LAWS PERTAINING TO MEDICAL

PRACTICES AND MEDICAL

ESTABLISHMENTS IN INDIA

MS. MERCY K KHAUTE

 business through which one or more physicians practice medicine

the science or practice of the diagnosis,
treatment, and prevention of disease (in
What is medical technical use often taken to exclude surgery)
practice?
a drug or other preparation for the treatment or
prevention of disease

tasks or functions that are delegated to a quali ed and properly trained employee, including the
administration of drugs

National Medical Commission Act 2019- Sec 2 (j) "medicine" means modern scienti c medicine in all its branches and
includes surgery and obstetrics, but does not include veterinary medicine and surgery
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 NATIONAL MEDICAL COMMISSION ACT 2019
AN OVER VIEW

• Provide quality and affordable medical education

• Ensure availability of medical practitioners in India

• Promote research in medical field

• Maintain ethical standard

• Establishment of grievance redressal mechanism

• Promote universal healthcare

 KEY HIGHLIGHTS OF THE ACT

Constitution of a National Medical Commission   
empowered to lay down policies for maintenance and regulation of medical institutions and medical professionals
empowered to frame guidelines for determining the fees and related charges in respect of 50% seats in private medical institutions and deemed universities.

Constitution of a Medical Advisory Council

The Council shall be a platform for the States and Union Territories for exchange of views and concerns

Conducting the National Eligibility-cum-Entrance Test at undergraduate level and National Exit Test for grant of license

Medical Assessment and Rating Board for setting up of medical institutions/colleges

Establishment of other regulatory bodies and committees - Advisory Board, Search Committee, Under Graduate Medical Education Board, Post
Graduate Medical Education Board, Medical Assessment and Rating Board and Ethics and Medical Registration Board for regulating and structuring formal
medical education.

***Community health service providers can now be granted a limited license to practice. These health service providers can only prescribe speci ed medicine for
primary and preventive healthcare***

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THE INDIAN NURSING COUNCIL ACT, 1947

To constitute an Indian Nursing Council in order to

establish a uniform standard of training for nurses,
midwives and health visitors
 THE CLINICAL ESTABLISHMENTS
(REGISTRATION AND REGULATION) ACT, 2010

 Registration of all clinical establishments in India

Regulation and implementation of standard practices all public and private establishments, including AYUSH establishments

Section 2 (c), a clinical establishment may be a hospital, maternity home, nursing home, dispensary, clinic, sanatorium or any other
institution that offer services for diagnosis, care or treatment of patients.

Exception of the establishments under the military forces

The registering authority facilitates policy formulation, resource allocation and determines standards of treatment. It can impose
nes for non-compliance of the provision of the Act.

The Act lays down Standard Treatment Guidelines for common disease conditions, for which a core committee of experts has been
formed.

Further, the Act makes all clinical establishments to provide medical care and treatment necessary to stabilize any individual who
comes or is brought to the clinical establishment in an emergency medical condition, particularly women who come for deliveries
and accident cases.
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 The National Council for Clinical Establishment

-responsible primarily for setting up standards for ensuring proper healthcare by the clinical establishment and develop the minimum standards and their
periodic review.

Clinical Establishments and procedure for registration of the Clinical Establishment

Section 11 of the Act mandates that no person shall run a clinical establishment unless it has been duly registered in accordance with the provisions of the
Act.

Minimum Standards to be followed by Clinical Establishments

Further, Section 12 of the Act lays down that for the registration and continuation of a Clinical Establishment, such clinical establishment shall ful ll the
conditions namely,
• the minimum standards of facilities and services
• the minimum requirement of personnel
• provisions for maintenance of records and reporting
• such other conditions as may be prescribed.
The minimum standards for hospitals are implemented on the basis of level of care provided by such hospitals.

The Pharmacy Act 1948

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Indian Public Health Standards (IPHS) Guidelines for

PRIMARY HEALTH CENTRES

 Objectives of Indian Public Health Standards (IPHS) for Primary Health Centres (PHC)
The overall objective of IPHS is to provide health care that is quality oriented and sensitive to the needs
of the community.
The objectives of IPHS for PHCs are:
i. To provide comprehensive primary health care
to the community through the Primary Health
Centres.
ii. To achieve and maintain an acceptable standard
of quality of care.
iii. To make the services more responsive and
sensitive to the needs of the community.

