Handouts For Health Law

Handouts
On
HEALTH LAW
by
DR. ABHINAV BHARDWAJ
1
HANDOUTS ON HEALTH LAW BY DR. ABHINAV BHARDWAJ
CONTENTS
1. INTRODUCTION TO HEALTH LAW: CONCEPT, DEFINITION OF HEALTH, AND

THE RIGHT TO HEALTH .................................................................................................... 4
2. CONSTITUTIONAL PROTECTIONS FOR HEALTH: FUNDAMENTAL RIGHTS
AND DIRECTIVE PRINCIPLES .......................................................................................... 6
3. INTERNATIONAL LAW AND HEALTH: AND IMPACT ................................................ 7
4. TRIPS AND PUBLIC HEALTH: KEY PROVISIONS AND IMPLICATIONS ................ 9
5. ALMA-ATA AND DOHA DECLARATIONS: SIGNIFICANCE IN HEALTH LAW .... 11
6. ROLE OF THE WORLD HEALTH ORGANIZATION IN PUBLIC HEALTH ............ 13
7. INTERNATIONAL HEALTH REGULATIONS AND GLOBAL HEALTH
GOVERNANCE..................................................................................................................... 15
8. COMPARISON OF INDIGENOUS AND ALLOPATHIC HEALTH SYSTEMS ........... 17
9. MEDICAL ETHICS: DEVELOPMENT, CONCEPT, AND IMPORTANCE ................. 19
10. DUTIES OF DOCTORS AND RIGHTS OF PATIENTS ................................................... 22
11. HOSPITAL AS AN INDUSTRY AND APPLICABILITY OF LABOUR LAWS ............. 24
12. MEDICAL NEGLIGENCE: UNDERSTANDING LIABILITY IN TORTS AND
CONSUMER PROTECTION ACT 1986 ............................................................................ 26
13. CONCEPTS OF VICARIOUS LIABILITY AND CRIMINAL LIABILITY IN
MEDICAL PRACTICE......................................................................................................... 28
14. LAW RELATING TO TERMINATION OF PREGNANCY AND ETHICAL
CONSIDERATIONS ............................................................................................................. 30
15. ORGAN TRANSPLANTATION: LEGAL AND ETHICAL ASPECTS ........................... 32
16. REGULATIONS ON PRE-NATAL DIAGNOSTIC TECHNIQUES ................................ 34
17. ARTIFICIAL INSEMINATION AND SURROGACY: LEGAL FRAMEWORK .......... 36
18. LEGALITY AND ETHICAL DEBATES ON EUTHANASIA .......................................... 38
19. MENTAL HEALTH CARE: LEGAL FRAMEWORK AND PATIENT RIGHTS .......... 40
20. OFFENCES AFFECTING PUBLIC HEALTH AND RELEVANT LEGAL
PROVISIONS......................................................................................................................... 42
21. EPIDEMIC LAWS AND PUBLIC HEALTH MANAGEMENT ...................................... 44
22. PUBLIC HEALTH POLICIES: AYUSHMAN BHARAT BILL, 2018, AND ITS
IMPACT.................................................................................................................................. 46
23. NATIONAL HEALTH MISSION AND GOALS ................................................................ 48
24. NATIONAL HEALTH POLICY, 2017 ................................................................................. 50
25. PATENT LAWS AND ACCESS TO MEDICINE: BALANCING RIGHTS AND
ACCESS .................................................................................................................................. 52
2
26. PRADHAN MANTRI BHARTIYA JANAUSHADHI PARIYOJANA (PMBJP) AND ITS
ROLE IN HEALTH CARE ................................................................................................... 54
27. NATIONAL LIST OF ESSENTIAL MEDICINE AND ITS IMPORTANCE .................. 56
28. NITI AAYOG ON HEALTH AND THE RELEVANCE OF AAROGYA SETU IN
PUBLIC HEALTH ................................................................................................................. 58
29. MEDICAL EXPERIMENTATION AND CLINICAL TRIALS: ETHICAL AND LEGAL
REQUIREMENTS ................................................................................................................. 61
30. INFORMED CONSENT, PRIVACY, AND CONFIDENTIALITY IN MEDICAL
PRACTICE............................................................................................................................. 63
31. MEDICAL EVIDENCE AND THE ROLE OF MEDICAL WITNESS IN LEGAL
PROCEEDINGS .................................................................................................................... 65
32. LEGAL PROCEDURES AND CONSIDERATIONS IN THE EXAMINATION OF A
LIVING PERSON.................................................................................................................. 67
33. LEGAL ASPECTS OF DEATH: POST-MORTEM EXAMINATION AND DYING
DECLARATION .................................................................................................................... 69
34. HEALTH LAW AND JUDICIARY: KEY CASES AND JUDGMENTS .......................... 71
35. UNDERSTANDING HEALTH INSURANCE: TYPES AND LEGAL FRAMEWORK 73
36. ANALYZING PUBLIC SERVICE RELATED SITUATIONS AND LEGAL
IMPLICATIONS OF NEGLIGENCE ................................................................................. 75
37. DISPOSAL OF MEDICAL AND SURGICAL WASTE: LEGAL GUIDELINES ........... 77
38. LIABILITIES OF HEALTH CARE UNITS: PUBLIC VS. PRIVATE SECTOR ........... 79
39. CASE STUDIES ON MEDICAL NEGLIGENCE AND LEGAL OUTCOMES ............. 81
40. ANALYSIS OF RECENT HEALTH POLICIES AND THEIR LEGAL IMPLICATIONS
................................................................................................................................................. 83
3
INTRODUCTION TO HEALTH LAW: CONCEPT, DEFINITION OF HEALTH, AND
THE RIGHT TO HEALTH
Introduction to Health Law

Health Law encompasses the federal, state, and local laws, regulations, and policies that
govern the healthcare industry. This includes laws applicable to the behavior of healthcare
providers, insurers, patients, and institutions. Health law touches on nearly every facet of the
system, ranging from the operation of healthcare facilities to the ethical concerns of medical
practice and the impact of technology on health-related activities.
In India, Health Law is an intricate web of legal directives that stem from the Constitution,
statutes passed by the Parliament and state legislatures, regulations framed by various
regulatory bodies, and judgements from the courts. The Indian legal framework for health
integrates principles of public health, insurance, information technology, consumer protection,
and human rights.
Definition of Health
The definition of health has evolved over time and varies between different legal and medical
paradigms:
 World Health Organization (WHO) Definition: Health is defined by the WHO as "a
state of complete physical, mental, and social well-being and not merely the absence of
disease or infirmity." This holistic definition emphasizes a comprehensive approach to
health, integrating physical, mental, and social health, and not merely focusing on the
absence of disease.
 Legal Definitions in India: In the context of Indian law, health is often tied to legal
interpretations given in various judicial decisions and policies. For instance, health-
related legal actions in India might often refer to the right to live with human dignity,
enshrined under Article 21 of the Constitution.
The Right to Health

Constitutional Provisions
The Right to Health in India, although not explicitly stated as a fundamental right in the
Constitution, is impliedly covered under Article 21, which guarantees a right to life and
4
personal liberty. This has been broadly interpreted by the Supreme Court to include the right to
health. Additionally, various Directive Principles of State Policy, particularly Articles 39(e),
41, and 47, place duties upon the state to improve public health standards and ensure the welfare
of its citizens.
Statutory Laws
Several Indian statutes also address health concerns:
 The Indian Medical Council Act, 1956: Governs the standards of medical education
and recognition of medical qualifications in India.
 The Drugs and Cosmetics Act, 1940: Regulates the import, manufacture, distribution,
and sale of drugs and cosmetics.
 The Consumer Protection Act, 2019: Protects the rights of consumers, including those
of patients, thereby indirectly influencing healthcare standards by handling medical
negligence cases.
Judicial Interpretations
Indian courts have played a pivotal role in the evolution of the right to health. Landmark
judgments have often expanded the interpretation of health rights, such as in the cases of:
 Paschim Banga Khet Mazdoor Samity vs State of West Bengal (1996): The Supreme
Court declared that the government must provide adequate medical facilities to every
citizen, and the lack of financial resources cannot be a reason for the state to neglect
this duty.
 Parmanand Katara vs Union of India (1989): Highlighted the right of every injured
person to get timely medical treatment, affirming that preserving human life is of
paramount importance.
International Influence
India is a signatory to several international treaties that influence its health law policies, such
as the International Covenant on Economic, Social and Cultural Rights (ICESCR), which
recognizes the right of everyone to the highest attainable standard of physical and mental
health. Compliance with these international norms also drives reforms in national health
policies and laws.
5
CONSTITUTIONAL PROTECTIONS FOR HEALTH: FUNDAMENTAL RIGHTS
AND DIRECTIVE PRINCIPLES
In India, the Constitution does not explicitly mention the "right to health" as a fundamental
right. However, the right to health is implicitly protected under several provisions of the
Constitution, particularly under the ambit of the Right to Life enshrined in Article
2Additionally, the Directive Principles of State Policy provide guidelines to the State to ensure
social and economic welfare, which includes the improvement of public health.
Fundamental Rights Related to Health
Article 21 - Right to Life and Personal Liberty
 Interpretation: The Supreme Court of India has broadly interpreted Article 21 to
include the right to health as an integral part of the right to life. This interpretation
mandates the State to ensure access to health facilities and services to all citizens.
 Key Cases:
 Paschim Banga Khet Mazdoor Samity vs State of West Bengal (1996): The
Supreme Court emphasized that it is the constitutional obligation of the State to
provide adequate medical services to every citizen.
 Vincent Panikurlangara vs Union of India (1987): The Court held that the
State’s responsibility to maintain health services is a facet of Article 21.
Article 23 - Prohibition of traffic in human beings and forced labor
 This article, while primarily addressing issues like human trafficking and forced labor,
indirectly impacts health rights by tackling conditions conducive to health issues and
exploitations that have dire health consequences.
Directive Principles of State Policy Relevant to Health
The Directive Principles, although not enforceable by any court, are fundamental in the
governance of the country, and it is the duty of the State to apply these principles in making
laws.
Article 39(e)
 It directs the State to ensure that the health and strength of workers, men and women,
and the tender age of children are not abused and that citizens are not forced by
economic necessity to enter avocations unsuited to their age or strength.
 Implication: Encourages the State to enact and enforce labor laws that prevent adverse
health effects due to labor conditions.
6
Article 41
 It directs the State to make effective provision for securing the right to work, to
education, and to public assistance in cases of unemployment, old age, sickness, and
disablement.
 Implication: This article encompasses the state’s responsibility towards individuals
who are unable to work due to health reasons, thereby indirectly supporting their right
to health.
Article 47
 It is one of the most direct references to health in the Directive Principles. It directs the
State to raise the level of nutrition and the standard of living and to improve public
health.
 Implication: This principle mandates the State to actively engage in the improvement
of health services and to ensure adequate nutrition to its citizens.
Article 48A
 It directs the State to protect and improve the environment and to safeguard the forests
and wildlife of the country.
 Implication: Environmental health, which is crucial for overall public health, is
emphasized under this article.
Intersection of Fundamental Rights and Directive Principles in Health Law

The Supreme Court has consistently used the Directive Principles in conjunction with the
Fundamental Rights to broaden the scope of health protections under the law. For instance, in
matters related to environmental pollution, the Court has linked the right to a healthy
environment as part of the Right to Life under Article 21, guided by the principles laid out in
Article 48A.
INTERNATIONAL LAW AND HEALTH: AND IMPACT
Introduction of International Law and Health

International health law primarily refers to the collective body of legal norms, agreements, and
principles developed by countries and international organizations to address global health
issues. These laws facilitate international cooperation and set standards to manage health risks,
7
promote public health, and enhance health care equity and access on a global scale. Important
international health law includes treaties, conventions, resolutions, and regulations that have
been established by entities such as the World Health Organization (WHO), the United Nations
(UN), and other global health bodies.
Key International Agreements and Instruments

World Health Organization (WHO)
 WHO Constitution (1946): Serves as a foundational treaty and states that the
enjoyment of the highest attainable standard of health is one of the fundamental rights
of every human being.
 International Health Regulations (IHR, 2005): Legally binding on 196 countries,
including India, these regulations aim to prevent and respond to acute public health
risks that have the potential to cross borders.
Other Key Treaties and Declarations
 The Alma-Ata Declaration (1978): Emphasizes the importance of primary health care
and sets an agenda for global health and development.
 The Sustainable Development Goals (SDGs, 2015): Adopted by all United Nations
Member States, including India, the SDGs include specific goals for health such as Goal
3 which aims to ensure healthy lives and promote well-being for all at all ages.
Impact of International Health Law on India
Policy Adoption and Adaptation

 India aligns its health policies with international standards and commitments. For
example, India's commitment to the SDGs has led to initiatives like the National Health
Mission which aim to improve health outcomes aligned with these global goals.
Legal and Regulatory Framework
 International treaties and guidelines influence Indian laws and regulations. For instance,
the Food Safety and Standards Authority of India (FSSAI) incorporates international
food safety standards established by the Codex Alimentarius Commission to regulate
and ensure food safety in India.
Public Health Preparedness and Response
8
 India’s compliance with the IHR (2005) involves developing core capacities for
surveillance and response to public health emergencies of international concern. This
was evident during the COVID-19 pandemic when India followed WHO guidelines and
protocols to manage and mitigate the crisis.
Access to Medicines
 India adheres to international agreements such as the Agreement on Trade-Related
Aspects of Intellectual Property Rights (TRIPS) which impacts the availability,
affordability, and accessibility of medicines. India has also used provisions allowed
under TRIPS to issue compulsory licenses for essential drugs, thereby making them
more accessible for its population.
Challenges in Implementation
While international laws provide a framework for health policy, their implementation often
faces challenges such as:
 Resource Constraints: Limited resources can hinder the effective implementation of
international health standards, especially in developing countries like India.
 Policy Prioritization: Balancing international commitments with domestic needs and
priorities can be challenging.
 Legal Harmonization: Incorporating international health laws into domestic legal
systems can be complex and requires legislative review and possible amendments.
TRIPS AND PUBLIC HEALTH: KEY PROVISIONS AND IMPLICATIONS
Introduction to TRIPS
The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) is an
international legal agreement between all the member nations of the World Trade Organization
(WTO). Established in 1995, TRIPS sets down minimum standards for many forms of
intellectual property (IP) regulation as applied to nationals of other WTO Members. It was
negotiated at the end of the Uruguay Round of the General Agreement on Tariffs and Trade
(GATT) in 1994 with the goal of harmonizing intellectual property legislation across member
countries.
9
Key Provisions Related to Public Health
Patents and Medicines
 TRIPS requires member states to grant patents in all fields of technology, including
pharmaceuticals, which must be protected for at least 20 years from the date of filing.
This provision impacts access to affordable medicines as it allows pharmaceutical
companies to maintain monopolies over their inventions, potentially leading to higher
drug prices.
Compulsory Licensing
 Article 31 of TRIPS permits member countries to use the subject matter of a patent
without the authorization of the right holder, under certain conditions. This is known as
compulsory licensing, and it is particularly significant for public health as it can be used
by governments to manufacture generic versions of patented medicines during health
crises, thus improving access to essential drugs.
Parallel Importation
 TRIPS allows for the exhaustion of IP rights, which enables the parallel importation of
patented drugs. This means that countries can import cheaper versions of patented
medicines from other countries where they are sold at lower prices, thus enhancing
access to affordable medication.
Implications for Public Health in India

Access to Medicines
 TRIPS has had a significant impact on India's pharmaceutical sector and access to
medicines. Prior to TRIPS, India did not grant product patents on medicines, allowing
domestic companies to produce generic versions of drugs patented elsewhere. Post-
TRIPS, India had to amend its patent laws (Indian Patent Act, 1970) to comply with the
TRIPS mandate of providing product patents, which has raised concerns about the
availability and affordability of medicines.
Compulsory Licences
 India has utilized the provision of compulsory licenses as a tool to ensure that essential
drugs remain accessible. For instance, in 2012, the Indian Patent Office granted a
compulsory license to a generic drug manufacturer for a cancer treatment drug that was
10
patented by a multinational company, citing the unaffordable cost of the drug as a
barrier to access.
Public Health Safeguards
 India's approach to implementing TRIPS includes several safeguards to protect public
health. These include provisions for compulsory licensing, government use, and parallel
imports. Additionally, India’s patent law includes strict criteria for patentability, which
prevents 'evergreening' – a practice where patent holders make slight modifications to
extend patent protection.
International and Domestic Critiques

