that every doctor doing USG is guilty of sex determination, until proven otherwise.
• Burden of proof is not on the prosecution (victim’s lawyer- Public Prosecutor).
• It’s the Doctor, who has to prove that he is not guilty just like in Rape & Dowry deaths.
• Its contradictory to principles of Indian laws, as in other criminal cases like theft or murder, the burden of proof is on the prosecution.7
Q. Why Doctors doing USG face negligence charges under Consumer Protection Act, unlike doctors doing sterilization under Family planning scheme?
• PCPNDT act doesn’t protect the doctor from Consumer Protection Act
• Faulty USG procedure in diagnosing congenital abnormalities is negligence
• Unlike Govt family planning schemes- Sterilization in MTP act- Failed sterilization is not negligence.
Because in family planning, doctor is working for the government to control population, unlike doing USG for wellbeing of foetus & pregnant.
Q. Why doctors doing illegal sex selection & abortion – considered as “heinous crime”?
Both PCPNDT & MTP are regulating doctors taking care of pregnant, because identifying sex of foetus & doing abortion of unwanted sex is contradictory under medical obligations of doctor of saving lives.
Q. How AA should respond to a complaint regarding violation of the PCPNDT Act?
• AA should –
• – as far as possible, not involve police for investigating cases under the Act as the cases under the Act are tried as complaint cases under the Code of Criminal Procedure, 1973 (2 of 1974).
• – investigate all the complaints within 24 hours of receipt of the complaint and complete the investigation within 48 hours of receipt of such compliant.4
Q. Why pregnant mother is not arrested in illegal abortion of female foetus in PCPNDT & any illegal abortion under MTP?
• Court’s Sympathy for pregnant patient’s critical state- as Why would a mother will kill her own child?
• No financial gain
• No Motive to directly harm.
• Public Sympathy for Pregnant.
Q. What is Catch “22” situation for Radiologists in PNDT?
Prescription required by Registered Gynecologist for doing prenatal procedures in Pregnant- “Catch 22” situation
• A catch-22 is a paradoxical situation from which an individual cannot escape because of contradictory rules. … Catch-22s often result from rules, regulations, or procedures that an individual is subject to but has no control over because to fight the rule is to accept it.
• If radiologist refuses to attend midnight obstetric emergency without prescription, he is guilty of breaching medical ethics.
• Whereas if he performs USG without prescription, he becomes culprit in PCPNDT – by AA.
• Self-referral – can’t be done by Radiologists unlike Gynecologists, as they are not clinicians.
• Anger & aggression among pregnant & her relatives (lay persons) against radiologist for refusing USG.
Q. Describe horrible case of Radiologist murdered for refusing USG?
• Gruesome murder of Dr Manish Garg at a small place in Jind in 2014.
• Dr Garg was earlier beaten up and his hospital vandalized as he had insisted on asking for photo ID proof from a patient before conducting an obstetric ultrasound.6
• Requirement of photo ID proof is as per PCPNDT Act.
• Dr Garg had lodged a FIR and had provided CCTV footage of the incident but no action was taken against those responsible.
• this is not the first incidence of a doctor’s murder in Haryana, giving example of Dr Ranveer Choudhary who was killed around five years ago and Dr Raman, who was murdered in Bhiwani.
• Haryana government which on one side asks doctors to work in rural and backward areas and on the other side does not give them even a semblance of a sense of security through its law and order machinery.6
Q. What is Catch “22” situation for Doctors in PNDT?
• Catch “22”-Advertising Sex selection is illegal- Section “22” – PCPNDT5
• Balaji Films- Kyunki saas bhi kabhi bahu thi- had a scene of sex selection by doctor
• Advertising on website- Ayurvedic drug maker advertised
• Name suggests- “Putra Jeevak” by Patanjali
• Article written in Marathi Magazine- How to have baby boy by jyotish, Mantra, tantra
Q. What do the Doctor Wants in changes in PNDT?
• Protection from getting arrested
• Prevention of legal hassle
• Progression in clinical Practice & career
• Permission to independent decision making in critical situations in emergency
• Doctors want to become Whistle-blowers & inform AA, if any pregnant asks for foetal sex.
• But AA has no power to take any legal action against pregnant lady.
• Police do not take any action against pregnant, has no legal provisions for preventing abortion & MTP allows pregnant to seek abortion for controlling family size.
Q. What the Govt wants in PNDT act?
• Due recognition to foetal rights, but parents lose the right to choose child’s sex & lose the right to abort the unwanted gender of child.
• Control over medical technology & medical professional’s malintent ion for making quick money- Audit of USG- Form F
• Ethical use of new technology for further R & D
Q. How to easy recall Do’s & Don’ts for Doctors in PNDT?
All R’s mnemonic
• Register the Centre dealing with pregnancy
• Renewal of Registration before expiry date
• Registration certificate copy display in centre
• Rejection of Registration – do not continue USG
• Register the Doctor doing USG- Gynecologist, Sonologist
• Radiologist should update Resignation to AA
• Records maintenance up-to-date
• Report to AA monthly
• Retain all documents for at least 2yrs
• Receive Declaration from pregnant, that no sex detection
• Remain alert & careful for protecting your career
• Refrain from disclosing sex of fetus.3
References: –
1. PCPNDT Act & Rules. 1994.
2. PCPNDT amendments 2003.
3. PCPNDT amendments 2014. http://cg.nic.in/health/pcpndt/Documents/GuidLine_02_21072016.pdf
4. Standard Operating Guidelines for District Appropriate Authorities by MOHFW -2016
5. Public notice in 2017 by PCPNDT committee in compliance to Hon’ble Supreme court directions via order dated 16-11-2016. http://haryanahealth.nic.in/userfiles/file/pdf/PNDT/2017/publicnotice_pndt_07032017.PDF
6. Medicos body condemns killing of doctor in Haryana. TNN | Sep 12, 2014.
7. Legal issues in Medical Practice. 1st Ed. 2016. Dr VP Singh. Jaypee publishers. Medicolegal outlook in PC- PNDT. Chapter 15, p 138.
8. Difference-between-act-and-rule. http://www.differencebetween.info/difference-between-act-and-rule.
prenatal sex determination hassles
THE NEW ‘QUIT INDIA’ MOVEMENT?
As a law-abiding doctor in medical profession for 22 years now, sometimes I really doubt that where exactly is this nation and its healthcare heading to.
1. An honest highly qualified Radiologist who is willing to co-operate with the silly law like PCPNDT is liable to go to jail even for a small mistake in a 3-page form F …BUT AN UNREGISTERED UNQUALIFIED QUACK CAN PRACTISE SEX DETERMINATION WITH HELP OF A HAND HELD CHINESE MACHINE without fear.
2. A patient can ask to a doctor openly that “is sex determination possible at your place? … BUT A DOCTOR HAS TO GIVE IT IN WRITING EVERY DAY…FOR EVERY SONOGRAPHY that he has neither detected nor disclosed the sex.
Just imagine a minister taking oath from the president every time he enters his office…or a bureaucrat signing a paper on each file that he is not going to be corrupt…or the court proceeding requiring everyone in the court to vouch with The GEETA/QURAN/BIBLE about speaking truth each time he opens his mouth.
This is how much the society has betrayed this noble profession… they are not happy YOU SIGNING THE AFFIDAVIT AT ONCE while registering in PCPNDT…THEY WANT YOU TO SAY IT EVERYTIME-EVERYDAY…. worst treatment than a criminal.
3. In all the criminal cases the police-the prosecutor have to prove that the accused is guilty…BUT IN PCPNDT IT IS THE RESPONSIBILITY OF THE DOCTOR TO PROVE THAT HE IS NOT GUILTY…IN FACT HE IS LABELLED AS A CRIMINAL and GUILTY BEFORE THE TRIAL IS COMPLETE…because his machine is sealed on suspicion alone…his reputation-image is maligned by publishing his name in media the very next day…and his registration suspended till the court acquits him at its own leisurely infinite schedule of tarikh pe tarikh.
4. A gunda /a politician can contest any election even if he is in jail…BUT A DOCTOR CAN NOT RENEW /REGISTER FOR A PCPNDT LICENCE just because he has a ‘criminal case’ for not filling some part of the FORM F
5. On one hand the government wants strict regulation/governance on all the imaging modalities (including CT /MRI…even A scan for ophthalmic ultrasound is being included as ‘a scanner’ by an over enthusiastic authority) but ON THE OTHER HAND A SIMPLE BLOOD TEST IS EASILY AVAILABLE FOR ANYONE …WHICH CAN DETECT SEX AS EARLY AS 5 WEEKS OF PREGNANCY.
6. The government doesn’t want a qualified well-trained Radiologist to visit more than 2 places and prevents him from utilizing his full potential BUT THEY WANT TO PROMOTE CREATING ‘SONOLOGISTS’ WITH MERELY 6 MONTHS TRAINING…. BECAUSE THERE IS SCARCITY OF QUALIFIED RADIOLOGISTS IN THE NATION.
7. The judiciary is already crippled with a huge back log of millions of pending cases but THEY WANT TO CREATE THOUSANDS OF NEW ‘CRIMINAL CASES’ OUT OF minor clerical errors JUST TO HARASS the educated-white collar doctor. If ten thousand doctors are facing criminal cases in the ACT AGSINST SEX DETERMINATION, why are there not even 10 couples facing the same music?
8. You are liable to face the charge of ‘not practicing within limitations of your specialty’ if you are a general physician and treat cardiac patients with your ‘limited’ knowledge (a recent high court verdict) BUT ALL THE AAYUSH DOCTORS (and now the pharmacists also) have THE PERMISSION TO TREAT ANY AILMENT WITH MODERN ALLOPATHIC MEDICINES…EVEN IF THEY ARE NOT TRAINED IN PHARMACOLOGY (because there is SCARCITY of doctors in Rural India…the court says…IS THE LIFE OF A RURAL INDIAN LESS PRECIOUS THAN THAT OF AN URBAN …to be treated carelessly by a half-baked inadequately qualified doctor ?! With the same logic, an auto driver should be allowed to fly an airplane because we don’t have adequate pilots.
8. The super-rich cricketers are showered with gifts and exemption of import tax…but taxes on life saving medical drugs/equipment (including all the imaging machines like USG CT MR have hardly changed)
9. A multiplex owner gets tax exemption for 5 years, IT industry gets enormous profits but have plenty of tax exemptions… BUT A DOCTOR OR A HOSPITAL who save lives of the citizens ARE LIABLE TO PAY ALL SORTS OF TAXES (property tax income tax profession tax octroi etc.)…and yes only a doctor is supposed to give handsome concessions… Do charity in his fees…
10. Govt hospitals have gone to dogs because of non-availability of good doctors and funds but THE PRIVATE HEALTHCARE SECTOR (small clinics and doctor-run small medium hospitals) WHICH CATERS TO 85 % OF THE POPULATION OF THIS VAST COUNTRY is systematically being crushed with unjust regulations like clinical establishment act…ONLY TO FAVOUR THE cash rich CORPORATE SECTOR
11. India has so many skilled IVF consultants and so many needy couples who are ready for donor eggs / surrogacy BUT THE NEW ART BILL is drafted with so much of vengeance against the doctors that ANY SANE /SENSIBLE SPECIALIST WILL KEEP HIM AWAY FROM DONORS/SURROGACY for all his life.
And all those poor needy women/widows who can earn some 4 lack rupees legitimately out of surrogacy to support their families will not have this option of lending their ovum’s/wombs to others. If blood donation and organ donation is a service to humanity…why is ovum donation/surrogacy being looked upon so skeptically? then why make the rules so complicated?
12. After spending millions on IIT, an engineer can fly to US without paying a paisa to the nation…BUT A DOCTOR HAS TO COMPULSORILY SERVE THE GOVT FOR 2 YEARS.
This list can go on and on…but the real ‘icing on the cake’ is those ever-increasing incidences of VIOLENCE AGAINST DOCTORS…just because in this era of consumerism the consumers want a 100 % result…always- without trying understand limitations of medicine as a science!
I just feel that there is a serious lack of common sense and complete absence of foresight amongst all the policy makers in HEALTHCARE… as a result- the inefficient but corrupt bureaucracy is going haywire, is not accountable for all the mess they all have created and resultantly the misery of the common population continues.
I am ‘realistic’ rather than ‘optimistic’ and hence feel that if this is the way INDIA treats its doctors…the day is not far when GOOD Indian doctors will be left with no choice but to ‘QUIT INDIA’…the process has already begun (try talking to a few post graduate medical students…and you will realize)
Prescription Drug Charges
Prescription drug abuse is a high priority for local and federal law enforcement. Because prescription drug overdose is the leading cause of accidental death in the United States, officials are taking prescription drug crimes more seriously now than ever.
This means if you are caught with a prescription drug charge, you could be facing serious consequences as police and the courts attempt to “send a message” to the rest of the population.
Charges
There are many ways that prescription drugs can get you into trouble with the law. The truth is: you can even face charges when the prescription is yours and it was written for a completely valid cause. While the laws vary widely from state to state, some common prescription drug crimes include:
Possession of a prescription drug without a lawful prescription
Obtaining prescription drugs by fraud
Forging a prescription
Selling prescription drugs, whether the original prescription is yours or not
Driving under the influence of prescription drugs
Doctor “shopping” (going to multiple doctors to obtain multiple prescriptions)
Identifying a prescription drug crime can be difficult for law enforcement in some situations. After all, who are they to determine whether or not you have a valid need for your pills? While being in possession of these drugs without a prescription is an obvious law violation, proving that you didn’t need your valid prescription to begin with presents much more of a challenge.
Prescription Drug Possession – Penalties
When it comes to prescription drug crimes and penalties, the charge and subsequent sentence you face depends on several factors, namely: what drug you are accused of possession, selling, etc., and how much of it you have. In some states, a single pill can warrant charges as serious as an entire bottle. In others, however, the quantity involved plays a bigger role.
Under the Controlled Substances Act, all drugs are classified by how dangerous they are into Schedules. Schedule I is the group of substances that are considered the most dangerous and addictive while Schedule V drugs carry the lowest risk of addiction. The chart below outlines the details of the federal drug schedules that most states have adopted.
Definition
Examples
Schedule I
Highest addiction risk
No accepted medical use
There are no prescription drugs classified as Schedule I substances.
Schedule II
High risk of abuse
High risk of physical and psychological addiction
oxycodone (OxyContin, Percocet), fentanyl, meperidine (Demerol), methadone (Dolophine), hydromorphone (Dilaudid)
Schedule III
Risk of abuse
Moderate or low risk of physical dependence, high risk of psychological dependence
Combination drugs containing less than 15% hydrocodone (Vicodin), not more than 90 mg. of codeine (Tylenol with Codeine), buprenorphine (Suboxone), ketamine, anabolic steroids
Schedule IV
Low potential for abuse
alprazolam (Xanax), carisoprodol (Soma), clonazepam (Klonopin), clorazepate (Tanxene), diazepam (Valium) lorazepam (Ativan), Rohypnol, sleep medications
Schedule V
Low risk of abuse
Cough medicines containing no more than 200 mg of codeine per 100 ml
The exact charge you face and the penalty heavily depend on the state in which you are charged. Many states follow the federally crafted Schedules precisely, while others have their own definitions in place.
In Arizona, for instance, you can be charged with a Class 5 Felony for “possession of narcotics” (oxycodone or morphine, for example) or a Class 1 Misdemeanor for “possession of dangerous drugs” which includes a variety of other non-narcotic prescriptions. In Texas, however, if you are caught in possession of a drug in what they call “penalty groups” 3 or 4 (which include most prescription drugs), you could face up to one year in jail and thousands of dollars in fines.
The best way to know for certain what you are up against is to discuss your case with a local criminal defines attorney, someone who knows how your state classifies and penalizes drug charges.
Sentencing Alternatives
Because accidental overdoses are becoming so widespread and illegal use of prescription drugs being called an “epidemic”, many jurisdictions are eager to help people accused of these crimes get drug treatment. If you are accused of a prescription drug offense, and especially if this is your first such offense, you may be able to avoid jail time by participating in drug treatment.
There are many alternative sentencing programs available. Drug courts are just one. These courts seek to help people bypass the traditional criminal courts in favor of courts that help them overcome addiction by following strict rules and attending drug treatment.
Even in jurisdictions where a drug court is not available, your attorney may be able to argue for leniency, or something called a deferred judgment, where you participate in probation (including treatment) in exchange for the charges being dropped.
Prescription drug offenses are serious crimes and should not be taken lightly. Let us put you in contact with a local criminal defense attorney today.
Problems with mental health act
Some of the problematic areas of the legislation are
a) definition of certain terms like *mental health establishment*
b) Capacity to consent for treatment (most problematic one)
c) Advance Directives
d) Nominated Representative
e) All issues /problems / litigation will be heard in *mental health board* which is a civil court (quasi-judicial body). Now most of the issues can be challenged in the Mental health board free of cost to the patient. Psychiatrist need to be there or hire a lawyer to defend.
No compensation for the time
Patient can also give complaints in medical council, consumer court, civil court, human rights commission, criminal court etc.
f) certain treatments are banned (ECT in children) need to take special permission
g) certain procedures are banned like seclusion
h) all research in mental health needs to get approval of *Mental health* authorities along with other existing once
i) Sec 107 and 108 prescribe severe punishment like two years imprisonment for not following the law
Brief problems of the present mental health care law ……… these are the few challenges one need to face
RECORD KEEPING: VARIOUS LAWS.
*Medical record-keeping and the law in India*
(Dr. Chandrashekhar Sohoni)
Deficient or inaccurate record-keeping is, by far, the commonest reason for legal sufferings of Indian doctors. Most of the penalization of doctors, whether under Consumer Protection Act or Pre-conception and Pre-natal Diagnostic Techniques Act, is based on defective record-keeping.
Following are the various legal provisions which mandate medical record-keeping by doctors and hospitals in India: –
1)–The Ethics Code Regulations, 2002 prescribed by Medical Council of India (MCI) under Indian Medical Council Act, 1956, regulation 1.3.1 states as follows: –
“1.3.1. Every Physician shall maintain the medical records pertaining to his / her indoor patients for a period of 3 years from the date of commencement of treatment in a standard proforma laid down by medical council of India and attached as Appendix 3.”
2)–The Clinical Establishment Act (CEA), 2010, section 12(1)(iii) provides for maintenance of medical records as a pre-requisite for initiation and continuation of registration of a clinical establishment under this Act. Since the CEA is a central Act that is optional for States, the rules framed under the Act by the adopting States will vary. However, there is a general guideline under CEA Rules, 2012 as follows:
“Copies of all records and statistics shall be kept with the clinical establishment concerned for at least 3 or 5 years or in accordance with any other relevant Act in force at the time under Section 12(1)(iii).”
3)–As per the provisions of the Limitation Act, 1963, civil suits for claiming damages can be instituted within 3 years of causation or discovery of damage, whichever is later. Thus, ordinarily, a patient aggrieved by an act of negligence of a doctor can file a civil case within a period of 3 years. However, under section 14 of the Limitations Act, the court can condone the delay in filing a case if the court is of the considered opinion that such delay is justified. Hence, a patient may be able to initiate legal action even after 3 years. This is especially important in cases of negligence related to pediatric patients. A patient who has suffered damage due to negligence of a doctor in childhood can initiate legal proceedings upon achieving adulthood. In such cases, courts may direct the doctor to present medical records which may be few decades old!
4)–As per section 24A (1) of the Consumer Protection Act (CPA), 1986, a consumer forum is allowed to admit a complaint only if the complaint is made within 2 years of the date of cause of action. Thus, under the CPA, a patient can ordinarily file a complaint against alleged negligence by a doctor within 2 years of the negligent act. However, under section 24A (2), the consumer forum can condone the delay in filing of a complaint if the forum is of the considered opinion that such delay is justified. Thus, a patient may be able to claim compensation via CPA even after 2 years. And in such a case, the consumer forum may direct the doctor to present medical records which may be few decades old!
5)–The Directorate General Health Services, Ministry of Health and Family Welfare (MOHFW) has specified period for which medical records should be preserved by hospitals (vide letter 10/3-68-MH, dated 31-08-1968) in Chapter XII of the Hospital Manual, 2002, as under: –
In-patient records — 10 years
Out-patient records — 5 years
Medico-legal records — 10 years
6)–Under the Pre-conception and Pre-natal Diagnostic Techniques (PCPNDT) Act, 1994, all prescribed records under the Act need to be preserved for a period of 2 years, and, in the event of a pending court case, till the final disposal of the case.
7)–Under the West Bengal Clinical Establishment Rules, 1951, (rule 18), all medical records need to be preserved for a minimum period of 5 years.
8)–As per Punjab Medical Manual (1934), medical records are to be preserved for 12 years.
9)–As per Income Tax Rules, 1962, Rule 6F (3), a medical professional need to keep and maintain for a period of 6 years from the end of relevant assessment year, the following: –
(i) A daily register of patients in Form 3C.
(ii) An inventory of the stock of drugs, medicines and other consumable accessories used for the purpose of his profession, as on the first and the last day of the previous year.
Thus, in this article, I have summarized the various laws in India which mandate time-bound record-keeping, both for in-patient as well as out-patient services. In my articles to come next, I shall discuss as to why accuracy of medical records in legally imperative, and how that can influence outcomes in medico-legal cases.
Revalidation
There has considerable talk of the eminent arrival of revalidation and annual appraisals for doctors in India. There is no clear direction or plans on how this process will be enforced or is planned. We know that this idea has been borrowed from the United Kingdom and I will try and explain how this system works here. The introduction of medical revalidation in the United Kingdom provides a key lever for healthcare improvement. Medical revalidation reinforces the duty of every doctor to meet their professional obligations as regards appraisal and revalidation. Revalidation of doctors is a key component of a range of measures designed to improve the quality of care for patients; it is the process by which the General Medical Council confirms the continuation of a doctor’s license to practice in the UK. The purpose of revalidation is to assure patients and the public, employers and other healthcare professionals that licensed doctors are up to date and fit to practice. Doctors in the UK have to undergo an annual appraisal and revalidation every 5 years. Responsible officers rely on robust appraisal outputs to help determine their periodic recommendations about doctors to the General Medical Council. As well as supporting the requirements of medical revalidation, appraisers help the doctors they appraise to reflect on their work and to identify their learning needs and career aspirations. They then work with the doctors to plan their future development in line with these needs, integrating with those of their employer(s) and the NHS. Well, conducted appraisals can improve job satisfaction and performance and may ultimately increase the quality and safety of patient care. Medical Appraisal is an annual professional review of your entire scope of practice providing you with an opportunity to reflect and learn from the year gone by. It is not a performance review or a judgement on your skills and knowledge. An appraisal is a platform to showcase your achievements for the year and structure a SMART personal development plan for the future. A good appraisal for the purposes of revalidation meets the standards of the Good Medical Practice (GMC) Framework for Appraisal and Revalidation and is underpinned by the following principles: It is annual. It takes account of a doctor’s whole practice and conduct. It takes into account and discusses the following six types of supporting information collected by the surgeon: Continuing professional development (CPD), Quality improvement activity, Significant events, Feedback from colleagues, Feedback from patients, Review of complaints and compliments. It includes both a formative element, revolving around the surgeon’s professional development, and a summative element, assessing the performance of the surgeon since the last appraisal. The focus throughout the appraisal process should be your reflection on both your activity and the outcomes as a result. It is essential to ensure that all medical practitioners have access to an experienced appraiser who is able to guide and assist them successfully through the key medical governance processes. The Medical Support Union and Medical appraisals the UK are fine examples of organizations that are committed to working with doctors and other healthcare professionals like nurses, midwives and other healthcare professionals by providing them with a comprehensive appraisal platform that meets their professional regulatory requirements as set out by the NHS procurement framework. We hope that revalidation in India takes shape and borrows the best concepts of the UK revalidation system.
Shakoor v Situ
Shakoor v. Situ (t/a Eternal Health Co) [2000] 4 All ER 181; [2001] 1 W.L.R. 410; (2001) 57 B.M.L.R. 178; Independent, May 25, 2000; is a first instance case in English tort law on the standard of care appropriate for an alternative medicine practitioner. Its controversial ruling elaborates on the “responsible body of medical men” test from Bolam v. Friern Hospital Management Committee.
Mr Abdul Shakoor went to a Nottingham based Chinese herbalist, which traded as the “Eternal Health Co.”[1] Mr Kang Situ, who ran the herbalist had trained for five years in China, gaining both a traditional “medicine” and “modern” medical qualifications. His grade was “excellent”. He had no British professional medical qualifications. In November 1994, Mr Situ prescribed a course of Chinese herbal remedies for Mr. Shakoor’s benign lipomata, a skin condition, which produces fatty tissue that lies just below the skin, but causes no risk to health. There is no treatment in the UK, except surgical removal. Mr. Shakoor was given a mix of twelve herbs in ten sachets which were to be taken on alternate days after a meal. After nine doses Mr. Shakoor got ill, nauseous, his eyes went yellow and he suffered heartburn. He vomited, and had abdominal pain. He went to hospital, and was diagnosed as having “probably hepatitis A”. His liver failed, he had hepatic necrosis. He had an operation, but he died in January 1995. In the post-mortem, his liver was found to contain Bai Xian Pi, or dictamens dasycarpus, which some evidence suggested could be hepatotoxic.
Bernard Livesey QC found that there was no way to establish that the herbs could be known to contain toxic substances. Yet on the balance of probabilities, the herbal concoction was the cause of death. It was held that Mr. Shakoor had an “idiosyncratic” reaction, a rare and unlucky allergic response to the herbal mix. He noted,
“unlike some alternative therapies, TCHM has a long and distinguished history; it has an oral tradition extending back some 4,000 years or more and a written tradition extending back some 2,000 years. It is practiced alongside modern medicine in China and accordingly, I am told, a larger proportion of the world’s population is treated by it than is treated by modern or western medicine. However, I learned little during the course of this trial as to the extent of current teaching, research, monitoring and verification of its practices in China or elsewhere.”[2]
He considered the argument that an herbalist should be held to the same standard as a normal NHS doctor, but disagreed.
“The Chinese herbalist, for example, does not hold himself out as a practitioner of orthodox medicine. More particularly, the patient has usually had the choice of going to an orthodox practitioner but has rejected him in favor of the alternative practitioner for reasons personal and best known to himself and almost certainly at some personal financial cost. Those reasons may include a passionate belief in the superiority of the alternative therapy or a fear of surgery or of reliance (perhaps dependence) on orthodox chemical medications which may have known undesirable side effects either short- or long-term or both.[3]
So long, said Livesey QC, as the herbalist complies with the UK’s laws, does not prescribe prohibited or regulated substances under the Pharmacy and Poisons Act 1933, the Medicines Act 1968 or the Abortion Act 1967, so long as the herbalist takes steps to keep abreast of pertinent information in the “orthodox” medical journals, it is appropriate to hold his standard of care to that of what a reasonable herbalist would do. In this case the prescription had not been inappropriate for a reasonable herbalist, and accordingly Mr. Situ of the Eternal Health Co. was not liable for the death of Mr. Shakoor.
Should Code of Medical Ethics be modernized
Last month the American Medical Association wrapped up its annual meeting in Chicago, where it has reached the final stages of modernizing its 167-year-old Code of Medical Ethics, last updated more than 50 years ago. The central role of ethics in medicine is reflected in the fact that, at the AMA’s first meeting in 1847, it treated the establishment of a code of ethics as one of its two principal orders of business. Much in medicine has changed since 1847, but this founding document, which most physicians and patients have never seen, still offers important insights that deserve to be reaffirmed.
Spanning 15 pages, the 1847 Code of Ethics addressed just three fundamental concerns: the duties physicians and patients owe each other, physicians’ duties to each other and the profession at large, and the reciprocal duties of the profession and the public. This structure, focused on moral duties, evinces an important feature of the authors’ view of medicine. Namely, medicine is essentially a moral enterprise, grounded in mutual responsibilities, in which patients, physicians, and the public unite to serve the interests of the suffering.
In fact, the preamble to the 1847 Code of Ethics states explicitly that medical ethics “must rest on the basis of religion and morality.” Ethics is not merely a matter of consensus, and the boundaries of professional ethics are not outlined by what a particular patient or physician might happen to agree to. The fact that an employment contract or informed consent form has been signed is insufficient. Professional ethics requires loyalty to ideals that transcend any particular person or group of people. Like taking an oath, it rests on the presumption that professionals serve something higher than themselves.
The preamble to the 1847 Code also acknowledges that, in framing their code of ethics, the authors have “the inestimable advantage of deducing its rules from the conduct of many eminent physicians who have adorned the profession by their learning and piety.” It explicitly holds up the example of the “Father of Medicine,” Hippocrates, by whose conduct and writing the duties of a physician “have never been more beautifully exemplified.” The Code’s authors emphasize that these ideals are not only aspirational but achievable, having been exemplified by “many.”
The first chapter stresses the physician’s duty to answer the call of the sick, which is all the deeper and more enduring “because there is no tribunal other than the physician’s own conscience to adjudge penalties for neglect.” In other words, the Code entrusts the ethics of medical practice not to lawmakers, the courts, or hospital executives, but to the conscience of each physician. We can detect and punish violators, the Code’s authors are saying, but it is impossible to legislate goodness, whose flame must ultimately burn nowhere else but in the hearts of professionals themselves.
The first chapter also states explicitly that physicians should never abandon a patient because a case is deemed incurable. In an era obsessed with improving measurable outcomes such as length of stay and cost of care, many of today’s healthcare leaders need a reminder that a physician’s contribution cannot be fully assayed in terms of cures. Incurable does not mean hopeless, and it is always possible to care well even for those who are dying. The authors state that physicians should strive to be “ministers of hope and comfort to the sick.”
In our day of shifting insurance contracts and medical super-specialization, physicians and patients are often strangers to one another. The second chapter of the Code stresses that, as much as possible, patients should entrust their family’s care to one physician, enabling a relationship to build over time. Simply knowing a patient’s vital signs, physical examination findings, and laboratory test results is not enough. The Code’s authors recognize that good medicine requires physicians to know their patients’ life circumstances, including the families and communities of which they are a part.
In stressing that physicians should be devoted to ends beyond self, the Code also invokes gratitude on the part of patients. The services physicians render, it says, “are of such a character that no mere pecuniary acknowledgment can repay them.” What transpires between patients and physicians, in other words, is not primarily an economic exchange. Simply tending to the elements of a legal contract would not completely fulfil it. To the contrary, the intimacy and dedication at the core of a good patient-physician relationship should inspire enduring gratitude.
Today we tend to see medicine as a scientific enterprise, placing our hopes in the advancement of knowledge and technology. But in the second chapter, the Code of Ethics argues that “no scientific attainments can compensate for want of moral principles.” Everyone holds out the hope of cures for cancer and Alzheimer’s disease, but good medicine is not merely good science. Science helps us understand how to relieve suffering, but it does not explain why should want to relieve suffering in the first place. For that, we must look to ethics and such extra-scientific virtues as compassion.
Today we take for granted the mass marketing of healthcare. But the 1847 Code regards advertising as “derogatory to the dignity of the profession.” There is an important difference between advertising and educating, and the two are not always easy to distinguish from one another. One aims primarily at inducing a customer to spend money, while the other seeks mainly to serve the needs of a patient. To advertise is to make a plea for customer’s business, thereby placing the relationship on a primarily economic footing, while educating treats the dignity of the patient as primary.
This helps to explain why the Code tends to avoid terms such as payment, preferring instead the seemingly awkward formulation of “pecuniary acknowledgment.” In our day, healthcare reform has come to be understood to be about paying for healthcare, focusing primarily on questions such as who pays and how much. To the authors of the AMA’s first Code of Ethics, however, medicine is not a commodity that can be delivered from the back of a truck like a refrigerator. At its best, it much more closely resembles a friendship, a relationship that can never be bought and sold.
The third chapter of the Code declares that there is no profession that more freely dispenses charitable services than medicine. A profession is defined in part by the fact that its members aspire to something beyond money, suggesting that physicians should naturally put tending to patients ahead of the money that the provision of services might or might not generate. In fact, the opportunity to care for a patient pro bono, for good, constitutes one of the most self-defining and reinforcing activities in which professionals can engage.
In our own day, federal and state programs have led many physicians to expect to be compensated for all the care they provide. But the Code calls upon physicians always to care for individuals in indigent circumstances “cheerfully and freely.” It regards the care of the indigent not as an unfortunate burden that physicians must grin and bear, but as a positive opportunity. It is not enough merely to provide such care. It must also be done from the professional’s own free will and even cheerfully, because it is in doing so that professionals give life to what they really believe in.
Some might suppose that a medical code of ethics dating back 167 years could not possibly speak to contemporary physicians and patients. After all, such a code predates the discovery of x-rays, antibiotics, and the structure of DNA. Yet even as medical science evolves at an ever-quickening pace, the core of professional ethics remains essentially unchanged, in large part because goodness is grounded in human character. It is impossible to be a good doctor without first being a good person. As the AMA seeks to “modernize” its Code of Ethics, it would do well to return to the enduring insights of its founders
SUNSHINE ACT
The Physician Payments Sunshine Act (Sunshine Act) requires manufacturers of drugs, medical devices and biologicals that participate in U.S. federal health care programs to report certain payments and items of value given to physicians and teaching hospitals.
Toolkit for Sunshine Act Manufacturers are required to collect and track payment, transfer and ownership information beginning Aug. 1, 2013. Manufacturers will submit the reports to the Centres for Medicare & Medicaid Services (CMS) on an annual basis. In addition, manufacturers and group purchasing organizations (GPOs) must report certain ownership interests held by physicians and their immediate family members.
The majority of the information contained in the reports will be available on a public, searchable website.
Physicians have the right to review their reports and challenge reports that are false, inaccurate or misleading.
The AMA offers the following toolkit so you can make sure you’re prepared when it’s time to review your 2013 financial data before it’s published online next year.
Tally for doctors
These days, I have received many queries from different doctors who want to know how they can keep their records in tally 9. So, today, I have made special tally tutorial for doctors and medical professionals who are interested to maintain their records in tally by themselves.
A doctor can easily maintain their records in tally 9. Tally 9, the accounting software provides all facility to doctors for recording all transaction of their medical profession which are given step by step.
Aim of this tutorial
• Guide the doctor for recording of transactions in tally 9
• Provide steps to the doctors for recording of transactions in tally 9
• After this doctor is enable to do all voucher entries by himself in tally 9
Ist step
Create company for medical profession: –
Tally → Company Info → Create → fill the form of creation of company → Accept the form
when you fill the form of company creation, you have to select maintain option as Account only because, a doctor does not purchase or sale of goods he is not businessman but he is service provider. So, no need to select Account with inventory.
2nd Step
Creation of ledger accounts of medical profession: –
This step is relating to creation of ledger of medical profession. In medical profession, doctor does not sell the goods so first of all change the master group of Sale Account into Professional fees Account
for this
Gateway of tally → Account Info → Group → Alter → select Sale Account → write professional fees on the place of sale account and accept this master group
“Now, If doctor starts new profession, then there is no need to show opening balance in ledger creation but if doctor is old and convert all his accounts from manual to tally 9 , he has to write opening balance of his different assets and liabilities in ledger creation of tally 9 . ”
Change Feature – F11
Maintain cost centre = yes
Change Configuration – F12
Use Advance entries in master under heading of Account Master = yes
Create Cost Center of each patient separately
Every cost centre must be for every patient.
Account Info → Cost Center → Create
Now create ledger
I am giving some examples: –
Gateway of tally → Account Info→ ledger → Create → Write following account under different groups
1 Capital of doctor Account (under Capital Account)
2 Equipment Account (Under fixed Assets Account
3 Furniture Account (Under Fixed Assets Account)
4 Consultancy Fees of Doctor Account (Under Professional Fees Account)
5 Operation Fees Account (Under professional Fees Account)
6 Gifts from patients Account (under Indirect income)
7 Inspection fees Account (Under professional fees Account)
8 Income from nursing home (Under indirect income)
9 Other professional income (Under professional fees Account)
10 Expenses of medicine purchases (Under indirect expenses)
11 Office Expense (Rent, lighting, water, salary of employees, telephone expenses (Under indirect expenses)
12 Depreciation on operation and extra- equipment’s and furniture and on other fixed assets (Under indirect expenses)
13 Motor car expenses (under indirect expenses)
14 Stationery expenses (under indirect expenses)
15 Conveyance expenses (under indirect expenses)
16 Any other expense (Under indirect expenses)
A doctor does not require to calculate gross profit because he is neither salesman nor sell any product. So, all expense will go under indirect expenses, there is no need to send any expenses under direct expenses group.
3rd Step
Pass the Voucher Entries in Accounting Vouchers
When any transaction happens
Ist when fees received from patients
for entering data in receipt voucher, take the following steps
1 Select accounting voucher at gateway of tally 9
2 Press F6 for receipt voucher
3 Press F2 date and enter current date
4 Select consultancy fees at ledger account
5 Enter Amount
6 Select the patient name at cost centre allocation
7 Enter brief case history, findings in voucher narration after this feed other voucher entries.
F4 – Contra Voucher
If a doctor deposit amount into bank or withdraw from bank at this time enter data in contra voucher
F5 Payment Voucher
All data entries relating to payment of all expenses
F7 Journal Voucher
All other voucher entries except above.
4th Step
Get the financial result from tally 9
Tally 9 is system which provide the financial information to doctors automatically in following way
• Brief history of patients
Display → statement of account → cost centre → cost centre breaks up
• prepare of income and expenditure Account (Change profit and loss account into income and expenditure account by going to alter position of groups)
• Prepare balance sheet
• Getting print of each report
The Criminal Justice and Public Order Act of 1994
a guide to the complexities of the Criminal Justice and Public Order Act of 1994.
This is a brief guide (courtesy of Freedom Network) to the CJA. A copy of the entire Act can be viewed online
Sections 61 & 62: Trespassers on land
Two or more persons trespassing on land (not including public highway land, e.g. verges & lay-bys) with the intention of living there may be directed to leave the land by the police if:
(a) there are 6 or more vehicles there; or
(b) if any damage has been caused to the land, e.g. crop damage); or
(c) ‘threatening or abusive words or behavior’ have been used against the occupier or their agents.
Not leaving ‘as soon as reasonably practicable’ is an offence; as is returning to the land within 3 months; the maximum sentence is 3 months in prison and/or a £2,500 fine. The police are also given powers to seize vehicles.
Sections 63, 64 & 65: Raves
A ‘rave’ is defined as a gathering of 100+ people, at which amplified music (‘wholly or predominantly characterized by the emission of a succession of repetitive beats'[!) is played which is likely to cause serious distress to the local community, in the open air and at night.
These sections give the police the power to order people to leave the land if they’re believed to be preparing to hold a rave (2 or more people); waiting for a rave to start (10+); actually, attending a rave (10+). Ignoring this direction, or returning to the land within the next week, are both offences, liable to 3 months’ imprisonment and/or a £2,500 fine.
Section 65 lets any uniformed constable who believes a person is on their way to a rave within a 5-mile radius to stop them and direct them away from the area – failure to comply can lead to a maximum fine of £1000.
Sections 66 & 67: Seizure
The arrangements authorizing police officers to enter land where a rave is in progress or anticipated. and which allow for the seizure, retention and charges for the confiscation of vehicles and sound equipment.
Section 68 & 69: Disruptive Trespassers
These refer to the new offence of ‘aggravated trespass’. Section 68 is committed by anyone trespassing on land in the open air (not including highways and roads) with the intent of intimidating other people engaged in ‘lawful activity’ on that land or adjoining land, so as to deter them, or obstructing/ disrupting them (‘lawful activities’ of course include such delights as fox-hunting; earth-raping etc. etc.…)
Section 69 gives the police sort of preventative powers to direct people to leave land. This direction can be made by a senior officer as long as at least one person is committing or intends to commit aggravated trespass, or there are two or more people present with the ‘common purpose’ of aggravated trespass.
Failure to comply with this direction carries a maximum penalty of 3 months in prison and/or a 2,500 fine.
Sections 70 & 71: Trespassory Assemblies
As an amendment to the Public Order Act of 1986, this part allows the police to apply to the local authority (or, in London, the Home Secretary) to prohibit ‘trespassory assemblies’ of 20+ people for up to 4 days with a 5-mile exclusion zone, as long as there is a risk of ‘serious disruption to the local community’, or of ‘significant damage’ to the land or buildings/ monuments on it which may have historical/ archaeological/ scientific importance.
Anyone organizing or inciting another to attend one of these may be arrested and imprisoned for up to three months. Attendance, and refusal to be directed away, is punished by arrest and a maximum fine of £1000.
Sections 72, 73 & 74: Squatters – and Protected Intended Occupiers
These mean changes to section 6 of the Criminal Law Act of 1977, and apply only to residential property. DROs (‘displaced residential occupiers’, an extremely rare phenomenon!) and PIOs (‘protected intended occupiers’) – or others who can prove that they are acting on behalf of them – are made exempt from the protection previously given squatters and are permitted to use violence to secure entry.
It becomes an offence not to leave premises when requested to by a PIO or DRO, liable to 6 months’ imprisonment and/or a fine of 5000. Section 74 introduces a new offence of deliberately or recklessly making a false statement to claim PIO status. The definition of a PIO has been extended slightly.
Sections 75 & 76: Interim Possession Orders
These sections introduce a new ‘faster’ way of evicting squatters. Once an IPO (interim possession order) has been granted by a court and all the legal procedures have been correctly followed, the ‘squatters’ must leave within 24 hours of its service. It covers any person who is there when the Order is served and even those who arrive afterwards – failing to leave or returning within one year are both offences.
The maximum penalty is 6 months in prison and/or a 5000 fine. Similarly, to above, section 75 makes it an offence for the owner to make a false or misleading statement to obtain an IPO.
Sections 77, 78 & 79: Unauthorized Campers
‘Unauthorized campers’ are people residing in a vehicle or vehicles on any part of the highway or any other land in the open air without permission of the owner.
Section 77 gives the local council the authority to direct an unauthorized camper to leave the land and remove all vehicles. It becomes an offence to not leave the land and remove all vehicles/ property ‘as soon as reasonably practicable’ or to re-enter the land within 3 months, liable to a fine of up to 1000.
A magistrates’ court can make an order under section 78 which allows the local council to take ‘reasonable steps’ to ensure the removal of a vehicle and any person residing within it. Another new offence is the willful obstruction of anyone engaged in the removal – maximum fine of 1000.
Section 80: Caravan Sites Act
The Caravan Sites Act of 1968 included a duty of local authorities to provide gypsy sites in their areas. Most local authorities never got anywhere near full, decent levels of provision, but section 80 repeals that duty, so leaving travelers with nowhere legal to stop.
Section 154: Intentional Harassment, Alarm or Distress
This section inserts a new section 4(a) into the Public Order Act of 1986. Designed for incidents of racial harassment, its definition means it has much wider potential uses, whether against football fans or peaceful protestors, both of whom is has already been used against.
It becomes an offence to intentionally either (a) use ‘threatening, abusive or insulting behavior, or disorderly behavior’; or (b) display ‘any writing, sign or visible representation which is threatening, abusive or insulting’; to cause someone ‘harassment, alarm or distress’. The maximum penalty is 6 months in prison and/or a fine of 5000.
Section 82: Possession of Articles or Information Useful to Terrorists
This section is to be inserted into the 1989 Prevention of Terrorism Act as a new Part IVa of that Act. Besides the offence of possessing articles ‘giving rise to a reasonable suspicion’ that they are to be used for terroristic reasons; it also becomes an offence to collect, record or simply possess ‘any information which is of such a nature as is likely to be useful to terrorists in planning or carrying out any act of terrorism…’
The information is described as that ‘not in the public domain’ but journalists, peace campaigners and other researchers regularly use such information in the course of their work.
The burden of proof lies on the accused to show that they had ‘reasonable excuse’ or ‘lawful authority’ to hold the information. Conviction can mean a prison sentence of up to 10 years and/or a fine. See Terrorism Acts 2000-2001 andblagged.freeserve.co.uk/
Other police powers, in less detail
Right to Silence
Up till now, anyone arrested has had the right to remain silent in police custody – a precious safeguard of a legal system based on the premise that everyone is innocent until proven guilty. Now, a jury can ‘draw adverse inference’ from the accused’s relying on evidence not mentioned to the police at the time of arrest.
Increased Stop & Search Powers
Similar to the old ‘sus’ laws, these give the police increased powers to declare areas as ‘stop & search zones’ because they anticipate that ‘serious incidents of violence’ may take place.
A direction can be made to cover an area for up to 24 hours, with possible 6-hour extension.
The police are then able to stop and question people at random, as well as searching vehicles, pedestrians and any bags for weapons and dangerous articles, without even suspecting that those people have committed an offence or intend to.
This is bound to affect young people from ethnic minorities who are much more likely to be stopped and searched than a white person.
Intimate Samples
The CJA introduces the compulsory taking of ‘intimate and non-intimate’ samples ( such as hair, saliva, skin, pubic hair, hair, blood, urine, semen – ‘reasonable force’ may be used in cases of non-cooperation!) from anyone charged with a ‘recordable offence’ ( some of these are relatively minor offences and the samples are not for use in the case). These samples will instead be used for a national DNA database.
Prisons
Privately-run prisons, unaccountable to public scrutiny and run on a profit-making basis, and due to be introduced, along with prison ships and ‘secure training centres’ for children aged 12 to 14. These young inmates can be strip-searched forcibly by a single member of staff; all their mail can be read and censored; all family visits can be stopped on the order of the Centre’s Director…
Bail conditions
Changes to the Police & Magistrates’ Act mean that the police will often be able to set bail conditions themselves without resorting to a magistrate in a court. This makes ultra-restrictive bail conditions much more likely.
The Healthcare Service Personnel and Clinical Establishments (Prohibition of violence and damage to property) Bill, 2019″ —
No. Z.28013/22/2019-MS Government of India Ministry of Health & Family Welfare
Department of Health & Family Welfare
(Medical Services Division) ******
Nirman Bhawan, New Delhi Dated: 2nd September, 2019
NOTICE
Subject: Draft Legislation titled “The Healthcare Service Personnel and Clinical Establishments (Prohibition of violence and damage to property) Bill, 2019” — regarding
Ministry of Health and Family Welfare, Government of India proposes to formulate a legislation to address the issue of violence against the healthcare service professionals and damage to property of clinical establishments. A Legislation titled as “The Healthcare Service Personnel and Clinical Establishments (Prohibition of violence and damage to property) Bill, 2019” has been prepared.
It has been decided to solicit objections and suggestions from public with regard to said draft legislation before the finalization of the draft Bill. The objections/suggestions may be forwarded within 30 days from the date of issue of this notice by email at us-ms-mohfwnic.in or to Shri. Rajeev Attri, Under Secretary (Medical Services Division), Ministry of Health and Family Welfare, Room No. 514(B), A-Wing, NirmanBhawan, New Delhi-110011. Only the comments received on the above-mail/ address and/or within the period of 30 days shall be taken into consideration.
2.
End: Draft Bill.
44k1171.-0
(Rajeev Attri) Under Secretary to the Govt. of India Tel: 011-23061883
THE HEALTHCARE SERVICE PERSONNEL AND CLINICAL ESTABLISHMENTS (PROHIBITION OF VIOLENCE AND DAMAGE TO PROPERTY) BILL, 2019.
A BILL
to prohibit violence against healthcare service personnel and damage or loss to property of clinical establishments and for matters connected therewith and incidental thereto.
WHEREAS, acts of violence causing injury or danger to life of healthcare service personnel and damage or loss to the property of clinical establishments are on the increase in the country creating unrest among healthcare service personnel resulting in hindrance to healthcare services in the country;
AND WHEREAS, to protect healthcare service personnel and property of clinical establishments against violence, it has become necessary to prohibit such acts of violence, to provide for punishment by making such acts of violence as cognizable and non-bailable offence and to provide compensation for injury to healthcare service personnel or for causing damage or loss to the property of clinical establishments;
BE it enacted by Parliament in the Seventieth Year of the Republic of India, as follows:
CHAPTER I PRELIMINARY
1. Short title, extent, application and commencement —
(1) This Act may be called the Healthcare Service Personnel and Clinical Establishments (Prohibition of violence and damage to property) Act, 2019.

by –
It extends to the whole of the India.
It applies to clinical establishments as defined in clause (a) of section 3 and registered under the Clinical Establishments (Registration and Regulation) Act, 2010 or under any State Act for the time being in force.
It shall come into force on such date as the Central Government may, by notification in the Official Gazette, appoint.
Application of other laws not barred- The provisions of this Act shall be in addition to, and not, save as otherwise expressly provided, in derogation of any other law for the time being in force.
Definitions— In this Act, unless the context otherwise requires— (a) “clinical establishment” means-
a hospital, maternity home, nursing home, dispensary, clinic, sanatorium or an institution by whatever name called that offers services, facilities requiring diagnosis, treatment or care for illness, injury, deformity, abnormality or pregnancy in any recognized system of medicine established and administered or maintained by any person or body of persons, whether incorporated or not; or
a place established as an independent entity or part of an establishment referred to in sub-clause (i), in connection with the diagnosis or treatment of diseases where pathological, bacteriological, genetic, radiological, chemical, biological investigations or other diagnostic or investigative services with the aid of laboratory or other medical equipment, are usually carried on, established and administered or maintained by any person or body of persons, whether incorporated or not;
and shall include a clinical establishment owned, controlled or managed

the Government or a department of the Government; or a Public Sector Undertaking or Autonomous Body of the Government;
a trust, whether public or private;
a corporation (including a society) registered under a Central, or Provincial or State Act, whether or not owned by the Government;
a local authority; and
a single doctor,
Explanation:
For the purposes of this clause, an ambulance or a mobile medical unit shall be deemed to be a clinical establishment if such vehicle is fitted with medical equipment and is used for providing healthcare service.
(b)” healthcare service personnel- in relation to a clinical establishment, shall include-
A registered medical practitioner, possessing a recognized medical qualification as defined in clause (h) of section 2 of the Indian Medical Council Act, 1956, and enrolled in a State Medical Register as defined in clause (k) of that section;
a medical practitioner registered for practicing in any other system of medicine which is recognized under any law for the time being in force;
a registered dentist, registered dental hygienist and registered dental mechanic as defined in clause (I) of Section 2 of the Dentist’s Act, 1948;
a registered nurse, midwife, auxiliary nurse-midwife and health visitor who is registered as such under section 15A of the Indian Nursing Council Act, 1947;
a medical student who is undergoing education or training in any system of medicine recognized by any law for the time being in force;

a nursing student who is undergoing education or training in nursing profession;
a para-medical workers, para-medical student and diagnostic services provider; and
ambulance driver and helper,
“section” means a section of the Act;
“violence” means an act which causes or may cause….
harm, injury, hurt, grievous hurt, intimidation to, or danger to the life of, a healthcare service personnel in discharge of duty, either within the premises of a clinical establishment or otherwise; or
obstruction or hindrance to a healthcare service personnel in discharge of duty, either within the premises of a clinical establishment or otherwise;
loss of or damage to any property or documents in a clinical establishment;
Words and expression used herein and not defined, but defined in Indian Penal Code or in the code of criminal procedure, 1973 shall have the meanings respectively assigned to them in those Codes.