Alma Aata Declaration 1978- HEALTH FOR ALL

 Medical Care Essential

OPD services: A total of 6 hours of OPD services

out of which 4 hours in the morning and 2 hours in the afternoon for six days in a week.

Minimum OPD attendance is expected to be 40 patients per doctor per day. In addition to six hours of duty at the PHC, it is desirable that
MO PHC shall spend at least two hours per day twice in a week for eld duties and monitoring.
24 hours emergency services: appropriate management of injuries and accident.
First Aid, stitching of wounds, incision and drainage of abscess, stabilisation of the condition of the patient before referral, Dog bite/snake
bite/scorpion bite cases, and other emergency conditions.

These services will be provided primarily by the nursing staff.

Medical Of cer may be available to attend to emergencies on call basis.

Referral services.
In-patient services (6 beds).
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Primary Health Centre covers a population of 20,000 in hilly, tribal, or dif cult areas and 30,000 populations in plain areas with 6 indoor/
observation beds.
• From Service delivery angle, PHCs may be of two types, depending upon the delivery case load – Type A and Type B.
Type A PHC: PHC with delivery load of less than 20 deliveries in a month, Besides one MBBS medical of cer, one AyUSH medical of cer
(desirable) has been provided to provided choices to the people
• Type B PHC: PHC with delivery load of 20 or more deliveries in a month

A Charter of Patients’ Rights for appropriate information to the bene ciaries, grievance redressal and constitution of Rogi Kalyan
Samiti/ Primary Health Centre Management Committee for better management and improvement of PHC services with
involvement of Panchayati Raj Institutions (PRI) has also been made as a part of the Indian Public Health Standards. The
monitoring process and quality assurance mechanism is also included.

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 Bio-Medical Waste Management Rules, 2016

These rules shall apply to all persons who generate, collect, receive, store, transport, treat, dispose, or handle bio
medical waste in any form including hospitals, nursing homes, clinics, dispensaries, veterinary institutions, animal
houses, pathological laboratories, blood banks, ayush hospitals, clinical establishments, research or educational
institutions, health camps, medical or surgical camps, vaccination camps, blood donation camps, rst aid rooms of
schools, forensic laboratories and research labs
Sec 2 e) "biological" 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;
(f) "bio-medical waste" means any waste, which is generated during the diagnosis, treatment or immunisation of
human beings or animals or research activities pertaining thereto or in the production or testing of biological or
in health camps, including the categories mentioned in Schedule I appended to these rules

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 UN Declaration of Commitment on Human Immunode ciency Virus and Acquired Immune De ciency Syndrome (2001)

The Human Immunode ciency Virus and Acquired Immune De ciency Syndrome (Prevention and Control)
Act, 2017

- to provide for the prevention and control of the spread of Human Immunode ciency Virus and Acquired Immune
De ciency Syndrome and for the protection of human rights of persons affected by the said virus and syndrome and for
matters connected therewith or incidental thereto.
.
.
.
And Whereas there is a need to protect the rights of healthcare providers and other persons in relation to Human
Immunode ciency Virus and Acquired Immune De ciency Syndrome

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 Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954

An Act to control the advertisement of drugs in certain cases, to prohibit the advertisement for certain purposes of remedies alleged to
possess magic qualities and to provide for matters connected therewith
Sec 2
(a) advertisement includes any notice, circular, label, wrapper, or other document, and any announcement made orally or by any means
of producing or transmitting light, sound or smoke

(c) magic remedy includes a talisman, mantra, kavacha, and any other charm of any kind which is alleged to possess miraculous powers
for or in the diagnosis, cure, mitigation, treatment or prevention of ny disease in human beings or animals or for affecting or in uencing
in any way the structure or any organic function of the body of human beings or animals

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mercykhaute1508@gmail.com