LAW AND MEDICINE

Indian civilization is one of the earliest civilizations and saw the development and
application of forensic medicine some 5000 years back. It was Manu who pioneered
to frame laws of India. His book Manusmriti was the only authoritative treaty on
law. Among the sacred scriptures of Vedas, Atharva Veda speak of a large number
of herbal medicines from which the early version of Ayurvedic medicine took the
cue. The first authoritative book on Indian medicine was the famous Agnevesa
Charaka Samhita, Which deals with the elaborate code of practice of physicians with
regard to their training, duties, privileges and their social status. It is from this book
that medical ethics originated.

Significant changes in the socio-economic aspects of the country needed an

advanced code of law. and during the 4th and third century, BC Kautilya's
Arthashastra was the much-needed code. And to supplement the code of law penal
codes were framed, medical practice was codified and the knowledge of physicians
was used to decide cases of death by poisoning and unnatural deaths. As the opinions
of physicians wear integrated with judicial decisions, the medical practice required
permission from the king and medical negligence was made punishable.
Ancient India produced the father of surgery the great Sushruta. The Sushruta
Samhita was composed sometime between the second and third centuries. It dealt
with various types of poisoning and methods of treatment for injuries pregnancy and
delivery. During the foreign occupation of India stagnation in the medico-legal
systems is observed. The Mughals brought with them a system of medical care that
is the Unani medicine. but its adaptability was limited. The British rule introduced
modern allopathic medicine and established hospitals in towns. Allopathic
medicines were made available in medical stores and were comparatively easier to
administer. these were readily acceptable to the Indians. Initially, there was
apprehension and suspicion but an educated society readily accepted the allopathic
medicines. It was in 1935 that the first Medical College of British India was
established. And the regulations and enactments for the medical profession were
made in the early 20th century.
The practice of medicine in other civilizations.
Chinese medicine.
Chinese medicine is known to have been developed on an organised effort and dates
back from 2700 BC. Their medical knowledge was based on two principles Yang,
the active masculine principle and Yin, a negative feminine principle. The balancing
of Yang and Yin leads to good health. The Chinese physicians used dietetics, water
therapy, massage, drugs, acupuncture and immunization. They have faith in their
traditional medicine along with modern medicine.
Egyptian medicine.
The Egyptian physicians practised medicine which dates back to 2000 BC. They
were trained in schools within the temples. Imhotep was a great doctor and was
regarded with divinity. Specialisation prevailed in Egypt with doctors for the eye,
head and tooth. They were paid by the state. The Egyptian physicians used castor
oil, opium, turpentine, minerals and root drugs.
Greek Medicine.
The early leader of Greek medicine was is Aesculaplus. (1200BC) He had two
daughters named Hygiea and Panacea who were worshipped as goddess of Health
and goddess of medicine. Their dynasties developed curative and preventive
medicines. The greatest physicians of Greek medicine was Hippocrates. He
introduced the application of clinical methods in medicine. His name has been
clearly associated with ‘hippocratic oath’ and is key to medical ethics. The
University of Alexandria became a seat of learning. And when Romans conquered
the greeks they borrowed knowledge of medicine. Galen was a great Roman medical
teacher.

Inter-relationship between law and medicine.

Professionals from Medical, technical, scientific and legal fields are rendering very
valuable services to society. They have their rights and obligations as well.
Professionals are required to be very careful when they perform their duties. A single
negligence will not only harm others but also bring disgrace to his professional
career including punishment. The medical profession is regarded with utmost respect
by the public and is one of the most esteemed professions in the social fabric.
Doctors engineers chemists and biologist have put their efforts together to offer
wonderful medical treatment. Today surgical operations are computerised and
chances of the error have been minimised. Open heart surgery, neurological
operations, test tube babies and organ transplantations are unique contributions from
surgeons. The medical profession is noble but the brightness is sometimes
shadowed. There are medicos who want to earn quick money through dubious
surgical operations and clinical tests. Apart from that a number of deaths occur due
to wrong diagnoses, errors in treatment and negligence. Private hospitals and nursing
homes are beyond the reach of the poor and they have to depend on public hospitals
for the much-needed treatment. There is a chronic problem of posting doctors in
rural health centres as they are unwilling to stay in rural areas where Civic amenities
are scanty. The medical profession may be disgraced by the un-dignified behaviour
of a few doctors but for the sufferings of the people, the infrastructure inadequacy
and skeletal manning are to be blamed. The Other aspect of the Healthcare system
is the allegations against medical men for negligence in respect of diagnosis,
treatment, anaesthesia and operation. It started long ago. In Rich vs Pierpont, It was
held that a medical man is not responsible merely because some other medical
practitioner may possibly have shown greater skill and knowledge, but he was bound
to excise that degree of skill and knowledge which is the court considers was
reasonably competent. Similarly, the court will make greater allowance for a mistake
on the part of a surgeon when the operation is a race against time in an emergency
as in the case of A.S Mittal vs State of UP.

Code of Medical Ethics

History and evolution of the concept of Medical Ethics is the classical example of
this poetic expression. Virtually, every human society has some forces of myth to
explain the origin of morality. Indian ethics was philosophical from its very birth. In
the Vedas (1500B.C.), ethics was an integral aspect of philosophical and religious
speculation about the nature of reality. The Vedas says how people ought to live and
is the oldest philosophical literature in the world. It was the first account of
philosophical ethics in human history

Code of Hammurabi: Code of Ethics

Hammurabi (1728 – 1686 B.C.) was the Sixth King of the first dynasty of
Babylon in Mesopotamia (present Iraq). He was a great and might ruler. He made
Babylon Supreme in his era. The Sun God Shamash is claimed to have presented
the code of laws to Hammurabi. The Legal Code contains 282 Laws – regulating
society, family life and occupation. The code is engraved on a 2 metre high stele
found in susa.

Iran in 1901 and at present preserved in the famous Louvre Museum in Paris,
France. The Medical Ethics contains instructions for conduct of physicians.
Professional fees were related to social rank of patients. Incompetence and
negligence was punished by draconian laws.

“If a physician has performed a major operation upon a lord with a broze lancet
and has saved his life, he shall receive ten shekels of silver, but if he caused the
death of such a notable, his hand would be chopped off. A doctor causing the death
of a slave would have to replace him.”

Babylon was the fertile Triangle of the Euphrates and Tigris rivers – birth place
of civilization and medicine. There were rules for preserving pubic health and
hygiene. The code was played publicly for the first time in recorded history. Thus,
Mesopotamia started Man and Medicine on the road to civilization – in a never-
ending quest for health and happiness though the road to happiness was not always
littered with roses. It was tortuous. It has ups and downs as the English novelist
and poet – Thomas Hardy (1840-1928) rightly said:
“Happiness is but an occasional episode in a general drama of pain”.

Please read and understand:

1. Georgetown mantra
2. Nazi experiments on Humans NUREMBERG CODE, 1947

What is Medical Ethics?

It is the branch of ethics that deals with moral issues in Medical Practice.
It is the system of moral principles that apply values to the practice of Clinical
Medicine and in Scientific Research.

It is the field which considers the application of principles and values to the
attitude and behavior of persons indulged in medical practice.
“ETHICS” is derived from the Greek word – “Ethikos” arising from “custom”
(French: “Ethos” meaning “custom”). It is the discipline concerned with morality
and moral obligation – the philosophical study of the moral values of human conduct
and of the rules and principles that ought to govern it. Medical ethics deals with the
principles of proper professional conduct concerning the right and duties of the
physician, himself or herself, his or her patients and fellow practitioners, as well as
the actions in the care of patients and in relations with their families.

The four pillars of medical ethics are:

● Beneficence (doing good)

● Non-maleficence (to do no harm)
● Autonomy (giving the patient the freedom to choose freely, where they are
able)
● Justice (ensuring fairness)

Confidentiality can also be an important aspect of medical ethics.

Autonomy: The patient has freedom of thought, intention and action when making
decisions regarding healthcare procedures. For a patient to make a fully informed
decision, he must understand all risks and benefits of the procedure and the
likelihood of success. That includes the need to tell the truth and to be faithful to
one’s commitments.

Beneficence: The term beneficence refers to actions that promote well being of
others. In medical context this means taking actions that serve the best interest of
patients and their families. Patients welfare is the first consideration.

