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Organ transplantation and legislation in India

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Introduction
Organ transplantation is the moving of an organ from one body to another or from a donor site on the patient's own body, for the purpose of replacing the recipient's damaged or absent organ. The emerging field of regenerative medicine is allowing scientists and engineers to create organs to be regrown from the patient's own cells.

Transplantation of Human Organs Act, 1994
It applies in the first instance to whole of the states of Goa, Himachal Pradesh and Maharashtra and to all the Union Territories and it shall also apply to such other states.
It is aimed at the regulation of removal, storage and transplantation of human organs for therapeutic purposes and for prevention of commercial dealings in human organs.

The main provisions of the act are as follows:

  • Brain death is identified as a form of death. Process and criteria for brain death certification(form 10).
  • Allows transplantation of human organs and tissues from living donors and cadavers 
  • Regulatory and advisory bodies for monitoring transplantation activity and their constitution defined.
  1. Appropriate Authority:  inspects and grants registration to hospitals for transplantation enforces required standards for hospitals, conducts regular inspections to examine the quality of transplantations. It may conduct investigations into complaints regarding breach of provisions of the Act, and has the powers of a civil court to summon any person, request documents and issue search warrants.
  2. Advisory Committee: : consisting of experts in the domain who shall advise the appropriate authority.
  3. Authorization Committee (AC): regulates living donor transplantation by reviewing each case to ensure that the living donor is not exploited for monetary considerations and to prevent commercial dealings in transplantation. Proceedings to be video recorded and decisions notified within 24 hours. Appeals against their decision may be made to the state or central government.
  4. Medical board (Brain Death Committee): Panel of doctors responsible for brain death certification. In case of non-availability of neurologist or neurosurgeon, any surgeon, physician, anaesthetist or intensivist, nominated by medical administrator in-charge of the hospital may certify brain death.
  • Living donors are classified as a near relative or a non-related donor. A near relatives such as spouse, mother, father, grandmother,etc needs approval from the doctor to donate his/her organ. A non-related donor needs the permission of an Authorization Committee established by the state to donate his/her organs.
  • Swap Transplantation where a near relative living donor is medically unfit with the recipient, the pair is permitted to do a swap transplant with another related unmatched donor.
  • Authorization is needed for organ donation after the brain death.
  • Organ retrieval permitted from any hospital with ICU facility once registered with the appropriate authority. Any hospital having Intensive Care Unit (ICU) facilities along with manpower, infrastructure and equipment as required to diagnose and maintain the brain-stem dead person and to retrieve and transport organs and tissues including the facility for their temporary storage, can register as a retrieval center.
  • Cost of donor management, transportation and preservation to be borne by the recipient, institution, government, NGO or society, and not by the donor family.
  • Infrastructure, equipment requirements and guidelines and standard operating procedures for tissue banks outlined.
  •  Non-governmental organisations, registered societies and trusts working in the field of organ or tissue removal, storage or transplantation will require registration.
  • The central government to establish a National Human Organs and Tissues Removal and Storage Network i.e. NOTTO (National Organ & Tissue Transplant Organisation), ROTTO (Regional Organ & Tissue Transplant Organisation) and SOTTO (State Organ & Tissue Transplant Organisation). Website www.notto.nic.in. Manner of establishing National or Regional or State Human Organs and Tissues Removal and Storage Networks and their functions clearly stated.
  • Penalties for removal of organ without authority, making or receiving payment for supplying human organs or contravening any other provisions of the Act have been made very stringent in order to serve as a deterrent for such activities.
  • The central government shall maintain a registry of the donors and recipients of human organs and tissues.

The various forms outlined in the rules are as follows:
Form 1: Near-relative consent
Form 2: Spouse consent
Form 3: Other than near-relative donor consent
Form 4: Psychiatrist evaluation of the donor
Form 5: HLA DNA profiling report
Form 7: Self consent for deceased donation
Form 8: Consent for organ donation from family (also applicable for minors)
Form 9: Consent for organ donation from unclaimed bodies
Form 10: Brain death declaration form
Form 11: Joint transplant application by donor / recipient
Form 12: Registration of hospital for organ transplantation
Form 13: Registration of hospital for organ retrieval
Form 16: Grant of registration
Form 17: Renewal of registration
Form 18: Decision by hospital authorization committee
Form 19: Decision by district authorization committee
Form 20: Verification of Domicile for non near-relative
Form 21: Letter from Embassy
Punishment for removal of human organ without authority
  • Imprisonment for term which may extend to 5 years and fine upto Rs. 10,000 or more.
  • If a person is a registered medical council for taking necessary action including removal of his name from council for period of 2 years first offence and permanently for the susequent offence.

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