Healthcare

1. Chanderprabhu Jain College of Higher Studies & School of Law
Plot No. OCF, Sector A-8, Narela, New Delhi – 110040
(Affiliated to Guru Gobind Singh Indraprastha University and Approved by Govt of NCT of Delhi & Bar Council of India)
SEMESTER: 9th SEMESTER
BA LLB/ BBA LLB
NAME OF THE SUBJECT:HEALTH CARE LAWS
UNIT-2
PROFESSIONAL OBLIGATIONS OF DOCTORS
FACULTY NAME: Mr. Mukul Sharma
Assistant Professor (Law)

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TRANSPLANTATION OF HUMANS ORGAN ACT
•The legislation called the Transplantation of Human Organ Act (THO) was
passed in India in 1994 to streamline organ donation and transplantation
activities.
•Broadly, the act accepted brain death as a form of death and made the sale of
organs a punishable offence. With the acceptance of brain death, it became
possible to not only undertake kidney transplantations but also start other solid
organ transplants like liver, heart, lungs, and pancreas.
•Despite the THO legislation, organ commerce and kidney scandals are
regularly reported in the Indian media.

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Kidney transplants in India first started in the 1970s and since that time,
India has been a leading country in this field on the Asian sub-continent.
The evolutionary history of transplants in the last four decades has
witnessed a different facet of transplant emerging in each decade.
The first 10 years were spent mastering the surgical techniques and
immune-suppression.
Its success resulted in a phenomenal rise in the numbers of transplants in
the next 10 years and unrelated kidney donation from economically weaker
sections started taking place with commerce in organ donation becoming
an acceptable integral part of the program.
After this was accepted, the ethics of transplants in India has always been
on a slippery slope and all kinds of nefarious activities were accepted as
normal practice.

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•The general dictum was “when you can buy one why donate?” The next
10 years saw an outcry from the physicians of the western world at the
growing numbers of these exploitative transplants being done in India.
•There were also protests from many sections in India. The pressure on the
Government saw the passing of the Transplantation of Human Organ Act
(THO) legislation that made unrelated transplants illegal and deceased
donation a legal option with the acceptance of brain death.
•Overcoming organ shortage by tapping into the pool of brain-dead
patients was expected to curb the unrelated transplant activity.

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For living donation - it defines who can donate without any legal formalities.
The relatives who are allowed to donate include mother, father, brothers, sisters,
son, daughter, and spouse. Recently, in the new Gazette grandparents have been
included in the list of first relatives. The first relatives are required to provide
proof of their relationship by genetic testing and/or by legal documents. In the
event of there being no first relatives, the recipient and donor are required to
seek special permission from the government appointed authorization committee
and appear for an interview in front of the committee to prove that the motive of
donation is purely out of altruism or affection for the recipient.
Brain-death and its declaration - brain death is defined by the following
criteria: two certifications are required 6 hours apart from doctors and two of
these have to be doctors nominated by the appropriate authority of the
government with one of the two being an expert in the field of neurology.

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•Regulation of transplant activities by forming an Authorization Committee
(AC) and Appropriate Authority (AA.) in each State or Union Territory. Each
has a defined role as follows:
•Role of Authorization Committee (AC) - The purpose of this body is to
regulate the process of authorization to approve or reject transplants between
the recipient and donors other than a first relative. The primary duty of the
committee is to ensure that the donor is not being exploited for monetary
consideration to donate their organ.
•The joint application made by the recipient and donor is scrutinized and a
personal interview is essential to satisfy to the AC the genuine motive of
donation and to ensure that the donor understands the potential risks of the
surgery. Information about approval or rejection is sent by mail to the
concerned hospitals. The decision to accept or reject a donor is governed by
Sub Clause (3), Clause 9 of Chapter II of the THO act.

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Role of Appropriate Authority (AA):
•The purpose of this body is to regulate the removal, storage, and
transplantation of human organs.
•A hospital is permitted to perform such activities only after being licensed
by the authority. The removal of eyes from a dead body of a donor is not
governed by such an authority and can be done at other premises and does
not require any licensing procedure.
•The powers of the AA include inspecting and granting registration to the
hospitals for transplant surgery, enforcing the required standards for
hospitals, conducting regular inspections of the hospitals to examine the
quality of transplantation.

