Medical Law

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Prof. Dr. Narendran Thiruthy
Rajiv Gandhi School of Intellectual Property Law
Indian Institute of Technology, Kharagpur

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N Lecture 16: Healthcare Policy and Law
• Components of Healthcare
• Role of the Government
• Constitutional Provisions on healthcare

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• Judiciary on healthcare
• Specific Laws Regulating healthcare

PT
• Schemes and Policies of the Government

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• Mixed Model of Healthcare
• Pharmacy Council of India

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• Ayushman Bharat
• National Health Mission

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N
Introduction
• India encounters significant obstacles in achieving
universal access to health services.
• India has demonstrated advancements in its

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development trajectory through the implementation of
strategic endeavours such as the National Health
Mission.

PT
• The issue of affordability, the presence of obstacles in
maintaining consistent quality nationwide, and the
attainment of equal health outcomes are matters of

N
concern in India, particularly due to the high out-of-
pocket expenses associated with private healthcare
services.
Components of Healthcare
• The healthcare industry in India encompasses
various ownership models, including

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– Public sector
– Private sector

PT
– Either Private or Public
– Mixed Models of both Private and Public
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Private Sector
• Healthcare providers in the private sector, which
are duly registered in accordance with the

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provisions of the Clinical Establishment Act, are
owned and operated by individuals or a collective
of individuals.

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• The establishments encompassing dispensaries,
clinics, nursing homes, and hospitals are capable of
N
implementing many systems of medicine, including
Allopathic, Ayurvedic, Homeopathic, or Unani.
Public Sector
• The public sector, conversely, is under the jurisdiction of
the Ministry of Health and Family Welfare (MoHFW),
which is a governmental entity in India.

EL
• These establishments also encompass dispensaries,
clinics, nursing homes, and hospitals that adhere to
diverse medical systems.

PT
• Moreover, it encompasses the comprehensive network
of government health facilities across India, comprising

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sub-centres, primary health centres, community health
centres, rural hospitals, urban health centres, municipal
hospitals, and other government healthcare
institutions.
Either Private or Public
• The health sector also encompasses several entities
such as pharmaceutical firms, chemist shops, research
organizations, medical colleges, and other health-

EL
related training and research facilities, which can be
either publicly or privately owned.

PT
• Various entities, including charitable institutions,
religious organizations such as churches, non-
governmental organizations (NGOs), and public sector
N
bodies such as atomic energy, railways, port trust,
reserve bank, and armed forces, possess a significant
number of these assets as well.
Mixed Models

• In a mixed model, the public and private sectors

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coexist side by side, much like they do in India,
where the public sector is responsible for providing

PT
services while the private sector is responsible for
providing care and insurance.

N
Role of the Government
• The central government establishes a comprehensive
framework and is responsible for allocating financial
resources to the state government for the purpose of

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implementing such programs.
• According to the provisions outlined in the Constitution,

PT
matters pertaining to public health, sanitation,
dispensaries, and hospitals are within the jurisdiction of

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the state (Entry 6, State List II), whereas population
control and family planning are included in the
Concurrent (Entry 20 A, List III).
Constitutional Provisions on healthcare
• Article 21 of the constitution ensures the
fundamental right to life, imposing upon the State

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the duty to safeguard the lives of all individuals.
• Article 39 (e): Directs the state to secure the health

PT
of workers
• Article 41 pertains to the provision of public aid in
N
situations involving old age, disease, and incapacity.
• According to Article 47, it is the responsibility of the
State to prioritize the enhancement of public health,
as well as the improvement of the standard of living
and nutritional status of its population. The primary
objective of the State is to strive towards the

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implementation of a policy that aims to prohibit the
use of intoxicating beverages and harmful

PT
pharmaceuticals, with the exception of their
legitimate use for medical purposes.
•
N
Article 243G (read with 11th Schedule, Entry 23)
empowers Panchayats and Municipalities to improve
public health.
Judiciary on Healthcare
• At Bandhua Mukti Morcha v Union of India & Ors
(1983), the Supreme Court of India construed the
right to health under Article 21, which guarantees

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life.
• In State of Punjab & Ors v Mohinder Singh

PT
Chawla, the Supreme Court stated that the right to
health is fundamental to the right to life and that
the government must provide health services.
N
• The court further upheld the State's health service
responsibilities in State of Punjab & Ors v Ram
Lubhaya Bagga.
Specific Laws Regulating healthcare
• The Government of India has set forward the objective of achieving
universal health coverage, recognizing that healthcare is a crucial
element of social welfare and progress.

EL
• The government enacts a range of legislations, statutes and schemes
with the aim of fostering a state of well-being among the populace.
• The following legislations and schemes encompass various aspects of

PT
the healthcare industry, including medical profession and education,
nursing profession and education, pharmacists and pharmacy
education, mental health, drug standards, advertisements pertaining

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to drugs and medicines, prevention of the spread of infectious or
contagious diseases between states, and prevention of adulteration of
food and drugs.
The Clinical Establishments (Registration and
Regulation) Act, 2010
• The enactment of the Clinical Establishments
(Registration and Regulation) Act, 2010 by the

EL
Central Government aims to develop a system for
the registration and regulation of clinical

PT
establishments across the nation.
• The primary objective of this act is to establish a

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set of minimum criteria for the facilities and
services offered by these establishments.
• The Act is inclusive of all categories of Clinical
Establishments, encompassing both therapeutic
and diagnostic types, operating within the public
and private sectors.

EL
• This includes establishments affiliated with all
recognized systems of medicine, as well as single

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doctor clinics.
• The sole exemption pertains to Clinical
N
Establishments operated by the Armed forces.
The Drugs and Cosmetics Act, 1940
• The Drugs and Cosmetics Act of 1940 is a
legislative enactment of the Parliament of India

EL
that governs the importation, production, and
dissemination of pharmaceutical substances within
the country.

PT
• The main aim of the legislation is to guarantee the
safety, efficacy, and adherence to quality standards
N
of pharmaceuticals and cosmetics being marketed
in India.
• The primary goals of the legislation encompass:
– the prevention of the production of counterfeit and
inferior pharmaceutical products.
– the importation of pharmaceutical substances into

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the nation of India, and regulatory measures to be
implemented, accordingly.

PT
– the production and distribution of Ayurvedic,
Siddha, and Unani medications, as it is necessary to

N
implement regulatory measures.
The Pharmacy Act of 1948
• The Pharmacy Act of 1948 was established by the
Parliament of India with the purpose of governing

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and overseeing the occupation and
implementation of pharmacy in the country.

PT
• The handling, formulation, dispensing, and storage
of medicines require a comprehensive and
specialized understanding, expertise, and training
possessed
“Pharmacists”.
by N professionals known as
• The Pharmacy Council of India (PCI) is the statutory
body that was formed in accordance with the provisions
outlined in the Pharmacy Act of 1948.
• The primary goals of the PCI are to establish a set of
educational standards that must be met in order to

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qualify as a pharmacist. This involves the development
of Education Regulations that outline the specific

PT
requirements that institutions must satisfy in order to
obtain approval from the PCI to provide pharmacy
education.
• N
The introduction of the Pharmacy (Amendment) Bill,
2023 has taken place in the Lok Sabha in August, 2023.
Bio-medical Waste Management
• The management of biomedical waste holds
significant importance in safeguarding the well-
being of healthcare of the general population, and

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the ecological surroundings.
• The inadequate management of biomedical waste

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has the potential to facilitate the transmission of
infectious diseases, pollute the surrounding
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environment, and pose a risk of hazardous
substance exposure to anyone involved in its
treatment.
Bio-medical Waste Management Rules, 2016
• To facilitate the process of disposal of wastes, the
Government of India introduced the Biomedical Waste
(Management and Handling) Rules, 1998, which encompass a

