HEALTH LAW NOTES

10 Marks Q & A

1. Definitions of following terms from the Pre-Conception and Pre-

Natal Diagnostic Techniques (PCPNDT) Act, 1994

a. Conceptus

This means any stage of a baby’s development inside the womb, starting from the
moment the sperm and egg join (fertilization) until the baby is born.
It includes both the embryo (early stage) and the foetus (later stage).

b. Embryo

An embryo is what we call the baby in the first 8 weeks of pregnancy, right after the
egg is fertilized.
During this time, the baby is just starting to form body parts like the heart and brain.

c. Foetus

After 8 weeks, the embryo becomes a foetus.

This is the stage where the baby is more developed — with arms, legs, organs, and
starts growing bigger until birth.

d. Pre-natal Diagnostic Procedures [section 2 (i)]

These are medical tests done during pregnancy to check if the baby has any health
problems.
Some examples include:

 Ultrasound (to see the baby in the womb)

 Amniocentesis (taking a small sample of fluid around the baby)
 Blood tests or other tissue tests

These tests should only be used for medical reasons, not to find out if the baby is a
boy or girl.
e. Sex Selection [Section 2 (O)]

This means trying to choose or decide whether to have a boy or a girl before or during
pregnancy.
For example: Using medicines or techniques to get a baby of a specific gender

Doing tests just to know the baby’s sex and then deciding whether to continue the
pregnancy

Sex selection is illegal in India, and the PCPNDT Act bans it to stop the misuse of
medical technology for choosing a child’s sex.

2. Right to Health as a Fundamental Right under Article 21 of the

Constitution of India

Article 21 of the Indian Constitution states: “No person shall be deprived of his life or
personal liberty except according to procedure established by law.” Though the
Constitution does not explicitly mention the right to health, the Supreme Court has
interpreted the term “life” under Article 21 to mean a life of dignity, which includes
good health, medical care, and a clean environment.

The judiciary has played a crucial role in recognizing the right to health as a part of
the right to life. The following case laws demonstrate how the courts have developed
and expanded this interpretation:

In Bandhua Mukti Morcha v. Union of India (1984), the Supreme Court held that
the right to live with human dignity includes the protection of health and strength of
workers and labourers, particularly those engaged in bonded labour.

In Consumer Education and Research Centre v. Union of India (1995), the Court
declared that the right to health and medical care is a fundamental right under Article
21, especially for workers in hazardous industries. Employers were directed to ensure
health protection and medical facilities.

In Paschim Banga Khet Mazdoor Samity v. State of West Bengal (1996), the Court
held that denial of emergency medical treatment by government hospitals amounts to
a violation of Article 21. The State has a constitutional duty to provide adequate
medical facilities and cannot escape liability due to lack of infrastructure.

In Parmanand Katara v. Union of India (1989), the Supreme Court ruled that every
doctor, whether in a government or private hospital, is duty-bound to provide
emergency medical aid to preserve life without waiting for legal formalities.

In State of Punjab v. Mohinder Singh Chawla (1997), the Court reaffirmed that the
right to health is an integral part of the right to life and it is the responsibility of the
State to provide adequate medical facilities.

In Vincent Panikurlangara v. Union of India (1987), the Court emphasized that the
maintenance and improvement of public health is the State’s constitutional obligation,
linking it to Article 21 and Directive Principles of State Policy.

In Navtej Singh Johar v. Union of India (2018), the Court, while dealing with
LGBTQ rights, highlighted that the right to life includes mental and emotional well-
being, thereby reinforcing that health includes both physical and mental aspects.

In CESC Ltd. v. Subhash Chandra Bose (1992), the Supreme Court recognized that
the right to health and medical care is a fundamental right of workers under Article 21
and must be ensured by the employer as part of the conditions of employment.

In Air India Statutory Corporation v. United Labour Union (1997), the Court held
that social security and health care are essential elements of the right to life and
dignity of workers, and the State must ensure such provisions.

In Municipal Council, Ratlam v. Vardhichand (1980), the Court linked public health
and sanitation to the right to live with dignity under Article 21, and directed the local
municipal body to take necessary steps for maintaining a clean and healthy
environment.

In conclusion, the Indian judiciary has consistently expanded the scope of Article 21
to include the right to health as a part of the fundamental right to life. It is now well
established that the State has a constitutional obligation to ensure affordable,
accessible, and adequate health care to all citizens.
3. Main provisions of Mental Healthcare Act, 2017. Main objective of
the Act.

