The Human Organ Transplantation Act, 1994 (THOA-94)

The Government of India adopted The Human Organ Transplantation Act in 1994 [38]. Each state has different set of rules and regulations to implement it. The gist of the law essentially is there should be no commercial dealings between the treating professional and also between recipient and kidney donors. The act has defined near-related donors; in 2011 paternal and maternal grandparents were included. It is the responsibility of the treating doctor to confirm the identity of the donor and recipient as well as their relationship. These facts and the informed consents have to be recorded in specific forms to be filled and countersigned by the head of the institution and have to be submitted to local- or state-based authorization committees.

The Appropriate Authority in each state is responsible for forming rules and procedures to be followed by transplant centers and to oversee all transplant activity in the state. Each Hospital Based Authorization Committee (HBAC) should consist of persons of high integrity, social status, and credibility or self-employed professionals like lawyers, chartered accountants, doctors, readers or professors, and renowned well-reputed personalities to be the members of this committee. The committee should have adequate representation of women. It should not have employees of the hospital where the transplant is to be performed. The recipient-donor pair along with their next of kin is to be interviewed by the HBAC for the approval of the transplant. The committee checks the complete forms as stipulated by the act, verifies the identity proofs, and satisfies the no pressure, voluntary consent by the donor without financial transaction between recipient and kidney donor. The HBAC gives approval to the transplant team to do the transplantation. In cases where donor is not a near relative or a paired/swap/exchange transplant after interviewing and verifying the documents, the committee passes the resolution which is signed by two members of HBAC and countersigned by the chairman of HBAC and forwarded to the State Appropriate Authority for the final approval. Foreign national’s legal document file is sent to the respective embassy for “No Objection Certificate” (NOC); after receiving the NOC, the file is sent to the chairman of the State Appropriate Authority. The Appropriate Authority schedules the personal interview of the recipient, donor, and next of kin and gives the permission to undertake the transplant. In India some state Appropriate Authorities do not call foreign nationals for personal interview of recipient and kidney donor along with next of kin. In these cases form no. 21, sent by the respective embassy is considered valid for approval.

National Organ and Tissue Transplant Organization (NOTTO) is a national-level organization set up under Directorate General of Health Services and Ministry of Health and Family Welfare, Government of India. On 15 June 2015, all transplant centers were notified that as per THOA rules every hospital doing transplant/ retrieval of organ/tissue must be registered with the NOTTO, which is located in New Delhi. Manual regarding registration is available on NOTTO website, i.e., www.notto.nic.in.