 International Pressure: India has faced significant international pressure, particularly
from developed countries and multinational pharmaceutical corporations, to tighten its
IP laws beyond what TRIPS requires.
 Domestic Advocacy: On the other hand, health advocates in India argue for the
maintenance of a balanced approach to IP that considers public health needs, advocating
for the use of TRIPS flexibilities to ensure access to affordable healthcare.
ALMA-ATA AND DOHA DECLARATIONS: SIGNIFICANCE IN HEALTH LAW
Alma-Ata Declaration
The Alma-Ata Declaration emerged from the International Conference on Primary Health Care
held in Alma-Ata, Kazakhstan in 1978, under the auspices of the World Health Organization
(WHO) and the United Nations Children's Fund (UNICEF). This declaration is significant as
it was the first international declaration underlining the importance of primary healthcare.
Key Provisions
 Primary Health Care Approach: The declaration emphasized that primary health care
(PHC) is key to attaining an acceptable level of health for all citizens worldwide. PHC
was described as essential health care based on practical, scientifically sound, and
socially acceptable methods and technology.
 Health as a Fundamental Human Right: The declaration asserts that health, defined
as a state of complete physical, mental, and social well-being, is a fundamental human
right.
11
 Call for Action: It calls for global action to protect and promote the health of all people,
highlighting the importance of community participation and the role of the state in
health care.
Significance in Health Law
 Influence on Policy: The Alma-Ata Declaration has influenced health policies globally
by prioritizing equitable access to health services and the integration of health into all
aspects of development.
 Legal Frameworks: In India, this declaration influenced the development of health-
related legal frameworks that support the expansion of primary health care services,
especially in rural areas, as part of the broader goal of achieving health for all.
Doha Declaration
The Doha Declaration on the TRIPS Agreement and Public Health was adopted by the WTO
Ministerial Conference in Doha, Qatar, in 200It addressed tensions between international
intellectual property agreements and public health concerns, specifically in the context of
access to medicines.
Key Provisions
 Flexibilities of TRIPS: The declaration affirms that the TRIPS Agreement does not and
should not prevent members from taking measures to protect public health. It
emphasizes that the Agreement can and should be interpreted and implemented in a
manner supportive of WTO members' rights to protect public health and, in particular,
to promote access to medicines for all.
 Compulsory Licensing: It specifically mentions that countries are free to determine
the grounds upon which compulsory licenses are granted.
 Parallel Importation: It reaffirms the right of WTO members to use the flexibility of
parallel importation without challenge.
Significance in Health Law
 Legal and Policy Frameworks: The Doha Declaration has had a profound impact on
the legal and policy frameworks concerning access to medicines. It empowered
countries, including India, to enact laws that facilitate the issuance of compulsory
licenses and support generic drug manufacturing, crucial for enhancing drug
accessibility.
12
 Judicial Decisions: The declaration has been cited in numerous legal debates and
judicial decisions worldwide, including India, as a foundational element supporting the
prioritization of public health over intellectual property rights in the context of essential
medicines.
Combined Impact on Health Law in India

 Primary Healthcare Emphasis: Alma-Ata’s principles are echoed in India’s
commitment to expanding primary health care services, seen in initiatives like the
National Health Mission.
 Access to Medicines: The Doha Declaration reinforced India's stance on the use of
TRIPS flexibilities, which has been critical in promoting access to affordable
medicines, especially regarding life-saving drugs and treatments for diseases like
HIV/AIDS and cancer.
 Legal Precedents: Both declarations have influenced the discourse around health law
in India, shaping legal precedents that ensure a balance between protecting intellectual
property rights and advancing public health objectives.
ROLE OF THE WORLD HEALTH ORGANIZATION IN PUBLIC HEALTH
Introduction to the World Health Organization (WHO)

The World Health Organization (WHO) is a specialized agency of the United Nations
responsible for international public health. It was established on April 7, 1948, with the
objective of promoting health, keeping the world safe, and serving the vulnerable. WHO's
primary role is to direct and coordinate international health within the United Nations’ system.
Its leadership in global health matters is crucial, especially in standard-setting, knowledge
dissemination, and providing technical support to countries.
WHO's Functions and Responsibilities

Setting Norms and Standards
 WHO is responsible for establishing international norms and standards in various
aspects of healthcare, including sanitation, infectious diseases, chronic diseases, and
13
health services. It provides scientifically validated guidelines and statistical information
on diseases and health events, which countries, including India, rely on for framing
their health policies.
Policy Formulation
 WHO helps countries in policy development, focusing on key health issues and aligning
them with broader health goals like those outlined in the Sustainable Development
Goals (SDGs). It assists countries in creating comprehensive national health policies,
strategies, and plans.
Technical Assistance
 Providing technical assistance to countries is one of WHO’s primary functions. This
includes capacity building, training health personnel, providing expertise in the field of
epidemiology, health statistics, and health care management.
Disease Prevention and Response
 WHO plays a leading role in coordinating international efforts against disease
outbreaks, pandemics, and emergencies. It monitors the global health situation and
assesses health trends to ensure preparedness and quick response to public health risks.
Research and Development
 WHO promotes and conducts research in various fields of health. It fosters partnerships
with other entities, organizes data collection, and disseminates valuable health
information worldwide.
WHO’s Impact on Health Law in India

Policy Influence
 WHO guidelines and standards significantly influence Indian health policy and legal
frameworks. For instance, India’s National Health Policy and initiatives like the
Universal Immunization Programme align with WHO recommendations.
Legal Reforms
 Health-related laws in India often incorporate WHO standards. For example,
regulations concerning the control of tobacco, drugs, and food safety are influenced by
WHO frameworks and conventions such as the Framework Convention on Tobacco
Control (FCTC).
Handling of Public Health Emergencies
14
 India collaborates with WHO for strategic action in managing public health
emergencies. During the COVID-19 pandemic, WHO provided guidelines that shaped
India's response, including testing protocols, treatment guidelines, and vaccine approval
processes.
Capacity Building
 WHO’s training programs and technical assistance have helped enhance the capabilities
of India’s health infrastructure. WHO collaborates with local institutions to train health
workers and administrators in various aspects of health care and public health
management.
Challenges and Critiques

Dependence on WHO Funding and Resources
 India’s reliance on WHO for funding, resources, and technical guidance is substantial.
This dependence sometimes restricts India’s ability to pursue independent health
policies tailored to local needs.
Criticism of WHO's Response Time and Efficiency
 WHO has been criticized globally, including by Indian health experts, for its response
times and efficiency, particularly in handling health emergencies like the Ebola and
COVID-19 outbreaks.
INTERNATIONAL HEALTH REGULATIONS AND GLOBAL HEALTH

GOVERNANCE
Introduction to International Health Regulations (IHR)

The International Health Regulations (IHR) are an international legal framework that is binding
on 196 countries, including all the member states of the World Health Organization (WHO).
First adopted in 1969 and subsequently revised in 2005 after the SARS outbreak in 2003, the
IHR aim to help the international community prevent and respond to acute public health risks
that have the potential to cross borders and threaten people worldwide.
Key Features of the IHR

Purpose and Scope
15
 The main purpose of the IHR (2005) is to prevent, protect against, control, and provide
a public health response to the international spread of disease while avoiding
unnecessary interference with international traffic and trade.
 Unlike earlier versions, the IHR (2005) is not limited to specific diseases but applies to
all health risks, irrespective of their origin or source.
Core Capacities
 The regulations require countries to develop, strengthen, and maintain core public
health capacities at ports, airports, and ground crossings.
 They must also build and maintain the capacity to detect, assess, notify, and report
public health events.
Notification and Reporting
 Countries are obliged to assess public health events using the IHR decision instrument
and to report events that may constitute a Public Health Emergency of International
Concern (PHEIC) to WHO within 24 hours of assessment.
Public Health Response
 The IHR emphasize the importance of a prompt and effective public health response to
prevent the international spread of diseases. This includes measures to manage risks
posed by travelers and goods, and the mobilization of global health resources.
Global Health Governance

Definition and Components
 Global health governance refers to the collective actions taken by various international
bodies and countries to deal with public health issues that transcend national
boundaries. It includes policies, norms, and regulations that are shaped by international
entities such as the WHO, the World Bank, and various global health initiatives.
Role of WHO
 WHO is the leading authority in global health governance, primarily responsible for
directing and coordinating international health work. It plays a key role in the
enforcement of IHR, offering guidance, support, and, if necessary, intervention during
public health emergencies.
Collaboration and Funding
 Effective global health governance relies on the collaboration between countries,
international organizations, civil society, and private entities. It is also dependent on
16
adequate funding mechanisms, which are often a mix of public and private
contributions.
Implications for Health Law in India

Legal Alignment and Reforms
 India has aligned its health laws and policies with the requirements of the IHR. This
includes upgrading surveillance and response systems at national and sub-national
levels.
 Legal frameworks such as the Epidemic Diseases Act have been updated to better
manage public health emergencies, reflecting IHR principles.
International Cooperation
 India actively participates in global health governance through its collaboration with
WHO and contributions to international health efforts. This participation ensures that
India is both a benefactor and beneficiary of global health security initiatives.
Capacity Building
 Adhering to the IHR has pushed India to build better health infrastructure and
capabilities, particularly in surveillance, laboratory capacity, and emergency response.
Challenges
 Challenges include maintaining sustained funding for IHR compliance, managing
federal-state coordination for health, and balancing public health priorities with
economic and political interests.
COMPARISON OF INDIGENOUS AND ALLOPATHIC HEALTH SYSTEMS
The healthcare landscape in India is marked by a coexistence of multiple medical systems

including indigenous (traditional) systems and allopathic (Western) medicine. This diversity is
legally recognized and institutionally supported, but each system follows different principles,
methodologies, and legal frameworks. Understanding the distinctions and how they are
governed is essential for law students studying health law in India.
Indigenous Health Systems

Types of Indigenous Systems
17
 Ayurveda: Derived from ancient Indian scriptures, it focuses on balance among body,
mind, spirit, and social wellbeing.
 Yoga: An ancient physical, mental, and spiritual practice originating in India.
 Unani: Based on the teachings of Greek physician Hippocrates and developed into a
medical system in Islamic culture, it was later brought to India.
 Siddha: Originating in South India, it relies heavily on herbal medicines, dietary
practices, and metal/mineral treatments.
 Homeopathy: Developed in Germany and based on the principle of "like cures like,"
it is widely practiced in India for its holistic approach to treatment.
Legal Framework
 Indigenous systems are governed by the Ministry of AYUSH, established in 2014 to
ensure the optimal development and propagation of AYUSH systems of healthcare.
 Regulations include educational standards, practice guidelines, and drug regulations
specific to each practice.
Allopathic Health System

Principles
 Allopathic medicine, also known as modern medicine, utilizes drugs, radiation, or
surgery to treat symptoms and diseases. It is based on modern scientific principles and
research.
Legal Framework
 Governed by the Ministry of Health and Family Welfare, which oversees health
policy, public health initiatives, and medical education.
 Regulated under various acts such as the Indian Medical Council Act, and the Drugs
and Cosmetics Act.
Key Differences in Approach and Practice

Approach to Health and Disease
 Indigenous Systems: Emphasize prevention and use holistic methods to treat the
imbalance of bodily elements.
 Allopathic System: Focuses on diagnosis and treatment of disease primarily through
pharmacological and invasive interventions.
Educational Path
18
 Indigenous Practitioners: Study under the educational standards and institutions
specified by the Ministry of AYUSH.
 Allopathic Practitioners: Graduates from medical schools regulated by the Medical
Council of India (MCI), which enforces strict standards and curricula based on modern
medical science.
Basis of Treatments
 Indigenous Treatments: Based on natural products and historical texts.
 Allopathic Treatments: Based on the latest research and clinical trials.
Legal Recognition and Implementation
 Indigenous systems, while legally recognized, often face challenges in mainstream
acceptance and integration into primary healthcare infrastructure.
 Allopathic medicine is the predominant system in urban areas and major hospitals and
is globally recognized.
Regulatory and Health Law Implications

Compliance and Standardization
 Ensuring compliance with respective legal frameworks poses challenges, particularly
in standardizing and regulating the efficacy and safety of indigenous medicines.
 Allopathic drugs undergo rigorous clinical trials and are closely regulated for safety and
effectiveness.
Integration into Public Health Policy
 There are ongoing efforts to integrate both systems in public health policy. For example,
the National Health Policy (NHP) 2017 of India encourages integration of AYUSH
practitioners and methods into the national health system at all levels.
Intellectual Property
 Allopathic system heavily relies on patents for drug formulations. In contrast,
indigenous systems often deal with issues of traditional knowledge and biopiracy,
requiring legal protections that recognize and preserve traditional wisdom.
MEDICAL ETHICS: DEVELOPMENT, CONCEPT, AND IMPORTANCE
19
Medical ethics is a vital field that intersects with law, involving the application of moral
principles to the practice of medicine. In India, as globally, medical ethics govern the conduct
of healthcare professionals and institutions, ensuring that medical practice is conducted in a
responsible and morally acceptable manner. Understanding the development, key concepts, and
the importance of medical ethics is crucial for law students focusing on health law.
Development of Medical Ethics

Historical Perspective
 Historically, the foundation of medical ethics can be traced back to the Hippocratic
Oath, a seminal document from ancient Greece that outlined the duties and
responsibilities of physicians.
 In India, medical ethics have also been influenced by traditional practices embedded in
Ayurveda, which emphasize ethics related to the doctor-patient relationship,
confidentiality, and the welfare of patients.
Modern Development
 The modern framework for medical ethics was largely developed in the 20th century,
following significant medical advancements and complex moral questions arising from
them, such as those related to end-of-life care, reproductive technologies, and organ
transplantation.
 Globally, seminal works like the Declaration of Helsinki and the Belmont Report have
shaped the principles underlying contemporary medical ethics, which have been
adapted in various forms across different jurisdictions, including India.
Key Concepts in Medical Ethics

Autonomy
 Respecting the patient’s right to make informed decisions about their own healthcare,
free from coercion or persuasion by healthcare providers.
Beneficence
 The principle that healthcare providers should act in the best interest of the patient,
promoting good and preventing harm.
Non-maleficence
 A commitment to not harm the patient. This principle is closely tied to the dictum
"primum non nocere," meaning "first, do no harm."
20
Justice
 Ensuring fairness in medical decisions, including the distribution of scarce health
resources and deciding who gets what treatment.
Confidentiality
 Maintaining privacy concerning patient information. This is legally protected in India
under both common law and specific statutes such as the Indian Medical Council
(Professional Conduct, Etiquette and Ethics) Regulations, 2002.
Importance of Medical Ethics

