The Transplantation of Human Organs and Tissues Act, 1994 (THOTA) is a landmark Act of the Parliament of India, enacted to regulate the removal, storage, and transplantation of human organs and tissues for therapeutic purposes. It was introduced by the Ministry of Health and Family Welfare and enacted on July 8, 1994, coming into force on February 4, 1995. The Act was created to combat the alarming rise in the illegal trade of human organs and the exploitation of economically disadvantaged individuals, as India lacked a unified law before 1994.
The core mechanism of the Act is the strict prohibition of commercial dealings in human organs and tissues, with violations punishable by up to 10 years imprisonment and a ₹20 lakh fine. The Act mandates that organ removal and transplantation can only occur in hospitals registered by an Appropriate Authority. A key provision is the establishment of Authorization Committees to scrutinize all living donor transplants, especially those between non-near relatives, to ensure the donation is altruistic and not commercially motivated. Section 9 restricts transplantation from a living donor to a non-near relative without this Committee's prior approval. Furthermore, the Act requires informed consent from the donor or the next of kin for deceased donation.
The original Act was significantly amended by the Transplantation of Human Organs (Amendment) Act, 2011, which expanded the scope to explicitly include tissues in the regulation. The 2011 Amendment also expanded the definition of "near relative" to include grandparents and grandchildren. It introduced the provision for organ swapping between medically mismatched near-relative pairs and mandated the registration of Tissue Banks under Section 14A. The Act connects to the National Organ Transplant Programme (NOTP), which works to establish a national network and registry for organ and tissue donation.