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The Parliament enacted The Transplantation of Human Organ Act in 1994 which received the assent of the President July 8, 1994. The main intent of the enactment was to regulate and control the use of human organs like storage, removal and transplantation for therapeutic function and to avoid the marketable use of these organs and such other matters related with the issue.

The Act defines ‘brain stem death’ as the phase at which the activities of the brain stem have enduringly and irretrievably come to an end and it is confirmed as per the provisions of the Act. If it is proved by evidence that due to the death of the brain stem a person has permanently lost his life or at any stage the live birth has happened in the cardio-pulmonary sense, such person is considered as ‘deceased person’ under the Act. In addition, where a person who have completed the age of eighteen has on his own accord consented the amputation of his human organ for therapeutic function he is said to be the ‘donor’.

The Act provides freedom to any donor to grant consent for the removal of his human organ sooner than his death for therapeutic functions in compliance with certain stipulations in the Act. Accordingly, if the donor has granted consent in writing in front of two witnesses, the legal representative of the deceased donor shall provide all practical services to a medical practitioner for the removal of that human organ from the dead body of the deceased donor. But where the donor has not granted the authority but at the same time no objection was raised by the donor for using his human organ, then the legal representative shall grant consent to remove human organ from the body of the deceased for therapeutic functions. In doing so the legal representative shall make sure that there is no objection for such removal of human organ from the deceased by any of his near relatives.

The medical practitioner who is lawfully authorized to remove the human organ from the dead body of the deceased donor shall conduct proper examination of the body before removing the organ and ensure that the person is dead and if the death of brain stem has happened, such death shall be authenticated by the Board of Medical Experts. The Board shall consist of the medical practitioner in whose hospital the brain stem death of the donor has happened, a specialist nominated by the approved authority, a neurologist or neurosurgeon authorized by the appropriate authority and a medical practitioner constantly treating the donor. Where any inquest is required to be conducted on the body from which the human organ have to be removed, then the services and authority to remove the organ shall not be permitted.

The medical practitioner in charge shall take necessary steps to preserve the human organ as provided under the Act. As a saving clause the Act states that the human organ removed before the death of the donor shall be transplanted no more than to the close relative of the donor. But where the organ is removed after the death of the donor as authorized by him, then the recipient shall be any person in need of such human organ. The Central and the State Governments shall establish Authorization Committees nominated by the respective Governments to discharge the functions under the Act. Only the hospitals registered under the Act shall have the authority to remove and transplant human organs.

The Act also authorizes the Central and the State Governments to constitute Appropriate Authorities to grant, suspend or revoke registration provided to a hospital. The authority is also entrusted to investigate complaints, inspect hospitals, prescribe standards to be followed by hospitals and undertake other activities specified under the Act. The Act also punishes for removal of human organ without authorization by the donor or any legal representative of the donor as stipulated by the legislation. The business dealings with human organs or the infringement of the provisions of the Act shall also be liable to be punished under the Act.

The present legislation annulled The Ear Drums and Ear Bones (Authority for Use for Therapeutic Purposes) Act, 1989 and The Eyes (Authority for Use for Therapeutic Purposes) Act, 1982. Recently the Parliament has enacted The Transplantation of Human Organs (Amendment) Act, 2011 which provides rigorous punishment for unauthorized organ and tissue transplantation. It also includes provision to prevent unlawful commercial dealings of human organs. One of the imperative features of the amending Act is the inclusion of tissues in addition to human organs for transplantation within the purview of the Act.