Editorials  53

Liver transplantation in India: Its evolution, problems and the way forward

In 1990 liver transplantation, the only effective treatment for end-stage liver disease, was being performed in most of the western world and Southeast Asia. The operative success rate then was 86% and the 5-year survival 70%.1 At the same time more than 200 000 people were dying in India every year from liver failure without any hope of receiving a transplant. The very small number of rich Indians who could spend Rs 10 million went for transplants to the USA or UK. Even there they were placed at the bottom of the waiting lists for cadaver (deceased donor) organs and were allocated a liver only if there was no suitable local recipient for it. This usually occurred after a waiting period away from home of up to 6 months.
   It was in that year that Late Shri Rajiv Gandhi, the then Prime Minister of India, after a visit abroad, asked the Minister of Health why heart and liver transplants were not being done in India. A committee set up by the Minister of Health to examine this issue identified 4 main challenges that had to be overcome. The first was to change the law to recognize brain death so that organs such as hearts and livers could be harvested from heart-beating cadavers. The second was to acquire expertise in what was thought to be the most technically difficult transplant operation. The third was to assure the public that organ transplantation was not always associated with ‘trading’ (the buying and selling of kidneys had given India an unfortunate reputation worldwide). The fourth hurdle was to convince policymakers that allocating large sums of money for a single procedure was in the national interest.
   All these issues were addressed simultaneously. There were already large numbers of Indian surgeons and anaesthetists who were working or had worked in transplant units abroad (some of whom had returned to India) who were eager to establish liver transplant facilities in India. The most difficult issue, in fact, would be public education. With support from the Ministry of Health, the WHO and The National Medical Journal of India,2 opinion leaders—journalists, non-governmental organizations, religious leaders and academics—were invited to 4 open conferences in Bombay, Madras, Calcutta (now Mumbai, Chennai and Kolkata, respectively) and Delhi.3 They were informed that recognizing brain death might have numerous benefits. Instead of ventilating brain dead ‘heart-beating’ cadavers our limited intensive care facilities could be diverted to saving patients who were still alive, relatives would be spared extended periods of unnecessary anguish and false hope while waiting beside what was essentially a corpse and, finally, organs such as the liver and heart which required heart-beating donors could be harvested for transplantation. Liver transplantation would save many young productive lives, hospitals in which the procedures were performed would automatically improve and this complex and costly procedure would be available locally to many Indians at a fraction of its cost abroad. It would also enhance India’s medical reputation worldwide. These meetings received wide coverage in the local and national media and there was a general feeling that it would be good to bring in a law to recognize brain death and ban trading of organs. This Journal published a booklet on the Calcutta proceedings 4 entitled Brain death and organ transplantation in India, which was used to disseminate information about the subject and answer queries. The government then set up another committee under the chairmanship of the eminent lawyer Dr L. M. Singhvi to examine these issues. In its report 5 this committee recommended that the law be changed to recognize brain death as a form of death and suggested strict rules regarding where, when and by whom cadaver organ transplantation could be performed. The Cabinet accepted the recommendations of the Singhvi Committee and, after some initial hiccups, the Transplantation of Human Organs Bill was passed by Parliament in the year 1994 and became law in 1995.
   The performance of India’s first heart transplant at the All India Institute of Medical Sciences (AIIMS), New Delhi, from a cadaver donor in 1994 heralded what was expected to be the beginning of a successful deceased donor liver transplant programme in India. Unfortunately this was not to be. The initial transplants that were done in the Apollo Hospitals, Chennai and AIIMS in 1995 and 1996 were unsuccessful and it was only in 1998 that the first successful cadaver transplant in India was done in Chennai by a surgeon from Singapore followed soon by a cadaver transplant and a living related transplant (where a portion of the liver is removed from a living donor) in the Indraprastha Apollo Hospitals, New Delhi. Except for the transplant procedures in the Apollo Hospital (New Delhi) there was little progress till 2004 since when there has been a major increase in numbers of liver transplant operations and centres in India. Until 2004, only 131 transplants had been done in 15 centres while by the May 2007, the total number of liver transplants had reached 318 in 18 centres. In other parts of the ‘developing’ world liver transplants have been reported from Brazil, Argentina, Vietnam as well as Turkey and Saudi Arabia (where the deceased donor v. living related transplant ratios are commendable—30:70 and 90:10, respectively). China is the only other developing country in which deceased donor liver transplants are being done regularly but it has been reported that many of the ‘voluntary’ donors have been executed prisoners—a practice that has attracted wide criticism.6 In India, liver transplantation has generally been ethical and reports of malpractice are extremely rare.
   The distribution of liver transplant activity in India is shown in Table I. These data demonstrate that the operation has been performed mainly in private sector hospitals (90%), from live donors (73%) and in Delhi (74%). It is difficult to report what the results have been nationwide—for obvious reasons—but to the best of our knowledge some transplant programmes have had not had a single survival while in others the operative success rate has reached a respectable 92%.6 The cost has varied between Rs 1.5 and 2 million rupees in hospitals which have a successful ongoing programme (it has been reported to be between Rs 400 000 and Rs 800 000 in some hospitals but