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set of standards and regulations.
• In 2016, the Indian government made the decision to release

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a revised set of regulations known as the Biomedical Waste
Management Rules, 2016.
• The primary objective of these revisions was to enhance the

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processes of collection, segregation, treatment, and disposal
of biomedical waste generated by hospitals and laboratories.
• Biomedical wastes are categorized into four distinct
color categories:
– “Yellow” Category include human anatomical waste, animal
anatomical waste, soiled waste, expired or discarded waste,
chemical waste, chemical liquid waste, discarded linen,
beddings contaminated with blood or body fluid, as well as
microbiology, biotechnology, and other clinical laboratory

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waste.
– The category referred to as "Red" encompasses recyclable
contaminated trash, namely waste derived from disposable

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products such as tubing, bottles, intravenous tubes and sets,
urine bags, syringes, and gloves.
– "White (Translucent)" encompasses many types of waste

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sharps, specifically those composed of metals that have been
used, contaminated, or discarded.
– And "blue" encompasses glass and metallic body implants
that are broken, infected, or abandoned.
The Mental Healthcare Act, 2017
• The Mental Healthcare Act of 2017 is a legislative
measure that aims to ensure the provision of
mental healthcare and related services to

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individuals suffering from mental illnesses.
• Additionally, its objective is to safeguard, advance,

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and ensure the rights of individuals in the context
of mental healthcare provision and services.

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• The legislation guarantees individuals with mental
illness the entitlement to lead a life characterized
by dignity, free from discrimination or harassment.
• Furthermore, it grants patients the entitlement to
avail themselves of various facilities encompassing
rehabilitation treatments within hospital settings,
as well as in the community, home, and sheltered

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and supported lodging.
• The legislation governs the investigation pertaining

PT
to individuals with mental illness and the
utilization of neurosurgical interventions.

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• The legislation is relatively vague on the provision
of community care.
The Medical Termination of
Pregnancy Act, 1971
• The enactment of the Medical Termination of
Pregnancy Act, 1971 (referred to as the "MTP Act") was
prompted by advancements in the realm of medical

EL
science, namely pertaining to the development of safer
abortion procedures.

PT
• The recently enacted Medical Termination of Pregnancy
(Amendment) Act 2021 aims to enhance the availability
of safe and lawful abortion services for therapeutic,
N
eugenic, humanitarian, and social reasons, with the goal
of promoting widespread access to comprehensive
healthcare.
• According to the amended legislation, a married
woman has the option to terminate a pregnancy
within a time frame of 20 weeks in situations
where a contraceptive technique or technology
has proven ineffective.

EL
• This provision enables unmarried women to
exercise their right to terminate a pregnancy for

PT
the aforementioned purpose.
• The disclosure of the identity and personal details
N
of a woman who has undergone the termination of
her pregnancy is prohibited, unless authorized by a
prevailing legislation.
• The implementation of the new legislation will
make a significant contribution towards the
reduction of preventable maternal death, so aiding
in the achievement of the Sustainable

EL
Development Goals (SDGs).
• The amendment to the MTP Act of 1971, is aimed

PT
to enhance women's empowerment through the
provision of comprehensive abortion care to

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ensure universal access to reproductive health
services.
Indian Penal Code, 1860
• Medical professionals may face legal consequences under various
sections of the Indian Penal Code, 1860, as follows:
– Section 269 of IPC pertains to acts of negligence that have the

EL
potential to facilitate the transmission of infectious diseases that
pose a significant risk to human life.
– Section 270 of IPC pertains to activities that possess a malignant

PT
nature and have the potential to facilitate the transmission of
infections or diseases that pose a significant risk to human life.
– Section 304A of the legal code pertains to the offense of causing
death by negligence.
N
– Section 338 pertains to the offense of causing grievous injury
through an act that poses a risk to the life or personal safety of
others.
Schemes and Policies of the

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Government

PT
N
National Health Policy, 2017
• The National Health Policy, which was introduced in
2017, serves as a replacement for the pre-existing
policy that was established in 2002.

EL
• The National Health Policy is an endeavor undertaken
by the Central Government of India with the aim of
enhancing the overall health infrastructure inside the

PT
country.
• This project encompasses all facets of the healthcare

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industry, including illness prevention, the promotion of
good health through cross-sectoral efforts, investments
in healthcare, the enhancement of human resources,
technological breakthroughs, and other related areas.
Government Health Insurance Schemes
• Government health insurance schemes refer to
programs implemented by the government to

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provide health insurance coverage to individuals
within a certain jurisdiction.
• These schemes aim to ensure that citizens have

PT
access to affordable and comprehensive
healthcare services, regardless of their
N
• These systems, which are either centrally or state-
sponsored, aim to offer health coverage at a
reasonable cost.
Ayushman Bharat program
• The Ayushman Bharat program, also referred to as
Pradhan Mantri Jan Aarogya Yojna (PMJAY), is a
government initiative in India that aims to provide

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universal health coverage to all citizens.
• The program encompasses intricate medical
interventions, including knee replacement, prostate

PT
cancer treatment, double valve replacement, and skull
surgery, with the aim of benefiting over 500 million
individuals in India.
• N
The policy provides coverage for expenses incurred over
a period of up to 15 days following hospitalization. The
data set consists of a total of 1393 medical treatments.
Aam Aadmi Bima Yojana (AABY)
• The AABY program extends coverage to individuals
within the low-income bracket, encompassing all
residents.

EL
• It offers insurance protection to either the primary
breadwinner or the head of the household. The
beneficiary or a family member is eligible to receive a

PT
sum of ₹75,000 in the event of the policyholder
experiencing loss of an eye or limbs.
•
N
The beneficiaries are provided under the following
circumstances: Mortality resulting from natural causes
or unforeseen incidents, as well as enduring or partial
incapacitation.
Universal Health Insurance Scheme (UHIS)
• The UHIS is a comprehensive healthcare program that aims
to provide coverage to all individuals, regardless of their
socio-economic status or pre-existing medical conditions.

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• The aforementioned program was executed with the
intention of providing protection to the most economically
disadvantaged households within the nation.

PT
• The policy offers a maximum coverage of ₹30,000 in the
event of a family member's hospitalization. For individuals

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who are employed and earning income, the remuneration
is set at ₹50 per day, with a maximum duration of 15 days.
The UHIS program is accessible to both individuals and
groups.
National Health Mission
• The National Health Mission (NHM) was initiated by the
government of India in 2013, incorporating the National
Rural Health Mission (established in 2005) and the

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National Urban Health Mission (established in 2013).
• The primary programmatic elements encompass Health

PT
System Strengthening in both rural and urban regions,
focusing on Reproductive-Maternal-Neonatal-Child and
Adolescent Health, as well as Communicable and Non-

•
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Communicable Diseases.
The NHM aims to attain comprehensive accessibility to
fair, cost-effective, and high-quality healthcare services.
• The National Health Mission (NHM) offers assistance to
States/Union Territories (UTs) in establishing new
facilities and improving existing ones in order to address
infrastructure deficiencies, in accordance with
established guidelines and in response to the needs

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expressed by the respective states/UTs.
• The NHM offers assistance for the provision of many

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complimentary services pertaining to maternity health,
child health, adolescent health, family planning, the
universal vaccination programme, as well as for
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prevalent diseases like as Tuberculosis, vector
transmitted diseases like Malaria, Dengue, Kala Azar,
and Leprosy.
Major Initiatives Supported Under NHM
• Janani Shishu Suraksha Karyakram (JSSK)
• Rashtriya Bal Swasthya Karyakram (RBSK)
• Implementation of Free Drugs and Free Diagnostics Service

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Initiatives.
• PM National Dialysis Programme

PT
• Implementation of National Quality Assurance Framework in
all public health facilities
• Mobile Medical Units (MMUs) & Tele-consultation services
•
•
Ayushman Bharat N
Pradhan Mantri Jan Arogya Yojana (AB-PMJAY).
• Healthcare policies are rules and guidelines that
govern healthcare services.
• Access, quality, cost management, and public health

EL
are all significant factors that contribute to their
importance.

