The Law & Rules Governing Organ Donation & Transplantation in India
Acts related to human organ donation
The Transplantation of Human Organs Act, 1994
The Transplantation of Human Organs Act, 1994 was enacted by the Parliament during 1994 and came into force on February 4, 1995 in the States of Goa, Himachal Pradesh and Maharashtra and all the Union Territories. Thereafter it was adopted by all States except the States of Jammu & Kashmir and Andhra Pradesh, which have their own legislations to regulate transplantation of Human Organs.
Purpose of the Act
The main purpose of the Act is to regulate the removal, storage and transplantation of human organs for therapeutic purposes and to prevent commercial dealings in human organs.
The Act contains detailed provisions relating to the authority for removal of human organs, preservation of human organs, regulation of hospitals conducting the removal, storage or transplantation of human organs, functions of appropriate authority, registration of hospitals and punishment/penalties for offences relating to aforesaid matters.
For more information, visit THOA Act – 1994
Transplantation of Human Organs (Amendment) Act, 2011
The Government of India enacted the Transplantation of Human Organs (Amendment) Act, 2011 that allows swapping of organs and widens the donor pool by including grandparents and grandchildren in the list. Some of the important amendments under this Act to promote organ donation are as follows.
- Provision of ‘Retrieval Centres’ for retrieval of organs from deceased donors and their registration under the amended Act.
- Definition of near relative expanded to include grandparents and grandchildren.
- Brain death certification Board has been simplified and more experts have been permitted for this certification.
- ‘Mandatory’ inquiry and informing option to donate in case of unfortunate event of brain stem death of ICU patient for the purpose of organ donation.
- Mandatory ‘Transplant Coordinator’ for coordinating all matters relating to removal or transplantation of human organs.
- National Human Organs and Tissues Removal and Storage Network at one or more places and regional network.
- National Registry of Donors and Recipients.
- Removal of eye has been permitted by a trained technician to facilitate eye donation.
Transplantation of Human Organs and Tissues Rules (THOT), 2014
The Transplantation of Human Organs and Tissues Rules (THOT), 2014 has many provisions to remove the impediments to organ donation while curbing misuse/misinterpretation of the rules. The following are a few
- The medical practitioner who will be part of the organ transplantation team for carrying out transplantation operation shall not be a member of the Authorisation Committee constituted under the Act.
- When the proposed donor or recipient or both are not Indian nationals or citizens whether near relatives or otherwise, the Authorisation Committee shall consider all such requests and the transplantation shall not be permitted if the recipient is a foreign national and donor is an Indian national unless they are near relatives.
- When the proposed donor and the recipient are not near relatives, the Authorisation Committee shall evaluate that there is no commercial transaction between the recipient and the donor and that no payment has been made to the donor or promised to be made to the donor or any other person
- Cases of swap donation referred to under subsection shall be approved by Authorisation Committee of hospital or district or State in which transplantation is proposed to be done and the donation of organs shall be permissible only from near relatives of the swap recipients.
- When the recipient is in a critical condition in need of life saving organ transplantation within a week, the donor or recipient may approach hospital in-charge to expedite evaluation by the Authorisation Committee.
- The quorum of the Authorisation Committee should be minimum four and is not complete without the participation of the Chairman, Secretary (Health) or nominee and Director of Health Services or nominee.
- Every authorised transplantation centre must have its own website. The Authorisation Committee is required to take final decision within twenty four hours of holding the meeting for grant of permission or rejection for transplant and the decision of the Authorisation Committee should be displayed on the notice board of the hospital and the website within twenty four hours of taking the decision. The website of transplantation centre shall be linked to State/Regional/National Networks through online system for organ procurement, sharing and transplantation.
- There would be an apex national networking organization at the centre. There would also be regional and State level networking organizations where large of number of transplantation of organ(s) or tissue (s) are performed. The State units would be linked to hospitals, Organ/Tissue matching Labs and Tissue Banks within their area and also to regional and national networking organisations. Such networks shall coordinate procurement, storage, transportation, matching, allocation and transplantation of organs/tissues and shall develop norms and standard operating procedures.
- A National Registry on Donors and recipients of Human Organ and Tissue accessible on-line through dedicated website having National, Regional and State level specificities will come into force. National/Regional registry shall be compiled based on similar registries at State level. The identity of the people in the database shall not be in public domain.