 
these have done about 10 cases each—not enough to standardise costs). The highest Indian figures are still about one-fifth of the current costs in western countries. What is of concern, however, is that living donor liver transplant, which puts the live donor at risk (there have been two donor deaths reported from India), is the dominant procedure. This is similar to the situation in Southeast Asia and Japan where cadaver organ donation is infrequent and in contrast to that in Europe and the USA where more than 90% of liver transplants are done from deceased donor organs. Other concerns are the poor performance of the public sector and the lack of transparency regarding the operative results. There are also reports that the organ trade is continuing albeit in a clandestine manner.
   It is now time to reassess the impact of the Transplantation of Human Organs Act, 1995 and suggest a way forward. After 3 recent and well-attended liver transplant conferences the consensus seems to be that the main thrust should be towards improving deceased donor organ donation. This might be done in various ways. The first step should be to advertise the benefits of donation after brain death through the print and electronic media. To facilitate organ retrieval there should be some minor amendments made to the Transplant Act of 1995. Presently, the Act requires 4 doctors to diagnose brain death on 2 occasions at an interval of at least 6 hours. Perhaps, we could follow the western model of requiring only 2 doctors to do so and the interval could be shortened to 2 hours. The small number of hospitals authorized by the government to perform transplants should be delinked from the large number of hospitals with intensive care units but without transplant facilities who should be allowed to diagnose brain death and conduct organ retrieval operations. The postmortem examination of a medicolegal case could be conducted during organ retrieval in the presence of a forensic expert approved by the government and agreement for organ donation could be included in print on the driving licence, following the North American and British patterns. More controversial amendments that have been proposed include a ‘required request’ law—requiring doctors to ask for organ donation in any brain dead patient. There are organizations, both in India and abroad, which advocate that the families of donors should be paid but we do not think that this would be acceptable to the vast majority of Indians. Performance-linked incentives to transplant coordinators are the norm in countries such as Spain and may be less controversial.
   Other thrust areas should be to make liver transplantation available to a wider population by reducing the cost from Rs 2 million to about Rs 0.5 million. Perhaps with increasing experience fewer pre- and postoperative investigations will be necessary, the hospital stay reduced, cheaper antibiotics and immunosuppressive drugs used, more deceased donor transplants done and the facility developed in designated public hospitals in different parts of the country. The main reason why public hospitals have not yet established liver transplant programmes are complicated and it might be because these institutions do not see liver transplants as a priority as these are expensive and make major demands on their scarce resources and trained manpower. However, we suggest that a closer collaboration with hospitals in the private sector which have successful programmes—we believe now that there is no reason to go abroad for either patients or doctors—will enable many more patients with liver failure to gain access to this life-saving treatment.
   All this seems now to be a bit farfetched but so was liver transplantation in India in the year 1990. There has been considerable progress since then and the procedure has been demonstrated to be feasible in India. We should now try and make it more accessible and affordable.

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