2. The Medical Termination of Pregnancy
Act, 1971 & Rules and Regulations, 2003
• This Act aims to encourage safe abortions by providing liberalized conditions for women to seek
abortion and for registered medical practitioners to perform the procedure under specified
conditions.
• Came into effect on 1st April 1972.
• Objective of the MTPAct, 1971
o To improve maternal health by preventing unsafe abortions and reducing maternal mortality
and morbidity.
o Legalizes abortion services under prescribed conditions.
o Promotes access to safe abortion services for women.
o De-criminalizes abortion seekers.
o Protects registered medical practitioners performing abortions under the Act from criminal
liability under the Indian Penal Code (Sections 315-316).
3. Grounds for Termination of Pregnancy (Section 3): Termination of pregnancy is permitted if:
1. Risk to life or health: Continuation of pregnancy poses a risk to the life of the woman or grave injury to
her physical or mental health.
2. Mental Health: If the pregnant woman is mentally unsound.
3. Substantial risk of fetal abnormalities: The fetus may suffer from physical or mental abnormalities
rendering it seriously handicapped.
4. Pregnancy caused by rape: Pregnancy resulting from sexual assault or rape.
5. Contraceptive failure: Failure of contraception in the case of married couples.
The woman’s actual or reasonably foreseeable environment may be considered while determining risks.
When Can Pregnancies Be Terminated?
o Gestational Limit (Section 3):
• Up to 20 weeks of gestation: Requires the opinion of a Registered Medical Practitioner (RMP)
formed in good faith.
• For pregnancies between 12 and 20 weeks, the opinion of two registered medical practitioners
(RMPs) is required.
o Consent Requirements (Section 3):
• Termination is allowed with the woman’s consent.
• If the woman is below 18 years or is mentally ill, consent of a guardian is required.
4. Place of Termination: Abortion can only be performed at:
• Hospitals maintained by the government.
• Places approved for this purpose by a District-Level Committee, with the CMHO as Chairperson.
Who Can Perform Termination of Pregnancy?
According to Section 2(h) and Rules under the Act, the procedure can be performed only by a Registered
Medical Practitioner (RMP) under the Indian Medical Council Act, 1956, who has:
o Holds a recognized Post-graduate degree or diploma in obstetrics and gynecology as per the Indian
Medical Council Act, 1956.
o Is registered in the State Medical Register.
o Has the required training or experience as prescribed by the Act.
• Completed six months of housemanship in obstetrics and gynecology.
• Conducted 25 cases of MTP in an approved institution, with at least five cases performed
independently.
5. • Training Requirements for Medical Practitioners
o For termination up to 12 weeks:
o Assisted in 25 cases of MTP, of which at least 5 cases were performed independently in a government hospital
or approved training institute.
o For termination up to 20 weeks:
o Holds a post-graduate degree/diploma in Obstetrics and Gynecology.
o Completed a 6-month house job in Obstetrics and Gynecology.
o Has one year of experience in Obstetrics and Gynecology at a hospital with all necessary facilities.
• Protection for Medical Practitioners
o Under Section 8, no registered medical practitioner shall be liable for any act performed in good faith
under this Act.
o Protects registered medical practitioners from penalization under the Indian Penal Code (Sections 315-
316) for performing abortions within the scope of the Act.
6. • MTP Amendment Act, 2021
oExtended gestational limit to 24 weeks for special categories of women (e.g.,
survivors of rape, incest).
oMedical Boards to assess pregnancies beyond 24 weeks in cases of substantial
fetal abnormalities.
7. Transplantation of Human Organs Act, 1994
The Transplantation of Human Organs Act (THO Act), 1994, was enacted by
the Indian Parliament to regulate the removal, storage, and transplantation of
human organs, combat unethical practices, and encourage voluntary donations.
The Act aimed to:
• Define the legal framework for organ donation and transplantation.
• Recognize brain death as a legal form of death to facilitate deceased organ
donation.
• Prohibit commercial trade in human organs, making it a punishable offense.
• Facilitate transplants beyond kidneys, including liver, heart, lungs, and pancreas.
• Set up regulatory authorities to oversee organ transplantation activities.
8. Evolution of Transplantation in India
• 1970s: India became a pioneer in kidney transplantation within the Asian subcontinent.