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•Follow-up medical care of donors and recipients, suspending or canceling the
registrations or erring hospitals, and conducting investigations into complaints
for breach of any provisions of the Act.
•The AA issues a license to a hospital for a period of 5 years at a time and can
renew the license after that period. Each organ requires a separate license.

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PRE-CONCEPTION AND PRE-NATAL
DIAGNOSTIC TECHNIQUES ACT, 1994.
•The strong law against female foeticide was enacted and suitably amended.
Over a decade has passed but results are unsatisfactory. Where lies the fault
in the law, its provisions, principles or expectations. Along these questions,
the Act has been analytically studied hereunder.
•Female foeticide is the beginning of the suffering of a woman in the course
of her Long suffering from womb to the tomb. It is a paradox that on the
one hand the Indian culture and tradition consider womanhood as sacred
and sacrosanct and on the other hand Indian women are killed in the
mother’s womb.

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Prohibitory Provisions:
Prohibitory provisions of the Act are contained in 4 Sections.
•First of all there is an express prohibition on the genetic clinics and
counseling centers etc. that they cannot employ not possess the
qualifications prescribed for the same as per the Act.
•No Genetic Counselling Centre or Genetic Laboratory or Genetic 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
qualifications as may be prescribed;

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•The central government and the state governments can appoint
Appropriate Authorities for the Union Territories which investigate the
breaches of this Act, they are the ones which provide the registration
certificates to the genetic lab centres etc.
•Regarding the registration of genetic counseling centre, genetic
laboratory and genetic clinic, an application shall be made to the
appropriate authority, in duplicate in Form A.

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•No medical geneticist, gynaecologist, paediatrician, registered medical
practitioner or any other person shall conduct or cause to be conducted or
aid in conducting by himself or through any other person, any pre-natal
diagnostic techniques at a place other than a place registered under this
Act.
•No person, organization, Genetic Counselling Centre, Genetic Laboratory
or Genetic Clinic, including clinic, laboratory or centre having ultrasound
machine or imaging machine or scanner or any other technology capable of
undertaking determination of sex of foetus or sex selection shall issue,
publish, distribute, communicate or cause to be issued, published,
distributed or communicated any advertisement, in any form, including
Internet, regarding facilities of pre-natal determination of sex or sex
selection before conception available at such centre, laboratory, clinic or at
any other place.

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Preventive-provisions:
•There are 6 provisions in the Act which are preventive in nature. They seek
to prevent the hostile actions of the medical professionals as well as the
society.
•No Genetic Counseling Centre, Genetic Laboratory or Genetic clinic shall
conduct any sex determination test, nor in any manner may disclose the sex
or help the people in sex selection in any manner.
•The private clinicians are prohibited under the Act, the government has
become stringent so the tests have become very experience. With the cameras
recording has rendered these tests very secretive, but the flouters have their
own methods of violating the law.

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Regulatory Provisions:
•As far as this Act is concerned there are 27 regulatory provisions in it.
•Under Section 4 of the Act it is said that the ultra sound tests may be
conducted only for specified purposes.
•A complete record of the ultra sound test has to be kept by the hospital
concerned otherwise it would be assumed that sex determination was carried
out.
•Form G has to be filled by the woman undergoing ultrasound wherein she
has to declare that she is undergoing the test.

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•Section 7 talks about a Central Supervisory Board for conducting various
functions under this Act.
•Sections 8-16 talk about the conditions of its members’ services, their
meetings and the facts about their vacancies, their functions etc.
•Every certificate of registration shall be valid for a period of five years from
the date of its issue.
•The certificate of registration is liable to be cancelled if the Appropriate
Authority feels it is essential in public interest.
•The offences under this Act are cognizable, non-compoundable and non-
bailable.
•Under this Act if the complaint is made by the Appropriate Authority, a
person or a social organization may take an action under the Act but they have
to give a notice to the Appropriate Authority.