PT
• Policy development is mostly led by governments,
who engage many stakeholders such as healthcare
N
professionals, organizations, patient groups,
insurance firms, and academia.
• https://www.ncbi.nlm.nih.gov/pmc/articles/PM
C7122919/

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• https://www.pci.nic.in/RTI.html

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• https://cdsco.gov.in/opencms/opencms/system
/modules/CDSCO.WEB/elements/download_file
N
_division.jsp?num_id=MTU1MA==
N
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 Medical Law

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Dr. Narendran Thiruthy
Rajiv Gandhi School of Intellectual Property Law
Indian Institute of Technology, Kharagpur

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N Lecture 17: Clinical Establishment Law
• Clinical Establishment
• Other aspects of Clinical Establishment:
• Blood Bank

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• Transplantation of Human Organs
• Medical Termination of Pregnancy

PT
• Psychiatric services
• Narcotic Drugs and Psychotropic Substances
N
• Bio-Medical Waste Disposal
• Ultrasound Equipment
• Clinical Establishment
• Registration & Regulation

EL
• Clinical Services
• Diagnostics

PT
• Devices and Equipment

N
Introduction
• There exist a multitude of regulations that ensure the
adherence to appropriate registration procedures

EL
during the construction of hospital facilities.
• These regulations further guarantee the safety of these
facilities for public utilization, encompassing the

PT
provision of essential infrastructure commensurate with
the projected workload and volume.
•
N
Additionally, periodic inspections are conducted to
verify compliance with these regulations.
The Clinical Establishments (Registration
and Regulation) Act, 2010
• The Clinical Establishments Act allows for the
registration and control of clinical establishments
throughout the country with the intention of

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prescribing basic minimum criteria for the facilities and
services of a certain type that are provided by the
clinical establishment.

PT
• The primary objective of the Clinical Establishment Act
is to establish a comprehensive database comprising

N
recognized Clinical Establishments, thereby ensuring
their accessibility and functionality. Hence, the primary
aim is to enhance the quality of public health by
eradicating unqualified practitioners.
Who is covered by the provisions of
this legislation?
• The Clinical Establishments Act applies to clinical

EL
establishments in both the public and private
sectors, encompassing all recognized systems of

PT
medicine, including Allopathy, Ayurveda, Yoga,
Naturopathy, Homoeopathy, Siddha, Unani, and
Sowa Rigpa.
N
• This includes any entities that are either owned,
controlled, or managed by the government, a
public or private trust, a business registered under
a Central, Provincial, or State Act (regardless of

EL
government ownership), a municipal authority, or
an individual medical practitioner.

PT
• The Act does not include clinical establishments
that are owned, controlled, or managed by the
Armed Forces.
N
What is clinical establishment?
• According to Section 2(c) of the Clinical Establishments
(Registration & Regulation) Act, 2010:
• A hospital, maternity home, nursing home, dispensary, clinic,

EL
sanatorium, or any other facility that provides services or
facilities needing diagnosis, treatment, or care for disease,

PT
injury, deformity, abnormality, or pregnancy
• It also includes diagnostic centers and laboratories, as well as
any other facilities that conduct forensic, bacteriological,

N
genetic, radiological, chemical, or biological investigations or
provide other services with the use of laboratory or other
medical equipment.
Salient features of the Act
• The Act facilitates the creation of a dependable and
inclusive database, or registry, for various clinical
establishments across the nation, at the district, state,

EL
and national levels.
• The legislation facilitates the categorization of different
therapeutic establishments and establishes

PT
fundamental minimum standards for each category.
• The Act establishes fundamental minimum criteria for
operation, employing a participatory and collaborative
N
method to guarantee consistency among all enterprises.
The minimum standards encompass essential
requirements that are obligatory.
• The Act facilitates the acquisition of information
and data by the government from clinical facilities
for the purpose of public health actions, such as
outbreak and disaster management.

EL
• The establishment of various multi-stakeholder
entities is outlined, including the National Council

PT
for Clinical Establishments at the national level, the
State Council for Clinical Establishments at the
state level, and the District Registration Authority
at each district. N
• The legislation permits a registration procedure
that consists of two stages - provisional
registration and permanent registration.
Provisional registration is achieved via a self-
declaration process, devoid of any inquiry or

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inspection.
• The process of permanent registration involves the

PT
categorization, classification, and communication
of minimal standards specific to each category.

N
• The Act mandates the disclosure of the registration
procedure and clinical establishment data to the
public, thereby promoting transparency.
• The Act mandates the disclosure of the registration
procedure and clinical establishment data to the
public, thereby promoting transparency.
• The rates and available facilities will be openly
exhibited at a conspicuous location within each

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establishment.
• The establishment of a registry for clinical facilities

PT
would be beneficial in the development of policies
and the distribution of resources.
N
• The cancellation of registration may take place at
any given time if the conditions for registration are
not adhered to.
• Clinical establishments are required to offer immediate
medical care within the limitations of their personnel
and resources.
• The Act has the potential to regulate and discourage
quackery by implementing a registration requirement

EL
that applies exclusively to clinical establishments
associated with recognized systems of medicine.
Consequently, it becomes imperative for all clinical

PT
establishments to get registration in order to operate
legally.
• The legislation establishes requirements for healthcare
N
providers to preserve records and reporting in
accordance with defined guidelines, as well as to give
requested information and data to the governing body.
Other Laws regulating aspects

EL
of Clinical Establishments

PT
N
Blood Bank
• If a hospital possesses a blood bank, it is obligated
to adhere to the space, manpower, and equipment
criteria outlined in the Drugs and Cosmetics Act.

EL
• In order to establish and operate a blood bank, it is
necessary to obtain a license from the Drug

PT
Standard Control Organization. The presence of a
blood bank within the hospital is a prerequisite for
this requirement.
N
• The duration of validity spans a period of five
years.
Transplantation of Human Organs
• In accordance with the Transplantation of Human
Organs Act of 1994, hospitals engaging in human

EL
organ transplantation or organ harvesting are
required to undergo registration with the relevant
authority.

PT
• Registration for transplantation is granted based
on the availability of the necessary infrastructure
N
required for the successful execution of the
procedure.
Medical Termination of Pregnancy
• In order to engage in the practice of "Medical
Termination of Pregnancy," hospitals are required to get
registration with their respective state in accordance
with the Medical Termination of Pregnancy Act of

EL
1971.
• The approval for conducting Medical Termination of

PT
Pregnancy (MTP) will only be granted once the
registration process is completed.
• It is imperative to comply with the regulations outlined
N
in the Medical Termination of Pregnancy (MTP) Act of
1971 in order to conduct a safe and legal termination of
pregnancy.
• The approval for Medical Termination of Pregnancy
(MTP) is granted under two distinct categories:
• Category A, which does not require an operation

EL
theatre facility, and
• Category B, which necessitates the availability of

PT
an operation theatre.

N
Psychiatric services
• Hospitals that offer specific treatments, such as
de-addiction, psychiatric problem treatment, and

EL
child/adolescent psychiatric clinics, are obligated
to undergo registration with their respective state

PT
government.
• The application of the Mental Healthcare Act,

N
2017 of India is extended to individuals in
question.
Narcotic Drugs and Psychotropic Substances
• Hospitals that employ the usage of Narcotic Drugs
and Psychotropic Substances (NDPS) for patient
care are required to acquire a license in

EL
accordance with the NDPS Act of 1985, as
regulated by the state's Food and Drug

PT
Administration.
• The license delineates the specific quantity and

N
category of Narcotic Drugs and Psychotropic
Substances (NDPS) that are permitted, and
necessitates periodic renewal.
Bio-Medical Waste Disposal
• The acquisition of authorization for the management of
biomedical waste from the Pollution Control Board
(PCB).