Protection of Patient Rights
 Medical ethics serve to protect patients’ autonomy, dignity, and rights. Ethical
guidelines help ensure that patients are treated with respect and that their informed
consent is obtained before any medical procedure.
Enhancing Public Trust
 Adherence to ethical principles in medicine is crucial for maintaining public trust in the
healthcare system. This trust is foundational to the effective delivery of healthcare
services.
Response to New Challenges
 The field of medicine is continually evolving, particularly with advances in technology
and research. Ethical guidelines must adapt to address new challenges such as genetic
testing, biotechnology, and data privacy issues.
Legal Implications
 Medical ethics are deeply intertwined with legal principles in healthcare. Breaches of
ethical conduct can lead to legal actions, including malpractice suits and punitive
measures by medical licensing boards.
Professional Integrity
 Ethical practice is integral to the professionalism that is expected in medicine. It guides
practitioners in their conduct and decision-making, ensuring that ethical dilemmas are
navigated with moral integrity.
Medical Ethics and Law in India
21
 In India, the Medical Council of India (MCI) regulates the professional conduct of
doctors through specified ethical rules, which are legally enforceable. Non-adherence
can result in suspension or cancellation of the license to practice.
 Indian courts often reference ethical guidelines while adjudicating medical negligence
and malpractice lawsuits, indicating the legal weight carried by ethical considerations
in judicial processes.
DUTIES OF DOCTORS AND RIGHTS OF PATIENTS
In the field of health law in India, the dynamics between the duties of doctors and the rights of
patients form a fundamental area of study. This relationship is governed by a mixture of legal
frameworks, ethical guidelines, and customary practices that aim to balance the professional
responsibilities of healthcare providers with the rights and interests of patients.
Duties of Doctors
Standard of Care
 Doctors are legally and ethically obligated to provide care that meets established
professional standards. This includes possessing adequate skills and knowledge,
applying them appropriately, and keeping abreast of advancements in medical science.
Informed Consent
 One of the most crucial legal duties is obtaining informed consent from patients before
undertaking any medical procedure or treatment. This involves informing the patient of
the potential risks, benefits, and alternatives in a manner they can understand.
Confidentiality
 Maintaining patient confidentiality is both a legal and ethical duty. Information about a
patient's health, treatment, or personal details must not be disclosed without consent,
except under specific circumstances defined by law (e.g., reporting infectious diseases).
Non-Discrimination
 Doctors must provide medical care without discrimination based on religion, race,
caste, sex, or socioeconomic status.
Duty to Report
22
 Certain situations, such as evidence of certain crimes, infectious diseases, or public
health emergencies, require doctors to break confidentiality and report to the
appropriate authorities.
Rights of Patients
Right to Information
 Patients have the right to receive accurate, relevant, and complete information about
their health status, medical conditions, and treatment options. This is crucial for
exercising informed consent.
Right to Choose and Refuse Treatment
 Patients have the right to accept or refuse treatment after receiving adequate
information about their condition and the proposed treatments.
Right to Privacy and Confidentiality
 The right to confidentiality of all information and records concerning their medical care.
Right to Second Opinion
 Patients can seek a second opinion regarding their diagnosis and treatment from another
qualified doctor.
Right to Quality Care
 Patients have the right to expect a standard of care in accordance with current medical
norms and practices.
Legal Frameworks Governing Duties and Rights

Indian Medical Council (Professional Conduct, Etiquette, and Ethics) Regulations, 2002
 These regulations outline the standards of professional conduct, etiquette, and ethics
that must be followed by practicing doctors in India.
Consumer Protection Act, 2019
 This act provides a framework for the redressal of consumer grievances, which includes
patients who can claim compensation for medical negligence.
Other Laws
 Various other laws and guidelines also influence the rights of patients and duties of
doctors, including the Mental Healthcare Act, 2017, and guidelines issued by the
National Human Rights Commission of India.
23
Challenges and Enforcement
Challenges in Enforcement
 Despite comprehensive legal and ethical guidelines, enforcement can be inconsistent.
Challenges include disparities in healthcare quality, variations in patient awareness of
their rights, and occasional reluctance among healthcare providers to fully disclose
information.
Role of the Judiciary
 The Indian judiciary plays a crucial role in interpreting and enforcing the rights of
patients and duties of doctors, often stepping in to fill gaps where legislative and
regulatory frameworks are ambiguous.
HOSPITAL AS AN INDUSTRY AND APPLICABILITY OF LABOUR LAWS
In the context of health law in India, understanding how hospitals function as industries and
how various labor laws apply to them is crucial. This area of study explores the intersection of
healthcare management, labor relations, and regulatory compliance. Hospitals, while primarily
focused on delivering healthcare services, also operate as complex organizations that employ
a large number of staff, each with specific rights and obligations under Indian labor laws.
Hospital as an Industry
Definition and Scope
 In India, hospitals are categorized as 'commercial establishments' under most state-
specific Shops and Establishments Acts. Furthermore, the Supreme Court of India has
recognized hospitals as an 'industry' under the Industrial Disputes Act, 1947, primarily
due to their organized nature of work and the employment of substantial labor forces.
 This designation is crucial as it subjects hospitals to various labor and employment laws
that govern industries in general, impacting everything from employment terms to
dispute resolution.
Employment Structure
 Hospitals employ a wide range of personnel including medical professionals (doctors,
nurses, pharmacists), administrative staff, technical support, and maintenance staff.
24
 The diverse nature of roles within a hospital implies a varied application of labor laws,
tailored to the nature of the employment and the specific duties performed by the
employees.
Applicability of Labour Laws

The Industrial Disputes Act, 1947
 This Act provides a legal framework for the resolution of industrial disputes. For
hospitals, this means that any conflict between the employers and employees, such as
wage disputes, layoffs, or unfair labor practices, must be addressed through the
mechanisms provided under this Act.
 Hospitals must set up grievance redressal mechanisms and comply with the rules
regarding layoffs, retrenchments, and closures as specified.
The Minimum Wages Act, 1948
 Ensures that all workers, including those in hospitals, are paid at least the minimum
wage. The applicability of minimum wages varies from state to state and the nature of
the work performed.
The Employees' State Insurance Act, 1948
 Provides for medical and cash benefits to employees in case of sickness, maternity, and
employment injury. This Act is applicable to non-medical staff in hospitals and becomes
mandatory once a hospital employs a minimum number of employees, typically 10 or
more.
The Maternity Benefit Act, 1961
 This Act applies to every hospital in India regardless of the number and type of
employees. It mandates paid leave for women employees for a period before and after
childbirth.
The Shops and Establishments Act
 Each state has its own act, but generally, these laws regulate hours of work, payment of
wages, leave, holidays, terms of service, and other conditions of work of employees in
commercial establishments, including hospitals.
Other Relevant Laws
 Payment of Gratuity Act, 1972: Applies to hospitals where ten or more persons are
employed, or were employed, on any day of the preceding twelve months.
25
 Contract Labour (Regulation and Abolition) Act, 1970: Regulates the employment
of contract labor in certain establishments, including hospitals, and provides for its
abolition under certain circumstances.

Compliance Issues
 The complex nature of employment in hospitals, ranging from highly skilled
professionals to contract workers, creates challenges in compliance, particularly with
respect to categorizing employees and applying the appropriate laws.
 Managing compliance with labor laws requires hospitals to maintain meticulous
records, adhere to statutory requirements, and ensure that all employee benefits are
properly administered.
Enforcement
 Enforcement is typically managed through inspections and audits by government
authorities. Hospitals must be prepared for periodic scrutiny under various labor laws
and need to establish comprehensive HR management policies to handle this.
MEDICAL NEGLIGENCE: UNDERSTANDING LIABILITY IN TORTS AND

CONSUMER PROTECTION ACT 1986
Medical negligence is a critical area of concern in health law in India, involving legal liability
for healthcare providers who fail to meet the standard of care expected in their profession.
Understanding the legal framework governing medical negligence, including liability under
tort law and the Consumer Protection Act, is essential for law students studying health law.
Medical Negligence under Tort Law

Definition
 Medical negligence refers to the failure of a healthcare professional to exercise
reasonable care and skill, resulting in harm or injury to a patient.
Elements of Medical Negligence
 Duty of Care: Healthcare professionals owe a duty of care to their patients to provide
treatment in accordance with accepted medical standards.
26
 Breach of Duty: The healthcare provider breaches this duty by failing to meet the
standard of care expected of a reasonably competent practitioner.
 Causation: The breach of duty must be the direct cause of the patient's injury or harm.
 Damages: The patient must suffer actual harm or injury as a result of the negligence.
Legal Precedents
 Indian courts have established several legal precedents in medical negligence cases,
such as the Bolam Test, which sets the standard of care based on what a reasonable
body of medical opinion would consider acceptable.
Liability under the Consumer Protection Act, 1986

Applicability
 The Consumer Protection Act (CPA) extends to healthcare services, treating patients as
consumers who are entitled to protection against deficient services.
 The Act applies to both public and private healthcare providers, including hospitals,
clinics, and individual practitioners.
Provisions
 Under the CPA, patients can file complaints against healthcare providers for deficiency
in services, including medical negligence.
 The Act provides for the establishment of Consumer Disputes Redressal Commissions
at the district, state, and national levels to adjudicate consumer disputes.
Compensation
 In cases of medical negligence, patients can seek compensation for damages, including
medical expenses, loss of income, and pain and suffering.
Legal Challenges and Defenses

Challenges
 Proving medical negligence can be challenging due to the complex nature of medical
treatment and the need for expert medical opinion.
 There may be delays in the adjudication of cases, leading to prolonged legal battles and
additional distress for the aggrieved parties.
Defenses
 Healthcare providers may raise several defenses in medical negligence cases, including:
 Standard of Care: Arguing that they adhered to the accepted standard of care.
27
 Contributory Negligence: Claiming that the patient's own actions contributed
to the harm suffered.
 Emergency Situations: Asserting that the circumstances were emergent, and
the best possible care was provided given the circumstances.
Recent Developments and Trends

Expansion of Liability
 Courts in India have been increasingly holding healthcare providers accountable for
medical negligence, with a focus on patient rights and consumer protection.
Role of Technology
 The use of technology, such as electronic health records and telemedicine, has raised
new legal questions and challenges concerning liability in medical practice.
CONCEPTS OF VICARIOUS LIABILITY AND CRIMINAL LIABILITY IN

MEDICAL PRACTICE
In the context of health law in India, understanding the concepts of vicarious liability and
criminal liability in medical practice is essential for law students. These legal concepts play
significant roles in determining the responsibility and accountability of healthcare
professionals and institutions in cases of medical negligence or malpractice.
Vicarious Liability in Medical Practice

Definition
 Vicarious liability refers to a situation where one party is held liable for the wrongful
actions of another party. In the medical context, hospitals or healthcare institutions can
be held liable for the negligent acts of their employees, including doctors, nurses, and
other healthcare staff.
Legal Basis
 The principle is rooted in the doctrines of "respondeat superior" (let the master answer)
and "qui facit per alium facit per se" (he who acts through another does himself).
Applicability
 Vicarious liability is applicable when:
28
 The negligent act was committed by an employee.
 The act occurred within the scope of employment.
 The employer had control over the employee’s actions at the time the negligence
occurred.
Implications
 Hospitals must ensure that their employees are adequately trained, competent, and
properly supervised.
 The liability is not limited to direct employees; it can extend to contractors and sub-
contractors if they are effectively under the control of the hospital.
Criminal Liability in Medical Practice

Definition
 Criminal liability in medical practice arises when a healthcare provider’s actions lead
to patient harm or death and are deemed criminally negligent or reckless.
Legal Framework
 Under the Indian Penal Code (IPC), sections relevant to criminal liability in medical
practice include:
 Section 304A: Causing death by negligence.
 Section 336: Act endangering life or personal safety of others.
 Section 337 and 338: Causing hurt or grievous hurt by act endangering life or
personal safety of others.
Standards for Criminal Negligence
 The threshold for criminal liability is higher than for civil negligence. It must be shown
that the healthcare provider had a "rash or negligent" disregard for the life and safety
of the patient.
 The Supreme Court of India has emphasized that simple lack of care, an error of
judgment, or an accident is not enough for criminal liability unless it was something
more serious than mere negligence.
Defenses
 Common defenses include the lack of intent to cause harm, proving that the healthcare
provider followed accepted clinical standards and practices, or demonstrating that the
harm was not a foreseeable consequence of the provider’s actions.
29
Case Law and Judicial Interpretation
 Jacob Mathew v. State of Punjab (2005)
 The Supreme Court laid down guidelines to protect doctors from frivolous or
unjust prosecution and held that a professional may be held liable for negligence
only if a competent professional in the same field would have judged the actions
as being below acceptable professional standards.
LAW RELATING TO TERMINATION OF PREGNANCY AND ETHICAL

CONSIDERATIONS
In India, the law relating to the termination of pregnancy is a significant aspect of health law,
balancing legal rights, medical ethics, and public health concerns. The Medical Termination of
Pregnancy (MTP) Act, enacted in 1971 and amended several times since, governs the
conditions under which a pregnancy can be legally terminated. This framework reflects ethical
considerations, societal norms, and advances in medical science.
The Medical Termination of Pregnancy (MTP) Act, 1971

Key Provisions
 Criteria for Termination: The MTP Act allows for the termination of pregnancy on
various grounds, including the risk to the physical or mental health of the woman, fetal
abnormalities, cases of rape, and failure of contraceptives in a marital relationship.
 Gestational Limit: Originally, the law permitted abortion up to 20 weeks of gestation.
With amendments in 2021, this has been extended up to 24 weeks for certain categories
of women, which include survivors of sexual assault, rape, or incest; minors; and other
vulnerable women such as disabled and mentally ill women.
 Approval Requirements: Termination within the first 12 weeks requires the opinion
of one registered medical practitioner; from 12 to 20 weeks, the opinions of two
registered medical practitioners are necessary. For pregnancies beyond 20 weeks due
to fetal abnormalities considered incompatible with life or if the child were born it
would suffer from such physical or mental abnormalities to be seriously handicapped,
approval from the state-level Medical Board is required.
30
 Consent: Consent of the pregnant woman is mandatory unless she is a minor or
mentally ill, in which case a guardian must provide consent.
Amendments and Updates
 The amendments aim to enhance the accessibility of safe, legal abortion services,
extend the gestational limit under certain conditions, and ensure dignity, autonomy,
confidentiality, and justice for women seeking abortion.
Ethical Considerations
Autonomy and Consent
 A foundational ethical principle in medical law is respecting the patient's autonomy. In
the context of abortion, this means upholding the woman's right to make informed
decisions about her body and reproductive health.
Confidentiality
 The privacy and confidentiality of women undergoing abortion are paramount.
Healthcare providers must ensure that patient data and circumstances surrounding the
abortion are kept confidential to protect the woman from social stigma and personal
distress.
Beneficence and Non-maleficence
 Healthcare providers are obligated to perform abortions under conditions that minimize
harm and optimize benefits, ensuring the procedure is performed using safe,
recommended methods that align with current medical standards.
Justice
 Ensuring that access to abortion services is fair and without discrimination is a crucial
ethical consideration. This involves addressing barriers that low-income, rural, and
other marginalized groups face in accessing these services.
Legal Challenges and Debates

Legal vs. Ethical Dilemmas
 Legal provisions do not always settle ethical dilemmas. For instance, the decision to
abort based on fetal abnormalities poses significant ethical challenges, relating to
debates over potential life, quality of life, and disability rights.
Rights of the Unborn vs. Rights of the Mother
31
 The legal system must balance the rights of the unborn child with the rights of the
mother, a complex ethical issue that touches on definitions of life and personhood.
ORGAN TRANSPLANTATION: LEGAL AND ETHICAL ASPECTS
Organ transplantation is a critical area in health law, encompassing both legal frameworks and
ethical considerations. In India, the regulation of organ transplantation is governed primarily
by the Transplantation of Human Organs and Tissues Act, 1994 (THOTA), which has been
amended to better regulate both the processes involved and the ethical issues arising from organ
and tissue transplant. Understanding these aspects is crucial for law students interested in health
law and bioethics.
Legal Framework in India