CHAPTER II OFFENCES AND PENALITIES
Prohibition of violence- No person shall indulge in any act of violence against a healthcare service personnel or cause any damage or loss to any property in a clinical establishment.
Offences and penalties: (1) Whoever commit violence or abets or incites commission of violence against any healthcare service personnel

or abets or incites or causes damage or loss to any property of a clinical establishment, shall, upon conviction, be punished with imprisonment for a term which shall not be less than six months but which may extend to five years, and with fine, which shall not be less than fifty thousand rupees but which may extend to five lakh rupees;
(2) Whoever, while committing violence as referred to in sub-section (1), causes grievous hurt as defined in section 320 of the Indian Penal Code to any healthcare service personnel, shall, upon conviction, be punished with imprisonment for a term which shall not be less than three years, but which may extend to ten years, and with fine, which shall not be less than two lakh rupees, but which may extend to ten lakh rupees.
Information of offence- Notwithstanding anything contained in the Code of Criminal Procedure, 1973, upon a written request of the aggrieved healthcare service personnel, it shall be mandatory for the person in charge of a clinical establishment to inform the officer in charge of the concerned police station of the commission of an offence under this Act.
Offence to be cognizable and non-bailable- Notwithstanding anything contained in the Code of Criminal Procedure, 1973, an offence punishable under this Act shall be cognizable and non-bailable.
Investigation of offence-Notwithstanding anything contained in the Code of Criminal Procedure, 1973, any case registered under this Act shall be investigated by a police officer not below the rank of Deputy Superintendent of Police.
Compensation for acts of violence –
(1) In addition to the punishment provided for the offence under section
5, the convicted person shall be liable to pay, by way of compensation
(i) an amount, twice the amount of fair market value of the damaged property or the loss caused, as may be determined by the court;
(ii)one lakh rupees for causing hurt to healthcare service personnel and five lakh rupees for causing grievous hurt to healthcare service personnel.
(2) If the convicted person does not pay the compensation granted under sub-section (1), the said sum shall be recovered as an arrear of land revenue under the Revenue Recovery Act, 1890.
THE INDIAN MEDICAL COUNCIL ACT, 1956
(102 of 1956)
30th December, 1956
(As amended by the Indian Medical Council (Amendment) Acts, 1964, 1993 & 2001)
AN ACT TO PROVIDE FOR THE RECONSTITUTION OF THE MEDICAL COUNCIL OF INDIA AND THE MAINTENANCE OF A MEDICAL REGISTER FOR INDIA AND FOR MATTERS CONNECTED THEREWITH.
Be it enacted by Parliament in the seventh year of the Republic of India as follows: –
1. SHORT TITLE, EXTENT & COMMENCEMENT
1. This Act may be called the Indian Medical Council Act, 1956.
2. It extends to the whole of India.
3. It shall come into force on such date as the Central Government may, by notification in the Official Gazette, appoint.
2. DEFINITIONS
In this Act, unless the context otherwise requires: –
a. “approved institution” means a hospital, health centre or other such institution recognized by a university as an institution in which a person may undergo the training, if any, required by his course of study before the award of any medical qualification to him.
b. “council” means the Medical Council of India constituted under this Act.
c. [“deleted” by Indian Medical Council (Amendment) Act, 1964.]
d. “Indian Medical Register” means the medical register maintained by the Council.
e. “Medical Institution” means any institution, within or without India, which grants degrees, diplomas or licenses in medicine.
f. “medicine” means modern scientific medicine in all its branches and includes surgery and obstetrics, but does not include veterinary medicine and surgery;
g. “Prescribed” means prescribed by regulations.
h. “recognized medical qualification” means any of the medical qualifications included in the Schedules.
i. “regulation” means a regulation made under section 33;
j. “State Medical Council” means a medical council constituted under any law for the time being in force in any State regulating the registration of practitioners of medicine.
k. “State Medical Register” means a register maintained under any law for the time being in force in any State regulating the registration of practitioners of medicine.
l. “University” means any University in India established by law and having a medical faculty.
3. CONSTITUTION & COMPOSITION OF THE COUNCIL
1. The Central Government shall cause to be constituted a council consisting of the following members, namely: –
1. One member from each State other than a Union Territory to be nominated by the Central Government in consultation with the State Government concerned.
2. One member from each University to be elected from amongst the members of the medical faculty of the University by members of the Senate of the University or in case the University has no Senate, by members of the Court.
3. One member from each State in which a State Medical Register is maintained, to be elected from amongst themselves by persons enrolled on such register who possess the medical qualifications included in the First or the Second Schedule or in Part II of the Third Schedule.
4. Seven members to be elected from amongst themselves by persons enrolled on any of the State Medical Registers who possess the medical qualifications included in Part I of the Third Schedule.
5. Eight members to be nominated by the Central Govt.
2. The President and Vice-President of the Council shall be elected by the members of the Council from amongst themselves.
3. No act done by the Council shall be questioned on the ground merely of the existence of any vacancy in, or any defect in the constitution of the Council.
4. MODE OF ELECTION
1. (a) An election under clause (b), clause (c) or clause (d) of sub-section (1) of section 3 shall be conducted by the Central Government in accordance with such rules as may be made by it in this behalf, and any rules so made may provide that pending the preparation of the Indian Medical Register in accordance with provisions of this Act, the members referred to in clause (d) of sub-section (1) of section 3 may be nominated by the Central Government instead of being elected as provided therein.
2. Where any dispute arises regarding any election to the Council, it shall be referred to the Central Government whose decision shall be final.
5. RESTRICTIONS ON NOMINATION AND MEMBERSHIP
1. No person shall be eligible for nomination under clause (a) of sub-section (1) of section 3 unless he possesses any of the medical qualifications included in the First and Second Schedules, resides in the State concerned, and where a State Medical Register is maintained in that State, is enrolled on that Register.
2. No person may at the same time serve as a member in more than one capacity.
6. INCORPORATION OF THE COUNCIL
The Council so constituted shall be a body corporate by the name of the Medical Council of India,
having perpetual succession and a common seal, with power to acquire and hold property, both movable and immovable, and to contract and shall by the said name sue and be sued.
7. TERM OF OFFICE OF PRESIDENT, VICE-PRESIDENT AND MEMBERS
1. The President or Vice-President of the Council shall hold office for a term not exceeding five years and not extending beyond the expiry of his term as member of the Council.
2. Subject to the provisions of this section, a member shall hold office for a term of five years from the date of his nomination or election or until his successor shall have been duly nominated or elected, whichever is longer.
3. An elected or nominated member shall be deemed to have vacated his seat if he is absent without excuse, sufficient in the opinion of the Council from three consecutive ordinary meetings of the Council, or in the case of a member elected under clause (b) of sub-section (1) of section 3, if he ceases to be a member of the medical faculty of the university concerned, or in the case of a member elected under clause (c) or clause (d) of that sub-section, if he ceases to be a person enrolled on the State Medical Register concerned.
4. A casual vacancy in the Council shall be filled by nomination or election, as the case may be, and the person nominated or elected to fill the vacancy shall hold office only for the remainder of the term for which the member whose place he takes was nominated or elected.
5. Members of the Council shall be eligible for re-nomination or re-election.
6. Where the said term of five years is about to expire in respect of any member, a successor may be nominated or elected at any time within three months before the said term expires but he shall not assume office until the said term has expired.
8. MEETINGS OF THE COUNCIL
1. The Council shall meet at least once in each year at such time and place as may be appointed by the Council.
2. Unless otherwise provided by regulations fifteen members of the Council shall form a quorum, and all the acts of the Council shall be decided by a majority of the members present and voting.
9. OFFICERS, COMMITTEES AND SERVANTS OF THE COUNCIL
The Council Shall:
1. constitute from amongst its members an Executive Committee and such other committees for general or special purposes as the Council deems necessary to carry out the purposes of this Act.
2. appoint a Registrar who shall act as Secretary and who may also, if deemed expedient, act as Treasurer.
3. employ such other persons, as the Council deems necessary to carry out the purposes of this Act.
4. require and take from the Registrar, or from any other employee, such security for the due performance of his duties as the Council deems necessary and
5. With the previous sanction of the Central Government fix the remuneration and allowances to be paid to the President, Vice-President and members of the Council and determine the conditions of service of the employees of the Council.
10. THE EXECUTIVE COMMITTEE
1. The Executive Committee, hereinafter referred to as the Committee shall consist of the President and Vice-President, who shall be members ex-officio and not less than seven and not more than ten other members who shall be elected by the Council from amongst its members.
2. The President and Vice-President shall be the President and Vice-President respectively of the Committee.
3. In addition to the powers and duties conferred and imposed upon it by this Act, the Committee shall exercise and discharge such powers and duties as the Council may confer or impose upon it by any regulations which may be made in this behalf.
10A. PERMISSION FOR ESTABLISHMENT OF NEW MEDICAL COLLEGE, NEW COURSE OF STUDY ETC.
1. Notwithstanding anything contained in this Act or any other law for the time being in force: –
1. no person shall establish a medical college
(or)
2. no medical college shall: –
1. open a new or higher course of study or training (including a postgraduate course of study or training) which would enable a student of such course or training to qualify himself for the award of any recognized medical qualification; or
2. increase its admission capacity in any course of study or training (including a postgraduate course of study or training), except with the previous permission of the Central Government obtained in accordance with the provisions of this section.
Explanation 1 – For the purposes of this section, “person” includes any University or a trust but does not include the Central Government.
Explanation 2 – For the purposes of this section “admission capacity” in relation to any course of study or training (including postgraduate course of study or training) in a medical college, means the maximum number of students that may be fixed by the Council from time to time for being admitted to such course or training.
2.
1. Every person or medical college shall, for the purpose of obtaining permission under sub-section (1), submit to the Central Government a scheme in accordance with the provisions of clause (b) and the central Government shall refer the scheme to the Council for its recommendations.
2. The Scheme referred to in clause (a) shall be in such form and contain such particulars and be preferred in such manner and be accompanied with such fee as may be prescribed.
3. On receipt of a scheme by the Council under sub-section (2) the Council may obtain such other particulars as may be considered necessary by it from the person or the medical college concerned, and thereafter, it may –
1. if the scheme is defective and does not contain any necessary particulars, give a reasonable opportunity to the person or college concerned for making a written representation and it shall be open to such person or medical college to rectify the defects, if any, specified by the Council.
2. consider the scheme, having regard to the factors referred to in sub-section (7) and submit the scheme together with its recommendations thereon to the Central Government.
4. The Central Govt. may after considering the scheme and the recommendations of the Council under sub-section (3) and after obtaining, where necessary, such other particulars as may be considered necessary by it from the person or college concerned, and having regard to the factors referred to in sub-section (7), either approve (with such conditions, if any, as it may consider necessary ) or disapprove the scheme, and any such approval shall be a permission under sub-section (1):
Provided that no scheme shall be disapproved by the Central Government except after giving the person or college concerned a reasonable opportunity of being heard; Provided further that nothing in this sub section shall prevent any person or medical college whose scheme has not been approved by the Central Government to submit a fresh scheme and the provisions of this section shall apply to such scheme, as if such scheme has been submitted for the first time under sub-section (1).
5. Where, within a period of one year from the date of submission of the scheme to the Central Government under sub-section (1), no order passed by the Central Government has been communicated to the person or college submitting the scheme, such scheme shall be deemed to have been approved by the Central Government in the form in which it had been submitted, and accordingly, the permission of the Central Government required under sub-section (1) shall also be deemed to have been granted.
6. In computing the time-limit specified in sub-section (5), the time taken by the person or college concerned submitting the scheme, in furnishing any particulars called for by the Council, or by the Central Government, shall be excluded.
7. The Council, while making its recommendations under clause (b) of sub-section (3) and the Central Government, while passing an order, either approving or disapproving the scheme under sub-section (4), shall have due regard to the following factors, namely: –
1. whether the proposed medical college or the existing medical college seeking to open a new or higher course of study or training, would be in a position to offer the minimum standards of medical education as prescribed by the Council under section 19A or, as the case may be under section 20 in the case of postgraduate medical education.
2. whether the person seeking to establish a medical college or the existing medical college seeking to open a new or higher course of study or training or to increase it admission capacity has adequate financial resources;
3. whether necessary facilities in respect of staff, equipment, accommodation, training and other facilities to ensure proper functioning of the medical college or conducting the new course or study or training or accommodating the increased admission capacity, have been provided or would be provided within the time-limit specified in the scheme.
4. whether adequate hospital facilities, having regard to the number or students likely to attend such medical college or course of study or training or as a result of the increased admission capacity, have been provided or would be provided within the time-limit specified in the scheme;
5. whether any arrangement has been made or programme drawn to impart proper training to students likely to attend such medical college or course of study or training by persons having the recognized medical qualifications;
6. the requirement of manpower in the field of practice of medicine; and any other factors as may be prescribed.
7. Where the Central Government passes an order either approving or disapproving a scheme under this section, a copy of the order shall be communicated to the person or college concerned.
10B. NON-RECOGNITION OF MEDICAL QUALIFICATIONS IN CERTAIN CASES.
1. Where any medical college is established except with the previous permission of the Central Government in accordance with the provisions of section 10A, no medical qualification granted to any student of such medical college shall a recognized medical qualification for the purposes of this Act.
2. Where any medical college opens a new or higher course of study or training (including a postgraduate course of study or training) except with the previous permission of the Central Government in accordance with the provisions of section 10A, no medical qualification granted to any student of such medical college on the basis of such study or training shall be a recognized medical qualification for the purposes of this Act.
3. Where any medical college increases its admission capacity in any course of study or training except with the previous permission of the Central Government in accordance with the provisions of section 10A, no medical qualification granted to any student of such medical college on the basis of the increase in its admission capacity shall be a recognized medical qualification for the purposes of this Act.
Explanation – For the purposes of this section, the criteria for identifying a student who has been granted a medical qualification on the basis of such increase in the admission capacity shall be such as may be prescribed.
10C. TIME FOR SEEKING PERMISSION FOR CERTAIN EXISTING MEDICAL COLLEGES, ETC.
1. If, after, the 1st day of June, 1992 and on and before the commencement of the Indian Medical Council (Amendment) Act, 1993 any person has established a medical college or any medical college has opened a new or higher course of study or training or increased the admission capacity, such person or medical college, as the case may be, shall seek, within a period of one year from the commencement of the Indian Medical Council (Amendment) Act, 1993 the permission of the Central Government in accordance with the provisions of section 10A.
2. If any person or medical college, as the case may be fails to seek the permission under sub section (1) the provisions of section 10B shall apply, so far as may be as if, permission of the Central Government under section 10A has been refused;
11. RECOGNITION OF MEDICAL QUALIFICATION GRANTED BY UNIVERSITIES OR MEDICAL INSTITUTIONS IN INDIA.
1. The medical qualifications granted by any university or medical Institution in India which are included in the first Schedule shall be recognized medical qualifications for the purposes of this Act.
2. Any university or medical Institution in India which grants a medical qualification not included in the First Schedule may apply to the Central Govt., to have such qualification recognized, and the Central Government, after consulting the Council, may, by notification in the official Gazette, amend the First Schedule so as to include such qualification therein, and any such notification may also direct that an entry shall be made in the last column of the First Schedule against such medical qualification declaring that it shall be a recognized medical qualification only when granted after a specified date.
12. RECOGNITION OF MEDICAL QUALIFICATIONS GRANTED BY MEDICAL INSTITUTIONS IN COUNTRIES WITH WHICH THERE IS A SCHEME OF RECIPROCITY
1. The medical qualifications granted by medical institutions outside India which are included in the Second Schedule shall be recognized medical qualifications for the purposes of this Act.
2. The Council may enter into negotiations with the Authority in any country outside India which by the law of such country is entrusted with the maintenance of a register of medical practitioners, for the settling of a scheme of reciprocity for the recognition of medical qualifications and in pursuance of any such scheme, the Central Government may, by notification in the official Gazette, amend the Second Schedule so as to include therein the medical qualification which the Council has decided should be recognized and any such notification may also direct that an entry shall be made in the last column of the Second Schedule against such medical qualification declaring that it shall be a recognized medical qualification only when granted after a specified date.
3. The Central Government, after consultation with the Council, may, by notification in the Official Gazette, amend the Second Schedule by directing that an entry be made therein in respect of any medical qualification declaring that it shall be recognized medical qualification only when granted before a specified date.
4. Where the Council has refused to recommend any medical qualification which has been proposed for recognition by any Authority referred to in sub-section (2) and that Authority applies to the Central Government in this behalf, the Central Government, after considering such application and after obtaining from the council a report, if any, as to the reasons for any such refusal, may by notification in the Official Gazette, amend the Second Schedule so as to include such qualification therein and the provisions of sub-section (2) shall apply to such notification.
13. RECOGNITION OF MEDICAL QUALIFICATION GRANTED BY CERTAIN MEDICAL INSTITUTIONS WHOSE QUALIFICATIONS ARE NOT INCLUDED IN THE FIRST OR SECOND SCHEDULE
1. The medical qualifications granted by medical institutions in India which are not included in the First Schedule and which are included in Part I of the Third Schedule shall also be recognized medical qualifications for the purposes of this Act.
2. The medical qualifications granted to a citizen of India: –
1. before the 15th day of August, 1947, by medical institutions in the territories now forming part of Pakistan, and,
2. before the 1st day of April, 1937, by medical institutions in the territories now forming part of Burma, which are included in part 1 of the Third Schedule shall also be recognized medical qualifications for the purposes of this Act.
3. The medical qualifications granted by medical institutions outside India, before such date as the Central Government may, by notification in the Official Gazette, specify which are included in Part Ian of the Third Schedule shall also be recognized medical qualifications for the purposes of this Act, but no person possessing any such qualification shall be entitled to enrolment on any State Medical Register unless he is a citizen of India and has undergone such practical training after obtaining that qualification as may be required by the rules or regulations in force in the country granting the qualification, or if he has not undergone any practical training in that country he has undergone such practical training as may be prescribed.
4. The Central Government, after consulting the Council, may, by notification in the Official Gazette, amend Part II of the Third Schedule so as to include therein any qualification granted by a medical institution outside India, which is not included in the Second Schedule.
Provided that after the commencement of the Indian Medical Council (Amendment) Act, 2001, no such amendment shall be made in Part II of the Third Schedule to include any primary medical qualification granted by any medical institution outside India:
Provided further that nothing contained in the first proviso shall apply to inclusion in Part II of the Third Schedule any primary medical qualification granted by any medical institution outside India to any person whose name is entered in the Indian Medical Register.
Explanation- For the purposes of this sub-section, “primary medical qualification” means any minimum qualification sufficient for enrolment on any State Medical Register or for entering the name in the Indian Medical Register.
(4A) A person who is a citizen of India and obtains medical qualification granted by any medical institution in any country outside India recognized for enrolment as medical practitioner in that country after such date as may be specified by the Central Government under sub-section (3), shall not be entitled to be enrolled on any Medical Register maintained by a State Medical Council or to have his name entered in the Indian Medical Register unless he qualified the screening test in India prescribed for such purpose and such foreign medical qualification after such person qualifies that said screening test shall be deemed to be the recognized medical qualification for the purposes of this Act for that person.
(4B) A person who is a citizen of India shall not, after such date as may be specified by the Central Government under sub-section (3), be eligible to get admission to obtain medical qualification granted by any medical institution in any foreign country without obtaining an eligibility certificate issued to him by the Council and in case any such person obtains such qualification without obtaining such eligibility certificate, he shall not be eligible to appear in the screening test referred to in sub-section (4A):
Provided that an Indian citizen who has acquired the medical qualification from foreign medical institution or has obtained admission in foreign medical institution before the commencement of the Indian Medical Council (Amendment) Act, 2001 shall not be required to obtain eligibility certificate under this sub-section but, if he is qualified for admission to any medical course for recognized medical qualification in any medical institution in India, he shall be required to qualify only the screening test prescribed for enrolment on any State Medical Register or for entering his name in the Indian Medical Register.
(4C) Nothing contained in sub-sections (4A) and (4B) shall apply to the medical qualifications referred to in section 14 for the purposes of that section.
5. Any medical institution in India which is desirous of getting a medical qualification granted by it included in Part I of the Third Schedule may apply to the Central Government to have such qualification recognized and the Central Government, after consulting the Council, may by notification in the Official Gazette, amend Part I of the Third Schedule so as to include such qualification therein, and any such notification may also direct that an entry shall be made in the last column of Part-I of the Third Schedule against such medical qualification declaring that it shall be a recognized medical qualification only when granted after a specified date.
14. SPECIAL PROVISION IN CERTAIN CASES FOR RECOGNITION OF MEDICAL QUALIFICATIONS GRANTED BY MEDICAL INSTITUTIONS IN COUNTRIES WITH WHICH THERE IS NO SCHEME OF RECIPROCITY.
1. The Central Government after consultation with the Council, may, by notification in the Official Gazette, direct that medical qualifications granted by medical institutions in any country out-side India in respect of which a scheme of reciprocity for the recognition of medical qualifications is not in force, shall be recognized medical qualification for the purposes of this Act or shall be so only when granted after a specified date:
Provided that medical practice by persons possessing such qualifications: –
1. shall be permitted only if such persons are enrolled as medical practitioners in accordance with the law regulating the registration of medical practitioners for the time being in force in that country;
2. shall be limited to the institution to which they are attached for the time being for the purposes of teaching, research or charitable work; and
3. shall be limited to the period specified in this behalf by the Central Government by general or special order.
2. In respect of any such medical qualification the Central Government, after consultation with the Council may, by notification in the Official Gazette direct that it shall be a recognized medical qualification only when granted before a specified date.
15. RIGHT OF PERSONS POSSESSING QUALIFICATIONS IN THE SCHEDULES TO BE ENROLLED.
1. Subject to the other provisions contained in this Act, the medical qualifications included in the Schedules shall be sufficient qualification for enrolment on any State Medical Register.
2. Save as provided in section 25, no person other than a medical practitioner enrolled on a State Medical Register: –
a. shall hold office as physician or surgeon or any other office (by whatever designation called) in Government or in any institution maintained by a local or other authority;
b. shall practice medicine in any State;
c. shall be entitled to sign or authenticate a medical or fitness certificate or any other certificate required by any law to be signed or authenticated by a duly qualified medical practitioner:
d. shall be entitled to give evidence at any inquest or in any court of law as an expert under section 45 of the Indian Evidence Act, 1872 on any matter relating to medicine.
3. Any person who acts in contravention of any provision of sub-section (2) shall be punished with imprisonment for a term which may extend to one year or with fine which may extend to one thousand rupees, or with both;
16. POWER TO REQUIRE INFORMATION AS TO COURSES OF STUDY AND EXAMINATIONS
Every University or medical institution in India which grants a recognized medical qualification shall furnish such information as the Council may, from time to time, require as to the courses of study and examinations to be undergone in order to obtain such qualification, as to the ages at which such courses of study and examinations are required to be undergone and such qualification is conferred and generally as to the requisites for obtaining such qualification.
17. INSPECTION OF EXAMINATIONS
1. The Committee shall appoint such number of medical inspectors as it may deem requisite to inspect any medical institution, college, hospital or other institution where medical education is given, or to attend any examination held by any University or medical institution for the propose of recommending to the Central Government recognition of medical qualifications granted by the University or medical institution.
2. The medical inspectors shall not interfere with the conduct of any training or examination, but shall report to the committee on the adequacy of the standards of medical education including staff, equipment, accommodation, training facilities prescribed for giving medical education or on the sufficiency of every examination which they attend.
3. The Committee shall forward a copy of any such report to the university or medical institution concerned and shall also forward a copy with the remarks of the University or institution thereon, to the Central Government.
18. VISITORS AT EXAMINATIONS
1. The Council may appoint such number of visitors as it may deem requisite to inspect any medical institution, college, hospital or other institution where medical education is given, or to attend any examination held by any University or medical institution for the purpose of granting recognized medical qualifications.
2. Any person, whether he is a member of the Council or not may be appointed as a visitor under this section but a person who is appointed as an inspector under section 17 for any inspection or examination shall not be appointed as a visitor for the same inspection or examination.
3. The visitors shall not interfere with the conduct of any training or examination but shall report to the President of the Council on the adequacy of the standards of medical education including staff, equipment, accommodation, training and other facilities prescribed for giving medical education or on the sufficiency of every examination which they attend.
4. The report of a visitor shall be treated as confidential unless in any particular case the President of the Council otherwise directs:
Provided that if the Central Government requires a copy of the report of a visitor, the Council shall furnish the same.
19. WITHDRAWAL OF RECOGNITION
1. When upon report by the Committee or the visitor it appears to the Council: –
1. that the courses of study and examination to be undergone in, or the proficiency required from candidates at any examination held by any University or medical institution,
2. that the staff, equipment accommodation, training and other facilities for instruction and training provided in such University or medical institution or in any college or other institution affiliated to that University, do not conform to the standards prescribed by the Council, the Council shall make a representation to that effect to the Central Government.
2. After considering such representation, the Central Govt. may send it to the State Government of the State in which the University or medical Institution is situated and the State Government shall forward it along with such remarks as it may choose to make to the University or Medical Institution, with an intimation of the period within which the University or medical institution may submit its explanation to the State Government.
3. On the receipt of the explanation or, where no explanation is submitted within the period fixed, then on the expiry of that period, the State Government shall make its recommendations to the Central Government
4. The Central Government, after making such further inquiry, if any, as it may think fit, may by notification in the official Gazette, direct that an entry shall be made in the appropriate Schedule against the said medical qualification declaring that it shall be a recognized medical qualification, only when granted before a specified date or that the said medical qualification if granted to students of a specified college or institution affiliated to any university shall be a recognized medical qualification only when granted before a specified date or, as the case may be, that the said medical qualification shall be a recognized medical qualification in relation to a specified college or institution affiliated to any University only when granted after a specified date.
19A. MINIMUM STANDARDS OF MEDICAL EDUCATION
1. The Council may prescribe the minimum standards of medical education required for granting recognized medical qualifications (other than postgraduate medical qualifications) by universities or medical institutions in India.
2. Copies of the draft regulations and of all subsequent amendments thereof shall be furnished by the Council to all State Governments and the Council shall before submitting the regulations or any amendment thereof, as the case may be, to the Central Government for sanction, take into consideration the comments of any State Government received within three months from the furnishing of the copies as aforesaid.
3. The Committee shall from time to time report to the Council on the efficacy of the regulations and may recommend to the Council such amendments thereof as it may think fit.
20. POST-GRADUATE MEDICAL EDUCATION COMMITTEE FOR ASSISTING COUNCIL IN MATTERS RELATING TO POST-GRADUATE MEDICAL EDUCATION
1. The Council may prescribe standards of Postgraduate Medical Education for the guidance of Universities, and may advise Universities in the matter of securing uniform standards for Postgraduate Medical Education throughout India, and for this purpose the Central Govt. may constitute from among the members of the Council a Postgraduate Medical Education Committee (hereinafter referred to as the Post-graduate Committee)
2. The Postgraduate Committee shall consist of nine members all of whom shall be persons possessing postgraduate medical qualifications and experience of teaching or examining postgraduate students of medicine.
3. Six of the members of the Postgraduate Committee shall be nominated by the Central Government and the remaining three members shall be elected by the Council from amongst its members.
4. For the purpose of considering postgraduate studies in a subject, the Postgraduate Committee may co-opt, as and when necessary, one or more members qualified to assist it in that subject.
5. The views and recommendations of the Postgraduate Committee on all matters shall be placed before the Council and if the Council does not agree with the views expressed or the recommendations made by the Postgraduate Committee on any matter, the Council shall forward them together with its observations to the Central Government for decision.
20A. PROFESSIONAL CONDUCT
1. The Council may prescribe standards of professional conduct and etiquette and a code of ethics for medical practitioners.
2. Regulations made by the Council under sub-section (1) may specify which violations thereof shall constitute infamous conduct in any professional respect, that is to say, professional misconduct, and such provisions shall have effect notwithstanding anything contained in any law for the time being in force.
21. INDIAN MEDICAL REGISTER
1. The Council shall cause to be maintained in the prescribed manner a register of medical practitioners to be known as the Indian Medical Register, which shall contain the names of all persons who are for the time being enrolled on any State Medical Register and who possess any of the recognized medical qualifications.
2. It shall be the duty of the Registrar of the Council to keep the Indian Medical Register in accordance with the provisions of this Act and of any orders made by the Council, and from time to time to revise the register and publish it in the Gazette of India and in such other manner as may be prescribed.
3. Such register shall be deemed to be public document within the meaning of the Indian Evidence Act, 1872 and may be proved by a copy published in the Gazette of India.
22. SUPPLY OF COPIES OF THE STATE MEDICAL REGISTERS
Each State Medical Council shall supply to the Council six printed copies of the State Medical Register as soon as may be after the commencement of this Act and subsequently after the first day of April of each year, and each Registrar of a State Medical Council shall inform the Council without delay of all additions to and other amendments in the State Medical Register made from time to time.
23. REGISTRATION IN THE INDIAN MEDICAL REGISTER
The Registrar of the Council, may, on receipt of the report of registration of a person in a State Medical Register or on application made in the prescribed manner by any such person, enter his name in the Indian Medical Register, Provided that the Registrar is satisfied that the person concerned possesses a recognized medical qualification.
24. REMOVAL OF NAMES FROM THE INDIAN MEDICAL REGISTER
1. If the name of any person enrolled on a State Medical Register is removed there from in pursuance of any power conferred by or under any law relating to medical practitioners for the time being in force in any State, the Council shall direct the removal of the name of such person from the Indian Medical Register.
2. Where the name of any person has been removed from a State Medical Register on the ground of professional misconduct or any other ground except that he is not possessed of the requisite medical qualifications or where any application made by the said person for restoration of his name to the State Medical Register has been rejected, he may appeal in the prescribed manner and subject to such conditions including conditions as to the payment of a fee as may be laid down in rules made by the Central Government in this behalf, to the Central Government, whose decision, which shall be given after consulting the Council, shall be binding on the State Government and on the authorities concerned with the preparation of the State Medical Register.
25. PROVISIONAL REGISTRATION
1. A citizen of India possessing a medical qualification granted by a medical institution outside India included in part II of the Third Schedule, who is required to undergo practical training as prescribed under sub section (3) of Section 13, shall, on production of proper evidence that he has been selected for such practical training in an approved institution be entitled to be registered provisionally in a State Medical Register and shall be entitled to practice medicine in the approved institution for the purposes of such training and for no other purpose.
2. A person who has passed the qualifying examination of any university or Medical Institution in India for the grant of a recognized medical qualification shall be entitled to be registered provisionally in a State Medical Register for the purpose of enabling him to be engaged in employment in a resident medical capacity in any approved institution, or in the Medical Service of the Armed Forces of the Union, and for no other purpose, on production of proper evidence that he has been selected for such employment.
3. The names of all persons provisionally registered under sub-section (1) or sub-section (2) in the State Medical Register shall be entered therein separately from the names of other persons registered therein.
4. A person registered provisionally as aforesaid who has completed practical training referred to in sub section (1) or who has been engaged for the prescribed period in employment in a resident medical capacity in any approved institution or in the Medical service of the Armed Forces of the Union, as the case may be, shall be entitled to registration in the State Medical Register under Section 15.
26. REGISTRATION OF ADDITIONAL QUALIFICATIONS
1. If any person whose name is entered in the Indian Medical Register obtains any title, diploma or other qualification for proficiency in sanitary science, public health or medicine which is a recognized medical qualification, he shall, on application made in this behalf in the prescribed manner be entitled to have any entry stating such other title, diploma or other qualification made against his name in the Indian Medical Register either in substitution for or in addition to any entry previously made.
2. The entries in respect of any such person in a State Medical Register shall be altered in accordance with the alterations made in the Indian Medical Register.
27. PRIVILEGES OF PERSONS WHO ARE ENROLLED ON THE INDIAN MEDICAL REGISTER
Subject to the conditions and restrictions laid down in this Act, regarding medical practice by persons possessing certain recognized medical qualifications, every person whose name is for the time being borne on the Indian Medical Register shall be entitled according to his qualifications to practice as a medical practitioner in any part of India and to recover in due course of law in respect of such practice any expenses, charges in respect of medicaments or other appliances, or any fees to which he may be entitled.
28. PERSONS ENROLLED ON THE INDIAN MEDICAL REGISTER TO NOTIFY CHANGE OF PLACE OF RESIDENCE OR PRACTICE
Every person registered in the Indian Medical Register shall notify any transfer of the place of his residence or practice to the Council and to the State Medical Council concerned, within thirty days of such transfer failing which his right to participate in the election of members to the Council or a State Medical Council shall be liable to be forfeited by order of the Central Government either permanently or for such period as may be specified therein.
29. INFORMATION TO BE FURNISHED BY THE COUNCIL AND PUBLICATION THEREOF
1. The Council shall furnish such reports, copies of its minutes, abstracts of its accounts, and other information to the Central Government as that Government may require.
2. The Central Government may publish in such manner as it may think fit, any report, copy, abstract or other information furnished to it under this section or under sections 17 and 18.
30. COMMISSION OF INQUIRY
1. Whenever it is made to appear to the Central Government that the Council is not complying with any of the provisions of this Act, the Central Government may refer the particulars of the complaint to a Commission of Inquiry consisting of three persons two of whom shall be appointed by the Central Government, one being a Judge of a High Court and one by the Council, and such Commission shall proceed to inquire in a summary manner and to report to the Central Government as to the truth of the matters charged in the complaint, and in case of any charge of default or of improper action being found by the commission to have been established, the Commission shall recommend the remedies, if any, which are in its opinion necessary.
2. The Central Government may require the Council to adopt the remedies so recommended within such time as, having regard to the report of the Commission, it may think fit, and if the Council fails to comply with any such requirement, the Central Government may amend the regulations of the Council, or make such provision or order or take such other steps as may seem necessary to give effect to the recommendations of the Commission.
3. A Commission of inquiry shall have power to administer oaths, to enforce the attendance of witnesses and the production of documents, and shall have all such other necessary powers for the purpose of any inquiry conducted by it as are exercised by a Civil Court under the Code of Civil Procedure, 1908.
31. PROTECTION OF ACTION TAKEN IN GOOD FAITH
No suit, prosecution or other legal proceeding shall lie against the Government, the Council or a State Medical Council or any Committee thereof, or any Officer or servant of the Government or Councils aforesaid for anything which is in good faith done or intended to be done under this Act.
32. POWER TO MAKE RULES
1. The Central Government may, by notification in the Official Gazette, make rules to carry out the purposes of this Act.
2. All rules made under this section shall be laid for not less than thirty days before both Houses of Parliament as soon as possible after they are made, and shall be subject to such modifications as Parliament may make during the session in which they are so laid or the session immediately following.
33. POWER TO MAKE REGULATIONS
The Council may, with the previous sanction of the Central Government, make regulations generally to carry out the purposes of this Act, and without prejudice to the generality of this power, such regulations may provide for: –
1. the management of the property of the Council and the maintenance and audit of its accounts;
2. the summoning and holding of meetings of the Council, the times and places where such meetings are to be held, the conduct of business thereat and the number of members necessary to constitute a quorum;
3. the resignation of members of the Council;
4. the powers and duties of the President and Vice-President
5. the mode of appointment of the Executive Committee and other Committees, the summoning and holding of meetings and the conduct of business of such Committees;
6. the tenure office, and the powers and duties of the Registrar and other officers and servants of the Council; (fa) the form of the scheme, the particulars to be given in such scheme, the manner in which the scheme is to be preferred and the fee payable with the scheme under clause (b) of sub-section (2) of section 10A; (fb) any other factors under clause (g) of sub-section (7) of section 10A; (fc) the criteria for identifying a student who has been granted a medical qualification referred to in the Explanation to sub-section (3) of section 10B;
7. the particulars to be stated, and the proof of qualifications to be given in applications for registration under this Act;
8. the fees to be paid on applications and appeals under this Act;
9. the appointment, powers, duties and procedure of medical inspectors and visitors;
10. the courses and period of study and of practical training to be undertaken, the subjects of examination and the standards of proficiency therein to be obtained, in Universities or medical institutions for grant of recognized medical qualifications;
11. the standards of staff, equipment, accommodation, training and other facilities for medical education;
12. the conduct of professional examination; qualifications of examiners and the conditions of admissions to such examinations;
13. the standards of professional conduct and etiquette and code of ethics to be observed by medical practitioners; and (m a) the modalities for conducting screening tests under sub-section (4A), and under the proviso to sub-section (4B), and for issuing eligibility certificate under sub-section (4B), of section 13,.
14. any matter for which under this Act provision may be made by regulations.
34. REPEAL OF ACT 27 OF 1933
1. The Indian Medical Council Act, 1933 is hereby repealed.
2. Notwithstanding anything contained in this Act, until the Council is constituted in accordance with the provisions of this Act: –
1. the Medical Council of India as constituted immediately before the commencement of this Act under the Indian Medical Council Act, 1933, with the addition of seven members nominated thereto by the Central Government from among persons enrolled on any of the State Medical Registers who possess the medical qualifications included in Part I of the 3rd Schedule to this Act (hereinafter referred to as the said Medical Council) shall be deemed to be the Council constituted under this Act and may exercise any of the powers conferred or perform any of the duties imposed on the Council; and any vacancy occurring in the said Medical Council may be filled up in such manner as Central Govt. may think fit; and
2. the Executive Committee and other Committees of the said Medical Council as constituted immediately before the commencement of this Act, shall be deemed to be the Executive Committee and the Committees constituted under this Act.
The Jan Aushadi Pariyojana: A primer for Indian doctors
Here is a primer for the practicing doctors on the “Janaushadhi” scheme which might help them to take better decisions if confronted by patients with dilemma.
Earlier this year the Medical Council of India reiterated that the medical fraternity should prescribe drugs with generic names. The government too, wants doctors to prescribe cheaper generic drugs and these are made available at the Jan Aushadhi stores across the country. The Janaushadhi yojna completes 9 years of being this year. This initiative, though far from being complete, has indeed ramped in the year gone by. The initiative was renamed as Pradhan Mantri Jan Aushadhi Yojana and renamed again as the Pradhan Mantri Bharatiya Janaushadhi Pariyojana (PMBJP).
Under the new administration, the program got a big push and the scheme has drastically brought down medicine prices for the drugs under its ambit. For example, the anti-diabetic drug glimepiride is priced at INR 4.02 under the government scheme while it costs INR 54 in regular stores. However, doctors still shy away from prescribing generic medicines. The reason often cited is about the faith and trust of the quality of medicines.
Here we attempt to provide some basic information on this ambitious and well-intentioned initiative with an aim to help the practicing doctors gain a better understanding how the PMBJP functions.
Some salient features of the revamped scheme are discussed here.
The list covers 23 major therapeutic categories including anti-infective, anti-diabetics, cardiovascular, anti-cancer among many others. The therapeutic categories covered by the scheme were too little in its previous form.
Unlike earlier practice where only public sector companies were tasked with supply, now, nearly 125 suppliers who hold WHO GMP certification have been allowed to supply to the scheme.
Earlier, only medicines manufactured by CPSUs were being supplied to Pradhan Mantri Bhartiya Jan Aushadhi Kendra. Since CPSUs are not able to make a supply of all the medicines proposed to be supplied to PMBJK, procurement of medicines which the CPSUs are not able to supply are being made from the private manufacturers. These medicines after getting tested from empaneled NABL Laboratories and sent to PMBJK through Super Stuckists/CEF agent/Distributors appointed by BPPI (Bureau of Pharma Public Sector Undertakings of India).
The Bureau of Pharma PSUs of India (BPPI), which is overseeing the program tests the medicines procured from the suppliers for its quality. Each drug batch is tested at BPPI’s empaneled National Accreditation Board for Testing and Calibration Laboratories (NABL) accredited laboratories for quality assurance, safety, and efficacy of medicines and conformation with required standards. The annual turnover of PMBJP has leapfrogged to INR 73.66 crore in 2017-18 (as on October 30, 2017) from INR 33.4 crore in 2016-17 and INR 12.43 crore in 2015-16.
Indian Railways plans to open Jan Aushadhi Kendras at nearly 1,000 railways stations. Petroleum Minister Dharmendra Pradhan announced in August this year that government would open Jan Aushadhi stores at PSU-run petrol pumps too. This would make it much easier for people to gain access to these services.
Supply still remains a problem, but the BPPI has assured that the problem will be taken care of through the implementation of direct procurement from nearby warehouses. Next, the government had also received feedback that doctors were earlier not writing generic names, which caused problems for patients to understand the medicines being given to them. On that front, the government is now pushing informally through talks with key medical organizations to ensure that the doctors write the generic names of the medicines along with brand names, or if possible, practice writing only generic names. In April this year, the prime minister promised a legal framework to ensure that doctors prescribed low-cost generic medicines instead of expensive branded medicines.
One of the issues highlighted by a news report was that the practice of accepting the lowest tender could potentially lead suppliers to cut corners on quality and affect patient health adversely.
However, the government has sought to allay these concerns by noting that each batch is tested and substandard products are rejected, with possible penal action and blacklisting for suppliers whose products are repeatedly found to be below quality. Moreover, the government has noted that the WHO GMP quality levels are globally acceptable and hence, testing against these norms was sure to filter out any bad quality products.
Overall, although there remain multiple issues regarding the implementation of the scheme, the program is likely to benefit patients through easier and cheaper availability of necessary medications. If the issues highlighted above are ironed out soon, the scheme might well be one of the best schemes that have recently been launched by the government
THE PERSONS WITH DISABILITIES (EQUAL OPPORTUNITIES, PROTECTION OF RIGHTS AND FULL PARTICIPATION) ACT, 1995
PWD ACT, 1995
THE PERSONS WITH DISABILITIES
(EQUAL OPPORTUNITIES, PROTECTION OF RIGHTS AND FULL PARTICIPATION) ACT, 1995
PUBLISHED IN PART II, SECTION 1 OF THE
EXTRAORDINARY GAZETTE OF INDIA
New Delhi, the 1st January, 1996/Pausa 11, 1917 (Saka)
The following Act of Parliament received the assent of the President on the 1st January, 1996, and is
hereby published for general information: – No.1 OF 1996
[1st January 1996]
An Act to give effect to the Proclamation on the Full Participation and Equality of the People with
Disabilities in the Asian and Pacific Region.
WHEREAS the Meeting to Launch the Asian and Pacific Decade of Disabled Persons 1993-2002
convened by the Economic and Social Commission for Asia and Pacific held at Beijing on 1st to 5th
December,1992, adopted the Proclamation on the Full Participation and Equality of People with
Disabilities in the Asian and Pacific Region;
AND WHEREAS India is a signatory to the said Proclamation; AND WHEREAS it is considered
necessary to implement the Proclamation aforesaid.
Be it enacted by Parliament in the Forty-sixth Year of the Republic of India as follows: –
Chapter I Preliminary
Chapter II the Central Coordination Committee
Chapter III the State Coordination Committee
Chapter IV Prevention and Early Detection of Disabilities
Chapter V Education
Chapter VI Employment
Chapter VII Affirmative Action
Chapter VIII Non – Discrimination
Chapter IX Research and Manpower Development
Chapter X Recognition of Institutions for Persons with Disabilities
Chapter XI Institution For Persons With Severe Disabilities
Chapter XII the Chief Commissioner and Commissioners for Persons
With Disabilities
Chapter XIII Social Security
Chapter XIV Miscellaneous
CHAPTER I: PRELIMINARY
1. (1) This Act may be called the Persons with Disabilities (Equal Opportunities, Protection of Rights
and Full Participation) Act, 1995.
(2) It extends to the whole of India except the State of Jammu and Kashmir.
(3) It shall come into force on such date as the Central Government may. by notification, appoint.
2. In this Act, unless the context otherwise requires, –
(a) “Appropriate Government” means, –
(i) In relation to the Central Government or any establishment wholly or substantially financed by that
Government, or a Cantonment Board constituted under the Cantonment Act, 1924, the Central
Government;
(ii) In relation to a State Government or any establishment wholly or substantially financed by that
Government, or any local authority., other than a Cantonment Board, the State Government;
(iii) In respect of the Central Co-ordination Committee and the Central Executive Committee, the
Central Government;
(iv) In respect of the State Co-ordination Committee and the State Executive Committee, the State
Government;
(b) “Blindness” refers to a condition where a person suffers from any of the following conditions,
namely: –
(i) Total absence of sight. or
(ii) Visual acuity not exceeding 6160 or 201200 (Snellen) in the better eye with correcting lenses; or
(iii) Limitation of the field of vision subtending an angle of 20 degree or worse;
(c) “Central Co-ordination Committee” means the Central Co-ordination Committee constituted under
sub-section (1) of section 3;
(d) “Central Executive Committee” means the Central Executive Committee constituted under subsection
(1) of section 9;
(e) “Cerebral palsy” means a group of non-progressive conditions of a person characterized by
abnormal motor control posture resulting from brain insult or injuries occurring in the pre-natal, perinatal
or infant period of development;
(f) “Chief Commissioner” means the Chief Commissioner appointed under subsection (1) of section
57;
(g) “Commissioner” means the Commissioner appointed under sub-section (1) of section 60;
(h) “Competent authority” means the authority appointed under section 50;
(i) “Disability” means (
I) Blindness;
(ii) Low vision;
(iii) Leprosy-cured;
(iv) Hearing impairment;
(v) Loco motor disability;
(vi) Mental retardation;
(vii) Mental illness;
(j) “Employer” means, –
(i) In relation to a Government, the authority notified by the Head of the Department in this behalf or
where no such authority is notified, the Head of the Department; and
(ii) In relation to an establishment, the chief executive officer of that the establishment;
(k) “Establishment” means a corporation established by or under a Central, Provincial or State Act, or
an authority or a body owned or controlled or aided by the Government or a local authority or a
Government company as defined in section 617 of ‘the Companies Act, 1956 and includes
Departments of a Government;
(l) “Hearing impairment” means loss of sixty decibels or more in the better year in the conversational
range of’ frequencies;
(m) “Institution for persons with disabilities” means an institution for the reception. Care, protection,
education, training, rehabilitation or any other service of persons with disabilities;
(n) “Leprosy cured person” means any person who has been cured of leprosy but is suffering from-
(i) Loss of sensation in hands or feet as well as loss of sensation and paresis in the eye and eye-lid but
with no manifest deformity;
(ii) Manifest deformity and paresis; but having sufficient mobility in their hands and feet to enable
them to engage in normal economic activity;
(iii) Extreme physical deformity as well as advanced age which prevents him from undertaking any
gainful occupation, and the expression “leprosy cured” shall be construed accordingly;
(o) “Loco motor disability” means disability of the bones, joints muscles leading to substantial
restriction of the movement of the limbs or any form of cerebral palsy,
(p) “Medical authority” means any hospital or institution specified for the purposes of this Act by
notification by the appropriate Government;
(q) “Mental illness” means any mental disorder other than mental retardation;
(r) “Mental retardation” means a condition of arrested or incomplete development of mind of a person
which is specially characterized by sub normality of intelligence;
(s) “Notification” means a notification published in the, Official Gazette;
(t) “Person with disability” means a person suffering from not less than forty per cent. of any disability
as certified by a medical authority;
(u) “Person with low vision” means a person with impairment of visual functioning even after
treatment or standard refractive correction but who uses or is potentially capable of using vision for
the planning or execution of a task with appropriate assistive device;
(v) “Prescribed” means prescribed by rules made under this Act;
“Rehabilitation” refers to a process aimed at enabling persons with disabilities to reach and
maintain their optimal physical, sensory, intellectual, psychiatric or social functional levels;
(x) “Special Employment Exchange” means any office or place established and maintained by the
Government for the collection and furnishing of information, either by keeping of registers or
otherwise, respecting-
(i) Persons who seek to engage employees from amongst the persons suffering from disabilities;
(ii) Persons with disability who seek employment;
(iii) Vacancies to which person with disability seeking employment may be appointed;
(y) “State Co-ordination Committee” means the State Co-ordination Committee constituted under subsection
(1) of section 19;
(z) “State Executive Committee” means the State Executive Committee constituted under sub-section
(l) of section 19
CHAPTER II: THE COORDINATION COMMITTEE
3. (1) The Central Government shall by notification constitute a body to be known as the Central Co-ordination
Committee to exercise the powers conferred on, and to perform the functions assigned to it, under this Act.
(2) The Central Co-ordination Committee shall consist of-
(a) The Minister in charge of the Department of Welfare in the Central Government, Chairperson, ex
officio;
(b) The Minister of State in-charge of the Department of Welfare in the Central Government, Vice-
Chairperson, ex officio;
(c) Secretaries to the Government of India in-charge of the Departments of Welfare, Education,
Woman and Child Development, Expenditure, Personnel, Training and Public Grievances, Health,
Rural Development, Industrial Development, Urban Affairs and Employment, Science and
Technology. Legal Affairs, Public Enterprises, Members, ex officio;
(d) Chief Commissioner, Member, ex officio;
(e) Chairman Railway Board, Member, ex officio;
(f) Director-General of Lab our, Employment and Training, Member, ex officio;
(g) Director, National Council for Educational Research and Training, Member, ex officio;
(h) Three Members of Parliament. of whom two shall be elected by the House of the People and one
by the Council of States, Members;
(I) Three persons to be nominated by the Central Government to represent the interests, which in the
opinion of that Government ought to be represented, Members;
(j) Directors of the-
(I) National Institute for the Visually Handicapped, Dehradun;
(ii) National Institute for the Mentally Handicapped, Secundrabad;
(iii) National Institute for the Orthopedically Handicapped, Calcutta;
(iv) Ali Yavar Jung National Institute for the Hearing Handicapped, Bombay,
Members, ex officio;
(k) Four Members to be nominated by the Central Government by rotation to represent the States and
the Union territories in such manner as may be prescribed by the Central Government:
Provided that no appointment under this clause shall be made except on the recommendation of the
State Government or, as the case may be, the Union territory;
(l) Five persons as far as practicable, being persons with disabilities. to represent non-governmental
Organizations or associations which are concerned with disabilities, to be nominated by the Central
Government, one from each area of disability, Members:
Provided that while nominating persons under this clause, the Central Government shall nominate at
least one woman and one person belonging to Scheduled Castes or Scheduled Tribes;
(m) Joint Secretary to the Government of India in the Ministry of Welfare dealing with the welfare of
the handicapped, Member-Secretary, ex officio.