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International Code of Medical Ethics
The International Code of Medical Ethics was adopted by the General
Assembly of the World Medical Association at London in 1949, amended in
1968, 1983 and 2006. It is a code based on the Declaration of Geneva and
the main goal is to establish the ethical principles of the physicians
worldwide, based on his duties in general, to his patients and to his
colleagues.
After the approval of the Declaration of Geneva, the II General Assembly of
the World Medical Association analyzed a report on "War Crimes and
Medicine". This prompted the WMA Council to appoint another Study
Committee to prepare an International Code of Medical Ethics, which after
an extensive discussion, was adopted in 1949 by the III General Assembly.

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The Declaration of Geneva was adopted by the General Assembly of
the World Medical Association at Geneva in 1948, amended in 1968, 1983,
1994, editorially revised in 2005 and 2006 and amended in 2017.
It is a declaration of a physician's dedication to the humanitarian goals
of medicine, a declaration that was especially important in view of the
medical crimes which had just been committed in German-occupied Europe.
The Declaration of Geneva was intended as a revision of the Hippocratic
Oath to a formulation of that oath's moral truths that could be comprehended
and acknowledged in a modern way. Unlike the case of the Oath of
Hippocrates, the World Medical Association calls the statement a "pledge".

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INDIAN MEDICAL CENTRAL COUNCIL ACT,
1970
THE CENTRAL CONCIL AND ITS COMMITTEES
Constitution of Central Council The Central Government shall, by notification
in the Official Gazette constitute for the purposes of this Act a Central Council
consisting of the following members, namely:-
(a) such number of members not exceeding five as may be determined by the
Central Government in accordance with the provisions of the First Schedule
for each of the Ayurveda, Siddha and Unani systems of medicine from each
State in which a State Register of Indian Medicine is maintained, to be elected
from amongst themselves by persons enrolled on that Register as practitioners
of Ayurveda, Siddha or Unani, as the case may be.

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(b) one member for each of the Ayurveda, Siddha and Unani systems
of medicine from each University to be elected from amongst
themselves by the members of the Faculty or Department (by
whatever name called) of the respective system of medicine of that
University;
(c) such number of members, not exceeding thirty per cent of the total
number of members elected under clauses (a) and (b), as may be
nominated by the Central Government, from amongst persons having
special knowledge or practical experience in respect of Indian
medicine

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DENTIST ACT, 1948
•The Dental Council of India was incorporated under The Dentists Act,
1948 to regulate dental education and the profession throughout India.
•It is financed by the Ministry of Health and Family Welfare and through the
local state dental councils. The Dental Council of India is constituted by an
act of parliament ‘The Dentists Act 1948’ with a view to regulate the dental
education, dental profession and dental ethics thereto-which came into
existence in March, 1949.
•The Council is composed of 6 constituencies representing Central
Government, State Government, Universities, Dental Colleges, Medical
Council of India and the Private Practitioners of Dentistry.

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•The Director-General of Health Services is Ex-Officio Member – both of the
Executive Committee and General Body. The Council elects from themselves
the President, Vice-President and the members of the Executive Committee.
•The elected President and the Vice-President are the Ex-Officio Chairman and
Vice Chairman of the Executive Committee.
•The Executive Committee is the governing body of this organisation, which
deals with all procedural, financial and day-to-day activities and affairs of the
Council.

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The Council is financed mainly by grants from the Govt. of India, Ministry of
Health & Family Welfare (Department of Health) though the other source of
income of the Council are:
•the 1/4th share of fees realized every year by various State Dental Councils
under section 53 of the Dentists Act,
•Inspection fee from the various Dental Institution for Inspecting under Section
15 of the Dentists Act, 1948 and
•application fee from the organization to apply for permission to set up new
Dental College, opening of higher Courses of study and increase of admission
capacity in Dental Colleges under section 10A of the Dentists Act, 1948 as
amended by the Dentists (Amendment) Act, 1993.

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The Homeopathy Central Council Act, 1973
The Central Council of Homoeopathy Act 1973, (Act 59), also called
the Homoeopathy Central Council Act, 1973, is an Act of the Parliament of
India to primarily structure the role of the Central Council of Homoeopathy and
to enable the regularization of the maintenance of a central register of issues and
entities related to the field of homoeopathy.
It included five chapters when it was initially passed.
The Act was amended in 2002, and the amendment—Homoeopathy Central
Council Amendment Act, 2002 (No. 51 of 2002)—was passed in December
2002.