Nonmaleficence: The principle of nonmaleficence holds that there is an obligation

not to inflict harm on others. It is closely associated with the maxim primum non
nocere (first do no harm). The principle of nonmaleficence supports the following
rules:

1.Do not kill.

2.Do not cause pain or suffering.
3.Do not incapacitate.
4.Do not cause offense.

There are three elements to Justice:

Distributive justice – fair distribution of limited healthcare resources

Rights-based justice – respect for people’s rights, such as prohibition of
discrimination
Legal justice – respect for the law.
On an individual patient level, there are some obvious elements to ‘Justice’– for
example, not discriminating against patients on the basis of their colour, race,
religion, etc; but can we refuse to perform cardiac surgery on a patient because they
smoke? Is that discrimination – punishing the patient for not stopping – or a fair
medical judgment based on their increased risk of complications at and after
surgery?

Duties of Physicians in General

1. A PHYSICIAN SHALL always maintains the highest standards of
professional conduct.
2. A PHYSICIAN SHALL not permit motives of profit to influence the free and
independent exercise of professional judgment on behalf of patients.
3. A PHYSICIAN SHALL, in all types of medical practice, be dedicated to
providing competent medical service in full technical and moral
independence, with compassion and respect for human dignity.
4. A PHYSICIAN SHALL deal honestly with patients and colleagues, and strive
to expose those physicians deficient in character or competence, or who
engage in fraud or deception.
The following practices are deemed to be unethical conduct:
a. Self advertising by physicians, unless permitted by the laws of the country
and the Code of Ethics of the national medical association.
b. Paying or receiving any fee or any other consideration solely to procure the
referral of a patient or for prescribing or referring a patient to any source.
5. A PHYSICIAN SHALL respect the rights of patients, of colleagues, and of
other health professionals, and shall safeguard patient confidences.
 6. A PHYSICIAN SHALL act only in the patient’s interest when providing
medical care which might have the effect of weakening the physical and
mental condition of the patient.
7. A PHYSICIAN SHALL use great caution in divulging discoveries or new
techniques or treatment through non- professional channels.
8. A PHYSICIAN SHALL certifies only that which he has personally verified.

Duties Of Physicians To The Sick

1. A PHYSICIAN SHALL always bear in mind the obligation of preserving
human life.
2. A PHYSICIAN SHALL owes his patients complete loyalty and all the
resources of his science. Whenever an examination or treatment is beyond the
physician’s capacity he should summon another physician who has the
necessary ability.
3. A PHYSICIAN SHALL preserve absolute confidentiality on all he knows
about his patients even after the patient have died.
4. A PHYSICIAN SHALL give emergency care as a humanitarian duty unless
he is assured that others are willing and able to give such care.
Duties of Physicians to Each Other
1. A PHYSICIAN SHALL behaves towards his colleagues, as he would have
them behave towards him.
2. A PHYSICIAN SHALL NOT entices patients from his colleagues.
3. A PHYSICIAN SHALL observe the principles of “The Declaration of
Geneva”
a. approved by the World Medical Association.

Informed Consent

Informed consent is a fundamental concept in medical ethics that requires

healthcare providers to obtain a patient's agreement to a medical intervention or
treatment after ensuring that the patient has been fully informed of the risks,
benefits, and alternatives of the proposed treatment. Informed consent is an ethical
principle that emphasizes the importance of respecting patients' autonomy, or their
right to make informed decisions about their medical care. It is also a legal
requirement in many jurisdictions, and failure to obtain informed consent may lead
to legal and ethical consequences.

As a prosecutor, one must be aware of when the idea of informed consent is

applicable. You need to see if there has been a complete disclosure of information
by the health provider to the patient about the diagnosis (the initial medical tests),
the nature of the proposed treatment to the patient, the risks and benefits associated
with the proposed treatment, and if there is any alternatives to the procedure. It
becomes pertinent to see if the patient is capable of understanding the information
provided by the healthcare providers and to make an informed decision. And had
voluntarily made the decision without any coercion. It includes the freedom to
withdraw consent at any time. You need to check and confirm if the healthcare
provider is competent to perform the procedure or possess the necessary skills and
knowledge. Finally the informed consent is the part of patients medical record. It
should include particulars about the information provided to the patient, the patient's
decision, and any questions or concerns raised by the patient. As this is essential
element of patient-centered care

1. Disclosure of information: The healthcare provider must provide the patient

with information about the diagnosis, nature of the proposed treatment, risks,
benefits, and alternatives. The information should be provided in a way that
is understandable to the patient.

2. Patient’s Capacity: The patient must be capable of understanding the

information provided and making an informed decision. ***If the patient is
not capable, a legally authorized representative may give informed consent
on the patient's behalf.

3. Voluntariness of the Patient: The patient must make the decision voluntarily,
without coercion, and must be free to withdraw consent at any time.

4. Competence of the healthcare provider: The healthcare provider must be

competent to perform the procedure or treatment and must have the necessary
skills and knowledge.
 5. Documentation of medical record: The consent process should be documented
in the patient's medical record, including the information provided to the
patient, the patient's decision, and any questions or concerns raised by the
patient.

Informed consent is an essential element of patient-centered care, ***which

prioritizes the patient's values, preferences, and needs.

Indian Scenario:
In India, the concept of informed consent is an important part of medical practice
and is recognized by the law as a fundamental right of patients.

The Medical Council of India has issued guidelines on informed consent, which
require that patients be provided with clear and complete information about the
proposed treatment, including its risks and benefits, and any alternative treatments
that may be available. The guidelines also require that the patient's consent be
obtained in writing and that the consent form be properly documented and retained
as part of the patient's medical records.

In the Indian context, informed consent is particularly important in situations

where patients may not be fully aware of their rights or may not have the necessary
information to make an informed decision about their treatment. This is especially
true in cases where the patient may not speak the same language as the healthcare
provider or may come from a disadvantaged or marginalized community.

However, in some cases, obtaining informed consent can be challenging. For

example, in emergency situations, when the patient is unconscious or unable to
provide consent, healthcare providers may need to make decisions on the patient's
behalf. In such cases, the law allows for a surrogate decision-maker, such as a
family member or a court-appointed guardian, to provide consent on the patient's
behalf.

Overall, while the concept of informed consent is recognized in India, its

implementation can vary depending on factors such as the patient's level of
education, the complexity of the medical procedure, and the cultural and social
context in which the treatment is being provided. Healthcare providers in India are
expected to be sensitive to these issues and to work closely with patients to ensure
that their rights are respected and their consent is properly obtained.

In India, there have been several significant legal cases related to informed consent
in the medical context. Here are a few examples:

1. Samira Kohli v. Dr. Prabha Manchanda (2008): In this case, the Supreme
Court of India emphasized the importance of informed consent and the need
for healthcare providers to fully disclose information to patients. The court
held that a patient has the right to be informed of the nature of the proposed
treatment, risks, benefits, and alternatives, and that a failure to obtain
informed consent may constitute medical negligence. Samira Kohli, a 44-
year-old single woman, met with Dr Manchanda on May 9, 1995, complaining
about prolonged menstrual bleeding. She was admitted and signed the consent
form for admission to hospital, medical treatment, and also surgery. The
surgical consent form said, “diagnostic and practical laparoscopy.
Laparotomy may be necessary. Under general anaesthesia, she was exposed
to a laparoscopic examination. While Samira was unconscious and
undergoing examination, Dr Lata Rangan came out of the operation theatre
and took the patient’s mother’s consent for a hysterectomy. Dr Manchanda
removed the uterus (abdominal hysterectomy), ovaries, and fallopian tubes
(bilateral salpingo-oophorectomy) of the patient after obtaining her mother’s
consent. Samira Kohli lodged a petition before the National Consumer
Disputes Redressal Commission on 19 January 1996, demanding Dr
Manchanda’s award of Rs 25 lakh

2. Martin F. D'Souza v. Mohd. Ishfaq (2016): In this case, the Supreme Court
of India ruled that informed consent must be obtained before any medical
intervention, even if the procedure is considered routine or minor. The court
held that obtaining informed consent is essential to protect a patient's
autonomy and dignity.

3. Anuradha Saha v. AMRI Hospitals Ltd. (2014): In this case, the National
Consumer Disputes Redressal Commission held that a doctor's failure to
 obtain informed consent can constitute medical negligence. The court
awarded compensation to the patient's family in a case where the patient died
due to medical negligence, including a failure to obtain informed consent. Dr.
Mukherjee prescribed Depo-Medrol, given to patients who suffer from
chronic conditions like rheumatoid arthritis, Toxic epidermal necrolysis.