Objective of the act :

1) Right to Access Healthcare; Everyone has the right to get affordable and good
quality mental health services.
2) Protection of Rights : People with mental illnesses must be treated with respect
and dignity, and they should not face discrimination.
3) Promote Mental Health : The Act works to pr omote mental health r ights and
ensure people can access treatment and support.
4) Regulate Mental Health Services : Establish rules and authorities to make sure
mental health services are safe and high quality.
5) Decriminalize Suicide Attempts : Suicide attempts are no longer criminal;
instead, people who attempt suicide should receive mental health care and
support.

Main Provisions of the Act:

1. Right to Mental Healthcare (Section 18): Every person has the right to access
mental healthcare services run or funded by the government. These services must
be affordable, of good quality, and available without discrimination.
2. Right to Dignity and Non-Discrimination (Section 20): Persons with mental
illness have the right to live with dignity and must not be discriminated against on
the basis of their illness.
3. Advance Directive (Section 5): A person can make an advance directive
specifying how they wish to be treated (or not treated) during a mental health
crisis. They can also appoint a nominated representative.
4. Nominated Representative (Section 14): Individuals can choose someone
(family, friend, guardian) to act on their behalf in making mental health decisions
if they are unable to do so.
5. Mental Health Authority: The Act provides for the establishment of Central and
State Mental Health Authorities to regulate mental health services, register
professionals and institutions, and ensure compliance.
6. Decriminalization of Suicide (Section 115): The Act decriminalizes suicide
attempts. It presumes that a person attempting suicide is under severe stress and
mandates care, not punishment.
7. Informed Consent and Confidentiality (Sections 21, 22): Mental health
professionals must obtain informed consent before treatment and maintain the
confidentiality of the patient’s information.
8. Prohibition of Inhuman Treatment (Section 95): Practices like chaining,
isolation, and sterilization of persons with mental illness are prohibited.
9. Free Treatment for Poor and Homeless (Section 18(7)): Persons who are
homeless or below the poverty line are entitled to free mental healthcare from
government facilities.

4. Main provisions of National Commission for Homoeopathy Act,

2020, objectives and implementation challenges.

The National Commission for Homoeopathy Act, 2020 was introduced to regulate and
improve the standards of homoeopathic education, practice, and research in India.
This Act replaces the Central Council of Homoeopathy (CCH) and aims to make
homoeopathy a more organized and credible system of medicine.

Main Provisions of the Act

1) Establishment of the National Commission for Homoeopathy (NCH): The

Act establishes the National Commission for Homoeopathy as the main body
responsible for regulating homoeopathic education, practice, and research across
India.
2) Homoeopathic Education Board (HEB): Under the NCH, the Homoeopathic
Education Board (HEB) is set up to regulate and standardize homoeopathic
education. The board will set guidelines for courses, exams, and qualifications for
homoeopathic practitioners.
3) National Eligibility-cum-Entrance Test (NEET): The Act makes it mandatory
for students to take the NEET (National Eligibility-cum-Entrance Test) for
admission to homoeopathic colleges. This ensures that only qualified students can
pursue a career in homoeopathy.
4) State and Central Councils: The Act provides for the formation of State
Homoeopathic Medical Councils to register practitioners and maintain a list of
qualified doctors in each state. This ensures that only registered and qualified
individuals can practice homoeopathy.
5) Promotion of Research: The Act encourages research in homoeopathy to
increase the scientific understanding and development of homoeopathic
treatments. This research is expected to strengthen the credibility of homoeopathy.
6) Penalties for Unlawful Practices: The Act specifies penalties for unregistered
practitioners and those involved in fraudulent practices. It also addresses issues
like misleading advertisements and unethical practices in homoeopathy.

Objectives of the Act

1) Improve the Quality of Education and Practice: The Act’s primary goal is to
ensure that homoeopathic education and practice in India are of the highest
standard, with proper training and professional qualifications.
2) Regulate Homoeopathic Practitioners: It seeks to ensure that only qualified and
registered practitioners are allowed to treat patients, thus ensuring better quality
healthcare.
3) Promote Research in Homoeopathy: The Act focuses on the development of
scientific research in the field of homoeopathy. This helps in improving treatment
methods and integrating homoeopathy with modern medical practices.
4) Standardize Education Nationwide: The Act aims to create a uniform standard
of education across the country, ensuring that all homoeopathic colleges follow
the same guidelines, curriculum, and examination system.
5) Ensure Public Health Protection: By regulating and monitoring the education
and practice of homoeopathy, the Act seeks to protect the public from unqualified
pr actitioner s and ensure better healthcare services.