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Central Council of Homeopathy is a statutory apex body under the Ministry
of AYUSH, Government of India. It was set up by the Government of
India in 1973, and is one of the Professional Councils of University Grants
Commission, formed to monitor higher education in India.
Any institution desiring to grant a qualification in homeopathy is required to
apply to the Council, which prescribes course curriculum and maintains
central registers of homeopaths The institution set up under the Central
Council of Homeopathy Act 1973.
Any university or similar institution in India offering either a degree or a
diploma in homeopathy can do so only if it is approved by CCH, apart from
being listed under the schedules of the above-mentioned act.

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Drugs and Cosmetics Act, 1940
The Drugs and Cosmetics Act, 1940 is an Act of the Parliament of India which
regulates the import, manufacture and distribution of drugs in India.
•The Act regulates the import, manufacture, and distribution of drugs in India.
•The primary objective of the act is to ensure that the drugs and cosmetics sold
in India are safe, effective and conform to state quality standards.
It was initially known as the Drug Act and was passed in 1940 and after several
amendments is known as the Drugs and Cosmetics Act, 1940.
The related Drugs and Cosmetics Rules, 1945 contains provisions for
classification of drugs under given schedules and there are guidelines for the
storage, sale, display and prescription of each schedule. This act was originally
known as the Drug Act and was passed in 1940.

26. Background
As per the 7th Schedule of the Indian Constitution, drugs fall under the
Concurrent List and the definition of medical devices was introduced in 1982,
under the definition of drugs under the Drugs and Cosmetics Act,1940.
A majority of medical devices and their sale is unregulated in India. At present,
only 24 high-risk medical devices, including cardiac stents, are regulated as
drugs by the Central Drugs Standards Control Organisation.
The Medical Devices Rules were introduced in 2017, and the Centre has also
formulated a report on a roadmap to medical devices.
It has been formulated in consultation with all the stakeholders, such as
AiMED, NITI Aayog, etc.The AiMeD is an Umbrella Association of Indian
Manufacturers of Medical Devices.

27. The Central Drugs Standards Control Organisation (CDSCO) is the
apex drug regulator in India.
The Health Ministry notification has said that all medical device
manufacturers will also have to register themselves on a centralized online
portal for the purposes of quality control and assurance.
The decision to include all the medical devices under the ambit of the
Drugs and Cosmetics Act,1940 was taken in consultation with the Drugs
Technical Advisory Board (DTAB).

28. Classification of medical devices
•The classification of the medical device rules along with the regulatory
approval and registration by the CDSCO is under the control of the Drug
Controller General of India (DCGI).
•All medical devices in India follow a regulatory framework based on the
drug regulations under the Drugs and Cosmetics Act, 1940 and the Drugs and
Cosmetic Rules, 1945.
•The newly notified rules further classify medical devices in four categories,
Class A, Class B, Class C, and Class D.
•Class A and Class B would have 36 months, while Class C and Class D will
have 42 months to subject themselves to strict quality control mechanisms
and come under the compliance regime.
•The regulatory requirements for the approval of the license for drugs and
medical devices are completely different.

29. Sl. No Classes of Medical
Device
Type of Medical
Device
Examples
1. Class A Low-risk absorbent cotton
balls, alcohol
swabs, etc.
2. Class B Moderate-low
risk
thermometer, BP
monitoring
device, etc.
3. Class C Moderate-high
risk
Implants, etc.
4. Class D High-risk heart valve, etc.

30. •The term "drug" as defined in the act includes a wide variety of
substance, diagnostic and medical devices.
•The act defines "cosmetic" as any product that is meant to be applied to
the human body for the purpose of beautifying or cleansing. The
definition however excludes soaps.
In 1964, the act was amended to include Ayurveda and Unani drugs.
The Section 16 of the act defines the standards of quality for drugs.
The Section 17 defines "misbranding". A drug is considered misbranded
if it claims to be of more therapeutic value than it actually is.
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31. The manufacturer of such a drug may be asked to suspend manufacture of
the drug under Section 18.
Section 27 deals with fake and adulterated drugs. The act requires more of
that ingredients of the drugs should be printed on the label.

32. THANK YOU