(3) The office of the Member of the Central Co-ordination Committee shall not disqualify its holder
for being chosen as or for being a Member of either House of Parliament.
4. (1) Save as otherwise provided by or under this Act a Member of Central Co-ordination Committee
nominated under clause (i) or clause (l) of sub-section (2) of section 3 shall hold office for a term of
three years from the date of his nomination:
Provided that such a Member shall, notwithstanding the expiration of his term, continue to hold office
until his successor enters upon his office.
(2) The term of office of an ex officio Member shall come to an end as soon as he ceases to hold the
office by virtue of which he was so nominated.
(3) The Central Government may if it thinks fit remove any Member nominated under clause (i) or
clause (1) of subsection (2) of section 3, before the expiry of his term of office after giving him a
reasonable opportunity of showing cause against the same.
(4) A Member nominated under clause (i) or clause (1) of subsection (2) of section 3 may at any time
resign his office by writing under his hand addressed to the Central Government and the seat of the
said Member shall thereupon become vacant.
(5) A casual vacancy in the Central Co-ordination Committee shall be filled by a fresh nomination and
the person nominated to fill the vacancy shall hold office only for the remainder of the term for which
the Member in whose place he was so Dominated.
(6) A Member nominated under clause (i) or clause (l) of subsection (2) of section 3 shall be eligible
for (7) Members nominated under clause (i) and clause (1) of sub-section (2) of section 3 shall receive
such allowances as may, be prescribed by the Central Government.
5. (1) No person shall be a Member of the Central Coordination Committee, who-
(a) Is, or at any time has been, adjudged insolvent or has suspended payment of his debts or has
compounded with his creditors, or
(b) Is of unsound mind and stands so declared by a competent court, or
(c) Is or has been convicted of an offence which, in the opinion of the Central Government, involves
moral turpitude, or
(d) Is or at any time has been convicted of an offence under this Act. or
(e) Has so abused in the opinion of the Central Government his position as a Member as to render his
continuance in the Central Coordination Committee detrimental to the interests of the general public.
(2) No order of removal shall be made by the Central Government under this section unless the
Member concerned has been given a reasonable opportunity of showing cause against the same.
(3) Notwithstanding anything contained in sub-section (1) or sub-section (6) of section 4, a Member
who has been removed under this section shall not be eligible for re-nomination as a Member?
6. If a Member of the Central Coordination Committee becomes subject to any of the disqualifications
specified in section 5, his scat shall become vacant.
7. Lie Central Coordination Committee shall meet at least once in every six months and shall observe
such rules of procedure in regard to the transaction of business at its meetings as may be prescribed by
the Central Government.
8. (1) Subject to the provisions of this Act, the function of the Central Coordination Committee shall
be to serve as the national focal point on disability matters and facilitate the continuous evolution of a
comprehensive policy towards solving the problems faced by persons with disabilities.
(2) In particular and without prejudice to the generality of the foregoing, the Central Coordination
Committee may perform all or any, of the following functions, namely: –
(a) Review and coordinate the activities of all the Departments of Government and other
Governmental and non-Governmental Organizations which are dealing with matters relating to
persons with disabilities;
(b) Develop a national policy to address issues faced by, persons with disabilities;
(c) Advise the Central Government on the formulation oil policies, programmes, legislation and
projects with respect to disability,
(d) Take up the cause of persons with disabilities with the concerned authorities and the international
organizations with a view, to provide for schemes and projects for the disabled in the national plans
and other programmes and policies evolved by the international agencies;
(e) Review in consultation with the donor agencies their funding policies from the perspective of them
impact on persons with disabilities;
(f) Take such other steps to ensure barrier free environment in public places, work places, public
utilities, schools and other institutions;
(g) Monitor and evaluate the impact of policies and programmes designed for achieving equality and
full participation of persons with disabilities;
(h) To perform such other functions as may be prescribed by the Central Government.
9. (1) The Central Government shall constitute a Committee to be known as the Central Executive
Committee to perform the functions assigned to it under this Act.
(2) The Central Executive Committee shall consist of-
(a) The Secretary to the Government of India in the Ministry of Welfare, Chairperson, ex officio;
(b) The Chief Commissioner, Member, ex officio;
(c) The Director-General for Health Services, Member, ex officio;
(d) The Director-General, Employment and Training, Member, ex officio;
(e) Six persons not below the rank of a Joint Secretary to the Government of India, to represent the
Ministries or Departments of Rural Development, Education. Welfare, Personnel Public Grievances
and Pension and Urban Affairs and Employment, Science and Technology, Members, ex officio;
(f) The Financial Advisor, Ministry of Welfare in the Central Government, Member, ex officio;
(g) Advisor (Tariff) Railway Board, Member, ex officio;
(h) Four members to be nominated by the Central Government, by rotation, to represent the State
Governments and the Union territories in such manner as may be prescribed by the Central
Government;
(i) One person to be nominated by the Central Government to represent the interest, which in the
opinion of the Central Government ought to be represented, Member;
(j) Five persons, as far as practicable, being persons with disabilities, to represent non-governmental
organizations or associations which are concerned with disabilities, to be nominated by the Central
Government, one from each area of disability, Members:
Provided that while nominating persons under this clause, the Central Government shall nominate at
least one woman and one person belonging to Scheduled Castes or Scheduled Tribes;
(k) Joint Secretary to the Government of India in the Ministry of Welfare dealing with the welfare of
the handicapped, Member-Secretary, ex officio.
(3) Members nominated under clause (i) and clause (j) of sub-section (2) shall receive such allowances
as may be prescribed by the Central Government.
(4) A Member nominated under clause (i) or clause (i) of sub-section (2) may at any time resign his
office by writing under his hand addressed to the Central Government and the scat of the said Member
shall thereupon become vacant.
10. (1) The Central Executive Committee shall be the executive body of the Central Coordination
Committee and shall be responsible for carrying out the decisions of the Central Coordination
Committee.
(2) Without prejudice to the provisions of sub-section (1), the Central Executive Committee shall also
perform such other functions as may be delegated to it by the Central Coordination Committee.
11. The Central Executive Committee shall meet at least once in three months and shall observe such
rules of procedure in regard to the transaction of business at its meetings as may be prescribed by the
Central Government.
12. (1) The Central Executive Committee may associate with itself in such manner and for such
purposes as may be prescribed by the Central Government any person whose assistance or advice it
my desire to obtain in performing any of its functions under this Act.
(2) A person associated with the Central Executive Committee under sub-section (1) for any purpose
shall have the right to take part in the discussions of the Central Executive Committee relevant to that
purpose, but shall not have a right to vote at a meeting of the said Committee, and shall not be a
member for any other purpose.
(3) A person associated with the said Committee under sub-section (1) for any purpose shall be paid
such fees and allowances, for attending its meetings and for attending to any other work of the said
Committee, as may be prescribed by the Central Government.
CHAPTER III: THE STATE COORDINATION COMMITTEE
13. (1) Every State Government shall, by notification, constitute a body to be known as the State
Coordination Committee to exercise the powers conferred on, and to perform the function assigned to
it, under this Act.
(2) the State Coordination Committee shall consist of-
(a) The Minister in-charge of the Department of Social Welfare in the State Government, Chairperson,
ex officio;
(b) the Minister of State in-charge of the Department of Social Welfare, if any, Vice-Chairperson, ex
officio;
(c) Secretaries to the State Government in-charge of the Departments of Welfare, Education, Woman
and Child Development, Expenditure, Personnel Training and Public Grievances, Health, Rural
Development, Industrial Development, Urban Affairs and Employment, Science and Technology,
Public Enterprises, by whatever name called, Members, ex officio;
(d) Secretary of any other Department, which the State Government considers necessary, Member, ex
officio;
(e) Chairman Bureau of Public Enterprises (by whatever name called) Member, ex officio;
(f) Five persons, as far as practicable, being persons with disabilities, to represent non-governmental
organizations or associations which are concerned with disabilities, to be nominated by the State
Government, one from each area of disability, Members:
Provided that while nominating persons under this clause, the State Government shall nominate at
least one woman and one person belonging to Scheduled Castes or Scheduled Tribes;
(g) Three Members of State Legislature, of whom two shall be elected by the Legislative Assembly
and one by the Legislative Council, if any;
(h) Three persons to be nominated by that State Government to represent agriculture, industry or trade
or any other interest, which in the opinion of State Government ought to be represented, Members, ex
officio;
(i) The Commissioner, Member, ex officio;
(j) Secretary to the State Government dealing with the welfare of the handicapped, Member-Secretary,
ex officio.
(3) Notwithstanding anything contained in this section, no State Coordination Committee shall be
constituted for a Union territory and in relation to a Union territory; the Central Coordination
Committee shall exercise the functions and perform the functions of a State Coordination Committee
for the Union territory:
Provided that in relation to a Union territory. The Central Coordination Committee may delegate all or
any of its powers and functions under this sub-section to such person or body of persons as the Central
Government may specify.
14. (1) Save as otherwise provided by or under this Act, a Member of a State Coordination Committee
nominated under clause (f) or clause (h) of subsection (2) of section 13 shall hold office for a term of
three years from the date of his nomination:
Provided that such a Member shall, notwithstanding the expiration of his term, continue to hold office
until his successor enters upon his office.
(2) The term of office of an ex officio Member shall come to an end as soon as he ceases to hold the
office by virtue of which he was so nominated.
(3) The State Government may, if it thinks fit, remove any7 Member nominated under clause (f) or
clause (h) of sub-section (2) of section 13, before the expiry of his term of office after giving him a
reasonable opportunity of showing cause against the same.
(4) A Member nominated under clause (f) or clause (h) of sub-section (2) of section 13 may. At any
time, resign his office by writing under his hand addressed to the State Government and the seat of the
said Member shall thereupon become vacant.
(5) A casual vacancy in the State Coordination Committee shall be filled by a fresh nomination and
the person nominated to fill the vacancy shall hold office only for the remainder of the term for which
the Member in whose place he was so nominated.
(6) A Member nominated under clause (f) and clause (h) of sub-section (2) of section 13 shall be
eligible for renomination.
(7) Members nominated under clause (f) and clause (h) of sub-section (2) of section13 shall receive
such allowances as may he prescribed by the State Government.
15. (1) No pet-son shall he a Member of the State Coordination Committee, who–
(a) Is, or at any time, has been adjudged insolvent or has suspended payment of his debts or has
compounded with his creditors, or
(b) Is of unsound mind and stands so declared by a competent court, or
(c) Is or has been convicted of an offence which in the opinion of the State Government involves
moral turpitude, or
(d) Is or at any time has been convicted of an offence under this Act or
(e) Has so abused, in the opinion of the State Government, his position as a member as to render his
continuance in the State Coordination Committee detrimental to the interests of the general public.
(2) No order of removal shall be made by the State Government under this section unless the Member
concerned has been given a reasonable opportunity of showing cause against the same.
(3) Notwithstanding anything contained in sub-section (1) or sub-section (6) of section 14, a Member
who has been removed under this section shall net be eligible for renomination as a Member.
16. If a Member of the State Coordination Committee becomes subject to any of the disqualifications
specified in section 15, his seat shall become vacant.
17. The State Coordination Committee shall meet at least once in every six months and shall observe
such rules of procedure in regard to the transaction of business at its meetings as may be prescribed.
18. (1) Subject to the provisions of this Act, the function of the State Coordination Committee shall be
to serve as the state focal point on disability matters and facilitate the continuous evolution of a
comprehensive policy towards solving the problems faced by persons with disabilities.
(2) In particular and without prejudice to the generality of the foregoing function the State
Coordination Committee may, within the State perform all or any of the following functions, namely.-
(a) Review and coordinate the activities of all the Departments of Government and other
Governmental and non-Govemmental Organizations which are dealing with matters relating to
persons with disabilities.,
(b) Develop a State policy to address issues faced by persons with disabilities;
(c) Advise the State Government on the formulation of policies. Programmes, legislation and projects
with respect to disability;
(d) Review, in consultation with the donor agencies, their funding from the perspective of their impact
on persons with disabilities;
(e) Take such other steps to ensure barrier free environment in pupil’s places. Work places, public
utilities, schools and other institutions;
(f) Monitor and evaluate the impact of policies and programmes designed for achieving equality and
full participation of persons with disabilities;
(g) To perform such other functions as may be prescribed by the State Government
19. (1) The State Government shall constitute a committee to be known as the State Executive
Committee to perform the functions assigned to it under this Act.
(2) The State Executive Committee shall consist of-
(a) The Secretary, Department of Social Welfare, Chairperson, ex officio;
(b) The Commissioner, Member, ex officio;
(c) Nine persons not below the rank of a Joint Secretary to the State Government, to represent the
Departments of Health, Finance, Rural Development, Education, Welfare, Personnel Public
Grievances, Urban Affairs Labor and Employment, Science and Technology, Members, ex officio;
(d) One person to be nominated by the State Government to represent the interest, which in the
opinion of the State Government ought to be represented. Member;
(e) Five persons, as far as practicable being persons with disabilities. to represent non-governmental
organizations or associations which are concerned with disabilities, to be nominated by the State
Government, one from each area of disability, Members:
Provided that while nominating persons under this clause, the State Government shall nominate at
least one woman and one person belonging to Scheduled Castes or Scheduled Tribes;
(f) Joint Secretary dealing with the disability division in the Department of Welfare, Member-
Secretary, ex officio.
(3) Members nominated under clause (d) and clause (e) of sub-section (2) shall receive such
allowances as may be prescribed by the State Government.
(4) A Member nominated under clause (d) or clause (e) may at any time resign his office by writing
under his hand addressed to the State Government and the scat of the said Member shall thereupon
become vacant.
20. (1) The State Executive Committee shall be the executive body of the State Coordination
Committee and shall be responsible for carrying out the decisions of the State Coordination
Committee.
(2) Without prejudice to the provisions of sub-section (1), the State Executive Committee shall also
perform such other functions as may be delegated to it by the State Coordination Committee.
21. The State Executive Committee shall meet at least once in three months and shall observe such
rules of procedure in regard to the transaction of business at its meetings as may be prescribed by, the
State Government.
22. (1) The State Executive Committee may associate with itself in such manner and for such purposes
as may he prescribed by the State Government any person whose assistance or advice it may desire to
obtain in performing any of its functions under this Act.
(2) A person associated with the State Executive Committee under sub-section (1) for any purpose
shall have the right to take part in the discussions of the State Executive Committee relevant to that
purpose, but shall not have a right to vote at a meeting of the said Committee, and shall not be a
member for any other purpose.
(3) A person associated wills the said Committee under sub-section (1) for any purpose shall be paid
such fees and allowances, for attending its meetings and for attending to any other work of the said
Committee, as may be prescribed by the State Government.
23. In the performance of its functions under this Act, –
(a) The Central Coordination Committee shall be bound by such directions in writing, as the Central
Government may give to it; and
(b) The State Coordination Committee shall be bound by such directions in writing, as the Central
Coordination Committee or the State, Government may give to it:
Provided that where a direction given by the State Government is inconsistent with any direction given
by the Central Coordination Committee, the matter shall be referred to the Central Government for its
decision.
24. No act or proceeding of the Central Coordination Committee, the Central Executive Committee, a
State Coordination Committee or a State Executive Committee shall be called in question on the
ground merely on the existence of any vacancy in or any defect in the constitution of such
Committees.
CHAPTER IV: PREVENTATION AND EARLY DETECTION OF DISABILITIES
25. Within the limits of their economic capacity and development, the appropriate Governments and
the local authorities, with a view to preventing the occurrence of disabilities, shall-
(a) Undertake or cause to be undertaken surveys, investigations and research concerning the cause of
occurrence of disabilities;
(b) Promote various methods of preventing disabilities;
(c) Screen all the children at least once in a year for the purpose of identifying “at-risk” cases;
(d) Provide facilities for training to the staff at the primary health centers;
(e) Sponsor or cause to be sponsored awareness campaigns and is disseminated or cause to be
disseminated information for general hygiene. Health and sanitation,
(f) Take measures for pre-natal, parental and post-natal care of mother and child;
(g) Educate the public through the pre-schools, schools, primary health Centers, village level workers
and anganwadi workers;
(h) Create awareness amongst the masses through television, radio and other mass media on the causes
of disabilities and the preventive measures to be adopted;
CHAPTER V: EDUCATION
26. The appropriate Governments and the local authorities shall-
(a) Ensure that every child with a disability has access to free education in an appropriate environment
till he attains the age of eighteen years;
(b) Endeavor to promote the integration of students with disabilities in the normal schools;
(c) Promote setting up of special schools in Government and private sector for those in need of special
education, in such a manner that children with disabilities living in any part of the country have access
to such schools;
(d) Endeavor to equip the special schools for children with disabilities with vocational training
facilities.
27. The appropriate Governments and the local authorities shall by notification make schemes for-
(a) Conducting part-time classes in respect of children with disabilities who having completed
education up to class fifth and could not continue their studies on a whole-time basis;
(b) Conducting special part-time classes for providing functional literacy for children in the age group
of sixteen and above;
(c) Imparting non-formal education by utilizing the available manpower in rural areas after giving
them appropriate orientation;
(d) Imparting education through open schools or open universities;
(e) Conducting class and discussions through interactive electronic or other media;
(f) Providing every child with disability free of cost special books and equipment needed for his
education.
28. The appropriate Governments shall initiate or cause to be initiated research by official and nongovernmental
agencies for the purpose of designing and developing new assistive devices, teaching
aids, special teaching materials or such other items as are necessary to give a child with disability
equal opportunities in education.
29. The appropriate Governments shall set up adequate number of teachers’ training institutions and
assist the national institutes and other voluntary organizations to develop teachers’ training
programmes specializing in disabilities so that requisite trained manpower is available for special
schools and integrated schools for children with disabilities.
30. Without prejudice to the foregoing provisions, (be appropriate Governments shall by notification
prepare a comprehensive education scheme which shall make Provision for-
(a) Transport facilities to the children with disabilities or in the alternative financial incentives to
parents or guardians to enable their children with disabilities to attend schools.
(b) The removal of architectural barriers from schools. colleges or other institution, imparting
vocational and professional training;
(c) The supply of books, uniforms and other materials to children with disabilities attending school.
(d) The grant of scholarship to students with disabilities.
(e) Setting up of appropriate fora for the redressal of grievances of parent, regarding the placement of
their children with disabilities;
(f) Suitable modification in the examination system to eliminate purely mathematical questions for the
benefit of blind students and students with low vision;
(g) Restructuring of curriculum for the benefit of children with disabilities;
(h) restructuring the curriculum for benefit of students with hearing impairment to facilitate them to
take only one language as part of their curriculum.
31. All educational institutions shall provide or cause to be provided amanuensis to blind students and
students with or low vision.
CHAPTER VI: EMPLOYMENT
32. Appropriate Governments shall–
(a) Identify posts, in the establishments, which can be reserved for the persons with disability;
(b) At periodical intervals not exceeding three years, review the list of posts identified and up-date the
list taking into consideration the developments in technology.
33. Every appropriate Government shall appoint in every establishment such percentage of vacancies
not less than three per cent. for persons or class of persons with disability of which one per cent. each
shall be reserved for persons suffering from-
(i) Blindness or low vision;
(ii) Bearing impairment;
(iii) Loco motor disability or cerebral palsy, in the posts identified for each disability:
Provided that the appropriate Government may, having regard to the type of work carried on in any
department or establishment, by notification subject to such conditions, if any, as may be specified in
such notification, exempt any establishment from the provisions of this section.
34. (1) The appropriate Government may, by notification. Require that from such date as May he
specified. By notification. The employer in every establishment shall furnish such information or
return as may be prescribed in relation to vacancies appointed for person, with disability that have
occurred or are about to occur in that establishment to such Special Employment Exchange as may be
prescribed and the establishment shall thereupon comply with such requisition.
(2) The form in which and the intervals of time for which information or returns shall be furnished and
the particulars, they shall contain shall be such as may be prescribed.
35. Any person authorized by the Special Employment Exchange in writing, shall have access to any
relevant record or document in the possession of any establishment, and may enter at any reasonable
time and premises where he believe such record or document to be, and inspect or take copies of
relevant records or documents or ask any question necessary for obtaining any information.
36. Where in any recruitment year any vacancy under section 33, cannot be filled up due to no availability
of a suitable person with disability or, for any other sufficient reason, such vacancy shall
be carried forward in the succeeding recruitment year and if; r the succeeding recruitment year also
suitable person with disability is not available, it may first be filled by interchange among the three
categories and only when there are no parson with disability available for the post in that Year, the
employer shall fill up the vacancy by appointment of a person, other than a person with disability:
Provided that if the nature of vacancies in an establishment is such that a given category of person can
not be employed, the vacancies may be interchanged among the three categories with the prior
approval of the appropriate Government.
37. (1) Every employer shall maintain such record in relation to the person. With disability employed
in his establishment in such form and in such manner as may be prescribed by the appropriate
Government.
(2) The records maintained under sub-section (1) shall be open to inspection at all reasonable hours by
such persons as may be authorized in this behalf by general or special order by the appropriate
Government.
38. (1) The appropriate Governments and local authorities shall by notification formulate schemes for
ensuring employment of persons with disabilities, and such schemes may provide for-
(a) The training and welfare of persons with disabilities;
(b) The relaxation of upper age limit;
(c) Regulating the employment;
(d) Health and safety measures and creation of a non-handicapping environment in places where
persons with disabilities are employed;
(e) The manner in which and the person by whom the cost of operating the schemes is to be defrayed;
and
(f) Constituting the authority responsible for the administration of the scheme.
39. All Government educational institutions and other educational institutions receiving aid from the
Government, shall reserve not less than three per cent seat for persons with disabilities.
40. The appropriate Governments and local authorities shall reserve not less than three per cent. in all
poverty alleviation schemes for the benefit of persons with disabilities.
41. The appropriate Governments and the local authorities shall, within the limits of their economic
capacity and development, provide incentives to employers both in public and private sectors to ensure
that at least five per cent. of their work force is composed of persons with disabilities.
CHAPTER VII: AFFIRMATIVE ACTION
42. The appropriate Governments shall by notification make schemes to provide aids and appliances to
persons with disabilities.
43. The appropriate Governments and local authorities shall by notification frame schemes in favor of
persons with disabilities, for the preferential allotment of land at concession] rates for-
(a) House;
(b) Setting up business;
(c) Setting up of special recreation centers;
(d) Establishment of special schools;
(e) Establishment of research centers;
(f) Establishment of factories by entrepreneurs with disabilities
CHAPTER VIII : NON-DISCRIMINATION
44. Establishments in the transport sector shall, within the limits of their economic capacity and development for
the benefit of persons with disabilities, take special measures to-
(a) Adapt rail compartments, buses. Vessels and aircrafts in such a way as to permit easy access to
such persons;
(b) Adapt toilets in rail compartments, vessels, aircrafts and waiting rooms in such a way as to permit
the wheel chair users to use them conveniently.
45. The appropriate Governments and the local authorities shall, within the limits of their economic
capacity and development. Provide for-
(a) Installation of auditory signals at red lights in the public roads for the benefit of persons with
visually handicap;
(b) Causing curb cuts and slopes to be made in pavements for the easy access of wheel chair users;
(c) Engraving on the surface of the zebra crossing for the blind or for persons with low vision;
(d) Engraving on the edges of railway platforms for the blind or for persons with low vision;
(e) Devising appropriate symbols of disability;
(f) Warning signals at appropriate places.
46. The appropriate Governments and the local authorities shall, within the limits of their economic
capacity and development, provide for-
(a) Ramps in public buildings;
(b) Braille symbols and auditory signals in elevators or lifts;
(c) Braille symbols and auditory signals in elevators or lifts;
(d) Ramps in hospitals, primary health centers and other medical care and rehabilitation institutions.
47. (1) No establishment shall dispense with or reduce in rank, an employee who acquires a disability
during his service.
Provided that, if an employee, after acquiring disability is not suitable for the post he was holding,
could be shifted to some other post with the same pay scale and service benefits.
Provided further that if it is not possible to adjust the employee against any post, he may be kept on a
supernumerary post until a suitable post is available or he attains the age of superannuation, whichever
is earlier.
(2) No promotion shall be denied to a person merely on the ground of his disability:
Provided that the appropriate Government may, having regard to the type of work carried on in any
establishment, by notification and subject to such conditions, if any, as may be specified in such
notification, exempt any establishment from the provisions of this section.
CHAPTER IX : RESEARCH AND MANPOWER DEVELOPMENT
48. The appropriate Governments and local authorities shall promote and sponsor research, inter alia,
in the following areas-
(a) Prevention of disability;
(b) Rehabilitation including community-based rehabilitation;
(c) Development of assistive devices including their psychosocial aspects;
(d) Job identification;
(e) On site modifications in offices and factories.
49. The appropriate Governments shall provide financial assistance to universities, other institutions of
higher learning, professional bodies and non-governmental research-. units or institutions, for
undertaking research for special education. rehabilitation and manpower development.
CHAPTER X: RECOGNITION OF INSTITUTIONS FOR PERSONS WITH DISABILITIES
50. The State Government shall appoint any authority, as it deems fit to be a competent authority for
the purposes of this Act.
51. Save as otherwise provided under this Act, no person shall establish or maintain any institution for
persons with disabilities except under and in accordance with a certificate of registration issued in this
behalf by the competent authority:
Provided that a person maintaining an institution for persons with disabilities immediately before the
commencement of this Act may continue to maintain such institution for a period of six months from
such commencement and if he has made an application for such certificate under this section within
the said period of six months, till the disposal of such application.
52. (1) Every application for a certificate of registration shall be made to the competent authority in
such form and in such manner as may be prescribed by the State Government.
(2) On receipt of an application under sub-section (1), the competent authority shall make such
enquiries as it may deem fit and where it is satisfied that the applicant has complied with the
requirements of this Act and the rules made thereunder it shall grant a certificate of registration to the
applicant and where it is not so satisfied the competent authority shall. by order. refuse to grant the
certificate applied for:
Provided that before making any order refusing to grant a certificate the competent authority shall give
to the applicant a reasonable opportunity of being heard and every order of refusal to grant a certificate
shall he communicated to the applicant in such manner as may be prescribed by the State Government.
(3) No certificate of registration shall be granted under sub-section (2) unless the institution with
respect to which an application has been made is in a position to provide such facilities and maintain
such standards as may be prescribed by the State Government.
(4) A certificate of registration granted under this section, –
(a) Shall, unless revoked under section 53, remain in force for such period as may, be prescribed by,
the State Government.
(b) May be renewed from time to time for a like period; and
(c) Shall be in such form and shall be subject to such conditions as may be Prescribed by the State
Government
(5) An application for renewal of a certificate of registration shall be made not less than sixty days
before the period of validity.
(6) The certificate of registration shall he displayed by the institution in a conspicuous place.
53. (1) the competent authority may, if it has reasonable cause to believe that the
Holder of the certificate of registration granted under sub-section (2) of section 52 has –
(a) Made a statement in relation to any application for the issue of renewal of the certificate which is
incorrect or false in material particulars; or
(b) Committed or has caused to be committed any breach of rules or any conditions subject to which
the certificate was granted,
it may after making such inquiry, as it deems fit, by order, revoke the certificate:
Provided that no such order shall he made until an opportunity is given to the holder of the certificate
to show cause as to why the certificate should not be revoked.
(2) Where a certificate in respect of an institution has been revoked under sub-section (1), such
institution shall cease to function from the date of such revocation.
Provided that where an appeal lies under section 54 against the order of revocation, such institution
shall cease to function—
(a) Where no appeal has been preferred immediately on the expiry of the period prescribed for the
filing of such appeal, or
(b) Where such appeal has been preferred, but the order of revocation has been upheld, from the date
of the order of appeal.
(3) On the revocation of a certificate in respect of an institution, the competent authority may direct
that any person with disability who is an inmate of such institution on the date of such revocation,
shall be-
(a) Restored to the custody of her or his parent, spouse or lawful guardian, as the case may be, or
(b) Transferred to any other institution specified by the competent authority.
(4) Every institution, which holds a certificate of registration, which is revoked, under this section
shall, immediately after such revocation. Surrender such certificate to the Competent authority.
54. (1) Any person aggrieved by the order of the competent authority, refusing to grant a certificate or
revoking a certificate may, within such period as may he prescribed by the State Government, prefer
an appeal to that Government against such refusal or revocation.
(2) The order of the State Government on such appeal shall he final.
55. Nothing contained in this Chapter shall apply, to an institution for persons with disabilities
established or maintained by the Central Government or State Government.
CHAPTER XI: INSTITUTION FOR PERSONS WITH SEVERE DISABILITIES
56. The appropriate Government may establish and maintain institutions for persons with severe
disabilities at such places as it thinks fit.
(2) Where, the appropriate Government is of opinion that any institution other than an institution.
Established under sub-section (1), is fit for the rehabilitation of the persons with severe disabilities, the
Government may recognize such institution as an institution for persons with severe disabilities for the
purposes of this Act:
Provided that no institution shall be recognized under this section unless such institution has complied
with the requirements of this Act and the rules made there under.
(3) Every institution established under sub-section (1) shall be maintained in such manner and satisfy
such conditions as may be prescribed b), the appropriate Government.
(4) For the purposes of this section “person with severe disability” means a person with eighty per
cent. or more of one or more disabilities.
CHAPTER XII: THE CHIEF COMMISSIONER AND COMMISSIONERS FOR PERSONS
WITH DISABILITIES
57. (1) The Central Government may, by notification appoint a Chief Commissioner for persons with
disabilities for the purposes of this Act.
(2) A person shall not be qualified for appointment as the Chief Commissioner unless he has special
knowledge or practical experience in respect of matters relating to rehabilitation.
(3) The salary and allowances payable to and other terms and conditions of service (including pension,
gratuity and other retirement benefits of the Chief Commissioner shall be such as may be prescribed
by the Central Government.
(4) The Central Government shall determine the nature and categories of officers and other employees
required to assist the Chief Commissioner in the discharge of his functions and provide the Chief
Commissioner with such officers and other employees as it thinks fit.
(5) The officers and employees provided to the Chief Commissioner shall discharge their functions
under the general superintendence of the Chief Commissioner.
(6) The salaries and allowances and other conditions of service of officers and employees provided to
the Chief Commissioner shall be such as may be prescribed by the Central Government.
58. The Chief commissioner shall —
(a) Coordinate the work of the Commissioners;
(b) Monitor the utilization of’ funds disbursed by the Central Government;
(c) Take steps to safeguard the rights and facilities made available to Persons with disabilities;
(d) Submit reports to the Central Government on the implementation of the Act at such intervals as
that Government may prescribe.
59. Without prejudice to the provisions of section 58 the Chief Commissioner may of his own motion
or on the application of any aggrieved person or otherwise look into complaints with respect to matters
relating to —
(a) Deprivation of rights of persons with Disabilities.
(b) Non-implementation of laws, rules, byelaws, regulations. Executive orders, guidelines or
instructions made or issued by the appropriate Governments and the local authorities for the welfare
and protection of rights or persons with disabilities. And take up the matter with the appropriate
authorities.
60. (1) Every State Government may, by notification appoint a Commissioner for persons with
disabilities for the purpose of this Act.
(2) A person shall not be qualified for appointment as a Commissioner unless he has special
knowledge or practical experience in respect of matters relating to rehabilitation.
(3) The salary and allowances payable to and other terms and conditions of service (including pension
gratuity and other retirement benefits) of the Commissioner shall be such as may he prescribed by the
State Government.
(4) The State Government shall determine the nature and categories of officers and other employees
required to assist the Commissioner in the discharge of his functions and provide the Commissioner
with such officers and other employees as it thinks fit.
(5) The officers and employees provided to the Commissioner shall discharge their functions under the
general superintendence of the Commissioner.
(6) The salaries and allowances and other conditions of service of officers and employees provided to
the Commissioner shall be such as may he prescribed by the State Government.
61. The Commissioner within the State shall-
(a) Coordinate with the departments of the State Government for the programmes and schemes, for the
benefit of persons with disabilities;
(b) Monitor the utilization of funds disbursed by the State Government;
(c) Take steps to safeguard the rights and facilities made available to persons with disabilities.
(d) Submit reports to the State Government on the implementation of the Act at such intervals as that
Government may prescribe and forward a copy thereof to the Chief Commissioner.
62. Without prejudice to the provisions of section 61 the Commissioner may of his own motion or on
the application of any aggrieved person or otherwise look into complaints with respect to matters
relating to—
(a) Deprivation of rights of persons with disabilities;
(b) Non-implementation of laws, rules, bye-laws, regulations, executive orders, guidelines or
instructions made or issued by the appropriate Governments and the local authorities for the welfare
and protection of rights of persons with disabilities, and take up the matter with the appropriate
authorities.
63. The Chief Commissioner and the Commissioners shall, for the purpose of discharging them
functions under this Act, have the same powers as are vested in a court under the Code of Civil
Procedure, 1908 while trying a suit, in respect of the following matters, namely: –
(a) Summoning and enforcing the attendance of witnesses;
(b) Requiring the discovery and production of any documents;
(c) Requisitioning any public record or copy thereof from any court or office;
(d) Receiving evidence on affidavits; and
(e) Issuing commissions for the examination of witnesses or documents.
(2) Every proceeding before the Chief Commissioner and Commissioners shall be a judicial
proceeding within the meaning directions 193 and 228 of the Indian Penal Code and the Chief
Commissioner, the Commissioner, the competent authority, shall be deemed to be a civil court for the
purposes of section 195 and Chapter XXVI of the Code of Criminal Procedure, 1973.
64. (1) The Chief Commissioner shall prepare in such form and at such time for each financial year as
may be prescribed by the Central Government an annual report giving a full account of his activities
during the previous financial year and forward a copy thereof to the Central Government.
(2) The Central Government shall cause the annual report to be laid before each House of Parliament
along with the recommendations explaining the action taken or proposed to be taken on the
recommendation made therein in so far as they relate to the Central Government and the reasons for
non-acceptance, if any, of any such recommendation or part.
65. (1) The Commissioner shall prepare in such form and at such time for each financial year as may
be prescribed by the State Government an annual report giving a full account of his activities during
the previous financial year and forward a copy thereof to the State Government.
The State Government shall cause the annual report to be laid before each State Legislature along with
the recommendations explaining the action taken or proposed to be taken on the recommendation
made therein in so far as they relate to the State Government and the reasons for non-acceptance, if
any, of any such recommendation or part.
CHAPTER XIII: SOCIAL SECURITY
66. (1) The appropriate Governments and the local authorities shall within the limits of their
economic capacity and development undertake or cause to be undertaken rehabilitation of all
persons with disabilities.
(2) For purposes of sub-section (1), the appropriate Governments and local authorities shall grant
financial assistance to non-governmental organizations.
(3) The appropriate Governments and local authorities while formulating rehabilitation policies shall
consult the non-governmental organizations working for the cause of persons with disabilities.
67. (1) The appropriate Government shall by notification frame an insurance scheme for the benefit of
its employees with disabilities.
(2) Notwithstanding anything contained in this section, the appropriate Government may instead of
framing an insurance scheme frame an alternative security scheme for its employees with disabilities.
68. The appropriate Governments shall within the limits of their economic capacity and development
shall by notification frame a scheme for payment of an unemployment allowance to persons with
disabilities registered with the Special Employment Exchange for more than two years and who could
not he placed in any gainful occupation.
CHAPTER XIV: MISCELLANEOUS
69. Whoever fraudulently avails or attempts to avail, any benefit meant for persons with disabilities,
shall be punishable with imprisonment for a term which may extend to two years or with fine which
may extend to twenty thousand rupees or with both.
70. The Chief Commissioner, the Commissioners and other officers and staff provided to them shall
be deemed to be public servants within the meaning of section 21 of the Indian Penal Code.
71. No suit, prosecution or other legal proceeding shall lie against the Central Government, the State
Governments or the local authority or any officer of the Government in respect of anything which is
done in good faith or intended to be done in pursuance of this Act and any rules or orders made there
under.
72. The provisions of this Act, or the rules made there under shall be in addition to, and not in
derogation of any other law for the time being in force or any rules, order or any instructions issued
there under, enacted or issued for the benefit of persons with disabilities.
73. (1) The appropriate Government may, by notification, make rules for carrying out the provisions of
this Act.
(2) In particular, and without prejudice to the generality of the foregoing powers, such rules may
provide for all or any of the following matters, namely:-
(a) The manner in which a State Government or a Union territory shall be chosen under clause (k) of
sub-section (2) of section 3;
(b) Allowances, which members shall receive under subsection (7) of section 4;
(c) Rules of procedure, which the Central Coordination Committee shall observe in regard to the
transaction of business in its meetings under section 7;
(d) Such other functions, which the Central Coordination Committee may perform under clause (h) of
sub-section (2) of section 8;
(e) The manner in which a State Government or a Union Territory shall be chosen under clause (h) of
sub-section (2) of section 9;
(f) The allowances, which the Members shall receive under sub-section (3) of section 9;
(g) Rules of procedure, which the Central Executive Committee shall observe in regard to transaction
of business at its meetings under section 11;
(h) The manner and purposes for which a person may be associated under sub-section (I) of section
12;
(i) Fees and allowances which a person associated with the Central Executive Committee shall
received under sub-section (3) of section 12;
(j) Allowances which members shall receive under sub-section (7) of section 14;
(k) Rules of procedure, which a State Coordination Committee shall observe in regard to transaction of
business in its meetings under section 17;
(l) Such other functions, which a State Coordination Committee may perform under clause (g) of subsection
(2) of section 18;
(m) The allowances, which Members shall receive under sub-section (3) of section 19;
(n) Rules of procedure, which a State Executive Committee shall observe in regard to transaction of
business at its meetings under section 21;
(o) The manner and purposes for which a person may be associated under sub-section (1) of section
22;
(p) Fees and allowances which a person associated with the State Executive Committee may receive
under sub-section (3) of Section 22;
(q) Information or return which the employer in every establishment should furnish and the Special
Employment Exchange to which such information or return shall be furnished under sub-section (1) of
section 34;
(r) The form and the manner in which record shall be maintained by an employer under sub-section (1)
of section 37;
(s) The form and manner in which an application shall be made under sub-section (1) of section 52;
(t) The manner in which an order of refusal shall be communicated under sub-section (2) of section
52;
(u) Facilities or standards required to be provided or maintained under sub-section (3) of section 52;
(v) The period for which a certificate of registration shall be valid under clause (a) of sub-section (4)
of section 52;
The form in which and conditions subject to which a certificate of registration shall be granted
under clause (c) of sub-section (4) of section 52;
(x) Period within which an appeal shall lie under sub-section (1) of section 54;
(y) The manner in which an institution for persons with severe disabilities shall be maintained and
conditions which have to be satisfied under sub-section (3) of section 56;
(z) The salary, allowances and other terms and conditions of service of the Chief Commissioner under
sub-section (6) of section 57;
(za) the salary, allowances and other conditions of service of officers and employees under sub-section
(6) of section 57;
(zb) intervals at which the Chief Commissioner shall report to the Central Government under clause
(d) of section 58;
(zc) the salary, allowances and other terms and conditions of service of the Commissioner under subsection
(3) of section 60;
(zd) the salary, allowances and other conditions of service of officers and employees under subsection
(6) of section 60;
(ze) intervals within which the Commissioner shall report to the State Government under clause (d) of
section 61;
(zf) the form and time in which annual report shall be prepared under sub-section (1) of section 64;
(zg) the form and time in which annual report shall be prepared under sub-section (1) of section 65;
(zh) any other matter which is required to be or may be prescribed.
(3) Every notification made by the Central Government under die proviso to section 33, proviso to
sub-section (2) of section 47, every scheme framed by it under section 27, section 30, sub-section (1)
of section 38. section 42, section 43, section 67, section 68 and every rule made by it under subsection
(1). shall be laid. as soon as may be after it is made, before each House of Parliament, while it
is in session for a tow period of thirty days which may be comprised in one session or in two or more
successive sessions, and if. before the expiry of the session immediately following the session or the
successive sessions aforesaid, berth Houses agree in making any modification in the rule, notification
or scheme, both Houses agree that the rule, notification or scheme should not be
Made, the rule, notification or scheme shall thereafter have effect only in such modified form or be of
no effect, as the case may be; so, however, that any such modification or annulment shall be without
prejudice to the validity of anything previously done under that rule. Notification or scheme, as the
case may be.
(4) Every notification made by the State Government under the provision to section 33 proviso to subsection
(2) of section 47, every scheme made by it under section 27, section 30, sub-section (1) of
section 38, section 42. section 43, section 67. section 68 and every rule made by it under sub-section
(1), shall be laid. as soon as may be after it is made, before each House of State Legislature, where it
consists of two Houses or where such legislature consists of one House before that House.
74. In section 12 of the Legal Services Authorities Act. 1987, for clause (d), the following clause shall
he substituted, namely: –
“(d) a person with disability as defined in clause (i) of section 2 of the Persons with Disabilities
(Equal Opportunities, Protection of Rights and Full Participation) Act. 1995.”
K. L. MOHANPURIA.
Secy. to the Govt. of India
Three vital supreme court decisions
It is only May of 2016, but Supreme Court of India has already taken 3 key decisions this year which will change the Indian healthcare completely. It is expected that these 3 key decisions will leave a huge impact on medical profession and healthcare practices in India. As we all know, the Supreme Court of India is the apex of the judicial system with the tremendous range of powers. It not only gives verdicts on criminal and civil disputes but also has special powers to question bureaucracy and legislative bodies of the government when it finds there is enough evidence of a breach of constitutional rights. In the last four months, the apex court has given three judgments that have a potential to change entire nation’s healthcare scenario. These decisions encourage transparency, better health and good ethical practices in the field of medicine. Let us visit these decisions: Supreme Court Will Monitor MCI: In the month of April, Supreme Court endorsed a wide variety of recommendations made by the parliamentary committee about the structure and irregularities observed in the functioning of Medical Council of India. As we are aware, MCI is responsible for registration of practitioners, policy decisions as well as granting permissions in medical education. After a significant uproar from the medical fraternity and general public, the Government of India decided to appoint a parliamentary committee to restructure MCI. While this restructuring takes place, the Supreme Court has appointed a panel led by Red. Chief Justice Lodha to monitor MCI’s function for at least a year. It is a rare occasion where Supreme Court has exercised its powers to appoint a direct committee to oversee any a government body. The move is welcomed by both medical fraternity and ruling government. One Common Medical Entrance: In a historic ruling last month, Supreme Court also abolished validity of separate entrance test for undergraduate and postgraduate medical education. The Supreme Court ruled in favor of petitioners who requested the court to quash separate medical entrances by various government and private institutions. The petitioners had sighted that aspiring medical students were being subjected to a lot of stress due to multiple entrance exams. Moreover, they also sighted that there was potential for corruption and deserving students were not able to take an opportunity if they could not pay large sums as donations. The supreme court quashed its own judgment of 2013 and established the constitutional validity of NEET (National Eligibility Entrance Test) and set dates for the same. There were several cases filed by private parties and state governments but Supreme Court largely refused to take cognizance of them. Pictorial warning on Tobacco products: The Supreme Court refused to give stay and ruled in favor of union health ministry guidelines which dictate tobacco product manufacturers to have pictorial warning covering 85% of the packaging. Despite the large protests from tobacco lobby and workers unions, Supreme Court gave thumbs up for the government notifications. It has been largely debated whether these pictorial warnings have any effects at all. But we should look at the data from countries such as Australia who imposed strong regulations such as health warning spreading about 85% percent and plain packaging. The data shows that tobacco consumption of Australia has dropped drastically since these policies were introduced in 2010 and steeper prices. For example, a pack of cigarettes which was 12.50 Australian Dollars in 2009, now costs about 25 Australian dollars. These policies are crucial for Indian healthcare where tobacco related disorders have a huge impact on both health and economy. It won’t be wrong to say that the Supreme Court has ruled in favor health of India. These three major decisions by the Supreme Court hold a promise and can be seen as new light on the horizon. It will be important to see how the implementation of these verdicts takes place.
Various perspectives on clinical establishment act
Clinical Establishment Act.
. EPILOGUE
The Vedas have long ago stated the fact that in kalium the do goaders would be hounded out and the corrupt would flourish. The clinical establishment act seems to fulfil this prophesy not in part but in full measures
There are stringent and huge monitory penalties for non-registration by any medical professional which are more than many criminal penalties of IPC.
Well, I’m sure quite a lot of Indians would have some sort of idea of what this is. Well, for the dummies, this act would lay down basic criteria for operationalizing clinics, hospitals, laboratories etc.
For the uninitiated person, who has no idea about the masala of Indian healthcare, the natural response would be – ‘Great, this is something each citizen would definitely benefit from. Access to quality healthcare at your beck and call’. Well, appearances can be very deceptive.
What would the CEA lead to in most of the regions of the country –
1. Healthcare which is already expensive would become more expensive.
2. Healthcare would become inaccessible to most of the Indian poor unless they live in a state which has good public healthcare.
3. Specialists would become more in demand. Their salaries would rocket sky-high
4. Most of the small nursing homes and hospitals especially mission hospitals would have to be closed down.
5. Healthcare would become an industry rather than a service
One among the multiple thoughts I had about the CEA was the fact that in spite of quite stringent rules, all through these years quacks and allied health professionals have been practicing medicine in almost the whole of our country. I wonder why the government should insist on specialists alone handling the clinical work.
“This Act is a step towards corporatization of healthcare. All small units of healthcare like clinics will not be able to survive if this Act is introduced. It has been made keeping the foreign countries in mind and this is the biggest flaw in it. According to the Act, each clinic should have one nurse and pharmacist each despite the fact that the WHO, in a 2010 report, has revealed that India is grappling with shortage of medical staff.”
“At least 70% of the total health services in the country are provided by clinics and they should not be restricted through the guidelines of this Act. Also, medical facilities in rural areas are already in a bad shape and with the requirements being asked at a medical establishment, it is next to impossible to run a clinic in rural areas. Not only will this be a problem for doctors as it needs high investment but also for the patients who will have to bear high cost.”
It’s worthwhile looking at a statement made by the IMA back in 2010 in this regard:
Clinical Establishments- Role of government and Healthcare Market
The Kerala Clinical Establishments (Registration, Accreditation and Regulation) Bill, 2009 which was in the news recently has invited the fury of Medical practitioners, clinical institutions, labs, pharmacies, scanning centres and agencies, as it intended to curtail their freedom. The healthcare sector in Kerala which is one of the most lucrative sectors has been contributing to the state’s GDP and providing employment to many people, especially women in Kerala. This includes people who are employed in Specialized Scanning Centres to nursing homes for old aged. With huge demand and high private participation, the sector has grown exponentially in term of numbers, reach and revenue. If you take the number of nurses alone, who constitutes the major part of the sector; the numbers are quite immense, taking into account those working in Kerala or India and those working abroad. Relative figures of people employed in laboratories; Scanning/Detection Centres are not available.
With its high literacy rates and progressive education programmes, Kerala trains a nursing workforce that is highly sought-after in the global labor market. This stands true for persons who are not nurses but possess the qualification or skills to be employed in various labs, pharmacies or clinical centres. Relatively large number of people work similarly in clinical establishments in other capacities.
In the current scenario the scope and nature of nurses and other non-nursing personnel’s is determined to a large extent by the situations or market existing in Kerala. The huge potential offered by the healthcare sector through hospitals, nursing homes, clinics and various agencies is the key to the large population of students graduating from various educational institutions imparting training from nursing to pharmacy. Depending on their qualifications (GNM, ANM and BSc for nurses), they are part of the market which is supposed to support the health and wellbeing of the entire population in Kerala and also abroad.
The proposed law throws the questions on whether it will stultify the market opportunities of nurses and others associated in the sector. The legislation requires mandatory registration of all clinical establishments which includes nursing homes, clinics and agencies. Further the Health Department can conduct quality checks and take action against erring institutions. It is a fact that the Healthcare and Nursing sector has become a business which involves millions of rupees. At the same time, it has been providing employment and catering to the requirements of a considerable population, maybe at a cost. The intent of the legislation is genuine, but the manner in which it is undertaken is doubtful. While regulation is required to check lack of quality or unethical issues, mandatory registration does not suffice. This stands true with most of the regulations, especially those related to Health and Environment. The recent Shawarma issue which made headlines is the perfect example of how health authorities failed in executing their mandate of checking and improving quality standards of food. They were more active in closing and sending notices to shops than assisting them to improve the standards or comply with it. A similar situation shall exist once the proposed Bill comes is passed and comes into effect.
The Department of Health and Medical Education and the various institutions like Medical Council and Nursing Council have been involved at various levels in regulating the nursing and other establishments. However, due to lack of personnel’s and facilities involved, they have not been able to function effectively. This has been one of the major reasons which has caused the sprouting of spurious institutions which has been duping students and people alike. The effect is appearance of unskilled people without means of employment, lack of skilled personnel to handle technologies used in scanning centres or laboratories and overall lack of professionalism in service. This has a larger impact on the persons who take the services of these clinical establishments paying huge cost but get sub-standard service. The issue is graver in case of healthcare services which directly affect the human life such as emergency services, basic life support, infection control etc. Mandatory registration cannot be an assured manner for preventing let alone reducing such instances, as they can very well function illegally without getting caught by law. Awareness and education of various stakeholders is required to avoid and stop the malpractices which affect the sector.
The current Bill does not address the issue of quality standards demanded by various professions, clinical establishments and those employed in such establishments. The Government can do a monitoring role of checking any malpractices, lack of standards, complaints etc. But it shall not interfere in the day to day functions of these establishments or discourage people from setting up such establishments.
Unfortunately, the situation in India is that tighter governmental control has only detracted entrepreneurs while on the other hand has created a monopoly for few players who were able to influence the system. In an unregulated environment like healthcare, definitely competition is bound to happen, but for the good. Maybe institutions like Competition Commission can check monopolies and give strictures on unethical practices adopted by various establishments.