Implementation Challenges

1) Resistance from Practitioners: Some practitioners, especially from rural areas,

may resist the new rules and the requirement of NEET for admission.
2) Lack of Infrastructure: Setting up the necessary administrative systems and
institutions at both the state and national levels could be difficult due to
resource limitations.
3) Awareness Issues: People may not fully understand the new system and could
be confused, especially in rural areas.
4) Research Funding Problems: Although the Act encourages research, there
might not be enough funding or facilities for it to grow properly.
5) Coordination Issues: There could be challenges in getting the National
Commission, State Councils, and education bodies to work smoothly together.
6) Old Practitioners’ Issues: Some older practitioners may not have formal
qualifications and might find it difficult to meet the new registration
requirements.

Conclusion : The National Commission for Homoeopathy Act, 2020 aims to bring
uniformity, quality, and scientific advancement to the homoeopathy sector in India.
By standardizing education and practice, regulating practitioners, and promoting
research, it seeks to improve the credibility and effectiveness of homoeopathy.
However, challenges like resistance to change, lack of infrastructure, and funding
issues could hinder its successful implementation.

5 Marks Q & A

1. Main objective of National Commission for Indian System of

Medicine Act, 2020.

The National Commission for Indian System of Medicine Act, 2020 was enacted to
regulate and promote the quality of education, practice, and research in the Indian
System of Medicine (ISM), which includes traditional systems like Ayurveda, Unani,
Siddha, and Homeopathy.

Main Objective of the Act:

The primary objective of the National Commission for Indian System of Medicine
Act, 2020 is to ensure that Indian System of Medicine (ISM) in India is regulated,
standardized, and modernized. This is done to ensure better education, professional
practice, and research in ISM, and to provide quality healthcare to the public.

Key Points of the Main Objective:

1. To Regulate ISM Education and Practice: The Act aims to regulate and
standardize the curriculum and examinations for courses in Ayurveda, Unani,
Siddha, and other ISM fields, ensuring that only qualified professionals practice
these systems of medicine.
2. To Improve the Quality of Healthcare: It seeks to ensure that practitioners of
ISM provide safe, effective, and scientifically grounded treatments to the public,
protecting patients from unqualified practitioners.
3. To Create a National Body for ISM: The Act establishes the National
Commission for Indian System of Medicine (NCISM) to oversee the regulation,
monitoring, and development of ISM in India, including registration of
practitioners and setting standards for education and research.
4. To Promote Research in ISM: The Act focuses on encouraging research and
development in ISM to bring these traditional systems in line with modern
scientific practices and to improve their credibility.
5. To Increase the Access to ISM Healthcare Services: By regulating ISM
practices and ensuring proper training for practitioners, the Act aims to improve
the accessibility and reliability of ISM-based healthcare services for the general
public.

2. Describe the major provisions of the Drugs and Cosmetics Act,

1940 that aim to regulate drug safety, efficacy, and quality.

The Drugs and Cosmetics Act, 1940 was enacted to regulate the safety, efficacy,
and quality of drugs and cosmetics in India. Below are the major provisions of the
Act that ensure drug safety, efficacy, and quality:

1) Approval of Drugs: Under the Act, drugs and cosmetics must be approved by
the Drugs Controller General of India (DCGI) before they can be marketed. The
approval ensures that only safe, effective, and quality-assured products are
available to the public.
2) Safety and Efficacy: Drugs are required to undergo clinical trials and tests to
prove their safety and efficacy. Drugs that fail to meet safety or effectiveness
standards cannot be sold or distributed in India. The Central Drugs Standard
Control Organization (CDSCO) oversees this process.
3) Quality Control: The Act establishes quality standards for drugs and cosmetics.
It ensures that manufacturers comply with Good Manufacturing Practices (GMP)
to produce safe and high-quality products. This is crucial to prevent
contamination and maintain product consistency.
4) Licensing and Registration: The Act mandates licensing for the manufacture,
sale, and distribution of drugs and cosmetics. This helps in controlling the
production and distribution of substandard or counterfeit products and ensures
that only licensed entities can produce and sell drugs.
5) Enforcement and Inspections: The Act empowers the State Drug Controllers to
carry out inspections and ensure compliance with the provisions. They have the
authority to seize substandard or counterfeit drugs and take legal action against
violators.

3. Main elements required to establish medical negligence in India,

with 3 to 4 landmark cases.

To establish medical negligence in India, certain key elements need to be proven.

