Chanderprabhu Jain College of Higher Studies

&
School of Law
An ISO 9001:2015 Certified Quality Institute
(Recognized by Govt. of NCT of Delhi, Affiliated to GGS Indraprastha University, Delhi)

E-Notes

Subject : HEALTH CARE LAWS

Class : B.A.LLB/BBA LL.B IX Sem
Paper Code : LLB 509
Faculty Name : Ms. Sunil Kumar

UNIT-2

I. PROFESSIONAL OBLIGATIONS OF DOCTORS

A. TRANSPLANTATION OF HUMAN ORGAN ACT, 1994

The main provisions of the THO act includes the following:

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.

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.

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• 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.

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

It 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 and follow-up medical care of donors and
recipients, suspending or cancelling 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.

B. PRE-CONCEPTION AND PRE-NATALDIAGNOSTIC TECHNIQUES ACT, 1994

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.

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.4 No Genetic Counselling
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School of Law
An ISO 9001:2015 Certified Quality Institute
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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; 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.

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.

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.

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• Form G has to be filled by the woman undergoing ultrasound wherein she has to declare
that she is undergoing the test.

• 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.

• 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.

• 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.

C. 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.

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School of Law
An ISO 9001:2015 Certified Quality Institute
(Recognized by Govt. of NCT of Delhi, Affiliated to GGS Indraprastha University, Delhi)

After the approval of the Declaration of Geneva, the II General Assembly of the World
Medical Association analysed 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.

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,
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".

D. INDIAN MEDICAL CENTRAL COUNCIL ACT, 1970

The Central Council 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.

(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;

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(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

E. 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.

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.

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 is
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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F. 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 in Homoeopathy Central Council
Amendment Act, 2002 was passed in December 2002.

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.

G. 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 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.

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.

The original act was prepared in accordance to the recommendations of the Chopra
Committee formed in 1930.
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An ISO 9001:2015 Certified Quality Institute
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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.

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 ingredient of
the drugs should be printed on the label.

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