The Transplantation of Human Organs and Tissues Act, 1994 (THOTA)
 Purpose: THOTA was enacted to regulate the removal, storage, and transplantation of
human organs and tissues for therapeutic purposes and to prevent commercial dealings
in human organs.
 Key Provisions:
 Definition of 'Brain Death': THOTA recognizes brain death as a form of legal
death, which is crucial for the harvesting of organs from deceased donors.
 Authorization Committees: The act mandates the establishment of Hospital
and State Authorization Committees to oversee the organ donation process,
ensuring all legal requirements are met, especially in cases of unrelated donors.
 Regulation of Hospitals: Only hospitals authorized by the government are
permitted to conduct transplants, ensuring facilities meet specific standards.
 Penalties for Violations: Severe penalties, including fines and imprisonment,
are stipulated for illegal organ trade and for medical professionals involved in
unethical practices related to organ transplantation.
Amendments and Updates
32
 2011 Amendments: Enhanced clarity on the definitions, introduced more stringent
regulations to curb organ trafficking, and expanded the scope to include tissues besides
organs.
 National Organ and Tissue Transplant Organization (NOTTO): Established to
maintain a registry of donations and transplants and to oversee and guide organ
allocation in the country.
Consent
 Informed Consent: Vital in both living donor and cadaveric transplant scenarios.
Donors and families must be fully informed of the risks, benefits, and rights before
consent is given.
 Voluntariness: Consent must be voluntary, free from coercion or undue influence,
particularly in the case of living donors.
Allocation of Organs
 Equity: Organs should be distributed based on medical need and likelihood of
transplant success, not on the basis of wealth, social status, or other discriminatory
factors.
 Transparency: Allocation processes must be transparent to maintain public trust in the
transplant system.
Conflict of Interest
 Medical professionals involved in transplantation should have no vested interest in the
recipient or donor beyond their medical care, ensuring decisions are made purely on
medical criteria.
Commercialization and Organ Trade
 Ethical guidelines universally condemn organ trade as it exploits the poor and
vulnerable. Legal provisions are stringent on this aspect, reflecting the ethical
consensus.
International Perspective and Compliance

Global Standards
 India's transplant laws align with global standards set by the World Health Organization
and the Declaration of Istanbul on organ trafficking and transplant tourism.
33
Cross-border Ethical Issues
 Issues arise with cross-border transplants, particularly with transplant tourism. Indian
law and international agreements aim to combat these practices by regulating both
inbound and outbound transplant activities.
Challenges and Future Directions

Challenges
 Despite robust legal frameworks, challenges like organ trafficking, lack of awareness
about donation, and familial consent for deceased donations persist.
 Balancing the need for organs with ethical acquisition and equitable distribution
remains complex.
Future Directions
 Enhancing public awareness and trust in the organ donation system.
 Improving legal and ethical education for medical professionals regarding
transplantation.
 Strengthening international cooperation to combat organ trade and ensure ethical
practices.
REGULATIONS ON PRE-NATAL DIAGNOSTIC TECHNIQUES
The use of pre-natal diagnostic techniques in India is governed by specific regulations aimed
at preventing sex-selective abortions and ensuring ethical medical practices. The primary legal
framework is the Pre-conception and Pre-natal Diagnostic Techniques (Prohibition of Sex
Selection) Act, 1994 (PCPNDT Act). This law addresses both the technical and ethical concerns
associated with prenatal diagnostics, especially focusing on combating gender-based
discrimination.
The Pre-conception and Pre-natal Diagnostic Techniques (PCPNDT) Act, 1994

Purpose and Scope
 The PCPNDT Act was enacted to prevent the misuse of pre-natal diagnostic techniques
for sex selection before or after conception and to regulate such techniques for legal
medical purposes.
34
 It covers all genetic counseling centers, genetic laboratories, and genetic clinics using
pre-natal diagnostic techniques.
Key Provisions
 Registration Requirement: All clinics, centers, and laboratories offering pre-natal
diagnostic services must be registered under the Act. Failure to register can lead to
significant penalties, including the cessation of operations.
 Prohibition of Sex Determination: The Act strictly prohibits the use of any prenatal
diagnostic technique for the purpose of determining the sex of the fetus.
 Record Keeping: Registered institutions must maintain detailed records of all
diagnostic tests conducted. These records are subject to inspection by appointed
authorities to ensure compliance.
 Informed Consent: Informed consent of the pregnant woman must be obtained in
writing before conducting any prenatal diagnostic tests. The Act mandates that the
consent form be in a language that the pregnant woman understands.
 Awareness and Reporting: The Act encourages the promotion of awareness against
the practice of prenatal sex determination and requires the appointment of Appropriate
Authorities at district and state levels to oversee and implement the Act.
Penalties
 Violations of the PCPNDT Act carry severe penalties, including imprisonment, fines,
and the suspension or revocation of the license to practice for medical professionals
involved in illegal practices under the Act.
Ethical Use of Technology
 The ethical use of pre-natal diagnostics is central to the PCPNDT Act, emphasizing that
these technologies should advance health and knowledge without fostering
discrimination.
 Ethical concerns also include ensuring that patients fully understand the implications
and potential results of diagnostic tests, safeguarding patient autonomy.
Gender Discrimination
 The misuse of prenatal diagnostic techniques for sex selection is a significant ethical
and social issue in India, contributing to gender imbalance and reinforcing gender
discrimination. The PCPNDT Act aims to curb these practices by legal means.
35
Implementation Challenges
Enforcement Issues
 Effective enforcement of the PCPNDT Act remains a challenge. Despite the legal
framework, clandestine operations and corruption can undermine efforts to eliminate
sex-selective practices.
 There is also a need for greater coordination between various governmental and non-
governmental organizations to ensure comprehensive implementation.
Social and Cultural Barriers
 Deep-rooted cultural preferences for male children in some regions make it difficult to
eradicate the demand for sex-selective diagnostics and abortions. This requires ongoing
education and cultural change initiatives.
ARTIFICIAL INSEMINATION AND SURROGACY: LEGAL FRAMEWORK
Artificial insemination and surrogacy involve complex legal considerations in India, with
specific laws designed to regulate these practices. These reproductive technologies raise
significant ethical, legal, and social issues, leading to the development of a framework that
governs the rights and responsibilities of all parties involved. This note will delve into the
relevant legislation, including the Surrogacy (Regulation) Act, 2021, and the rules surrounding
artificial insemination.
Legal Framework for Artificial Insemination

Definition and Scope
 Artificial insemination is a medical procedure used to treat infertility. It involves
directly inserting sperm into a woman’s cervix or uterine cavity to facilitate fertilization.
The sperm may be from the woman’s partner (homologous) or a donor (heterologous).
Legal Considerations
 Consent: Written informed consent from both the spouse or partner and the donor (if
applicable) is required.
36
 Anonymity of Donor: The identity of a sperm donor typically remains confidential,
although recent legal discussions suggest possible changes to this policy to align with
the rights of the child to know their biological origins.
 Regulatory Oversight: Clinics offering artificial insemination services must adhere to
standards and guidelines set by the Indian Council of Medical Research (ICMR) and
are subject to the provisions of the Assisted Reproductive Technology (Regulation) Act,
once it is enacted.
Legal Framework for Surrogacy
The Surrogacy (Regulation) Act, 2021
 Purpose: This Act was introduced to regulate surrogacy in India, prohibiting
commercial surrogacy to protect surrogate mothers from exploitation and ensuring the
ethical use of surrogacy.
Key Provisions
 Prohibition of Commercial Surrogacy: Only altruistic surrogacy is permitted, where
no charges, expenses, fees, remuneration or monetary incentive of any kind, except
medical expenses, are allowed.
 Eligibility Criteria for Intended Parents: Couples must be Indian citizens, married
for at least five years, with at least one partner having a fertility issue. Single
individuals, unmarried couples, and same-sex couples are not eligible under current
legislation.
 Eligibility Criteria for Surrogate Mothers: A surrogate must be a close relative of the
intended parents, married, having a child of her own, and between the ages of 25-35
years. She can only be a surrogate once in her lifetime.
 Insurance for Surrogate Mother: The intended parents must ensure that the surrogate
mother is insured for a period of 36 months covering postpartum delivery
complications.
 Parental Custody: The intended parents are the legal parents of the child born through
surrogacy. The surrogate mother has no parental rights over the child.
Ethical and Social Considerations
 Protection of Surrogate's Rights: The law aims to protect the rights of surrogate
mothers by ensuring that they are not coerced into surrogacy and by providing them
with medical and insurance benefits.
37
 Child’s Rights: The law guarantees that children born through surrogacy have the same
rights as other children.
Challenges and Critiques

Restricted Access: The restrictive nature of the Surrogacy Act, which limits surrogacy to
heterosexual married couples and close relatives as surrogates, has been criticized for excluding
single individuals, unmarried couples, and LGBTQ+ communities.
Implementation Issues: Effective implementation of these laws remains a challenge,
particularly in ensuring that the surrogate’s consent is informed and voluntary and in enforcing
the medical and insurance provisions effectively.
Ethical Debates: The prohibition of commercial surrogacy has sparked debates about the
autonomy and freedom of choice for women, questioning whether such decisions should be
legally or personally governed.
LEGALITY AND ETHICAL DEBATES ON EUTHANASIA
Euthanasia, often referred to as "mercy killing," is a contentious issue involving the deliberate
ending of a life to relieve pain and suffering. In India, this topic intertwines complex legal
interpretations and deep ethical debates. The legal stance on euthanasia is shaped by various
court rulings, notably the landmark judgment in Aruna Shanbaug's case, which led to the
recognition of passive euthanasia under strict guidelines.
Legal Framework
Definition and Types of Euthanasia
 Active Euthanasia: Involves the intentional act of causing the death of a patient
through a direct intervention. Active euthanasia is illegal in India.
 Passive Euthanasia: Involves withdrawing life support or discontinuing medical
treatments that prolong the life of a patient who is in a permanent vegetative state (PVS)
or terminally ill. Passive euthanasia is legal in India under strict conditions.
Supreme Court Rulings
38
 Aruna Shanbaug Case (2011): The Supreme Court of India differentiated between
active and passive euthanasia. It ruled that passive euthanasia could be legally allowed
if supervised by a proper legal framework.
 Common Cause (A Regd. Society) v. Union of India (2018): The Court allowed
passive euthanasia and recognized the right to refuse medical treatment. It also
approved the concept of an advance directive (or living will), whereby individuals can
specify their non-consent to artificial life support, should they become terminally ill or
go into a PVS in the future.
Legal Guidelines and Procedures
 Advance Directives: Individuals can make a living will specifying their wishes
regarding the continuation or withdrawal of medical treatment in case they are rendered
incapable of making such decisions later.
 Medical Board Evaluation: The decision to withdraw life support must be approved
by a Medical Board and confirmed by a second board upon appeal before being carried
out.
 Judicial Oversight: The ultimate decision for passive euthanasia may require approval
from the High Court of the state where the patient is hospitalized, ensuring a judicial
check over potential misuse.
Ethical Debates
Autonomy and Consent
 Proponents argue that euthanasia respects patient autonomy and the right to choose a
dignified death rather than prolonged suffering. Critics worry about the potential for
abuse and the pressure it could place on vulnerable patients to opt for death due to
societal or familial pressure.
Quality of Life
 The argument for euthanasia often hinges on the perceived quality of life. Supporters
claim that patients who suffer from terminal illnesses with no hope of recovery and
enduring great pain should have the option to end their life peacefully.
Slippery Slope Argument
 Opponents of euthanasia fear the slippery slope effect, wherein legalizing euthanasia
could lead to less stringent measures and potentially non-voluntary euthanasia, where
the decision is made without the patient’s explicit consent.
39
Sanctity of Life
 Many ethical arguments against euthanasia stem from the moral conviction that life
inherently holds value. According to this view, euthanasia, even if voluntary, is morally
unacceptable because it undermines the intrinsic value of human life.
Societal and Cultural Perspectives
 In a culturally diverse society like India, religious and cultural beliefs significantly
impact the euthanasia debate. Most Indian religions and philosophical traditions place
a strong emphasis on the sanctity and spiritual significance of life, which can conflict
with the concept of euthanasia.
MENTAL HEALTH CARE: LEGAL FRAMEWORK AND PATIENT RIGHTS
Mental health care in India is governed by a specific legal framework designed to protect the
rights of individuals with mental illnesses, ensuring they receive care and treatment without
discrimination and with full dignity. The principal legislation governing this area is the Mental
Healthcare Act, 2017, which represents a significant shift towards a rights-based approach to
mental health care. Understanding this act is crucial for law students interested in health law,
as it sets the standards for treatment, rights, and protections for individuals with mental health
conditions.
Mental Healthcare Act, 2017

 Enacted to align with the United Nations Convention on the Rights of Persons with
Disabilities (UNCRPD), the Mental Healthcare Act, 2017, provides a framework that
focuses on protecting the rights of individuals with mental illnesses and ensuring access
to mental health care.
Key Provisions
 Right to Access Mental Health Care: The Act guarantees every individual the right to
access mental health care and treatment from services run or funded by the government.
It includes affordable, good quality, and easy access to services.
 Advance Directive: Allows individuals to create a legally binding document stating
their preferred method of treatment and nominate representatives to ensure their
treatment preferences are respected.
40
 Decriminalization of Attempt to Suicide: Under the Act, any person who attempts
suicide is presumed to be under severe stress, and it is not treated as a criminal act but
rather a condition requiring treatment and support.
 Prohibition of Discrimination: The Act prohibits discrimination on any basis
(including gender, sex, sexual orientation, religion, culture, caste, social or political
beliefs, class, or disability) against those with mental health conditions in a variety of
settings, including employment, education, and the provision of healthcare.
 Rights During Treatment: Patients have the right to information, confidentiality, legal
services, and the ability to contact others while receiving care. They also have the right
to be treated in a less restrictive environment.
Establishment of Authorities
 Central and State Mental Health Authority: These bodies are established to register,
supervise, and maintain a register of all mental health establishments. They also train
law enforcement officials and other relevant parties on the human rights of those with
mental health conditions.
Legal Capacity and Consent

Consent to Treatment
 The Act emphasizes the importance of obtaining informed consent from individuals
undergoing treatment, barring emergencies. If a person is unable to give consent, the
nominated representative may do so.
 Informed Consent: Individuals must be informed about their health condition, the
nature of treatment proposed, and all the alternatives available, including less restrictive
treatment options.
Patient Rights and Protections

Confidentiality
 Health professionals must maintain confidentiality concerning all aspects of the
individual's mental health, treatment plan, and personal information, except in
situations where there is a risk of harm or legal requirements to disclose such
information.
Right to Community Living
41
 The Act advocates for community-based treatment, ensuring individuals with mental
health conditions live with dignity and are part of their communities, rather than being
institutionalized.
Right to Legal Aid
 The Act ensures free legal services to those with mental health conditions, making it
easier for them to file complaints and appeals concerning deficiencies in the provision
of care.
Challenges and Implementation

Awareness and Stigma
 Despite progressive legislation, there remains a significant stigma associated with
mental illness in India, which can impede the effective implementation of the law.
Resource Allocation
 The effectiveness of the Mental Healthcare Act also depends on the availability of
sufficient funding and resources to implement its provisions fully, including the
establishment of adequate mental health services across the country.
OFFENCES AFFECTING PUBLIC HEALTH AND RELEVANT LEGAL

PROVISIONS
Public health in India is safeguarded through various legal provisions that categorize certain
actions as offenses when they endanger health. These laws aim to protect the public from
activities that pose a risk to health, encompassing issues such as sanitation, food safety, and the
spread of infectious diseases. Understanding these legal mechanisms is essential for law
students specializing in health law, as they delineate the intersection of law, health, and societal
welfare.
The Indian Penal Code (IPC)

Key Sections Related to Public Health
 Section 269: Negligent act likely to spread infection of disease dangerous to life. This
provision covers acts done unlawfully and negligently, which are known to likely cause
the spread of any life-threatening disease.
42
 Section 270: Malignant act likely to spread infection of disease dangerous to life. This
section addresses actions with a deliberate intention to spread infections that could be
dangerous to life, distinguishing it from Section 269 by the aspect of malignancy.
 Section 272: Adulteration of food or drink intended for sale. Penalizes the adulteration
of any article of food or drink, making it noxious with the intent to sell such items.
 Section 273: Sale of noxious food or drink. This section criminalizes the sale of any
food or drink that has been contaminated or adulterated, thereby making it harmful to
health.
The Epidemic Diseases Act, 1897

 Enacted to tackle the spread of epidemic diseases, this Act grants special powers to state
governments and central government to implement measures necessary to control and
prevent the outbreak of diseases.
Key Features
 Special Measures: Allows states to prescribe regulations to control epidemics,
including inspections of persons traveling by railway or otherwise, and the segregation
of those suspected of being infected.
 Penalties: Non-compliance with regulations under this Act can result in punishment
under Section 188 of the IPC (Disobedience to order duly promulgated by public
servant).
The Food Safety and Standards Act, 2006