Medical negligence occurs when a healthcare professional fails to provide the
standard of care expected, resulting in harm to the patient. Here are the main elements
required to establish medical negligence, along with landmark cases:

1. Duty of Care: The medical professional must owe a duty of care to the patient.
This means there is an obligation to provide proper treatment and care based on
medical knowledge and standards.
2. Breach of Duty: There must be a breach of the duty of care. This occurs when
the medical professional fails to meet the expected standard of care. A breach can
happen through an act of commission (doing something wrong) or omission
(failing to do something required).
3. Causation: There must be a direct link between the breach of duty and the harm
caused. The patient's injury must be caused by the negligence of the healthcare
 provider. The harm should be a foreseeable result of the medical professional’s
actions or inactions.
4. Damage or Harm: The patient must have suffered actual harm or injury due to
the breach of duty. This could be physical, emotional, or financial harm resulting
from the negligence.

Landmark Cases in Medical Negligence in India:

 Indian Medical Association v. V.P. Shanta (1995): The Supreme Court ruled
that doctors are service providers under the Consumer Protection Act. If a patient
suffers due to negligence, they can seek compensation as a consumer.
 Dr. Laxman Balkrishna Joshi v. Dr. Trimbak Bapu Godbole (1969): The
court stated that doctors must adhere to the standar d of car e expected from
professionals in their field. Failur e to follow pr oper medical pr ocedur es can
lead to negligence.
 Samira Kohli v. Dr. Prabha Manchanda (2008): The Supreme Court
emphasized the importance of infor med consent before any medical procedure.
Performing a procedure without proper consent is considered negligence.
 V. Kishan Rao v. Nikhil Super Speciality Hospital (2010): The court held that
doctors must have the necessar y skills for the medical procedures they perform.
If they fail to meet the expected standard of care, it is medical negligence.

4. Key provisions of The Pre-Conception and Pre-Natal Diagnostic

Techniques (PCPNDT) Act, 1994

The Pre-Conception and Pre-Natal Diagnostic Techniques (PCPNDT) Act, 1994 was
made to stop sex selection and female foeticide in India. It controls the use of certain
medical tests during pregnancy to prevent misuse for determining the sex of the baby.

Key Provisions of the PCPNDT Act, 1994 :

1. Regulating Medical Tests: The Act controls the use of pre-natal tests like
ultrasound or amniocentesis, which can be used to check the health of the baby.
These tests are allowed only for medical reasons, not to find out the baby’s
gender.
2. Ban on Sex Determination: The Act bans the use of these tests for finding out
the sex of the baby. It is illegal to use these tests to choose the sex of the child
because this could lead to female foeticide (killing female babies before birth).
3. Registration of Clinics: Any clinic or hospital that offers these tests must be
registered with the government. They need a license to ensure they follow the law
and use tests only for medical reasons, not for gender selection.
4. Appointment of Authorities: The government appoints special authorities at
national, state, and district levels to monitor and enforce the rules of the Act.
They check if clinics are following the law and investigate complaints.
5. Maintaining Records: Clinics must keep detailed records of every test they do.
These records help ensure that tests are being used for the right purposes and not
for illegal sex determination.
6. Penalties for Violations: If someone breaks the law, they can face heavy fines or
imprisonment. This includes people who do sex determination tests or perform
abortions based on the sex of the baby.
7. Public Awareness: The Act also encourages spreading awareness about gender
equality and the importance of not discriminating against female children. It
works to educate people on the harm caused by choosing babies based on gender.

Conclusion: The PCPNDT Act is meant to stop female foeticide and sex-selective
abortion. It regulates the use of prenatal diagnostic tests, makes sure clinics are
properly registered, and imposes strong penalties for breaking the rules. It plays a key
role in protecting the rights of female children and promoting gender equality.

5. Legal Issues arising from Clinical trials and biomedical research

involving human subjects in India.

In India, clinical trials and biomedical research involving human subjects present
several legal issues due to concerns about ethics, patient rights, and safety. These
issues need to be carefully managed to ensure that the research is conducted in a fair,
transparent, and accountable manner. Below are the key legal issues:

