In 1989 the situation in India regarding human organ transplantation was, to put it mildly, out of step with the rest of the civilised world. The organ trade was legal and widespread and, among the solid organs, only kidney transplants were being done. Patients with heart and liver failure were dying without any hope of transplantation. In the West the trafficking in human organs that was prevalent in India was regarded as abhorrent and there were strict laws banning this trade. Nearly all the kidneys those were transplanted were being harvested from cadavers. In addition to this heart and liver transplants had become commonplace, their techniques were standardised and, with the introduction of the drug cyclosporine which suppressed the immune system and prevented the rejection of the transplanted organ, 80% of the recipients were living one year and 50% were alive after 5 years.

Shri Rajiv Gandhi, the then Prime Minister of India, asked the Minister of Health why heart and liver transplants were not being done in this country so the ministry set up a committee with the task of defining the problems that need to be solved before these operations were possible.

The committee identified two major problems.

Firstly, Indian law did not recognise brain death and it was uncertain that the concept would be acceptable to the Indian population. Death in the Indian Penal Code was defined as 'death unless the contrary appears from the context' or 'the permanent disappearance of all evidence of life at any time after live birth has taken place'. These definitions were clearly inadequate as well as confusing. Further, they did not allow transplantation of organs such as the heart and liver which required a heart-beating, brain-dead donor.

The second problem defined was the prevalent trade in human organs. There was widespread repugnance in this country at this exploitation of the poor by the rich and at the idea of human body parts being treated as commodities. There was also concern that organ recipients risked contracting undisclosed diseases from donors such as AIDS and hepatitis and that the situation was fostering criminal activities involving middlemen and even physicians. The Committee felt that if the organ trade were allowed to continue there would be little possibility of developing a cadaver organ donation programme. It recommended that legislation be prepared to legalise the concept of brain death, to prohibit the sale of human organs and to prevent abuse of the law.

Four major conferences were held to familiarise and sound opinions from people from all walks of life regarding brain death and banning the organ trade.

These conferences took place in Bombay, Madras, Calcutta and Delhi. It appeared during the discussions that took place and the subsequent reports in the media that public opinion was strongly in favour of these legislative changes.

The Government then established a committee under the chairmanship of Dr. L M. Singhvi, the eminent constitutional lawyer to clarify: (a) the concept of brain death and its definitions:(b) the desirability of enacting separate legislation for this purpose and the legal, medical, and social implications of such as legislation;(c) the safeguards to be adopted to prevent the misuse of the concept of brain death and (d) the manner in which the concept of brain death should be utilised to facilitate the availability of human organs for transplantation.

The report of the Singhvi Committee was submitted In June 1991 and received Cabinet approval in October of the same year.

On 5 May 1993, the Transplantation of Human Organs Bill was submitted to the Rajya Sabha where it received unanimous approval. In December 1991, however, the Lok Sabha decided to refer the Bill to a Select Committee for further examination. The latter suggested amendments suggesting the inclusion of in-laws as near relatives and the payment of living donors. These were not accepted by the Union Cabinet and on 15 June 1994 the Bill was passed by Lok Sabha. It received Presidential assets on the 8th of July 1934. India's first successful heart transplantation from an organ harvested from a brain dead donor was performed in the All India Institute of Medical Sciences on 3 August 1994.

The Transplantation of Human Organs Act provides for the regulation of the removal, storage, and transplantation of human organs for therapeutic purpose and for prevention of Commercial dealings of human organs.

The principal matters covered are:

a. Authority for the removal of human organ

Any donor over 18 years of age may grant authorisation in writing before his or her death in the presence of two witnesses one of whom must be a near relative. Brain death has be certified by board of four medical experts—the registered medical practitioner in charge of the hospital, a member of a panel approved by the Appropriate Authority, a neurologist or neurosurgeon and the attending physician. After this permission to remove an organ may be given by a near relative. No organ donations are permitted from living donor unless they are near relatives (spouse, son, daughter, father, mother brother or sister or if there is "affection or attachment" between the donor and recipient. To verify attachment prior approval must be obtained from an Authorisation Committees set up by the Government.

b. Regulation of hospitals

Hospitals carrying out organ transplantation must be registered by the Appropriate Authority (whose officers are appointed by the Central or State Governments) for the purposes of granting or canceling the registration of hospitals, enforcing standards, investigating breaches of the Act, and inspecting hospitals periodically.

c. Registration of hospitals

A hospital may not be registered to carry out transplantation procedure unless the Appropriate Authority is satisfied that it is adequately equipped and able to maintain the necessary standards.

d. Offences and penalties

The unauthorised removal of human organs is punishable with imprisonment for up to five years and a fine of up lo Rs.10, 000. Physicians involved in organ trading will be struck off the Medical Register for two years for a first offence and permanently for subsequent offence! There are also penalties for soliciting or offering organs against payment.

THE PRESENT SITUATION IN INDIA

Although the Act has been in place for 3 years its effect on organ transplantation in India has been rather disappointing. Cadaver donation of organs is still very rare for many reasons Firstly, because there is lack of awareness, even among doctors, that brain death is a form of death. There is thus indecisiveness on the part of all healthcare workers about asking for organ donation and distrust and sometimes violence, by the relations of potential donor directed against treating physicians who may broach this delicate subject Then there are very few ‘transplant coordinators' trained to explain the benefit of the new life given to recipient by the donation of organs from a brain dead cadaver. Relatives are also worried that the body may be mutilated, the funeral arrangements delayed and who should pay the maintenance costs of the donor after brain death. It is still not clear in India whether Islam permits the donation of organs from dead persons although brain death is recognised in Saudi Arabia am other Middle Eastern countries.

The organ trade is continuing albeit less openly and in smaller numbers. It has been alleged that many members of Authorisation Committees take decisions regarding 'affection and attachment' of living donors which are based on financial considerations; thus one committee rejected only 22 out of 998 applications submitted to it for verifications of an emotional relationship. A further deterrent to donation and transplantation is because the results of heart and liver transplants performed in this country have not reached international standards so physicians are unwilling to refer patients till they arc too ill to undergo an' procedure. The cost for a liver transplant is also a prohibitive 15 to 40 lakhs.

The solutions to these problems lie in making strenuous efforts to improve cadaver donation by increasing public awareness through the media and support for organisations like ORBC (Organ Retrieval and Banking Organisation) and Ganadarpan. Till this is done it is justifies to continue the live related donor programmes for the kidney and liver which are in place in many hospitals but which carry with them a risk, albeit small, to the donor,

Has the Act therefore been a failure? I believe not. It has allowed the start of heart, live and lung transplantation programmes in Delhi, Chennai, Mumbai and Bangalore. In Chennai 88 renal transplants have been done from cadavers in the past four years. What is sorely needed is to improve public awareness about the benefits of organ donation. This is where Ganadarpan must play a major role.