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Legal Ambit

The Transplantation of Human Organs Act of 1994 and the Transplantation of Human Organs Rules of 1995, as well as their subsequent amendments (the most recent for the Act was in 2011 and the most recent for the rules was in 2015), govern the entire process of organ donation.

The President signed the Act on July 8, 1994, with the goal of regulating the "removal, storage, and transplantation of human organs for therapeutic purposes, as well as the prevention of commercial dealings in human organs and matters connected with or incidental thereto."

Because health-related issues are included in India's State List, each state must pass a resolution to adopt this Act.

  • Only those over the age of 18 are capable of consenting to organ donation. If he or she is under the age of 18, his or her guardians or parents can consent to organ donation on his or her behalf.
  • The law makes it illegal to buy or sell organs. If found guilty, you could face up to 10 years in prison and a fine of up to 120 lakhs (it used to be 5 years and â110,000 when the Act was passed). Furthermore, under Section 370 of the Indian Penal Code, anyone who forcibly removes organs (without consent) faces a sentence of 7–10 years in prison and a fine.
  • A person who wishes to donate organs after death can do so in writing and with two witnesses. His wish may be fulfilled after his death.
  • A competent doctor must certify that a person is brain-dead as detailed in Form 10 of the Act. This death must be certified by:

    A competent doctor must certify a personas brain-dead, the process of which is given in Form 10 of the Act. This death has to be certified by:

    (i) the registered medical practitioner in charge of the hospital where the brain-stem death occurred;

    (ii) an independent registered medical practitioner, who must be a specialist, to be nominated by the registered medical practitioner specified in clause I from a panel of names approved by the appropriate authority; and an independent registered medical practitioner, who must be a specialist, to be nominated by the registered medical practitioner specified in clause I from a panel of names approved by the appropriate power.

    (iii) a neurologist or neurosurgeon to be nominated by the registered medical practitioner named in clause I from a panel of names approved by the Appropriate Authority and

    (iv) the registered medical practitioner treating the person who has suffered brain-stem death. ' This must be completed twice in the span of six hours.

  • Permission from family members (next of kin) is required to retrieve organs from a brain-dead person. The consent to donate organs can be given by the hospital's person-in-charge or on his behalf by his employee in the case of an unclaimed body if it is not claimed within 48 hours after death.
  • Organs for donation can be harvested before a person's body is sent for a post-mortem if the organs are unrelated to the reason for the post-mortem.
  • The Act requires any hospital that wishes to participate in the organ donation process to register. The appropriate state authority must issue a "certificate of registration" to every hospital. They must also notify the Human Organ Retrieval Centre of the transplantation in writing.
  • The Act also requires the registration of a tissue bank that stores tissues (such as heart valves, bones, and so on).
  • The central government keeps track of the donors and recipients through a registry.
  • The Act establishes the National Organ and Tissue Transplant Organisation (NOTTO), the Regional Organ and Tissue Transplant Organisation (ROTTO), and the State Organ and Tissue Transplant Organisation (SOTTO). These serve as the focal points for activities such as coordination and networking for organ and tissue procurement and distribution, as well as policy development and public awareness.
  • Under the Act, doctors must meet certain qualifications. Qualifications and experience for different organs vary depending on the law.
  • In total, there are 21 forms in the Act that deal with consent, death certification, registration, and other topics.