1) Informed Consent: Informed consent is the most crucial legal requirement for
clinical trials. Participants must be fully informed about the nature of the research,
the risks involved, and their rights before agreeing to participate. Failure to obtain
 valid consent can lead to legal consequences, as it violates the participant's right
to autonomy and personal decision-making.
2) Protection of Vulnerable Groups: Vulnerable groups like pregnant women,
minors, and those with mental disabilities require special protection during
clinical trials. The legal issue arises when these groups are exploited or not given
additional safeguards, leading to potential human rights violations.
3) Adverse Events and Patient Safety: Adverse events or harmful side effects
from trial drugs or procedures must be properly monitored and reported. Failure
to manage or report these events can lead to lawsuits for medical negligence or
failure to ensure safety. Researchers or sponsors may be held liable for harm
caused to participants.
4) Ethical Approval and Regulatory Compliance: Clinical trials must obtain
ethical approval from an Ethics Committee and comply with regulations set by
bodies like the Drugs Controller General of India (DCGI). Non-compliance with
ethical standards or failure to obtain approval can lead to legal sanctions or
revocation of licenses for researchers and institutions.
5) Data Privacy and Confidentiality: Participants' personal and medical data must
be protected and kept confidential. Breaching confidentiality or mishandling
sensitive data can result in violations of privacy rights, leading to legal action
under laws such as the Information Technology Act and Data Protection Laws.

Conclusion: The key legal issues in clinical trials and biomedical research in India
involve informed consent, vulnerable group protection, adverse event management,
regulatory compliance, and data privacy. These issues must be carefully handled to
ensure the ethical conduct of trials, protection of participants' rights, and compliance
with legal standards.

6. Definitions of the following terms from National Commission for

Homoeopathy Act, 2020:

1. Homoeopathy (Section 2(i)): Homoeopathy is a system of medicine that uses

natural substances such as plants, minerals, or animals. These substances are
processed in a specific way and used in very diluted forms to help treat various health
issues. The key idea behind homoeopathy is “like cures like,” meaning that a
substance causing certain symptoms in a healthy person is used in tiny amounts to
cure similar symptoms in a sick person.

2. State Register (Section 2(o)): The State Register is a list maintained by the State
Medical Council of each state. It includes the names and details of all qualified
homoeopathic practitioners who are legally allowed to practice in that state. This
register ensures that only trained and authorized professionals can treat people with
homoeopathy in the state.

3. State Medical Council (Section 2(n)): The State Medical Council is an official
body in each state that regulates the practice of medicine, including homoeopathy.
The council ensures that only qualified practitioners are allowed to practice and
maintains the State Register. The council also looks after the conduct of
homoeopathic doctors and takes action if there are complaints against them.

Conclusion: These terms are important to understand how the National Commission
for Homoeopathy Act, 2020 regulates the practice of homoeopathy in India. It ensures
that only qualified and licensed practitioners are allowed to provide treatment, helping
to maintain high standards of healthcare.

2 Marks Q & A

1. Constitutional article that ensures the right to emergency medical treatment in

India
Answer: Article 21 of the Constitution of India ensures the Right to Life, which
includes the right to emergency medical treatment as held by the Supreme Court in
various judgments.
2. The landmark case made it mandatory for doctors to provide immediate
medical aid to accident victims
Answer: The landmark case is Parmanand Katara v. Union of India (1989), where
the Supreme Court ruled that doctors must give immediate aid to accident victims,
without waiting for police procedures.
3. Act that regulates the manufacture and sale of medicines
Answer: The Drugs and Cosmetics Act, 1940 regulates the manufacture, sale,
distribution, and quality of drugs and cosmetics in India.
4. Article of the Indian Constitution that regulates the state to improve public
health
Answer: Article 47 of the Constitution directs the State to raise the level of nutrition
and standard of living and improve public health as a part of Directive Principles
of State Policy.
5. Central authority that regulates drugs and pharmaceuticals in India
Answer: The Central Drugs Standard Control Organization (CDSCO) is the main
regulatory authority for drugs and pharmaceuticals in India under the Ministry of
Health and Family Welfare.
6. Constitutional writ used to enforce the right to health services by a public
authority
Answer: The writ of Mandamus is issued by the court to compel a public authority
to perform its legal duty, including providing health services.
7. Advisory board provides expert guidance under the Drugs and Cosmetics Act
Answer: The Drugs Technical Advisory Board (DTAB) is the statutory body that
gives expert advice on technical matters under the Drugs and Cosmetics Act.
8. Punishment for causing death by administering spurious drugs under Indian
law
Answer: Under Section 27(a) of the Drugs and Cosmetics Act, a person causing
death by spurious drugs may face imprisonment up to life and a fine not less than
₹10 lakh or three times the value of the drugs.
9. Fundamental right that protects patient confidentiality and medical records in
India
Answer: Article 21 (Right to Life and Personal Liberty) includes the right to privacy,
which protects patient confidentiality and medical records, as reinforced by the
Puttaswamy case (2017).
10. Civil remedy available to victims of medical negligence in India
Answer: Victims of medical negligence can file a complaint in Consumer Court
under the Consumer Protection Act, 2019 for compensation and legal remedy.