• 1980s: Rise in transplants; unrelated kidney donations for monetary gain became widespread.
Commercialization of organ donation became an integral part of the transplant system.
• 1990s: Ethical concerns led to the passage of the THO Act to address exploitative practices.
The Act made unrelated transplants illegal and introduced deceased organ donation as a
legal alternative.
• 2000s and Beyond: Despite the Act, illegal organ trade and ethical concerns remain
significant challenges. The government passed the 2011 Amendment to plug loopholes.
Transplantation of Human Organs and Tissues Rules, 2014, were introduced for stricter
enforcement.
9. Key Sections of the THO Act
• Definitions:
• Brain Death [Section 2 (d)]: "Brain death" is legally recognized as a form of death, distinct from a coma or vegetative
state.
• Deceased Donor [Section 2(e)]: A person who has been declared brain dead or has died due to cardiac arrest.
• Living Donor [Section 2(f)]: A person who is alive and voluntarily donates an organ to a recipient. Living donation is
strictly regulated to prevent commercial transactions.
• Human Organ [Section 2(g)]: A human organ includes any part of the human body, whether it is an organ, tissue, or a
specific cell type. This definition ensures that the Act covers not just solid organs like kidneys or liver but also corneas,
skin, and tissues.
• Transplantation [Section 2(h)]: Transplantation refers to the removal of an organ from a living or deceased donor and
its implantation into a recipient. Must follow proper medical procedures and be conducted at an authorized transplant
center. This Act ensures that all transplants are conducted ethically and legally to prevent organ trafficking.
• Hospital [Section 2(i)]: A hospital is any institution recognized for conducting organ transplants. It must be registered
with the Appropriate Authority to legally perform organ transplants.
• Authorization Committee (AC) [Section 2(o)]: A government-appointed committee that verifies living donor
applications and ensures that no commercial dealings are involved in organ donation.
• Appropriate Authority (AA) [Section 2(p)]: Regulatory body that grants licenses to hospitals for organ transplantation.
Responsible for monitoring compliance, investigating complaints, and enforcing penalties.
10. Regulation of Organ Transplantation
• Section 3: Legal Authority to Remove, Store, and Transplant Human Organs [CHECK SECTION AND ADD MORE]
• No hospital, doctor, or institution can remove, store, or transplant a human organ unless explicit authorization has been obtained.
• Only licensed transplant centers are permitted to perform organ transplants.
• Storage of Human Organs:
• Organs must be stored in licensed tissue banks under regulated conditions.
• Only registered hospitals and research centers can store organs for transplantation or research.
• Section 4: Criteria for Deceased Organ Donation
• Deceased donation is permitted when:
✅ A person has been certified brain dead by a medical board.
✅ The deceased had voluntarily pledged their organs in their lifetime, or the family consents to donation.
✅ The hospital is authorized to conduct transplants.
✅ The retrieval process follows strict medical and ethical guidelines.
• Brain Death Certification Process:
• Conducted by a panel of four doctors:
• Registered Medical Practitioner treating the patient.
• Neurologist or Neurosurgeon.
• Hospital Administrator.
• Independent Doctor not involved in the treatment.
• Consent Requirements:
• If the deceased had pledged their organs, no further consent is required.
• If the deceased had not registered, the next of kin must provide consent.
• Organ Allocation and Distribution:
• Organs from deceased donors must be allocated based on a waiting list system.
• Prioritization is based on medical urgency and compatibility, not financial or social status.
11. • Section 6: Prohibition on Organ Trade and Commercial Transactions
• 🚫 Absolute Ban on Buying and Selling Organs
• The Act strictly prohibits the sale or purchase of human organs for commercial gain.
• No person or hospital can engage in organ trafficking or financially exploit donors.
• 🚫 Criminal Penalties for Violations
• Any person involved in organ trade is liable for:
• Imprisonment: 5-10 years.
• Fine: ₹20 lakh to ₹1 crore.
• Doctors or hospitals found guilty may have their licenses revoked.
• 🚫 Prohibition on Brokers and Middlemen
• The Act makes it illegal for any middleman or broker to arrange organ transplants.
• Hospitals must conduct due diligence to ensure no financial transactions occur between donor and
recipient.
• 🚫 Stricter Rules for Foreign Nationals
• Foreign patients seeking organ transplants in India must:
• Provide valid medical documents from their home country.