Purpose
 This Act consolidates various acts & orders that have hitherto handled food related
issues in various Ministries and Departments. It establishes the Food Safety and
Standards Authority of India (FSSAI) for laying down science-based standards for
articles of food and to regulate their manufacture, storage, distribution, sale and import.
Key Provisions
 Licensing and Registration of Food Businesses: Ensures that food business operators
cannot legally operate without obtaining a license.
 Prohibition of Unsafe Food: Specifically prohibits the manufacture, sale, or
distribution of unsafe, misbranded, substandard, or food containing extraneous matter.
43
 Penalties: Provides for penalties of varying degrees, from monetary fines to
imprisonment, depending on the nature and severity of the offense.
The Public Health Act, 1939
 This Act provides for the prevention and control of infectious diseases and improves
public health facilities. It gives local authorities the mandate to ensure the maintenance
of public health in municipalities and local regions.
Key Aspects
 Control of Infectious Diseases: Measures include notification of infectious diseases,
disinfection, isolation, vaccination, and other public health responses.
 Public Health Infrastructure: Mandates the establishment and maintenance of public
conveniences, proper waste disposal, and other sanitation-related services.
EPIDEMIC LAWS AND PUBLIC HEALTH MANAGEMENT
Epidemic laws in India are crucial components of the legal framework used to manage and
control the spread of infectious diseases. These laws enable the government and public health
authorities to take necessary actions during health crises to ensure public safety and well-being.
Understanding these laws is essential for law students who wish to specialize in health law, as
they illustrate how legal tools are deployed in the context of public health emergencies.
The Epidemic Diseases Act, 1897

 The Epidemic Diseases Act of 1897 is a colonial-era law enacted to combat the bubonic
plague in Bombay. It provides broad, emergency powers to state governments and the
central government to implement measures necessary to control and prevent the
outbreak of diseases.
Key Provisions
 Special Powers for Central and State Governments: The Act empowers state
governments to prescribe temporary regulations to be observed by the public to manage
and control epidemics. Similarly, the central government can take measures and
44
prescribe regulations for the inspection of any ship or vessel leaving or arriving at any
port and for the detention of any person intending to sail therein, or arriving thereby.
 Penalties: Non-compliance with regulations under this Act can lead to punishment
under Section 188 of the IPC (Disobedience to order duly promulgated by public
servant).
Public Health Response to COVID-19

Legal Measures
 During the COVID-19 pandemic, the Epidemic Diseases Act was extensively invoked
along with the Disaster Management Act, 2005, to enforce lockdowns, social distancing
measures, and other emergency steps.
 Disaster Management Act, 2005: This Act was used alongside the Epidemic Diseases
Act to provide a legal framework for the management of disasters, including the
pandemic. It facilitated the central and state governments in releasing funds and
implementing a coordinated response to the crisis.
Criticisms and Legal Challenges
 The broad and somewhat vague powers granted by the Epidemic Diseases Act have
been critiqued for lacking specificity and safeguards against abuse, highlighting the
need for more detailed public health legislation.
The Public Health (Prevention, Control, and Management of Epidemics, Bio-Terrorism,

and Disasters) Bill
Purpose and Scope
 Proposed to replace the outdated Epidemic Diseases Act, this Bill aims to provide a
clear, detailed, and modern legal framework to manage public health emergencies,
including epidemics and bioterrorism.
 Key Features: Includes provisions for the prevention and control of epidemics,
mechanisms for coordination between the central and state governments, and guidelines
for responding to bioterrorism threats and natural disasters.
State-Specific Public Health Laws

Variability and Scope
45
 Several states in India have their own public health laws that complement the central
legislation, such as the Bombay Public Health Act, 1949, and the Delhi Public Health
Act, 1994.
 These laws often provide specific measures for the control of diseases within state
boundaries, detailing the responsibilities of local health authorities and the public.
International Health Regulations (IHR) and Global Compliance

Global Health Security
 India is a signatory to the IHR (2005), which requires countries to develop, strengthen,
and maintain the ability to detect, report, and respond to public health threats. These
regulations also influence domestic laws and policies regarding public health
emergency preparedness and response.
PUBLIC HEALTH POLICIES: AYUSHMAN BHARAT BILL, 2018, AND ITS IMPACT
Ayushman Bharat, also known as the Pradhan Mantri Jan Arogya Yojana (PMJAY), represents
a significant reform in public health policy in India, introduced in 2018. It aims to address
health issues at multiple levels — primary, secondary, and tertiary. This comprehensive
healthcare initiative is particularly focused on the underserved and economically vulnerable
sections of society. Understanding this program is crucial for law students specializing in health
law as it offers insights into the intersection of policy, law, and healthcare access.
Ayushman Bharat
Two Major Components
 Health and Wellness Centers (HWCs): Aimed at creating 150,000 health and
wellness centers across India to deliver comprehensive primary health care, covering
maternal and child health services, prevention and management of non-communicable
diseases (NCDs), free essential drugs and diagnostic services.
 National Health Protection Scheme (NHPS): Often referred to as ModiCare, this
component provides a health insurance cover of up to Rs 5 lakh per family per year for
secondary and tertiary care hospitalization across public and private empaneled
hospitals in India.
46
Goals and Objectives
 Enhance the accessibility and affordability of healthcare services.
 Prevent the impoverishing effects of healthcare-related expenses.
 Promote preventive healthcare practices and improve the quality of health care.
Legal Framework
Policy Implementation
 The implementation of PMJAY does not rely on a specific bill passed in the parliament
but rather operates under the existing National Health Mission framework, directed and
funded through central and state government partnerships.
Regulatory Oversight
 The National Health Authority (NHA) has been established to administer the PMJAY,
ensuring compliance with policy guidelines and the efficient rollout of services.
Impact of Ayushman Bharat

On Healthcare Access
 The scheme has significantly widened healthcare access for the poorest, who were
previously without any form of health insurance. It aims to cover over 500 million
beneficiaries, spanning rural and urban areas.
On Healthcare Costs
 By providing substantial insurance for hospitalization expenses, it reduces the out-of-
pocket expenditure for many families, potentially transforming the economic realities
of accessing healthcare.
On Healthcare Quality
 With the increased engagement of both public and private sectors in healthcare
provision, there is potential for improving the quality of healthcare services, given that
facilities must meet certain criteria to be empaneled under the scheme.
Challenges
 Funding: Sustaining the financial model of Ayushman Bharat is a significant challenge,
involving extensive resources from the central and state governments.
 Implementation: Differences in healthcare infrastructure across states can lead to
uneven implementation and varying levels of service quality.
47
 Fraud and Abuse: Ensuring that the benefits reach the intended recipients without
misuse involves constant monitoring and robust governance mechanisms.
Critical Analysis and Future Directions

Legal and Policy Challenges
 The absence of a dedicated legislative act for Ayushman Bharat raises questions about
its long-term sustainability and governance structure. Legal backing could potentially
provide more robust protection and a framework for addressing grievances and
improving services.
Integration with Existing Health Programs
 Integrating this scheme with other existing programs without overlap or redundancy
remains a logistical and administrative challenge.
NATIONAL HEALTH MISSION AND GOALS
The National Health Mission (NHM) is a comprehensive health initiative launched by the
Government of India in April 2005 under the Ministry of Health and Family Welfare. The NHM
subsumes its predecessors, the National Rural Health Mission (NRHM) and the National Urban
Health Mission (NUHM), aiming to make health services accessible, affordable, and of good
quality for the country's rural and urban populations, especially the vulnerable sections. This
initiative is pivotal in understanding public health governance and the legal frameworks that
support health policies in India.
Objectives of the National Health Mission

Reduce Mortality Rates
 Focus on reducing infant mortality rate (IMR), maternal mortality ratio (MMR), and
mortality rates for children under 5 years of age.
Improve Maternal Health
 Enhance access to responsible, effective, and high-quality healthcare services pre,
during, and post-pregnancy and childbirth.
Prevention and Control of Communicable and Non-Communicable Diseases
48
 Implement strategies for the prevention and control of diseases through an integrated
approach, which includes increased disease surveillance, improved sanitation, and more
accessible medical intervention.
Population Stabilization
 Address issues related to family planning and population stabilization to improve
overall health and reduce demographic pressure.
Access to Integrated Comprehensive Primary Health Care
 Promote universal access to equitable, affordable, and quality health care services that
are accountable and responsive to people's needs.
Promote Healthy Lifestyles
 Encourage healthy lifestyle choices through awareness campaigns targeting nutrition,
sanitation, hygiene, and the harmful effects of substance abuse.
Strategies and Features

Decentralization
 Empowers district-level officials and local Panchayati Raj Institutions to manage, plan,
and allocate resources for health projects, ensuring that strategies are region-
appropriate and effectively address local health issues.
Community Ownership
 Engages community health workers and volunteers such as Accredited Social Health
Activists (ASHAs), Auxiliary Nurse Midwives (ANMs), and local practitioners to
ensure grassroots mobilization and support.
Integration of Health Services
 Merges vertical health and family welfare programs to ensure optimized and unified
service delivery, focusing on holistic treatment and care across various health domains.
Use of Technology
 Implements e-health and m-health strategies to enhance the quality of healthcare service
delivery, aiming to make data collection and health monitoring more efficient and
widespread.
Legal and Policy Framework

Governance and Oversight
49
 The NHM operates under the aegis of the Ministry of Health and Family Welfare, with
specific guidelines and regulations formulated to govern its implementation,
monitoring, and evaluation processes.
Funding and Financial Management
 Financial management systems are streamlined to ensure proper allocation of funds,
with special provisions for incentivizing states through mission flexibility and
performance grants.
Impact and Challenges

Achievements
 Significant progress in reducing child and maternal mortality rates, improving
immunization coverage, and enhancing the reach of health services to the poorest and
most vulnerable sections of society.
Challenges
 Variability in program implementation across states due to differing state policies and
capacities.
 Persistent issues with healthcare infrastructure, workforce shortages, and maintaining
the quality of services, particularly in rural and remote areas.
NATIONAL HEALTH POLICY, 2017
The National Health Policy (NHP) of 2017 is a comprehensive framework aimed at prioritizing
the role of health in the socio-economic development of India. This policy replaces the previous
health policy from 2002 and addresses the emergent health concerns attributed to socio-
economic and demographic changes over the last 15 years. For law students studying health
law, the NHP 2017 provides critical insights into the government’s approach to public health,
emphasizing preventive healthcare, and the achievement of universal health coverage.
Goals and Objectives

Achieving Universal Health Coverage (UHC)
 This includes accessibility to essential healthcare services, medications, and vaccines
for all without financial hardship.
50
Reinforcing Public Healthcare
 The policy aims to strengthen the primary healthcare system by proposing the
establishment of health and wellness centers that deliver comprehensive healthcare.
Reducing Non-Communicable Diseases (NCDs)
 Prioritizes the reduction of NCDs, such as cardiovascular diseases, cancers, chronic
respiratory diseases, and diabetes, through better screening, prevention, and
management.
Promoting Health and Wellness
 Emphasis on preventive healthcare with campaigns focusing on sanitation, hygiene, and
the promotion of physical activity.
Aligning Health and Development
 Recognizes health as a crucial component of socio-economic development, making
health improvement an essential criterion for measuring economic growth.
Policy Strategies
Increase Health Expenditures
 The policy recommends increasing public health expenditure to 2.5% of the GDP from
the current 1.15%, aimed at broadening health service coverage and increasing the
quality of care.
Human Resources for Health
 Addresses the acute shortage of healthcare professionals by proposing the creation and
filling of more positions within the healthcare sector, improved training, and better
compensation.
Preventive and Promotive Health
 Enhances focus on broader social determinants of health through an integrated approach
which includes clean water, sanitation, education, and nutrition.
Information Technology Integration
 Leverages digital health technology solutions like telemedicine and mobile health
applications to enhance healthcare delivery and access.
Key Features
Health Card
51
 Proposes the creation of a health card linked to a health facility for every individual.
This card will cover three generations of a person’s family, aiding in the systematic
health assessment of familial diseases.
Free Drugs and Diagnostics
 The policy advocates that no one should suffer due to the non-availability of drugs or
diagnostics. As such, it proposes making these universally accessible at government
healthcare institutions.
Ayushman Bharat Scheme
 Even though not initially part of the NHP 2017, Ayushman Bharat, launched in 2018,
aligns closely with the policy’s objectives, aiming to provide health insurance and
establish primary healthcare through health and wellness centers.
Legal and Ethical Considerations

Right to Health
 While the policy does not explicitly state health as a fundamental right, it does suggest
it as a ‘justiciable’ right, which is a significant step towards recognizing health as a
basic human right in India.
Equity
 Ensures that healthcare services are not denied to anyone due to financial constraints,
aiming for equitable health access across different population segments, including
vulnerable groups.
PATENT LAWS AND ACCESS TO MEDICINE: BALANCING RIGHTS AND ACCESS
The intersection of patent laws and access to medicine represents a critical area of study in
health law, especially pertinent in developing countries like India. Patent laws protect the rights
of inventors by granting them exclusive rights to their inventions for a limited period. However,
this protection can sometimes clash with the public health goal of ensuring broad access to
affordable medicines. Understanding how to balance these interests is essential for law students
focusing on health law and policy.
Patent Laws in India
52
The Indian Patent Act, 1970
 The principal legislation governing patents in India, which was significantly amended
in 2005 to make Indian laws WTO-compliant, particularly aligning with the TRIPS
Agreement.
 Patents in the pharmaceutical sector protect the processes and products that are new,
involve an inventive step, and are capable of industrial application.
Compliance with TRIPS
 The Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement
mandates that member countries provide patent protection for at least 20 years.
However, TRIPS also allows flexibilities such as compulsory licensing, which India
has incorporated into its patent law.
Balancing Patent Rights and Access to Medicines

Compulsory Licensing
 Section 84 of the Indian Patent Act allows for compulsory licensing, which authorizes
the government to allow someone else to produce the patented product or process
without the consent of the patent owner under certain conditions.
 This mechanism is crucial for enhancing access to life-saving drugs that are otherwise
unavailable or unaffordable due to patent protection.
Section 3(d) of the Indian Patent Act
 A unique provision aimed at preventing evergreening of patents, which involves
making slight modifications to existing drugs to extend the patent life. Section 3(d)
requires that changes to already patented drugs must show increased efficacy to be
patentable.
 This provision was upheld in the landmark case of Novartis AG v. Union of India, where
the Supreme Court denied a patent for the cancer drug Glivec, arguing that the new
version of the drug did not enhance efficacy as required under the law.
Challenges in Balancing Rights and Access

Innovation vs. Affordability
 Pharmaceutical companies argue that patent protection is necessary to recoup the high
costs of drug research and development, which drives innovation in drug
manufacturing.
53
 Conversely, public health advocates argue that such protections make drugs
unaffordable to a large segment of the population, particularly in developing countries.
Legal and Ethical Considerations
 Ethical considerations arise regarding the right to health and whether intellectual
property laws should prioritize corporate profits over human lives.
 Legally, there is a constant tug-of-war between enhancing access to drugs and
protecting the economic interests of pharmaceutical companies.
Global Perspectives and the Role of India

India as the 'Pharmacy of the Developing World'
 India is a significant exporter of generic drugs, supplying affordable medicine to many
developing countries.
 The Indian approach to patents, especially its strict standards for patentability and the
use of compulsory licensing, serves as a model for other nations seeking to balance
patent rights with public health needs.
International Pressure and Trade Negotiations
 India faces ongoing pressure from developed countries and multinational
pharmaceutical corporations to tighten its patent laws beyond TRIPS requirements.
 Balancing international relations with domestic health priorities remains a challenging
area for India’s legal and health policy frameworks.
PRADHAN MANTRI BHARTIYA JANAUSHADHI PARIYOJANA (PMBJP) AND ITS

ROLE IN HEALTH CARE
The Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP), formerly known as the Jan
Aushadhi Scheme, is an initiative launched by the Government of India that aims to provide
quality medicines at affordable prices to the masses through special kendra’s known as Pradhan
Mantri Bhartiya Janaushadhi Kendras (PMBJKs). Initiated by the Department of
Pharmaceuticals, Ministry of Chemicals and Fertilizers, this program is a critical component
of India's public health policy.
Objectives of PMBJP
54
Provide Access to Affordable Medicines
 The main objective of the PMBJP is to make quality generic medicines available at
affordable prices to all, particularly the poor and disadvantaged, through exclusive
outlets known as PMBJKs.
Reduce Out-of-Pocket Expenditures on Healthcare
 By lowering the cost of medicines, the scheme aims to reduce the overall out-of-pocket
expenditures on health, which is a major barrier to healthcare access in India.
Promote the Use of Generic Medicines
 The scheme also aims to educate the public about the efficacy of generics which are
equivalent in quality to branded medicines but are available at a fraction of the cost.
Mechanism and Implementation

Establishment of Janaushadhi Stores
 PMBJKs are set up to sell generic drugs. These stores are run through the support of
state governments, NGOs, public and private sector hospitals, and charitable
institutions.
Quality Assurance
 Medicines provided under the scheme are procured only from WHO-GMP certified
manufacturers, ensuring they meet high standards of quality.
Pricing Strategy
 The prices of the medicines sold at PMBJKs are significantly lower (typically 50-90%
cheaper) than the corresponding branded medicines in the market.
Legal and Policy Framework

Government Support
 The scheme is supported by the Government of India, which provides grants and
assistance for setting up PMBJKs. State governments are also encouraged to participate
by providing space for the stores.
Intellectual Property Considerations
 The focus on generic medicines also touches upon intellectual property rights (IPR)
issues, particularly patents. The scheme is aligned with India's patent laws, which allow
for the manufacture of generic versions of patented medicines under certain conditions,
such as compulsory licensing.
55
Impact on Healthcare in India
Improved Access to Medicines
 The PMBJP has significantly increased access to essential medicines across various
parts of India, contributing to better health outcomes.
Economic Impact
 By reducing the cost of medicines, the scheme has made healthcare more affordable for
the economically weaker sections of society.
Awareness of Generic Medicines
 There has been a noticeable increase in public awareness and acceptance of generic
medicines as a viable alternative to more expensive branded options.