EL
• To receive this authorization, it is necessary to establish
a partnership with a Common Biomedical Waste

PT
Treatment Facility Operator (CBWTF).
• In every region, there exists a specifically designated
Central Bio-Medical Waste Treatment Facility (CBWTF)
N
that has been duly approved by the government to
undertake the management and disposal of bio-medical
waste.
Use of Ultrasound Equipment
• There are rules about how pre-natal diagnostic
methods can be used in the Pre-Conception & Pre-
Natal Diagnostic methods Act, 1994 (PC-PNDT Act).

EL
• The Act was made by the Government of State to rule
over all healthcare facilities in the state that have

PT
Ultrasound equipment.
• The Act also says that all radiologists, sonologists, and
doctors who use USG machines must have their names
N
written on the PC-PNDT certificate or on a different
sheet that must be shown with the PC-PNDT
registration certificate.
• The healthcare system in India is characterized by a
universal care system that is administered by the
constituent states and territories.

EL
• The attainment of independence in 1947 marked the
commencement of a new era in the advancement of

PT
structured healthcare services, resulting in several
privileges for citizens.
• The laws discussed in this lecture ensures that hospital
N
facilities are established through a formal registration
process and adhere to safety standards for the benefit of
the general public.
• https://cdsco.gov.in/opencms/opencms/en/

• https://www.pci.nic.in/RTI.html

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• https://cpcb.nic.in/

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N
PT
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 Medical Law

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Prof. Dr. Chaitanya Mittal
Dr. B.C Roy Multi Specialty Medical Research Centre
Indian Institute of Technology, Kharagpur

PT
N Lecture 18: Legal liability of Hospitals
/Clinical Establishments
• Direct Liability of Hospitals
• Vicarious Liability of Hospitals
• Liability of Hospitals under

EL
Specific Laws

PT
N
• Reasonable care and skill
• Independent Contractors
• Adulterated or counterfeit

EL
pharmaceutical products
• Respondent superior

PT
N
Introduction
• Indian hospitals have been subjected to legal
accountability for their provision, or lack thereof,

EL
of medical services, either on an individual basis or
through the principle of vicarious liability.

PT
• Legal action can be initiated against them for
carelessness in many legal forums, including

N
Criminal Courts, Civil Courts, or Consumer Forums.
 Liability of
a Hospital

EL
PT
Direct Vicarious
Liability N Liability
Direct Liability of Hospitals
• In this context, the term "direct liability" refers to
the hospital's failure to meet certain service

EL
standards, which in turn renders the facility
dangerous and unfit for medical treatment.
• The following are some of the circumstances under

PT
which a hospital may be held directly liable:
• Inadequate maintenance of the hospital, which led
N
to the patient being injured or perhaps dying as a
result.
• Failure to provide a safe and sufficient
environment as guaranteed, such as in the case
where the patient is adversely affected by faulty
equipment, incompetent staff, inadequate

EL
accommodations, etc.
• Under the Consumer Protection Act, deceptive or

PT
misleading signboards, advertisements, and
notices, as well as false claims of availability of
specific facilities, may be viewed as a defect in
N
services or as unfair trade practices.
• Damages may be paid for such malpractices, and in
some cases, the law may even prohibit the
business from continuing to operate.

EL
• Charging for a facility that was not supplied, or
charging more than what is specified in the

PT
displayed list of charges or agreed upon, is
unethical. This includes charging for a facility that
was not provided.
N
• There is a choice between mandatory and optional
testing for HIV and hepatitis B.
• When testing is legally done without the consent
of the patient, it is referred to as required testing.

EL
• For example, screening for blood donors, sperm
donors, and organ donors all fall under the
category of mandatory testing.

PT
• In other circumstances, it is optional, and the
specific written approval of the patient is required
N
in order to respect his or her requirement that the
information be kept confidential.
• Incorrect preservation of treatment records and
failure to pass over such data to the patient or his
authorized attendant/legal authorities within 72
hours, both of which are violations of the Medical

EL
Council of India Regulations, 2002. The Medical
Council of India Regulations were created in 2002.

PT
• If such records are not given to the patient or the
attendant, this may also be considered a violation
of the Consumer Protection Act of 1986 due to the
N
fact that it constitutes a defect in services.
Vicarious Liability of Hospitals
• Vicarious liability is when an employer is held
responsible for the negligent actions of their
workers.

EL
• This would apply to a hospital in its capacity as an
employer.

PT
• The employer is accountable not only for his own
actions and omissions but also for those of his
N
workers, so long as the actions in question took
place within the parameters of the employee's job
responsibilities.
• The legal principles of "respondent superior“,
which translates to "let the master answer“, and
"qui facit per alium facit per se“, which translates
to "He who acts through another does the act
himself“, form the foundation of this liability.

EL
• The "borrowed servant doctrine" is a legal principle
that provides an exception to the general principle
described above.

PT
• This principle states that an employer is not
accountable for the actions of an employee when
N
that employee is performing their job duties while
directly under the supervision of another
employer.
• For instance, if a surgeon who works at one
hospital travels to another hospital to perform an
operation there, the first hospital may be held
accountable for the actions of the traveling

EL
surgeon because the procedure was conducted at
the second hospital.

PT
• In today's world, the vast majority of medical
professionals are not employed by the respective

N
hospitals but rather work as independent
contractors.
• The doctor's relationship with the hospital will
determine whether or not the doctor is considered
an employee of the facility where he or she
practices medicine.

EL
• However, a hospital cannot avoid its legal
responsibility by just claiming that it is unable to

PT
suo moto perform any type of surgery or
amputation and that it was only responsible for
providing the necessary infrastructure, nursing
N
services, support workers, and technicians.
Smt. Rekha Gupta v. Bombay Hospital
Trust and Anr
• Not only is the hospital accountable for the staff
that it provides, but it is also responsible for

EL
independent contractors like anesthetists,
surgeons or even doctors, depending on the
circumstances, who admit a patient or perform an

PT
operation on them.
• This was decided by the National Consumer
N
Disputes Redressal Commission in the matter of
Smt. Rekha Gupta v. Bombay Hospital Trust and
Anr. 2003 (2) CPJ 160 (NCDRC)
Joseph Alias Pappachan v. Dr. George
Moonjerly
• In the case of Joseph Alias Pappachan v. Dr. George
Moonjerly, 1994 (1) KLJ 782 (Ker. HC) it was decided

EL
that "persons who run hospitals are in law under the
same duty as the humblest doctor: whenever they
accept a patient for treatment, they must use

PT
reasonable care and skill to ease him of his ailment."
• This decision was made based on the fact that "persons
N
who run hospitals are in law under the same duty as the
humblest doctor.“
• The administration of the hospital simply does not
possess the necessary capabilities.
• They are responsible for it through the personnel

EL
that they hire, and if that staff is irresponsible in
providing treatment, the employer is just as liable

PT
for the carelessness as anybody else who employs
others to perform his responsibilities on his
behalf.
N
• It has been decided that the state may be held
directly liable for negligent acts that take place in
government hospitals in the event that there is a
lack of appropriate facilities, equipment, or staff.
• Additionally, the state may be held vicariously

EL
liable for negligent acts that are committed by its
own medical professionals.

