The Organ Transplantation Act of 1994 regulates the removal, storage, and transplantation of human organs and tissues for therapeutic purposes in India. It aims to prevent commercial dealings in human organs. The Act allows any donor over 18 to authorize organ donation after death and establishes a board of medical experts to certify brain stem death. Hospitals must register and comply with regulations to conduct organ transplantations. Unauthorized removal or sale of organs is punishable by up to 10 years in prison and large fines.
2. Transplantation of Human Organs Act 1994
◦ Later amended in 2011 and 2012
Transplantation of Human Organs and Tissue Rules 2013
◦ Aimed at the regulation of removal, storage and transplantation of human organs
and tissues for therapeutic purposes and for prevention of commercial dealings in
human organs.
3. Authorization
◦ Any donor i.e., a person of age 18 years can authorize the removal of any organ of their body after
their death, for therapeutic purposes. The person lawfully in possession of the donor’s dead body can
grant to a registered medical practitioner all the reasonable facilities for removal of the human organ,
unless he has any reason to believe the donor has subsequently revoked the authority aforesaid.
◦ And if a person hasn’t given any prior authorization for the removal of human organs after death, the
person lawfully in possession of the dead body can authorize unless he has no reason to believe that
any near relative has objection.
◦ Finally, the authorization must only be given to a registered medical practitioner, and before any
removal of human organs, life in that person should be extinct or appear to be a brain stem death
which has been certified by a board of medical experts.
4. Board of medical experts
◦ Registered medical practitioner in charge of the hospital in which the brain stem
death has occurred.
◦ An independent registered medical practitioner being a specialist.
◦ Neurologist or Neurosurgeon has to be nominated by the medical officer in
charge of the hospital and in their absence, a surgeon or physician who is not a
member of the transplantation team.
◦ The registered medical practitioner treating the person whose brain-stem death
has occurred.
◦ *Transplant surgeon should never be a part of the team.
5. Scenarios
In the case of the body of a person requires post-
mortem examination
◦ Person competent under this act can give
authorization, if such organ will not be required
for the purpose of postmortem examination.
In the case of the donor whose application is given
by the recipient and distant relative
◦ The distant relative along with the recipient should
jointly submit form no.1 and form no. 10 to obtain
permission from the authorization committee.
◦ If any donor authorizes the removal of his organ
before his death to such a recipient not being a
relative, but by the reason of affection or
attachment towards the recipient, such organ shall
not be removed without the approval of the
authorization committee.
6. In the case of an unclaimed dead body
◦ If the body has not been claimed by any of the relatives within 48 hours from the
time of death, the authority for removal of the organs can be given to the
management in control of the hospital/prison.
7. Regulation of Hospitals conducting the removal, storage or
transplantation of human organs
◦ No one is authorized to remove human organs for any purpose other than
therapeutic purpose.
◦ No registered medical practitioner should undertake the removal or
transplantation without explaining the possible effects, complications and the
hazards which are connected with the removal and transplantation.
8. Authorization committees constituted by the state
government
◦ An application jointly made by the donor and the recipient before the authorization committee
and after satisfying that the applicants have complied with the requirements of this act can grant
the approval.
◦ Hospitals conducting the removal, storage and transplantation of human organs should be
registered under this act.
◦ The state government shall appoint officers as authority to inspect the hospitals periodically of
their quality of transplantation and facilities for it. All of which account for the suspension or the
approval of registration of the hospital under this act.
◦ Hospitals may appeal against the decision of the committee to the state government.
9. Trial and punishments of offences under this act
◦ The offender is liable for punishment for up to 10 years and a fine up to 20 lakh rupees for the offences
which include illegal transplantations, storage, preservations and selling.
◦ One who submits false affidavits may be punished with imprisonment up to 10 years and fine up to 1 crore
rupees.
◦ It also repeals 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.
◦ *Bone marrow transplantation will not come under Organ Transplantation Act.
◦ If there is a biological incompatibility between the donor and a recipient who are relatives, mutual organ
transplantations can be done between the donor and the recipient with prior approval from the committee,
this mutual exchange of organs is called as a Swap Transplantation(allowed according to the amendment
made in 2014).
10. No human organ shall be taken from a minor or a
mentally challenged individual
◦ If a donor is a foreign national and the recipient is an Indian national, organ
transplantation can be done with the prior permission of the authorization committee,
provided the donor and the recipient are relatives.
◦ Extreme caution will be taken in cases where the donor is of Indian origin and the
recipient is not a citizen of India, for the issue of a NOC for the organ transplantation.
◦ *HLA matching should be done for organ transplantation.
◦ Organs that cannot be transplanted from a dead body include the brain and urinary
bladder.
11. Ethical issues in Organ Transplantation
◦ Risk to the life of the living donor.
◦ Commercialization of organ transplantation.
◦ Organ trafficking and transplant tourism.
◦ Death in organ transplantation from cases of brain stem death.
The above issues can be solved only by proper implementation of legal,
ethical, humanitarian principles in organ transplantation and without any vested
interest.