Education, training and skill development of nurses or clinicians employed or seeking employment in clinical establishments is one of the most important areas which the government needs to interfere. Unless we have specialized ITI like institutions for health care professionals, it will be difficult to expect quality from them. The scope of specialized and integrated programmes for medical practitioners, pharmacists, lab technicians etc. is immense and the government should assist private entrepreneurs to impart training. The government can provide funding to such institutions and also build favorable employment opportunities for those graduating and possessing the necessary skills. It is therefore important to provide better facilities and upgrade technologies in the existing colleges or institutions imparting such training. As it has been found that those people passing out does not possess the necessary skill required by the profession. On the job training shall be made a norm with frequent exposure trips and knowledge acquisition.
Laws like the Kerala Clinical Establishments should be focused on creating standards, educating people, and assisting establishments to build a quality environment for co-creation and co-habitation. Over the years, the healthcare market itself shall break the bad eggs with the help of the monitoring lens of the government.
Prepared by Madhu.S, Team Lead, Centre for Public Policy Research (project@cppr.in)
“The sincerity of the govt. may be appreciated, if it initiate[s] and strives to eradicate the quacks and quackery from our country which has been crippling our society’s health in the guise of providing first-aid care….[putting] corporate hospitals and rural area hospital in same line to accredit-ate is unjustifiable as it favors corporatization of health care and jeopardizing the health services within reach of common man”
Unresolved issues in the Act
While in many ways a regulatory framework is essential, there are still unresolved problems with the Act. Some of them are listed here.
Section 12(2)
It states thus: “The clinical establishment shall undertake to provide within the staff and facilities available, such medical examination and treatment as may be required to stabilize the emergency medical condition of any individual who comes or is brought to such clinical establishment.”
What this boils down to is that all clinical establishments are expected to stabilize a patient in an emergency medical condition before transferred to another hospital. Such interventions, the Act says are to be made “within the staff and facilities available.” But one doesn’t have to stretch the imagination to see that its interpretations can vary.
The original Supreme Court directive on this regard was meant for providing life-saving first aid for victims of accidents. It’s quite unrealistic-and potentially unfair to the doctors to extend this to any and all emergency situations.
Lack of provision for extra machinery for additional workload of regulating private clinics
In this backdrop, it’s hard to see how a fair implementation of the Act is possible-affecting not just the doctors but also the patients. For instance, the Act has called for the establishment of the National Council-which is supposed to have a special secretary: the director-general (DG) of health services, Ministry of Health and Family Welfare as an ex-officio member and chairperson.
This implies that important decisions could be delayed if the DG cannot squeeze out more time for this additional task. There are to be no additional appointments at the state level to manage this work. And at the district level, the situation could be potentially worse. For in the districts the chairperson and the secretary of the registering authority are to be the district collector and the district health officer respectively. Needless to say, this increases their workload by a long stretch, causing further delays in getting things done.
Those who wish to appeal against the order of the district health authority must approach the state council
Even if a marginal number of establishments from a state wish to go for an appeal, this would amount to a substantial volume of appeals from within distinct district registering authorities. But the doctors must approach the state capital for matters related to the disputes. That’s on ordeal that could be avoided with a simplified provision.
These are but a few of the issues that one finds in the Act, giving the doctors substantial basis for opposing it.
Such issues point to the necessity for a more involved discussion between the government and the medical fraternity. The key issue here is the provision of adequate healthcare to a huge number of people. And it’s the state’s job to ensure that care-givers, regardless of the size of their institutions are able to provide that in the best possible manner, facing minimal hassles.
I personally have much misgiving to the regulations of the Act in the present form.
1. In a country like India which is very vast and the majority of the population (about 70%) lives in villages, it is going to be very difficult for anybody to set up hospitals in semi-urban and rural areas. The stipulations are going to be very hard to meet that setting up a hospital would hardly be a profitable venture. The other side is that even if hospitals are set up, the cost of care would be quite expensive. Almost all of us have mostly depended on small clinics or nursing homes which are run by a single doctor with the help of a nurse or by a doctor family. In fact, quite a lot of us may have knowingly or unknowingly gone to an unqualified practitioner or quack for our small medical problems. At present I live in a place where almost 95% of the population go to a quack first for treatment. They have bungled up cases where the patient ultimately died. However, nobody has been able to do anything. The only reason being that these guys are the only people who have some knowledge about medicine in remote settings. And they come very cheap. The regulations appear to be giving more importance for corporate multi-specialty hospitals. This is quite protectionist in nature towards encouraging a corporate model which will ensure that healthcare is only available at a premium in the absence of an efficient public health care system.
2. There is enough scientific evidence that family practice and nurse practitioner based primary care is as efficient, and rather more people friendly than specialist doctors in full-fledged hospital set ups.
3. If you consider any of the complex clinical conditions one can think of, the primary level of care is much more important than high tech healthcare. We have examples of countries like Brazil and South Africa, where Family Medicine graduates have major role in healthcare. The present regulations would only increase costs. If you look at the regulations, the first level of treatment is going to be a Level 1 Hospital which needs to have a staffing of at least 6 for a place which do not have inpatient care.
4. Most of our tertiary care centres are burdened with primary care. It is not uncommon for any faculty in our medical colleges who end up complaining that most of the patients that they see could have been easily managed at a Primary Health Centre or even by a Nurse practitioner. The ultimate result is that quite a many of our specialists are over-worked to the extent that they are not able to do justice to the specialized skills they’ve obtained.
If we can think of changes that can be proposed, I would propose the following –
1. Legalizing Nurse-Practioners Care: Nurses should be trained to treat simple illnesses allowed to prescribe medicines. A major need would be to allow a category of health entrées which are entirely run by nurses who may or may not supervised by doctors. At least for populations who have poor access to healthcare, they would be a major boon. In fact, such nurse-led primary care centres have already been in existence in the country, mainly facilitated by various congregations of the Catholic Church.
2. Provision for single doctor healthcare centres: We are all very familiar with such single doctor establishments. A 100 square feet room with a familiar friendly face to whom you ran when you had a toothache or a cold. You pay about 50 rupees and then you pay some more for the medicines and some basic investigations. The whole process took not more than half an hour. If the regulations in its present form are accepted and finalized, the family doctor would be history.
Section 55 of the act enlists the ‘Rights of patients’ as follows:
(1) The patients and / or Person authorized by patient shall receive the relevant information about the nature, cause of illness, proposed care, and the expected results of treatment, possible complications and the expected costs.
(2) Confidentiality of treatment and privacy during examination. Examination of female patient should be carried out in presence of female attendant.
(3) Person suffering from HIV/AIDS shall not be denied care.
(4) Complaint register should be made available in Clinical establishment.
(5) List of Specialists along with Qualifications Should be displayed at prominent place in Clinical establishment.
(6) Patient has the right to seek second opinion. All medical and diagnostic reports shall be made available to the patient or authorized person to facilitate second opinion.
(7) Patient and / or Person authorized by patient or guardian if patient is minor has a right to have an access to his / her clinical records during admission to Clinical establishment and Photocopy of indoor papers should be made available on demand after discharge.
(8) Discharge card should be issued to patient mentioning: Diagnosis, clinical findings, results of investigations, treatment given, the patient’s condition at the time of discharge and advice to patient.
(9) Patient has right to choose registered pharmacy or recognized diagnostic center at his / her own responsibility.
(10) Protection ensured by statutory guidelines and legally enabled provisions applicable to Clinical Establishments which are conducting clinical research.
(11) Informed consent prior to potentially hazardous tests / treatment.
Thus, if the intents of the Act are preserved, it is likely to benefit both-the patients and the health care service providers alike.
Cl. 2(c)(i) defines clinical establishments as facilities with beds. Thus, out-patient clinics which comprise 60-70% of private healthcare (Report of the Working Group on Clinical Establishments, Professional Services Regulation and Accreditation of Healthcare Infrastructure (RWG)) are automatically excluded. Independent laboratories and radiology facilities that perform diagnostic and/or investigative services are covered under 2(c)(ii). Outpatient surgery, now-a-days a common feature in the United States (see this report), is beginning to catch on in India as well – several scientific reports have been published involving specific surgical procedures – though no actual numbers are available on the pervasiveness of their practice in freestanding clinics (A good guess may be that less capital intensive procedures (e.g. traditional forms of cataract surgery) are more prevalent). Facilities conducting such procedures are usually attached to outpatient clinics, require patients’ presence only for the duration of the operation itself followed by a brief period of post-operative supervision usually amounting in toto to less than a full day and warrant no beds or admission. Such facilities too, notwithstanding the substantive nature of care involved, would not come under the purview of this act.
Cl. 5 empowers the government to develop ‘proper’ as well as minimum standards for healthcare. The latter alone is to be applied in reviewing the state of any facility. In a country with limited information about the nature and quality of healthcare, no national program for development of practice guidelines or medical review criteria (World Bank Report, 2003) in addition to vast regional and social disparities, creating such standards will be quite a difficult task. The RWG acknowledges this (para 37) and being a long-drawn process, recommends delinking it from registration (para 40(x)), a view incorporated in the draft bill.
Cl. 10 designates the District Health Officer (DHO) or Chief Medical Officer (CMO) as the district registering authority for registration of clinical establishments in each district. The DHO/CMO also shoulders responsibilities for the management of government facilities in that district. This leads to a conflict of interest.
Cl. 39 has a limiting stipulation that the register must be maintained in digital format. There is a concern that newer non-digital technologies may therefore be excluded.
Is state regulation a smart idea? This fundamental question at the heart of the debate has no easy answer. The RWG which recommended this step (para 67) does not appear to have seriously debated the merits of this solution. The report discusses briefly the problems of quality and lack of regulation in the private sector (para 6) and from there, jumps to a discussion on the forms of regulation, previous legislations, their inadequacies, and comparative approaches in other countries, with little mention of how legislative enactment will address specific issues, how far it ought to go or why it is a superior approach relative to the rest. It does stress that central legislation is necessary to ensure uniform standards (para 26). However, to foster cooperation and mitigate the skepticism of the private healthcare establishment, the National Council which is tasked with developing standards (Cl. 5) is required to adopt a consultative approach (Cl. 7).
A World Bank (WB) Report from 2003 titled ‘Health Policy Research in South Asia: Building Capacity for Reform’, a goldmine of information on the private sector (the RWG appears to have drawn from it at several places), summarizes the various malpractices that previous studies have noted in the private sector (p. 235): “Stories abound of problems with diagnostic and treatment practices; with inadequate facilities and equipment; and of doctors over-prescribing, subjecting patients to unnecessary investigations and interventions, charging patients exorbitantly, using unethical and irrational practices, and failing to provide information to patients.” The report, similar to several other studies, generally favors regulation though its authors (who are all prominent in the field) are not entirely in agreement upon the way forward. One of them recommends decentralization and a better regulatory regime (p .59); a second, writing in greater detail upon this question strongly argues for a ‘minimum set of basic regulations covering the licensing of practitioners and institutions, measures to ensure minimum standards of quality, guidelines regarding pricing, and actions to prevent the oversupply of services (including technology)’ (p. 240); a third, though convinced of the imperative for state intervention, insists that rigorous evaluation is a necessary prerequisite for there is little understanding of the regulatory mechanisms already put in place (p. 250). It must be noted however that many of the studies that recorded evidence of malpractice were not limited to private hospitals and nursing homes. They often focused on individual healthcare providers and also included those operating in exclusively ambulatory clinics with no separate assessment of the proportional contributions in each type of setting. Given the predominance of such clinics, regulatory scrutiny of a large fraction of such ethical violations will be precluded under the terms of this legislation.
The RWG also insists that though ‘state-specific variations would certainly exist; the need of the hour is [to have] uniform standards’ (para 34). The bill, in the statement of objects and reasons, repeats this theme (para 3). All of which brings us to the next question: Is a uniform standard a good idea? The definitive answer will have to wait till these standards are actually enunciated. One can speculate based on the wording of the bill and the RWG of the ministry’s thinking.
Cl. 12(i) entails minimum standards of facilities and services and cl. 12(ii) of personnel, for clinical establishments to meet the requirements of the Act. Regarding facilities, the legislation is likely to have beneficial effects at least with regard to private institutions in urban areas. Important findings previously reported in limited studies have been a lack of hygienic conditions and limitations of space (Nandraj, 1994). Both are easily identified though the latter may be difficult to remedy in a congested urban environment (that study was conducted in Bombay). How much leeway may be offered by the regulating authority for such locations remains to be seen.
Services can be loosely categorized into two: those that directly relate to patient care and those that are either peripheral to patient care but involve interfacing with the public or are more directly concerned with the institution’s own upkeep. The former includes medical, surgical, nursing and other services that directly relate to patient care whose practices are governed by professional guidelines and the conduct of whose professionals, to a significant extent, is overseen by professional bodies and also comes within the ambit of other laws (such as the Consumers’ Protection Act, 1986). Any regulation may end up interfering with not only the jurisdiction of these bodies but affect professional autonomy and are likely to engender profound resistance. However, egregious instances of medical errors that get reported often involve poor professional practice or judgment. Several previous efforts have resulted in little noticeable alteration in practices, their failure being blamed on ‘weakness’, lack of clarity or relevance, strong resistance from practitioners and state apathy (Bhat, 1999; Nayar, 2002). Some provisions to examine medical records for irregularities already exist on the statute in some states but have not been implemented (Bhat, 1996). It remains to be seen whether a similar fate awaits this renewed effort with no verification mechanism put in place to check whether the developed standards are being regularly followed (Prominent instances attracting media attention may still lead to exacting regulatory scrutiny in the absence of a routinely enforced system of auditing records of private health centers). The second kind of services are more amenable to regulation – governments and accreditation agencies usually target them in their efforts to improve quality of healthcare. The same is likely in India also. In fact, the RWG mentions the standards developed by the National Accreditation Board for Hospitals and Healthcare Providers (NABH), a constituent board of the Quality Council of India (QCI) (para 62). Other accrediting bodies have also emerged (para 63 and 64). It is quite possible that the standards adopted finally under this Act will be significantly drawn from some of these existing models.
Personnel problems abound in the healthcare sector. Apart from the widely publicized issue of rural doctor shortage, nursing shortages have also been reported. The vast differences in the number of medical colleges in different states (Supe and Burdick, 2006) also means that the number of graduating physicians will continue to be uneven with location, lifestyle preferences and linguistic barriers potentially preventing large-scale redistribution from overserved to underserved areas. These problems, being rooted in the existing system of incentives and restrictions, are destined to remain for a while. The question here is: how will new regulations affect them? If the medical education system is anything to go by, the answer is: adversely. Professional medical colleges are bound by the standards for faculty recruitment laid down by the MCI and risk losing their recognition should they flout those norms. At the same time, they have been facing an acute shortage of faculty in several (primarily non-clinical) specialties for which the blame is partly laid at the door of the MCI with calls to reduce these requirements to address this issue. Similar staff shortages exist in the general healthcare sector as well. Allopathic hospitals sometimes operate with homeopathic house surgeons (Nandraj, 1994) and recruit untrained nurses (Bhat, 1996; WB Report, 2003). If qualification requirements are strictly enforced, private institutions, faced with the prospect of losing their license, may either rise in revolt or resort to a variety of unsavory methods to pass inspection (see ‘Hoodwinking the medical council’ in this news item). In rural areas, this problem has been overcome to some extent by existing personnel performing additional services outside the scope of their training. I knew of a surgeon in a popular rural facility in North Karnataka who also doubled as a gynecologist and was said to be proficient in performing orthopedics surgery when the regular orthopedic surgeon was out of town. The WB Report acknowledges this practice in Uttar Pradesh (p. 274-5) but recognizing that the alternative is the absence of any service, recommends allowing it to continue ‘for now’ with the rider that full disclosure be made by practitioners to community leaders and the public. A proviso to cl. 13(2) insists that ‘in prescribing the standards for clinical establishments, the Central Government shall have regard to the local conditions. I found this somewhat ironical – are not the notions of uniformity and Central intervention antithetical to the idea of a local solution? Are Central experts truly more conscious and sensitive of local considerations than local health officials? In any case, not providing for some flexibility in the regulations framed under Cl. 12(ii) will certainly hurt rural providers. How these diverse requirements will be handled remains to be seen.
There have also been various reports of a variety of inadequacies in the conduct of individual providers – widespread absenteeism, unfilled vacant posts, incompetence and tardy work ethic (Nandraj, 1994; Das and Hammer, 2004; Hammer et al, 2006). Many of these have been reported in the public sector and the lack of robust accountability practices has been blamed for this (Hammer et al, 2006). How will better regulatory standards impact this? Cl. 42-44 allow the government to levy fines for failing to conform and a proviso to cl. 32(3(b)) allows for the institution to be restrained from ‘carrying on’ if there is imminent danger to the health and safety of patients. As mentioned before (vide supra), with the DHO/CMO holding overall responsibility for government facilities in the district, the ensuing conflict of interest makes it quite unlikely that he/she would be willing to take strong action against erring individuals or facilities. Apart from this, the coercive impact is blunted as any fine levied is merely one arm of the government paying another. There may be more severe consequences if a facility is actually forced to shut down for non-compliance. That is however likely to be a rare event; if it is serious enough to scandalize the government or even otherwise jolt it into action, the finger will once again point to the very DHO/CMO who ordered it. Thus, even if better accountability standards are developed and adopted, these constraints are likely to hamper their effective implementation.
Apart from uniformity between states, the RWG also talks about parity between public and private healthcare institutions (para 36): “Private sector players are quick to accuse the govt. of observing double standards in prescribing minimum standards for private establishments and doing nothing to improve the pathetic conditions in public health institutions. This issue would need to be addressed in the right spirit by the government. No exemptions have been provided for government institutions in laws framed for management of bio medical waste, setting up of blood banks and pre-natal diagnostic tests etc. All these laws have had salutary impact on their specific areas. All the more reason that government establishments should also be required to register and comply with prescribed standards.” On the face of it, the initiative is a laudable one. However, Ajay Mahal, in the WB Report from 2003, quoting classical economic theory has this to say (p. 59): “…particularly the suggestion to improve the quality of public sector care, run[s] into the problematic observation made by Besley and Coate (1991) that greater equity can be achieved and insurance for the poor improved if the quality of available public services is not ‘too high’. They argue that the interests of the poor could be served by the public sector if the richer groups start using private care or unsubsidized public facilities such as paid inpatient wards. For this to happen, however, the non-poor would have to perceive the quality of care in the private, unsubsidized facilities as being better than that of subsidized public services.” He also found that the BIMARU states and Orissa have the least egalitarian distribution of public health subsidies, i.e., the wealthier sections use public health facilities more than the poorer sections of society. If the prescribed minimum standards are high enough to require both public and private establishments to upgrade their facilities causing greater parity, it might then end up worsening the targeting of subsidies to impoverished sections and enhance healthcare disparities. The same result would also occur if private establishments, finding themselves unable to meet the requirements, simply shut shop or move elsewhere.
The Indian Medical Association (IMA) which has consistently resisted state regulation, not surprisingly, came out against this particular effort also. As it alleges, this is, in a sense, a return to the license-permit raj with registration and inspection becoming potential focal points of corruption.
In conclusion, in a highly diverse country such as ours, I remain skeptical about a nationwide effort to bring uniformity through state-mandated regulation. The Act may well have some positive effects characterized by noticeable improvements in the urban private sector institutions. However, a full assessment must include the entire array of costs and benefits incurred by all constituent parts of the healthcare system as well as its participants. Only a few states have so far signed on to this initiative. If this remains the case, it may eventually provide an opportunity after it has been implemented (if at all it comes into effect), to examine, through comparative analysis, how effective it has turned out to be.
India can boast of a flourishing and diverse medical industry. The ailing has a variety of options and treatments to choose from, including the best modern hospitals and the traditional homeopathy and Ayurveda cures. With a market of more than a billion people readily available, clinical establishments of all sorts have mushroomed and thrived. Medical malpractice however, has also grown proportionately. News of fake doctors, fake medicines, inadequate facilities, outdated equipment, and incompetent and negligent staff is no longer rare.
The Central government has, with the intention of regulating clinical establishments, sought to introduce the Clinical Establishments (Registration and Regulation) Act, 2010 (“the Act”). The malice of introducing defective legislation seems not limited to the Lok pal Bill.
The Act seems to me a confused piece of legislation that has been passed without much debate. It is bound to face constitutional hurdles. The purpose of the Act, according to its Preamble, is to provide for the registration and regulation of clinical establishments with a view to prescribe minimum standards of facilities and services that may be provided by them. While there are many Central and state legislations that seek to regulate the medical profession, the objective of establishing a regulatory structure where all clinical establishments are required to meet certain standards seems to be a noble one.
However, a perusal of the Act shows that there is no nexus between the Act as it stands, and the objects that it seeks to achieve. The first strange anomaly is in Section 1 itself, as per which, the Act shall come into force only in the states of Arunachal Pradesh, Himachal Pradesh, Mizoram, and Sikkim, and the Union Territories. Given the aim of the Act to prescribe minimum facilities in order to improve the larger public health, it seems extremely odd to selectively implement the Act in only four states and the Union Territories.
The Act applies to all “clinical establishments” defined under Section 2 (c). The definition is an unnaturally wide one, and includes hospitals, maternity homes, nursing homes, dispensaries, clinics, sanatoriums and institutions that offers services or facilities requiring diagnosis, treatment or care for illness, injury, deformity, abnormality or pregnancy, in any recognized system of medicine. “Recognized system of medicine” under the Act covers Allopathy, Yoga, Naturopathy, Ayurveda, Homeopathy, Siddha, and Unani systems of medicine, as well as any other system of medicine that may be recognized by the Central government. Every conceivable range of treatment is sought to be included within the parameters of the Act. Under Section 11 of the Act, no person can run a clinical establishment unless it has been duly registered in accordance with the provisions of the Act. A severe monetary penalty is provided under the Act for carrying on an establishment without registration.
This in itself would not be overly onerous, if it was not for the extremely unreasonable standards that the Act mandates every clinical establishment, in every recognized system of medicine, to have. Section 2 (d) of the Act incorporates a very vast definition of ‘emergency medical condition’ (which includes symptoms of sufficient severity, including severe pain, that may cause serious bodily impairment or dysfunction), and imposes on every clinical establishment, the duty to provide facilities ‘to stabilize’ an ‘emergency medical condition’ and to provide such medical treatment necessary to assure within reasonable medical probability, that no material deterioration results during the transfer of the individual from a clinical establishment. What this effectively means is that if a person has a heart attack and is taken to a Yoga centre, the Yoga centre must provide for the minimum medical treatment necessary to ‘stabilize’ him, in terms of the definition above. Quite clearly, this seems like an unworkable and even an unconstitutional onus to impose.
The above features of the Act curtail the right of medical practitioners to carry on their occupation, under Article 19 (1)(g) of the Constitution of India, 1950. The Act forces clinical establishments to provide services that they may not wish to provide at all. Implicit in the right to carry on an occupation under Article 19 (1)(g) is the right not to carry on a particular occupation. While this obligation is imposed, the Act is completely silent on how these clinical establishments will be remunerated for the services to be provided under the Act. This obligation of the State to improve public health is being transferred to the private establishments, in the guise of regulation.
The Act also seems to suffer from the vice of excessive delegation of non-delegable functions. Section 3 of the Act establishes a ‘National Council’ with the powers of classifying all clinical establishments and developing minimum applicable standards. Under Section 12 of the Act, every clinical establishment must have these prescribed conditions of minimum standards and requirements necessary for registration and continuation. Therefore, the Act purports “to prescribe minimum standards of facilities and services” and to “determine the standards for clinical establishments”. No such prescription of any standards for facilities and services, are however discernible from the text of the Act. Instead, the Act delegates this essential legislative function to the Central Government and the National Council, empowering them to prescribe the necessary standards. To impose a stringent regulatory regime, without prescribing the parameters of the regime and any guideline based on which the delegate can formulate minimum standards, seems to me an abdication of the constitutional duty to lay down the law and an unconstitutional delegation of non-delegable powers to the Executive.
Not unsurprisingly, a lot of medical associations and doctors who have become aware of this legislation, are strongly opposing it. The Act, applicable to the Union Territory of Chandigarh, was recently challenged in the Punjab and Haryana High Court, but the challenge was withdrawn as premature because the Act was yet to come into force through a notification. Nevertheless, what is being argued is that, the conditions that are sought to be imposed under the Act, can only be provided by large scale, multi-specialty hospitals, and therefore in the guise of providing a regulatory framework, the Act will virtually eliminate small and medium-scale clinical establishments, creating a monopoly in favor of large hospitals.
The Act therefore may have the completely opposite effect of the object it seeks to achieve. Instead of improving the standards of public health, it may lead to depriving several millions of people of adequate healthcare facilities, which are provided by individual doctors or small clinical establishments. While the regulation of clinical establishments is important, the Act as it stands today, is discriminatory and vague, and in my opinion, will not meet the strong constitutional objections that will be raised against it in the future.
IMA proposals are …
The bill unleashes license raj with powers of penalties up to 5 lacs. The registering authority can impose fines for noncompliance and if a CE fails to pay the same, it would be recovered as an arrears of land revenue.
The penalties are stringent and for first offence the penalties are more than that in IPC. For first offence it is 1000 INR, then for second offence it is 50000 and for third offence it is 5 lacs. Disobeying any direction or obstruction to inspection entails Rs 5 lac penalty.
The bill unleashes license Raj with draconian powers to the inspectors with little provision for appeal.
Are doctors doing some illegal work to be harassed like this
IMA proposes that the act should not be implemented at all. If at all government is adamant and hell bent it should be such the single doctors’ clinics to be considered for minimal registration only without applying strict rules. The provision should be prospective in implementation and old clinics and hospitals should be excluded.
IMA wants that only those establishment with indoor facilities should be included in the act. Also, till date existing establishments should be exempted from the provisions of the act.
IMA Proposes that the requirements of pharmacist and clinical psychologists in various places should be done away. Pharmacists are not needed as most drugs are formulated and psychologists are mostly non-medical persons masquerading as doctors.
IMA proposes that the ethics and rules are different and should not be mixed. Stabilizing a patient is ethical and making a rule is like asking an inappropriate person to treat the disease and waste time in referral.
Danielle Ofri on what plagues American medical system, one of the costliest in the world writes that insurance and consumer affair concerns makes American doctors do too much of paper work which is more than the time spent in treating patients. This is what we are trying to imitate. IMA proposes that section of the act which entails reporting data of the patient be withdrawn completely. Other than notifiable communicable diseases, no data will be provided to the government as it will hamper direct patient care, considering our large population.
A bitter pill?
India can boast of a flourishing and diverse medical industry. The ailing has a variety of options and treatments to choose from, including the best modern hospitals and the traditional homeopathy and Ayurveda cures. With a market of more than a billion people readily available, clinical establishments of all sorts have mushroomed and thrived. Medical malpractice however, has also grown proportionately. News of fake doctors, fake medicines, inadequate facilities, outdated equipment, and incompetent and negligent staff is no longer rare.
The Central government has, with the intention of regulating clinical establishments, sought to introduce the Clinical Establishments (Registration and Regulation) Act, 2010 (“the Act”). The malice of introducing defective legislation seems not limited to the Lok pal Bill.
The Act seems to me a confused piece of legislation that has been passed without much debate. It is bound to face constitutional hurdles. The purpose of the Act, according to its Preamble, is to provide for the registration and regulation of clinical establishments with a view to prescribe minimum standards of facilities and services that may be provided by them. While there are many Central and state legislations that seek to regulate the medical profession, the objective of establishing a regulatory structure where all clinical establishments are required to meet certain standards seems to be a noble one.
However, a perusal of the Act shows that there is no nexus between the Act as it stands, and the objects that it seeks to achieve. The first strange anomaly is in Section 1 itself, as per which, the Act shall come into force only in the states of Arunachal Pradesh, Himachal Pradesh, Mizoram, and Sikkim, and the Union Territories. Given the aim of the Act to prescribe minimum facilities in order to improve the larger public health, it seems extremely odd to selectively implement the Act in only four states and the Union Territories.
The Act applies to all “clinical establishments” defined under Section 2 (c). The definition is an unnaturally wide one, and includes hospitals, maternity homes, nursing homes, dispensaries, clinics, sanatoriums and institutions that offers services or facilities requiring diagnosis, treatment or care for illness, injury, deformity, abnormality or pregnancy, in any recognized system of medicine. “Recognized system of medicine” under the Act covers Allopathy, Yoga, Naturopathy, Ayurveda, Homeopathy, Siddha, and Unani systems of medicine, as well as any other system of medicine that may be recognized by the Central government. Every conceivable range of treatment is sought to be included within the parameters of the Act. Under Section 11 of the Act, no person can run a clinical establishment unless it has been duly registered in accordance with the provisions of the Act. A severe monetary penalty is provided under the Act for carrying on an establishment without registration.
The Act seeks to regulate shady medical establishments—but it has unreasonable standards. Image above is taken from unzoki’s photo stream on Flickr, here. Image (but not the rest of this work) is licensed under a Creative Commons Attribution-ShareAlike 2.0 Generic License.
The Act seeks to regulate shady medical establishments—but it has unreasonable standards.
2.0 Generic License.
This in itself would not be overly onerous, if it was not for the extremely unreasonable standards that the Act mandates every clinical establishment, in every recognised system of medicine, to have. Section 2 (d) of the Act incorporates a very vast definition of ‘emergency medical condition’ (which includes symptoms of sufficient severity, including severe pain, that may cause serious bodily impairment or dysfunction), and imposes on every clinical establishment, the duty to provide facilities ‘to stabilize’ an ‘emergency medical condition’ and to provide such medical treatment necessary to assure within reasonable medical probability, that no material deterioration results during the transfer of the individual from a clinical establishment. What this effectively means is that if a person has a heart attack and is taken to a Yoga centre, the Yoga centre must provide for the minimum medical treatment necessary to ‘stabilize’ him, in terms of the definition above. Quite clearly, this seems like an unworkable and even an unconstitutional onus to impose.
The above features of the Act curtail the right of medical practitioners to carry on their occupation, under Article 19 (1)(g) of the Constitution of India, 1950. The Act forces clinical establishments to provide services that they may not wish to provide at all. Implicit in the right to carry on an occupation under Article 19 (1)(g) is the right not to carry on a particular occupation. While this obligation is imposed, the Act is completely silent on how these clinical establishments will be remunerated for the services to be provided under the Act. This obligation of the State to improve public health is being transferred to the private establishments, in the guise of regulation.
The Act also seems to suffer from the vice of excessive delegation of non-delegable functions. Section 3 of the Act establishes a ‘National Council’ with the powers of classifying all clinical establishments and developing minimum applicable standards. Under Section 12 of the Act, every clinical establishment must have these prescribed conditions of minimum standards and requirements necessary for registration and continuation. Therefore, the Act purports “to prescribe minimum standards of facilities and services” and to “determine the standards for clinical establishments”. No such prescription of any standards for facilities and services, are however discernible from the text of the Act. Instead, the Act delegates this essential legislative function to the Central Government and the National Council, empowering them to prescribe the necessary standards. To impose a stringent regulatory regime, without prescribing the parameters of the regime and any guideline based on which the delegate can formulate minimum standards, seems to me an abdication of the constitutional duty to lay down the law and an unconstitutional delegation of non-delegable powers to the Executive.
Not unsurprisingly, a lot of medical associations and doctors who have become aware of this legislation, are strongly opposing it. The Act, applicable to the Union Territory of Chandigarh, was recently challenged in the Punjab and Haryana High Court, but the challenge was withdrawn as premature because the Act was yet to come into force through a notification. Nevertheless, what is being argued is that, the conditions that are sought to be imposed under the Act, can only be provided by large scale, multi-specialty hospitals, and therefore in the guise of providing a regulatory framework, the Act will virtually eliminate small and medium-scale clinical establishments, creating a monopoly in favor of large hospitals.
The Act therefore may have the completely opposite effect of the object it seeks to achieve. Instead of improving the standards of public health, it may lead to depriving several millions of people of adequate healthcare facilities, which are provided by individual doctors or small clinical establishments. While the regulation of clinical establishments is important, the Act as it stands today, is discriminatory and vague, and in my opinion, will not meet the strong constitutional objections that will be raised against it in the future.
(Animesh Sharma is an advocate at the Punjab and Haryana High Court.)
This entry was posted in History, Human Rights, Litigation and tagged analysis, clinical establishments, courts, hospitals, Lokpal Bill, medical law, medicine on September 8, 2011.
The Clinical Establishments Bill, 2007: Boon or Bane?
The Clinical Establishments (Registration and Regulation Bill), 2007 is one of the important bills pending before the house that has somehow escaped the scrutiny of its more controversial counterpart-in-passage, the Broadcasting Bill. It may however have equally prominent implications for healthcare across the country. It has been introduced in parliament and is currently pending passage.
The bill notes in the introduction that healthcare in India is of uneven and uncertain quality, its supervision poor and there are few incentives in the current healthcare delivery system conducive providing enough incentives for improvement in efficiency. It also states that concerns voiced by the general public as well as a number of stakeholders coupled with the general perception of an inadequate regulatory framework is sought to be addressed by central legislation to create a uniform standard of facilities and services across the states. The highlights, provisions of the bill and relevant government documents can all be accessed from the PRS website (I thank Mr. Venkatesan for sending me the brief). The highlights of the provisions are as indicated below:
As the name suggests, it seeks to register and regulate, and set standards for clinical establishments. It shall be applicable to all union territories and four states. Other states may adopt the Bill.
A clinical establishment is defined as a hospital, maternity home, nursing home and any similar facility with beds. The definition also includes a laboratory that carries out pathological, bacteriological and other diagnostic services.
The central government shall establish a National Council. Its main functions include prescribing standards for clinical establishments and maintaining a register of clinical establishments.
Every clinical establishment will need to register. The Bill provides for both provisional registration and permanent registration upon satisfaction of prescribed conditions.
The district registering authority is responsible for registering clinical establishments, inspecting such establishments and cancelling registrations in case of non-compliance with prescribed standards.
Several of these have been criticized. The website also provides a brief analysis of the contentious provisions and issues. These, with a few additions, have been detailed below.
Cl. 2(c)(i) defines clinical establishments as facilities with beds. Thus, out-patient clinics which comprise 60-70% of private healthcare (Report of the Working Group on Clinical Establishments, Professional Services Regulation and Accreditation of Healthcare Infrastructure (RWG)) are automatically excluded. Independent laboratories and radiology facilities that perform diagnostic and/or investigative services are covered under 2(c)(ii). Outpatient surgery, now-a-days a common feature in the United States (see this report), is beginning to catch on in India as well – several scientific reports have been published involving specific surgical procedures – though no actual numbers are available on the pervasiveness of their practice in freestanding clinics (A good guess may be that less capital intensive procedures (e.g. traditional forms of cataract surgery) are more prevalent). Facilities conducting such procedures are usually attached to outpatient clinics, require patients’ presence only for the duration of the operation itself followed by a brief period of post-operative supervision usually amounting in toto to less than a full day and warrant no beds or admission. Such facilities too, notwithstanding the substantive nature of care involved, would not come under the purview of this act.
Cl. 5 empowers the government to develop ‘proper’ as well as minimum standards for healthcare. The latter alone is to be applied in reviewing the state of any facility. In a country with limited information about the nature and quality of healthcare, no national program for development of practice guidelines or medical review criteria (World Bank Report, 2003) in addition to vast regional and social disparities, creating such standards will be quite a difficult task. The RWG acknowledges this (para 37) and being a long-drawn process, recommends delinking it from registration (para 40(x)), a view incorporated in the draft bill.
Cl. 10 designates the District Health Officer (DHO) or Chief Medical Officer (CMO) as the district registering authority for registration of clinical establishments in each district. The DHO/CMO also shoulders responsibilities for the management of government facilities in that district. This leads to a conflict of interest.
Cl. 39 has a limiting stipulation that the register must be maintained in digital format. There is a concern that newer non-digital technologies may therefore be excluded.
Is state regulation a smart idea? This fundamental question at the heart of the debate has no easy answer. The RWG which recommended this step (para 67) does not appear to have seriously debated the merits of this solution. The report discusses briefly the problems of quality and lack of regulation in the private sector (para 6) and from there, jumps to a discussion on the forms of regulation, previous legislations, their inadequacies, and comparative approaches in other countries, with little mention of how legislative enactment will address specific issues, how far it ought to go or why it is a superior approach relative to the rest. It does stress that central legislation is necessary to ensure uniform standards (para 26). However, to foster cooperation and mitigate the skepticism of the private healthcare establishment, the National Council which is tasked with developing standards (Cl. 5) is required to adopt a consultative approach (Cl. 7).
A World Bank (WB) Report from 2003 titled ‘Health Policy Research in South Asia: Building Capacity for Reform’, a goldmine of information on the private sector (the RWG appears to have drawn from it at several places), summarizes the various malpractices that previous studies have noted in the private sector (p. 235): “Stories abound of problems with diagnostic and treatment practices; with inadequate facilities and equipment; and of doctors over-prescribing, subjecting patients to unnecessary investigations and interventions, charging patients exorbitantly, using unethical and irrational practices, and failing to provide information to patients.” The report, similar to several other studies, generally favors regulation though its authors (who are all prominent in the field) are not entirely in agreement upon the way forward. One of them recommends decentralization and a better regulatory regime (p .59); a second, writing in greater detail upon this question strongly argues for a ‘minimum set of basic regulations covering the licensing of practitioners and institutions, measures to ensure minimum standards of quality, guidelines regarding pricing, and actions to prevent the oversupply of services (including technology)’ (p. 240); a third, though convinced of the imperative for state intervention, insists that rigorous evaluation is a necessary prerequisite for there is little understanding of the regulatory mechanisms already put in place (p. 250). It must be noted however that many of the studies that recorded evidence of malpractice were not limited to private hospitals and nursing homes. They often focused on individual healthcare providers and also included those operating in exclusively ambulatory clinics with no separate assessment of the proportional contributions in each type of setting. Given the predominance of such clinics, regulatory scrutiny of a large fraction of such ethical violations will be precluded under the terms of this legislation.
The RWG also insists that though ‘state-specific variations would certainly exist; the need of the hour is [to have] uniform standards’ (para 34). The bill, in the statement of objects and reasons, repeats this theme (para 3). All of which brings us to the next question: Is a uniform standard a good idea? The definitive answer will have to wait till these standards are actually enunciated. One can speculate based on the wording of the bill and the RWG of the ministry’s thinking.
Cl. 12(i) entails minimum standards of facilities and services and cl. 12(ii) of personnel, for clinical establishments to meet the requirements of the Act. Regarding facilities, the legislation is likely to have beneficial effects at least with regard to private institutions in urban areas. Important findings previously reported in limited studies have been a lack of hygienic conditions and limitations of space (Nandraj, 1994). Both are easily identified though the latter may be difficult to remedy in a congested urban environment (that study was conducted in Bombay). How much leeway may be offered by the regulating authority for such locations remains to be seen.
Services can be loosely categorized into two: those that directly relate to patient care and those that are either peripheral to patient care but involve interplaying with the public or are more directly concerned with the institution’s own upkeep. The former includes medical, surgical, nursing and other services that directly relate to patient care whose practices are governed by professional guidelines and the conduct of whose professionals, to a significant extent, is overseen by professional bodies and also comes within the ambit of other laws (such as the Consumers’ Protection Act, 1986). Any regulation may end up interfering with not only the jurisdiction of these bodies but affect professional autonomy and are likely to engender profound resistance. However, egregious instances of medical errors that get reported often involve poor professional practice or judgment. Several previous efforts have resulted in little noticeable alteration in practices, their failure being blamed on ‘weakness’, lack of clarity or relevance, strong resistance from practitioners and state apathy (Bhat, 1999; Nayar, 2002). Some provisions to examine medical records for irregularities already exist on the statute in some states but have not been implemented (Bhat, 1996). It remains to be seen whether a similar fate awaits this renewed effort with no verification mechanism put in place to check whether the developed standards are being regularly followed (Prominent instances attracting media attention may still lead to exacting regulatory scrutiny in the absence of a routinely enforced system of auditing records of private health centres). The second kind of services are more amenable to regulation – governments and accreditation agencies usually target them in their efforts to improve quality of healthcare. The same is likely in India also. In fact, the RWG mentions the standards developed by the National Accreditation Board for Hospitals and Healthcare Providers (NABH), a constituent board of the Quality Council of India (QCI) (para 62). Other accrediting bodies have also emerged (para 63 and 64). It is quite possible that the standards adopted finally under this Act will be significantly drawn from some of these existing models.
Personnel problems abound in the healthcare sector. Apart from the widely publicized issue of rural doctor shortage, nursing shortages have also been reported. The vast differences in the number of medical colleges in different states (Supe and Burdick, 2006) also means that the number of graduating physicians will continue to be uneven with location, lifestyle preferences and linguistic barriers potentially preventing large-scale redistribution from overserved to underserved areas. These problems, being rooted in the existing system of incentives and restrictions, are destined to remain for a while. The question here is: how will new regulations affect them? If the medical education system is anything to go by, the answer is: adversely. Professional medical colleges are bound by the standards for faculty recruitment laid down by the MCI and risk losing their recognition should they flout those norms. At the same time, they have been facing an acute shortage of faculty in several (primarily non-clinical) specialties for which the blame is partly laid at the door of the MCI with calls to reduce these requirements to address this issue (Ananthakrishnan, 2007). Similar staff shortages exist in the general healthcare sector as well. Allopathic hospitals sometimes operate with homeopathic house surgeons (Nandraj, 1994) and recruit untrained nurses (Bhat, 1996; WB Report, 2003). If qualification requirements are strictly enforced, private institutions, faced with the prospect of losing their license, may either rise in revolt or resort to a variety of unsavoury methods to pass inspection (see ‘Hoodwinking the medical council’ in this news item). In rural areas, this problem has been overcome to some extent by existing personnel performing additional services outside the scope of their training. I knew of a surgeon in a popular rural facility in North Karnataka who also doubled as a gynecologist and was said to be proficient in performing orthopedic surgery when the regular orthopedic surgeon was out of town. The WB Report acknowledges this practice in Uttar Pradesh (p. 274-5) but recognizing that the alternative is the absence of any service, recommends allowing it to continue ‘for now’ with the rider that full disclosure be made by practitioners to community leaders and the public. A proviso to cl. 13(2) insists that ‘in prescribing the standards for clinical establishments, the Central Government shall have regard to the local conditions. I found this somewhat ironical – are not the notions of uniformity and Central intervention antithetical to the idea of a local solution? Are Central experts truly more conscious and sensitive of local considerations than local health officials? In any case, not providing for some flexibility in the regulations framed under Cl. 12(ii) will certainly hurt rural providers. How these diverse requirements will be handled remains to be seen.
There have also been various reports of a variety of inadequacies in the conduct of individual providers – widespread absenteeism, unfilled vacant posts, incompetence and tardy work ethic (Nandraj, 1994; Das and Hammer, 2004; Hammer et al, 2006). Many of these have been reported in the public sector and the lack of robust accountability practices has been blamed for this (Hammer et al, 2006). How will better regulatory standards impact this? Cl. 42-44 allow the government to levy fines for failing to conform and a proviso to cl. 32(3(b)) allows for the institution to be restrained from ‘carrying on’ if there is imminent danger to the health and safety of patients. As mentioned before (vide supra), with the DHO/CMO holding overall responsibility for government facilities in the district, the ensuing conflict of interest makes it quite unlikely that he/she would be willing to take strong action against erring individuals or facilities. Apart from this, the coercive impact is blunted as any fine levied is merely one arm of the government paying another. There may be more severe consequences if a facility is actually forced to shut down for non-compliance. That is however likely to be a rare event; if it is serious enough to scandalize the government or even otherwise jolt it into action, the finger will once again point to the very DHO/CMO who ordered it. Thus, even if better accountability standards are developed and adopted, these constraints are likely to hamper their effective implementation.
Apart from uniformity between states, the RWG also talks about parity between public and private healthcare institutions (para 36): “Private sector players are quick to accuse the govt. of observing double standards in prescribing minimum standards for private establishments and doing nothing to improve the pathetic conditions in public health institutions. This issue would need to be addressed in the right spirit by the government. No exemptions have been provided for government institutions in laws framed for management of bio medical waste, setting up of blood banks and pre-natal diagnostic tests etc. All these laws have had salutary impact on their specific areas. All the more reason that government establishments should also be required to register and comply with prescribed standards.” On the face of it, the initiative is a laudable one. However, Ajay Mahal, in the WB Report from 2003, quoting classical economic theory has this to say (p. 59): “…particularly the suggestion to improve the quality of public sector care, run[s] into the problematic observation made by Besley and Coate (1991) that greater equity can be achieved and insurance for the poor improved if the quality of available public services is not ‘too high’. They argue that the interests of the poor could be served by the public sector if the richer groups start using private care or unsubsidized public facilities such as paid inpatient wards. For this to happen, however, the nonpoor would have to perceive the quality of care in the private, unsubsidized facilities as being better than that of subsidized public services.” He also found that the BIMARU states and Orissa have the least egalitarian distribution of public health subsidies, i.e., the wealthier sections use public health facilities more than the poorer sections of society. If the prescribed minimum standards are high enough to require both public and private establishments to upgrade their facilities causing greater parity, it might then end up worsening the targeting of subsidies to impoverished sections and enhance healthcare disparities. The same result would also occur if private establishments, finding themselves unable to meet the requirements, simply shut shop or move elsewhere.
The Indian Medical Association (IMA) which has consistently resisted state regulation, not surprisingly, came out against this particular effort also. As it alleges, this is, in a sense, a return to the license-permit raj with registration and inspection becoming potential focal points of corruption.
In conclusion, in a highly diverse country such as ours, I remain sceptical about a nationwide effort to bring uniformity through state-mandated regulation. The Act may well have some positive effects characterized by noticeable improvements in the urban private sector institutions. However, a full assessment must include the entire array of costs and benefits incurred by all constituent parts of the healthcare system as well as its participants. Only a few states have so far signed on to this initiative. If this remains the case, it may eventually provide an opportunity after it has been implemented (if at all it comes into effect), to examine, through comparative analysis, how effective it has turned out to be.