4. Kusum Sharma v. Batra Hospital and Medical Research Centre (2010):

In this case, the Delhi High Court held that a patient's consent must be
obtained for any medical treatment, including surgery. The court emphasized
that the patient must be fully informed of the nature of the procedure, the risks
and benefits, and the alternatives, and that the consent must be voluntary and
informed.

Vicarious Liability

Vicarious liability is a legal principle that holds one party (the principal) responsible
for the actions of another party (the agent). In the medical context, vicarious liability
is a legal doctrine that holds healthcare institutions, such as hospitals, clinics, and
medical practices, responsible for the actions of their employees, including
physicians, nurses, and other healthcare professionals.

Under the principle of vicarious liability, if a healthcare professional employed by a

healthcare institution commits an act of medical negligence, the institution may be
held liable for the resulting harm or injury to the patient. This means that the patient
may be able to bring a legal claim against the healthcare institution, rather than just
the individual healthcare professional.

Vicarious liability is based on the idea that healthcare institutions have a

responsibility to ensure that their employees are competent and qualified to perform
their duties, and that they provide adequate supervision and training. If a healthcare
institution fails to fulfill this responsibility and an employee causes harm to a patient
due to medical negligence, the institution may be held liable for the employee's
actions.
Vicarious liability is an important legal principle in medical law, as it allows patients
to hold healthcare institutions accountable for the actions of their employees. It also
provides an incentive for healthcare institutions to ensure that their employees are
properly trained and qualified, and to take steps to prevent medical errors and
improve patient safety.

Here are some of the key case laws related to vicarious liability in medical law:

International Case law

● Cassidy v Ministry of Health (1951) - As mentioned earlier, this case

established the principle that a hospital can be held vicariously liable for the
negligent acts of its employees, including doctors and nurses.

● Bolam v Friern Hospital Management Committee (1957) - This case

established the principle that doctors are held to the standard of care expected
of a reasonably competent practitioner in their field. If a doctor falls short of
this standard, they may be found negligent, and the hospital that employed
them may be held vicariously liable for their negligence.

● Montgomery v Lanarkshire Health Board (2015) - This case involved a

pregnant woman who was not informed of the risks associated with vaginal
delivery, including the risk of shoulder dystocia, which her baby experienced
during delivery. The court held that the doctor had a duty to provide the patient
with all relevant information to allow her to make an informed decision about
her treatment. The case is significant because it clarified the legal standard for
informed consent and affirmed the principle of vicarious liability for doctors
and hospitals.

Indian Cases
1. Indian Medical Association v. V.P. Shantha (1995): This case established
that hospitals and nursing homes can be held vicariously liable for the actions
of their employees, including doctors and nurses.

Dr. V.P. Shantha, a resident of Bangalore, filed a public interest litigation

(PIL) in the Supreme Court of India alleging that doctors were accepting
commissions from pharmaceutical companies for prescribing their drugs. She
argued that this practice was unethical, and that it was leading to over-
prescription of expensive and unnecessary drugs, thereby burdening patients
with high medical bills.

The Indian Medical Association (IMA), a national organization representing

doctors in India, was impleaded as a party in the case. The IMA argued that
the practice of accepting commissions was not unethical, and that it was a
common practice in the medical profession.

The Supreme Court of India held that the practice of doctors accepting
commissions from pharmaceutical companies was unethical and amounted to
a violation of the medical profession's code of ethics. The court also held that
this practice was leading to over-prescription of drugs, and that it was putting
an undue financial burden on patients.

The court directed the Medical Council of India (MCI) to issue guidelines
prohibiting doctors from accepting commissions or gifts from pharmaceutical
companies for prescribing their drugs. The court also directed the MCI to take
appropriate disciplinary action against doctors who violated these guidelines.

The judgment in this case was a significant milestone in Indian medical law,
as it established the principle that doctors have a duty to act in the best
interests of their patients and that accepting commissions or gifts from
pharmaceutical companies can compromise this duty. It also emphasized the
importance of ethical conduct in the medical profession and set a precedent
for the regulation of the medical profession in India.

2. Spring Meadows Hospital v. Harjol Ahluwalia (1998): This case held that
hospitals can be held vicariously liable for the actions of independent
 contractors who provide services to the hospital, such as radiologists or
anesthesiologists.
Harjol Ahluwalia, a seven-year-old boy, was admitted to Spring Meadows
Hospital for surgery to correct his squint. The surgery was performed by Dr.
S.N. Mishra, who was assisted by Dr. D.K. Gupta. After the surgery, Harjol
complained of pain and swelling in his left eye. Despite several complaints,
the doctors failed to take any action, and Harjol was discharged from the
hospital.

A few days later, Harjol's condition worsened, and he was taken to another
hospital, where it was discovered that he had suffered a severe infection and
that his left eye was irreversibly damaged. As a result, Harjol became
permanently blind in his left eye.

Harjol's parents filed a medical negligence claim against Spring Meadows

Hospital, Dr. Mishra, and Dr. Gupta, alleging that they had failed to provide
appropriate care and treatment to Harjol. The case was heard by the National
Consumer Disputes Redressal Commission, which held that the hospital and
the doctors were negligent and that they had breached their duty of care
towards Harjol.

The court found that the doctors had failed to diagnose and treat the infection
in a timely manner, which had caused Harjol's blindness. The court also held
that the hospital was vicariously liable for the negligence of its employees,
including the doctors who had treated Harjol. As a result, the court awarded
compensation of Rs. 7.5 lakhs to Harjol's parents.

3. Kusum Sharma v. Batra Hospital (2010): This case established that doctors
and hospitals can be held vicariously liable for the actions of their employees,
even if the employee was not directly supervised by the employer.
In 1996, Kusum Sharma, a 50-year-old woman, underwent a hysterectomy
(surgical removal of the uterus) at Batra Hospital and Medical Research
Centre in New Delhi. Following the surgery, she experienced severe pain and
discomfort and was readmitted to the hospital several times over the next few
weeks. Despite receiving treatment, her condition continued to deteriorate,
and she eventually died on June 6, 1996.
 Kusum Sharma's husband and sons filed a complaint against the hospital and
the doctors involved in the surgery, alleging medical negligence and seeking
compensation for their loss. The case went through several rounds of
litigation, with the hospital and doctors denying any wrongdoing.

In 2008, the Supreme Court of India ruled in favor of Kusum Sharma's family,
holding the hospital and doctors vicariously liable for her death due to
medical negligence. The court noted that the doctors had failed to exercise
the required standard of care and skill during the surgery, resulting in
complications that ultimately led to Kusum Sharma's death.

4. Jacob Mathew v. State of Punjab (2005): This case held that doctors and
hospitals can be held vicariously liable for the actions of their employees, even
if the employee was acting outside the scope of their employment.
The case involved a patient who died while undergoing treatment for an acute
exacerbation of chronic bronchial asthma. The patient's family alleged that
the doctors treating him had been negligent and had not provided adequate
care.

The case was heard by the Supreme Court of India, which considered several
issues related to medical negligence, including the standard of care expected
of doctors, the duty of care owed to patients, and the role of expert testimony
in determining negligence.

5. Dr. Laxman Balkrishna Joshi v. Trimbak Bapu Godbole (1969): This case
established that doctors can be held vicariously liable for the actions of their
employees, even if the employee was acting negligently or in a manner that
was contrary to the doctor's instructions.
The case involved a patient who underwent surgery to remove a cyst from his
back. During the surgery, the patient suffered nerve damage that resulted in
permanent disability in his leg.

The patient alleged that the doctor who performed the surgery had been
negligent and had not provided adequate care, which had resulted in the nerve
damage.
 The case was heard by the Supreme Court of India, which considered several
issues related to medical negligence, including the standard of care expected
of doctors, the duty of care owed to patients, and the role of expert testimony
in determining negligence.

The court held that doctors owe a duty of care to their patients, which requires
them to exercise reasonable skill and care when providing treatment. The
standard of care expected of doctors is that of a reasonably competent
practitioner in the same field of medicine.

