The transplantation of human organs and tissues in India is governed by the Transplantation of Human Organs and Tissues Act, 1994, (hereinafter referred to as “Act”) and the Transplantation of Human Organs and Tissues Rules 2014 (hereinafter referred to as “Rules”) framed thereunder and as amended from time to time.
- The definition of the term “near relative” means spouse, son, daughter, father, mother, brother, sister, grandfather, grandmother, grandson or granddaughter.
- Where any human organ, tissue or both is to be removed from the body of the person in the event of his brain stem death, such removal shall be approved by the board of medical experts in the manner prescribed by the Act and the Rules thereunder.
- An organ shall not be removed from the body of the donor before his death and transplanted into the recipient if they are not 'near relatives', unless they follow the procedures laid down under the Act and the Rules.
- All transplantation of human organs shall require prior approval from the Competent Authority / Hospital based Authorisation Committee / State Authorisation Committee. In the event of the donor and recipient being 'near relatives' and either of them is a foreign national, the approval of the State Authorisation Committee or Hospital based Authorisation Committee, (constituted as per the Act and Rules) is mandatory.
- The Act prescribes punishment for persons who are commercially dealing in human organs and also for removal of human organs without authority. There shall be no suit or other legal proceeding against any person for anything which is done in good faith in accordance with the provisions of the Act or corresponding Rules framed thereunder.
- The Hospital shall mandatorily have its Authorisation Committee duly constituted by the State Government, if such hospital is performing more than 25 transplants in a year.
- When the living donor is unrelated and if donor or recipient belongs to a State or Union territory, other than the State or Union territory where the transplantation is proposed to be undertaken, verification of residential status by Tehsildar or any other authorised officer for the purpose with a copy marked to the Appropriate Authority of the State or Union territory of domicile of donor or recipient for their information shall be required and in case of any doubt of organ trafficking, the Appropriate Authority of the State or Union territory of domicile or the Tehsildar or any other authorised officer shall inform police department for investigation and action as per the provisions of the Act.
- The documents for approval of transplantation would be processed by the Registered Medical Practitioner and administrative division of the Institution for transplantation while the approval will be granted by the competent authority / hospital based authorisation committee / State Authorisation Committee, as the case may be.
- The hospital performing kidney transplant will have to obtain and possess a valid license granted by the appropriate authority to perform such transplantations.
Transplant between unrelated donor and recipient
The Act and Rules permit transplantation between unrelated donor and recipient who do not fall under the category of near relative as defined under the Act. All other conditions as mentioned above shall remain the same as with a donation of an organ from a near relative.
This relates to transplantation of an organ received from a brain dead individual. Once brain death is established, the patient is kept on life support, till the decision to donate is taken. The statutory authority appointed by the government is informed. If the family is willing for the donation, informed consent will be obtained from the next of kin. The statutory authority appointed by the government shall confirm the patient's eligibility for the donation. Doctors approved by the statutory authority appointed by the government will perform a set of tests to certify brain stem death. The statutory authority appointed by the Government shall select the recipient based on the waiting list and tissue matching results.