PT
• In a few instances, the court has gone so far as to
order the government doctor whose carelessness
N
has been proven to pay the complaint
compensation for the wrong they have suffered.
Liability of Hospitals under

EL
Specific Laws

PT
N
The Clinical Establishments (Registration
and Regulation) Act, 2010
• A clinical establishment without registration is
subject to a penalty of up to fifty thousand rupees

EL
on the first violation, two lakh rupees on the
second violation, and five lakh rupees on any

PT
subsequent violation.
• Anyone who knowingly works in an unregistered
N
clinical establishment faces a fine of up to twenty-
five thousand rupees.
• The Authority shall convene an inquiry in the
required way after giving any individual a
reasonable opportunity to be heard to impose any

EL
monetary penalty.
• The authority shall consider the clinical

PT
establishment's category, size, kind, and local
conditions when imposing the monetary penalty.
N
The Drugs and Cosmetics Act, 1940
• The Drugs and Cosmetics Act of 1940 stipulates a
range of penalties for violations.

EL
• The topic of concern pertains to the presence of
adulterated or counterfeit pharmaceuticals. The

PT
potential legal consequences for the offense
include a maximum prison sentence of three years
N
and a monetary penalty of up to 5,000 rupees.
• The possession or distribution of adulterated or
counterfeit pharmaceutical substances may result in a
prison sentence ranging from three to five years, as well
as a monetary penalty of at least 5,000 rupees.
• The use of illicit substances in violation of regulations.

EL
The potential legal consequences for the offense
include a maximum prison term of three years, a

PT
monetary penalty of up to 5,000 rupees, or a
combination of both.
• The possession and distribution of adulterated drugs is
N
punishable by a prison term ranging from one to three
years, as well as a fine of at least 5,000 rupees.
• The possession or sale of counterfeit or
contaminated cosmetics may result in a prison
sentence of up to three years and a fine of at least
50,000 rupees or three times the confiscated

EL
cosmetics' worth, whichever is greater.
• The court has the authority to impose a prison

PT
sentence for a duration of less than one year,
provided that there are sufficient and exceptional
N
justifications for doing so.
The Drugs, Medical Devices and
Cosmetics Bill, 2023
• The Drugs, Medical Devices and Cosmetics Bill,
2023 (the “Drugs Bill”) seeks to replace the Drugs

EL
and Cosmetics Act, 1940.
• Medical devices were considered a part of "drugs"

PT
under the Drugs and Cosmetics Act, 1940 and both
sorts of products were subject to the same set of
restrictions.
N
• Nevertheless, given the enhanced complexity and
technological advancements of medical devices, it
is evident that they should be treated as a

EL
separate category.
• Consequently, the Drugs, Medical Devices and

PT
Cosmetics Bill, 2023 establishes distinct regulations
for these devices, distinct from those governing
medications.
N
Medical Termination of Pregnancy
Act, 1971
• The act of terminating a pregnancy by an individual
who is not a registered medical practitioner is

EL
considered a criminal offense under the Indian
Penal Code, 1860.

PT
• This offense is punishable by a term of rigorous
imprisonment, which must be a minimum of two
N
years but may extend up to seven years, as
specified in the aforementioned Code.
Liability of Hospitals under the Act
• Individuals who terminate a pregnancy in a location
other than the one specified in the Act will be subject to
punitive measures, including a term of rigorous

EL
imprisonment ranging from a minimum of two years to
a maximum of seven years.

PT
• Individuals who possess ownership of a location that
has not been sanctioned in accordance with the Act

N
shall be subject to a penalty of rigorous imprisonment.
The duration of this imprisonment shall not be less than
two years, but may extend up to seven years.
The Medical Termination of
Pregnancy (Amendment) Act, 2021
• The primary objective of the Medical Termination
of Pregnancy (Amendment) Bill, 2021 is to

EL
enhance women's accessibility to secure and
lawful abortion services based on medicinal,
eugenic, humanitarian, or societal justifications.

PT
• The Amendment to the MTP Act aims to extend
the upper gestation limit from 20 to 24 weeks for
specific groups of women, such as survivors of
N
rape, victims of incest, and other vulnerable
women (including differently-abled women and
minors).
• A single provider's opinion will be necessary for
pregnancies up to 20 weeks, but two physicians'
opinions will be required for terminating
pregnancies between 20 and 24 weeks.

EL
• The upper limit for gestation does not apply when
there are significant fetal abnormalities diagnosed

PT
by the Medical Board.
• The identity and personal information of a woman

N
whose pregnancy has been terminated shall
remain confidential, unless disclosed to an
individual authorized by current legislation.
Mental Healthcare Act, 2017
• Individuals who operate a mental health
establishment without proper registration are

EL
subject to penalties ranging from a minimum of
five thousand rupees to a maximum of fifty
thousand rupees for the first offense.

PT
• For a second offense, the penalty increases to a
minimum of fifty thousand rupees and may extend
N
up to two lakh rupees.
• Subsequent offenses carry a penalty ranging from
a minimum of two lakh rupees to a maximum of
five lakh rupees.

EL
• Individuals who intentionally assume the role of a
mental health professional within an unregistered

PT
mental health establishment, as defined by this
legislation, shall be subject to a penalty of up to
twenty-five thousand rupees.
N
Biomedical Waste Management
Rules of 2016
• According to the Bio Medical Waste Management
Rules of 2016, the responsibility for enforcing the

EL
BMWM Rules of 2016 rests with the occupant or
the individual who possesses administrative
authority over the healthcare institution.

PT
• The individual in question will bear responsibility
for any potential damage inflicted upon the
N
environment or individuals as a result of
mishandling the by-products produced by the
facility.
• In the event of any infringement, the individual in
possession shall bear responsibility for legal
proceedings pursuant to section 15 of the
Environment (Protection) Act of 1986.

EL
• Legal actions for the infringement of the provisions
under Section 15 of 'The Environment (P) Act,

PT
1986' encompass the following measures:
• Individuals may be subject to imprisonment for a

N
maximum period of five years, a fine of up to one
lakh rupees, or both.
• In the event of persistent violation, an extra
fine of up to five thousand rupees may be
imposed for each day of the infraction.

EL
• If the violation persists for more than one year
from the initial date of violation, the

PT
perpetrator may be subject to imprisonment
for a duration of up to seven years, as
N
determined by the respected courts.
The Transplantation of Human
Organs Act, 1994
• The Transplantation of Human Organs Act, 1994
was legislated by the Parliament in 1994 and

EL
became effective on February 4, 1995.
• The primary objective of the Act is to govern the

PT
extraction, preservation, and transplantation of
human organs for medical treatment and to

N
prohibit any commercial transactions involving
human organs.
• The Act includes comprehensive provisions
regarding
– the authorization for the removal of human organs,
– the preservation of human organs,

EL
– the regulation of hospitals that carry out the
removal, storage or transplantation of human
organs,

PT
– the responsibilities of the appropriate authority,
– the registration of hospitals and
N
– the consequences for offenses related to the
aforementioned matters.
Amendment in 2011
• The Transplantation of Human Organs Act, 1994
underwent amendments in 2011.

EL
• The revised legislation is currently referred to as
the Transplantation of Human Organs and Tissues

PT
Act (THOTA), 2011 and then Rules 2014.
• The Act includes several significant reforms aimed
N
at promoting organ donation.
– The modified Act includes the establishment of
“Retrieval Centres” to facilitate the retrieval of
organs from deceased donors and their
registration.
– The definition of "near relative" has been

EL
enlarged to encompass grandparents and
grandkids.

PT
– Swap Donation (Donor Exchange) is covered.
– The process of certifying brain death by the
N
Brain Death Certification Board has been
simplified, allowing for the inclusion of other
experts in this certification.
– An obligatory investigation and notification choice
to contribute in the event of the regrettable
occurrence of brain stem death of an intensive care
unit (ICU) patient, with the intention of organ
donation.

EL
– A 'Transplant Coordinator' is required to oversee
and manage all aspects pertaining to the extraction
or transplantation of human organs.