Challenges
 Despite its successes, the scheme faces challenges such as the perception of lower
efficacy of generics, supply chain issues, and competition from the private sector.
 Ensuring consistent availability of a broad range of medicines in PMBJKs is another
ongoing challenge.
Future Directions
 There is potential for the expansion of PMBJKs to cover more regions, especially rural
and underserved areas.
 Further efforts are needed to improve the supply chain and logistics to ensure consistent
medicine availability.
NATIONAL LIST OF ESSENTIAL MEDICINE AND ITS IMPORTANCE
The National List of Essential Medicines (NLEM) of India is a key component of the healthcare
system, delineating the minimum medicine needs for the population. This list is curated with
an emphasis on the most cost-effective, essential medicines required to meet the majority of
the health care needs. Understanding the NLEM is crucial for law students specializing in
health law as it demonstrates the government's approach to ensuring the availability and
affordability of fundamental healthcare services.
56
Concept and Development of NLEM
Definition
 The NLEM lists medications considered to be the most effective and safe to meet the
important needs of the health care system.
Criteria for Inclusion
 Medicines are chosen based on their efficacy, safety, cost-effectiveness, and whether
they address the needs of the majority of the population.
Updates and Reviews
 The list is periodically updated to incorporate new medicines based on current health
needs and to remove medicines as newer, more effective treatments become available.
Legal and Regulatory Framework

Regulatory Authority
 The Ministry of Health and Family Welfare is responsible for updating and publishing
the NLEM, guided by an expert committee that includes pharmacologists, pharmacists,
clinicians, and public health experts.
Integration with Other Policies
 The NLEM is a crucial element of broader health policy and drug control measures. It
influences drug pricing under the Drug Price Control Orders (DPCO) issued by the
National Pharmaceutical Pricing Authority (NPPA), ensuring that essential drugs
remain affordable.
Importance of the NLEM

Ensuring Affordability
 Essential medicines listed in the NLEM are subject to price regulation. This prevents
price gouging and ensures that essential drugs are affordable to the general population,
reducing the financial burden of healthcare.
Promoting Rational Use of Medicines
 By defining a list of essential medicines, the NLEM promotes rational drug use,
encouraging healthcare providers to prescribe cost-effective and essential drugs over
more expensive or less effective alternatives.
Standardizing Healthcare Treatments
57
 The NLEM serves as a reference point for healthcare providers, including hospitals and
clinics, guiding them on preferred treatments and ensuring a standardized approach to
patient care across the country.
Accessibility
 The government prioritizes the procurement and distribution of medicines on the
NLEM, ensuring that they are widely available, even in remote areas.
Impact on Public Health
Enhanced Healthcare Delivery
 With a focus on essential medicines, healthcare systems can prioritize their procurement
and use, enhancing the overall efficiency of healthcare delivery.
Reduction in Healthcare Costs
 The focus on essential, cost-effective medicines helps to keep the overall cost of
healthcare manageable for both the government and the public.
Improved Health Outcomes
 Access to essential medicines is a key factor in improving health outcomes, particularly
in underprivileged and underserved communities.
Challenges
Selection and Prioritization
 Determining which medicines are essential can be challenging, given the diverse health
needs and limited resources.
Supply Chain Issues
 Ensuring consistent availability of all essential medicines across diverse geographic and
socio-economic settings remains a challenge.
Compliance and Enforcement
 While the NLEM guides drug use and procurement, ensuring adherence by all
healthcare providers and pharmacies can be challenging.
NITI AAYOG ON HEALTH AND THE RELEVANCE OF AAROGYA SETU IN

PUBLIC HEALTH
58
NITI Aayog (National Institution for Transforming India), established in 2015, serves as the
premier policy think tank of the Government of India, providing both directional and policy
inputs. In the health sector, NITI Aayog plays a crucial role in shaping health policies, planning,
and ensuring the effective implementation of various initiatives. One significant contribution
during the COVID-19 pandemic has been the development and promotion of the Aarogya Setu
app, which exemplifies the use of technology in managing public health emergencies.
NITI Aayog’s Focus on Health

Policy Formulation
 NITI Aayog is involved in crafting strategic and long-term policies and programs for
the Government of India. In the health sector, this includes policies aimed at improving
hospital infrastructure, increasing accessibility to healthcare services, and enhancing
the quality and affordability of healthcare.
Promotion of Digital Health
 A significant area of focus has been the promotion of digital health initiatives. NITI
Aayog has been instrumental in pushing for a more digitized healthcare environment,
which includes telemedicine, digital health records, and mobile health applications.
Health Index Report
 NITI Aayog regularly publishes the Health Index Report, which ranks the states and
union territories based on their performance on various health parameters. This serves
as a benchmark and motivates state governments to improve their health services.
Aarogya Setu: A Digital Intervention in Public Health

Development and Purpose
 Launched in April 2020, Aarogya Setu is a mobile application developed by the Indian
government to help control the spread of COVID-19. The app uses GPS and Bluetooth
features to track the infection and notifies users if they are in close proximity to
someone who has tested positive for the virus.
Features and Functionality
 Contact Tracing: Alerts users if they have been near another user who has tested
positive for COVID-19.
 Self-Assessment Tool: Provides a risk score based on the user’s interaction with others,
using the app’s algorithm.
59
 Health and Safety Guidelines: Offers updated health guidelines and information on
COVID-19.
Legal and Privacy Concerns
 The app has raised significant privacy concerns regarding data collection, storage, and
usage. Critics have questioned the transparency and the extent of personal data being
collected.
 The government has responded by publishing the app's source code and asserting that
all personal data collected by Aarogya Setu is encrypted and is not shared with third
parties.
Relevance of Aarogya Setu in Public Health

Enhancing Public Health Surveillance
 Aarogya Setu represents a novel approach to public health surveillance, allowing for
real-time health monitoring and early detection of potential outbreaks.
Policy Decision Support
 Data collected through Aarogya Setu can assist policymakers in making informed
decisions regarding lockdown implementations, resource allocation, and other public
health interventions.
Public Health Messaging
 The platform serves as an effective medium for disseminating public health messages
directly to the populace, ensuring that accurate and timely health information reaches
even remote areas.

Ensuring Data Privacy
 Continuous efforts need to be made to strengthen the data privacy measures and address
the public's concerns about data misuse.
Increasing User Adoption
 For contact tracing apps like Aarogya Setu to be effective, a significant proportion of
the population needs to use them consistently.
Integrating with Health Systems
 Integrating data from Aarogya Setu with other health informatics systems could
enhance its utility, making it a more robust tool for managing public health.
60
MEDICAL EXPERIMENTATION AND CLINICAL TRIALS: ETHICAL AND LEGAL
REQUIREMENTS
Medical experimentation and clinical trials are fundamental to advancing medical knowledge
and improving public health. However, they raise significant ethical and legal issues,
particularly with respect to the safety, rights, and welfare of participants. In India, these
activities are tightly regulated to ensure that they adhere to both ethical standards and legal
requirements. Understanding these regulations is crucial for law students specializing in health
law, as they encapsulate the balance between scientific progress and the protection of individual
rights.
Legal Framework in India

Drugs and Cosmetics Act, 1940
 This act provides guidelines for the import, manufacture, distribution, and sale of drugs
and cosmetics. The Drugs and Cosmetics Rules, 1945, amended over time, include
specific provisions for conducting clinical trials.
New Drugs and Clinical Trials Rules, 2019
 These rules, under the Drugs and Cosmetics Act, provide a detailed regulatory
framework for approving and monitoring clinical trials in India, aiming to ensure the
safety, rights, and well-being of participants.
Role of Central Drugs Standard Control Organization (CDSCO)
 The CDSCO, under the Ministry of Health and Family Welfare, is the main regulatory
body overseeing clinical trials in India. It ensures that trials are conducted in accordance
with global and national standards.
Ethical Guidelines
Indian Council of Medical Research (ICMR) Guidelines
 The ICMR's "Ethical Guidelines for Biomedical Research on Human Participants"
outline the ethical principles that must be followed in any research involving human
participants in India. These guidelines emphasize informed consent, confidentiality,
risk minimization, and the need for a clear scientific rationale.
61
Institutional Ethics Committee (IEC)
 Every institution conducting or supporting biomedical research involving human
participants must have an Ethics Committee, accredited by the CDSCO, which reviews
and approves the research protocols to ensure compliance with ethical norms.
Key Requirements for Clinical Trials

Informed Consent
 Obtaining informed consent from participants is a fundamental requirement. Consent
must be freely given, based on full disclosure of the risks and benefits, and participants
must understand their rights to withdraw at any time.
Compensation for Injury
 Trials must include provisions for compensating participants in case of trial-related
injuries. This is a legal requirement aimed at safeguarding participants against the
inherent risks of clinical trials.
Registration of Trials
 All clinical trials must be registered with the Indian Clinical Trials Registry. This
promotes transparency and enables public access to information about ongoing clinical
research.
Vulnerable Populations
 Special protections are required for trials involving vulnerable populations (e.g.,
minors, pregnant women, or economically disadvantaged individuals), ensuring that
their participation is justified and they are not subject to coercion.
International Guidelines and Compliance

Declaration of Helsinki
 Often cited in Indian legal and ethical guidelines, this is an international standard
defining ethical principles for medical research involving human subjects, including
expectations for privacy, informed consent, and ethical review processes.
Good Clinical Practice (GCP)
 GCP is an international quality standard for designing, conducting, and reporting trials
that involve human participants. Compliance with GCP ensures the ethical and
scientific quality of the conduct of clinical trials.
62
Oversight and Monitoring
 Effective enforcement of regulations remains a challenge. Continuous monitoring and
audits are required to ensure compliance with both legal and ethical standards.
Public Awareness
 There is a need for greater public awareness about the rights of clinical trial participants
and the ethical standards trials must uphold.
Balancing Risk and Innovation
 Regulators and researchers must balance the potential risks to participants with the
benefits of developing new medical treatments and interventions.
INFORMED CONSENT, PRIVACY, AND CONFIDENTIALITY IN MEDICAL

PRACTICE
Informed consent, privacy, and confidentiality are foundational principles in medical practice,
safeguarding patients' rights and ensuring ethical healthcare delivery. For law students studying
health law in India, understanding these principles within the context of the Indian legal system
is crucial. These principles are governed by a combination of statutory laws, professional
guidelines, and ethical norms.
Informed Consent
Definition and Importance
 Informed consent is the process by which a fully informed patient can participate in
choices about their healthcare. It originates from the patient's right to direct what
happens to their body and from ethical standards in medicine.
Legal Requirements
 The Indian Medical Council (Professional conduct, Etiquette and Ethics) Regulations,
2002, mandates that physicians obtain voluntary informed consent from their patients
before performing any treatment or surgery. It should cover the nature and purpose of
the treatment, expected benefits and risks, and the likelihood of success.
Supreme Court Judgments
63
 The Supreme Court of India has upheld the importance of informed consent in several
landmark cases, treating it as an essential aspect of patients' rights. In cases like Samira
Kohli vs. Dr. Prabha Manchanda, the court elaborated on the scope and implications of
informed consent in medical practice.
Privacy and Confidentiality

Privacy in Healthcare
 Privacy in healthcare refers to the right of patients to have their health information,
including treatment details, protected from unauthorized disclosure. The right to
privacy is a fundamental right under Article 21 of the Indian Constitution.
Confidentiality
 Confidentiality, closely linked to privacy, involves the obligation of healthcare
providers to keep patient information secret unless consent has been given for its
disclosure. It is both an ethical obligation and a legal duty.
Legal Framework
 Various laws address confidentiality and privacy in healthcare settings, including the
Indian Medical Council Regulations and the Information Technology Act, 2000, which
details the penalties for breach of confidentiality and privacy in electronic forms.
Ethical Guidelines and Standards

Role of Medical Ethics
 The Indian Medical Council's ethical guidelines insist on maintaining patient
confidentiality unless there is a compelling reason that serves a larger public interest or
is required by law.
International Influence
 Global norms and treaties, such as the Declaration of Helsinki and International
Covenant on Civil and Political Rights (ICCPR), influence Indian standards and
practices, particularly in the handling of medical information and the conduct of clinical
trials.
Challenges in the Digital Age
Digital Health Records
 With the move towards digitization of medical records, maintaining privacy and
confidentiality presents new challenges. The Digital Information Security in Healthcare
64
Act (DISHA) is proposed legislation aimed at establishing an electronic health
information exchange in India while ensuring data protection.
Consent in Telemedicine
 The Telemedicine Practice Guidelines issued in 2020 by the Ministry of Health and
Family Welfare include provisions for obtaining consent through digital modes,
recognizing the nuances of online medical consultations.
Enforcement and Legal Recourse

Regulatory Bodies
 The Indian Medical Council and state medical councils are responsible for enforcing
ethical guidelines and can take disciplinary actions against non-compliance.
Legal Actions
 Patients have the right to seek legal recourse through civil and criminal courts against
violations of privacy or breaches of confidentiality.
MEDICAL EVIDENCE AND THE ROLE OF MEDICAL WITNESS IN LEGAL

PROCEEDINGS
In legal proceedings, medical evidence often plays a crucial role in clarifying the facts of a
case, particularly in personal injury, medical malpractice, criminal, and family law cases.
Medical witnesses, including doctors and other healthcare professionals, provide expert
testimony to help courts understand the medical aspects of a case. For law students studying
health law in India, understanding the nuances of medical evidence and the role of medical
witnesses is essential for effectively navigating and leveraging these resources in legal
contexts.
Medical Evidence in Legal Contexts

Definition and Importance
 Medical evidence consists of medical records, expert opinions, lab test results, and other
health-related information presented in legal proceedings. It can be critical in
establishing causes of injuries, determining medical negligence, or assessing the extent
of physical or psychological damages.
65
Types of Medical Evidence
 Clinical Records: These include a patient's medical history, diagnostic test results,
treatment records, and notes by healthcare providers.
 Forensic Evidence: Utilized primarily in criminal cases, involving assessments that
may include toxicology reports, autopsy reports, and forensic psychology evaluations.
 Expert Testimony: Specialized medical insights provided by qualified health
professionals on specific medical issues pertinent to a case.
The Role of Medical Witness