Medical Negligence

Medical negligence refers to the failure of a medical professional or healthcare

provider to provide reasonable and competent care to a patient, which results in harm
or injury to the patient. This may involve an act of omission (such as failing to
diagnose a condition) or an act of commission (such as administering the wrong
medication). Medical negligence occurs when a doctor, nurse, or other healthcare
professional breaches their duty of care to a patient, by failing to meet the accepted
standard of care for their profession. In order to prove medical negligence, it must
be established that the healthcare provider owed a duty of care to the patient, that
they breached this duty of care, and that this breach resulted in harm or injury to the
patient. Medical negligence can have serious consequences for patients, including
physical injury, emotional trauma, and financial hardship.

"Negligent per se" and "res ipsa loquitur" are legal doctrines used in cases of
negligence to establish liability.

Negligent per se is a doctrine that holds a person or entity liable for negligence if
they violate a law or regulation that is designed to protect the public. In other words,
if a person or entity violates a statute or regulation, they may be considered negligent
per se, and may be held liable for any resulting harm or injury. This doctrine
presumes negligence, and the plaintiff need not prove the standard of care or breach
of duty, as the violation of the law itself establishes the breach.

Res ipsa loquitur is a Latin term that means "the thing speaks for itself". It is a
doctrine that allows a plaintiff to establish a defendant's negligence based on the
circumstances surrounding an injury, without direct evidence of how the injury
occurred. In order to use res ipsa loquitur, the plaintiff must show that the injury is
the type that would not have occurred without negligence, that the defendant had
exclusive control over the instrumentality or situation that caused the injury, and that
the plaintiff did not contribute to the injury. If these requirements are met, the burden
of proof shifts to the defendant to prove that they were not negligent.

Both negligent per se and res ipsa loquitur are used to establish liability in cases of
negligence, and may be used in combination with other legal doctrines and evidence
to prove negligence and establish liability.

Res Ipsa loquitur cases

1. Ybarra v. Spangard (1944): This case involved a plaintiff who underwent

surgery and woke up with injuries to his shoulder and arm. The plaintiff did
not know how the injuries occurred, but argued that the doctrine of res ipsa
loquitur should apply. The court agreed and held that the circumstances of the
injury were such that it was more likely than not that the defendants (the
surgeon, anesthesiologist, and hospital) were negligent.

2. Rajendra Prasad vs. Modi Hospital and Others (2006): In this case, the
plaintiff underwent a hysterectomy procedure at Modi Hospital in Kota,
Rajasthan. Following the surgery, the plaintiff experienced severe abdominal
pain and was admitted to the hospital several times for treatment. During one
of these admissions, an ultrasound revealed the presence of a foreign object
in her abdomen. A subsequent operation revealed that a pair of scissors had
been left inside the plaintiff's uterus during the hysterectomy procedure.

The plaintiff filed a medical negligence lawsuit against the hospital and the
doctors involved in the surgery, alleging that they had breached their duty of
care by failing to remove the scissors after the procedure. The defendants
denied any negligence and argued that the scissors had likely been left inside
the plaintiff's uterus during a subsequent medical procedure.

The court found in favor of the plaintiff, holding that the defendants were
negligent in leaving the scissors inside the plaintiff's body and that this
negligence had caused the plaintiff to suffer physical and emotional harm.
 The court awarded the plaintiff damages for medical expenses, pain and
suffering, and loss of income.

Hospitals as an Industry

Sec.2 (j) of the Industrial Disputes Act, 1947 defines ‘industry’ as “any business,
trade, undertaking, manufacture, or calling of employers and includes any calling,
service, employment, handicraft or industrial occupation or avocation of workmen”.
This definition is too generic and has led to numerous contradicting interpretations.
An industry exists only when there is relationship between employers and
employees, the former is engaged in business, trade, undertaking, manufacture or
calling of employers and the latter is engaged in the calling, service, employment,
handicraft or industrial occupation and avocation.

STATE OF BOMBAY v. HOSPITAL MAZDOOR SABHA

In 1960, Hospital Mazdoor Sabha Case brought hospitals within ambit of industry.
This case involved payment of retrenchment compensation to workmen in JJ
Hospitals, Mumbai. The Management pleaded that the Hospital was not involved in
any trade or business and hence they are not industry. Court framed a working
principle that any systematic activity for production or distribution of goods or
services done with help of employees in the manner of a trade or business is an
industry. The services in the hospital were held to be material services and hence
Hospitals are industry under the Industrial Disputes Act.

MANAGEMENT OF SAFDARJANG HOSPITAL v. KULDIP SINGH

In 1967, Safdarjung Hospital Case This Case dealt with same issue again: Is Hospital
an industry? This case reversed the judgment of Hospital Mazdoor Sabha Case as it
provided clarity on how to determine whether an activity is industry or not.

Safdarjung Case developed a strong logic for deciding what constitutes service.
“Material services involve an activity carried on through co-operation between
employers and employees to provide the community with the use of something such
as electric power, water, transportation, mail delivery, telephones and the like.”Such
material services qualify to be included as Industry. But for professionals like
Doctors, Lawyers, Teachers, material service do not arise as they are not engaged in
occupation in which employers and employees co-operate. Hence, organizations like
Hospitals and Educational institutions do not fall within industry.

DHANRAJGIRI HOSPITAL v. WORKMEN

In Dhanrajgiri Hospital v. Workmen, the main activity of the hospital was imparting
of training in nursing and the beds in the hospital were meant for their practical
training. It was held not to be an industry, as it was not carrying on any economic
activity in the nature of trade or business.

BANGALORE WATER SUPPLY AND SEWERAGE BOARD v. RAJAPPA

In Bangalore Water Supply and Sewerage Board v A. Rajappa, the court constituted
a seven-judge bench to enter into a detailed examination of earlier decisions with a
view to finding out a rational basis for determining whether activities like
professions, club, educational institutions, research institutes, cooperatives,
charitable projects, domestic servants, governmental functions, and so on, fall within
or outside the scope of the statutory expression ‘industry”.

The majority opinion not only answered it in the affirmative, but exploded the
judicial myth. The court overruled its earlier decision in Management of Safdarjung
Hospital, National and Dhanrajagirji Hospital v The Workmen. After reviewing
earlier decisions of the court this case devised a triple test to determine whether an
activity can be called industry or not. These tests were:

Any industry where:

(a) (i) A Systematic activity, (ii) Organized by cooperation between employer and
employee (the direct and substantial element is commercial), (iii) For the production
and distribution of goods and services calculated to satisfy human wants and wishes
(not spiritual or religious but inclusive of material things) or services geared to
celestial bliss, i.e. making, of a large scale prasad or (food), prima facie enterprise.
(b) Absence of profit motive of gainful objective is irrelevant be the venture in the
public, joint, private or other sector.
4. Dominant nature test – whether there is complex of activities, the test would be
predominant nature of services and integrated nature of departments. All
departments integrated with industry will also be industry.

5. The exceptions to industry are-

1. Casual activities (because they are not systematic).
2. Small clubs, co – operatives, research labs, gurukuls which have an essentially
non employee character.
3. Single door lawyer taking help from clerk (because there is no organized
labour).
4. Selfless charitable activities carried on through volunteers e.g. free legal or
medical service.
5. Sovereign functions – strictly understood, i.e., maintenance of law and order,
legislative functions and judicial
 Socio Ethical Aspects

Artificial Insemination
Artificial insemination (AI) is a method of assisted reproductive technology in which
sperm is introduced into the female reproductive tract using medical techniques,
rather than through natural sexual intercourse.

In AI, semen is collected from a male donor or a male partner of the woman
undergoing the procedure. The semen is then processed in a laboratory to
concentrate the sperm and remove any non-sperm components. The processed
semen is then inserted into the woman's cervix or uterus, depending on the technique
used, at the time of ovulation to increase the chances of fertilization and conception.

There are different types of AI techniques, including intrauterine insemination (IUI),

intracervical insemination (ICI), and intratubal insemination (ITI). AI can be used
in various situations, including male infertility, unexplained infertility, and same-
sex couples.

There are different types of artificial insemination.