• Seek approval from the Authorization Committee.
• Prove that no commercial transaction is involved.
12. • Regulation and Oversight (Sections 13-16, 18-19, 23)
• Section 13-14: Establishment of the Authorization Committee (AC) and Appropriate
Authority (AA).
• Section 15: Licensing of hospitals to perform organ transplants.
• Section 16: Standards for hospitals and periodic inspections.
• Section 18-19: Suspension of hospital licenses in case of violations.
• Section 23: Penalties for offenses under the Act.
13. Brain Death and Its Declaration
• What is Brain Death? [Sec 2(d)]
• Brain death is an irreversible loss of all brain functions, including the
brainstem.
• Unlike coma, brain death is legally considered death and allows for organ
donation.
• Criteria for Brain Death Declaration
• Medically confirmed by a panel of doctors, as per the Schedule of the Act.
Hospitals must have a registered brain death declaration panel.
• Declared by a neurologist/neurosurgeon, intensivist, and treating physician at
an authorized transplant center.
• Certifications are required by two government-nominated doctors, at least 6
hours apart. One must be a neurology expert.
• Brain death allows for deceased organ donation, provided there is prior
consent from the individual (through registration) or the next of kin.
14. • Deceased Donor Transplants:
• Allowed only when a person has been medically certified as brain dead or has suffered cardiac death.
• Organs from a deceased donor can be harvested for transplantation with appropriate consent. Consent from the next
of kin is mandatory if the deceased had not registered as an organ donor.
• Commonly donated organs: Kidneys, liver, heart, lungs, pancreas, and corneas.
• Living Organ Donation - Rules and Regulations (Section 9)
• First-degree Relatives:
• Only near relatives such as parents, siblings, children, spouses, and grandparents are allowed to donate without
special approval.
• Proof required through genetic testing or legal documentation.
• Non-relatives require approval from the Authorization Committee.
• Conditions for Non-Related Donations
• Both donor and recipient must appear before the AC for verification.
• Purpose of donation must be altruistic, not commercial.
• Joint application and interview required to establish legitimacy.
• Commonly donated organs from living donors: Kidney, liver lobe, and part of the pancreas.
15. Role of the Authorization Committee (AC)
• Established under Section 9 to:
• Regulate transplants between recipients and unrelated donors.
• Ensures no financial exploitation of donors.
• Function:
• Scrutinize joint applications by recipient and donor.
• Conduct personal interviews to verify motive and ensure no monetary
exploitation.
• Approve or reject applications based on the authenticity of altruistic motives.
• Decisions must be communicated in writing to hospitals.
• Governed by Clause (3), Chapter II of the Act
16. Role of Appropriate Authority (AA)
Defined under Sections 13–16 of the Act.
• Key Functions:
• Regulates Transplantation: Regulates removal, storage, and transplantation of human organs.
• Hospital Inspections: Ensure compliance with transplant regulations.
• Granting Licenses: Grant licenses to hospitals for organ transplantation. Each organ transplant requires a
separate license.
• Suspending Registrations: In case of legal or ethical violations.
• Investigation of Complaints: Against unauthorized transplants.
Licensing and Registration
• License Validity: 5 years, renewable upon expiration.
• Separate License: Required for each organ transplantation.
• Exemptions: Removal of eyes from deceased donors is not governed by this procedure.
17. Amendments and Rules
• 2011 Amendment Act
• Strengthened penalties for illegal transplants.
• Allowed swapping of organs between willing donor-recipient pairs.
• Transplantation of Human Organs and Tissues Rules, 2014
• Defined standard operating procedures for organ transplantation.
• Mandated compulsory registration of brain-death cases.
• Notification issued to regulate human organ and tissue transplantation.
• Enhanced ethical practices and procedural clarity.
Challenges and Way Forward
• Persistent Challenges:
• Illegal Organ Trade: Despite laws, black-market organ trade and scandals continue to surface.
• Lack of Awareness: Organ shortage remains a critical issue due to low rates of organ donation because of
misconceptions.
• Inadequate Infrastructure: Few hospitals have the necessary facilities.
• Ethical Concerns: Cases of coercion and exploitation of poor donors.
• Solutions:
• Public Awareness Campaigns: Promote voluntary organ donation.