PT
– The National Human Organs and Tissues Removal
and Storage Network operates at multiple locations
N
and includes a regional network.
– National Database of Donors and Recipients to be
created
– A skilled technician has been authorized to
perform the removal of the eye in order to
facilitate eye donation.
– In order to safeguard the weak and
impoverished, stricter punishments have been

EL
established for the act of trading organs,
including imprisonment of up to 10 years and a

PT
fine of up to Rs One lakh.
– The Act has implemented stricter measures for
N
minors and foreign nationals, as well as a
complete ban on organ donation from those
with mental disabilities.
Transplantation of Human
Organs Act, 1994
• Individuals who provide their services to a hospital

EL
and engage in the unauthorized removal of human
organs for transplantation, either by conducting,

PT
assisting, or associating with such activities, shall
be subject to imprisonment for a maximum period
N
of five years and a fine not exceeding ten thousand
rupees.
When Medical Practitioner commits the
offense
• In the event that an individual is a registered
medical practitioner, the Appropriate Authority is

EL
required to inform the respective State Medical
Council.
• The Council will then take appropriate measures,

PT
which may include removing the individual's name
from the Council's register.
N
• For the first offense, the removal will be for a
duration of two years, whereas for subsequent
offenses, the removal will be permanent.
When Hospital commits the offense
• In the event that a company commits an offense
that is subject to punishment under this Act, all
individuals who were in a position of authority and

EL
responsibility for overseeing and managing the
company's business operations at the time the

PT
offense was committed, in addition to the
company itself, shall be considered culpable for the
offense.
N
• Consequently, they shall be subject to legal
proceedings and appropriate penalties.
• The intricate legal dynamics among hospitals, physicians,
and paramedical personnel give rise to challenges that
pose difficulties for courts in reaching resolutions.

EL
• The hospital bears both a vicarious and an intrinsic duty
of care, which can be considered as a corporate

PT
obligation, towards its patients.
• There exists a need not only to create initial standards of
care, but also to engage in ongoing monitoring of these
N
standards and implement proactive methods to ensure
their regular updates.
• https://www.ncbi.nlm.nih.gov/pmc/articles/PMC
5109761/

EL
• https://cdsco.gov.in/opencms/opencms/en/

PT
• https://www.pci.nic.in/RTI.html

N
• https://cpcb.nic.in/
N
PT
EL
 Medical Law

EL
Dr. Narendran Thiruthy
Rajiv Gandhi School of Intellectual Property Law
Indian Institute of Technology, Kharagpur

PT
N Lecture 19: Legal responsibility in Diagnostics
• Medical Devices Regulations
• Classification of Medical Devices

EL
• Central and State Licensing Authority
• Standardization of Diagnostic Methods

PT
• Regulations on Pre-natal diagnostics.

N
• Medical Devices
• Regulatory Law

EL
• Standardization
• Pre-natal diagnostics

PT
• Licensing Authority

N
Introduction
• Diagnostic laboratories are crucial components of
the healthcare system, furnishing vital data to

EL
physicians and clinicians to facilitate patient
treatment.

PT
• They have a vital function in the identification and
surveillance of illnesses, as well as in the
prevention and management of the transmission
of infections. N
• Ensuring quality maintenance in the diagnostic
laboratory is not a one-time task, but rather an
ongoing process that demands daily attention and
implementation at each stage.
• This can be guaranteed by -

EL
– Highly skilled and knowledgeable personnel
– The laboratory utilizes high-quality equipment that

PT
is meticulously maintained.
– Appropriate preservation of the specimen
N
– Appropriate manipulation of specimens by
laboratory personnel and others.
 EL
Existing Legal Framework

PT
N
Medical Devices Rules, 2017
• As part of the diagnostics regulation framework,
Medical Devices Rules, 2017 (“MD Rules”) govern

EL
medical device manufacturing, import, sale,
distribution, and quality and safety supervision.
• It categorizes risks, sets product standards, and

PT
sets license dates.
• The Medical Devices Rules, 2017 has undergone
N
several amendments thereafter.
Classification of Medical Devices
• The categorization of medical devices in India is
delineated in the Medical Devices Rules, 2017.

EL
• The categorization is determined by the intended
application and the corresponding hazards, and it

PT
is partially in accordance with the criteria
established by the Global Harmonization Task
Force (GHTF).
• N
The classification system in India comprises four
distinct classes.
• Class A: Low-risk devices.
– Includes devices such as thermometers and
blood pressure monitors.
– Subject to relatively simple regulatory

EL
requirements.

PT
• Class B: Low to moderate risk.
– Examples include hypodermic needles, suction

N
equipment and bone fixation plates.
– Requires compliance with more regulatory
controls compared to Class A.
• Class C: Moderate to high risk.
– Devices like cardiac stents and orthopedic
implants fall into this category.
– Subject to more rigorous regulatory scrutiny
and may require clinical data.

EL
• Class D: High-risk devices.

PT
– Implantable devices such as implantable
defibrillators and drug-eluting stents.
N
– Requires the highest level of regulatory control,
including comprehensive data on safety and
efficacy.
• It is expected that all medical equipment would
adhere to the standards outlined below.
a) The Central Government has established a standard for
medical devices, specifically those outlined by the
Bureau of Indian Standards (BIS).

EL
b) In cases where there is an absence, according to the
standards established by the International Organization
for Standardization (ISO), the International Electro

PT
Technical Commission (IEC), or any other relevant
Pharmacopoeial standards.

N
c) In cases when both (a) and (b) are not present,
adherence to the manufacturer's verified requirements is
required.
Licensing Authorities
Licensing
Authorities:

EL
PT
Central State
Licensing Licensing
Authority N Authority
Central Licensing Authority
Rule 8 (1) of the Medical Rules, 2017: “The Central Licensing
Authority shall be the competent authority for enforcement of
these rules in matters relating to-

EL
(i) import of all Classes of medical devices;
(ii) manufacture of Class C and Class D medical devices;

PT
(iii) clinical investigation and approval of investigational
medical devices;

N
(iv) clinical performance evaluation and approval of new in
vitro diagnostic medical devices and;
(v) co-ordination with the State Licensing Authorities.”
State Licensing Authority
Rule 8 (2) of the Medical Rules, 2017: “The State
Drugs Controller, by whatever name called, shall be

EL
the State Licensing Authority and shall be the
competent authority for enforcement of these rules
in matters relating to-

PT
(i) manufacture for sale or distribution of Class
A or Class B medical devices;
N
(ii) sale, stock, exhibit or offer for sale or
distribution of medical devices of all classes.”
Registration of Laboratory
• To request registration of a medical device testing
laboratory for the purpose of testing or evaluating
medical devices on behalf of a manufacturer, an

EL
application must be submitted to the Central
Licensing Authority via the online portal.

PT
• A registration that has been granted will stay valid
indefinitely, unless it is suspended or terminated.

N
However, the registration holder must pay a
registration retention fee in order to maintain the
validity of the registration.
Conditions for registration of medical
device testing laboratory
• The location where the test or evaluation will take
place must have adequate lighting, ventilation and

EL
space.
• Prior to the granting of the registration to any
laboratory, the premises must undergo an

PT
inspection by the Medical Device Officer.
• If the purpose is to conduct experiments that
N
involve the utilization of animals, the applicant
must establish an animal facility and adhere to the
supplementary criteria.
Clinical Establishments Act, 2010
• The Clinical Establishments Act aims to register
and regulate clinical establishments in the country.

EL
Its purpose is to define and enforce minimum
standards for the facilities and services offered by

PT
these establishments.
• The objective of the Clinical Establishment Act is to
provide access to a comprehensive database of
N
authorized Clinical Establishments.
Definition of Clinical Establishments
Section 2 (c) “clinical establishment” means—
“…. (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,

EL
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,

PT
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

N
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”
Conditions for Registration
• The Clinical Establishments must meet the required
minimum criteria of facilities and services for
registration and renewal.

