Organ donation in India: How the system works and what law says

Source: The post “Organ donation in India: How the system works and what law says” has been created based on “Organ donation in India: How the system works and what law says” published in “Business Standard” on 3rd October 2026.

UPSC Syllabus: GS-2-Governance

Context: The Karnataka High Court recently allowed a 52-year-old unmarried man to altruistically donate one of his kidneys to an unrelated recipient. The state government informed the court that it is in the process of formulating guidelines to establish a mechanism for regulating cases of altruistic organ donation. This case raises questions about India’s regulation of organ donation, the legality of altruistic donation to unrelated recipients, and safeguards against organ trading.

About Organ donation in India and Legal framework

1. Organ donation in India is primarily regulated by the Transplantation of Human Organs and Tissues Act (THOTA), 1994, along with its 2011 amendments and 2014 Rules.
2. The framework aims to facilitate organ transplantation while ensuring voluntary donation, informed consent and prevention of commercial organ trade.
3. THOTA, 1994 regulates the removal, storage and transplantation of human organs and tissues for therapeutic purposes.
4. It provides rules for both living and deceased donors.
5. It also aims to prevent commercial dealings in human organs and tissues.

Institutional Framework

1. NOTTO (National Organ and Tissue Transplant Organisation) functions at the national level.
   1. It maintains the national registry of donors and recipients.
   2. It establishes protocols and oversees fair organ distribution.
   3. It implements the National Organ Transplant Programme.
2. ROTTOs (Regional Organ and Tissue Transplant Organisations) and SOTTOs (State Organ and Tissue Transplant Organisations) operate at regional and state levels.
3. Together, this three-tier system coordinates organ procurement, waiting lists and awareness.

Who Can Donate?

1. THOTA permits donation by living donors as well as deceased donors after cardiac or brain death.
2. Living donors are broadly classified as:
   1. Near relatives, including spouses, children, grandchildren, siblings, parents and grandparents.
   2. Non-related donors, who require approval from an Authorisation Committee.
3. A near-relative donation requires permission from the doctor in charge of the transplant centre, while non-related donation requires clearance from the appropriate State Authorisation Committee.

About Altruistic Organ Donation

• Altruistic donation means donating an organ without expecting monetary payment or any prohibited benefit.
• It is legally permitted under Section 9(3) of THOTA for non-relatives when motivated by “affection or attachment” or other special reasons, provided there is no commercial transaction.
• Non-related donations are subject to strict scrutiny by the Authorisation Committee.
• The Committee examines whether the donation is Voluntary, Free from financial motives and Free from pressure, inducement, influence or allurement.
• The 2014 Rules prescribe forms requiring donors and recipients to disclose the reasons for donation and affirm that the decision is voluntary.
• Courts, including the Kerala and Karnataka High Courts, have recognised genuine altruistic and anonymous donations to strangers, while stressing that authorities should not reject them merely on vague suspicion.
  • Kerala has established formal guidelines for altruistic donations, while Karnataka is developing structured protocols.

Prevention of Illegal Organ Trade

• THOTA prohibits commercial dealings in human organs.
• Section 19 penalises:
  • Paying or receiving money for supplying an organ.
  • Offering or seeking an organ for payment.
  • Negotiating arrangements involving payment.
  • Managing organisations involved in commercial organ transactions.
  • Advertising paid organ supply.
  • Creating or submitting false documents to disguise a commercial donation as a legitimate donation.
• Unauthorised removal of an organ can attract up to 10 years’ imprisonment and a fine up to ₹20 lakh.
• Commercial dealings can attract 5–10 years’ imprisonment and a fine of ₹20 lakh to ₹1 crore.

International Framework

1. The WHO Guiding Principles on Human Cell, Tissue and Organ Transplantation, endorsed by the World Health Assembly, provide the main international framework for organ donation and transplantation.
2. These principles apply to organs obtained from both living and deceased donors and emphasise voluntary and non-remunerated donation, informed consent, donor protection and equitable allocation of organs.
3. Altruistic donation is recognised as an important principle under the WHO framework.
4. The WHO encourages countries to establish systems for the voluntary and non-remunerated donation of organs from both living and deceased donors.
5. However, the specific rules governing altruistic donation are determined by individual countries through their national laws.

Challenges

1. A major challenge is distinguishing genuine altruistic donation from disguised commercial transactions.
2. Excessive suspicion may discourage legitimate donations, while inadequate scrutiny may facilitate organ trafficking.
3. Differences in implementation and guidelines across states can also create uncertainty.

Way Forward

1. States should develop clear and uniform protocols for altruistic and unrelated donations.
2. Authorisation Committees should ensure transparent, timely and evidence-based scrutiny.
3. Strong coordination among NOTTO, ROTTOs and SOTTOs should be maintained.
4. Public awareness should be strengthened to promote voluntary and non-commercial organ donation.
5. Strict verification of documents and financial relationships should continue to prevent commercial exploitation.
6. The system should balance individual autonomy and altruism with safeguards against coercion, fraud and organ trafficking.

Conclusion: India’s organ donation framework seeks to create a balance between facilitating life-saving transplantation and preventing exploitation. A transparent, voluntary and non-commercial system, supported by effective institutional coordination and safeguards, can strengthen public trust and ethical organ transplantation

Question: Discuss the legal and institutional framework governing organ donation in India. How does it balance altruistic donation with the need to prevent commercial organ trading?

Source: Business Standard