Organ Transplantation laws in India

 

Organs transplant has proven to be a boon for us. This miracle of medical science and technology has saved countless lives. The number of patients needing a transplant outnumbers the donors available, making the government step in and make laws to stop illegal activities involving the commercialisation of organ transplantation. 

Laws Governing Organ Transplantation in India

Organ Transplantation has a shorter history as compared to other developed nations. The first kidney transplant was done in May 1965 at the King Edward Memorial Hospital at Bombay. Transplantation activities increased in the 80s and 90s. However, a new trend of kidney trade started in the 80s. Foreigners from all over the world started to flock to India for transplantation from a paid donor. 

The government of India enforced the Transplantation of Human Organs Act (THOA) in 1994. Subsequently, in 1995 the Transplantation of Human Organs Rules came in force. The Act made commercialisation of organs a punishable offence. It also legalised the concept of brain dead in India, allowing deceased donation by obtaining organs from brain stem dead person.

 

What is Brain Dead?

Brain Dead is a state where all brain activities have stopped and cannot be reversed. Even if the heart is working due to ventilator, the patient can be safely pronounced to be dead in such a situation.

According to the Transplantation of Human Organs Act “brain-stem death” means the stage at which all functions of the brain stem have permanently and irreversibly ceased and is so certified by Medical experts.

 

Regulation of Cadaver Donation

Section 3-8 of the Act regulates the Cadaver Donation. According to section 3, any person can, before his or her death, in writing authorise in the presence of two witnesses the removal of any organ of his body after his death. In a case where a person did not make such authorisation, the person who is lawfully in possession of the dead body can authorise the removal of any organ of the deceased person. Provided, unless he has reason to believe that any near relative of the deceased person has an objection to the same.

 

Regulation of Living Donation

Section 9 of the Act provides provisions for living donation. The Act provides a separate procedure of living donation by near relatives and living donation by an unrelated donor. 

Section 2(i) defines near relatives as son, daughter, father, mother, brother or sister, grandfather, grandmother, grandson, or granddaughter. The near relative has to fill an application form and submit it to the competent authority (i.e., the head of the hospital or the committee constituted by the hospital, called Hospital Authorisation Committee). The committee then interviews the donor, recipient and their relatives. The whole interview is to be video recorded. If satisfied, it gets approval for transplantation.

In case of an unrelated donor, an application form has to be submitted to the Hospital Authorization Committee. After scrutinising the application and interviewing the donor, the recipient, and their relatives, the Hospital Authorization Committee will forward the application to the State Authorization Committee, which will again scrutinise the application. Then interview the donor, the recipient, and their relatives. The interview on both levels has to be video recorded.

 

Regulation of “Hospitals”

Section 10 and Section 14 provides that unless registered no hospital or Human Organ Retrieval Centre can commence any activity relating to removal, storage, or transplantation of any human organ or tissue.

For registration, the hospital has to be in a position such as specialised services, possess such skilled workforce and equipment, and maintain such standards as may be prescribed from time to time. Furthermore, to register as a Human Organ Retrieval Centre under the Act, the hospital shall have Intensive Care Unit facilities along with infrastructure, equipments and manpower as required to diagnose and maintain the brain-stem dead person.

 

Regulation of Medical Practitioners

According to Section 3(4) of the Act, organ removal can only be done by a registered medical practitioner. Registration is not required for a medical practitioner, but the transplantation has to be conducted in a registered hospital. Section 2(n) of the Act defines a “registered medical practitioner” to mean a medical practitioner who possesses any recognised medical qualification as defined in clause (h) of Section 2 of the Indian Medical Council Act, 1956 (5) and who is enrolled on a State Medical Register as defined in clause (k) of that section. 

 

Punishment

According to Section 18 of the Act, a person is to be punished with imprisonment for a term which may extend to 10 years and with fine which may extend to Rs. 20 lakhs if he is involved in the removal of any human organs without authority. Suppose the person convicted is a medical practitioner. In that case, his name shall be reported by the Appropriate Authority to the respective State Medical Council for taking necessary action.

According to section 19, if a person does commercial dealing of human organs, he will be punished with imprisonment for a term which shall be not less than five years but which may extend to 10 years and shall be liable to fine which shall not be less than Rs. 20 lakhs but may extend to Rs. 1 crore.

According to Section 20 of the Act, any person who contravenes any other provision of the Act can be punished with imprisonment for a term which may extend to 5 years or with fine which may extend to Rs. 20 lakhs.