The Transplantation of Human Organs and Tissues Act, 1994

Summary of the Transplantation of Human Organs and Tissues Act, 1994
Key Provisions
• Authorization for Organ and Tissue Removal: The Act permits the removal of human organs and tissues from living donors and deceased persons with informed consent and in accordance with prescribed procedures.
• Living and Deceased Donation: It lays down the conditions for organ and tissue donation by living donors, including near relatives and, in specified circumstances, unrelated donors with prior approval from the competent authority. It also provides for cadaveric donation after certification of death.
• Certification of Brain-Stem Death: The Act recognises brain-stem death as a form of death for the purpose of organ donation and prescribes the procedure for its certification by a duly constituted medical board.
• Authorization Committees: The Act provides for the establishment of Authorization Committees to scrutinise and approve certain transplants, particularly those involving donors who are not near relatives, to prevent commercial dealings.
• Registration of Hospitals: Hospitals carrying out organ or tissue transplantation must be registered under the Act and comply with prescribed standards and procedures.
• Prohibition of Commercial Dealings: The Act prohibits the buying, selling, or commercial trading of human organs and tissues and prescribes stringent penalties for violations, including organ trafficking and related offences.
• Appropriate Authority: The Act provides for the appointment of Appropriate Authorities to regulate transplantation activities, inspect hospitals, grant or cancel registrations, and ensure compliance with the Act.
• Rule-making Power: The Central Government is empowered to make rules for implementing the provisions of the Act.

Legislative History:

The Transplantation of Human Organs and Tissues Act, 1994

● Act Title - The Transplantation of Human Organs and Tissues Act, 1994

● Act Number / Year - 42 of 1994

● Act ID (India Code) - 199442

● Assent Date - July 8, 1994

● Enforcement Date - February 4, 1995

● Nodal Ministry - Ministry of Health and Family Welfare

Precedent & Historical Rationale

● Absence of Uniform National Legislation, Brain-Stem Death Recognition, and Commercial Organ Trade - Prior to 1994, organ donation and transplantation in India were governed by fragmented and obsolete state-level statutes (such as the Eyes (Authority for Use for Therapeutic Purposes) Act, 1982 or the Ear Drums and Ear Bones Act, 1982), which did not cover major solid organs like kidneys, livers, or hearts. Indian law lacked a legal definition and recognition of "brain-stem death", making deceased organ retrieval legally impossible, while the absence of strict penal prohibitions led to widespread commercial trafficking, exploitation of vulnerable living donors, and illicit "kidney rackets".

● Constitutional Resolution under Article 252 and Comprehensive Regulatory Architecture - Because "Public health and sanitation; hospitals and dispensaries" is a State Subject under Entry 6 of List II (State List) of the Seventh Schedule to the Constitution of India, the State Legislatures of Goa, Himachal Pradesh, and Maharashtra passed resolutions under Article 252(1) empowering Parliament to enact a uniform central law. The Act was formulated to regulate the removal, storage, and transplantation of human organs (and later tissues) for therapeutic purposes, officially recognize brain-stem death, prohibit commercial dealings in human organs with severe criminal penalties, establish hospital Authorization Committees to scrutinize living non-related donor claims, and mandate registration of transplant centers under designated Appropriate Authorities.

Parliamentary Trajectory & Enactment

● Formulation & Introduction - Drafted by the Ministry of Health and Family Welfare pursuant to the resolutions passed by the State Legislatures under Article 252(1) of the Constitution and the recommendations of the Dr. L.M. Singhvi Expert Committee; introduced as The Transplantation of Human Organs Bill, 1992 in the Rajya Sabha on August 20, 1992, and subsequently referred to a Select Committee of Parliament.

● Parliamentary Passage - Incorporating the Select Committee's recommendations, the Bill was debated and passed by the Rajya Sabha on June 14, 1994, and considered, debated, and passed by the Lok Sabha on June 15, 1994, during the Budget/Summer Session.

● President's Assent - Received the assent of the President of India (Dr. Shankar Dayal Sharma) on July 8, 1994.

● Enforcement - Enforced on February 4, 1995.

Sources - Parliamentary Debates (Lok Sabha & Rajya Sabha), Report of the Select Committee on the Transplantation of Human Organs Bill, The Gazette of India, India Code, and Ministry of Health and Family Welfare.