1. A.I.H. Artificial insemination with semen obtained from the husband.

2. A.I.D. - Artificial insemination with semen obtained from a donor.

An AIH child raises no question of surrogate parenthood being a product of its own
parent's seeds. It can be regarded as legitimate, and process of impregnation both
justifiable and unobjectionable. In the case of AID, fertilization takes place inside
the woman's body with two possible variations. An AID child is, thus, genetically
linked to a parent outside its own family.
Earlier, a popular form of artificial insemination was AIC, in which the sperm of the
husband and a donor were mixed. The advantage of this procedure was that it could
not be conclusively stated that the husband was not the father of the child. This was
important in an age where artificial insemination was considered to be immoral and
tantamount to adultery, with the resulting child being considered as illegitimate and
having no inheritance rights. With the acceptance of artificial insemination in
society, the popularity of AIC diminished.
History of AI
Many people think of artificial insemination as a modern technology but it has a long
history. Thus, apparently artificial insemination was attempted on Juana, wife of
King Henry IV of Castile. In 1677 the Dutch scientist Anton van Leeuwenhoek saw
spermatozoa through the newly invented microscope. Efforts to develop practical
methods for AI were started in Russia in 1899. Papers on artificial insemination in
horses had been published by 1922. By the mid 1940's artificial insemination
AI is typically recommended for the treatment of infertility due to:
1. Mild to moderate male factor infertility
2. "Unexplained" infertility
3. Cervical mucus insufficiency
4. Hostile cervical mucus
5. Various structural abnormalities in the woman

Legal Challenges
1. In India there is no legislation regarding artificial insemination. But the doctor
has to follow the general principle of law.
2. Conception of the wife by AI does not amount to the consummation of
marriage; if there was no successful sexual act due to the impotence of the
husband. The marriage can be declared null and void and in that case the child
will be illegitimate.
3. "AID" does not amount to adultery, even if it was done without the consent of
the husband.
The doctor while doing an insemination has to observe the following.
1. Doctor should obtain signed request from the wife and husband and wife
2. Should obtain a written informed consent from both the husband and wife.
3. Should keep detailed clinical records
4. The details of the donor should be kept as a secret in the case of A.I.D.
5. A female attainder nurse should be present at the time of insemination;
6. It is better to obtain the consent of the donor and his wife.
7. Should observe reasonable skill and care and prevent complications.

Medico-legal Aspects

Firstly, it is important to note that the Indian Council of Medical Research

(ICMR) has issued guidelines for the practice of artificial insemination,
including sperm donation, in the country. These guidelines outline the ethical and
legal aspects of the practice and provide specific requirements that must be met by
medical practitioners and facilities offering artificial insemination services.

One of the key legal issues related to artificial insemination in India is the
determination of parentage. In cases where donor sperm is used, the identity of the
donor is generally kept confidential. However, in some situations, such as cases of
divorce or child custody disputes, the issue of parentage may need to be legally
determined.

Another legal issue is related to the use of surrogate mothers. While surrogacy
is legal in India, there are specific guidelines that must be followed, including the
requirement that surrogacy can only be used in cases where the couple is unable
to conceive naturally. There have also been cases of exploitation of surrogate
mothers in India, leading to calls for increased regulation of the practice.

In addition, there are legal and ethical considerations related to the use of genetic
testing in artificial insemination. While genetic testing can provide important
information about the health of the fetus, there are concerns about the potential
misuse of this information, including discrimination based on genetic
predispositions to certain diseases.

In Vitro Fertilization (Ivf) And Embryo Transfer (Et):

Commonly known as 'Test Tube Baby' IVF involves fertilization of an ovum outside
the body and consequently transfer of embryo into the uterus of the woman. "In
vitro" is Latin word mean "in glass", which referred as the test tubes, however neither
glass nor test tubes are being used; the term is used generically for laboratory
procedures. IVF is probably the most widely practiced assisted conception procedure
in the world.
History of IVF
The technique was developed in the United Kingdom by Doctors Patrick Steptoe
and Robert Edwards. The first so-called "test-tube baby", Louise Brown, was born
as a result on July 25, 1978 amid intense controversy over the safety and morality of
the procedure.

The first in-vitro fertilization, to produce test tube baby "Durga" in India and second
in the world was performed by a Calcutta based doctor Dr.Subhash Mukhopadhyay
on October 3, 1978. Both these events caused public debate, criticism and even
social professional ostracism of those involved in initiating life outside the body.
Besides these obstacles the techniques of IVF has survived as a method of choice
for treating some type of infertility.
Legitimacy of the child born through ART:
A child born through ART shall be presumed to be the legitimate child of the couple,
born within wedlock and with consent of both the spouses and with all the attendant
rights of parentage, support and inheritance. Sperm/oocyte donors shall have no
parental right or duties in relation to the child and their anonymity shall be protected.
A child can be given status of legitimacy also by adoption. In Strand v. Strand.
The husband had been given visitation rights in a divorce petition, but the wife later
tried to have these rights rescinded in the ground that her child was illegitimate. She,
however, admitted that she had undergone AID with her husband's consent. The
court held that the husband should retain his right and because he had consented for
AID the child was not illegitimate.
Adultery in case of ART
ART in a married woman with the consent of the husband does not amount to
adultery on part of the wife or the donor, as there is no sexual intercourse involved.
AID without the husband's consent can be ground for divorce or judicial separation.
The question whether recourse to AID in the absence of husband's consent amounts
to adultery was probably raised for the first time before a Canadian court on Oxford
v. Oxford(58 O.L.R. 251 (1921)). The husband petitioned for divorce on the ground
of the wife's adultery. The wife asserted that the child born to her was the result of
AID. The court disbelieved the wife and emphatically stated that such a woman
commits adultery.

Right of an unmarried woman to AID

There is no legal bar on an unmarried woman going for AID. A child born to a single
woman through AID is deemed to be legitimate. However, it is universally
recommended that AID should be performed only on married women and that, too,
with the written consent of her husband, a two-parent family being always better for
the child whose interests must outweigh all other interests.

Surrogacy
Surrogacy is an arrangement in which a woman carries and delivers a baby for
another person or couple. The surrogate mother may be genetically related to the
baby or not, depending on the type of surrogacy. In traditional surrogacy, the
surrogate mother's own egg is fertilized with sperm from the intended father or a
donor, while in gestational surrogacy, the surrogate carries a baby conceived through
in vitro fertilization (IVF) using the eggs and sperm of the intended parents or
donors. Surrogacy can be a complex process involving legal, ethical, and emotional
issues for all parties involved.
Medico-legal Aspects
Surrogacy is a complex legal issue in India that has been regulated by various laws,
including the Indian Contract Act, the Indian Succession Act, and the Indian Penal
Code. The legal framework around surrogacy has undergone several changes in the
past few years.

In 2021, the Indian government passed the Surrogacy (Regulation) Act, 2021, which
prohibits commercial surrogacy and allows only altruistic surrogacy. Under this bill,
surrogacy is only allowed for Indian heterosexual couples who have been married
for at least five years and are unable to conceive a child.

In terms of medico-legal aspects, the Surrogacy (Regulation) Bill, 2020 requires that
surrogacy clinics maintain detailed records of the medical history of surrogates and
intended parents, as well as any other medical information that may be relevant.
Surrogacy clinics are also required to conduct medical and psychological evaluations
of surrogates and intended parents before the surrogacy agreement is finalized.

Additionally, the bill mandates that surrogacy agreements must be legally binding
and include provisions for the welfare of the surrogate and the child. The surrogate
must also give informed consent to the surrogacy agreement, and she must not be
exploited or subjected to any kind of physical or emotional harm.

The medico-legal aspects of surrogacy in India involve a complex interplay of

various laws and regulations aimed at protecting the rights of surrogates, intended
parents, and the child.

Baby Manji Yamada Case (2008): In this case, a surrogate mother in India gave birth
to a child, Baby Manji Yamada, who was conceived using the sperm of a Japanese
man and an egg donor. The Japanese man and his wife had separated before the child
was born, and the surrogate mother did not want to keep the child. The case raised
questions about the legality of surrogacy in India and the rights of the child. The
Supreme Court of India eventually granted custody of the child to the Japanese man.
Baby M Case (2012): In this case, a couple in Mumbai had used artificial
insemination to have a child. However, the child was born with a genetic disorder,
and the couple sued the doctor for medical negligence. The Supreme Court of India
ruled that the doctor was not liable for the genetic disorder and that the couple had
consented to the risks of artificial insemination.

R. S. Sharma vs. Union of India (2018): In this case, the Supreme Court of India
issued guidelines for the regulation of surrogacy in India. The court ruled that
commercial surrogacy should be banned in India and that only close relatives could
act as surrogates. The court also directed the government to establish a regulatory
body to oversee surrogacy arrangements in the country.