Definition and Functions
 A medical witness, or expert witness in medical cases, is a healthcare professional with
specialized knowledge deemed beyond that of an average person. Their expertise is
used to interpret and clarify medical evidence so that laypersons, such as jurors or
judges, can understand the medical context of the issues at hand.
Qualifications
 Typically, a medical witness should be a practicing healthcare professional or an
academic with substantial experience and recognition in their field. They must be
credentialed in the area that is relevant to the case at hand.
Responsibilities
 Medical witnesses are expected to provide impartial, unbiased opinions based on their
expertise. They should base their testimony on generally accepted practices and
evidence-based conclusions.
Legal Framework and Guidelines

Regulation
 In India, the Indian Evidence Act, 1872, governs the admissibility of expert evidence,
including medical evidence. Section 45 of the Act allows expert opinions on points of
science or art (which includes medicine) to be considered as evidence.
Ethical Guidelines
 The Medical Council of India provides ethical guidelines that stipulate the duties and
responsibilities of medical practitioners, including those acting as expert witnesses.
Medical witnesses must adhere to principles of confidentiality, informed consent, and
neutrality.
66
Challenges in Medical Testimony
Subjectivity
 Despite the expectation of objectivity, medical opinions can sometimes be subjective.
Different experts might have different opinions based on the same set of facts.
Complexity
 Medical evidence can often be complex and difficult for laypersons to understand,
potentially leading to misinterpretation if not adequately explained.
Cross-Examination
 Medical witnesses must be prepared to withstand rigorous cross-examination from
opposing legal counsel who may seek to discredit their testimony or highlight
inconsistencies.
Impact on Legal Outcomes

Influence on Judgements
 Effective medical testimony can significantly influence the outcome of legal
proceedings by providing clarity and substantiating claims or defenses with scientific
evidence.
Settlements
 Credible medical evidence often leads to settlements before a case reaches trial, as it
can provide clear indications of the strengths or weaknesses of a case.
LEGAL PROCEDURES AND CONSIDERATIONS IN THE EXAMINATION OF A

LIVING PERSON
The examination of a living person in legal contexts typically involves medical evaluations
conducted to determine the impact of alleged injuries or to ascertain the health condition of an
individual as it pertains to legal proceedings. This process must be conducted ethically and in
accordance with legal standards to protect the rights of the individual being examined and to
ensure that the medical evidence gathered is admissible and relevant in court. This note outlines
67
the legal procedures and considerations relevant to such examinations in India, focusing on
their application in both civil and criminal cases.
Legal Basis for Examination

Criminal Cases
 Under the Code of Criminal Procedure, 1973 (CrPC), provisions such as Sections 53,
53A, and 54 allow for the medical examination of accused persons. These sections
mandate examinations to collect evidence that may prove or disprove the involvement
of the person in a crime (e.g., DNA sampling, injury assessment).
Civil Cases
 In civil law, particularly in personal injury claims or family law disputes (such as
divorce or child custody), medical examinations may be ordered to assess the health
status or injury claims of individuals. The court may order a medical examination to
ensure fair proceedings and accurate fact-finding.
Consent and Ethical Considerations

Informed Consent
 Consent is a cornerstone of medical ethics. In legal contexts, however, a court order
may sometimes override the need for consent, especially in criminal investigations.
Nevertheless, the individual should be informed about the nature and purpose of the
examination.
Ethical Guidelines
 The Indian Medical Council (Professional conduct, Etiquette and Ethics) Regulations,
2002, emphasizes that all medical practitioners must adhere to ethical guidelines, even
when conducting court-ordered examinations. This includes respecting patient dignity
and confidentiality.
Procedures for Examination

Examination Protocol
 Medical examinations must be conducted by qualified healthcare professionals. The
process should be thorough and impartial, adhering to established medical practices for
such examinations.
Documentation
68
 Detailed records of the examination findings must be meticulously maintained. These
records should include observations, medical history provided, tests conducted, results,
and any conclusions drawn from the findings.
Reporting
 A comprehensive report based on the examination must be prepared for submission to
the requesting authority (e.g., court, police). This report should be clear, objective, and
devoid of any ambiguity as it is a critical piece of evidence.
Rights of the Examined Individual

Right to Privacy
 The right to privacy must be upheld during the examination process. Sensitive
information must be handled confidentially, and disclosures should be limited to what
is legally required.
Right to Legal Representation
 In criminal cases, the individual has the right to have legal representation during the
process, though this may vary in civil cases depending on the court’s directions and the
nature of the examination.
Challenges and Legal Remedies

Disputes Over Findings
 Disputes may arise over the findings of the medical examination. In such cases, a
second opinion or re-examination by an independent medical expert may be sought.
Legal Recourse
 If an individual believes that the examination was conducted unethically or in violation
of their rights, they may seek legal recourse. Complaints can be lodged with medical
boards or courts, depending on the nature of the violation.
LEGAL ASPECTS OF DEATH: POST-MORTEM EXAMINATION AND DYING

DECLARATION
In the realm of health law in India, the legal aspects of death encompass important procedures
such as post-mortem examinations and the concept of dying declarations. These elements play
69
critical roles in legal investigations, particularly in criminal law, by helping to establish the
cause of death and the circumstances surrounding a crime. Law students focusing on health
law must understand the procedural, ethical, and legal frameworks governing these practices.
Post-mortem Examination (Autopsy)

Purpose and Importance
 A post-mortem examination, commonly referred to as an autopsy, is a detailed and
systematic examination of a body after death. The primary purpose is to determine the
cause of death, the state of health of the person before death, and whether any medical
diagnosis and treatment before death were appropriate.
Legal Framework
 Under the Indian legal system, autopsies can be classified into two categories: medico-
legal and clinical (or pathological). Medico-legal autopsies are conducted in cases of
unnatural deaths, suspicious deaths, or deaths without a clear medical cause, under the
authority of the police and by order of a magistrate (Section 174 CrPC).
Procedures and Protocols
 The procedure for conducting a medico-legal autopsy is outlined in the Code of
Criminal Procedure, 197The autopsy must be conducted by a qualified forensic expert
under the guidelines provided by the Ministry of Health and Family Welfare. The
procedure is meticulous and is meant to preserve evidence and provide accurate results.
Documentation and Reporting
 The findings from a post-mortem examination are documented in a post-mortem report.
This report is crucial in legal proceedings, particularly in establishing the cause of death
and the presence of any foul play.
Dying Declaration
Definition and Legal Significance
 A dying declaration is a statement made by a person who believes they are about to die,
concerning the cause or circumstances of their death. Under Indian law, dying
declarations are covered under Section 32 of the Indian Evidence Act, 1872, and are
considered relevant whether the person survives or not.
Admissibility in Court
70
 Dying declarations are admissible as evidence based on the belief that dying persons
are unlikely to lie (‘Nemo moriturus praesumitur mentiri’ - A man will not meet his
maker with a lie in his mouth). However, the authenticity and voluntariness of the
declaration must be established, and it should be clear, unambiguous, and complete.
Procedures for Recording
 Ideally, a dying declaration should be recorded by a magistrate, but if this is not
possible, especially in emergency situations, a medical officer or even a police officer
may record the declaration. It is crucial that the person making the declaration is of
sound mind.
Challenges and Limitations
 The reliability of dying declarations can be contested based on the mental state and
medical condition of the declarant, potential coaching, or influence from others present,
and inconsistencies in the narrative.
HEALTH LAW AND JUDICIARY: KEY CASES AND JUDGMENTS
Health law in India encompasses a wide array of issues, ranging from patient rights to medical
negligence, and from public health policies to ethical medical practices. The Indian judiciary
has played a pivotal role in shaping health law through various landmark cases and judgments.
These decisions not only clarify legal principles but also set precedents for the handling of
health-related legal issues. Below is a detailed analysis of key cases and judgments relevant to
health law in India, which are essential for law students to understand the practical applications
and implications of health law.
Medical Negligence
Indian Medical Association vs. V.P. Shantha (1995)
 This landmark Supreme Court case extended the scope of services under the Consumer
Protection Act, 1986, to include medical services, thus bringing medical professionals
under its purview. This case established that patients could seek redress for medical
negligence under consumer law, not just civil tort.
Kunal Saha vs. AMRI (2009)
71
 This is one of the most significant cases of medical negligence in India, involving the
death of a patient due to alleged medical malpractice. The Supreme Court awarded a
compensation of nearly ₹6 crores, highlighting the seriousness with which medical
negligence was to be treated.
Right to Health
State of Punjab vs. Mohinder Singh Chawla (1997)
 The Supreme Court declared that the right to health is integral to the right to life under
Article 21 of the Constitution. It emphasized that the government has a constitutional
obligation to provide health facilities.
Paschim Banga Khet Mazdoor Samity vs. State of West Bengal (1996)
 The Supreme Court ruled that the state must provide adequate medical services to
preserve human life, holding that the lack of financial resources cannot be a reason for
the state to shirk this responsibility.
Reproductive Rights
Suchita Srivastava & Anr vs. Chandigarh Administration (2009)
 The Supreme Court upheld the reproductive rights of women as a part of their personal
liberty under Article 2It ruled that a mentally retarded woman had the right to continue
her pregnancy, emphasizing informed consent and autonomy in reproductive decisions.
Devika Biswas vs. Union of India (2016)
 This case dealt with the issue of mass sterilization camps in India. The Supreme Court
criticized the government's approach and laid down guidelines to ensure the dignity and
rights of women undergoing sterilization, emphasizing informed consent and post-
operative care.
HIV and Public Health

Mr. X vs. Hospital Z (1998)
 This case brought up the issue of privacy versus the right to be informed in the context
of HIV/AIDS. The Supreme Court initially ruled that a hospital could disclose the HIV
positive status of a person to his fiancée, citing public health concerns over individual
privacy. This judgment sparked a significant debate on the rights of HIV/AIDS patients.
72
End of Life Care
Aruna Shanbaug vs. Union of India (2011)
 In this case, the Supreme Court addressed the issue of euthanasia in India for the first
time. While it rejected active euthanasia, it allowed passive euthanasia under strict
guidelines, acknowledging the concept of the right to die with dignity.
Common Cause (A Regd. Society) vs. Union of India (2018)
 The Supreme Court allowed 'living wills' and issued comprehensive guidelines for
passive euthanasia, emphasizing the autonomy of patients in deciding the course of
their end-of-life care.
UNDERSTANDING HEALTH INSURANCE: TYPES AND LEGAL FRAMEWORK
Health insurance in India plays a crucial role in ensuring that individuals have access to medical
services without facing the severe financial hardship that can come with sudden illness. Health
insurance policies cover the cost of medical treatments and have become increasingly
important in the context of rising healthcare costs. Law students studying health law in India
must understand the different types of health insurance available and the legal framework that
governs these policies to better advocate for client rights and navigate regulatory issues.
Types of Health Insurance in India

Individual Health Insurance
 This insurance covers health expenses for only one individual, with the policyholder
paying a fixed annual premium. The policy covers various expenses including
hospitalization, day-care procedures, and sometimes pre and post-hospitalization care.
Family Floater Policy
 A family floater policy covers the entire family under one sum insured, which can be
utilized by any/all members of the family. This type of policy typically offers a cost
advantage over individual policies.
Group Health Insurance
 Often provided by employers, group health insurance covers all employees under a
single policy. Premiums are generally lower, and the coverage may extend to family
members. The terms of group policies can vary significantly.
73
Senior Citizen Health Insurance
 Specifically designed for individuals aged 60 and above, these policies cater to the
needs of older adults and cover diseases typically associated with old age. These
policies can be more expensive due to the higher risk associated with older individuals.
Critical Illness Insurance
 Instead of providing general medical coverage, critical illness insurance provides a
lump sum amount to the insured upon the diagnosis of specific serious illnesses listed
in the policy. This type of insurance typically covers illnesses like cancer, heart attacks,
and kidney failures.
Legal Framework Governing Health Insurance

Insurance Regulatory and Development Authority of India (IRDAI)
 IRDAI is the regulatory body responsible for overseeing all insurance activities in India,
including health insurance. It ensures that insurance practices are fair, transparent, and
meet the needs of the public.
The Insurance Act, 1938
 This Act provides the basic legal framework for all insurance operations in India. It
includes provisions relating to the registration of insurance companies, their operations,
and the overall management of these firms.
The Insurance Regulatory and Development Authority Act, 1999
 Established the IRDAI and provided it with the authority to regulate and develop the
insurance industry in India, including health insurance.
Consumer Protection Act, 1986
 Under this Act, consumers of insurance products can seek redressal for grievances
related to deficiencies in service. The Act is crucial for policyholders who face issues
such as wrongful denial of claims or lack of transparency in policy terms.
Critical Legal Issues in Health Insurance

Policy Disclosure and Transparency
 Insurance companies are legally required to disclose all pertinent information to
consumers, including exclusions, premium calculations, and terms and conditions of
the policy. Non-disclosure or misrepresentation can lead to legal action.
Claim Settlement
74
 The legal framework ensures that claims are processed within a stipulated time frame.
Delays or rejections that are not justified can be contested by policyholders.
Portability
 IRDAI regulations allow policyholders to switch from one insurer to another without
losing the benefits accrued from the previous policy, including the waiting period for
pre-existing conditions.
Consumer Courts
 Policyholders can approach consumer courts if they believe that their claims have been
wrongfully denied or that they have been subjected to unfair practices.
ANALYZING PUBLIC SERVICE RELATED SITUATIONS AND LEGAL

IMPLICATIONS OF NEGLIGENCE
Public service in the context of health law in India primarily refers to healthcare services
provided by government-run institutions. The legal implications of negligence in such settings
are significant, given the government's duty to provide health services as part of its obligation
to ensure the right to life under Article 21 of the Indian Constitution. For law students studying
health law, understanding how legal principles apply to public health services and the
consequences of negligence is crucial for advocating for patients' rights and improving public
health policies.
Public Health Services in India

Scope and Duty
 The Indian government operates a vast network of healthcare facilities, from primary
health centers in rural areas to specialized government hospitals in urban centers. These
institutions are mandated to provide accessible, affordable, and quality healthcare to the
public.
Legal Obligations
 The obligation of the state to provide health services is not only a policy mandate but
also a constitutional requirement inferred from the right to life (Article 21 of the
Constitution). The Supreme Court of India in cases like Paschim Banga Khet Mazdoor
75
Samity vs. State of West Bengal has held that the government has an obligation to
provide timely medical treatment to preserve human life.
Legal Framework Governing Public Health Services

The National Health Policy
 The National Health Policy (NHP), most recently updated in 2017, provides a
framework for the provision of equitable and accessible healthcare across public and
private sectors. The NHP aims to improve the quality of healthcare services and ensure
their responsiveness to the needs of the population.
Clinical Establishments (Registration and Regulation) Act, 2010
 This Act provides for the registration and regulation of all clinical establishments in
India and sets the minimum standards of facilities and services provided by them.
Negligence in Public Health Services

Definition and Standard of Care
 In legal terms, negligence refers to the breach of a duty caused by the omission to do
something that a reasonable man, guided by considerations which ordinarily regulate
human affairs, would do. In the context of healthcare, this means the failure to provide
the standard of care that would reasonably be expected of a medical professional or
institution.
Vicarious Liability
 Public health institutions are liable for the acts of their employees under the principle
of vicarious liability. This means that if a healthcare professional employed by a
government hospital commits an act of negligence, the hospital itself can be held liable.
Landmark Judgments
 Kunal Saha vs. AMRI: The Supreme Court awarded substantial compensation for
medical negligence, underscoring the accountability of healthcare providers.
 Paschim Banga Khet Mazdoor Samity vs. State of West Bengal: Highlighted the
state's duty to provide adequate medical facilities to treat every patient with minimal
standards of care.
Remedies and Legal Recourse

