The Transplantation of Human Organs and Tissues Act, 1994
🔹 OBJECTIVE OF THE ACT
To regulate organ and tissue transplants from both living and deceased donors.
To prohibit commercial trading in human organs.
To define legal authority and procedures for organ donation and transplantation.
To promote ethical practices in the transplantation field.
🔹 SCOPE & APPLICABILITY
Initially applied to a few states and union territories.
Later adopted by most Indian states with or without modifications.
Applies to both living and cadaveric (brain-dead) donations.
🔹 KEY DEFINITIONS UNDER THE ACT
Human Organ: Any part of a human body that can be transplanted (e.g., kidney, liver, heart).
Tissue: Part of the body like skin, cornea, bone marrow, etc.
Donor: A person who voluntarily donates an organ or tissue.
Recipient: The person who receives the transplant.
Near Relative: Includes spouse, son, daughter, father, mother, brother, or sister.
🔹 IMPORTANT PROVISIONS OF THE ACT
1. Regulation of Removal and Transplantation (Sections 3-9)
Organ removal can be done only:
For therapeutic purposes.
After the written consent of the donor.
In the case of deceased donors, after confirmation of brain death by a medical board.
Living Donors:
Must be a near relative.
If not a relative, special approval is needed from the Authorization Committee.
Deceased Donors:
Consent must be given by next of kin.
Brain death must be certified by a panel of four doctors.
2. Authorization Committee (Section 9)
Formed to scrutinize and approve transplants from non-relatives to prevent commercial dealings.
Verifies:
Identity of donor and recipient.
Relationship between them.
Voluntariness and lack of coercion or monetary inducement.
3. Prohibition of Commercial Trade (Section 19)
No person shall:
Buy or sell human organs or tissues.
Advertise or seek to find donors for money.
Violation leads to imprisonment (5-10 years) and fine (₹20 lakh or more).
4. Regulation of Hospitals (Sections 10-12)
Only registered hospitals can conduct organ transplant surgeries.
Must maintain proper records and follow all protocols.
Subject to inspection by authorities.
5. Punishments (Section 18-22)
Illegal removal or trade in organs can lead to:
Imprisonment (up to 10 years).
Heavy fines (up to ₹20 lakh or more).
Deregistration of hospitals or medical professionals involved.
🔹 AMENDMENTS TO THE ACT
2011 Amendment (Key highlights):
Included tissues along with organs.
Allowed swapping of organs (paired exchange donation).
Stricter regulations for foreign recipients.
Encouraged organ donation through brain death declaration.
Introduced National Organ and Tissue Transplant Organization (NOTTO).
🔹 IMPORTANT CASE LAWS
1. Smt. Sunil Batra v. Union of India (2010)
The court held that consent and voluntariness of the donor are essential.
Highlighted the misuse of transplant approvals through fabricated relationships.
2. Kuldeep Singh v. State of Tamil Nadu (2005)
The petitioner was denied transplant due to absence of near relation.
The court emphasized the role of Authorization Committee in exceptional approvals, especially where emotional or humanitarian grounds are involved.
3. Manikantan v. State of Kerala (2008)
Case related to illegal kidney trade.
Exposed loopholes in the system, prompting stronger implementation of THOTA provisions.
4. Dr. L.H. Hiranandani Hospital Kidney Scam (2016, Mumbai)
A major case where a kidney transplant was conducted based on forged documents showing fake relationship.
Led to arrests of hospital staff and stricter scrutiny of transplant documentation.
🔹 CHALLENGES & CRITICISMS
Low awareness about organ donation.
Fake documentation to show relationship.
Black market still exists despite the law.
Delays in approvals for genuine cases, especially for unrelated donors.
Shortage of organs due to low cadaver donations.
🔹 WAY FORWARD / SUGGESTIONS
Strict implementation of THOTA.
Wider public awareness campaigns.
Use of technology and Aadhaar to verify relationships.
Encouragement of cadaver donations through hospitals.
Better training of Authorization Committees.
🔹 CONCLUSION
The Transplantation of Human Organs and Tissues Act, 1994 is a critical piece of legislation to regulate organ donation and protect the dignity and rights of both donors and recipients. While it has curbed organ trafficking to an extent, better enforcement, transparency, and public participation are essential to make organ donation ethical, accessible, and efficient in India.
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