X vs. Union of India (2018): In this case, a lesbian couple had a child through
artificial insemination, and the child was issued a birth certificate with the names of
both mothers. However, the government refused to recognize the child as a legal heir
of the mothers. The Delhi High Court ruled that the child was entitled to inheritance
rights and directed the government to issue a new birth certificate with the names of
both mothers.

What are the legal and ethical implications of artificial insemination and
surrogacy? How do these practices intersect with human rights, particularly
the right to bodily autonomy and reproductive freedom?

Artificial insemination and surrogacy are reproductive technologies that have both
legal and ethical implications. The ethical implications of these practices center on
issues such as bodily autonomy, reproductive freedom, and the rights of children
born through these methods.

In terms of legal implications, the laws surrounding artificial insemination and

surrogacy vary widely depending on the country and even the state or province.
Some jurisdictions have strict regulations governing who can access these
technologies, who can act as a surrogate, and what rights the surrogate and intended
parents have. Other jurisdictions have more permissive laws that allow for greater
flexibility in the use of these technologies.

One of the primary ethical concerns with artificial insemination and surrogacy is the
issue of consent and bodily autonomy. Critics argue that these practices can be
exploitative, particularly when women are used as surrogates. In some cases, women
may be coerced into becoming surrogates, or they may not fully understand the
implications of the process. This can lead to situations where women feel that they
have no choice but to carry a child for someone else.

Another ethical concern is the potential for these practices to be used for eugenic
purposes. For example, some people may use artificial insemination or surrogacy to
select for certain genetic traits, which could reinforce existing social hierarchies or
exacerbate inequalities.

In terms of human rights, the right to bodily autonomy and reproductive freedom are
central to the debate over artificial insemination and surrogacy. People have the right
to make decisions about their own bodies and reproductive choices, and this includes
the decision to use assisted reproductive technologies. However, critics argue that
surrogacy can infringe on the bodily autonomy of the surrogate, who may be
required to undergo medical procedures and carry a child to term against their will.

The rights of children born through artificial insemination and surrogacy are also a
concern. Children have the right to know their biological parents and to have access
to information about their genetic background. However, in cases where sperm or
egg donors are anonymous or surrogates are used, this information may not be
readily available.

Overall, the legal and ethical implications of artificial insemination and surrogacy
are complex and multifaceted. While these technologies have the potential to help
people build families, they also raise serious questions about consent, bodily
autonomy, and human rights. It is important for policymakers, healthcare providers,
and individuals to carefully consider these issues when making decisions about
whether to use these technologies.

Euthanasia
In India, euthanasia is not legal and is considered ethically controversial. Euthanasia
refers to the intentional ending of a person's life to relieve their suffering. There are
two types of euthanasia: active and passive.
Active euthanasia involves the deliberate administration of lethal substances or the
use of lethal force to end a person's life, while passive euthanasia involves
withholding or withdrawing life-sustaining treatment to allow a natural death.
The Supreme Court of India in 2018, recognised 'passive euthanasia' or the
withdrawal of life support to a terminally-ill patient, as legal. However, active
euthanasia remains illegal in India and is punishable under the Indian Penal Code.
The ethical concerns surrounding euthanasia revolve around the sanctity of life, the
potential for abuse, and the fear of making a mistake. Advocates for euthanasia argue
that it is a compassionate and humane way to end the suffering of individuals who
are terminally ill or in a vegetative state, and who have no hope for recovery.
Opponents argue that euthanasia undermines the value of life and the importance of
protecting vulnerable individuals from abuse.
In summary, while passive euthanasia has been legalised in India, active euthanasia
remains illegal, and there are ongoing debates about the ethical implications of
legalising euthanasia in India.

What are the pros and cons of Euthanasia?

Pros:
● Patient autonomy: Legalizing euthanasia gives patients the autonomy to
decide when and how they want to die, providing them with the option of
ending their suffering when they have no hope of recovery.
● End-of-life care: Legalizing euthanasia would encourage better end-of-life
care, including palliative care, and would give patients more options in
managing their pain and suffering.
 ● Compassion: Legalizing euthanasia allows for a compassionate and humane
way for patients to end their suffering, rather than forcing them to continue
suffering or resorting to more painful or dangerous methods of ending their
life.
● Reduce healthcare costs: Legalizing euthanasia could potentially reduce
healthcare costs, as end-of-life care can be expensive and euthanasia can be a
more cost-effective option.
● Reduce medical malpractice: Legalizing euthanasia could potentially reduce
cases of medical malpractice, as patients would have the option of ending their
suffering instead of pursuing futile medical treatments.

Cons:
● Slippery slope: Legalizing euthanasia could lead to a slippery slope, where it
becomes easier to justify euthanasia for people with conditions other than
those for which it was intended.
● Life is sacred: Many people believe that life is sacred and that euthanasia
violates this fundamental belief.
● Palliative care: Legalizing euthanasia could lead to a reduction in the
availability of and funding for palliative care, which may lead to patients
being encouraged to choose euthanasia rather than receiving the best possible
end-of-life care.
● Medical ethics: Euthanasia goes against the medical ethics of "do no harm"
and may be viewed as a violation of the medical profession's duty to preserve
life.
● Religious and cultural values: Euthanasia is viewed as morally wrong by some
religious and cultural groups, and legalizing it could lead to legal and cultural
conflicts.

What are the ethical implications of legalising euthanasia?

Legalizing euthanasia in India would have significant ethical implications, both

positive and negative. Some of the ethical implications are:
 1. Autonomy: Legalizing euthanasia would recognize the autonomy and self-
determination of patients who wish to end their life due to suffering from an
incurable disease or terminal illness. This would allow individuals to make
decisions about their own lives, even when those decisions are difficult.
2. Patient welfare: Legalizing euthanasia could help prevent patients from
suffering unnecessarily due to their illness, especially when they have reached
a point where their quality of life has diminished significantly. In this sense,
euthanasia could be viewed as an act of compassion towards the patient.
3. Abuse: However, there is a risk of abuse if euthanasia is not regulated
properly. There is a possibility that euthanasia may be used as a means of
getting rid of unwanted individuals or as a way of saving resources in the
healthcare system. There is also a danger of coercion, where family members
or healthcare providers could pressure patients into choosing euthanasia.
4. Religious and cultural values: Another important ethical implication of
legalizing euthanasia is the impact on religious and cultural values. In India,
there are various religious and cultural practices that view euthanasia as
morally wrong, and legalizing it could lead to conflicts and controversies.
5. Palliative care: Legalizing euthanasia could lead to a decrease in funding for
palliative care, which provides support and comfort to patients at the end of
their lives. Palliative care has been shown to improve the quality of life for
terminally ill patients, and it is important that it is not neglected or replaced
by euthanasia.

What are the legal implications?

1. Regulatory framework: Legalizing euthanasia would require the
establishment of a regulatory framework that sets out the conditions and
procedures under which it can be carried out. This would include regulations
regarding who can request euthanasia, the role of physicians and healthcare
providers in the decision-making process, and the process for obtaining
consent from the patient.
2. Criminal law: Euthanasia is currently illegal under Indian criminal law, and
legalizing it would require amendments to the Indian Penal Code to exempt
certain forms of euthanasia from the definition of homicide or suicide.
3. Medical liability: Legalizing euthanasia would raise issues of medical
liability, especially in cases where the decision to carry out euthanasia is
 challenged by family members or other interested parties. Physicians and
healthcare providers would need to be protected from legal liability for
carrying out euthanasia under the appropriate conditions and with the
appropriate consent.
4. Healthcare system: Legalizing euthanasia would have implications for the
healthcare system, particularly in terms of resource allocation and funding.
The healthcare system would need to ensure that palliative care and other end-
of-life care options are still available and properly funded.
5. Religious and cultural values: As mentioned earlier, euthanasia is viewed as
morally wrong by some religious and cultural groups in India, and legalizing
it could lead to legal and cultural conflicts.
6. Legal precedents: Legalizing euthanasia would set important legal precedents
for the right to die and end-of-life care, which would have implications for
future cases and decisions.

The decision to legalize euthanasia in India requires a careful consideration of the

ethical implications involved. It is important to ensure that any legislation is
accompanied by strict regulations and safeguards to prevent abuse and ensure that
the dignity and autonomy of the patient is respected.