FAQs on Telemedicine Practice Guidelines From patients/ Care-seekers’ point of view
1. How can I know whom to contact or how to get in touch with the doctor (Registered Medical Practitioner, RMP) on telemedicine? The patient can contact any RMP of modern medicine duly registered with MCI/State Medical Councils; and if he/she agrees to provide a telemedicine consult, then it means mutual consent has been given. Also Read – Telemedicine cannot be used for conduct surgical or invasive procedure: MCI tells doctors Advertisement 2. I am old and unable to physically visit a hospital and I have a nurse taking care of my clinical condition. Can I ask my nurse to consult on my behalf and how can she enable me for a better consultation? Definitely. Your nurse (duly trained and registered in Nursing Council) can consult on your behalf if you record your consent with the RMP for the same during teleconsultations. The RMP can request your Nurse to do routine clinical examination (for which nurse is duly trained) and provide the requisite information, and then RMP can provide health care advice, counselling and prescribe appropriate medications. 3. In case of an emergency, can I call any RMP for immediate advice? Yes, you may call any RMP for advice for a medical emergency, but you cannot insist for advice if the RMP chooses not to reply or give any specific advice. 4. How would teleconsultation be useful in an emergency? In case of alternative care is not immediately feasible, teleconsultation might be the only way to provide timely care. In such situations, RMPs may provide consultation to their best judgment. Such services might be limited to first aid, life-saving measure, counselling, and advice on referral. However, telemedicine should be avoided for emergency care to the possible extent especially when alternative in-person care is available. 5. Would an RMP be entitled to a fee for his/her consultation through telemedicine also? As per the guidelines, an RMP is authorized to charge a fee for a consultation and provide a receipt for the same. 6. Can an RMP refuse or discontinue teleconsultation at any point of time? The guidelines allow an RMP to refuse or discontinue a teleconsultation, with due notice to the patient, during any time of the consultation process. Similar liberty has also been provided to the patients. 7. Are the prescriptions provided via teleconsultation legally valid and how do I ensure that the RMP is qualified for the prescription? It is mandated in the guidelines that for all teleconsultations, the RMP should identify him/herself and also mention/ display his/her MCI/State Medical Council registration number. It is also mandatory that the RMP issues prescription as per the specified format, which should have his/her digital signature and the Registration number. The Registration of the RMP can always be counter checked if desired on the websites of relevant Medical Councils. 8. How do we know that our privacy is not breached by teleconsultation? The Guidelines have laid down strict norms for the RMPs not to breach the privacy of the patients in any form. However, the RMP cannot be held responsible if there is reasonable evidence to believe that patient’s privacy and confidentiality have been compromised by a technology breach or by a person other than RMP. 9. If I am on follow-up care for a Chronic condition (say Diabetes), for how long can I continue to request for a refill for my medications to my RMP? The Guidelines define follow-up consultation for a maximum period of 6 months. After this period, an in-person consultation is mandatory. 10. We are a group of Technology Platform providers for enabling teleconsultations on behalf of patients with RMPs. How does the guideline enable us? Section 5 of the Telemedicine Guidelines has laid down specific guidelines for the same and may please be referred to. From RMP/ Care-givers’ point of view 1. Who are entitled to provide telemedicine consultation? As on date all Registered Medical Practitioners (RMP) under the IMC Act, 1956 can provide telemedicine consultations but only after they qualify the prerequisites. 2. What are the prerequisites to be for doing a telemedicine consultation? The MCI is in the process of developing an online telemedicine course for ensuring uniformity. Once the course is developed, it will be mandatory for all RMPs to undertake this course within three years of its notification. Thereafter, it will be compulsory for all RMPs who wish to tele-consult to have undergone such a course. As on date, all RMPs can tele-consult, provided they follow the Telemedicine Practice Guidelines notified under IMC Act, 1956. 3. Can a Health Worker and Caregivers do teleconsultation for a patient? Yes, a health worker such as Auxiliary Nurse Midwife (ANM)/Nurse etc. can-do teleconsultation for a given patient. The guidelines mention the framework for such a scenario. 4. In case I feel the patient requires a physical examination, how do I ensure that? The RMP has the right to pause his/her teleconsultation and recommend an in-patient consultation. Besides, if during the teleconsultation it appears that a physical examination is mandatory but not feasible on the mode being used for the consultation, the teleconsultation should be aborted and the patient referred for an in-person review. 5. Do I need to keep screenshots and records to safeguard myself? Yes. It is specified in guidelines. It is incumbent on the RMP to maintain the following records/ documents for the period, as prescribed from time to time. These include Log or record of Telemedicine interaction (e.g. Phone logs, email records, chat/ text record, video interaction logs etc.). The RMP should retain patient records, reports, documents, images, diagnostics, data (Digital or non-Digital) etc. utilized in the telemedicine consultation. Specifically, in case a prescription is shared with the patient, the RMP is required to maintain the prescription records as required for in-person consultations. 6. Recently, I have heard in legal disputes that judgment has been given that doctors are not supposed to communicate on WhatsApp. What is the status after these guidelines? With the notification of Telemedicine Practice Guidelines under the IMC Act, 1956 RMPs under IMC Act, 1956 are now empowered and legally protected to provide teleconsultation by any mode, for various settings, as specified in the document. 7. What are the legal effects of inadequate management as perceived by a patient? The Telemedicine Guidelines comprehensively provides various settings under which different modes of teleconsultation can be undertaken and also enunciates steps to be undertaken to prevent any miscommunication between the patient and RMP. Besides, it also mentions steps to be taken to ensure documentation and thereby avoid legal issues. If despite these measures, the patient still perceives inadequate management, which can also happen in an in-person consultation, the legal issues need to be dealt in a similar way. 8. What happens if a doctor does not want or wishes not to attend to a request made by phone or WhatsApp? The Telemedicine Guidelines mention that an RMP has the liberty not to attend a teleconsultation request made by a patient. 9. What if a patient calls at an odd time like midnight when the RMP is not on duty? The RMP can choose either to attend the call or not. The RMP can also choose not to provide consultation to the patient (if it does not suit the RMP) during on-duty hours also. 10. In trauma and in an acute emergency, if the RMP asks for immediate referral to a hospital and a patient insists on tele-management, what to do? The doctor should record his/her statement about the advice given regarding referral for an in-person consult (as specified in the guidelines) and referral. In case the patient insists, the best possible care that can be given on tele-consult in the form of advice, counselling, first-aid measures to enable immediate relief should be provided. In case the consultation is through a Health Worker of another RMP, advice on medications, as specified in the guidelines can be given. 11. In case of problems with internet connectivity, the resultant telephonic consult may be of poor quality. What should be done in this context? If the issue of connectivity is in the beginning of the consult, the RMP may choose not to proceed with the consultation, citing the reasons. If the issue of poor connectivity happens during the course of communication, the same can be recorded and kept as proof. 12. Will the prescription sent online as an image or scan be honoured by the local chemist? Yes, the following are specified in the guidelines: If the RMP has prescribed medicines, RMP shall issue a prescription as per the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations and shall not contravene the provisions of the Drugs and Cosmetics Act and Rules. A sample format is suggested in Annexure 2 of the document. RMP shall provide a photo, scan, a digital copy of a signed prescription or e-Prescription to the patient via email or any messaging platform. In case the RMP is transmitting the prescription directly to a pharmacy, he/ she must ensure explicit consent of the patient that entitles him/her to get the medicines dispensed from any pharmacy of his/ her choice 13. Do I need a print out of the prescription? No, an e-prescription as specified in the guidelines will be sufficient. However, it should comply with the guidelines as mentioned. 14. For that matter if some investigations are needed and the doctor asks for them through telecommunication, will the Pathology Lab/Imaging Centre, etc. honour it? Yes, the labs or centres, etc. will honour it. The Telemedicine guidelines clearly mention that counselling a patient may also involve ordering new investigations if deemed necessary by the RMP. 15. How to tackle the issue of payment of fees to an RMP, as a patient may be reluctant to pay as the physical examination is not possible? For the purpose of fees in telemedicine consultation, the guidelines specify that Telemedicine consultations should be treated the same way as in-person consultations from a fee perspective and an RMP may charge an appropriate fee for the Telemedicine consultation provided. The very fact that the teleconsultation has been initiated, it means that both patient and doctor have mutually consented for the same. These are specified in the flowcharts accompanying the Guidelines. 16. The RMP may advise beyond his jurisdiction, for which he may not have specialization. How to take care of this issue? Once a teleconsultation has been initiated on mutual consent between a patient and a consulting RMP, then the RMP can advise on the health issues to the best of his knowledge. All RMPs can practice modern medicine and are also aware of the jurisdiction of their specialization. 17. Can schedule H class of Drugs be prescribed by teleconsultation? Which classes of drugs have been enabled by the guidelines for tele prescriptions? The drug prescription in Telemedicine guidelines is based on the clinical scenario, the judgement of the RMP and the mode of consultation, as specified in the framework. Hence, specific nomenclatures such as Schedule H, etc. classes of drugs have been avoided. The classification of list of drugs provided in the document is based on practical clinical pathways. A prohibited list of drugs is also given and this is specified as to include Schedule X of Drug and Cosmetic Act and Narcotic, Psychotropic substances. As such these lists of drugs mentioned in guidelines can be amended from time to time based on directions of the MCI and MoHFW. 18. Can I prescribe antibiotics on teleconsultation? Antibiotics can be prescribed by the RMP if he/she is strongly convinced about the same based on the type and mode of tele-consultation. As such, all teleconsultations mandate clear documentation of provisional diagnosis and reasons for prescription of particular drug. This is as well applicable for antibiotics. As in all scenarios, the RMP will be responsible for his/her prescriptions. 19. Can I prescribe injectable medications on teleconsultation? Prescriptions for injectable medicines can only be given if the consultation is between an RMP with another RMP. In certain circumstances, it may be prescribed to a Health Worker for administration to a given patient. In such a scenario, the RMP must be confident of the setting of the facility and the technical expertise of the Health Worker. The exceptions to these would be prescribing some follow-up medications which are available only as injections such as Insulin, Low Molecular Weight Heparin, Vaccines, etc. 20. I run a busy OPD and cannot attend to many patients at the same time. Can I record a teleconsultation through my allied healthcare professional on video and then, prescribe medications off-line to the patient? No, this is absolutely not allowed in the guidelines. The very premise of teleconsultation through a Health worker (as per the guidelines) dictates that the RMP, Health worker, and the patient introduce themselves to each other and give mutual consent for the teleconsultation. The role of Health workers is just to facilitate the process of teleconsultation to enable RMP to make informed decisions during this process. These are possible only on a live consultation. It would be highly unethical for an offline consultation through a health worker. 21. We are a group of RMPs who would like to start a ‘Telemedicine Clinic’ to care for the needy patients who would approach us. How do the guidelines help us do that? Foremost, you have to decide the appropriateness of telemedicine consult and its mode for a given scenario, as specified in the guidelines. You will have to record all teleconsultations and would be responsible for all consultations provided by telemedicine. Broadly, the following are the services your group could provide: 1. Health education 2. Guide patients for an appropriate in-patient consult 3. If it’s a follow-up consult for a patient whom you have seen, can prescribe for medications for optimizing that particular medical condition to the patient or care-giver 4. If it’s a new clinical condition which can be reasonably diagnosed on a video-call (such as Dermatological lesions etc), then you can prescribe medications to the patient or care-giver 5. If you are a group of specialists, then, can advise other RMPs appropriately 6. If you have a Health Worker on the field with the patient, then you can prescribe medications based on the Health Workers’ inputs provided these are as per norms of the guidelines. 7. In case of emergency clinical conditions, provide advice for immediate relief, first-aid and guide/ facilitate appropriately for an immediate in-patient consult. 22. Could you try to expand on the list of conditions by examples, which you can advise on Video-call consultation? Video consultation gives an added advantage of visual perception (provided it is of reasonably good quality) which is crucial for many clinical conditions. For instance, an RMP can take suitable teleconsultation pathways for conditions such as: 1. Pallor and Koilonychia: Prescribe Iron tablets on first-consultation and advice further investigations 2. Jaundice/ Cyanosis: Advice for urgent referral for in-patient consultation 3. Trauma: Can assist in Tele-triaging through a Health Worker 4. Respiratory distress: Assess work of breathing and advice another RMP/ Health Worker for appropriate intervention 5. Rheumatic conditions: Can assess the range of motion of joints through a health worker and can modify medications during a follow-up consultation 6. Tele-radiology, Tele-ophthalmology, Tele-pathology can be leveraged for discussion between two RMPs. To read the notification, click on the link below
List of laws related to doctors in India
Law Related to Governing the Commissioning of Hospital
S. noName of Act / RuleYear
1.Society registration Act
1960
2.Companies Act
1956
3.Municipality to Local Authority
4.Delhi Fire Service Act,
2007
5.Delhi Fire Prevention and Fire Safety Act,
1986
6.Fire safety rules
1987
7.Electricity rules
1956
8.Delhi lift Act1942
9.Bombay Lifts Act,
1939
10.Delhi nursing home registration Act
1953
11.Bombay Nursing Homes Registration (Amendment) Act,
2005
12.Bombay Nursing Homes Registration (Extension and Amendment) Act,
1959
13.Bombay Nursing Homes Registration Act,
1949
14.Radiation protection certificate for radiology dept from BARC
15.Atomic energy regulatory body approval for radiology / nuclear medicine services under the atomic energy Act1962
16.Atomic energy ( safe disposal of radioactive waste) rules1987
17.Indian telegraph Act
1885
18.Clinical Establishments Bill2010
19.BUILDING AND OTHER CONSTRUCTION WORKERS (REGULATION OF EMPLOYMENT AND CONDITIONS OF SERVICE) ACT.1908
20.The Registration Act.1908
21.THE NATIONAL CAPITAL TERRITORY OF DELHI LAWS (SPECIAL PROVISIONS) SECOND BILL2007
22.Government Buildings Act
1899
23.Karnataka Medical Registration (Amendment) Act
2003
24.Red Cross Society (Allocation of Property) Act1936
25.St. John Ambulance Association (India) Transfer of Funds Act,1956
Law Related to Governing the Commissioning of Hospital
Laws Governing the Qualifications / Practice and Conduct of Professionals
Law Governing Storage / Sale of Drugs and Safe Medication
Law Governing Biomedical Research
Law Governing to Management of Patients
Law Governing Medico Legal Aspects
Law Governing The Safety of Patients, Public and Staff within the Hospital Premises and Environmental Protection
Law Governing the Safety of Patients, Public and Staff within the Hospital Premises
Laws Governing the Employment of Manpower
Law Governing to Professional Training and Research
Regulations Governing the Business Aspects of Hospital
Law Related to Governing the Commissioning of Hospital
Laws Governing the Qualifications / Practice and Conduct of Professionals
S. noName of Act / RuleYear
1.Indian medical council Act1956
2.Indian medical council (professional conduct, etiquette and ethics) regulations,2002
3.Indian medical degrees Act
4.Registration of medical practitioners with state medical councils
5.Indian nursing council Act
1947
6.Delhi nursing council Act1997
7.The ICN Code of ethics for nurses
8.The Dentists Act
1948
9.The Dentists ( code of ethics regulation)1976
10.Dental council of India regulations
2006
11.AICTE rules of physiotherapy rules
12.All India council for Technical Education ACT1987
13.The Apprenticeship Act
1961
14.Rehabilitation Council of India Act,
1992
15.Rehabilitation Council of India (Amendment) Act,
2000
16.Kerala Anatomy Act
1957
17.Kerala Co-operative Hospital Complex and the Academy of Medical Sciences (Taking over the Management) Act,
1997
18.Kerala Professional Colleges or Institutions (Prohibition of Capitation Fee, Regulation of Admission, Fixation of Non-exploitative Fee and Other Measures to Ensure Equity and Excellence in Professional Education) Amendment Act
2007
19.Karnataka Anatomy Act1957
Law Governing Storage / Sale of Drugs and Safe Medication
S. noName of Act / RuleYear
1.Drugs and cosmetic Act
1940
2.Drug and cosmetic Act amendment1982
3.The drug and cosmetics rules (Amendment 2005)1945
4.The drugs control Act1950
5.Pharmacy Act
1948
6.License for possession and use of Rectified / denatured spirit
7.Narcotics and psychotropic substances Act
1985
8.Central excise Act ( for permit to use and store sprit )
1944
9.Retail drug license
10.VAT Act
11.. Central sales Tax Act1956
12.Sales of good Act
1930
13.Adulteration of drugs (IPC Sec 274)
14.Sales of adulterated drugs ( IPC Sec 275 )
15.Sales of drug as different drug or preparation ( IPC Sec 276 )
16.Negligent conduct with regard to poisonous substances (IPC Sec 284)
17.Blood bank regulations under Drugs and cosmetic ( 2nd amendment ) rules ,1999
18.Homoeopathy Central Council (Amendment) Act
2002
19.Homoeopathy Central Council Act,
1973
Law Governing Biomedical Research
S. noName of Act / RuleYear
1.Breeding of and Experiments on Animals (Control and Supervision )Amendment Rules
2005
2.Reconstitution of Committee for the Purpose of Control and Supervision of Experiments on Animals(CPCSEA).
Law Governing to Management of Patients
S. noName of Act / RuleYear
1.Drugs and magic remedies ( objectionable ) advertisements Act 1954
1954
2.PNDT Act
1994
3.Pre conception and prenatal diagnostic techniques ( prohibition of sex selection ) Rules,
1996
4.MTP Act
1997
5.MTP Rules
1971
6.Transplantation of human organ Act
1994
7.
Transplantation of human organ Rule
1995
8.Rules for insurance cover for the sterilization cases
9.Laws of contract section 13 (Consent
10.Birth and death and marriage registration act1886
11.Delhi registration of birth and deaths act1969
12.Indian lunacy Act
1912
13.The epidemic disease Act
1897
14.. Delhi Municipal corporation ( Malaria and other mosquito Borne disease ) Bye Law1975
15.Lepers act
1975
16.Guardians and wards Act
1890
17.. National guidelines for clinical management of HIV / AIDS , NACO, Govt Of India.
18.Manual for control of hospital associated infections : SOPs, NACO , Govt of India
19.The Mental Health Act
1987
20.Ear Drums and Ear Bones (Authority for Use for Therapeutic Purposes) Act
1982
21.Eyes (Authority for Use for Therapeutic Purposes) Act
1982
Law Governing Medico Legal Aspects
S. noName of Act / RuleYear
1.Law of privileged communications
2.Indian Evidence act (disclosure of privileged / confidential patient related information before a court of law – under protest)
3.Law of torts
4.Consumer protection Act
1986
5.Protection of human rights Act
6.IPC section 52
7.IPC section 80
8.IPC section 89
9.IPC section 92
10.IPC section 93
11.IPC section 269
Law Governing The Safety of Patients, Public and Staff Within the Hospital Premises and Environmental Protection
S. noName of Act / RuleYear/Amendment
1.Biomedical medical waste management handling rules
1998/2000
2.Water ( prevention and control of pollution) Act
1974
3..The Water (Prevention and Control of Pollution) Cess (Amendment) Act,
2003
4.The Water (Prevention and Control of Pollution) Act
1974/1988
5.The Water (Prevention and Control of Pollution) Cess Rules
1978
6.The Water (Prevention and Control of Pollution) Rules
1975
7.The Noise Pollution (Regulation and Control) (Amendment) Rules
2010
8.The Noise Pollution (Regulation and Control) (Amendment) Rules2006
9.The Noise Pollution (Regulation and Control) (Amendment) Rules2006
10.The Noise Pollution (Regulation and Control) (Amendment) Rules2002
11.The Noise Pollution (Regulation and Control) (Amendment) Rules
2000
12.Business) Rules1975/1976
13.Rules regarding the safe discharge of effluents in the public sewers / drains
14.DMC sanitation and public health Bye laws1959
15.Air ( prevention and control of pollution ) act
1981/1987
16.The Air (Prevention and Control of Pollution) (Union Territories) Rules,1983
17.The Air (Prevention and Control of Pollution) Rules
1982
18.Environment protection Act
1986
19.Environment protection Rule
1986
20.Environment protection Act1996
21..Noise pollution control Rules
2000
22.IPC sec 269 ( negligent act likely to spread infection or disease dangerous to life , unlawfully or negligently
23.IPC sec 278 ( making atmosphere noxious to health
Law Governing The Safety of Patients, Public and Staff within the Hospital Premises
S. noName of Act / RuleYear
1.Indian Boilers Act
1923
2.Explosive Act 1884 (for diesel storage)
1884
3.Petroleum Act + storage Rules2002
4.Gas cylinder Rules
2004
5.Rules for provision of safe drinking water
6.Rules for provision of uninterrupted power supply
7.Prevention of food adulteration Act
1954
8.The radiation surveillance procedures for the medical application of radiation1989
9.Radiation protection Rules
1971
10.AERB safety code no . AERB/SC/Med -2 ( REV -1)2001
11.Insecticide Act
1968
12.Arms Act,
1950
13.IPC Sec 336 ( act endangering life and personal safety of others)
14.IPC Sec 337 (causing hurt by act endangering life and personal safety of others)
15..IPC Sec 338 ( causing grievous hurt by act endangering the life and personal safety of others
16.The Indian fatal accidents Act
1955
17.The cigarettes and other Tobacco products ( prohibition of advertisement and Regulation of trade and commerce , production , supply and distribution ) bill
2003
18..Prohibition of smoking in public places Rules
2008
19..Prohibition of smoking in public places Rules2008
20.The Tamilnadu Medicare service persons and Medicare service institutions( prevention of violence and damage or loss to property ) Act
2008
21.The Tamilnadu Medicare service persons and Medicare service institutions( prevention of violence and damage or loss to property ) Act2008
22.Vaccination Act
1880
23.Vaccination (Repeal) Act
2001
24.Disaster Management Act
2005
25.Protection of Human Rights Act
1993
Laws Governing the Employment of Manpower
S. noName of Act / RuleYear
1.Child Labour Act
2.Citizenship Act
1955
3.Employees provident fund and misc provision Act
1952
4.ESI Act
1948
5.ESI ( central ) Rules
1950
6.Employment exchange ( compulsory notification of vacancies ) act
1959
7.Equal remuneration Act
1976
8.Minimum Wedge Act
1948
9.Payment of bonus Act
1965
10.Payment of Gratuity Act
1972
11.Payment of wages Act
1936
12.PPF Act
1968
13.TDS Act
14.Maternity Benefit (Amendment) Act,
2008
15.Workmen’s Compensation Act
1923
16.Workmen’s Compensation (Amendment) Act
2009
17.Indian Trade Union Act1926
18.Industrial Disputes Act
1947
19.Shops and factories Act (for national holidays)
20.Negotiable instrument Act
1881
21.Persons with Disabilities Act
1995
22.SC and ST Act
1989
23.Weekly Holidays Act
1942
24.Official Secrets Act
1923
25.Persons With Disabilities (Equal Opportunities, Protection of Rights and Full Participation) Act
1995
26.Karnataka Prohibition of Violence against Medicare Service Personnel and Damageto Property in Medicare Service Institutions Act
2009
27.Information Technology (Amendment) Act
2008
28.Information Technology Act
2000
Law Governing to Professional Training and Research
S. noName of Act / RuleYear
1.MCI rules for internship training
2.National board of examinations Rules for DNB training
3.Nursing Council of India Rules for staring school / college of nursing
4..ICMR rules governing Medical Research
Regulations Governing The Business Aspects of Hospital
Sr noName of Act / RuleYear/Amendment
1.Charitable and religious trust Act
1920
2.Contract Act1982
3.Income Tax ACT
1961
4.Customs Act
1962
5..Foreign Exchange management Act
1999
6.Insurance Act
1938
7.Rules for display of Red Cross Insignia
8.Sales of good Act
1930
9.Vehicle registration certificate
10.Wireless operation certificate from post and telegraphs
11.Cable television network ACT1995
12.Gift Tax Act
1958
13.Copyright Act1982
14.The Public Liability Insurance Act
1991/1992
15.The Public Liability Insurance Rules
1991/1993
Rights of patients-
As much as hospitals are places of hope, of second chances and recovery, they can also be the cause of severe anxiety and financial burden for many. When a loved one is seriously ill or injured, we tend to completely trust a hospital and its doctors, without so much as a shadow of a doubt. Now, we are not saying that someone can take advantage of this situation, but it is crucial for everyone to know about their rights at every place.
Keeping this in mind, the Ministry of Health and Family Welfare (MoHFW) has recently released a ‘Charter of Patients Rights’ that compiles the lawful rights as stated in the Constitution of India. Here is the list:
1. Right to Information
Physicians or their qualified assistants are required to provide adequate information about your illness, its diagnosis (provisional or confirmed, as it may be), proposed investigation and possible complications to the patient. If the patient is not in a state to understand this, the physician or their assistant is required to provide the information to the caretaker.
This has to be done in a simple language that the patient or caretaker will understand.
Apart from this, patients have the right to know the identity and professional status of every doctor and assistant as well as the primary doctor who is treating them.
Information regarding costs of treatment needs to be given in writing.
2. Right to records and reports
Patients or their respective caretakers have the right to access the originals or copies of case papers, indoor patient records and investigation reports. Investigation reports have to be made available to them within 24 hours of admission or 72 hours of discharge.
The hospital is responsible for providing a discharge summary or a death summary, in the case of a death, to the caretakers or kin of the patient with original copies of investigations.
3. Right to emergency medical care
In an emergency situation, you can avail medical care in any government or private hospital. Under Article 21 of the Constitution, which ensures that every person has the right to life and personal liberty, you have the right to prompt emergency care by doctors without compromise on quality or safety and without having to pay full or an advanced fee to the hospital.
4. Right to informed consent
If a hospital decides upon carrying an invasive investigation or surgery or chemotherapy on a patient, they require to do so after completing an appropriate policy procedure. The doctor primarily in charge of a patient has to explain the risks, consequences and procedure of the investigation or surgery in detail and a simple language before providing the protocol consent form to the patient or to the responsible caretaker.
5. Right to confidentiality, human dignity and privacy
Now this one is a fairly known right, especially if you follow TV shows about hospitals or doctors. The code of ethics dictates doctors to hold information about the illness and treatment plan for the patient in strict confidentiality from everyone except the patient and their caretakers.
Unless it is an exceptional case where sharing this information is “in the interest of protecting other or due to public health considerations.”
In the case of a female patient, she has the right to demand the presence of another woman if the medical practitioner checking or treating her is male. Having said this, the hospital is responsible for upholding the dignity of every patient, irrespective of their gender.
6. Right to non-discrimination
The above point brings us to the rights of a patient being upheld without discrimination based on their illness, condition, HIV status or on their gender, age, religion, caste, ethnicity, sexual orientation, linguistic or geographical or social origins.
Based on the above characteristics, no person can be subjected to discriminatory treatment, and the staff of the hospital is responsible for ensuring this.
7. Right to safety and quality care according to standards
Here is a brief list of provisions that come under the list of quality care standards-
– Safety and security.
– Cleanliness, infection control measures and sanitation facilities and safe drinking water.
– Healthcare that abides by the latest standards, norms and guidelines under the National Accreditation Board for Hospitals (NABH).
– To be attended to, treated and cared for in a professional manner and with the principles of medical ethics.
– Right to seek redressal by patient or caretakers.
8. Right to choose alternative treatment options if available
Hospital staff and doctors are responsible for clarifying all treatment options to the patient/caretakers. After a thorough study of their choices, the patient/caretakers can choose to opt for a treatment that may or may not be the doctor’s primary recommendation. This also means that once the patient/caretakers choose this alternative treatment, they will shoulder the responsibility of its consequences.
9. Right to a second opinion
Doctors and the hospital must respect your decision if you choose to seek a second opinion from a doctor/hospital of your choice. They are responsible for handing over all record documents and other relevant information should you choose to approach a different doctor. The hospital can neither stop you nor discourage you from going elsewhere, only give a detailed explanation of the health condition and repercussions in case of delay in treatment.
In case you choose to come back to the first hospital after getting your second opinion, the hospital still cannot compromise on the quality of healthcare services.
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10. Right to transparency in rates, and care according to prescribed rates wherever relevant
As mentioned above, the patient has the right to have a written account of the costs they will have to bear for the treatment they are receiving. As evidence for this, hospitals are required to have printed brochures and prominent display boards bearing the names and rates of medical procedures that are available with them. Detailed schedules of key rates need to be displayed in conspicuous places and need to be in both, English as well as the local language.
Patients have the right to get medicines, devices and implants at rates decided by the National Pharmaceutical Pricing Authority (NPPA) and other relevant authorities. Patients have the right to receive health care services that cost within the range prescribed by the Central and State governments, at the time of receiving it.
11. Right to choose the source for obtaining medicines or tests
As a patient or a caretaker, you have the right to choose which registered pharmacy you wish to buy your medical supplies from. This also includes getting an investigation procedure (like a blood test, for example) from any diagnostic centre or laboratory registered under the National Accreditation Board for Laboratories (NABL).
12. Right to proper referral and transfer, which is free from perverse commercial influences
If a patient must be transferred from one healthcare centre to another, a proper and detailed justification must be given to them/caretakers along with various options of the new healthcare centre. They must also be given a list of treatments/medicines that need to be continued after the transfer. This step cannot be taken unless the patient or their caretaker accept it.
Needless to say, these decisions cannot be influenced by reasons like “kickbacks, commissions, incentives, or other perverse business practices.”
13. Right to protection for patients involved in clinical trials
According to the MoHFW, “All clinical trials must be conducted in compliance with the protocols and Good Clinical Practice Guidelines issued by Services, Govt. of India as well as all applicable statutory provisions of Amended Drugs and Cosmetics Act, 1940 and Rules, 1945 Central Drugs Standard Control Organization, Directorate General of Health.” These points include consent by the patient, written prescription of drugs or intervention, privacy etc. You can read in detail about the guidelines here.
14. Right to protection of participants involved in biomedical and health research
In case a patient is involved in a biomedical or health research procedure, their consent needs to be taken in a written format. Their right to dignity, privacy and confidentiality needs to be upheld even during the research. If the participant suffers direct physical, psychological, social, legal or economic harm, they are eligible for financial or other assistance by the hospital.
Whatever benefits the hospital gets from the research must be made available to relevant individuals, communities and the general population.
15. Right to be discharged, right to receive the body of a deceased person from the hospital
“A patient has the right to be discharged and cannot be detained in a hospital, on procedural grounds such as [a] dispute in payment of hospital charges. Similarly, caretakers have the right to the dead body of a patient who had been treated in a hospital, and the dead body cannot be detailed on procedural grounds, including non-payment/dispute regarding payment of hospital charges against wishes of the caretakers,” says the MoHFW.
16. Right to Patient Education
Here is a list of things that a patient needs to be informed about by the hospital. These need to be addressed in the language that the patient/caretaker understands.
– Major facts about their condition
– Healthy living practices
– Their rights and responsibilities
– Health insurance schemes relevant to them
– Relevant entitlements (for charitable hospitals)
– How to seek redressal of grievances
17. Right to be heard and seek redressal
Last but not the least, every patient has the right to address his grievances and give feedback about the healthcare and treatment they received at the hospital or from a particular doctor/assistant.
The MoHFW further adds, ” Patients and caregivers have the right to seek redressal in case they are aggrieved, on account of infringement of any of the above-mentioned rights in this charter. This may be done by lodging a complaint with an official designated for this purpose by the hospital/healthcare provider and further with an official mechanism constituted by the government such as Patients’ rights Tribunal Forum or Clinical establishments regulatory authority as the case may be.
THE CONSUMER PROTECTION ACT, 2019
MINISTRY OF LAW AND JUSTICE
(Legislative Department)
New Delhi, the 9th August, 2019/Shravana 18, 1941 (Saka)
The following Act of Parliament received the assent of the President on the 9th August, 2019, and is hereby published for general information:—
THE CONSUMER PROTECTION ACT, 2019
NO. 35 OF 2019
[9th August, 2019.]
An Act to provide for protection of the interests of consumers and for the said purpose, to establish authorities for timely and effective administration and settlement of consumers’ disputes and for matters connected therewith or incidental thereto.
BE it enacted by Parliament in the Seventieth Year of the Republic of India as follows:—
CHAPTER I
PRELIMINARY
1. Short title, extent, commencement and application.
(1) This Act may be called the Consumer Protection Act, 2019.
(2) It extends to the whole of India except the State of Jammu and Kashmir.
(3) It shall come into force on such date as the Central Government may, by notification, appoint and different dates may be appointed for different States and for different provisions of this Act and any reference in any such provision to the commencement of this Act shall be construed as a reference to the coming into force of that provision.
(4) Save as otherwise expressly provided by the Central Government, by notification, this Act shall apply to all goods and services.
2. Definitions.
In this Act, unless the context otherwise requires,—
(1) “advertisement” means any audio or visual publicity, representation, endorsement or pronouncement made by means of light, sound, smoke, gas, print, electronic media, internet or website and includes any notice, circular, label, wrapper, invoice or such other documents;
(2) “appropriate laboratory” means a laboratory or an organisation—
(i) recognised by the Central Government; or
(ii) recognised by a State Government, subject to such guidelines as may be issued by the Central Government in this behalf; or
(iii) established by or under any law for the time being in force, which is maintained, financed or aided by the Central Government or a State Government for carrying out analysis or test of any goods with a view to determining whether such goods suffer from any defect;
(3) “branch office” means—
(i) any office or place of work described as a branch by the establishment; or
(ii) any establishment carrying on either the same or substantially the same activity carried on by the head office of the establishment;
(4) “Central Authority” means the Central Consumer Protection Authority
established under section 10;
(5) “complainant” means—
(i) a consumer; or
(ii) any voluntary consumer association registered under any law for the time being in force; or
(iii) the Central Government or any State Government; or
(iv) the Central Authority; or
(v) one or more consumers, where there are numerous consumers having the same interest; or
(vi) in case of death of a consumer, his legal heir or legal representative; or
(vii) in case of a consumer being a minor, his parent or legal guardian;
(6) “complaint” means any allegation in writing, made by a complainant for obtaining any relief provided by or under this Act, that—
(i) an unfair contract or unfair trade practice or a restrictive trade practice has been adopted by any trader or service provider;
(ii) the goods bought by him or agreed to be bought by him suffer from one or more defects;
(iii) the services hired or availed of or agreed to be hired or availed of by him suffer from any deficiency;
(iv) a trader or a service provider, as the case may be, has charged for the goods or for the services mentioned in the complaint, a price in excess of the price—
(a) fixed by or under any law for the time being in force; or
(b) displayed on the goods or any package containing such goods; or
(c) displayed on the price list exhibited by him by or under any law for the time being in force; or
(d) agreed between the parties;
(v) the goods, which are hazardous to life and safety when used, are being offered for sale to the public—
(a) in contravention of standards relating to safety of such goods as required to be complied with, by or under any law for the time being in force;
(b) where the trader knows that the goods so offered are unsafe to the public;
(vi) the services which are hazardous or likely to be hazardous to life and safety of the public when used, are being offered by a person who provides any service and who knows it to be injurious to life and safety;
(vii) a claim for product liability action lies against the product manufacturer, product seller or product service provider, as the case may be;
(7) “consumer” means any person who—
(i) buys any goods for a consideration which has been paid or promised or partly paid and partly promised, or under any system of deferred payment and includes any user of such goods other than the person who buys such goods for consideration paid or promised or partly paid or partly promised, or under any system of deferred payment, when such use is made with the approval of such person, but does not include a person who obtains such goods for resale or for any commercial purpose; or
(ii) hires or avails of any service for a consideration which has been paid or promised or partly paid and partly promised, or under any system of deferred payment and includes any beneficiary of such service other than the person who hires or avails of the services for consideration paid or promised, or partly paid and partly promised, or under any system of deferred payment, when such services are availed of with the approval of the first mentioned person, but does not include a person who avails of such service for any commercial purpose.
Explanation.—For the purposes of this clause,—
(a) the expression “commercial purpose” does not include use by a person of goods bought and used by him exclusively for the purpose of earning his livelihood, by means of self-employment;
(b) the expressions “buys any goods” and “hires or avails any services” includes offline or online transactions through electronic means or by teleshopping or direct selling or multi-level marketing;
(8) “consumer dispute” means a dispute where the person against whom a
complaint has been made, denies or disputes the allegations contained in the complaint;
(9) “consumer rights” includes,—
(i) the right to be protected against the marketing of goods, products or services which are hazardous to life and property;
(ii) the right to be informed about the quality, quantity, potency, purity, standard and price of goods, products or services, as the case may be, so as to protect the consumer against unfair trade practices;
(iii) the right to be assured, wherever possible, access to a variety of goods, products or services at competitive prices;
(iv) the right to be heard and to be assured that consumer’s interests will receive due consideration at appropriate fora;
(v) the right to seek redressal against unfair trade practice or restrictive trade practices or unscrupulous exploitation of consumers; and
(vi) the right to consumer awareness;
(10) “defect” means any fault, imperfection or shortcoming in the quality, quantity, potency, purity or standard which is required to be maintained by or under any law for the time being in force or under any contract, express or implied or as is claimed by the trader in any manner whatsoever in relation to any goods or product and the expression “defective” shall be construed accordingly;
(11) “deficiency” means any fault, imperfection, shortcoming or inadequacy in the quality, nature and manner of performance which is required to be maintained by or under any law for the time being in force or has been undertaken to be performed by a person in pursuance of a contract or otherwise in relation to any service and includes—
(i) any act of negligence or omission or commission by such person which causes loss or injury to the consumer; and
(ii) deliberate withholding of relevant information by such person to the consumer;
(12) “design”, in relation to a product, means the intended or known physical and material characteristics of such product and includes any intended or known formulation or content of such product and the usual result of the intended manufacturing or other process used to produce such product;
(13) “direct selling” means marketing, distribution and sale of goods or provision of services through a network of sellers, other than through a permanent retail location;
(14) “Director-General” means the Director-General appointed under sub-section (2) of section 15;
(15) “District Commission” means a District Consumer Disputes Redressal Commission established under sub-section (1) of section 28;
(16) “e-commerce” means buying or selling of goods or services including digital products over digital or electronic network;
(17) “electronic service provider” means a person who provides technologies or processes to enable a product seller to engage in advertising or selling goods or services to a consumer and includes any online market place or online auction sites;
(18) “endorsement”, in relation to an advertisement, means—
(i) any message, verbal statement, demonstration; or
(ii) depiction of the name, signature, likeness or other identifiable personal characteristics of an individual; or
(iii) depiction of the name or seal of any institution or organisation, which makes the consumer to believe that it reflects the opinion, finding or experience of the person making such endorsement;
(19) “establishment” includes an advertising agency, commission agent, manufacturing, trading or any other commercial agency which carries on any business, trade or profession or any work in connection with or incidental or ancillary to any commercial activity, trade or profession, or such other class or classes of persons including public utility entities in the manner as may be prescribed;
(20) “express warranty” means any material statement, affirmation of fact, promise or description relating to a product or service warranting that it conforms to such material statement, affirmation, promise or description and includes any sample or model of a product warranting that the whole of such product conforms to such sample or model;
(21) “goods” means every kind of movable property and includes “food” as defined in clause (j) of sub-section (1) of section 3 of the Food Safety and Standards Act, 2006;
(22) “harm”, in relation to a product liability, includes—
(i) damage to any property, other than the product itself;
(ii) personal injury, illness or death;
(iii) mental agony or emotional distress attendant to personal injury or illness or damage to property; or
(iv) any loss of consortium or services or other loss resulting from a harm referred to in sub-clause (i) or sub-clause (ii) or sub-clause (iii), but shall not include any harm caused to a product itself or any damage to the property on account of breach of warranty conditions or any commercial or economic loss, including any direct, incidental or consequential loss relating thereto;
(23) “injury” means any harm whatever illegally caused to any person, in body, mind or property;
(24) “manufacturer” means a person who—
(i) makes any goods or parts thereof; or
(ii) assembles any goods or parts thereof made by others; or
(iii) puts or causes to be put his own mark on any goods made by any other person;
(25) “mediation” means the process by which a mediator mediates the consumer disputes;
(26) “mediator” means a mediator referred to in section 75;
(27) “member” includes the President and a member of the National Commission or a State Commission or a District Commission, as the case may be;
(28) “misleading advertisement” in relation to any product or service, means an advertisement, which—
(i) falsely describes such product or service; or
(ii) gives a false guarantee to, or is likely to mislead the consumers as to the nature, substance, quantity or quality of such product or service; or
(iii) conveys an express or implied representation which, if made by the manufacturer or seller or service provider thereof, would constitute an unfair trade practice; or
(iv) deliberately conceals important information;
(29) “National Commission” means the National Consumer Disputes Redressal Commission established under sub-section (1) of section 53;
(30) “notification” means a notification published in the Official Gazette and the
term “notify” shall be construed accordingly;
(31) “person” includes—
(i) an individual;
(ii) a firm whether registered or not;
(iii) a Hindu undivided family;
(iv) a co-operative society;
(v) an association of persons whether registered under the Societies Registration Act, 1860 or not;
(vi) any corporation, company or a body of individuals whether incorporated or not;
(vii) any artificial juridical person, not falling within any of the preceding sub-clauses;
(32) “prescribed” means prescribed by rules made by the Central Government, or, as the case may be, the State Government;
(33) “product” means any article or goods or substance or raw material or any extended cycle of such product, which may be in gaseous, liquid, or solid state possessing intrinsic value which is capable of delivery either as wholly assembled or as a component part and is produced for introduction to trade or commerce, but does not include human tissues, blood, blood products and organs;
(34) “product liability” means the responsibility of a product manufacturer or product seller, of any product or service, to compensate for any harm caused to a consumer by such defective product manufactured or sold or by deficiency in services relating thereto;
(35) “product liability action” means a complaint filed by a person before a District Commission or State Commission or National Commission, as the case may be, for claiming compensation for the harm caused to him;
(36) “product manufacturer” means a person who—
(i) makes any product or parts thereof; or
(ii) assembles parts thereof made by others; or
(iii) puts or causes to be put his own mark on any products made by any other person; or
(iv) makes a product and sells, distributes, leases, installs, prepares, packages, labels, markets, repairs, maintains such product or is otherwise involved in placing such product for commercial purpose; or
(v) designs, produces, fabricates, constructs or re-manufactures any product before its sale; or
(vi) being a product seller of a product, is also a manufacturer of such product;
(37) “product seller”, in relation to a product, means a person who, in the course of business, imports, sells, distributes, leases, installs, prepares, packages, labels, markets, repairs, maintains, or otherwise is involved in placing such product for commercial purpose and includes—
(i) a manufacturer who is also a product seller; or
(ii) a service provider, but does not include—
(a) a seller of immovable property, unless such person is engaged in the sale of constructed house or in the construction of homes or flats;
(b) a provider of professional services in any transaction in which, the sale or use of a product is only incidental thereto, but furnishing of opinion, skill or services being the essence of such transaction;
(c) a person who—
(I) acts only in a financial capacity with respect to the sale of the product;
(II) is not a manufacturer, wholesaler, distributor, retailer, direct seller or an electronic service provider;
(III) leases a product, without having a reasonable opportunity to inspect and discover defects in the product, under a lease arrangement in which the selection, possession, maintenance, and operation of the product are controlled by a person other than the lessor;
(38) “product service provider”, in relation to a product, means a person who provides any service in respect of such product;
(39) “regulations” means the regulations made by the National Commission, or as the case may be, the Central Authority;
(40) “Regulator” means a body or any authority established under any other law for the time being in force;
(41) “restrictive trade practice” means a trade practice which tends to bring about manipulation of price or its conditions of delivery or to affect flow of supplies in the market relating to goods or services in such a manner as to impose on the consumers unjustified costs or restrictions and shall include—
(i) delay beyond the period agreed to by a trader in supply of such goods or in providing the services which has led or is likely to lead to rise in the price;
(ii) any trade practice which requires a consumer to buy, hire or avail of any goods or, as the case may be, services as condition precedent for buying, hiring or availing of other goods or services;
(42) “service” means service of any description which is made available to potential users and includes, but not limited to, the provision of facilities in connection with banking, financing, insurance, transport, processing, supply of electrical or other energy, telecom, boarding or lodging or both, housing construction, entertainment, amusement or the purveying of news or other information, but does not include the rendering of any service free of charge or under a contract of personal service;
(43) “spurious goods” means such goods which are falsely claimed to be genuine;
(44) “State Commission” means a State Consumer Disputes Redressal Commission established under sub-section (1) of section 42;
(45) “trader”, in relation to any goods, means a person who sells or distributes any goods for sale and includes the manufacturer thereof, and where such goods are sold or distributed in package form, includes the packer thereof;
(46) “unfair contract” means a contract between a manufacturer or trader or service provider on one hand, and a consumer on the other, having such terms which cause significant change in the rights of such consumer, including the following, namely:—
(i) requiring manifestly excessive security deposits to be given by a consumer for the performance of contractual obligations; or
(ii) imposing any penalty on the consumer, for the breach of contract thereof which is wholly disproportionate to the loss occurred due to such breach to the other party to the contract; or
(iii) refusing to accept early repayment of debts on payment of applicable penalty; or
(iv) entitling a party to the contract to terminate such contract unilaterally, without reasonable cause; or
(v) permitting or has the effect of permitting one party to assign the contract to the detriment of the other party who is a consumer, without his consent; or
(vi) imposing on the consumer any unreasonable charge, obligation or condition which puts such consumer to disadvantage;
(47) “unfair trade practice” means a trade practice which, for the purpose of promoting the sale, use or supply of any goods or for the provision of any service, adopts any unfair method or unfair or deceptive practice including any of the following practices, namely:—
(i) making any statement, whether orally or in writing or by visible representation including by means of electronic record, which—
(a) falsely represents that the goods are of a particular standard, quality, quantity, grade, composition, style or model;
(b) falsely represents that the services are of a particular standard, quality or grade;
(c) falsely represents any re-built, second-hand, renovated, reconditioned or old goods as new goods;
(d) represents that the goods or services have sponsorship, approval, performance, characteristics, accessories, uses or benefits which such goods or services do not have;
(e) represents that the seller or the supplier has a sponsorship or approval or affiliation which such seller or supplier does not have;
(f) makes a false or misleading representation concerning the need for, or the usefulness of, any goods or services;
(g) gives to the public any warranty or guarantee of the performance, efficacy or length of life of a product or of any goods that is not based on an adequate or proper test thereof:
Provided that where a defence is raised to the effect that such warranty or guarantee is based on adequate or proper test, the burden of proof of such defence shall lie on the person raising such defence;
(h) makes to the public a representation in a form that purports to be—
(A) a warranty or guarantee of a product or of any goods or services; or
(B) a promise to replace, maintain or repair an article or any part thereof or to repeat or continue a service until it has achieved a specified result, if such purported warranty or guarantee or promise is materially misleading or if there is no reasonable prospect that such warranty, guarantee or promise will be carried out;
(i) materially misleads the public concerning the price at which a product or like
products or goods or services, have been or are, ordinarily sold or provided, and, for
this purpose, a representation as to price shall be deemed to refer to the price at which the product or goods or services has or have been sold by sellers or provided by suppliers generally in the relevant market unless it is clearly specified to be the price at which the product has been sold or services have been provided by the person by whom or on whose behalf the representation is made;
(j) gives false or misleading facts disparaging the goods, services or trade of another person.
Explanation.—For the purposes of this sub-clause, a statement that is,—
(A) expressed on an article offered or displayed for sale, or on its wrapper or
container; or
(B) expressed on anything attached to, inserted in, or accompanying, an article offered or displayed for sale, or on anything on which the article is mounted for
display or sale; or
(C) contained in or on anything that is sold, sent, delivered, transmitted or in any other manner whatsoever made available to a member of the public, shall be deemed to be a statement made to the public by, and only by, the person who had caused the statement to be so expressed, made or contained;
(ii) permitting the publication of any advertisement, whether in any newspaper or otherwise, including by way of electronic record, for the sale or supply at a bargain price of goods or services that are not intended to be offered for sale or supply at the bargain price, or for a period that is, and in quantities that are, reasonable, having regard to the nature of the market in which the business is carried on, the nature and size of business, and the nature of the advertisement.
Explanation.—For the purpose of this sub-clause, “bargain price” means,—
(A) a price that is stated in any advertisement to be a bargain price, by reference to an ordinary price or otherwise; or
(B) a price that a person who reads, hears or sees the advertisement, would reasonably understand to be a bargain price having regard to the prices at which the product advertised or like products are ordinarily sold;
(iii) permitting—
(a) the offering of gifts, prizes or other items with the intention of not providing them as offered or creating impression that something is being given or offered free of charge when it is fully or partly covered by the amount charged, in the transaction as a whole;
(b) the conduct of any contest, lottery, game of chance or skill, for the purpose of promoting, directly or indirectly, the sale, use or supply of any product or any business interest, except such contest, lottery, game of chance or skill as may be prescribed;
(c) withholding from the participants of any scheme offering gifts, prizes or other items free of charge on its closure, the information about final results of the scheme.
Explanation.—For the purpose of this sub-clause, the participants of a scheme shall be deemed to have been informed of the final results of the scheme where such results are within a reasonable time published, prominently in the same newspaper in which the scheme was originally advertised;
(iv) permitting the sale or supply of goods intended to be used, or are of a kind likely to be used by consumers, knowing or having reason to believe that the goods do not comply with the standards prescribed by the competent authority relating to performance, composition, contents, design, constructions, finishing or packaging as are necessary to prevent or reduce the risk of injury to the person using the goods;
(v) permitting the hoarding or destruction of goods, or refusal to sell the goods or to make them available for sale or to provide any service, if such hoarding or destruction or refusal raises or tends to raise or is intended to raise, the cost of those or other similar goods or services;
(vi) manufacturing of spurious goods or offering such goods for sale or adopting deceptive practices in the provision of services;
(vii) not issuing bill or cash memo or receipt for the goods sold or services rendered in such manner as may be prescribed;
(viii) refusing, after selling goods or rendering services, to take back or withdraw defective goods or to withdraw or discontinue deficient services and to refund the consideration thereof, if paid, within the period stipulated in the bill or cash memo or receipt or in the absence of such stipulation, within a period of thirty days;
(ix) disclosing to other person any personal information given in confidence by the consumer unless such disclosure is made in accordance with the provisions of any law for the time being in force.
3. Central Consumer Protection Council.
(1) The Central Government shall, by notification, establish with effect from such date as it may specify in that notification, the Central Consumer Protection Council to be known as the Central Council.
(2) The Central Council shall be an advisory council and consist of the following members, namely:—
(a) the Minister-in-charge of the Department of Consumer Affairs in the Central Government, who shall be the Chairperson; and
(b) such number of other official or non-official members representing such interests as may be prescribed.
4. Procedure for meetings of Central Council.
(1) The Central Council shall meet as and when necessary, but at least one meeting of the Council shall be held every year.
(2) The Central Council shall meet at such time and place as the Chairperson may think fit and shall observe such procedure in regard to the transaction of its business as may be prescribed.
5. Objects of Central Council.
The objects of the Central Council shall be to render advice on promotion and protection of the consumers’ rights under this Act.
6. State Consumer Protection Councils.
(1) Every State Government shall, by notification, establish with effect from such date as it may specify in such notification, a State Consumer Protection Council for such State to be known as the State Council.
(2) The State Council shall be an advisory council and consist of the following members, namely:—
(a) the Minister-in-charge of Consumer Affairs in the State Government who shall be the Chairperson;
(b) such number of other official or non-official members representing such interests as may be prescribed;
(c) such number of other official or non-official members, not exceeding ten, as may be nominated by the Central Government.
(3) The State Council shall meet as and when necessary but not less than two meetings shall be held every year.
(4) The State Council shall meet at such time and place as the Chairperson may think fit and shall observe such procedure in regard to the transaction of its business, as may be prescribed.
7. Objects of State Council.
The objects of every State Council shall be to render advice on promotion and protection of consumer rights under this Act within the State.
8. District Consumer Protection Council.
(1) The State Government shall, by notification, establish for every District with effect from such date as it may specify in such notification, a District Consumer Protection Council to be known as the District Council.
(2) The District Council shall be an advisory council and consist of the following members, namely:—
(a) the Collector of the district (by whatever name called), who shall be the Chairperson; and
(b) such number of other official and non-official members representing such interests as may be prescribed.
(3) The District Council shall meet as and when necessary but not less than two meetings shall be held every year.
(4) The District Council shall meet at such time and place within the district as the Chairperson may think fit and shall observe such procedure in regard to the transaction of its business as may be prescribed.
9. Objects of District Council.
The objects of every District Council shall be to render advice on promotion and protection of consumer rights under this Act within the district.
CHAPTER III
CENTRAL CONSUMER PROTECTION AUTHORITY
10. Establishment of Central Consumer Protection Authority.
(1) The Central Government shall, by notification, establish with effect from such date as it may specify in that notification, a Central Consumer Protection Authority to be known as the Central Authority to regulate matters relating to violation of rights of consumers, unfair trade practices and false or misleading advertisements which are prejudicial to the interests of public and consumers and to promote, protect and enforce the rights of consumers as a class.
(2) The Central Authority shall consist of a Chief Commissioner and such number of other Commissioners as may be prescribed, to be appointed by the Central Government to exercise the powers and discharge the functions under this Act.
(3) The headquarters of the Central Authority shall be at such place in the National Capital Region of Delhi, and it shall have regional and other offices in any other place in India as the Central Government may decide.
11. Qualifications, method of recruitment, etc., of Chief Commissioner and Commissioners.
The Central Government may, by notification, make rules to provide for the qualifications for appointment, method of recruitment, procedure for appointment, term of office, salaries and allowances, resignation, removal and other terms and conditions of the service of the Chief Commissioner and Commissioners of the Central Authority.
12. Vacancy, etc., not to invalidate proceedings of Central Authority.
No act or proceeding of the Central Authority shall be invalid merely by reason of—
(a) any vacancy in, or any defect in the constitution of, the Central Authority; or
(b) any defect in the appointment of a person acting as the Chief Commissioner or as a Commissioner; or
(c) any irregularity in the procedure of the Central Authority not affecting the merits of the case.
13. Appointment of officers, experts, professionals and other employees of Central Authority.
(1) The Central Government shall provide the Central Authority such number of officers and other employees as it considers necessary for the efficient performance of its functions under this Act.
(2) The salaries and allowances payable to, and the other terms and conditions of service of, the officers and other employees of the Central Authority appointed under this Act shall be such as may be prescribed.
(3) The Central Authority may engage, in accordance with the procedure specified by regulations, such number of experts and professionals of integrity and ability, who have special knowledge and experience in the areas of consumer rights and welfare, consumer policy, law, medicine, food safety, health, engineering, product safety, commerce, economics, public affairs or administration, as it deems necessary to assist it in the discharge f its functions under this Act.
14. Procedure of Central Authority.
(1) The Central Authority shall regulate the procedure for transaction of its business and allocation of its business amongst the Chief Commissioner and Commissioners as may be specified by regulations.
(2) The Chief Commissioner shall have the powers of general superintendence, direction and control in respect of all administrative matters of the Central Authority:
Provided that the Chief Commissioner may delegate such of his powers relating to administrative matters of the Central Authority, as he may think fit, to any Commissioner
(including Commissioner of a regional office) or any other officer of the Central Authority.