• Stronger Law Enforcement: Strict action against illegal trade by strictly enforcing the THO Act provisions.
• Encouraging Deceased Donation: Streamlined processes for deceased donation. Expanding brain-dead donor pools.
• Building More Transplant Centers: Increase accessibility for patients.
![Key Sections of the THO Act
• Definitions:
• Brain Death [Section 2 (d)]: "Brain death" is legally recognized as a form of death, distinct from a coma or vegetative
state.
• Deceased Donor [Section 2(e)]: A person who has been declared brain dead or has died due to cardiac arrest.
• Living Donor [Section 2(f)]: A person who is alive and voluntarily donates an organ to a recipient. Living donation is
strictly regulated to prevent commercial transactions.
• Human Organ [Section 2(g)]: A human organ includes any part of the human body, whether it is an organ, tissue, or a
specific cell type. This definition ensures that the Act covers not just solid organs like kidneys or liver but also corneas,
skin, and tissues.
• Transplantation [Section 2(h)]: Transplantation refers to the removal of an organ from a living or deceased donor and
its implantation into a recipient. Must follow proper medical procedures and be conducted at an authorized transplant
center. This Act ensures that all transplants are conducted ethically and legally to prevent organ trafficking.
• Hospital [Section 2(i)]: A hospital is any institution recognized for conducting organ transplants. It must be registered
with the Appropriate Authority to legally perform organ transplants.
• Authorization Committee (AC) [Section 2(o)]: A government-appointed committee that verifies living donor
applications and ensures that no commercial dealings are involved in organ donation.
• Appropriate Authority (AA) [Section 2(p)]: Regulatory body that grants licenses to hospitals for organ transplantation.
Responsible for monitoring compliance, investigating complaints, and enforcing penalties.](https://image.slidesharecdn.com/healthlaw-3-250222091713-eed0c097/85/Health-LAW-3-pptx-9-320.jpg)
![Regulation of Organ Transplantation
• Section 3: Legal Authority to Remove, Store, and Transplant Human Organs [CHECK SECTION AND ADD MORE]
• No hospital, doctor, or institution can remove, store, or transplant a human organ unless explicit authorization has been obtained.
• Only licensed transplant centers are permitted to perform organ transplants.
• Storage of Human Organs:
• Organs must be stored in licensed tissue banks under regulated conditions.
• Only registered hospitals and research centers can store organs for transplantation or research.
• Section 4: Criteria for Deceased Organ Donation
• Deceased donation is permitted when:
✅ A person has been certified brain dead by a medical board.
✅ The deceased had voluntarily pledged their organs in their lifetime, or the family consents to donation.
✅ The hospital is authorized to conduct transplants.
✅ The retrieval process follows strict medical and ethical guidelines.
• Brain Death Certification Process:
• Conducted by a panel of four doctors:
• Registered Medical Practitioner treating the patient.
• Neurologist or Neurosurgeon.
• Hospital Administrator.
• Independent Doctor not involved in the treatment.
• Consent Requirements:
• If the deceased had pledged their organs, no further consent is required.
• If the deceased had not registered, the next of kin must provide consent.
• Organ Allocation and Distribution:
• Organs from deceased donors must be allocated based on a waiting list system.
• Prioritization is based on medical urgency and compatibility, not financial or social status.](https://image.slidesharecdn.com/healthlaw-3-250222091713-eed0c097/85/Health-LAW-3-pptx-10-320.jpg)
![Brain Death and Its Declaration
• What is Brain Death? [Sec 2(d)]
• Brain death is an irreversible loss of all brain functions, including the
brainstem.
• Unlike coma, brain death is legally considered death and allows for organ
donation.
• Criteria for Brain Death Declaration
• Medically confirmed by a panel of doctors, as per the Schedule of the Act.
Hospitals must have a registered brain death declaration panel.
• Declared by a neurologist/neurosurgeon, intensivist, and treating physician at
an authorized transplant center.
• Certifications are required by two government-nominated doctors, at least 6
hours apart. One must be a neurology expert.
• Brain death allows for deceased organ donation, provided there is prior
consent from the individual (through registration) or the next of kin.](https://image.slidesharecdn.com/healthlaw-3-250222091713-eed0c097/85/Health-LAW-3-pptx-13-320.jpg)