Landmark case laws

1. Aruna Ramchandra Shanbaug v. Union of India (2011): This case involved a
nurse who was in a persistent vegetative state for 42 years after being sexually
assaulted by a hospital staff member. The Supreme Court of India allowed
passive euthanasia under certain circumstances, such as when a patient is in a
vegetative state with no hope of recovery and when the decision to withdraw
life support is taken by a close relative or a legal guardian.
2. Gian Kaur v. State of Punjab (1996): In this case, the Supreme Court of India
held that the right to life under Article 21 of the Constitution does not include
the right to die. The court also held that abetment to suicide is a criminal
offence under the Indian Penal Code.
3. Common Cause (A Regd. Society) v. Union of India (2018): This case
involved a petition filed by an NGO seeking legal recognition of living wills
and the right to die with dignity. The Supreme Court recognized the right to
die with dignity as a fundamental right under Article 21 of the Constitution
 and allowed individuals to make advance directives or living wills, which
would come into effect if they become terminally ill and unable to make
decisions about their medical treatment.
4. State of Maharashtra v. Maruti Sripati Dubal (1987): In this case, the Bombay
High Court held that the withdrawal of life support to a patient in a permanent
vegetative state is permissible under certain circumstances.

Euthanasia, or assisted dying, is legal in a few countries around the world. These
countries are:
1. Belgium: Euthanasia has been legal in Belgium since 2002, and it is available
to both Belgian citizens and non-citizens who meet certain conditions.
2. Canada: Canada legalized medically-assisted dying in 2016, and it is available
to eligible Canadian citizens and permanent residents who are experiencing
intolerable suffering due to a serious medical condition.
3. Colombia: In Colombia, euthanasia has been legal since 1997, and it is
available to patients who have a terminal illness or a serious and incurable
condition that causes unbearable suffering.
4. Luxembourg: Euthanasia was legalized in Luxembourg in 2009, and it is
available to residents of the country who are experiencing unbearable physical
or psychological suffering due to an incurable illness.
5. Netherlands: Euthanasia has been legal in the Netherlands since 2002, and it
is available to Dutch citizens and residents who meet certain conditions, such
as having an incurable illness and experiencing unbearable suffering.
6. New Zealand: In 2021, New Zealand passed the End of Life Choice Act,
which legalizes euthanasia for people who meet certain conditions, such as
having a terminal illness and experiencing unbearable suffering.
7. Spain: Spain legalized euthanasia in 2021, and it is available to people who
are suffering from a serious or incurable illness, and who meet certain
conditions.
It is important to note that even in countries where euthanasia is legal, there are often
strict regulations and protocols in place to ensure that the procedure is carried out
only in certain circumstances and under certain conditions.

Stem Cell therapy

Stem cell therapy is a type of medical treatment that uses stem cells to repair, replace,
or regenerate damaged tissues and organs. Stem cells are unspecialized cells that
have the ability to differentiate into different types of cells, such as muscle cells,
bone cells, and nerve cells. They also have the ability to self-renew, which means
they can create more stem cells.
Stem cell therapy involves taking stem cells from a donor, usually from the patient's
own body (autologous), a compatible donor (allogeneic), or from a stem cell bank,
and then processing and manipulating them in a laboratory to create specific types
of cells that can be used for medical treatment.
Stem cell therapy has the potential to treat a variety of medical conditions, including:
● Neurological conditions, such as Parkinson's disease, multiple sclerosis, and
spinal cord injuries
● Orthopedic injuries and conditions, such as arthritis and cartilage damage
● Cardiovascular disease, such as heart failure and coronary artery disease
● Blood disorders, such as leukemia and sickle cell anemia
● Autoimmune diseases, such as lupus and Crohn's disease
● Burns and wounds
Stem cell therapy is still a relatively new field, and its use is still being studied and
developed. There are also ethical concerns around the use of stem cells, particularly
embryonic stem cells, which has led to restrictions on their use in some countries.
Nonetheless, stem cell therapy has the potential to revolutionize medical treatment
for a range of conditions and may become an important part of medical care in the
future.
Case laws and references
● The National Guidelines for Stem Cell Research and Therapy (2013): In 2013,
the Indian Council of Medical Research (ICMR) released the National
Guidelines for Stem Cell Research and Therapy. These guidelines were aimed
at regulating stem cell research and therapy in India and ensuring that it is
conducted in an ethical and safe manner.
● The Reliance Life Sciences Case (2014): In 2014, the Mumbai High Court
ordered Reliance Life Sciences to stop offering stem cell therapy for a range
of conditions until it obtained proper regulatory approvals. The court found
 that Reliance had not obtained the necessary approvals from the Drug
Controller General of India (DCGI) and was therefore operating illegally.
● The Stempeutics Case (2018): In 2018, Stempeutics Research, a Bengaluru-
based stem cell research company, was granted approval by the DCGI to
conduct clinical trials for a stem cell therapy for osteoarthritis. This was the
first time that a stem cell therapy had been approved for clinical trials in India.
● The NCRM Case (2019): In 2019, the Madras High Court issued a notice to
the Nichi-In Centre for Regenerative Medicine (NCRM) for allegedly offering
unapproved stem cell therapies. The court also asked the ICMR to investigate
the matter and report back to the court.

● The Indian Council of Medical Research (ICMR) Guidelines case: In 2017,

the Delhi High Court directed the ICMR to create guidelines for stem cell
therapy in India to regulate the use of stem cells in medical treatment.
● The Dr. B.S. Rajput vs. Union of India case: In 2018, the Delhi High Court
ordered a crackdown on unlicensed stem cell clinics in India, following a
public interest litigation filed by Dr. B.S. Rajput.
● The Public Interest Litigation (PIL) on stem cell therapy case: In 2020, the
Supreme Court of India issued a notice to the Central Government seeking its
response to a PIL filed by the NGO, Advait Life-Education and Mediation
Service, seeking regulation of stem cell therapy in India.
● The Ramaiah Advanced Test Tube Baby Centre case: In 2021, the Karnataka
High Court ordered the Ramaiah Advanced Test Tube Baby Centre to pay
compensation to a patient who suffered from complications after undergoing
stem cell therapy at the clinic.
Personalised Medicines
Personalized medicine refers to the tailoring of medical treatment to the individual
characteristics of each patient, taking into account their genetic, environmental, and
lifestyle factors. The development of personalized medicine in India is still in its
early stages, but progress is being made in various areas.

One of the key factors driving the development of personalized medicine in India is
the increasing availability of genomic sequencing technologies. With the decreasing
costs of genome sequencing, it is becoming more feasible to sequence an
individual's genome and identify genetic variations that may impact their
health.

In addition, several Indian companies are investing in the development of

personalized medicine, including the Tata group, which has established a joint
venture with the American company Medtronic to develop personalized medicine
solutions. Other companies such as Medgenome, Strand Life Sciences, and
Mapmygenome are also working in this area.

The Indian government has also taken steps to support the development of
personalized medicine. The Department of Biotechnology has established the Indian
Pharmacogenomics Consortium to develop a pharmacogenomics database that can
be used to tailor drug treatments to individual patients.

However, there are also challenges facing the development of personalized medicine
in India. These include the need for more data on the genetic and environmental
factors that affect health in the Indian population, as well as the need for more
trained professionals in this area.

The development of personalized medicine in India is still in its early stages, but
progress is being made, and there is great potential for personalized medicine to
improve healthcare outcomes for Indian patients.

Development of Law

Personalized medicine is an emerging field that tailors medical treatments to an

individual's specific genetic makeup, lifestyle, and environmental factors. In India,
the development of personalized medicine and the associated legal and
regulatory framework is still in its early stages, but there have been some
important developments in recent years.
One of the most significant legal developments in the field of personalized
medicine in India was the introduction of the National Health Policy 2017,
which included a section on personalized medicine. The policy emphasized the
need to develop a regulatory framework for personalized medicine and to promote
research and development in this area.

In addition, the Indian government has introduced several initiatives to support the
development of personalized medicine, such as the establishment of the Indian
Pharmacopoeia Commission's Pharmacogenomics Laboratory, which is aimed
at developing and validating genetic testing protocols for use in personalized
medicine.

On the judicial front, there have been some important cases relating to personalized
medicine in India. For example, in 2018, the Delhi High Court issued a landmark
judgment in the case of Roche v. Cipla, which dealt with the issue of patent
infringement in the context of personalized medicine. The court held that Cipla
had infringed Roche's patent for a personalized medicine used to treat lung cancer,
and ordered Cipla to pay damages to Roche.