15. Investigation Wing.
(1) The Central Authority shall have an Investigation Wing headed by a Director- General for the purpose of conducting inquiry or investigation under this Act as may be directed by the Central Authority.
(2) The Central Government may appoint a Director-General and such number of Additional Director-General, Director, Joint Director, Deputy Director and Assistant Director, from amongst persons who have experience in investigation and possess such qualifications, in such manner, as may be prescribed.
(3) Every Additional Director-General, Director, Joint Director, Deputy Director and Assistant Director shall exercise his powers, and discharge his functions, subject to the general control, supervision and direction of the Director-General.
(4) The Director-General may delegate all or any of his powers to the Additional Director-General or Director, Joint Director or Deputy Director or Assistant Director, as the case may be, while conducting inquiries or investigations under this Act.
(5) The inquiries or the investigations made by the Director- General shall be submitted to the Central Authority in such form, in such manner and within such time, as may be specified by regulations.
16. Power of District Collector.
The District Collector (by whatever name called) may, on a complaint or on a reference made to him by the Central Authority or the Commissioner of a regional office, inquire into or investigate complaints regarding violation of rights of consumers as a class, on matters relating to violations of consumer rights, unfair trade practices and false or misleading advertisements, within his jurisdiction and submit his report to the Central Authority or to the Commissioner of a regional office, as the case may be.
17. Complaints to authorities.
A complaint relating to violation of consumer rights or unfair trade practices or false or misleading advertisements which are prejudicial to the interests of consumers as a class, may be forwarded either in writing or in electronic mode, to any one of the authorities,namely, the District Collector or the Commissioner of regional office or the Central Authority.
18. Powers and functions of Central Authority.
(1) The Central Authority shall—
(a) protect, promote and enforce the rights of consumers as a class, and prevent violation of consumers rights under this Act;
(b) prevent unfair trade practices and ensure that no person engages himself in unfair trade practices;
(c) ensure that no false or misleading advertisement is made of any goods or services which contravenes the provisions of this Act or the rules or regulations made thereunder;
(d) ensure that no person takes part in the publication of any advertisement which is false or misleading.
(2) Without prejudice to the generality of the provisions contained in sub-section (1), the Central Authority may, for any of the purposes aforesaid,—
(a) inquire or cause an inquiry or investigation to be made into violations of consumer rights or unfair trade practices, either suo motu or on a complaint received or on the directions from the Central Government;
(b) file complaints before the District Commission, the State Commission or the National Commission, as the case may be, under this Act;
(c) intervene in any proceedings before the District Commission or the State Commission or the National Commission, as the case may be, in respect of any allegation of violation of consumer rights or unfair trade practices;
(d) review the matters relating to, and the factors inhibiting enjoyment of, consumer rights, including safeguards provided for the protection of consumers under any other law for the time being in force and recommend appropriate remedial measures for their effective implementation;
(e) recommend adoption of international covenants and best international practices on consumer rights to ensure effective enforcement of consumer rights;
(f) undertake and promote research in the field of consumer rights;
(g) spread and promote awareness on consumer rights;
(h) encourage non-Governmental organisations and other institutions working in the field of consumer rights to co-operate and work with consumer protection agencies;
(i) mandate the use of unique and universal goods identifiers in such goods, as may be necessary, to prevent unfair trade practices and to protect consumers’ interest;
(j) issue safety notices to alert consumers against dangerous or hazardous or unsafe goods or services;
(k) advise the Ministries and Departments of the Central and State Governments on consumer welfare measures;
(l) issue necessary guidelines to prevent unfair trade practices and protect consumers’ interest.
19. Power of Central Authority to refer matter for investigation or to other Regulator.
(1) The Central Authority may, after receiving any information or complaint or directions from the Central Government or of its own motion, conduct or cause to be conducted a preliminary inquiry as to whether there exists a prima facie case of violation of consumer rights or any unfair trade practice or any false or misleading advertisement, by any person, which is prejudicial to the public interest or to the interests of consumers and if it is satisfied that there exists a prima facie case, it shall cause investigation to be made by the Director- General or by the District Collector.
(2) Where, after preliminary inquiry, the Central Authority is of the opinion that the matter is to be dealt with by a Regulator established under any other law for the time being in force, it may refer such matter to the concerned Regulator along with its report.
(3) For the purposes of investigation under sub-section (1), the Central Authority, the Director General or the District Collector may call upon a person referred to in sub-section (1) and also direct him to produce any document or record in his possession.
20. Power of Central Authority to recall goods, etc.
Where the Central Authority is satisfied on the basis of investigation that there is sufficient evidence to show violation of consumer rights or unfair trade practice by a person, it may pass such order as may be necessary, including—
(a) recalling of goods or withdrawal of services which are dangerous, hazardous or unsafe;
(b) reimbursement of the prices of goods or services so recalled to purchasers of such goods or services; and
(c) discontinuation of practices which are unfair and prejudicial to consumers’ interest:
Provided that the Central Authority shall give the person an opportunity of being heard before passing an order under this section.
21. Power of Central Authority to issue directions and penalties against false or misleading advertisements.
(1) Where the Central Authority is satisfied after investigation that any advertisement is false or misleading and is prejudicial to the interest of any consumer or is in contravention of consumer rights, it may, by order, issue directions to the concerned trader or manufacturer or endorser or advertiser or publisher, as the case may be, to discontinue such advertisement or to modify the same in such manner and within such time as may be specified in that order.
(2) Notwithstanding the order passed under sub-section (1), if the Central Authority is of the opinion that it is necessary to impose a penalty in respect of such false or misleading advertisement, by a manufacturer or an endorser, it may, by order, impose on manufacturer or endorser a penalty which may extend to ten lakh rupees:
Provided that the Central Authority may, for every subsequent contravention by a manufacturer or endorser, impose a penalty, which may extend to fifty lakh rupees.
(3) Notwithstanding any order under sub-sections (1) and (2), where the Central Authority deems it necessary, it may, by order, prohibit the endorser of a false or misleading advertisement from making endorsement of any product or service for a period which may extend to one year:
Provided that the Central Authority may, for every subsequent contravention, prohibit such endorser from making endorsement in respect of any product or service for a period which may extend to three years.
(4) Where the Central Authority is satisfied after investigation that any person is found to publish, or is a party to the publication of, a misleading advertisement, it may impose on such person a penalty which may extend to ten lakh rupees.
(5) No endorser shall be liable to a penalty under sub-sections (2) and (3) if he has exercised due diligence to verify the veracity of the claims made in the advertisement regarding the product or service being endorsed by him.
(6) No person shall be liable to such penalty if he proves that he had published or arranged for the publication of such advertisement in the ordinary course of his business:
Provided that no such defence shall be available to such person if he had previous knowledge of the order passed by the Central Authority for withdrawal or modification of such advertisement.
(7) While determining the penalty under this section, regard shall be had to the following, namely:—
(a) the population and the area impacted or affected by such offence;
(b) the frequency and duration of such offence;
(c) the vulnerability of the class of persons likely to be adversely affected by such offence; and
(d) the gross revenue from the sales effected by virtue of such offence.
(8) The Central Authority shall give the person an opportunity of being heard before an order under this section is passed.
22. Search and seizure.
(1) For the purpose of conducting an investigation after preliminary inquiry under sub-section (1) of section 19, the Director-General or any other officer authorised by him in this behalf, or the District Collector, as the case may be, may, if he has any reason to believe that any person has violated any consumer rights or committed unfair trade practice or causes any false or misleading advertisement to be made, shall,—
(a) enter at any reasonable time into any such premises and search for any document or record or article or any other form of evidence and seize such document, record, article or such evidence;
(b) make a note or an inventory of such record or article; or
(c) require any person to produce any record, register or other document or article.
(2) The provisions of the Code of Criminal Procedure, 1973, relating to search and seizure shall apply, as far as may be, for search and seizure under this Act.
(3) Every document, record or article seized under clause (a) of sub-section (1) or produced under clause (c) of that sub-section shall be returned to the person, from whom they were seized or who produced the same, within a period of twenty days of the date of such seizure or production, as the case may be, after copies thereof or extracts therefrom certified by that person, in such manner as may be prescribed, have been taken.
(4) Where any article seized under sub-section (1) are subject to speedy or natural decay, the Director-General or such other officer may dispose of the article in such manner as may be prescribed.
(5) In the case of articles other than the articles referred to in sub-section (4), provisions contained in clause (c) of sub-section (2) of section 38 shall mutatis mutandis apply in relation to analysis or tests.
23. Designation of any statutory authority or body to function as Central Authority.
The Central Government may, if it considers necessary, by notification, designate any statutory authority or body to exercise the powers and perform the functions of the Central Authority referred to in section 10.
24. Appeal.
A person aggrieved by any order passed by the Central Authority under sections 20 and 21 may file an appeal to the National Commission within a period of thirty days from the date of receipt of such order.
25. Grants by Central Government.
The Central Government may, after due appropriation made by Parliament by law in this behalf, make to the Central Authority grants of such sums of money as that Government may think fit for being utilised for the purposes of this Act.
26. Accounts and audit.
(1) The Central Authority shall maintain proper accounts and other relevant records and prepare an annual statement of accounts in such form and manner as may be prescribed in consultation with the Comptroller and Auditor-General of India.
(2) The accounts of the Central Authority shall be audited by the Comptroller and Auditor-General of India at such intervals as may be specified by him and any expenditure incurred in connection with such audit shall be payable by the Central Authority to the Comptroller and Auditor-General of India.
(3) The Comptroller and Auditor-General of India or any other person appointed by him in connection with the audit of the accounts of the Central Authority shall have the same rights, privileges and authority in connection with such audit as the Comptroller and Auditor-General of India generally has, in connection with the audit of the Government accounts and, in particular, shall have the right to demand the production of books, accounts, connected vouchers and other documents and papers and to inspect any of the offices of the Central Authority.
(4) The accounts of the Central Authority as certified by the Comptroller and Auditor-General of India or any other person appointed by him in this behalf together with the audit report thereon shall be forwarded annually to the Central Government which shall cause the same to be laid before each House of Parliament.
27. Furnishing of annual reports, etc.
(1) The Central Authority shall prepare once in every year, in such form, manner and at such time as may be prescribed, an annual report giving full account of its activities during the previous year and such other reports and returns, as may be directed, and copies of such report and returns shall be forwarded to the Central Government.
(2) A copy of the annual report received under sub-section (1) shall be laid, as soon as may be after it is received, before each House of Parliament.
CHAPTER IV
CONSUMER DISPUTES REDRESSAL COMMISSION
28. Establishment of District Consumer Disputes Redressal Commission.
(1) The State Government shall, by notification, establish a District Consumer Disputes Redressal Commission, to be known as the District Commission, in each district of the State:
Provided that the State Government may, if it deems fit, establish more than one District Commission in a district.
(2) Each District Commission shall consist of—
(a) a President; and
(b) not less than two and not more than such number of members as may be prescribed, in consultation with the Central Government.
29. Qualifications, etc., of President and members of District Commission.
The Central Government may, by notification, make rules to provide for the qualifications, method of recruitment, procedure for appointment, term of office, resignation and removal of the President and members of the District Commission.
30. Salaries, allowances and other terms and conditions of service of President and members of District Commission.
The State Government may, by notification, make rules to provide for salaries and allowances and other terms and conditions of service of the President, and members of the District Commission.
31. Transitional provision.
Any person appointed as President or, as the case may be, a member of the District Commission immediately before the commencement of this Act shall hold office as such as President or, as the case may be, as member till the completion of his term for which he has been appointed.
32. Vacancy in office of member of District Commission.
If, at any time, there is a vacancy in the office of the President or member of a District Commission, the State Government may, by notification, direct—
(a) any other District Commission specified in that notification to exercise the jurisdiction in respect of that district also; or
(b) the President or a member of any other District Commission specified in that notification to exercise the powers and discharge the functions of the President or member of that District Commission also.
33. Officers and other employees of District Commission.
(1) The State Government shall provide the District Commission with such officers and other employees as may be required to assist the District Commission in the discharge of its functions.
(2) The officers and other employees of the District Commission shall discharge their functions under the general superintendence of the President of the District Commission.
(3) The salaries and allowances payable to, and the other terms and conditions of service of, the officers and other employees of the District Commission shall be such as may be prescribed.
34. Jurisdiction of District Commission.
(1) Subject to the other provisions of this Act, the District Commission shall have jurisdiction to entertain complaints where the value of the goods or services paid as consideration does not exceed one crore rupees:
Provided that where the Central Government deems it necessary so to do, it may prescribe such other value, as it deems fit.
(2) A complaint shall be instituted in a District Commission within the local limits of whose jurisdiction,—
(a) the opposite party or each of the opposite parties, where there are more than one, at the time of the institution of the complaint, ordinarily resides or carries on business or has a branch office or personally works for gain; or
(b) any of the opposite parties, where there are more than one, at the time of the institution of the complaint, actually and voluntarily resides, or carries on business or has a branch office, or personally works for gain, provided that in such case the permission of the District Commission is given; or
(c) the cause of action, wholly or in part, arises; or
(d) the complainant resides or personally works for gain
(3) The District Commission shall ordinarily function in the district headquarters and may perform its functions at such other place in the district, as the State Government may, in consultation with the State Commission, notify in the Official Gazette from time to time.
35. Manner in which complaint shall be made.
(1) A complaint, in relation to any goods sold or delivered or agreed to be sold or delivered or any service provided or agreed to be provided, may be filed with a District Commission by—
(a) the consumer,—
(i) to whom such goods are sold or delivered or agreed to be sold or delivered or such service is provided or agreed to be provided; or
(ii) who alleges unfair trade practice in respect of such goods or service;
(b) any recognised consumer association, whether the consumer to whom such goods are sold or delivered or agreed to be sold or delivered or such service is provided or agreed to be provided, or who alleges unfair trade practice in respect of such goods or service, is a member of such association or not;
(c) one or more consumers, where there are numerous consumers having the same interest, with the permission of the District Commission, on behalf of, or for the benefit of, all consumers so interested; or
(d) the Central Government, the Central Authority or the State Government, as the case may be:
Provided that the complaint under this sub-section may be filed electronically in such manner as may be prescribed.
Explanation.—For the purposes of this sub-section, “recognised consumer association” means any voluntary consumer association registered under any law for the time being in force.
(2) Every complaint filed under sub-section (1) shall be accompanied with such fee and payable in such manner, including electronic form, as may be prescribed.
36. Proceedings before District Commission.
(1) Every proceeding before the District Commission shall be conducted by the President of that Commission and atleast one member thereof, sitting together:
Provided that where a member, for any reason, is unable to conduct a proceeding till it is completed, the President and the other member shall continue the proceeding from the stage at which it was last heard by the previous member.
(2) On receipt of a complaint made under section 35, the District Commission may, by order, admit the complaint for being proceeded with or reject the same:
Provided that a complaint shall not be rejected under this section unless an opportunity of being heard has been given to the complainant:
Provided further that the admissibility of the complaint shall ordinarily be decided within twenty-one days from the date on which the complaint was filed.
(3) Where the District Commission does not decide the issue of admissibility of the complaint within the period so specified, it shall be deemed to have been admitted.
37. Reference to mediation.
(1) At the first hearing of the complaint after its admission, or at any later stage, if it appears to the District Commission that there exists elements of a settlement which may be acceptable to the parties, except in such cases as may be prescribed, it may direct the parties to give in writing, within five days, consent to have their dispute settled by mediation in accordance with the provisions of Chapter V.
(2) Where the parties agree for settlement by mediation and give their consent in writing, the District Commission shall, within five days of receipt of such consent, refer the matter for mediation, and in such case, the provisions of Chapter V, relating to mediation, shall apply.
38. Procedure on admission of complaint.
(1) The District Commission shall, on admission of a complaint, or in respect of cases referred for mediation on failure of settlement by mediation, proceed with such complaint.
(2) Where the complaint relates to any goods, the District Commission shall,—
(a) refer a copy of the admitted complaint, within twenty-one days from the date of its admission to the opposite party mentioned in the complaint directing him to give his version of the case within a period of thirty days or such extended period not exceeding fifteen days as may be granted by it;
(b) if the opposite party on receipt of a complaint referred to him under clause (a) denies or disputes the allegations contained in the complaint, or omits or fails to take any action to represent his case within the time given by the District Commission, proceed to settle the consumer dispute in the manner specified in clauses (c) to (g);
(c) if the complaint alleges a defect in the goods which cannot be determined without proper analysis or test of the goods, obtain a sample of the goods from the complainant, seal it and authenticate it in the manner as may be prescribed and refer the sample so sealed to the appropriate laboratory along with a direction that such laboratory to make an analysis or test, whichever may be necessary, with a view to finding out whether such goods suffer from any defect alleged in the complaint or from any other defect and to report its findings thereon to the District Commission within a period of forty-five days of the receipt of the reference or within such extended period as may be granted by it;
(d) before any sample of the goods is referred to any appropriate laboratory under clause (c), require the complainant to deposit to the credit of the Commission such fees as may be specified, for payment to the appropriate laboratory for carrying out the necessary analysis or test in relation to the goods in question;
(e) remit the amount deposited to its credit under clause (d) to the appropriate laboratory to enable it to carry out the analysis or test mentioned in clause (c) and on receipt of the report from the appropriate laboratory, it shall forward a copy of the report along with such remarks as it may feel appropriate to the opposite party;
(f) if any of the parties disputes the correctness of the findings of the appropriate laboratory, or disputes the correctness of the methods of analysis or test adopted by the appropriate laboratory, require the opposite party or the complainant to submit in writing his objections with regard to the report made by the appropriate laboratory;
(g) give a reasonable opportunity to the complainant as well as the opposite party of being heard as to the correctness or otherwise of the report made by the appropriate laboratory and also as to the objection made in relation thereto under clause (f) and issue an appropriate order under section 39.
(3) The District Commission shall, if the complaint admitted by it under sub-section (2) of section 36 relates to goods in respect of which the procedure specified in sub-section (2) cannot be followed, or if the complaint relates to any services,—
(a) refer a copy of such complaint to the opposite party directing him to give his version of the case within a period of thirty days or such extended period not exceeding fifteen days as may be granted by the District Commission;
(b) if the opposite party, on receipt of a copy of the complaint, referred to him under clause (a) denies or disputes the allegations contained in the complaint, or omits or fails to take any action to represent his case within the time given by the District Commission, it shall proceed to settle the consumer dispute—
(i) on the basis of evidence brought to its notice by the complainant and the opposite party, if the opposite party denies or disputes the allegations contained in the complaint, or
(ii) ex parte on the basis of evidence brought to its notice by the complainant, where the opposite party omits or fails to take any action to represent his case within the time given by the Commission;
(c) decide the complaint on merits if the complainant fails to appear on the date of hearing.
(4) For the purposes of sub-sections (2) and (3), the District Commission may, by order, require an electronic service provider to provide such information, documents or records, as may be specified in that order.
(5) No proceedings complying with the procedure laid down in sub-sections (1) and (2) shall be called in question in any court on the ground that the principles of natural justice have not been complied with.
(6) Every complaint shall be heard by the District Commission on the basis of affidavit and documentary evidence placed on record:
Provided that where an application is made for hearing or for examination of parties in person or through video conferencing, the District Commission may, on sufficient cause being shown, and after recording its reasons in writing, allow the same.
(7) Every complaint shall be disposed of as expeditiously as possible and endeavour shall be made to decide the complaint within a period of three months from the date of receipt of notice by opposite party where the complaint does not require analysis or testing of commodities and within five months if it requires analysis or testing of commodities:
Provided that no adjournment shall ordinarily be granted by the District Commission unless sufficient cause is shown and the reasons for grant of adjournment have been recorded in writing by the Commission:
Provided further that the District Commission shall make such orders as to the costs occasioned by the adjournment as may be specified by regulations:
Provided also that in the event of a complaint being disposed of after the period so specified, the District Commission shall record in writing, the reasons for the same at the time of disposing of the said complaint.
(8) Where during the pendency of any proceeding before the District Commission, if it appears necessary, it may pass such interim order as is just and proper in the facts and circumstances of the case.
(9) For the purposes of this section, the District Commission shall have the same powers as are vested in a civil court under the Code of Civil Procedure, 1908 while trying a suit in respect of the following matters, namely:—
(a) the summoning and enforcing the attendance of any defendant or witness and examining the witness on oath;
(b) requiring the discovery and production of any document or other material object as evidence;
(c) receiving of evidence on affidavits;
(d) the requisitioning of the report of the concerned analysis or test from the appropriate laboratory or from any other relevant source;
(e) issuing of commissions for the examination of any witness, or document; and
(f) any other matter which may be prescribed by the Central Government.
(10) Every proceeding before the District Commission shall be deemed to be a judicial proceeding within the meaning of sections 193 and 228 of the Indian Penal Code, and the District Commission shall be deemed to be a criminal court for the purposes of section 195 and Chapter XXVI of the Code of Criminal Procedure, 1973.
(11) Where the complainant is a consumer referred to in sub-clause (v) of clause (5) of section 2, the provisions of Order I Rule 8 of the First Schedule to the Code of Civil Procedure, 1908 shall apply subject to the modification that every reference therein to a suit or decree shall be construed as a reference to a complaint or the order of the District Commission thereon.
(12) In the event of death of a complainant who is a consumer or of the opposite party against whom the complaint has been filed, the provisions of Order XXII of the First Schedule to the Code of Civil Procedure, 1908 shall apply subject to the modification that every reference therein to the plaintiff and the defendant shall be construed as reference to a complainant or the opposite party, as the case may be.
39. Findings of District Commission.
(1) Where the District Commission is satisfied that the goods complained against suffer from any of the defects specified in the complaint or that any of the allegations contained in the complaint about the services or any unfair trade practices, or claims for compensation under product liability are proved, it shall issue an order to the opposite party directing him to do one or more of the following, namely:—
(a) to remove the defect pointed out by the appropriate laboratory from the goods in question;
(b) to replace the goods with new goods of similar description which shall be free from any defect;
(c) to return to the complainant the price, or, as the case may be, the charges paid by the complainant along with such interest on such price or charges as may be decided;
(d) to pay such amount as may be awarded by it as compensation to the consumer for any loss or injury suffered by the consumer due to the negligence of the opposite party:
Provided that the District Commission shall have the power to grant punitive damages in such circumstances as it deems fit;
(e) to pay such amount as may be awarded by it as compensation in a product liability action under Chapter VI;
(f) to remove the defects in goods or deficiencies in the services in question;
(g) to discontinue the unfair trade practice or restrictive trade practice and not to repeat them;
(h) not to offer the hazardous or unsafe goods for sale;
(i) to withdraw the hazardous goods from being offered for sale;
(j) to cease manufacture of hazardous goods and to desist from offering services which are hazardous in nature;
(k) to pay such sum as may be determined by it, if it is of the opinion that loss or injury has been suffered by a large number of consumers who are not identifiable conveniently:
Provided that the minimum amount of sum so payable shall not be less than twenty-five per cent. of the value of such defective goods sold or service provided, as the case may be, to such consumers;
(l) to issue corrective advertisement to neutralise the effect of misleading advertisement at the cost of the opposite party responsible for issuing such misleading advertisement;
(m) to provide for adequate costs to parties; and
(n) to cease and desist from issuing any misleading advertisement.
(2) Any amount obtained under sub-section (1) shall be credited to such fund and utilised in such manner as may be prescribed.
(3) In any proceeding conducted by the President and a member and if they differ on any point or points, they shall state the point or points on which they differ and refer the same to another member for hearing on such point or points and the opinion of the majority shall be the order of the District Commission:
Provided that the other member shall give his opinion on such point or points referred to him within a period of one month from the date of such reference.
(4) Every order made by the District Commission under sub-section (1) shall be signed by the President and the member who conducted the proceeding:
Provided that where the order is made as per majority opinion under sub-section (3), such order shall also be signed by the other member.
40. Review by District Commission in certain cases.
The District Commission shall have the power to review any of the order passed by it if there is an error apparent on the face of the record, either of its own motion or on an application made by any of the parties within thirty days of such order.
41. Appeal against order of District Commission.
Any person aggrieved by an order made by the District Commission may prefer an appeal against such order to the State Commission on the grounds of facts or law within a period of forty-five days from the date of the order, in such form and manner, as may be prescribed:
Provided that the State Commission may entertain an appeal after the expiry of the said period of forty-five days, if it is satisfied that there was sufficient cause for not filing it within that period:
Provided further that no appeal by a person, who is required to pay any amount in terms of an order of the District Commission, shall be entertained by the State Commission unless the appellant has deposited fifty per cent. of that amount in the manner as may be prescribed:
Provided also that no appeal shall lie from any order passed under sub-section (1) of section 81 by the District Commission pursuant to a settlement by mediation under section 80.
42. Establishment of State Consumer Disputes Redressal Commission.
(1) The State Government shall, by notification, establish a State Consumer Disputes Redressal Commission, to be known as the State Commission, in the State.
(2) The State Commission shall ordinarily function at the State capital and perform its functions at such other places as the State Government may in consultation with the State Commission notify in the Official Gazette:
Provided that the State Government may, by notification, establish regional benches of the State Commission, at such places, as it deems fit.
(3) Each State Commission shall consist of—
(a) a President; and
(b) not less than four or not more than such number of members as may be prescribed in consultation with the Central Government.
43. Qualifications, etc., of President and members of State Commission.
The Central Government may, by notification, make rules to provide for the qualification for appointment, method of recruitment, procedure of appointment, term of office, resignation and removal of the President and members of the State Commission.
44. Salaries, allowances and other terms and conditions of service of President and members of State Commission.
The State Government may, by notification, make rules to provide for salaries and allowances and other terms and conditions of service of the President and members of the State Commission.
45. Transitional provision.
Any person appointed as President or, as the case may be, a member of the State Commission immediately before the commencement of this Act shall hold office as such, as President or member, as the case may be, till the completion of his term.
46. Officers and employees of State Commission.
(1) The State Government shall determine the nature and categories of the officers and other employees required to assist the State Commission in the discharge of its functions and provide the Commission with such officers and other employees as it may think fit.
(2) The officers and other employees of the State Commission shall discharge their functions under the general superintendence of the President.
(3) The salaries and allowances payable to and the other terms and conditions of service of, the officers and other employees of the State Commission shall be such as may be prescribed.
47. Jurisdiction of State Commission.
(1) Subject to the other provisions of this Act, the State Commission shall have jurisdiction—
(a) to entertain—
(i) complaints where the value of the goods or services paid as consideration, exceeds rupees one crore, but does not exceed rupees ten crore:
Provided that where the Central Government deems it necessary so to do, it may prescribe such other value, as it deems fit;
(ii) complaints against unfair contracts, where the value of goods or services paid as consideration does not exceed ten crore rupees;
(iii) appeals against the orders of any District Commission within the State; and
(b) to call for the records and pass appropriate orders in any consumer dispute which is pending before or has been decided by any District Commission within the State, where it appears to the State Commission that such District Commission has exercised a jurisdiction not vested in it by law, or has failed to exercise a jurisdiction so vested or has acted in exercise of its jurisdiction illegally or with material irregularity.
(2) The jurisdiction, powers and authority of the State Commission may be exercised by Benches thereof, and a Bench may be constituted by the President with one or more members as the President may deem fit:
Provided that the senior-most member shall preside over the Bench.
(3) Where the members of a Bench differ in opinion on any point, the points shall be decided according to the opinion of the majority, if there is a majority, but if the members are equally divided, they shall state the point or points on which they differ, and make a reference to the President who shall either hear the point or points himself or refer the case for hearing on such point or points by one or more of the other members and such point or points shall be decided according to the opinion of the majority of the members who have heard the case, including those who first heard it:
Provided that the President or the other members, as the case may be, shall give opinion on the point or points so referred within a period of one month from the date of such reference.
(4) A complaint shall be instituted in a State Commission within the limits of whose jurisdiction, —
(a) the opposite party or each of the opposite parties, where there are more than one, at the time of the institution of the complaint, ordinarily resides or carries on business or has a branch office or personally works for gain; or
(b) any of the opposite parties, where there are more than one, at the time of the institution of the complaint, actually and voluntarily resides, or carries on business or has a branch office or personally works for gain, provided in such case, the permission of the State Commission is given; or
(c) the cause of action, wholly or in part, arises; or
(d) the complainant resides or personally works for gain.
48. Transfer of cases.
On the application of the complainant or of its own motion, the State Commission may, at any stage of the proceeding, transfer any complaint pending before a District Commission to another District Commission within the State if the interest of justice so requires.
49. Procedure applicable to State Commission.
(1) The provisions relating to complaints under sections 35, 36, 37, 38 and 39 shall, with such modifications as may be necessary, be applicable to the disposal of complaints by the State Commission.
(2) Without prejudice to the provisions of sub-section (1), the State Commission may also declare any terms of contract, which is unfair to any consumer, to be null and void.
50. Review by State Commission in certain cases.
The State Commission shall have the power to review any of the order passed by it if there is an error apparent on the face of the record, either of its own motion or on an application made by any of the parties within thirty days of such order.
51. Appeal to National Commission.
(1) Any person aggrieved by an order made by the State Commission in exercise of its powers conferred by sub-clause (i) or (ii) of clause (a) of sub-section (1) of section 47 may prefer an appeal against such order to the National Commission within a period of thirty days from the date of the order in such form and manner as may be prescribed:
Provided that the National Commission shall not entertain the appeal after the expiry of the said period of thirty days unless it is satisfied that there was sufficient cause for not filing it within that period:
Provided further that no appeal by a person, who is required to pay any amount in terms of an order of the State Commission, shall be entertained by the National Commission unless the appellant has deposited fifty per cent. of that amount in the manner as may be prescribed.
(2) Save as otherwise expressly provided under this Act or by any other law for the time being in force, an appeal shall lie to the National Commission from any order passed in appeal by any State Commission, if the National Commission is satisfied that the case involves a substantial question of law.
(3) In an appeal involving a question of law, the memorandum of appeal shall precisely state the substantial question of law involved in the appeal.
(4) Where the National Commission is satisfied that a substantial question of law is involved in any case, it shall formulate that question and hear the appeal on that question:
Provided that nothing in this sub-section shall be deemed to take away or abridge the power of the National Commission to hear, for reasons to be recorded in writing, the appeal on any other substantial question of law, if it is satisfied that the case involves such question of law.
(5) An appeal may lie to the National Commission under this section from an order passed ex parte by the State Commission.
52. Hearing of appeal.
An appeal filed before the State Commission or the National Commission, as the case may be, shall be heard as expeditiously as possible and every endeavour shall be made to dispose of the appeal within a period of ninety days from the date of its admission:
Provided that no adjournment shall ordinarily be granted by the State Commission or the National Commission, as the case may be, unless sufficient cause is shown and the reasons for grant of adjournment have been recorded in writing by such Commission:
Provided further that the State Commission or the National Commission, as the case may be, shall make such orders as to the costs occasioned by the adjournment, as may be specified by regulations:
Provided also that in the event of an appeal being disposed of after the period so specified, the State Commission or the National Commission, as the case may be, shall record in writing the reasons for the same at the time of disposing of the said appeal.
53. Establishment of National Consumer Disputes Redressal Commission
(1) The Central Government shall, by notification, establish a National Consumer Disputes Redressal Commission, to be known as the National Commission.
(2) The National Commission shall ordinarily function at the National Capital Region and perform its functions at such other places as the Central Government may in consultation with the National Commission notify in the Official Gazette:
Provided that the Central Government may, by notification, establish regional Benches of the National Commission, at such places, as it deems fit.
54. Composition of National Commission.
The National Commission shall consist of—
(a) a President; and
(b) not less than four and not more than such number of members as may be prescribed.
55. Qualifications, etc., of President and members of National Commission.
(1) The Central Government may, by notification, make rules to provide for qualifications, appointment, term of office, salaries and allowances, resignation, removal and other terms and conditions of service of the President and members of the National Commission:
Provided that the President and members of the National Commission shall hold office for such term as specified in the rules made by the Central Government but not exceeding five years from the date on which he enters upon his office and shall be eligible for re-appointment:
Provided further that no President or members shall hold office as such after he has attained such age as specified in the rules made by the Central Government which shall not exceed,—
(a) in the case of the President, the age of seventy years;
(b) in the case of any other member, the age of sixty-seven years.
(2) Neither the salary and allowances nor the other terms and conditions of service of President and members of the National Commission shall be varied to his disadvantage after his appointment.
56. Transitional provision.
The President and every other member appointed immediately before the commencement of section 177 of the Finance Act, 2017 shall continue to be governed by the provisions of the Consumer Protection Act, 1986 and the rules made thereunder as if this Act had not come into force.
57. Other officers and employees of National Commission.
(1) The Central Government shall provide, in consultation with the President of the National Commission, such number of officers and other employees to assist the National Commission in the discharge of its functions as it may think fit.
(2) The officers and other employees of the National Commission shall discharge their functions under the general superintendence of the President of the National Commission.
(3) The salaries and allowances payable to, and the other terms and conditions of service of, the officers and other employees of the National Commission shall be such as may be prescribed.
58. Jurisdiction of National Commission.
(1) Subject to the other provisions of this Act, the National Commission shall have jurisdiction—
(a) to entertain—
(i) complaints where the value of the goods or services paid as consideration exceeds rupees ten crore:
Provided that where the Central Government deems it necessary so to do, it may prescribe such other value, as it deems fit;
(ii) complaints against unfair contracts, where the value of goods or services paid as consideration exceeds ten crore rupees;
(iii) appeals against the orders of any State Commission;
(iv) appeals against the orders of the Central Authority; and
(b) to call for the records and pass appropriate orders in any consumer dispute which is pending before or has been decided by any State Commission where it appears to the National Commission that such State Commission has exercised a jurisdiction not vested in it by law, or has failed to exercise a jurisdiction so vested, or has acted in the exercise of its jurisdiction illegally or with material irregularity.
(2) The jurisdiction, powers and authority of the National Commission may be exercised by Benches thereof and a Bench may be constituted by the President with one or more members as he may deem fit:
Provided that the senior-most member of the Bench shall preside over the Bench.
(3) Where the members of a Bench differ in opinion on any point, the points shall be decided according to the opinion of the majority, if there is a majority, but if the members are equally divided, they shall state the point or points on which they differ, and make a reference to the President who shall either hear the point or points himself or refer the case for hearing on such point or points by one or more of the other members and such point or points shall be decided according to the opinion of the majority of the members who have heard the case, including those who first heard it:
Provided that the President or the other member, as the case may be, shall give opinion on the point or points so referred within a period of two months from the date of such reference.
59. Procedure applicable to National Commission.
(1) The provisions relating to complaints under sections 35, 36, 37, 38 and 39 shall, with such modifications as may be considered necessary, be applicable to the disposal of complaints by the National Commission.
(2) Without prejudice to sub-section (1), the National Commission may also declare any terms of contract, which is unfair to any consumer to be null and void.
60. Review by National Commission in certain cases.
The National Commission shall have the power to review any of the order passed by it if there is an error apparent on the face of the record, either of its own motion or on an application made by any of the parties within thirty days of such order.
61. Power to set aside ex parte orders.
Where an order is passed by the National Commission ex parte, the aggrieved party may make an application to the Commission for setting aside such order.
62. Transfer of cases.
On the application of the complainant or of its own motion, the National Commission may, at any stage of the proceeding, in the interest of justice, transfer any complaint pending before the District Commission of one State to a District Commission of another State or before one State Commission to another State Commission.
63. Vacancy in office of President of National Commission.
When the office of President of the National Commission is vacant or a person occupying such office is, by reason of absence or otherwise, unable to perform the duties of his office, these shall be performed by the senior-most member of the National Commission:
Provided that where a retired Judge of a High Court or a person who has been a Judicial Member is a member of the National Commission, such member or where the number of such members is more than one, the senior-most person amongst such members, shall preside over the National Commission in the absence of President of that Commission.
64. Vacancies or defects in appointment not to invalidate orders.
No act or proceeding of the District Commission, the State Commission or the National Commission shall be invalid by reason only of the existence of any vacancy amongst its members or any defect in the constitution thereof.
65. Service of notice, etc.
(1) All notices, required by this Act to be served, shall be served by delivering or transmitting a copy thereof by registered post acknowledgment due addressed to opposite party against whom complaint is made or to the complainant by speed post or by such courier service, approved by the District Commission, the State Commission or the National Commission, as the case may be, or by any other mode of transmission of documents including electronic means.
(2) Without prejudice to the provisions contained in sub-section (1), the notice required by this Act may be served on an electronic service provider at the address provided by it on the electronic platform from where it provides its services as such and for this purpose, the electronic service provider shall designate a nodal officer to accept and process such notices.
(3) When an acknowledgment or any other receipt purporting to be signed by the opposite party or his agent or, as the case may be, by the complainant is received by the District Commission, the State Commission or the National Commission, as the case may be, or postal article containing the notice is received back by such District Commission, State Commission or the National Commission, with an endorsement purporting to have been made by a postal employee or by any person authorised by the courier service to the effect that the opposite party or his agent or complainant had refused to take delivery of the postal article containing the notice or had refused to accept the notice by any other means specified in sub-section (1) when tendered or transmitted to him, the District Commission or the State Commission or the National Commission, as the case may be, shall declare that the notice has been duly served on the opposite party or to the complainant, as the case may be:
Provided that where the notice was properly addressed, pre-paid and duly sent by registered post acknowledgment due, a declaration referred to in this sub-section shall be made notwithstanding the fact that the acknowledgment has been lost or misplaced, or for any other reason, has not been received by the District Commission, the State Commission or the National Commission, as the case may be, within thirty days from the date of issue of notice.
(4) All notices required to be served on an opposite party or to complainant, as the case may be, shall be deemed to be sufficiently served, if addressed in the case of the opposite party, to the place where business or profession is carried on, and in case of the complainant, the place where such person actually and voluntarily resides.
66. Experts to assist National Commission or State Commission.
Where the National Commission or the State Commission, as the case may be, on an application by a complainant or otherwise, is of the opinion that it involves the larger interest of consumers, it may direct any individual or organisation or expert to assist the National Commission or the State Commission, as the case may be.
67. Appeal against order of National Commission.
Any person, aggrieved by an order made by the National Commission in exercise of its powers conferred by sub-clause (i) or (ii) of clause (a) of sub-section (1) of section 58, may prefer an appeal against such order to the Supreme Court within a period of thirty days from the date of the order:
Provided that the Supreme Court may entertain an appeal after the expiry of the said period of thirty days if it is satisfied that there was sufficient cause for not filing it within that period:
Provided further that no appeal by a person who is required to pay any amount in terms of an order of the National Commission shall be entertained by the Supreme Court unless that person has deposited fifty per cent. of that amount in the manner as may be prescribed.
68. Finality of orders.
Every order of a District Commission or the State Commission or the National Commission, as the case may be, shall, if no appeal has been preferred against such order under the provisions of this Act, be final.
69. Limitation period.
(1) The District Commission, the State Commission or the National Commission shall not admit a complaint unless it is filed within two years from the date on which the cause of action has arisen.
(2) Notwithstanding anything contained in sub-section (1), a complaint may be entertained after the period specified in sub-section (1), if the complainant satisfies the District Commission, the State Commission or the National Commission, as the case may be, that he had sufficient cause for not filing the complaint within such period:
Provided that no such complaint shall be entertained unless the District Commission or the State Commission or the National Commission, as the case may be, records its reasons for condoning such delay.
70. Administrative control.
(1) The National Commission shall have the authority to lay down such adequate standards in consultation with the Central Government from time to time, for better protection of the interests of consumers and for that purpose, shall have administrative control over all the State Commissions in the following matters, namely:—
(a) monitoring performance of the State Commissions in terms of their disposal by calling for periodical returns regarding the institution, disposal and pendency of cases;
(b) investigating into any allegations against the President and members of a State Commission and submitting inquiry report to the State Government concerned along with copy endorsed to the Central Government for necessary action;
(c) issuance of instructions regarding adoption of uniform procedure in the hearing of matters, prior service of copies of documents produced by one party to the opposite parties, furnishing of english translation of judgments written in any language, speedy grant of copies of documents;
(d) overseeing the functioning of the State Commission or the District Commission either by way of inspection or by any other means, as the National Commission may like to order from time to time, to ensure that the objects and purposes of the Act are best served and the standards set by the National Commission are implemented without interfering with their quasi-judicial freedom.
(2) There shall be a monitoring cell to be constituted by the President of the National Commission to oversee the functioning of the State Commissions from the administrative point of view.
(3) The State Commission shall have administrative control over all the District Commissions within its jurisdiction in all matters referred to in sub-section (1).
(4) The National Commission and the State Commissions shall furnish to the Central Government periodically or as and when required, any information including the pendency of cases in such form and manner as may be prescribed.
(5) The State Commission shall furnish, periodically or as and when required to the State Government any information including pendency of cases in such form and manner as may be prescribed.
71. Enforcement of orders of District Commission, State Commission and National Commission.
Every order made by a District Commission, State Commission or the National Commission shall be enforced by it in the same manner as if it were a decree made by a Court in a suit before it and the provisions of Order XXI of the First Schedule to the Code of Civil Procedure, 1908 hall, as far as may be, applicable, subject to the modification that every reference therein to the decree shall be construed as reference to the order made under this Act.
72. Penalty for noncompliance of order.
(1) Whoever fails to comply with any order made by the District Commission or the State Commission or the National Commission, as the case may be, shall be punishable with imprisonment for a term which shall not be less than one month, but which may extend to three years, or with fine, which shall not be less than twenty-five thousand rupees, but which may extend to one lakh rupees, or with both.
(2) Notwithstanding anything contained in the Code of Criminal Procedure, 1973, the District Commission, the State Commission or the National Commission, as the case may be, shall have the power of a Judicial Magistrate of first class for the trial of offences under sub-section (1), and on conferment of such powers, the District Commission or the State Commission or the National Commission, as the case may be, shall be deemed to be a Judicial Magistrate of first class for the purposes of the Code of Criminal Procedure, 1973.
(3) Save as otherwise provided, the offences under sub-section (1) shall be tried summarily by the District Commission or the State Commission or the National Commission, as the case may be.
73. Appeal against order passed under section 72.
(1) Notwithstanding anything contained in the Code of Criminal Procedure, 1973, where an order is passed under sub-section (1) of section 72, an appeal shall lie, both on facts and on law from—
(a) the order made by the District Commission to the State Commission;
(b) the order made by the State Commission to the National Commission; and
(c) the order made by the National Commission to the Supreme Court.
(2) Except as provided in sub-section (1), no appeal shall lie before any court, from any order of a District Commission or a State Commission or the National Commission, as the case may be.
(3) Every appeal under this section shall be preferred within a period of thirty days from the date of order of a District Commission or a State Commission or the National Commission, as the case may be:
Provided that the State Commission or the National Commission or the Supreme Court, as the case may be, may entertain an appeal after the expiry of the said period of thirty days, if it is satisfied that the appellant had sufficient cause for not preferring the appeal within the said period of thirty days.
CHAPTER V
MEDIATION
74. Establishment of consumer mediation cell.
(1) The State Government shall establish, by notification, a consumer mediation cell to be attached to each of the District Commissions and the State Commissions of that State.
(2) The Central Government shall establish, by notification, a consumer mediation cell to be attached to the National Commission and each of the regional Benches.
(3) A consumer mediation cell shall consist of such persons as may be prescribed.
(4) Every consumer mediation cell shall maintain—
(a) a list of empanelled mediators;
(b) a list of cases handled by the cell;
(c) record of proceeding; and
(d) any other information as may be specified by regulations.
(5) Every consumer mediation cell shall submit a quarterly report to the District Commission, State Commission or the National Commission to which it is attached, in the manner specified by regulations.
75. Empanelment of mediators.
(1) For the purpose of mediation, the National Commission or the State Commission or the District Commission, as the case may be, shall prepare a panel of the mediators to be maintained by the consumer mediation cell attached to it, on the recommendation of a selection committee consisting of the President and a member of that Commission.
(2) The qualifications and experience required for empanelment as mediator, the procedure for empanelment, the manner of training empanelled mediators, the fee payable to empanelled mediator, the terms and conditions for empanelment, the code of conduct for empanelled mediators, the grounds on which, and the manner in which, empanelled mediators shall be removed or empanelment shall be cancelled and other matters relating thereto, shall be such as may be specified by regulations.
(3) The panel of mediators prepared under sub-section (1) shall be valid for a period of five years, and the empanelled mediators shall be eligible to be considered for re-empanelment for another term, subject to such conditions as may be specified by regulations.
76. Nomination of mediators from panel.
The District Commission, the State Commission or the National Commission shall, while nominating any person from the panel of mediators referred to in section 75, consider his suitability for resolving the consumer dispute involved.
77. Duty of mediator to disclose certain facts.
It shall be the duty of the mediator to disclose—
(a) any personal, professional or financial interest in the outcome of the consumer dispute;
(b) the circumstances which may give rise to a justifiable doubt as to his independence or impartiality; and
(c) such other facts as may be specified by regulations.
78. Replacement of mediator in certain cases.
Where the District Commission or the State Commission or the National Commission, as the case may be, is satisfied, on the information furnished by the mediator or on the information received from any other person including parties to the complaint and after hearing the mediator, it shall replace such mediator by another mediator.
79. Procedure for mediation.
(1) The mediation shall be held in the consumer mediation cell attached to the District Commission, the State Commission or the National Commission, as the case may be.
(2) Where a consumer dispute is referred for mediation by the District Commission or the State Commission or the National Commission, as the case may be, the mediator nominated by such Commission shall have regard to the rights and obligations of the parties, the usages of trade, if any, the circumstances giving rise to the consumer dispute and such other relevant factors, as he may deem necessary and shall be guided by the principles of natural justice while carrying out mediation.
(3) The mediator so nominated shall conduct mediation within such time and in such manner as may be specified by regulations.
80. Settlement through mediation.
(1) Pursuant to mediation, if an agreement is reached between the parties with respect to all of the issues involved in the consumer dispute or with respect to only some of the issues, the terms of such agreement shall be reduced to writing accordingly, and signed by the parties to such dispute or their authorised representatives.
(2) The mediator shall prepare a settlement report of the settlement and forward the signed agreement along with such report to the concerned Commission.
(3) Where no agreement is reached between the parties within the specified time or the mediator is of the opinion that settlement is not possible, he shall prepare his report accordingly and submit the same to the concerned Commission.
81. Recording settlement and passing of order.
(1) The District Commission or the State Commission or the National Commission, as the case may be, shall, within seven days of the receipt of the settlement report, pass suitable order recording such settlement of consumer dispute and dispose of the matter accordingly.
(2) Where the consumer dispute is settled only in part, the District Commission or the State Commission or the National Commission, as the case may be, shall record settlement of the issues which have been so settled and continue to hear other issues involved in such consumer dispute.
(3) Where the consumer dispute could not be settled by mediation, the District Commission or the State Commission or the National Commission, as the case may be, shall continue to hear all the issues involved in such consumer dispute.
CHAPTER VI
PRODUCT LIABILITY
82. Application of Chapter.
This Chapter shall apply to every claim for compensation under a product liability action by a complainant for any harm caused by a defective product manufactured by a product manufacturer or serviced by a product service provider or sold by a product seller.
83. Product liability action.
A product liability action may be brought by a complainant against a product manufacturer or a product service provider or a product seller, as the case may be, for any harm caused to him on account of a defective product.
84. Liability of product manufacturer.
(1) A product manufacturer shall be liable in a product liability action, if—
(a) the product contains a manufacturing defect; or
(b) the product is defective in design; or
(c) there is a deviation from manufacturing specifications; or
(d) the product does not conform to the express warranty; or
(e) the product fails to contain adequate instructions of correct usage to prevent any harm or any warning regarding improper or incorrect usage.
(2) A product manufacturer shall be liable in a product liability action even if he proves that he was not negligent or fraudulent in making the express warranty of a product.
85. Liability of product service provider.
A product service provider shall be liable in a product liability action, if—
(a) the service provided by him was faulty or imperfect or deficient or inadequate in quality, nature or manner of performance which is required to be provided by or under any law for the time being in force, or pursuant to any contract or otherwise; or
(b) there was an act of omission or commission or negligence or conscious withholding any information which caused harm; or
(c) the service provider did not issue adequate instructions or warnings to prevent any harm; or
(d) the service did not conform to express warranty or the terms and conditions of the contract.
86. Liability of product sellers.
A product seller who is not a product manufacturer shall be liable in a product liability action, if—
(a) he has exercised substantial control over the designing, testing, manufacturing, packaging or labelling of a product that caused harm; or
(b) he has altered or modified the product and such alteration or modification was the substantial factor in causing the harm; or
(c) he has made an express warranty of a product independent of any express warranty made by a manufacturer and such product failed to conform to the express warranty made by the product seller which caused the harm; or
(d) the product has been sold by him and the identity of product manufacturer of such product is not known, or if known, the service of notice or process or warrant cannot be effected on him or he is not subject to the law which is in force in India or the order, if any, passed or to be passed cannot be enforced against him; or
(e) he failed to exercise reasonable care in assembling, inspecting or maintaining such product or he did not pass on the warnings or instructions of the product manufacturer regarding the dangers involved or proper usage of the product while selling such product and such failure was the proximate cause of the harm.
87. Exceptions to product liability action.
(1) A product liability action cannot be brought against the product seller if, at the time of harm, the product was misused, altered, or modified.
(2) In any product liability action based on the failure to provide adequate warnings or instructions, the product manufacturer shall not be liable, if—
(a) the product was purchased by an employer for use at the workplace and the product manufacturer had provided warnings or instructions to such employer;
(b) the product was sold as a component or material to be used in another product and necessary warnings or instructions were given by the product manufacturer to the purchaser of such component or material, but the harm was caused to the complainant by use of the end product in which such component or material was used;
(c) the product was one which was legally meant to be used or dispensed only by or under the supervision of an expert or a class of experts and the product manufacturer had employed reasonable means to give the warnings or instructions for usage of such product to such expert or class of experts; or
(d) the complainant, while using such product, was under the influence of alcohol or any prescription drug which had not been prescribed by a medical practitioner.
(3) A product manufacturer shall not be liable for failure to instruct or warn about a danger which is obvious or commonly known to the user or consumer of such product or which, such user or consumer, ought to have known, taking into account the characteristics of such product.
CHAPTER VII
OFFENCES AND PENALTIES
88. Penalty for noncompliance of direction of Central Authority.
Whoever, fails to comply with any direction of the Central Authority under sections 20 and 21, shall be punished with imprisonment for a term which may extend to six months or with fine which may extend to twenty lakh rupees, or with both.
