Legal Scenario

‘Earth Needs Your Organs More Than Heaven’

The entire process of organ donation is governed by the Transplantation of Human Organs Act, 1994 and the Transplantation of Human Organs Rules, 1995 and their subsequent amendments – the last for the Act being in 2011 and for the rules being in 2015.
The Act received the assent of the President on 8th July, 1994 with an objective to provide for the ‘regulation of removal, storage and transplantation of human organs for therapeutic purposes and for the prevention of commercial dealings in human organs and for matters connected therewith or incidental thereto’.
The matters related to health fall on the State List in India, so every state in India has to adopt this Act by passing a resolution.
Let’s better understand the law pertaining to organ donation in India, in layman’s terms.

• A person is capable of giving consent to organ donation only if he/she is above 18 years of age. If he/she is a minor, guardians or parents can consent to donating their organs.
• The buying and selling of organs are prohibited under the law. If one is convicted of the offence, one can be sent to upto 10 years imprisonment and be asked to pay a fine of upto ₹20lakhs (was 5 years and ₹10,000 when the Act commenced). Also, under Section 370 of The Indian Penal Code, a person who does forced removal or organs (without consent) is liable to be sentenced to jail for 7-10 years and a fine.
• A person who intends to donate organs after his death can in writing and in the presence of two witnesses, state his wish to do so. After his death, his wish can be carried out.
• 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:
  1. the registered medical practitioner in charge of the hospital in which brain-stem death has occurred;
  2. an independent registered medical practitioner, being a specialist, to be nominated by the registered medical practitioner specified in clause (i), from the panel of names approved by the Appropriate authority;
  3. a neurologist or a neurosurgeon to be nominated by the registered medical practitioner specified in clause (i), from the panel of names approved by the Appropriate Authority; and
  4. the registered medical practitioner treating the person whose brain-stem death has occurred.’ This has to be done twice within 6 hours.
• Consent of the family members (next of kin) has to be obtained to retrieve organs from a brain-dead person. In case of an unclaimed body, if it is not claimed for 48 hours after death, the consent to donate organs can be given by the person-in-charge of the hospital or on his behalf by his employee.
• If the body of a person is to be sent for post-mortem, then organs for the purpose of donation can be harvested before the process begins if the organs are in no way related to the reason for the post-mortem.
• Any hospital that is to be undertake the process of organ donation has to be registered under the Act. Every hospital has to have a ‘certificate of registration’ by the appropriate state authority. They must also inform in writing to Human Organ Retrieval Centre about the organ transplantation.
• A tissue bank that stores tissues (that include heart valves, bones etc.) also has to be registered under The Act.
• A registry is maintained by the central government of the donors and the recipients.
• There is National Organ & Tissue Transplant Organisation (NOTTO), Regional Organ & Tissue Transplant Organisation (ROTTO) and State Organ & Tissue Transplant Organisation (SOTTO), set up under the Act. The function of these is to act as the apex centre for activities of coordination and networking for procurement and distribution of Organs and Tissues and registry, along with setting policies and creating awareness.
• There are qualification listed for the doctors in the Act. For different organs, the qualifications and experience vary as per the law.
• There are a total of 21 forms that deal with consent, death certification, registration etc. in the Act.