Another important case was the Novartis case (Novartis v. Union of India &
Others), which dealt with the issue of patentability of a personalized medicine. In
2013, the Indian Supreme Court ruled that Novartis could not obtain a patent for
its cancer drug, Glivec, because the drug was not a new invention and did not meet
the requirements for patentability under Indian law.

While the development of personalized medicine in India is still in its early stages,
there have been some important legal and judicial developments in recent years. The
Indian government's support for research and development in this area, as well as
the evolving legal and regulatory framework, suggest that personalized medicine is
likely to become an increasingly important part of India's healthcare landscape in the
years to come.
Please look into the articles Ive shared with you guys.
Article 1- TB
a. In India there is an increase in tuberculosis
b. Dr Lange says there has been a large increase in Multi-Drug Resistant
Tuberculosis (MDR-TB).
c. Densily populated areas like Delhi, Mumbai etc is a promising area for the
viruses and bacteria to mutate itself and development of Multi-Drug Resistant
Tuberculosis (MDR-TB).
d. He finds immense potential in personalised medicine and says biomarkers
from urine and blood samples can in future be used to determine the duration
of TB treatment. Precision or personalised medicine is tailoring disease
prevention and treatment and takes into account particular genes,
environments, lifestyle and provides treatment to the right patient at the right
time.
Article 2- Maymygenome
a. Reliance Industries’ (RIL) entry into the genomic testing space through its
subsidiary, Strand Life Sciences, has generated fresh interest in the business.
b. Last year, the company announced a `6,999 offer for its test kit. This is a once-
in-a-lifetime test and is therefore, a one-time expense.(compared to RIL
1200/-)
c. Acharya believes preventive genomics is going to bring in personalised
medicine and this is not futuristic but is already happening on ground
d. Mapmygenome’s tests cover preventive genomics, diagnostics, ancestry and
infectious diseases to detect disease predisposition, carrier status, inherited
genetic disorders, heart health, skin and haircare, and fitness. While
Mapmygenome offers both preventive and clinical tests, the company is more
focused on preventive genomics.
e. The company not only generates these reports but also offers genetic
counselling sessions and suggests ways to reduce risks and make corrections
or go in for further screenings.
f. Consumers place an order online and kits are sent to their homes.
Mapmygenome picks up the kits from homes, which are sent to their main
laboratory in Hyderabad, and the report is shared electronically. This enables
the company to keep costs down
Article 3- PM and AI/ML
1. The genetic testing landscape is rapidly evolving with the introduction of new
and advanced technologies allowing for more efficient and affordable
solutions. Consequently, these advancements continue to generate complex
and large volumes of genetic data rapidly.
2. Machine Learning (ML) techniques can be used to identify disease patterns,
classify patients with ease, develop clinical forecasting models, and inspect
the impact of medication on disease, in addition to boosting the speed of
analysis.
3. The electronic patient health record (EHR) that contains both structured and
unstructured data is a source of big data. It contains information related to
socio-demographics, medical conditions, genetics, and treatments. The big
data techniques help in developing computer models that helps the clinician
to organize the data, recognize patterns, interpret results, and set thresholds
for actions.
4. The big data for health will play an important in pharmacogenetics and
stratified healthcare for precision medicine. Patients with a similar cancer
subtype often respond differently when challenged with the same
chemotherapeutics. Already precision medicine is becoming a part of regular
diagnostics where a patient is tested for certain gene mutations before the drug
is prescribed and/or a clinical decision is made.
Questions
In Delhi, A couple bribes a hospital to find out the sex of the baby. When
they came to know that foetus is a female, they aborted. Whether the
hospital is guilty for disclosing the gender of baby to the couple. Comment
with relevant provision.

The act of disclosing the gender of a fetus is illegal in India under the Pre-
Conception and Pre-Natal Diagnostic Techniques (PCPNDT) Act, 1994. The
act was introduced to prevent female foeticide and to promote gender equality.
The act prohibits sex determination and sex-selective abortions.

In the given scenario, the hospital is guilty of violating the provisions of the
PCPNDT Act by disclosing the gender of the fetus to the couple. The couple
is also guilty of violating the act by seeking the information and subsequently
opting for a sex-selective abortion.

Under Section 23 of the PCPNDT Act, any person who contravenes the
provisions of the act is liable to be punished with imprisonment for a term
which may extend to 3 years and with a fine which may extend to Rs. 10,000
for the first offense, and imprisonment which may extend up to 7 years and
with a fine which may extend to Rs. 1,00,000 for a subsequent offense.

Therefore, both the hospital and the couple are guilty of violating the
PCPNDT Act, and legal action can be taken against them. It is important to
ensure strict implementation of the act to prevent sex-selective abortions and
promote gender equality.

A woman in Mumbai has undergone surrogacy once in her life time and
again she tried to get conceived as a surrogate mother but the hospital
authorities denied going with the mechanism. She approaches court as
her ‘Right to life’ was violated. Decide
The right to life is a fundamental human right, and it includes the right to
reproductive autonomy. However, the right to reproductive autonomy is not
an absolute right and is subject to certain restrictions and limitations.

In the given scenario, the woman has previously undergone surrogacy, and
she wishes to do so again. However, the hospital authorities have denied her
request to act as a surrogate mother. It is important to note that surrogacy is a
complex and often controversial issue, and it is subject to various legal and
ethical considerations.

In India, commercial surrogacy is not allowed, and only altruistic surrogacy

is permitted under the Surrogacy (Regulation) Bill, 2020, which has been
passed by the Indian Parliament. Under altruistic surrogacy, a woman can act
as a surrogate mother only for altruistic purposes, and not for commercial
gain.

Therefore, the hospital authorities may have denied the woman's request for
surrogacy due to legal or ethical concerns related to commercial surrogacy or
the provisions of the Surrogacy (Regulation) Bill, 2020. The hospital
authorities have a duty to act in accordance with the law and ethical principles,
and if they believe that the woman's request for surrogacy is in violation of
the law or ethical principles, they have the right to deny her request.

However, if the woman believes that her right to reproductive autonomy has
been violated, she may approach the court and seek redressal. The court will
consider the facts of the case and determine whether the hospital authorities'
decision was legal and ethical or not. If the court finds that the woman's right
to reproductive autonomy has been violated, it may direct the hospital
authorities to reconsider their decision or provide an appropriate remedy.
Elucidate the Legal and ethical aspects of organ donation and
transplantation.
Organ donation and transplantation is a complex issue with both legal and
ethical implications. Here are some of the key legal and ethical aspects:
Legal Aspects:
Consent: Organ donation and transplantation require informed consent from
the donor or their family members. In India, the Transplantation of Human
Organs Act, 1994, mandates that organ donation should be done voluntarily
without any coercion, and the donor or their family should give informed
consent.
Brain Death: Brain death is an essential criterion for organ donation. The
Transplantation of Human Organs Act, 1994, recognizes brain death as a legal
definition of death and lays down guidelines for determining brain death.
Allocation and distribution: The allocation and distribution of organs for
transplantation is a legal issue. In India, the National Organ and Tissue
Transplant Organization (NOTTO) is responsible for the allocation and
distribution of organs for transplantation.
Illegal organ trafficking: Illegal organ trafficking is a significant concern in
organ donation and transplantation. The Transplantation of Human Organs
Act, 1994, prohibits the buying and selling of organs and prescribes severe
punishments for offenders.

Ethical Aspects:
Autonomy: The right to autonomy is an essential ethical principle in organ
donation and transplantation. The donor or their family members have the
right to make informed decisions about organ donation.
Beneficence and non-maleficence: The ethical principles of beneficence and
non-maleficence require that organ donation and transplantation should be
done in a manner that maximizes benefits and minimizes harm to the donor
and recipient.
Fairness and justice: The allocation and distribution of organs should be done
in a fair and just manner, without any discrimination or bias.
Dignity and respect: Organ donation and transplantation should be done with
dignity and respect for the donor and recipient, their families, and their
cultural and religious beliefs.
In conclusion, organ donation and transplantation is a complex issue with both
legal and ethical implications. It is essential to adhere to the legal framework
and ethical principles while carrying out organ donation and transplantation
to ensure that it is done in a fair, just, and ethical manner.