89. Punishment for false or misleading advertisement.
Any manufacturer or service provider who causes a false or misleading advertisement to be made which is prejudicial to the interest of consumers shall be punished with imprisonment for a term which may extend to two years and with fine which may extend to ten lakh rupees; and for every subsequent offence, be punished with imprisonment for a term which may extend to five years and with fine which may extend to fifty lakh rupees.
90. Punishment for manufacturing for sale or storing, selling or distributing or importing products containing adulterant.
(1) Whoever, by himself or by any other person on his behalf, manufactures for sale or stores or sells or distributes or imports any product containing an adulterant shall be punished, if such act—
(a) does not result in any injury to the consumer, with imprisonment for a term which may extend to six months and with fine which may extend to one lakh rupees;
(b) causing injury not amounting to grievous hurt to the consumer, with imprisonment for a term which may extend to one year and with fine which may extend to three lakh rupees;
(c) causing injury resulting in grievous hurt to the consumer, with imprisonment for a term which may extend to seven years and with fine which may extend to five lakh rupees; and
(d) results in the death of a consumer, with imprisonment for a term which shall not be less than seven years, but which may extend to imprisonment for life and with fine which shall not be less than ten lakh rupees.
(2) The offences under clauses (c) and (d) of sub-section (1) shall be cognizable and non-bailable.
(3) Notwithstanding the punishment under sub-section (1), the court may, in case of first conviction, suspend any licence issued to the person referred to in that sub-section, under any law for the time being in force, for a period up to two years, and in case of second or subsequent conviction, cancel the licence.
Explanation.—For the purposes of this section,—
(a) “adulterant” means any material including extraneous matter which is employed or used for making a product unsafe;
(b) “grievous hurt” shall have the same meaning as assigned to it in section 320 of the Indian Penal Code.
91. Punishment for manufacturing for sale or for storing or selling or distributing or importing spurious goods.
(1) Whoever, by himself or by any other person on his behalf, manufactures for sale or stores or sells or distributes or imports any spurious goods shall be punished, if such act—
(a) causing injury not amounting to grievous hurt to the consumer, with imprisonment for a term which may extend to one year and with fine which may extend to three lakh rupees;
(b) causing injury resulting in grievous hurt to the consumer, with imprisonment for a term which may extend to seven years and with fine which may extend to five lakh rupees;
(c) results in the death of a consumer, with imprisonment for a term which shall not be less than seven years, but may extend to imprisonment for life and with fine which shall not be less than ten lakh rupees.
(2) The offences under clauses (b) and (c) of sub-section (1) shall be cognizable and non-bailable.
(3) Notwithstanding the punishment under sub-section (1), the court may, in case of first conviction, suspend any licence issued to the person referred to in that sub-section, under any law for the time being in force, for a period up to two years, and in case of second or subsequent conviction, cancel the licence.
92. Cognizance of offence by court.
No cognizance shall be taken by a competent court of any offence under sections 88 and 89 except on a complaint filed by the Central Authority or any officer authorised by it in this behalf.
93. Vexatious search.
The Director General or any other officer, exercising powers under section 22, who knows that there are no reasonable grounds for so doing, and yet—
(a) searches, or causes to be searched any premises; or
(b) seizes any record, register or other document or article, shall, for every such offence, be punished with imprisonment for a term which may extend to one year, or with fine which may extend to ten thousand rupees or with both.
CHAPTER VIII
MISCELLANEOUS
94. Measures to prevent unfair trade practices in e-commerce, direct selling, etc.
For the purposes of preventing unfair trade practices in e-commerce, direct selling and also to protect the interest and rights of consumers, the Central Government may take such measures in the manner as may be prescribed.
95. Presidents, members, Chief Commissioner, Commissioner and certain officers to be public servants.
The Presidents and members of the District Commission, the State Commission and the National Commission, and officers and other employees thereof, the Chief Commissioner and the Commissioner of the Central Authority, the Director General, the Additional Director General, the Director, the Joint Director, the Deputy Director and the Assistant Director and all other officers and employees of the Central Authority and other persons performing any duty under this Act, while acting or purporting to act in pursuance of any of the provisions of this Act, shall be deemed to be public servants within the meaning of section 21 of the Indian Penal Code.
96. Compounding of offences.
(1) Any offence punishable under sections 88 and 89, may, either before or after the institution of the prosecution, be compounded, on payment of such amount as may be prescribed:
Provided that no compounding of such offence shall be made without the leave of the court before which a complaint has been filed under section 92:
Provided further that such sum shall not, in any case, exceed the maximum amount of the fine, which may be imposed under this Act for the offence so compounded.
(2) The Central Authority or any officer as may be specially authorised by him in this behalf, may compound offences under sub-section (1).
(3) Nothing in sub-section (1) shall apply to person who commits the same or similar offence, within a period of three years from the date on which the first offence, committed by him, was compounded.
Explanation.—For the purposes of this sub-section, any second or subsequent offence committed after the expiry of a period of three years from the date on which the offence was
previously compounded, shall be deemed to be a first offence.
(4) Where an offence has been compounded under sub-section (1), no proceeding or further proceeding, as the case may be, shall be taken against the offender in respect of the offence so compounded.
(5) The acceptance of the sum of money for compounding an offence in accordance with sub-section (1) by the Central Authority or an officer of the Central Authority empowered in this behalf shall be deemed to amount to an acquittal within the meaning of the Code of Criminal Procedure, 1973.
97. Manner of crediting penalty.
The penalty collected under section 21 and the amount collected under section 96 shall be credited to such fund as may be prescribed.
98. Protection of action taken in good faith.
No suit, prosecution or other legal proceeding shall lie against the Presidents and members of the District Commission, the State Commission and the National Commission, the Chief Commissioner, the Commissioner, any officer or employee and other person performing any duty under this Act, for any act which is in good faith done or intended to be done in pursuance of this Act or under any rule or order made thereunder.
99. Power to give directions by Central Government.
(1) Without prejudice to the foregoing provisions of this Act, the Central Authority, shall, in exercise of its powers or the performance of its functions under this Act, be bound by such directions on questions of policy, as the Central Government may give in writing to it from time to time:
Provided that the Central Authority shall, as far as practicable, be given an opportunity to express its views before any direction is given under this sub-section.
(2) The decision of the Central Government whether a question is one of policy or not shall be final.
100. Act not in derogation of any other law.
The provisions of this Act shall be in addition to and not in derogation of the provisions of any other law for the time being in force.
101. Power of Central Government to make rules.
(1) The Central Government may, by notification, make rules for carrying out any of the provisions contained in this Act.
(2) Without prejudice to the generality of the foregoing power, such rules may provide for, —
(a) the other class or classes of persons including public utility entities under clause (19) of section 2;
(b) the contest, lottery, game of chance or skill which are to be exempted under item (b) of sub-clause (iii) of clause (47) of section 2;
(c) the manner of issuing bill or cash memo or receipt for goods sold or services rendered under sub-clause (vii) of clause (47) of section 2;
(d) the number of other official or non-official members of the Central Council under clause (b) of sub-section (2) of section 3;
(e) the time and place of meeting of Central Council and the procedure for the transaction of its business under sub-section (2) of section 4;
(f) the number of Commissioners in the Central Authority under sub-section (2) of section 10;
(g) the qualifications for appointment, method of recruitment, procedure of appointment, term of office, salaries and allowances, resignation, removal and other terms and conditions of service of the Chief Commissioner and other Commissioners of the Central Authority under section 11;
(h) the salaries and allowances payable to, and the other terms and conditions of service of, the officers and other employees of the Central Authority under sub-section (2) of section 13;
(i) the qualifications for appointment of Director General, Additional Director General, Director, Joint Director, Deputy Director and Assistant Director and the manner of appointment under sub-section (2) of section 15;
(j) the manner of taking copies or extracts of document, record or article seized or produced before returning to the person under sub-section (3) of section 22;
(k) the officer and the manner of disposing of articles which are subject to speedy or natural decay under sub-section (4) of section 22;
(l) the form and manner for preparing annual statement of accounts by the Central Authority in consultation with the Comptroller and Auditor-General of India under sub-section (1) of section 26;
(m) the form in which, and the time within which, an annual report, other reports and returns may be prepared by the Central Authority under sub-section (1) of section 27;
(n) the qualifications for appointment, method of recruitment, procedure for appointment, term of office, resignation and removal of President and members of the District Commission under section 29;
(o) the other value of goods and services in respect of which the District Commission shall have jurisdiction to entertain complaints under proviso to sub-section (1) of section 34;
(p) the manner of electronically filing complaint under the proviso to sub-section (1) of section 35;
(q) the fee, electronic form and the manner of payment of fee for filing complaint under sub-section (2) of section 35;
(r) the cases which may not be referred for settlement by mediation under sub-section (1) of section 37;
(s) the manner of authentication of goods sampled in case of the National Commission under clause (c) of sub-section (2) of section 38;
(t) any other matter which may be prescribed under clause (f) of sub-section (9) of section 38;
(u) the fund where the amount obtained may be credited and the manner of utilisation of such amount under sub-section (2) of section 39;
(v) the form and the manner in which appeal may be preferred to the State Commission under section 41;
the qualifications for appointment, method of recruitment, procedure for appointment, term of office, resignation and removal of the President and members of
the State Commission under section 43;
(x) the other value of goods and services in respect of which the State Commission shall have jurisdiction under the proviso to sub-clause (i) of clause (a) of sub-section (1) of section 47;
(y) the form and manner of filing appeal to the National Commission, and the manner of depositing fifty per cent. of the amount before filing appeal, under sub-section (1) of section 51;
(z) the number of members of the National Commission under clause (b) of section 54;
(za) the qualifications, appointment, term of office, salaries and allowances, resignation, removal and other terms and conditions of service of the President and members of the National Commission under sub-section (1) of section 55;
(zb) the salaries and allowances payable to, and other terms and conditions of service of, the officers and other employees of the National Commission under sub-section (3) of section 57;
(zc) the other value of goods and services in respect of which the National Commission shall have jurisdiction under the proviso to sub-clause (i) of clause (a) of sub-section (1) of section 58;
(zd) the manner of depositing fifty per cent. of the amount under the second proviso to section 67;
(ze) the form in which the National Commission and the State Commission shall furnish information to the Central Government under sub-section (4) of section 70;
(zf) the persons in the consumer mediation cell under sub-section (3) of section 74;
(zg) the measures to be taken by the Central Government to prevent unfair trade practices in e-commerce, direct selling under section 94;
(zh) the amount for compounding offences under sub-section (1) of section 96;
(zi) the fund to which the penalty and amount collected shall be credited under section 97; and
(zj) any other matter which is to be, or may be, prescribed, or in respect of which provisions are to be, or may be, made by rules.
102. Power of State Government to make rules.
(1) The State Governments may, by notification, make rules for carrying out the provisions of this Act:
Provided that the Central Government may, frame model rules in respect of all or any of the matters with respect to which the State Government may make rules under this section, and where any such model rules have been framed in respect of any such matter, they shall apply to the State until the rules in respect of that matter is made by the State Government and while making any such rules, so far as is practicable, they shall conform to such model rules.
(2) In particular, and without prejudice to the generality of the foregoing power, such rules may provide for all or any of the following matters, namely:—
(a) the other class or classes of persons including public utility entities under clause (19) of section 2;
(b) the contest, lottery, game of chance or skill which are to be exempted under item (b) of sub-clause (iii) of clause (47) of section 2;
(c) the number of other official or non-official members of the State Council under clause (b) of sub-section (2) of section 6;
(d) the time and place of meeting of the State Council and the procedure for the transaction of its business under sub-section (4) of section 6;
(e) the number of other official and non-official members of District Council under clause (b) of sub-section (2) of section 8;
(f) the time and place of meeting of the District Council and procedure for the transaction of its business under sub-section (4) of section 8;
(g) the number of members of the District Commission under clause (b) of sub-section (2) of section 28;
(h) the salaries and allowances payable to, and other terms and conditions of service of, the President and members of the District Commission under section 30;
(i) the salaries and allowances payable to, and other terms and conditions of service of, the officers and other employees of the District Commission under sub-section (3) of section 33;
(j) the manner of authentication of goods sampled by the State Commission and the District Commission under clause (c) of sub-section (2) of section 38;
(k) the manner of depositing fifty per cent. of the amount before filing appeal under second proviso to section 41;
(l) the number of members of the State Commission under sub-section (3) of section 42;
(m) the salaries and allowances payable to, and other terms and conditions of service of, the President and members of the State Commission under section 44;
(n) the salaries and allowances payable to, and other terms and conditions of service of, the officers and other employees of the State Commission under sub-section (3) of section 46;
(o) the form in which the State Commission shall furnish information to the State Government under sub-section (5) of section 70;
(p) the persons in the consumer mediation cell under sub-section (3) of section 74;
(q) any other matter which is to be, or may be prescribed, or in respect of which provisions are to be, or may be, made by rules.
103. Power of National Commission to make regulations.
(1) The National Commission may, with the previous approval of the Central Government, by notification, make regulations not inconsistent with this Act to provide for all matters for which provision is necessary or expedient for the purpose of giving effect to the provisions of this Act.
(2) In particular, and without prejudice to the generality of the foregoing power, such regulations may make provisions for—
(a) the costs for adjournment to be imposed by the District Commission under the second proviso to sub-section (7) of section 38;
(b) the costs for adjournment to be imposed by the State Commission or the National Commission, as the case may be, under the second proviso to section 52;
(c) the maintenance of any other information by the consumer mediation cell under sub-section (4) of section 74;
(d) the manner of submission of quarterly report by consumer mediation cell to the District Commission, the State Commission or the National Commission under sub-section (5) of section 74;
(e) the qualifications and experience required for empanelment as mediator, the procedure for empanelment, the manner of training empanelled mediators, the fee payable to empanelled mediator, the terms and conditions for empanelment, the code of conduct for empanelled mediators, the grounds on which, and the manner in which, empanelled mediators shall be removed or empanelment shall be cancelled and the other matters relating thereto under sub-section (2) of section 75;
(f) the conditions for re-empanelment of mediators for another term under sub-section (3) of section 75;
(g) the other facts to be disclosed by mediators under clause (c) of section 77;
(h) the time within which, and the manner in which, mediation may be conducted under sub-section (3) of section 79; and
(i) such other matter for which provision is to be, or may be, made by regulation.
104. Power of Central Authority to make regulations.
(1) The Central Authority may, with the previous approval of the Central Government, by notification, make regulations not inconsistent with this Act, for the purpose of giving effect to the provisions of this Act.
(2) In particular, and without prejudice to the generality of the foregoing power, such regulations may provide for all or any of the following matters, namely:—
(a) the procedure for engaging experts and professionals and the number of such experts and professionals under sub-section (3) of section 13;
(b) the procedure for transaction of business and the allocation of business of the Chief Commissioner and Commissioner under sub-section (1) of section 14;
(c) the form, manner and time within which, inquiries or investigation made by the Director-General shall be submitted to the Central Authority under sub-section (5) of section 15; and
(d) such other matter for which provision is to be, or may be, made by regulation.
105. Rules and regulations to be laid before each House of Parliament.
(1) Every rule and every regulation made under this Act shall be laid, as soon as may be after it is made, before each House of Parliament, while it is in session, for a total period of thirty days which may be comprised in one session or in two or more successive sessions, and if, before the expiry of the session immediately following the session or the successive sessions aforesaid, both Houses agree in making any modification in the rule or regulation or both Houses agree that the rule or regulation shall thereafter have effect only in such modified form or be of no effect, as the case may be; so, however, that any such modification or annulment shall be without prejudice to the validity of anything previously done under that rule or regulation.
(2) Every rule made by a State Government under this Act shall be laid as soon as may be after it is made, before the State Legislature.
106. Power to remove difficulties.
If any difficulty arises in giving effect to the provisions of this Act, the Central Government may, by order in the Official Gazette, make such provisions not inconsistent with the provisions of this Act as appear to it to be necessary or expedient for removing the difficulty:
Provided that no such order shall be made after the expiry of a period of two years from the commencement of this Act.
107. Repeal and savings.
(1) The Consumer Protection Act, 1986 is hereby repealed.
(2) Notwithstanding such repeal, anything done or any action taken or purported to have been done or taken under the Act hereby repealed shall, in so far as it is not inconsistent with the provisions of this Act, be deemed to have been done or taken under the corresponding provisions of this Act.
(3) The mention of particular matters in sub-section (2) shall not be held to prejudice or affect the general application of section 6 of the General Clauses Act, 1897 with regard to the effect of repeal.
DR. G. NARAYANA RAJU,
Secretary to the Govt. of Ind
NMC ACT
The National Medical Commission Bill, 2019 was introduced by the Minister of Health and Family Welfare, Dr. Harsh Vardhan in Lok Sabha on July 22, 2019. The Bill seeks to repeal the Indian Medical Council Act, 1956 and provide for a medical education system which ensures: (i) availability of adequate and high quality medical professionals, (ii) adoption of the latest medical research by medical professionals, (iii) periodic assessment of medical institutions, and (iv) an effective grievance redressal mechanism. Key features of the Bill include:
Constitution of the National Medical Commission: The Bill sets up the National Medical Commission (NMC). Within three years of the passage of the Bill, state governments will establish State Medical Councils at the state level. The NMC will consist of 25 members, appointed by the central government. A Search Committee will recommend names to the central government for the post of Chairperson, and the part time members. The Search Committee will consist of seven members including the Cabinet Secretary and five experts nominated by the central government (of which three will have experience in the medical field).
Members of the NMC will include: (i) the Chairperson (must be a medical practitioner), (ii) Presidents of the Under-Graduate and Post-Graduate Medical Education Boards, (iii) the Director General of Health Services, Directorate General of Health Services, (iv) the Director General, Indian Council of Medical Research, and (v) five members (part-time) to be elected by the registered medical practitioners from amongst themselves from states and union territories for a period of two years.
Functions of the National Medical Commission: Functions of the NMC include: (i) framing policies for regulating medical institutions and medical professionals, (ii) assessing the requirements of healthcare related human resources and infrastructure, (iii) ensuring compliance by the State Medical Councils of the regulations made under the Bill, (iv) framing guidelines for determination of fees for up to 50% of the seats in private medical institutions and deemed universities which are regulated under the Bill.
Medical Advisory Council: Under the Bill, the central government will constitute a Medical Advisory Council. The Council will be the primary platform through which the states/union territories can put forth their views and concerns before the NMC. Further, the Council will advise the NMC on measures to determine and maintain minimum standards of medical education.
Autonomous boards: The Bill sets up autonomous boards under the supervision of the NMC. Each autonomous board will consist of a President and four members, appointed by the central government. These boards are: (i) the Under-Graduate Medical Education Board (UGMEB) and the Post-Graduate Medical Education Board (PGMEB): These Boards will be responsible for formulating standards, curriculum, guidelines, and granting recognition to medical qualifications at the undergraduate and post graduate levels respectively. (ii) The Medical Assessment and Rating Board (MARB): MARB will have the power to levy monetary penalties on medical institutions which fail to maintain the minimum standards as laid down by the UGMEB and PGMEB. The MARB will also grant permission for establishing a new medical college, starting any postgraduate course, or increasing the number of seats. (iii) The Ethics and Medical Registration Board: This Board will maintain a National Register of all licensed medical practitioners, and regulate professional conduct. Only those included in the Register will be allowed to practice medicine. The Board will also maintain a separate National Register for community health providers.
Community health providers: Under the Bill, the NMC may grant a limited license to certain mid-level practitioners connected with the modern medical profession to practice medicine. These mid-level practitioners may prescribe specified medicines in primary and preventive healthcare. In any other cases, these practitioners may only prescribe medicines under the supervision of a registered medical practitioner.
Entrance examinations: There will be a uniform National Eligibility-cum-Entrance Test for admission to under-graduate and post-graduate super-speciality medical education in all medical institutions regulated under the Bill. The NMC will specify the manner of conducting common counselling for admission in all such medical institutions.
The Bill proposes a common final year undergraduate examination called the National Exit Test for the students graduating from medical institutions to obtain the license for practice. This test will also serve as the basis for admission into post-graduate courses at medical institutions under this Bill.
SUROGACY BILL
Chapter II
Regulation of Surrogacy Clinics
3. On and from the date of commencement of this Act,
(i) no surrogacy clinic, unless registered under this Act, shall conduct or associate with, or help in any manner, in conducting activities relating to surrogacy and surrogacy procedures;
(ii) no surrogacy clinic, paediatrician, gynaecologist, embryologist, registered medical practitioner or any person shall conduct, offer, undertake, promote or associate with or avail of commercial surrogacy in any form;
(iii) no surrogacy clinic shall employ or cause to be employed or take services of any person, whether on honorary basis or on payment who does not possess such qualifications as may be prescribed;
(iv) no registered medical practitioner, gynaecologist, paediatrician, embryologist or any other person shall conduct or cause to be conducted or aid in conducting by himself or through any other person surrogacy or surrogacy procedures at a place other than a place registered under this Act;
(v) no surrogacy clinic, registered medical practitioner, gynaecologist, paediatrician, embryologist or any other person shall promote, publish, canvass, propagate or advertise or cause to be promoted, published, canvassed, propagated or advertised which –
(a) is aimed at inducing or is likely to induce a woman to act as a surrogate mother;
(b) is aimed at promoting a surrogacy clinic for commercial surrogacy or promoting commercial surrogacy in general;
(c) seeks or aimed at seeking a woman to act as a surrogate mother;
(d) states or implies that a woman is willing to become a surrogate mother; or
(e) advertises commercial surrogacy in print or electronic media or in any other form;
(vi) no surrogacy clinic, registered medical practitioner, gynaecologist, paediatrician, embryologist, intending couple or any other person shall conduct or cause abortion during the period of surrogacy without the written consent of the surrogate mother and on authorisation of the same by the appropriate authority concerned:
Provided that the authorisation of the appropriate authority shall be subject to, and in compliance with, the provisions of the Medical Termination of Pregnancy Act, 1971;
(vii) no surrogacy clinic, registered medical practitioner, gynaecologist, paediatrician, embryologist, intending couple or any other person shall store a human embryo or gamete for the purpose of surrogacy:
Provided that nothing contained in this clause shall affect such storage for other legal purposes like sperm banks, IVF and medical research for such period and in such manner as may be prescribed.
(viii) no surrogacy clinic, registered medical practitioner, gynaecologist, paediatrician, embryologist, intending couple or any other person shall be involved in any form of sex selection for surrogacy.
The Food Safety and Standards (Contaminants, toxins and Residues) Regulations, 2011.
1.1.1: These regulations may be called the Food Safety and Standards (Contaminants, toxins and Residues) Regulations, 2011.
1.1.2: These regulations shall come into force on or after 5th August, 2011
2.1 : Metal Contaminants
2.1.1
1. Chemicals described in monographs of the Indian Pharmacopoeia when used in foods, shall not contain metal contaminants beyond the limits specified in the appropriate monographs of the Indian Pharmacopoeia for the time being in force.
2. Notwithstanding the provisions of regulation 2.1.1 (1), no article of food specified in Column 2 of the table below shall contain any metal specified in excess of the quantity specified in Column 3 of the said table:
Name of the metal contaminantsArticle of foodParts per Million by weight
1. Lead(i) Beverages;
Concentrated soft drinks (but not including concentrates used in the manufacture of soft drinks)0.5
Fruit and vegetable juice (including tomato juice, but not including lime juice and lemon juice)1.0
Concentrates used in the manufacture of soft drinks, lime juice and lemon juice2.0
(ia) Baking powder10
(ib) Edible oils and fats0.5
(ic) Infant Milk substitute and Infant foods0.2
(id) Turmeric whole and powder10.0
(ii) Other foods
Anhydrous dextrose and dextrose monohydrate, edible oils & fats, refined white sugar (sulphated ash content not exceeding 0.03 per cent)0.5
Ice-cream, iced lollies and similar frozen confections1.0
Canned fish, canned meats, edible gelatin, meat extracts and hydrolysed protein, dried or dehydrated vegetables (other than onions)5.0
All types of sugar, sugar syrup, invert sugar and direct consumption coloured sugars with sulphated ash content exceeding 1.0 per cent5.0
Raw sugars except those sold for direct consumption or used for manufacturing purpose other than the manufacture of refined sugar.5.0
Edible molasses, caramel liquid and solid glucose and starch conversion products with a sulphated ash content exceeding 1.0 per cent5.0
Cocoa powder5.0 on the dry fat free substance
Yeast and yeast products5.0 on the dry Matter
Tea, dehydrated onions, dried herbs and spices flavourings, alginic acid, alignates, agar, carrageen and similar products derived from seaweed10.0 on the dry matter
Liquid pectin, chemicals not otherwise specified, used as ingredients or in the preparation or processing of food10.0
Food colouring other than caramel10.0 on the dry colouring matter
Solid pectin50.0
Hard boiled sugar confectionery2.0
Iron fortified common salt2.0
Corned beef, luncheon meat, Cooked Ham, Chopped meat, Canned chicken, Canned mutton and Goat meat and other related meat products2.5
Brewed vinegar and Synthetic vinegarNil
(iii) Foods not specified2.5
2. Copper(i) Beverages:
Soft drinks excluding concentrates and Carbonated water7.0
Carbonated water1.5
Toddy5.0
Concentrates for soft drinks20.0
(ii) Other Foods
Chicory-dried or roasted, coffee beans, flavourings/pectin liquid30.0
Colouring matter30.0 on dry colouring matter
Edible gelatin30.0
Tomato ketchup50.0 on the dried total solids
Yeast and yeast products60.0 on the dry matter
Cocoa powder70.0on the fat free substance
Tomato puree, paste, powder, juice and cocktails100.0 on the dried tomato solid
Tea150.0
Pectin-solid300.0
Hard boiled sugar confectionery5.0
Iron Fortified Common Salt2.0
Turmeric whole and powder5.0
Juice of orange, grape, apple, tomato, pineapple and lemon5.0
Pulp and pulp products of any fruit5.0
Infant milk substitute and Infant foods15.0(But not less than 2.8)
Brewed Vinegar and Synthetic vinegarNil
Caramel20
(iii) Foods not specified30.0
3. Arsenic(i) Milk0.1
(ii) Beverages :
Soft drink intended for consumption after dilution except carbonated water0.5
Carbonated water0.25
Infant Milk substitute and Infant foods0.05
Turmeric whole and powder0.1
Juice of orange, grape, apple, tomato, pineapple and lemon0.2
Pulp and pulp products of any fruit0.2
Preservatives, anti-oxidants, emulsifying and stabilising agents and synthetic food colours3.0 on dry matter
Ice-cream, iced lollies and similar frozen confections0.5
Dehydrated onions, edible gelatin, liquid pectin2.0
Chicory-dried or roasted
4.0
Dried herbs, finings and clearing agents, solid pectin all grades, spices5.0
Food colouring other than synthetic colouring.5.0 on dry colouring matter
Hard boiled sugar confectionery1.0
Iron Fortified Common Salt1.0
Brewed Vinegar and Synthetic Vinegar0.1
(iii) Foods not specified1.1
4. Tin(i) Processed and canned products250.0
(i-a) Hard boiled sugar confectionery5.0
(i-aa) Jam, Jellies and Marmalade250
Juice of orange, apple, tomato, pineapple and lemon250
Pulp and pulp products of any fruit250
(i-b) Infant Milk substitute and Infant foods5.0
(i-c) Turmeric whole and powderNil
(i-d) Corned beef, Luncheon meat, Cooked Ham, Chopped meat, Canned chicken, Canned mutton and Goat meat
250
(ii) Foods not specified250
5. Zinc(i) Ready-to-drink beverages5.0
Juice of orange, grape, tomato, pipeapple and lemon5.0
Pulp and pulp products of any fruit5.0
(i-a) Infant milk substitute and Infant foods50.0 (but) not less than 25.0)
(ii) Edible gelatin100.0
(ii-a) Turmeric whole and powder25.0
(iii) Fruit and Vegetable products50.0
(iii-a) Hard boiled sugar confectionery5.0
(iv) Foods not specified50.0
6. Cadmium(i) Infant Milk substitute and Infant foods0.1
(ii) Turmeric whole and powder0.1
(iii) Other foods1.5
7. MercuryFish0.5
Other foods1.0
8.Methyl MercuryAll foods0.25
9. ChromiumRefined Sugar20 ppb
10. NickelAll hydrogenated, patially hydrogenated, interesterified vegetable oils and fats such as vanaspati, table margarine, bakery and industrialmargarine, bakery shortening, fat spread and partially hydrogenated soyabean oil1.5
2.1 Sale of certain admixtures prohibited
2.1.1 Not withstanding the provisions of 2.7 of labelling and packaging regulations no person shall either by himself or by any servant or agent sell—
(1) cream which has not been prepared exclusively from milk or which contains less than 25 per cent. of milk fat;
(2) milk which contains any added water;
(3) ghee which contains any added matter not exclusively derived from milk fat;
(4) skimmed milk (fat abstracted) as milk;
(5) a mixture of two or more edible oils as an edible oil;
(6) vanaspati to which ghee or any other substance has been added;
(7) turmeric containing any foreign substance;
(8) mixture of coffee and any other substance except chicory;
(9) dahi or curd not prepared from boiled, pasteurised or sterilized milk;
(10) milk or a milk product specified in Food Safety and Standards (Food Products Standards and Food Additives) regulations, 2011 containing a substance not found in milk, except as provided in the regulations.
Provided that the Central Government or the Food Authority may, by notification in the Official Gazette exempt any preparations made of soluble extracts of coffee from the operation of this regulation.
Provided further that proprietary food articles relating to Regulation 2.1.1(8) shall be exempted from the operation of this Regulation
Provided further that in respect of regulation 2.1.1(5), a maximum tolerance of 15.0 red units in 1 cm. Cell of Lovibond scale is permitted when oil is tested for Boudouin test without dilution that is to say by shaking vigorously for 2 minutes, 5 ml. Of the sample with 5 ml. of the hydrochloric acid (specific gravity 1.19) and 0.3 ml. of 2 percent alcoholic solution of furfural and allowing to standing for 5 miutes.
Provided further that in respect of Regulation 2.1.1(5) a maximum tolerance limit of 10 red units in one cm. cell on Lovibond scale is permitted when the oil is tested for Halphen’s test without dilution, that is to say, by shaking 5 ml. of the sample with 5 ml. of sulphur solution (one per cent (w/v) solution of sulphur in carbon-di-sulphide mixed with equal volume of amyl alcohol), in a closed system (test tube 250 x 25 Cm.) heating in hot water (700C- 80°C) for a few minutes with occasional shaking until carbon-di-sulphide is boiled off and the sample stops foaming and then placing the tube on saturated brine bath, capable of being regulated at 1100C-1150C for 2.5 hours
Provided also that prohibition in Regulation 2.1.1 (5) shall remain inoperative in respect of admixture of any two edible vegetable oils as one edible vegetable oil, where –
(a) the proportion by weight of any vegetable oil used in the admixture is not less than 20 per cent. by weight; and
(b) the admixture of edible vegetable oils, is processed or packed and sold, by the Department of Civil Supplies, Government of India (Directorate of Vanaspati, Vegetable Oils and Fats) or by the agencies in public, private or Joint Sector authorized by the Department, or by the National Dairy Development Board or by the State Cooperative Oilseeds Growers Federation or Regional and District Cooperative Oilseeds Growers Union set up under National Dairy Development Board’s Oilseeds and Vegetable Oil Project or by the Public Sector undertakings of Central and State Governments, in sealed packages weighing not more than 15 litres under Agmark Certification Mark compulsorily and bearing the label declaration as laid down in the Regulation 2.4.2 (11) of Food Safety and Standards (Packaging and Labelling) Regulations, 2011 and
(c) the quality of each edible oil used in the admixture conforms to the relevant standard prescribed by these regulations
2.2 : Restriction on use of certain ingredient:
2.2.1: No person in any State shall, with effect from such date as the state government concerned may by notification in the official gazette specify in this behalf, sell or offer or expose for sale, or have in his possession for the purpose of sale, under any description or for use as an ingredient in the preparation of any article of food intended for sale:—
(a) Kesari gram (Lathyrus sativus) and its products.
(b) Kesari dal (Lathyrus sativus) and its products.
(c) Kesari dal flour (Lathyrus sativus) and its products.
(d) A mixture of Kesari gram (Lathyrus sativus) and Bengal-gram (Cicer arietinum) or any other gram.
(e) A mixture of Kesari dal (Lathyrus sativus) and Bengal-gram dal (Cicer arietinum) or any other dal.
(f) A mixture of Kesari dal (Lathyrus sativus) flour and Bengal-gram (Cicer arietinum) flour or any other
flour.
1AssameseKhesari, Teora.
2BengaliKhesari, Teora, Kassur, Batura.
3BihariKhesari, Teora, Kassur, Batura.
4EnglishChikling vetch.
5GujaratiLang.
6HindiKhesari, Kessur, Kesari, Kassartiuri,Batura, Chapri, Dubia, Kansari, Kesori, Latri, Tinra, Tiuri, Kassor.
7KannadaLaki Bele, Kessari Bele.
8MalyalamKesari, Lanki, Vattu.
9TamilMuku.
10MarathiLakheri, Batri, Lakhi, Lang, Mutra, Teora, Botroliki-dal, Lakh.
11OriyaKhesra, Khesari, Khesari dal.
12PersianMasang.
13PunjabiKisari, Chural, Karas, Karil, Kasa Kesari, Chapa.
14SanskritSandika, Triputi.
15SindhiMatter.
16TeluguLamka
Food Safety and Standards (Prohibition and Restrictions on Sales) Regulations, 2011
2.3 Prohibition and Restriction on sale of certain products
2.3.1: Prohibition on sale of food articles coated with mineral oil: No person shall sell or offer or expose for sale or have in his premises for the purpose of sale under any description, food articles which have been coated with mineral oil, except where the addition of mineral oil is permitted in accordance with the standards laid down in these Regulations and Food Safety and Standards (Food Products Standards and Food Additives) regulations, 2011.
2.3.2: Restriction on sale of Carbia Callosa and Honey dew.:Carbia Callosa and Honey dew shall be sold only in sealed containers bearing Agmark seal.
2.3.3: Food resembling but not pure honey not be marketed as honey: No person shall use the word ‘honey’ or any word, mark, illustration or device that suggests honey on the label or any package of, or in any advertisement for, any food that resembles honey but is not pure honey.
2.3.4: Product not to contain any substance which may be injurious to health: Tobacco and nicotine shall not be used as ingredients in any food products.
2.3.5: Prohibition of use of carbide gas in ripening of fruits: No person shall sell or offer or expose for sale or have in his premises for the purpose of sale under any description, fruits which have been artificially ripened by use of acetylene gas, commonly known as carbide gas.
2.3.6: Sale of Fresh Fruits and Vegetables: The Fresh Fruits and Vegetables shall be free from rotting and free from coating of waxes, mineral oil and colours.
Provided that fresh fruits may be coated with bees wax (white and yellow) or carnauba wax or shellac wax at level not exceeding Good Manufacturing Practices under proper label declaration as provided in Regulation 2.4.5 (44) of Food Safety and Standards (Packaging and Labelling) regulations, 2011.
2.3.7: Sale or use for sale of admixtures of ghee or butter prohibited: No person shall sell or have in his possession for the purpose of sale or for use as an ingredient in the preparation of an article of food for sale a mixture of ghee or butter and any substance
(1) prepared in imitation of or as a substitute for ghee or butter, or
(2) consisting of or containing any oil or fat which does not conform to the definition of ghee;
Provided that where a mixture prohibited by this regulation is required for the preparation of an article of food, such mixture shall be made only at the time of the preparation of such article of food.
2.3.8: Restriction on sale of ghee having less Reichert value than that specified for the area where such ghee is sold.
(1) The ghee having less Reichert value and a different standard for Butyro-refractometer reading at 400 C than that specified for the area in which it is imported for sale or storage shall not be sold or stored in that area except under the ‘AGMARK’ seal:
Provided that such ghee may be (i) sold lose, after opening the ‘AGMARK’ sealed container, in quantities not exceeding two kilograms at a time, and (ii) used in the preparation of confectionery (including sweetmeats).
(2) A person selling:—
(i) ghee in such manner as specified in Regulation 2.3.8 (1) and
(ii) confectionery (including sweetmeats) in the preparation of which such ghee is used, shall give a declaration, in the Form A, to the Food Safety Officer when a sample thereof is taken by him for analysis under Section 47 of the Act and also to a purchaser desiring to have the sample analysed under Section 40 of the Act.
(iii) If on analysis such sample is found to be conforming to the standards of quality prescribed for the area where it is alleged to have been produced, the ghee shall not be deemed to be adulterated by reason only that it does not conform to the standards of quality prescribed for the area where it is sold.
2.3.9: Restriction on sale of Til Oil produced in Tripura, Assam and West Bengal.
Til Oil (Sesame Oil) obtained from white sesame seeds, grown in Tripura, Assam and West Bengal having different standards than those specified for til oil shall be sold in sealed containers bearing Agmark label. Where this til oil is sold or offered for sale without bearing an Agmark label, the standard given for til oil shall apply.
2.3.10: Restriction on sale of Kangra tea.
Kangra tea shall be sold or offered for sale only after it is graded and marked in accordance with the provisions of the Agricultural Produce (Grading and Marking) Act, 1937 (1 of 1937) and the regulations made there under.
2.3.11: Condition for sale of flavoured tea: Flavoured tea shall be sold or offered for sale only by those manufacturers who are registered with Tea Board. Registration number shall be mentioned on the label. It shall be sold only in packed conditions with label declaration as provided in the Regulation 2.4.5 (23) of Food Safety and Standards (Packaging and Labelling) regulations, 2011.
2.3.12: Restriction on sale of common salt – No person shall sell or offer or expose for sale or have in his premises for the purpose of sale, the common salt, for direct human consumption unless the same is iodized:
Provided that common salt may be sold or exposed for sale or stored for sale for iodization, iron fortification, animal use, preservation, manufacturing medicines, and industrial use, under proper label declarations, as specified in the Regulation 2.4.5 (21 & 42) of Food Safety and Standards (Packaging and Labelling) regulations, 2011.
2.3.13: Use of flesh of naturally dead animals or fowls prohibited.
No person shall sell or use as an ingredient in the preparation of any article of food intended for sale, the flesh of any animal or fowl which has died on account of natural causes.
2.3.14: Restrictions relating to conditions for sale
(1) No person shall store, expose for sale or permit the sale of any insecticide in the same premises where articles of food are stored, manufactured or exposed for sale:
Provided that nothing in this regulation shall apply to the approved household insecticides which have been registered as such under the Insecticides Act 1968 (46 of 1968).
Explanation.—For the purpose of this regulation, the word ‘insecticide’ has the same meaning as assigned to it in the Insecticides Act, 1968 (46 of 1968).
(2) No person shall sell or serve food in any “commercial establishment” in plastic articles used in catering and cutlery, unless the plastic material used in catering and cutlery articles, conform to the food grade plastic, specified in these regulations.
Explanation:- For the purpose of the Regulation 2.3.14 (2), “commercial establishment” means any establishment, called by whatever name, being run\ managed by any person or by any authority of the Government\ Semi-Government or by any corporate\ registered body which deals in the business of selling or serving food.
(3) Iron fortified common salt shall be sold only in high density polyethylene bag (HDPE) 14 mesh, density 100 kg/m3, unlaminated package which shall bear the lable as specified in the Regulation 2.4.5 (21 & 42) of Food Safety and Standards (Packaging and Labelling) regulations, 2011.
(4) No person shall manufacture, sell, store or exhibit for sale, an infant milk food, infant formula and milk cereal based weaning food, processed cereal based weaning food and follow up formula except under Bureau of Indian Standards Certification Mark.
(5) Condensed milk sweetened, condensed skimmed milk sweetened, milk powder, skimmed milk powder, partly skimmed milk powder and partly skimmed sweetened condensed milk shall not be sold except under Indian Standards Institution Certification Mark.
(6) Every package of cheese (hard), surface treated with Natamycin, shall bear the label as specified in the Regulation 2.4.5 (33) of Food Safety and Standards (Packaging and Labelling) regulations, 2011.
(7) No person shall sell protein rich atta and protein rich maida except in packed condition mentioning the names of ingredients on the label.
(8) No person shall sell sal-seed fat for any other purpose except for bakery and confectionery and it shall be refined and shall bear the label declaration as specified in the Regulation 2.4.5 (19) of Food Safety and Standards (Packaging and Labelling) regulations, 2011.
(9) No person shall sell confectionery weighing more than 500 gms. except in packed condition and confectionery sold in pieces shall be kept in glass or other suitable containers.
(10) All edible oils, except coconut oil, olive oil, imported in crude, raw or unrefined form shall be subjected to the process of refining before sale for human consumption. Such oil shall bear a label declaration as laid down in the Regulation 2.4.2 of Food Safety and Standards (Packaging and Labelling) regulations, 2011.
(12) Coloured and flavoured table margarine shall only be sold in a sealed package weighing not more than 500 gms, with a label declaring addition of colour and flavour as required under these regulations.
(13) The fat spread shall not be sold in loose form. It shall be sold in sealed packages weighing not more than 500 gms. The word ‘butter’ shall not be associated while labelling the product. The sealed package shall be sold or offered for sale only under AGMARK Certification mark bearing the label declaration as provided under Regulation 2.4.2 of Food Safety and Standards (Packaging and Labelling) regulations, 2011 beside other labelling requirements under these regulations.
(14) No person shall sell compounded asafoetida exceeding one kilogram in weight except in a sealed container with a label.
(15) No person shall sell powdered spices and condiments except ‘under packed conditions.
(17) No person shall manufacture, sell or exhibit for sale packaged drinking water except under the Bureau of Indian Standards Certification Mark.
(18) No person shall manufacture, sell or exhibit for sale mineral water except under the Bureau of Indian Standards Certification Mark”;
Explanation:— For the purpose of regulation 2.3.14 (18), the expression “mineral water” shall have the same meaning as assigned to it in the Regulation 2.9.7 of Food Safety and Standards (Food Products Standards and Food Additive) Regulations, 2011.
(19) No person shall sell any food product wherein artificial sweetener is permitted under these regulations, except under packed condition and as per the labelling requirements prescribed under the regulation 2.4.5 (24, 25, 26, 28 & 29) of Food Safety and Standards (Packaging and Labelling) regulations, 2011.
(20) Conditions for sale of irradiated food.- All irradiated food shall be sold in pre-packed conditions only. The type of packaging material used for irradiated food for sale or for stock for sale or for exhibition for sale or for storage for sale shall conform to the packaging and labelling requirements specified in the regulation 2.4.4 of Food Safety and Standards (Packaging and Labelling) regulations, 2011.
2.3.15: Special provisions relating to sale of vegetable oil and fat
(1) No person shall sell or expose for sale, or distribute, or offer for sale, or dispatch, or deliver to any person for the purpose of sale any edible oil –
(a) Which does not conform to the standards of quality as provided in the Food Safety and Standards Act, 2006 (34 of 2006) and rules/regulations made there under; and
(b) Which is not packed in a container, marked and labelled in the manner as specified in FSSAI regulations
Provided that the State Government may, in the public interest, for reasons to be recorded in writing, in specific circumstances and for a specific period by a notification in the Official Gazette, exempt any edible oil from the provisions of this Act.
(2) No vegetable oil shall contain any harmful colouring, flavouring or any other matter deleterious to health;
(3) No vegetable oil other than those specified under the list below or oil or fat of animal or mineral origin shall be used in the manufacture of the products or shall otherwise be present therein;
List of vegetable oils Vanaspati shall be prepared from:
(a)Coconut oil
(b)Cottonseed oil
(c)Dhupa oil
(d)Groundnut oil
(e)Kokrum oil
(f)Linseed oil
(g)Mahua oil
(h)Maize (Corn) oil
(i)Mango kernel oil
(j)Mustard/Rapeseed oil
(k)Nigerseed oil
(l)Palm oil
(m)Phulwara oil
(n)Rice bran oil
(o)Sunflower (Kard/seed) oil
(p)Salseed oil (up to 10%)
(q)Sesame oil
(r)Soyabean oil
(s)Sunflower oil
(t)Watermelon seed oil
(u)Vegetable oils imported for edible purposes.
(4) No colour shall be added to hydrogenated vegetable oil unless so authorized by Food Authority, but in no event any colour resembling the colour of ghee shall be added. If any flavour is used, it shall be distinct from that of ghee, in accordance with a list of permissible flavours and such quantities as may be prescribed by the Food Authority
(5) No anti-oxidant, synergist, emulsifier or any other such substance other than those permitted by these regulations be added to any vegetable oil except with the prior sanction of the Food Authority.
(6) Restriction on the use of solvent.
No solvent other than n-Hexane (Food Grade) shall be used in the extraction of cocoa butter, oils and fats and edible soya flour.
The quantity solvent mentioned in the column (1) of the Table below, in the food mentioned in column (2) of the said Table, shall not exceed the tolerance limits prescribed in column (3) of the said Table:
Name of SolventArticle of foodTolerance limits mg/kg (ppm)
Hexane (Food Grade)(a) Refined solvent extracted cocoa butter5.00
(b) Refined solvent extracted oils and fats5.00
(c) solvent extracted edible soya flour10.00
Laboratory And Sample Analysis
2.1 : Notified Laboratories for Import
2.1.1 The sample of any imported article will be sent by the Authorized Officer for analysis. The Food Analyst of any of the following notified laboratories or any other laboratories notified by the Food Authority from time to time. having jurisdiction over the area in which the sample was taken.
laboratories
.KolkataOrissa
Jharkhand
Pradesh
Mizoram
Bengal
.GhaziabadPunjab
Uttarakhand
Pradesh
Pradesh
Uttarakhand
.MysoreLakshadweep,
Nadu
.PuneMaharashtra
Gujarat
Food Safety and Standards Regulations, 2011- Laboratory And Sample Analysis
2.2 : Referral Laboratory
2.2.1 : Functions- In addition to the functions entrusted to it under the Act, the Referral Laboratory shall carry out the following functions, namely:
1) analysis of samples of food sent by any officer or authority authorized by the Food Authority for the purpose and submission of the certificate of analysis to the authorities concerned;
2) investigation for the purpose of fixation of standard of any article of food;
3) investigation in collaboration with the laboratories of Food analysts in the various States and such other laboratories and institutions which the Food Authority may approve on its behalf, for the purpose of standardizing methods of analysis.
4) ensuring that the laboratory follows the scientific protocols laid down for handling/testing the articles of
food.
5) maintaining high standards of accuracy, reliability and credibility in the operation of the laboratory and
achieving and maintaining the required levels of accreditation and reliability.
6) laying down mechanism for ensuring that personnel of the laboratory adhere to high professional standards and discipline.
7) Such other conditions, as the Authority may lay down for Referral Laboratories.
8) Capacity building by way of organizing professional training, workshops and seminars for the Food analyst, laboratory personnel in the states specified by the Food authority.
2.2.2 : State/ Union Territory/ Local Area of Referral Laboratory
Air (Prevention and Control of Pollution) Act, 1981
No. 14 of 1981
[29th March, 1981]
An Act to provide for the prevention, control and abatement of air pollution, for the establishment, with a view to carrying out the aforesaid purposes, of Boards, for conferring on and assigning to such Boards powers and functions relating thereto and for matters connected therewith.
WHEREAS decisions were taken at the United Nations Conference on the Hum an Environment held in Stockholm in June, 1972, in which India participated, to take appropriate steps for the preservation of the natural resources of the earth which, among other things, include the preservation of the quality of air and control of air pollution;
AND WHEREAS it is considered necessary to implement the decisions aforesaid in so far as they relate to the preservation of the quality of air and control of air pollution;
BE it enacted by Parliament in the Thirty-second Year of the Republic of India as follows :-
CHAPTER I – PRELIMINARY
1. Short title, extent and commencement.
(1) This Act may be called the Air (Prevention and Control of Pollution) Act, 1981.
(2) It extends to the whole of India.
(3) It shall come into force on such datel as the Central Government may, by notification in the Official Gazette, appoint.
2. Definitions.
In this Act, unless the context otherwise requires,-
(a) “air pollutant” means any solid, liquid or gaseous substance 2[(including noise)] present in the atmosphere in such concentration as may be or tend to be injurious to human beings or other living creatures or plants or property or environment;
(b) “air pollution” means the presence in the atmosphere of any air
(c) “approved appliances” means any equipment or gadget used for the bringing of any combustible material or for generating or consuming any fume, gas of particulate matter and approved by the State Board for the purpose of this Act;
(d) “approved fuel” means any fuel approved by the State Board for the purposes of this Act;
(e) “automobile” means any vehicle powered either by internal combustion engine or by any method of generating power to drive such vehicle by burning fuel;
(f) “Board” means the Central Board or State Board;
(g) “Central Board- means the 3[Central Board for the Prevention and Control of Water Pollution] constituted under section 3 of the Water (Prevention and Control of Pollution) Act, 1974;
(h) “chimney” includes any structure with an opening or outlet from or through which any air pollutant may be emitted,
(i) “control equipment” means any apparatus, device, equipment or system to control the quality and manner of emission of any air pollutant and includes any device used for securing the efficient operation of any industrial plant;
(j) “emission” means any solid or liquid or gaseous substance coming out of any chimney, duct or flue or any other outlet;
(k) “industrial plant” means any plant used for any industrial or trade purposes and emitting any air pollutant into the atmosphere;
(l) “member” means a member of the Central Board or a State Board, as the case may be, and includes the Chairman thereof,
4[(m) “occupier”, in relation to any factory or premises, means the person who has control over the affairs of the factory or the premises, and includes, in relation to any substance, the person in posse ssion of the substance;]
(n) “prescribed” means prescribed by rules made under this Act by the Central Government or as the case may be, the State government;
(o) “State Board” mleans,-
(i) in relation to a State in which the Water (Prevention and Control of Pollution) Act, 1974, is in force and the State Government has constituted for that State a 5[State Board for the Prevention and Control of Water Pollution] under section 4 of that Act, the said State Board; and
(ii) in relation to any other State, the State Board for the Prevention and Control of Air Pollution constituted by the State Government under section 5 of this Act.
The Transplantation of Human Organs Act, 1994
An Act to provide for the regulation of removal, storage and transplantation of human organs for therapeutic purposes and for the prevention of commercial dealings in human organs and for matters connected therewith or incidental thereto.