EL
• The personnel must meet the stipulated minimum
standards.
• Requirements for the upkeep of records and submission

PT
of reports as specified;
• The clinical establishment is obligated to offer medical
examination and treatment, utilizing the existing staff
N
and facilities, to stabilize the emergency medical
condition of any individual who arrives or is transported
to the establishment.
Other Conditions
• Exhibit the Registration certificate conspicuously.
• Exhibit the fees levied for each category of service

EL
rendered and amenities offered, prominently in
both the local language and English, for the

PT
convenience of patients.
• Apply the rates for each category of procedures and

N
services within the range of rates established and
released by the Central Government periodically, in
collaboration with the State Governments.
• Ensure adherence to the Standard Treatment
Guidelines established and released by the Central
Government or State Government, as applicable.
• Preserve and furnish Electronic Medical/Health
Records of each patient, as prescribed and issued

EL
by the Central Government or State Government,
as applicable, periodically.

PT
• Ensure the proper upkeep and dissemination of
information and statistics in compliance with all
N
other relevant and currently enforced laws and
regulations.
Minimum Standards for Medical Diagnostic
Laboratories (or Pathological Laboratories)
• The Government of India introduced the
‘Minimum Standards for Medical Diagnostic

EL
Laboratories’ as a schedule in Clinical
Establishments (Central Government) Rules, 2012
• Clinical establishments typically utilize laboratory

PT
or other medical equipment to conduct various
diagnostic or investigative services, including but
N
not limited to pathological, bacteriological,
genetic, radiological, chemical, and biological
investigations.
• The afore-mentioned institutions are required to
adhere to the prescribed minimum requirements for
facilities and services outlined in the Schedule.
• This notification has categorized these establishments
into three distinct entity classifications:

EL
• Basic Composite
• Medium

PT
• Advanced
• The requirements for each category of establishment
N
have been further divided into “desirable” and
“essential.”
• The standards cover the following areas:
– Infrastructure
– Human Resources

EL
– Medical instruments and testing tools
– Procedures and rules

PT
– Legal and government rules
– Upkeep of records
N
Drawbacks
• The legislation presents the following drawbacks that
have resulted in a disparity between desired goals and
actual results.

EL
• According to the statutory framework, the Clinical
Establishments Act is exclusively applicable to states

PT
that voluntarily decide to implement it.
• In the states where the Act is currently in effect and

N
operational, the regulatory role is restricted to the
issuance of laboratory registrations and the
maintenance of a registry of clinical institutions.
• Laboratories engage with the regulatory
authority just during the registration process,
whereupon they provide documentation
demonstrating their adherence to the

EL
specified standards for registration.
• Once a permanent registration is obtained,

PT
there exists no system for evaluating the
operational efficiency of laboratories or
N
addressing patient grievances under the Act.
Shops and Establishments Law
• Private Laboratories are typically subject to
regulations in accordance with the provisions

EL
outlined in the Shops and Establishments law,
which governs matters such as holidays,
cleanliness standards, and working hours.

PT
• It is obligatory for such entities falling under the
purview of the Act to seek registration under the
N
corresponding state legislation.
• It is not necessary for the central and state
government entities to acquire registration under
the Shop and Establishment Act.
• The Certificate or licensing serves as a

EL
fundamental registration for the business.
• This Certificate is issued for the purpose of

PT
acquiring various other licenses and registrations
related to business operations.
• It functions as evidence of the existence of the
N
business establishment.
The Pre-Conception and Pre-Natal Diagnostic
Techniques (Prohibition of Sex Selection) Act of 1994
• The Pre-Conception and Pre-Natal Diagnostic
Techniques Act of 1994 prohibits the practice of pre-

EL
natal sex determination. The regulatory framework was
widened after 2003 amendment.

PT
• Any genetic counselling center, genetic laboratory, or
genetic clinic that provides counselling or performs pre-
natal diagnostic techniques, such as in vitro fertilization
N
(IVF) with the capability of sex selection
(Preimplantation genetic diagnosis), are subject to
regulation under the PCPNDT Act and are prohibited.
• The diagnostic laboratories sector in India is anticipated
to have substantial expansion due to increasing
healthcare demand.
•

EL
It is important to acknowledge that the lack of
regulation within this industry remains a significant
worry, since it offers potential risks to patients.

PT
• There exists a lack of awareness among individuals
regarding the distinction between an accredited

• N
laboratory and a non-accredited laboratory.
The absence of legislation is the primary reason for this
situation.
• https://pib.gov.in/indexd.aspx

• https://nabl-india.org/

EL
• https://cdsco.gov.in/opencms/opencms/en/

PT
• https://www.pci.nic.in/RTI.html
N
N
PT
EL
 Medical Law

EL
Dr. Narendran Thiruthy
Rajiv Gandhi School of Intellectual Property Law
Indian Institute of Technology, Kharagpur

PT
N Lecture 20: Penalties for non-compliance
• Necessity of regulatory compliance
• Regulatory Authorities
• Central Drugs Standard Control Organization

EL
(CDSCO)
• Indian Council of Medical Research (ICMR)

PT
• The National Accreditation Board for Testing and
Calibration Laboratories (NABL)
• Penalties for non-compliance under specific Laws
N
• Standardization
• Accreditation

EL
• Testing and calibration
• Quality Management System (QMS)
•

PT
Regulatory Compliance
• Penalties

N
Introduction
• All sectors, including medical laboratories, are required
to comply with regulatory standards.
•

EL
Regulatory compliance serves to foster accreditation,
adherence to legal requirements, ethical
considerations, and the enhancement of patient safety.

PT
• Non-compliance within the healthcare sector is an
essential aspect that warrants careful consideration,

N
since it carries significant implications such as the
imposition of fines, legal repercussions, and other
sanctions.
Necessity of regulatory compliance
• There are several imperative justifications for the
necessity of regulatory compliance in medical

EL
laboratories.

PT
• Quality assurance: Ensuring adherence to
regulations ensures that the laboratory produces
N
accurate, reliable, and uniform outcomes for both
patients and medical practitioners.
• Patient safety: which pertains to the measures and
practices implemented within healthcare settings to
minimize the risk of harm. Regulatory compliance plays
a crucial role in ensuring patient safety by mitigating the
occurrence of errors, contamination, and other adverse

EL
incidents during laboratory testing.

PT
• Legal Compliance: A number of laws, pertaining to data
security, health and safety, and medical equipment,

N
must be followed by medical laboratories. It is essential
to abide by these regulations in order to prevent fines,
penalties, and other consequences.
• Ethics: Medical laboratories regularly examine human
samples and deal with sensitive patient data, raising
ethical concerns. Maintaining the public's trust and
confidence requires adhering to ethical guidelines

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pertaining to informed consent and patient
confidentiality.

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• Accreditation: Many laboratories apply for
accreditation from outside agencies to demonstrate
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that they adhere to quality standards and laws. Gaining
accreditation can help a laboratory increase revenue,
attract more customers, and enhance its reputation.
 Regulatory Authorities
• The three important regulatory bodies in India:
• Central Drugs Standard Control Organization

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(CDSCO);
• Indian Council of Medical Research;

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• The National Accreditation Board for Testing
and Calibration Laboratories (NABL)
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Central Drugs Standard Control
Organization (CDSCO)
• The Central Drugs Standard Control Organization
(CDSCO) serves as the principal regulating

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authority for medical devices within the
jurisdiction of India.

PT
• The CDSCO is tasked with the responsibility of
supervising the importation, production,
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commercialisation, and dissemination of medical
devices within the nation.
• The Central Drugs Standard Control Organization
(CDSCO) is responsible for ensuring that medical
devices adhere to established safety, quality, and
efficacy criteria.