Civil Liability
76
 Victims of medical negligence can seek compensation through civil courts under the
law of torts. The quantum of compensation typically depends on the extent of injury
and the degree of negligence.
Criminal Liability
 In cases where negligence is gross and results in severe harm or death, criminal charges
can be brought under Section 304A of the Indian Penal Code (IPC) for causing death
by negligence.
Consumer Protection Act
 Since healthcare services are considered 'services' under the Consumer Protection Act,
1986, patients can also seek redress through consumer forums for deficiencies in
service.
DISPOSAL OF MEDICAL AND SURGICAL WASTE: LEGAL GUIDELINES
The disposal of medical and surgical waste is a critical issue in health law due to its direct
impact on public health and the environment. In India, the management of biomedical waste is
governed by specific regulations designed to mitigate the risks associated with hazardous
materials. For law students studying health law, understanding the legal framework that
regulates the disposal of medical waste is essential for ensuring compliance with the law and
advocating for environmental safety and public health.
Medical and Surgical Waste

Definition
 Medical and surgical waste, often referred to as biomedical waste, includes any waste
that is generated during the diagnosis, treatment, or immunization of human beings or
animals. This can range from used needles and syringes to soiled gauze and surgical
instruments.
Categories
 Biomedical waste is categorized based on the risk it poses, including but not limited to
infectious waste, pathological waste, sharp waste, chemical waste, and pharmaceutical
waste.
77
Legal Framework
Biomedical Waste Management Rules, 2016
 The primary legislation governing the disposal of medical waste in India is the
Biomedical Waste Management Rules, 2016, issued under the Environment
(Protection) Act, 198These rules replaced the earlier 1998 rules to enhance the
collection, segregation, processing, treatment, and disposal of biomedical waste.
Key Provisions
 Segregation: The rules mandate the segregation of biomedical waste into four
categories at the point of generation, according to type of waste, each in different color-
coded containers to facilitate safe handling and disposal.
 Pre-treatment: Certain categories of waste, like microbiology waste, must be pre-
treated through disinfection or sterilization at the healthcare facility before disposal.
 Authorization and Annual Reporting: Healthcare facilities generating biomedical
waste must obtain authorization from the State Pollution Control Board (SPCB) or
Pollution Control Committee (PCC). Facilities are also required to submit annual
reports detailing the quantities and categories of waste handled.
Role of Pollution Control Boards
 The SPCB and PCCs are tasked with monitoring the implementation of these rules,
issuing authorizations to biomedical waste handlers, and taking action against facilities
that violate the standards.
Responsibilities of Healthcare Facilities

Waste Minimization and Management
 Healthcare facilities must implement procedures to minimize waste generation and
ensure that waste is treated and disposed of in an environmentally sound manner.
Training and Record Keeping
 Facilities must provide regular training to all healthcare and housekeeping staff on
proper waste handling and emergency procedures. They must also maintain records
related to waste generation, collection, and disposal.
Handling and Transport
 Proper handling, collection, and transportation of biomedical waste are crucial for
preventing risks to health and the environment. Facilities must ensure that waste is
handled safely and transported in specially designed vehicles.
78
Enforcement and Penalties
Inspections and Monitoring
 The SPCB and PCC regularly inspect healthcare facilities to ensure compliance with
biomedical waste management rules. They assess practices and facilities for adherence
to the segregation, collection, treatment, and disposal guidelines.
Penalties
 Violations of the Biomedical Waste Management Rules can lead to penalties including
closure of facility, revocation of license, and financial penalties, depending on the
severity of the non-compliance.
LIABILITIES OF HEALTH CARE UNITS: PUBLIC VS. PRIVATE SECTOR
In India, the health care sector is divided into public and private entities, each governed by a
range of legal frameworks that define their operations and liabilities. Understanding the
differences in liabilities for public and private health care units is crucial for law students
specializing in health law, as these distinctions impact legal strategies, compliance, and
advocacy. This note explores the legal liabilities of health care units in both sectors with respect
to medical negligence, compliance with health standards, and patient rights.
Legal Framework Governing Health Care Units

Applicable Laws
 Public Sector: Governed primarily by constitutional provisions and public law,
including the Indian Penal Code (IPC), Consumer Protection Act 1986 (revised in
2019), and specific health regulations like the Clinical Establishments (Registration and
Regulation) Act, 2010.
 Private Sector: Besides the laws applicable to the public sector, private entities also
adhere to corporate laws, such as the Companies Act, 2013, and regulations specific to
private investment and operations.
Medical Negligence
Definition and Application
79
 Medical negligence in both sectors is defined as a breach of duty of care by health care
providers that results in harm to the patient. The standard used is what a reasonably
competent professional in the same field would do under similar circumstances.
Public Sector Liabilities
 Public hospitals, being government-run, are often scrutinized under stricter public
interest standards. However, claims against them can be complex due to sovereign
immunity, which protects government bodies from certain lawsuits.
 Case Law: In the landmark case Paschim Banga Khet Mazdoor Samity vs. State of
West Bengal (1996), the Supreme Court held the state responsible for providing
necessary medical facilities to every citizen.
Private Sector Liabilities
 Private entities are liable under both civil and criminal law for medical negligence.
They face legal actions in the form of malpractice suits and can be sued under consumer
protection laws since they operate commercially.
 Case Law: Indian Medical Association vs. V.P. Shantha (1995) clarified that medical
professionals and hospitals fall under the ambit of 'service providers' as per the
Consumer Protection Act.
Compliance with Health Standards

Public Sector
 Must comply with national health policies and standards set forth by various acts and
regulations, focusing on public welfare. Public hospitals must maintain standards
despite often dealing with resource constraints.
Private Sector
 Faces rigorous regulatory scrutiny, similar to public entities but with additional
standards often imposed by accreditation bodies like NABH (National Accreditation
Board for Hospitals & Healthcare Providers). Compliance is generally higher due to
market competition and patient expectations.
Patient Rights and Confidentiality

Public Sector
80
 Bound by fundamental rights under the Constitution, public hospitals must ensure equal
treatment to all patients. Challenges often arise in maintaining patient confidentiality
and rights due to overcrowding and underfunding.
Private Sector
 Although equally obligated to uphold patient rights, private hospitals typically have
better resources to ensure privacy, confidentiality, and patient care. However, they are
also more frequently subjected to litigation over breaches of patient rights.
Enforcement and Penalties

Public Sector
 Often subject to administrative review and penalties by government authorities. Rarely
face closure but can experience significant restructuring following major incidents or
public outrages.
Private Sector
 Subject to legal actions including significant financial compensation and punitive
damages. Can also face revocation of licenses or closure for severe violations.
CASE STUDIES ON MEDICAL NEGLIGENCE AND LEGAL OUTCOMES
Medical negligence is a significant area of focus within health law in India, dealing with
instances where health care providers fail to deliver the standard of care expected, resulting in
harm to the patient. The legal framework addressing medical negligence involves principles
from tort law, contract law, and specific statutes such as the Consumer Protection Act,
198Understanding key case studies helps law students grasp how theoretical principles are
applied in real-world scenarios and the judicial reasoning behind various legal outcomes.
Indian Medical Association vs. V.P. Shantha (1995)

This landmark Supreme Court case established that medical services fall within the scope of
'services' under the Consumer Protection Act, 1986, making it possible for patients to seek
redressal for medical negligence in consumer forums.
Facts: A complaint was made against a doctor and his hospital under the Consumer Protection
Act, claiming damages for medical negligence.
81
Legal Issue: Whether medical professionals and their establishments can be considered 'service
providers' under the Consumer Protection Act.
Judgment: The Supreme Court held that medical practitioners, except where services are
rendered free of charge or under a contract of personal service, fall within the ambit of 'service'
as defined in the Consumer Protection Act.
Legal Outcome: This judgment empowered patients to file complaints against medical
practitioners and hospitals in consumer courts, which often provide quicker remedies than
regular civil courts.
Kunal Saha vs. AMRI (2009)

This case is known for the highest compensation ever awarded in India for medical negligence,
totaling approximately INR 1crores.
Facts: Dr. Kunal Saha, an NRI, sued doctors and a hospital in Kolkata after his wife died due
to alleged medical negligence.
Legal Issue: The extent of liability and the amount of compensation due for medical
negligence.
Judgment: The Supreme Court found the hospital and four doctors guilty of negligence and
determined the compensation based on various factors including the loss of life and suffering,
loss of income, and medical expenses incurred.
Legal Outcome: The case underscored the accountability of medical professionals and
institutions and established benchmarks for compensation amounts in cases of medical
negligence.
Paschim Banga Khet Mazdoor Samity vs. State of West Bengal (1996)
A significant case in which the Supreme Court emphasized the state's obligation to provide
adequate medical facilities as part of the right to life under Article 21 of the Constitution.
Facts: A laborer was injured and was refused treatment at several government hospitals due to
a lack of facilities.
Legal Issue: Whether the denial of treatment constituted a violation of the right to life under
Article 21.
Judgment: The Supreme Court held that the state's failure to provide timely medical treatment
to the injured man violated his right to life. The court directed the state to provide adequate
medical facilities.
82
Legal Outcome: This case reinforced the government's duty to ensure health care accessibility
and set a precedent for the state's responsibility in providing health services.
Jacob Mathew vs. State of Punjab (2005)

This Supreme Court case is important for defining the guidelines for criminal liability in cases
of medical negligence.
Facts: A patient died due to an alleged lack of oxygen supply, and the attending physician was
charged with criminal negligence.
Legal Issue: The criteria under which a medical professional can be charged with criminal
negligence.
Judgment: The Supreme Court held that for a medical professional to be criminally negligent,
there must be evidence of gross negligence or incompetence; mere lack of necessary care,
precaution, or attention might constitute civil liability but not criminal.
Legal Outcome: The judgment provided clarity on the distinction between civil and criminal
liability in medical negligence cases, setting a high threshold for criminal prosecution.
ANALYSIS OF RECENT HEALTH POLICIES AND THEIR LEGAL IMPLICATIONS
In recent years, India has introduced several significant health policies aimed at improving the
accessibility, affordability, and quality of healthcare services. These policies not only have
profound impacts on the health of the population but also carry important legal implications.
Law students studying health law need to understand these policies both in the context of public
health goals and the legal frameworks that govern their implementation. This note will analyze
some key recent health policies in India and discuss their legal implications.
National Health Policy (NHP) 2017

The NHP 2017 replaces the previous 2002 policy, aiming to achieve universal health coverage
and aligning its goals with international health targets such as the Sustainable Development
Goals.
Key Features:
 Emphasizes the role of the private sector in achieving health goals.
 Promotes preventive and promotive health care.
83
 Aims to increase public health expenditure to 2.5% of GDP by 2025.
Legal Implications:
 Right to Health: The policy strengthens the legal basis for the right to health as it seeks
to ensure universal health coverage. This may lead to increased legal actions if the state
fails to meet its policy commitments.
 Regulatory Reforms: Increased involvement of the private sector necessitates robust
regulatory frameworks to ensure compliance with health standards, fair pricing, and
prevention of unethical practices.
 Data Privacy: The policy's focus on digital health technologies raises issues related to
data protection and privacy, necessitating strict compliance with laws like the
Information Technology Act and any forthcoming personal data protection legislation.
Ayushman Bharat - Pradhan Mantri Jan Arogya Yojana (PM-JAY) 2018

Launched in 2018, PM-JAY is one of the world's largest health insurance schemes, intended to
cover over 500 million people. It provides a health insurance cover of up to ₹5 lakh per family
per year for secondary and tertiary care hospitalization.
Key Features:
 Covers most secondary care and many tertiary care procedures.
 Cashless and paperless access to health services.
Legal Implications:
 Consumer Protection: The scheme brings a large segment of private hospitals under
government insurance schemes, which raises issues related to consumer protection and
service quality.
 Insurance Regulation: This scheme alters the landscape of health insurance in India,
creating new legal challenges in terms of policyholder rights and insurer obligations.
 Contractual Obligations: There are potential legal disputes over contractual
obligations between hospitals, insurance companies, and the government.
Mental Healthcare Act, 2017

This Act was introduced to provide better healthcare for persons suffering from mental illness
and to ensure their rights and dignity are maintained.
Key Features:
 Rights-based approach to mental health treatment.
84
 Decriminalizes suicide, treating such individuals as in need of care and support, rather
than as criminals.
 Mandates the provision of mental healthcare and services without discrimination.
Legal Implications:
 Human Rights: Strengthens the legal rights of the mentally ill and may lead to legal
action against institutions that fail to comply with the standards set by the Act.
 Liability Issues: Healthcare providers may face increased liabilities, particularly in
terms of ensuring consent and adherence to the procedures set forth in the Act.
 Regulatory Oversight: Increased need for oversight of mental health facilities and
practitioners, potentially leading to more frequent inspections and stricter licensing
requirements.
85

Handouts For Health Law

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Handouts For Health Law

Uploaded by

Copyright:

Available Formats

Handouts

1. INTRODUCTION TO HEALTH LAW: CONCEPT, DEFINITION OF HEALTH, AND

Introduction to Health Law

The Right to Health

Intersection of Fundamental Rights and Directive Principles in Health Law

INTERNATIONAL LAW AND HEALTH: AND IMPACT

Introduction of International Law and Health

Key International Agreements and Instruments

Impact of International Health Law on India

Policy Adoption and Adaptation

TRIPS AND PUBLIC HEALTH: KEY PROVISIONS AND IMPLICATIONS

Implications for Public Health in India

International and Domestic Critiques

ALMA-ATA AND DOHA DECLARATIONS: SIGNIFICANCE IN HEALTH LAW

Combined Impact on Health Law in India

ROLE OF THE WORLD HEALTH ORGANIZATION IN PUBLIC HEALTH

Introduction to the World Health Organization (WHO)

WHO's Functions and Responsibilities

WHO’s Impact on Health Law in India

Challenges and Critiques

INTERNATIONAL HEALTH REGULATIONS AND GLOBAL HEALTH

Introduction to International Health Regulations (IHR)

Key Features of the IHR

Global Health Governance

Implications for Health Law in India

COMPARISON OF INDIGENOUS AND ALLOPATHIC HEALTH SYSTEMS

The healthcare landscape in India is marked by a coexistence of multiple medical systems

Indigenous Health Systems

Allopathic Health System

Key Differences in Approach and Practice

Regulatory and Health Law Implications

MEDICAL ETHICS: DEVELOPMENT, CONCEPT, AND IMPORTANCE

Development of Medical Ethics

Key Concepts in Medical Ethics

Importance of Medical Ethics

Medical Ethics and Law in India

DUTIES OF DOCTORS AND RIGHTS OF PATIENTS

Legal Frameworks Governing Duties and Rights

HOSPITAL AS AN INDUSTRY AND APPLICABILITY OF LABOUR LAWS

Applicability of Labour Laws

Challenges and Enforcement

MEDICAL NEGLIGENCE: UNDERSTANDING LIABILITY IN TORTS AND

Medical Negligence under Tort Law

Liability under the Consumer Protection Act, 1986

Legal Challenges and Defenses

Recent Developments and Trends

CONCEPTS OF VICARIOUS LIABILITY AND CRIMINAL LIABILITY IN

Vicarious Liability in Medical Practice

Criminal Liability in Medical Practice

LAW RELATING TO TERMINATION OF PREGNANCY AND ETHICAL

The Medical Termination of Pregnancy (MTP) Act, 1971

Legal Challenges and Debates

ORGAN TRANSPLANTATION: LEGAL AND ETHICAL ASPECTS

Legal Framework in India

International Perspective and Compliance

Challenges and Future Directions

REGULATIONS ON PRE-NATAL DIAGNOSTIC TECHNIQUES

The Pre-conception and Pre-natal Diagnostic Techniques (PCPNDT) Act, 1994

ARTIFICIAL INSEMINATION AND SURROGACY: LEGAL FRAMEWORK

Legal Framework for Artificial Insemination

Challenges and Critiques

LEGALITY AND ETHICAL DEBATES ON EUTHANASIA

MENTAL HEALTH CARE: LEGAL FRAMEWORK AND PATIENT RIGHTS