Whereas it is expedient to provide for the regulation of removal, storage and transplantation of human organs for therapeutic purposes and for the prevention of commercial dealings in human organs;
And whereas Parliament has no power to make laws for the States with respect to any of the matters aforesaid except as provided in Articles 249 and 250 of the Constitution;
And whereas in pursuance of clause (1) of Article 252 of the Constitution, resolutions have been passed by all the Houses of the Legislatures of the States of Goa, Himachal Pradesh and Maharashtra to the effect that the matters aforesaid should be regulated in those States by Parliament by law;
Be it enacted by Parliament in the Forty-fifth Year of the Republic of India as follows: —
CHAPTER I-PRELIMINARY
1. Short title, application and commencement. —
(1) This Act may be called the Transplantation of Human Organs Act, 1994.
(2) It applies, in the first instance, to the whole of the States of Goa, Himachal Pradesh and Maharashtra and to all the Union territories and it shall also apply to such other States which adopts this Act by resolution passed in that behalf under clause (1) of Article 252 of the Constitution.
(3) It shall come into force in the States of Goa, Himachal Pradesh and Maharashtra and in all the Union territories on such as the Central Government may, by notification, appoint and in any other State which adopts this Act under clause (1) of Article 252 of the Constitution, on the date of such adoption; and any reference in this Act to the commencement of this Act shall, in relation to any State or Union territory, means the date on which this Act comes into force in such State or Union territory.
2. Definitions. — In this Act, unless the con otherwise requires. —
(a) “advertisement” includes any form of advertising whether to the public generally or to any section of the public or individually to selected persons;
(b) “Appropriate Authority” means the Appropriate Authority appointed under Section 13;
(c) “Authorisation Committee” means the committee constituted under clause (a) or clause (b) of sub-section (4) of Section 9;
(d) “brain-stem death” means the stage at which all functions of the brain-stem have permanently and irreversibly ceased and is so certified under sub-section (6) of Section 3;
(e) “deceased person” means a person in whom permanent disappearance of all evidence of life occurs, by reason of brain-stem death or in a cardio-pulmonary sense, at any time after live birth has taken place;
(f) “donor” means any person, not less than eighteen years of age, who voluntarily authorises the removal of any of his human organs for therapeutic purposes under sub-section (1) or sub-section (2) of Section 3;
(g) “hospital” includes a nursing home, clinic, medical centre, medical or teaching institution for therapeutic purposes and other like institution;
(h) “human organ” means any part of a human body consisting of a structured arrangement of tissues which, if wholly removed, cannot be replicated by the body;
(i) “near relative” means spouse, son, daughter, father, mother, brother or sister;
(j) “notification” means a notification published in the Official Gazette;
(k) “payment” means payment in money or money’s worth but does not include any payment for defraying or reimbursing —
(i) the cost of removing, transporting or preserving the human organ to be supplied; or
(ii) any expenses or loss of earnings incurred by a person so far as reasonably and directly attributable to his supplying any human organ from his body;
(l) “prescribed” means prescribed by rules made under this Act;
(m) “recipient” means a person into whom any human organ is, or is proposed to be, transplanted;
(n) “registered medical practitioner” means a medical practitioner who possesses any recognised medical qualification as defined in clause (h) of Section 2 of the Indian Medical Council Act, 1956 (102 of 1956), and who is enrolled on a State Medical Register as defined in clause (k) of that section;
(o) “therapeutic purposes” means systematic treatment of any disease or the measures to improve health according to any particular method or modality; and
(p) “transplantation” means the grafting of any human organ from any living person or deceased person to some other living person for therapeutic purposes.
The Pharmacy Act, 1948
(8 of 1948)1
[4th March, 1948.]
An Act to regulate the profession of pharmacy.
Whereas it is expedient to make better provision for the regulation of the profession and practise of pharmacy and for that purpose to constitute Pharmacy Councils;
It is hereby enacted as follows: —
CHAPTER 1 – INTRODUCTORY
1. Short title, extent and commencement. —
(1) This Act may be called the Pharmacy Act, 1948.
2[(2) It extends to the whole of India except the State of Jammu and Kashmir.]
(3) It shall come into force at once, but Chapters III, IV and V shall take effect in a particular State from such date 3[***] as the State Government may, by notification in the Official Gazette, appoint in this behalf:
4[Provided that where on account of the territorial changes brought about by the reorganisation of States on the 1st day of November, 1956, Chapters III, IV and V have effect only in a part of a State, the said Chapters shall take effect in the remaining part of that State from such date as the State Government may in like manner appoint.]
2. Interpretation. — In this Act, unless there is anything repugnant in the subject or context,—
(a) “agreement” means an agreement entered into under section 20;
(b) “approved” means approved by the Central Council under section 12 or section 14;
5[(c) “Central Council” means the Pharmacy Council of India constituted under section 3;
(d) “Central Register” means the register of pharmacists maintained by the Central Council under section 15 A;
(da) “Executive Committee” means the Executive Committee of the Central Council or of the State Council, as the context may require;
(e) “Indian University” means a University within the meaning of section 3 of the University Grants Commission Act, 1956, (3 of 1956) and includes such other institutions, being institutions established by or under a Central Act, as the Central Government may, by notification in the Official Gazette, specify in this behalf;]
6[(f) “medical practitioner” means a person—
(i) holding a qualification granted by an authority specified or notified under section 3 of the Indian Medical Degrees Act, 1916 (7 of 1916), or specified in the Schedules to the Indian Medical Council Act, 1956 (102 of 1956); or
(ii) registered or eligible for registration in a medical register of a State meant for the registration of persons practising the modern scientific system of medicine; or
(iii) registered in a medical register of a State, who, although not falling within sub-clause(i) or sub-clause (ii) is declared by a general or special order made by the State Government in this behalf as a person practising the modern scientific system of medicine for the purposes of this Act; or
(iv) registered or eligible for registration in the register of dentists for a State under the Dentists Act, 1948 (16 of 1948); or
(v) who is engaged in the practise of veterinary medicine and who possesses qualifications approved by the State Government;]
(g) “prescribed” means in Chapter II prescribed by regulations made under section 18, and elsewhere prescribed by rules made under section 46;
7[(h) “register” means a register of pharmacists prepared and maintained under Chapter IV;
(i) “registered pharmacist” means a person whose name is for the time being entered in the register of the State in which he is for the time being residing or carrying on his profession or business of pharmacy;
(j) “State Council” means a State Council of Pharmacy constituted under section 19, and includes a Joint State Council of Pharmacy constituted in accordance with an agreement under section 20;
(k) “University Grants Commission” means the University Grants Commission established under section 4 of the University Grants Commission Act, 1956 (3 of 1956).]
8[**]
—————————————————————–
1. For Statement of Objects and Reasons, see Gazette of India, 1947, pt. V, p. 469; and for Report of select committee, see Gazette of India, 1948, pt. V, p. 6
The Act has been extended to Dadra and Nagar Haveli by Reg. 6 of 1963, sec. 2 and Sch.1; to Pondicherry by Reg. 7 of 1963, sec. 3 and Sch I; to Goa, Daman and Diu by Reg. 11 of 1963, sec. 3 and Sch. And to Lakshadweep by Reg. 8 of 1965, sec. 3 and Sch.
The Act has been modified in its application to the States of Maharashtra, Gujarat, Mysore and Rajasthan by S.O. 2814, dated 14th August, 1964, Gazette of India, 1964 Extra., Pt. II Sec. 3(ii), p. 717. The Act has been modified in its application to the State of Tamil Nadu by the Madras adaptation of Laws (Central Acts) Order, 1957 and the Madras Adaptation of Laws (Central Acts) Order, 1961.
2. Subs. by Act 24 of 1959, sec. 2, for sub-section (2) (w.e.f. 1-5-1960).
3. The words “not later than three years from the commencement of this Act, omitted by Act 24 of 1959” sec. 2, (w.e.f. 1-5-1960).
4. Ins. by Act of 24 of 1959 sec. 2 (w.e.f. 1-5-1960).
5. Subs. by Act 70 of 1976, sec. 2, for clauses (c), (d) and (e) (w.e.f.1-9-1976).
6. Subs. by Act 24 of 1959, sec. 3, for clause (f) (w.e.f. 1-5-1960).
7. Subs. by Act 70 of 1976, sec. 2, for clauses (h), (i) and (j) (w.e.f. 1-5-1976).
8. Clause (k), ins by the A.O. 1950 was omitted by Act 24 of 1959, sec. 3 (w.e.f. 1-5-1960).
Bio-Medical Waste (Management and Handling) Rules, 1998
New Delhi, 20th July, 1998
S.O. 630 (E).-Whereas a notification in exercise of the powers conferred by Sections 6, 8 and 25 of the Environment (Protection) Act, 1986 (29 of 1986) was published in the Gazette vide S.O. 746 (E) dated 16 October, 1997 inviting objections from the public within 60 days from the date of the publication of the said notification on the Bio-Medical Waste (Management and Handling) Rules, 1998 and whereas all objections received were duly considered..
Now, therefore, in exercise of the powers conferred by section 6, 8 and 25 of the Environment (Protection) Act, 1986 the Central Government hereby notifies the rules for the management and handling of bio-medical waste.
1. SHORT, TITLE AND COMMENCEMENT:
(1) These rules may be called the Bio-Medical Waste (Management and Handling) Rules, 1998.
(2) They shall come into force on the date of their publication in the official Gazette.
2. APPLICATION:
These rules apply to all persons who generate, collect, receive, store, transport, treat, dispose, or handle bio medical waste in any form.
3. DEFINITIONS: In these rules unless the context otherwise requires
(1) “Act” means the Environment (Protection) Act, 1986 (29 of 1986);
(2) “Animal House” means a place where animals are reared/kept for experiments or testing purposes;
(3) “Authorisation” means permission granted by the prescribed authority for the generation, collection, reception, storage, transportation, treatment, disposal and/or any other form of handling of bio-medical waste in accordance with these rules and any guidelines issued by the Central Government.
(4) “Authorised person” means an occupier or operator authorised by the prescribed authority to generate, collect, receive, store, transport, treat, dispose and/or handle bio-medical waste in accordance with these rules and any guidelines issued by the Central Government;
(5) “Bio-medical waste” means any waste, which is generated during the diagnosis, treatment or immunisation of human beings or animals or in research activities pertaining thereto or in the production or testing of biologicals, and including categories mentioned in Schedule I;
(6) “Biologicals” means any preparation made from organisms or micro-organisms or product of metabolism and biochemical reactions intended for use in the diagnosis, immunisation or the treatment of human beings or animals or in research activities pertaining thereto;
(7) “Bio-medical waste treatment facility” means any facility wherein treatment. disposal of bio-medical waste or processes incidental to such treatment or disposal is carried out;
(8) “Occupier” in relation to any institution generating bio-medical waste, which includes a hospital, nursing home, clinic dispensary, veterinary institution, animal house, pathological laboratory, blood bank by whatever name called, means a person who has control over that institution and/or its premises;
(9) “Operator of a bio-medical waste facility” means a person who owns or controls or operates a facility for the collection, reception, storage, transport, treatment, disposal or any other form of handling of bio-medical waste;
(10) “Schedule” means schedule appended to these rules;
Drugs and Cosmetics Act, 1940
INTRODUCTION
In 1937 a Bill was introduced in the Central Legislative Assembly to give effect to the recommendations of the Drugs Enquiry Committee to regulate the import of drugs into British India. This Bill was referred to the Select Committee and the Committee expressed the opinion that a more comprehensive measure for the uniform control of manufacture and distribution of drugs as well as of imports was desirable. The Central Government suggested to the Provincial Governments to ask the Provincial Legislatures to pass resolutions empowering the Central Legislature to pass on Act for regulating such matters relating to control of drugs as fall within the Provincial sp here. Provincial Governments got the resolution passed from the Provincial Legislatures and sent them to the Central Government for getting through the Bill to regulate the import, manufacture, distribution and sale of Drugs and Cosmetics. Thereupon the Drugs and Cosmetics Bill was introduced in the Central Legislative Assembly.
STATEMENT OF OBJECTS AND REASONS
1. In order to give effect to the recommendations of the Drugs Enquiry Committee,, in so far as they relate to matters with which the Central Government is primarily concerned, a Bill to regulate the import of drugs into British India was introduced in the Legislative Assembly in 1937. The Select Committee appointed by the Legislative Assembly was of the opinion that a more comprehensive measure providing for the uniform control of the manufacture and distribution of drugs as well as of import was desirable. The Government of India accordingly asked Provincial Governments to invite the Provincial Legislatures to pass resolutions under section 103 of the Government of India Act, 1935, empowering the Central Legislature to pass an Act for regulating such matters relating to the control of drugs as fall within the Provincial Legislative List. Such resolutions have now been passed by all Provincial Legislatures.
2. Chapter II of the Bill establishes a Board of Technical Experts to advise the Central and Provincial Governments on technical matters.
3. Chapter III provides for the control of the import of drugs into British India. The executive power under this chapter will accordingly be exercised by the Central Government.
4. Chapter IV relates to control of the manufacture, sale and distribution of drugs and contains the provisions which it is proposed should be enacted in exercise of the powers conferred by the resolutions under section 103 of the Government of India Act passed by the Provincial Legislatures. The executive power under Chapter IV will be exercised by the Provincial Government.
5. The First Schedule prescribes the standards to be complied with by imported drugs and the Second Schedule prescribes the standards to be complied with the drugs manufactured, sold or distributed in India. The standards prescribed in the two Schedules are identical. The Central Government will have power to amend the First Schedule, but power to amend the Second Schedule will rest with Provincial Government.
6. The Government of India have considered to what extent provision can be made to secure the maintenance of unformity in standards and in other important matters in which uniformity is desirable. They understand that it would be ultra vires of Central Legislature to assign to any authority other than the Provincial Government’s authority conferred by the Bill in respect of matters falling within the Provincial Legislative field. For this reason it is not possible to assign the power to fix standards and to make rules to any single authority. In order to assure that before any action is taken due consideration is given to the desirability of maintaining uniformity, provision has been made in Chapter VI for a single Technical Advisory Board which both Central and Provincial Government will be required to consult before modifying the standards set up by the Bill or before making rules under the Bill.
ACT 23 OF 1940
The Drugs and Cosmetics Bill was passed by the Central Legislative Assembly and it received the assent of the Governor General on 10th April, 1940 and thus became the Drugs and Cosmetics Act, 1940 (23 of 1940).
LIST OF AMENDING ACTS AND ADAPTATION ORDERS
1. The Repealing and Amending Act, 1949 (40 of 1949).
2. The Adoption of Laws Order, 1950
3. The part B States (Laws) Act, 1951 (3 of 1951).
4. The Drugs (Amendment) Act, 1955 (11 of 1955).
5. The Drugs (Amendment) Act, 1960 (35 of 1960).
6. The Drugs (Amendment) Act, 1962 (21 of 1962).
7. The Drugs and Cosmetics (Amendment) Act, 1964 (13 of 1964).
8. The Drugs and Cosmetics (Amendment) Act, 1972 (19 of 1972).
9. The Drugs and Cosmetics (Amendment) Act, 1982 (68 of 1982).
10. The Drugs and Cosmetics (Amendment) Act, 1986 (71 of 1986).
Preamble
(23 OF 1940)
[10th April, 1940]
An Act to regulate the import, manufacture, distribution and sale of drugs [(Note: Ins. by Act 21 of 1962, sec.2 (w.e.f. 27-7-1964)) and cosmetics].
WHEREAS it is expedient to regulate the [(Note: Subs. by the A.O. 1950, for certain words.) import, manufacture, distribution and sale] of drugs [(Note: Subs. by the A.O. 1950, for certain words.) and cosmetics];
AND WHEREAS the Legislatures of all the Provinces have passed resolutions in terms of section 103 of the Government of India Act, 1935, in relation to such of the above-mentioned matters and matters ancillary thereto as are enumerated in List II of the Seventh Schedule to the said Act;
It is hereby enacted as follows :-
1. Short title, extent and commencement.
(1) This Act may be called the Drugs [(Note: Ins. by Act 21 of 1962, sec.3 (w.e.f. 27-7-1964). and Cosmetics] Act, 1940.
(2) It extends to the whole of India (Note: The words “except the State of Jammu and Kashmir” omitted by Act 19 of 1972, sec.2).
(3) It shall come into force at once; but Chapter-III shall take effect only from such date (Note: 1st April, 1947; see Notification No. F.28(10) (3) 45H(I), dated 2nd September, 1946, Gazette of India, 1946, Pt. I, p.1349. Chapter IV came into force in the State of Delhi, Ajmer and Coorg on 1st April, 1947, see Notification No. F.28(10) (3) 45H(I), Chapter III and IV came into force in the States of Himachal Pradesh, Bilaspur, Kutch, Bhopal, Tripura, Vindhya Pradesh and Manipur on 1st April, 1953, vide Notification No. S.R.O. 663, dated 30the March,1953, Gazette of India, Pt. II, Sec.3, p.451. Chapter IV came into force in the Union Territory of Dadra and Nagar Haveli w.e.f. 1st August, 1968, see. Notification No. ADM/Law/117 (74), dated 20th July, 1968, Gazette of India, Pt. III, Sec.3, p.128. The Act is extended to Dadra and Nagar Haveli by Reg. 6 of 1963, Sec.2 and Sch.I; to Pondicherry by Reg. 7 of 1963, sec.3 and Sch. I; to Goa, Daman and Diu by Reg.11 of 1963, sec.3 and Sch. and to Laccadive, Minicoy and Amindivi Islands by Reg. 8 of 1965, sec.3 and Sch.) as the Central Government may, by notification in the Official Gazette, appoint in this behalf, and Chapter IV shall take effect in a particular State only from such date as the State Government may, by like notification, appoint in this behalf :
[(Note: Added by Act 19 of 1972, sec.2) Provided that in relation to the State of Jammu and Kashmir, Chapter III shall take effect only from such date (Note: 24th August, 1974, vide. Notification No. S.O. 2185, dated 9th August, 1974, Gazette of India, 1974, Pt. II, Sec. 3(ii), p.2331) after the commencement of the Drugs and Cosmetics (Amendment) Act, 1972, as the central Government may, by notification in the Official Gazette, appoint in this behalf.]
2. Application of other laws not barred. – The provisions of this Act shall be in addition to, and not in derogation of, the Dangerous Drugs Act, 1930, and any other law for the time being in force.
THE PREVENTION OF FOOD ADULTERATION ACT, 1954
INTRODUCTION –
Food is one of the basic necessities for sustenance of life. Pure, fresh and healthy diet is most essential for the health of the people. It is no wonder to say that community health is national wealth.
Adulteration of food-stuffs was so rampant, widespread and persistent that nothing short of a somewhat drastic remedy in the form of a comprehensive legislation became the need of the hour. To check this kind of anti-social evil a concerted and determined onslaught was launched by the Government by introduction of the Prevention of Food Adulteration Bill in the Parliament to herald an era of much needed hope and relief for the consumers at large.
STATEMENT OF OBJECTS AND REASONs
Laws existed in a number of States in India for the prevention of adulteration of food- stuffs, but they lacked uniformity having been passed at different times without mutual consultation between States. The need for Central legislation for the whole country in this matter has been felt since 1937 when a Committee appointed by the Central Advisory Board of Health recommended this step. ‘Adulteration of food-stuffs and other goods’ is now included in the Concurrent List (III) in the Constitution of India. It has, therefore, become possible for the Central Government to enact an all India legislation on this subject. The Bill replaces all local food adulteration laws where they exist and also applies to those States where there are no local laws on the subject. Among others, it provides for —
(i) a Central Food Laboratory to which food samples can be referred to for final opinion in disputed cases (clause 4),
(ii) a Central Committee for Food Standards consisting of representatives of Central and State Governments to advise on matters arising from the administration of the Act (clause 3), and
(iii) the vesting in the Central Government of the rule-making power regarding standards of quality for the articles of food and certain other matters (clause 22).
ACT 37 OF 1954
The Prevention of Food Adulteration Bill was passed by both the house of Parliament and received the assent of the President on 29th September, 1954. It came into force on Ist June, 1955 as THE PREVENTION OF FOOD ADULTERATION ACT, 1954 (37 of 1954).
LIST OF ADAPTATION ORDER AND AMENDING ACTs
1. The Adaptation of Laws (No.3) Order, 1956.
2. The Prevention of Food Adulteration (Amendment) Act, 1964 (49 of 1964).
3. The Prevention of Food Adulteration (Amendment) Act, 1971 (41 of 1971).
4. The Prevention of Food Adulteration (Amendment) Act, 1976 (34 of 1976).
5. The Prevention of Food Adulteration (Amendment) Act, 1986 (70 of 1986).
Prevention of Food Adulteration Act, 1954
(37 OF 1954)
[29th September, 1954
An Act to make provision for the prevention of adulteration of food.
Be it enacted by Parliament in the Fifth Year of the Republic of India as follows: —
Short title, extent and commencement —
(1) This Act may be called the Prevention of Food Adulteration Act, 1954.
(2) It extends to the whole of India .
(3) It shall come into force on such date2 as the Central Government may, by notification in the Official Gazette, appoint.
2. Definitions —
In this Act unless the context otherwise requires,—
(i) “adulterant” means any material which is or could be employed for the purposes of adulteration;
(ia) “adulterated”—an article of food shall be deemed to be adulterated—
(a) if the article sold by a vendor is not of the nature, substance or quality demanded by the purchaser and is to his prejudice, or is not of the nature, substance or quality which it purports or is represented to be;
(b) if the article contains any other substance which affects, or if the article is so processed as to affect, injuriously the nature, substance or quality thereof;
(c) if any inferior or cheaper substance has been substituted wholly or in part for the article so as to affect injuriously the nature, substance or quality thereof;
(d) if any constituent of the article has been wholly or in part abstracted so as to affect injuriously the nature, substance or quality thereof ;
(e) if the article had been prepared, packed or kept under insanitary conditions whereby it has become contaminated or injurious to health;
(f) if the article consists wholly or in part of any filthy, putrid, , rotten, decomposed or diseased animal or vegetable substance or is insect-infested or is otherwise unfit for human consumption;
(g) if the article is obtained from a diseased animal;
(h) if the article contains any poisonous or other ingredient which renders it injurious to health;
(i) if the container of the article is composed, whether wholly or in part, of any poisonous or deleterious substance which renders its contents injurious to health;
(j) if any colouring matter other than that prescribed in respect thereof is present in the article, or if the amounts of the prescribed colouring matter which is present in the article are not within the prescribed limits of variability;
(k) if the article contains any prohibited preservative or permitted preservative in excess of the prescribed limits;
(l) if the quality or purity of the article falls below the prescribed standard or its constituents are present in quantities not within the prescribed limits of variability, but which renders it injurious to health;
(m) if the quality or purity of the article falls below the prescribed standard or its constituents are present in quantities not within the prescribed limits of variability but which does not render it injurious to health:
Provided that, where the quality or purity of the article, being primary food, has fallen below the prescribed standards or its constituents are present in quantities not within the prescribed limits of variability in either case, solely due to natural causes and beyond the control of human agency, then, such article shall not be deemed to be adulterated within the meaning of this sub-clause.
Explanation — Where two or more articles of primary food are mixed together and the resultant article of food—
(a) is stored, sold or distributed under a name which denotes the ingredients thereof; and
(b) is not injurious to health, then, such resultant article shall not be deemed to be adulterated within the meaning of this clause;
(ii) “Central Food Laboratory” means any laboratory or institute established or specified under section 4;
(iii) “Committee” means the Central Committee for Food Standards constituted under section 3;
(iv) “Director of the Central Food Laboratory” means the person appointed by the Central Government by notification in the Official Gazette as the Director of the Central Food Laboratory and includes any person appointed by the Central Government in like manner to perform all or any of the functions of the Director under this Act:
Provided that no person who has any financial interest in the manufacture, import or sale of any article of food shall be appointed to be a Director under this clause ;
(v) “food” means any article used as food or drink for human consumption other than drugs and water and includes—
(a) any article which ordinarily enters into, or is used in the composition or preparation of, human food,
(b) any flavouring matter or condiments, and
(c) any other article which the Central Government may, having regard to its use, nature, substance or quality, declare, by notification in the Official Gazette, as food for the purposes of this Act;
(vi) “Food (Health) Authority” means the Director of Medical and Health Services or the Chief Officer in-charge of Health administration in a State, by whatever designation he is known, and includes any officer empowered by the Central Government or the State Government, by notification in the Official Gazette, to exercise the powers and perform the duties of the Food (Health) Authority under this Act with respect to such local area as may be specified in the notification;
(vii) “local area” means any area, whether urban or rural, declared by the Central Government or the State Government by notification in the Official Gazette, to be a local area for the purposes of this Act;
(viii) “local authority” means in the case of :—
(1) a local area which is—
(a) a municipality, the municipal board or municipal corporation;
(b) a cantonment, the cantonment authority ;
(c) a notified area, the notified area committee;
(2) any other local area, such authority as may be prescribed by the Central Government or the State Government under this Act;
(viiia) “Local (Health) Authority”, in relation to a local area, means the officer appointed by the Central Government or the State Government, by notification in the Official Gazette, to be in-charge of Health administration in such area with such designation as may be specified therein:
(viiib) “manufacture” includes any process incidental or ancillary to the manufacture of an article of food;
(ix) “misbranded”— an article of food shall be deemed to be misbranded—
(a) if it is an imitation of, or is a substitute for, or resembles in a manner likely to deceive, another article of food under the name of which it is sold, and is not plainly and conspicuously labelled so as to indicate its true character;
(b) if it is falsely stated to be the product of any place or country;
(c) if it is sold by a name which belongs to another article of food;
(d) if it is so coloured, flavoured or coated, powdered or polished that the fact that the article is damaged is concealed or if the article is made to appear better or of greater value than it really is;
(e) if false claims are made for it upon the label or otherwise;
(f) if, when sold in packages which have been sealed or prepared by or at the instance of the manufacturer or producer and which bear his name and address, the contents of each package are not conspicuously and correctly stated on the outside thereof within the limits of variability prescribed under this Act;
(g) if the package containing it, or the label on the package bears any statement, design or device regarding the ingredients or the substances contained therein, which is false or misleading in any material particular; or if the package is otherwise deceptive with respect to its contents;
(h) if the package containing it or the label on the package bears the name of a fictitious individual or company as the manufacturer or producer of the article;
(i) if it purports to be, or is represented as being, for special dietary uses, unless its label bears such information as may be prescribed concerning its vitamin, mineral, or other dietary properties in order sufficiently to inform its purchaser as to its value for such uses;
(j) if it contains any artificial flavouring, artificial colouring or chemical preservative, without a declaratory label stating that fact, or in contravention of the requirements of this Act or rules made thereunder;
(k) if it is not labelled in accordance with the requirements of this Act or rules made thereunder;
(x) “package” means a box, bottle, casket, tin, barrel, case, receptacle, sack, bag, wrapper or other thing in which an article of food is placed or packed;
(xi) “premises” include any shop, stall, or place where any article of food is sold or manufactured or stored for sale;
(xii) “prescribed” means prescribed by rules made under this Act;
(xiia) “primary food” means any article of food, being a produce of agriculture or horticulture in its natural form;
(xiii) “sale” with its grammatical variations and cognate expressions, means the sale of any article of food, whether for cash or on credit or by way of exchange and whether by wholesale or retail, for human consumption or use, or for analysis, and includes an agreement for sale, an offer for sale, the exposing for sale or having in possession for sale of any such article, and includes also an attempt to sell any such article;
(xiv) “sample” means a sample of any article of food taken under the provisions of this Act or of any rules made thereunder;
(xv) the word “unwholesome” and “noxious” when used in relation to an article of food mean respectively that the article is harmful to health or repugnant to human use.
COMMENTS
(i) Even mere addition of salt to chili powder makes it injurious to health as it was still considered adulterated within the meaning of sub-clause (m) of clause (ia) of section 2 of the Act on the ground that the quantity and purity of the article falls below the prescribed standard ; Gauranga Aich v. State of Assam, 1990 (2) FAC 41.
(ii) Liquor (including country liquor) is an article used as a drink and is meant for human consumption and for the purposes of the Prevention of Food Adulteration Act, 1954 is included in the definition of “food” under clause (v) of section 2; State of Himachal Pradesh v. Raja Ram, 1990 (2) FAC 231.
2A. Rule of construction —
Any reference in this Act to a law which is not in force in the State of Jammu and Kashmir shall, in relation to that State, be construed as a reference to the corresponding law, if any, in force in that State.
Narcotic Drugs and Psychotropic Substances Act 1985
Act No. 61 of 1985
[16th September, 1985.]
An Act to consolidate and amend the law relating to narcotic drugs, to make stringent provisions for the control and regulation of operations relating to narcotic drugs and psychotropic substances 1*[ to provide for the forfeiture of property derived from, or used in, illicit traffic in narcotic drugs and psychotropic substances, to implement the provisions of the International Conventions on Narcotic Drugs and Psychotropic Substances].and for matters connected therewith.
BE it enacted by Parliament in the Thirty-sixty Year of the Republic of India as follows –
CHAPTER I – PRELIMINARY
1. Short title, extent and commencement.
(1) This Act may be called the Narcotic Drugs and Psychotropic Substances Act, 1985.
(2) It extends to the whole of India.
(3) It shall come into force on such date 2* as the Central Government may, by notification in the Official Gazette, appoint, and different dates may be appointed for different provisions of this Act and for different States and any reference in any such provision to the commencement of this Act shall be construed in relation to any State as a reference to the coming into force of that provision in that State.
2. Definitions. In this Act, unless the context otherwise requires
(i) “addict” means a person addicted to any narcotic drug or psychotropic substance;
(ii) “Board” means the Central Board of Excise and Customs constituted under the Central Boards of Revenue Act, 1963 (54 of 1963),
(iii) “cannabis (hemp)” means –
(a) charas, that is, the separated resin, in whatever form, whether crude or purified, obtained from the cannabis plant and also includes concentrated preparation and resin known as hashish oil or liquid hashish;
(b) ganja, that is, the flowering or fruiting tops of the cannabis plant (excluding the seeds and leaves when not accompanied by the tops), by whatever name they may be known or designated; and
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1. Ins. by Act 2 of 1989, s. 2 (w.e.f. 29.5.1989).
2. This Act came in to force in the whole of India on 14-11-1985: Vide Notification No. S.O. 821 (E) dated, 14-11-1985, Gazette of India, Extraordinary, 1985, Part II, Section-3 (ii).
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(c) any mixture, with or without any neutral material, of any of the above forms of cannabis or any drink prepared there from;
(iv) “cannabis plant” means any plant of the genus cannabis;
(v) “coca derivative” means –
(a) crude cocaine, that is, any extract of coca leaf which can be used, directly or indirectly, for the manufacture of cocaine;
(b) ecgonine and all the derivatives of ecgonine from which it can be recovered;
(c) cocaine, that is, methyl ester of benzoyl-ecgonine and its salts; and
(d) all preparations containing more than 0.1 per cent. of cocaine;
(vi) “coca leaf” means –
(a) the leaf of the coca plant except a leaf from which all ecgonine, cocaine and any other ecgonine alkaloids have been removed;
(b) any mixture thereof with or without any neutral material, out does not include any preparation containing not more than 0.1 per cent. of cocaine;
(vii) “coca plant” means the plant of any species of the genus Frythroxylon;
1*(i) “controlled substance” means any substance which the Central Government may, having regard to the available information as to its possible use in the production or manufacture of narcotic drugs or psychotropic substances or to the provisions of any International Convention, by notification in the Official Gazette, declare to be a controlled substance,
(viii) “conveyance” means a conveyance of any description whatsoever and includes any aircraft, vehicle or vessel;
1*(a) “illicit traffic”, in relation to narcotic drugs and psychotropic substances, means –
cultivating any coca plant or gathering any portion of caca plant;
cultivating the opium poppy or any cannabis plant;
engaging in the production, manufacture, possession, sale, purchase, transportation, warehousing, concealment, use or consumption, import inter-State, export inter-State, import into India, export from India or transshipment, of narcotic drugs or psychotropic substances;
dealing in any activities in narcotic drugs or psychotropic substances other than those referred to in sub-clauses (i) to (ii); or
handling or letting out any premises for the carrying on of any of the activities referred to in sub-clauses (i) to (iv), other than those permitted under this Act, or any rule or order made, or any condition of any license, term or authorization issued, there under, and includes –
(1) financing, directly or indirectly, any of the aforementioned activities;
(2) abetting or conspiring in the furtherance of or in support of doing any of the aforementioned activities; and
(3) harboring persons engaged in any of the aforementioned activities;
(ix) “International Convention” means –
(a) the Single Convention on Narcotic Drugs, 1961 adopted by the United Nations Conference at New York in March, 1961;
(b) the Protocol, amending the Convention mentioned in sub-clause (a), adopted by the United Nations Conference at Geneva in March, 1972;
(c) the Convention on Psychotropic Substances, 1971 adopted by the United Nations Conference at Vienna in February, 1971; and
(d) any other international convention, or protocol or other instrument amending an international convention, relating to narcotic drugs or psychotropic substances which may be ratified or acceded to by India after the commencement of this Act;
(x) “manufacture”, in relation to narcotic drugs or psychotropic substances, includes –
(1) all processes other than production by which such drugs or substances may be obtained;
(2) refining of such drugs or substances;
(3) transformation of such drugs or substances; and
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1. Ins. by Act 2 of 1989, s. 3 (w.e.f. 29-5-1989.
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(4) making of preparation (otherwise than in a pharmacy on prescription) with or containing such drugs or substances;
(xi) “manufactured drug” means –
(a) all coca derivatives, medicinal cannabis, opium derivatives and poppy straw concentrate;
(b) any other narcotic substance or preparation which the Central Government may, having regard to the available information as to its nature or to a decision, if any, under any International Convention, by notification in the Official Gazette, declare not to be a manufactured drug;
(xii) “medicinal cannabis”, that is, medicinal hemp, means any extract or tincture of cannabis (hemp);
(xiii) “Narcotics Commissioner” means the Narcotics Commissioner appointed under section 5;
(xiv) “narcotic drug” means coca leaf, cannabis (hemp), opium, popy straw and includes all manufactured drugs;
(xv) “opium” means –
(a) the coagulated juice of the opium poppy; and
(b) any mixture, with or without any neutral material, of the coagulated juice of the opium poppy, but does not include any preparation containing not more than 0.2 per cent. of morphine;
(xvi) “opium derivative” means –
(a) medicinal opium, that is, opium which has undergone the processes necessary to adapt it for medicinal use in accordance with the requirements of the Indian Pharmacopoeia or any other pharmacopoeia notified in this behalf by the Central Government, whether in powder form or granulated or otherwise or mixed with neutral materials;
(b) prepared opium, that is, any product of opium obtained by any series of operations designed to transform opium into an extract suitable for smoking and the dross or other residue remaining after opium is smoked;
(c) phenanthrene alkaloids, namely, morphine, codeine, thebaine and their salts;
(d) diacetylmorphine, that is, the alkaloid also known as diamorphine or heroin and its salts; and
(e) all preparations containing more than 0.2 per cent. of morphine or containing any diacetylmorphine;
(xvii) “opium poppy” means –
(a) the plant of the species Papaver somniferum L; and
(b) the plant of any other species of Papaver from which opium or any phenanthrene alkaloid can be extracted and which the Central Government may, by notification in the Official Gazette, declare to be opium poppy for the purposes of this Act;
(xviii) “poppy straw” means all parts (except the seeds) of the opium poppy after harvesting whether in their original form or cut, crushed or powdered and whether or not juice has been extracted therefrom;
(xix) “poppy straw concentrate” means the material arising when poppy straw has entered into a process for the concentration of its alkaloids;
(xx) “preparation”, in relation to a narcotic drug or psychotropic substance, means any one or more such drugs or substances in dosage form or any solution or mixture, in whatever physical state, containing one or more such drugs or substances;
(xxi) “Prescribed” means prescribed by rules made under this Act;
(xxii) “production” means separation of opium, poppy straw, coca leaves or cannabis from the plants from which they are obtained;
(xxiii) “Psychotropic substance” means any substance, natural or synthetic, or any natural material or any salt or preparation of such substance or material included in the list of psychotropic substances specified in the Schedule;
(xxiv) “to import inter-State” means to bring into a State or Union territory in India from another State or Union territory in India;
(xxv) “to import into India”, with its grammatical variations and cognate expressions, means to bring into India from a place outside India and includes the bringing into any port or airport or place in India of a narcotic drug or a psychotropic substance intended to be taken out of India without being removed from the vessel, aircraft, vehicle or any other conveyance in which it is being carried.
Explanation.–For the purposes of this clause and clause (xxvi), “India” includes the territorial waters of India;
(xxvi) “to export from India”, with its grammatical variations and cognate expressions, means to take out of India to a place outside India;
(xxvii) “to export inter-State” means to take out of a State or Union territory in India to another State or Union territory in India;
(xxviii) “to transport” means to take from one place to another within the same State or Union territory;
(xxviia) “use” in relation to narcotic drugs and psychotropic substances, means any kind of use except personal consumption;
(xxix) Words and expressions used herein and not defined but defined in the Code of Criminal Procedure, 1973 (2 of 1973) have the meanings respectively assigned to them in that Code.
Explanation. –For the purposes of clauses (v), (vi), (xv) and (xvi) the percentages in the case of liquid preparations shall be calculated on the basis that a preparation containing one per cent. of a substance means a preparation in which one gram of substance, if solid, or one mililitre of substance, if liquid, is contained in every one hundred mililitre of the preparation and so on in proportion for any greater or less percentage :
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1. Ins. by Act 2 of 1989, s. 3 (w.e.f. 29-5-1989).
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Provided that the Central Government may, having regard to the developments in the field of methods of calculating percentages in liquid preparations prescribe, by rules, any other basis which it may deem appropriate for such calculation.
3. Power to add to or omit from the list of psychotropic substances.
The Central Government may, if satisfied that it is necessary or expedient so to do on the basis of–
(a) the information and evidence which has become available to it with respect to the nature and effects of, and the abuse or the scope for abuse of, any substance (natural or synthetic) or natural material or any salt or preparation of such substance or material; and
(b) the modifications or provisions (if any) which have been made to, or in, any International Convention with respect to such substance, natural material or salt or preparation of such substance or material, by notification in the Official Gazette, add to, or, as the case may be, omit from, the list of psychotropic substances specified in the Schedule such substance or natural material or salt or preparation of such substance or material.
Maternity Benefit Act, 1961
(53 of 1961)
[12th December, 1961]
INTRODUCTION
The object of maternity leave and benefit is to protect the dignity of motherhood by providing for the full and healthy maintenance of women and her child when she is not working. With the advent of modern age, as the number of women employees is growing, the maternity leave and other maternity benefits are becoming increasingly common. But there was no beneficial piece of legislation in the horizen which is intended to achieve the object of doing social justice to women workers employed in factories, mines and plantation.
ACT 53 OF 1961
With the object of providing maternity leave and benefit to women employee the Maternity Benefit Bill was passed by both the Houses of Parliament and subsequently it received the assent of President on 12th December, 1961 to become an Act under short title and numbers “THE MATERNITY BENEFIT ACT, 1961 (53 OF 1961)”.
An Act to regulate the employment of women in certain establishments for certain period before and after child-birth and to provide for maternity benefit and certain other benefits.
BE it enacted by Parliament in the Twelfth Year of the Republic of India as follows:-
1. Short title, extent and commencement.-
(1) This Act may be called the Maternity Benefit Act, 1961.
(2) It extends to the whole of India 1[* * *].
(3) It shall come into force on such date 2 as may be notified in this behalf in the Official Gazette,-
3[(a) in relation to mines and to any other establishment wherein persons are employed for the exhibition of equestrian, acrobatic and other performances, by the Central Government; and]
(b) in relation to other establishments in a State, by the State Government.
2. Application of Act.-4[(1) It applies, in the first instance,-
(a) to every establishment being a factory, mine or plantation including any such establishment belonging to Government and to every establishment wherein persons are employed for the exhibition of equestrian, acrobatic and other performances;
(b) to every shop or establishment within the meaning of any law for the time being in force in relation to shops and establishments in a State, in which ten or more persons are employed, or were employed, on any day of the preceding twelve months:]
Provided that the State Government may, with the approval of the Central Government, after giving not less than two month’s notice of its intention of so doing, by notification in the Official Gazette, declare that all or any of the provisions of this Act shall apply also to any other establishment or class of establishments, industrial, commercial, agricultural or otherwise.
(2) 5[Save as otherwise provided in 6[sections 5A and 5B] nothing contained in this Act] shall apply to any factory or other establishment to which the provisions of the Employees, State Insurance Act, 1948 (34 of 1948), apply for the time being.
COMMENTS
The word establishment has a wide meaning and it generally denotes a shop, a commercial organisation or a public institution, provided that they are not specifically exempted by the appropriate government from the applicability of the Act; Thomas Eapen v. Assistant Labour Officer, 1993 LLR 800 (Ker).
1st November, 1963: vide Notification No. S.O. 2920, dated 5th October, 1963, Gazette of India, Pt.II, sec. 3, page 3735.
Subs. by Act 52 of 1973, sec.2 (w.e.f. 1-3-1975).
Subs. by Act 61 of 1988 sec.2 (w.e.f. 10-1-1989).
Subs. by Act 53 of 1976, sec.2 (w.e.f. 1-5-1976).
Insecticides Act, 1968
[46 of 1968, Dt. 2-9-1968]
An Act to regulate the import, manufacture, sale, transport, distribution and use of insecticides with a view to prevent risk to human beings or animals, and for matters connected therewith.
Be it enacted by parliament in the nineteenth year of the republic of India as follows :-
1. Short title, extent and commencement
a. This Act may be called the Insecticide Act, 1968.
b. It extends to the whole of India.
c. It shall come into force on such date as the central Government may, by notification in the Official Gazette, appoint and different dates may be appointed for different states and for different provision of this Act.
2. Application of other laws not barred
The provisions of this Act shall be in addition to, and not in derogation of, any other law for the time being in force.
3. Definitions
In this Act, unless the context otherwise requires,
a. “animals” means animals useful to human beings and include fish and fowl, and such kinds of wild life as the Central Government may, by notification in the Official Gazette, specify, being kinds which in its opinion, it is desirable to protect or preserve;
b. “Board” means the Central Insecticide Board constituted under section 4;
c. “Central Insecticide Laboratory” means the Central Insecticide Laboratory established, or as the case may be, the institution specified under section 16;
d. “Import” means bringing into any place within the territories to which this Act extends from a place outside those territories;
e. “insecticides” means:
i. any substance specified in the Schedule; or
ii. such other substances (including fungicides and weedicides) as the Central Government may, after consultation with the Board, by notification in the Official Gazette, include in the schedule from time to time; or
iii. any preparation containing any one or more of such substances;
f. “Insecticide Analyst” means an Insecticide Analyst appointed under section 19.
g. “Insecticide Inspector” means an Insecticide Inspector appointed under section 20;
h. “label” means any written, printed or graphic matter on the immediate package and on every other covering in which the package is placed or packed and includes any written, printed or graphics matter accompanying the insecticides;
i. “licensing officer” means a licensing officer appointed under section 12;
j. “manufacture” in relation to any insecticide, include:
i. any process or part of a process for making, altering, finishing, packing, labelling, breaking up or otherwise treating or adopting any insecticides with a view to its sale, distribution or use but does not include the packing or breaking up for any insecticides in the ordinary course of retail business; and
ii. any process by which a preparation containing an insecticide is formulated;
k. “misbranded” – an insecticide shall be deemed to be misbranded-
i. if its label contains any statement, design or graphic representation relating thereto which is false or misleading in any material particular, or if its package is otherwise deceptive in respect of its contents; or
ii. if it is an imitation of, or is sold under the name of, another insecticide; or
iii. if its label does not contain a warning or caution which may be necessary and sufficient, if complied with to prevent risk to human beings or animals;
iv. if any word, statement or other information required by or under this Act to appear on the label not displayed thereon such conspicuous manner as the other words, statements, design or graphic matter have been displayed on the label and such terms as to render it likely to be read and understood by any ordinary individual under customary conditions of purchase and use; or
v. if it is not packed or labelled as required by or under this Act, or
vi. if it is not registered in the manner required by or under this Act; or
vii. if the label contains any reference to registration other than the registration number; or
viii. if the insecticide has a toxicity which is higher than the level prescribe or is mixed or packed with any substance so as to alter its nature or quality or contains any substance which is not include in the registration;
l. “package” means a box, bottle, casket, tin, barrel, case, receptacle, sack, bag, wrapper, or thing in which an insecticide is placed or packed;
m. “premises” means any land, shop, stall or place where any insecticide is sold or manufactured or stored or used, and include any vehicle carrying insecticides;
n. “prescribed” means prescribe by rules made under this Act;
o. “register” with its grammatical variations and cognate expressions, means register under this Act;
p. “sale” with its grammatical variations and cognate expressions, means the sale of any insecticide whether for cash or on credit and whether by wholesale or retail, and includes an agreement for sale, an offer for sale, the exposing for sale or having in possession for sale of any insecticide and include also an attempt to sell any such insecticide;
q. “State Government” in relation to a Union Territory, means the administrator thereof;
r. “worker” means a person employed under a contract of service or apprenticeship.
1. the garden, grounds and out-houses, if any appertaining to such building or part of a building, and
2. any fittings fixed to such building or part of a building for the more beneficial enjoyment thereof. Public premises (eviction of unauthorized accupants) act, 1971, s. 2 (c).
Rehabilitation Council Act of India Act 1992
No. 34 of 1992
(1st September, 1992)
An Act to provide for the constitution of Rehabilitation Council of India for regulating the training of rehabilitation professionals and the maintenance of a Central Rehabilitation Register and for Matters connected therewith or incidental thereto.
Be it enacted by Parliament in the Forty-third Year of the Republic of India as follows:-
CHAPTER I – Preliminary
Short title and Commencement
This Act may be called the Rehabilitation Council of India Act,1992 It shall come into force on such date as the Central Government may, by notification in the Official Gazette, appoint.
Definition
In this Act, unless the context otherwise requires,-
1. “Chairperson” means the Chairperson of the Council appointed under sub-section (3) section 3;
2. “Council” means the Rehabilitation Council of India constituted under section 3;
3. “handicapped” means a person-
* visually handicapped;
* hearing handicapped ;
* suffering from locomotor disability; or
* suffering from mental retardation;
4. “hearing handicapped” means with hearing impairment of 70 decibels and above, in better ear or total loss of hearing in both ears;
5. “locomotor disability” means a person’s inability to execute distinctive activities associated with moving, both himself and objects from place to place and such inability resulting from affliction of either bones joints muscles or nerves;
6. “member” means a member appointed under sub-section (3) of section 3 and includes the Chairperson;
7. “Member-Secretary” means the Member-Secretary appointed under sub-section (1) of section 8;
8. “mental retardation” means a condition of arrested or incomplete development of mind of person which is specially characterized by sub-normality of intelligence;
9. “notification means” a notification published in the Official Gazette;
10. “prescribed” means prescribed by regulation;
11. “recognized rehabilitation qualifications” means any of the qualifications included in the Schedule;
12. “Register” means the Central Rehabilitation Register maintained under sub-section (1) of section 23;
13. “regulation” means regulation made under the Act; “rehabilitation professional” means-
1. audiologists and speech therapists; clinical psychologists;
2. hearing aid and ear mould technicians;
3. rehabilitation engineers and technicians;
4. special teachers for educating and training the handicapped;
5. vocational counselors, employment officers and placement officers dealing with handicapped;
6. multi-purpose rehabilitation therapists, technicians; or
7. such other category of professionals as the Central Government may, in consultation with the Council, notify from time to time;
14. “visually handicapped” means a persons who suffers from any of the following conditions namely –
1. total absence of sight;
2. visual acquity not exceeding 6/60 or 20/200(snellen) in the better eye with the correcting lenses; or
3. limitation of the field of vision subtending and angle of degree or worse.
Any reference in this Act to any enactment or any provision thereof shall, in relation to an area in which such enactment or such provision is not in force, be construed as a reference to the corresponding law or the relevant provision of the corresponding law is any in force is that area.
The Pre-Natal Diagnostic Techniques (PNDT) Act & Rules
Introduction
The Pre-natal Diagnostic Techniques (Regulation and Prevention of Misuse) Act, 1994, was enacted and brought into operation from 1st January, 1996, in order to check female foeticide. Rules have also been framed under the Act. The Act prohibits determination and disclosure of the sex of foetus . It also prohibits any advertisements relating to pre-natal determination of sex and prescribes punishment for its contravention. The person who contravenes the provisions of this Act is punishable with imprisonment and fine.
Recently, PNDT Act and Rules have been amended keeping in view the emerging technologies for selection of sex before and after conception and problems faced in the working of implementation of the ACT and certain directions of Hon’ble Supreme Court after a PIL was filed in May, 2000 by CEHAT and Ors, an NGO on slow implementation of the Act. These amendments have come into operation with effect from 14th February, 2003
The PNDT (PRINCIPAL) ACT 1994
The PNDT (PRINCIPAL) RULES 1996
The PNDT Advisory Committee Rules, 1996
The PNDT Amendment Act, 2002
The PNDT Amendment Rule, 2003
Pre-Natal Diagnostic Techniques (Regulation and Prevention of Misuse) Rules, 1996
Short title and commencement.-
(1) These rules may be called the Pre-natal Diagnostic Techniques (Regulation and Prevention of Misuse) Rules, 1996.
(2) They shall come into force on the date of their publication in the Official Gazette.
1. Definitions.- In these rules, unless the context otherwise requires:-
(a) “Act” means The Pre-natal Diagnostic Techniques (Regulation and Prevention of Misuse) Act, 1994 (57 of 1994);
(b) “employee” means a person working in or employed by a Genetic Counselling Centre, a Genetic Laboratory or a Genetic Clinic, and includes those working on part-time, contractual, consultancy, honorary or on any other basis;
(c) “Form” means a Form appended to these rules;
(d) “Schedule” means a Schedule appended to these rules;
(e) “Section” means a section of the Act;
(f) words and expressions used herein and not defined in these rules but defined in the Act, shall have the meanings, respectively, assigned to them in the Act.
Medical Termination of Pregnancy ACT, 1971
(Act No. 34 of 1971)
(10th August 1971)
An Act to provide for the termination of certain pregnancies by registered Medical Practitioners and for matters connected therewith or incidental thereto.
Be it enacted by Parliament in the Twenty-second Year of the Republic of India as follows :-
Short title, extent and commencement –
(1)This Act may be called the Medical Termination of Pregnancy Act, 1971.
(2)It extends to the whole of India except the State of Jammu and Kashmir.
(3)It shall come into force on such date as the Central Government may, by notification in the Official Gazette, appoint.