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• The Central Drugs Standard Control Organization
(CDSCO) carries out inspections and audits in order
to verify the adherence of medical device firms to

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standards pertaining to safety, quality, and efficacy.
• Additionally, it offers direction regarding the
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procedure of approval and the prerequisites for
distinct categories of products.
• Medical device Manufacturers are required to
acquire a License from the Central Drugs Standard
Control Organization (CDSCO).
• An online registration gateway for medical devices
is maintained by the Central Drugs Standard

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Control Organization (CDSCO).
• The online portal facilitates the submission of

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applications by manufacturers for the registration
of their medical equipment, thereby enhancing the
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efficiency of the registration process.
Indian Council of Medical Research
• The Indian Council of Medical Research (ICMR),
located in New Delhi, serves as the pre-eminent
institution in India responsible for the

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development, coordination, and advancement of
biomedical research.

PT
• ICMR stands as one of the most ancient medical
research organizations globally.

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• The objective of ICMR is to strive towards the
improvement of public health and wellness among
the Indian population.
• The research priorities of the Council align with the
National health priorities, encompassing areas
such as
– the control and management of communicable diseases,
– fertility control,

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– maternal and child health,
– control of nutritional disorders,
– development of alternative strategies for health care

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delivery,
– containment of environmental,
–
–
–
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occupational health problems within safety limits
major non-communicable diseases
Mental health research and drug research
• The Indian Council of Medical Research (ICMR) has
undergone significant transformation from its
previous designation as the Indian Research Fund
Association (IRFA).

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• The Indian Council of Medical Research (ICMR) is
also responsible for hosting the Clinical Trials

PT
Registry-India (CTRI).
• The mission of the Clinical Trials Registry-India

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(CTRI) is to ensure that all clinical trials conducted
in India are prospectively registered, i.e. before the
enrolment of the first participant.
National Accreditation Board for Testing and
Calibration Laboratories (NABL)
• The National Accreditation Board for Testing and
Calibration Laboratories (NABL) is an independent

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organization operating under the supervision of
the Department of Science and Technology,

PT
Government of India.
• Its primary objective is to grant accreditation to

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clinical laboratories in the country for their testing
and calibration activities.
• The sole accreditation agency approved by the
Government of India is responsible for conducting
third-party assessments of the quality and
technical competency of laboratories.

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• NABL also establishes connections with the Asia
Pacific Laboratory Accreditation Cooperation and
the International Laboratory Accreditation

PT
Cooperation by means of sharing links.
• NABL plays a crucial role in fostering trust and
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ensuring high quality standards in laboratories by
assessing their competence.
• NABL offers accreditation in various significant
areas of Science and Engineering including
Biological, Chemical, Electrical, Electronics,
Mechanical, Fluid-Flow, Non-Destructive,
Photometry, Radiological, Thermal, and Forensics

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disciplines within testing facilities. Additionally,
NABL provides accreditation in Electro-Technical,
Mechanical, Fluid Flow, and Thermal disciplines.

PT
• Accreditation is a formal acknowledgement of a
healthcare organization's adherence to established
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standards, which is substantiated by an impartial
external evaluation of the organization's
performance in regard to these standards.
PENALTIES FOR NON-

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COMPLIANCE UNDER

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SPECIFIC LAWS
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Medical Devices Rules
• All manufacturers or importers of medical devices
across all classifications are obligated to undergo

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compulsory registration of their medical
equipment with the Drugs Controller General of
India (DCGI).

PT
• In the event that a producer or importer does not
secure the necessary registration, they will be
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unable to distribute their medical equipment
within the Indian market.
• The registration process is considered complete
once the individual has obtained the Registration
Number.
• It is imperative for all manufacturers and importers

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to prominently exhibit the registration number on
the label of their products.

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• After a manufacturer or importer completes the
registration process for their medical devices, they
are required to adhere to the Quality Management
N
System (QMS) with strict compliance.
• In the event that the Drug Controller General of
India (DCGI) identifies any instances of non-
compliance with the Quality Management System
(QMS), it possesses the authority to suspend or

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revoke the registration.
• The Central Licensing Authority (CLA) is

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responsible for the authentication of papers and
the examination of the quality and safety of

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medical device classifications in response to
instances of failure or complaints.
• If the registered manufacturer or importer fails to
adhere to any provision of the Medical Device
Rules, the Clinical Laboratory Accreditation (CLA)
provides them with the opportunity to present a
written explanation as to why an order for the

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cancellation of their registration should not be
issued.

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• Upon receiving this explanation, the CLA has the
authority to either cancel or suspend the
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registration, either in its entirety or in relation to
any medical device associated with the identified
failure, for a duration determined by the CLA.
Clinical Establishments Act, 2010
• Operating a clinical establishment without
registration is prohibited.

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• A financial penalty will be assessed if a clinical
establishment is operating without registration.

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• First Contravention- a maximum penalty of Fifty
Thousand rupees
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• Second Contravention– a maximum penalty of Two
Lakh Rupees
• Any further violation may result in a fine of up to
five Lakh rupees.
• If a clinical establishment fails to pay issued fines,
it will face consequences.

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• The district administration has the authority to
recover the amount and close down the clinical

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establishment.
• However, Appeals can be made for any orders
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issued by the Registering Authority.
Shops and Establishments Law
• The penalties prescribed by the Shops and
Establishments Act differ among states.

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• It may consist of monetary or operational
consequences, with imprisonment being a

PT
possibility in certain instances.
• Although the monetary values are substantial, the
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possibility of receiving a closure notice due to non-
compliance also exists.
The Pre-Conception and Pre-Natal Diagnostic
Techniques (Prohibition of Sex Selection) Act of 1994
• Section 22-26 provides penalties for contravention of the
provisions of the Act.

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• Section 22 explicitly forbids the promotion or marketing of any
clinic, laboratory, or similar establishment that is engaged in
the practice of radiology, imaging techniques, or any other

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procedures associated with the facility for determining the sex
or sex selection of a fetus before birth.

•
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Violation of the provision stated in this section would result in
penalties, including a maximum prison sentence of three years
and a fine that can go up to ten thousand rupees.
• Section 23 of the act pertains to the actions of
gynecologists, medical practitioners, owners of
genetic laboratories, counselling centers, clinics,
and employees of such establishments who
provide professional or technical services. If any of

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these individuals violate any provisions outlined in
this act while delivering their services, then,

PT
– the individual will be subject to a prison sentence of up
to three years, along with a fine of up to ten thousand
rupees.

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– Upon further conviction, this penalty may escalate to a
maximum of five years of imprisonment, accompanied
by a fine of up to fifty thousand rupees.
• Additionally, the relevant authority may notify the
state medical council of the name of the medical
person involved in the contravention.

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• The purpose of this is to take appropriate action,
suspend registration if charges are filed, and

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remove the individual's name from the council's
register for a period of five years upon conviction,
and permanently upon subsequent convictions.
N
• According to Section 23 of the act, if any person,
including the husband or relatives, is found guilty
of forcing a pregnant woman to undertake any pre-
natal diagnostics, which is prohibited under the

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Act, they may face jail for up to three years and a
fine of fifty thousand rupees.

PT
• Upon subsequent conviction, the individual may
face imprisonment for a maximum of five years
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and a fine of up to 1 lakh rupees.
• Section 26 pertains to the transgressions made by
companies, whether done with awareness or

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carelessness. If the offense is committed with the
approval of the individual in charge of the
company's management, they will be held

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accountable and penalized appropriately.

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• In order to obtain comparability, standardization of diagnostic
techniques is essential. The primary objectives of the
regulations are twofold: firstly, to mitigate the problem of

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inaccurate diagnosis and secondly, to ensure quality treatment
to the patients.

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• The stringent penalties ensure that diagnostic laboratories and
clinical establishments adhere to the quality standards and

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conditions prescribed by the regulatory bodies.
• https://cdsco.gov.in/opencms/opencms/en/Ho
me/

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• https://main.icmr.nic.in/

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• https://nabl-india.org/

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