pp. 215-220 in
Bioethics in Asia
Editors: Norio Fujiki and Darryl R. J. Macer, Ph.D.
Eubios Ethics Institute
Copyright 2000, Eubios Ethics Institute
All commercial rights reserved. This publication may be reproduced for limited educational or academic use, however please enquire with the author.
6.4. Ethics and Human Genome Studies and Genetic Services in India
Ishwar C. Verma.
Sir Ganga Ram Hospital, New Delhi 110060, India
In discussing bioethics in Asia mention must be made of Professor Norio Fujiki, who has made signal contributions to develop and nurture it by organizing collaborative studies and by creating opportunities for bio-ethicists in developing countries to interact with their colleagues in Japan and western countries. A word of appreciation also for Dr. Darryl Macer. This quiet and unassuming New Zealander, who has made Japan his home, has given a new dimension to the field of bioethics by scientific methods of study, by his numerous publications and by inspiring many brilliant young students to take up this speciality. This team has spread the principles and message of ethics in all countries of Asia. This paper presents some of the ethical dilemmas which occur in genetic practice and research in India, and how these are being resolved.
Poverty and ethics
The fundamental ethical principles which govern the practice of medicine are patient autonomy, beneficence, non-maleficence and justice. In India traditionally there is great respect for the doctor, who is considered almost a demi-god (Advani, 1980). The patient thus relies heavily on the doctors advice to decide what should be done. The doctors word is rarely questioned and is scrupulously followed. Only in recent times has the doctors been brought under the purview of the Consumer Protection Act (1986). The Act aims to protect the rights of consumers through settlement of disputes by consumer tribunals at the district, state and national level. The Act defines a consumer as any person who buys goods or hires services for a consideration". This definition is broad enough to encompass a patient as a consumer who obtains professional services from a physician for a fee. The medical profession , expectedly, opposed it. However, the Supreme Court upheld the contention that the Act should apply to medical professionals. The Government hospitals who do not charge a fee for their service , or charge only minimally, are still not under the purview of this Act.
The huge population in India with poor or limited resources for basic human needs like food, housing, education and health combined with cultural and religious practices modify the application of these principles. The low socio-economic status compels many people in their decision making to be guided by the fact that "survival is more important than ethics", and that "quality of life is more important than sanctity of life" (Siva Subramaniam, 1986) .
Table 1 compares the demographic indicators in India with those in Thailand, Japan, USA and UK. It emphasizes the huge population in India, high birth rate, and an infant mortality rate 9-18 times more than that of USA or Japan. Most striking is the per capita income which is 79x less than that in USA, and 116x less than that in Japan. Adult literacy is also almost 1/2 of that observed in USA/Japan. It is thus easy to see why child labor is common in India (FlorCruz et al.,1996). This has been the cause of much hue and cry in the West, and there have been attempts to boycott the products of those industries which employ children. The fact remains that these children have to engage in labor to survive. The alternate for "labor" is death for them.
Similarly it becomes obvious why organ donations (kidneys, corneas and even skin) became commercialized in India (Chugh and Jha, 1996). There are numerous case histories reported in magazines that by donating a kidney a person was able to marry off his daughter, and open a small shop so as to earn a living for the rest of his life. The doctor was able to save the life of some one with kidney failure who was otherwise doomed to die. However the intermediaries who acted as touts by enticing unsuspecting village folk to donate their kidneys made the most money, and some really gruesome cases were highlighted by the press. The practice roused the conscience of the people of India and the Transplantation of Human Organs Act 1994 was passed for regulation of removal, storage, and transplantation of human organs (Dureja, 1994). To prevent commercial dealings it permitted donation of organs only by the relatives , except in exceptional circumstances. It also defined "Brain stem death" to facilitate cadaveric transplants (Vas, 1990). However cadaveric transplants have not yet taken off because of cultural resistance to pledge organs for donation.
Table 1: Demographic indicators in different countries
India Thailand Japan USA UK
___ ___________________________________________ _______
Population (millions) 944.5 58.7 125.4 269.4 58.1
Annual births (millions) 24.3 0.99 1.28 3.83 0.70
Infant Mortality rate (/1000) 73 31 4 8 6
Under 5 Mortality rate 111 38 6 8 7
Life expectancy (years) 62 69 80 76 77
Adult literacy (%) 52 94 >95 99 >95
GNP (US$ per capita) 340 2740 39640 26980 18700
Modified from "The State of the Worlds Children 1998," UNICEF.
Genetic counseling - directive or non-directive ?
Let us consider the case of a young couple from a village. The wife had a pregnancy of 15 weeks. Maternal serum alpha fetoprotein was raised to 4 MOM (Multiples of Median). Ultrasound showed that the baby had a small spine bifida. In keeping with usual practice, I gave non-directive counseling, explained the burden of the disease, and asked the couple to make their choice. The couple was unable to decide and asked me to tell them in clear terms whether they should abort or continue the pregnancy. I explained to them that most persons in India, under similar circumstances would chose abortion. One can see, therefore, that if the patient is illiterate, and has poor understanding of genetics non-directive counseling does not work, and the genetic counselor has to give more directive counseling.
Table 2.: Genetic Counseling at Sir Ganga Ram Hospital ( n = 475 )
Indication No. %
Reproductive genetics 185 38.9
Prenatal diagnosis 91
Recurrent abortions 62
Mental retardation 132 27.8
Thalassemia, Hemophilia, Leukemia 52 10.9
Muscle dystrophy, Spinal muscular atrophy 41 8.6
Spina bifida, Malformations 32 6.7
Short stature, Hypogonadism, Pubertal problems 19 4.0
Skeletal dysplasias, Craniosynostosis 14 2.9
The burden of genetic disease is high in developing countries due to the limited facilities for rehabilitation, and the socio-economic cost of looking after these children. Therefore prevention, prenatal screening and prenatal diagnosis of genetic disease are important for the people (Verma et al. 1992). Table 2 lists the reasons for genetic counseling over a 6 months period in Sir Ganga Ram Hospital. This is a private trust hospital where I am currently working, although about 30% of patients are treated free of cost through the general out-patients department. It will be noted that the commonest indication for seeking genetic counseling is "reproductive genetics", of which prenatal diagnosis is the most important. In fact many parents will not fully investigate their child with genetic disease until they decide to have another child, and it becomes necessary to define the exact cause in the affected child. It is so because in their perception "why investigate the cause of a disease if there is no treatment for it".
It would be no good to do prenatal diagnosis, unless one can carry out abortion of an affected fetus. In 1971 India passed the Medical Termination of Pregnancy Act. It was enacted not for encouraging family planning but for preventing and stopping the large scale illegal and unhygienic abortions which were being done resulting in many deaths from complications of the procedure. The Act liberalized the abortion laws, and abortion is currently readily available in government and non government clinics avoiding many maternal deaths (Verma and Singh, 1991).
Soon the technology for identification of Y chromosome by fluorescence became available, along-with ultrasonography to visualize the fetus. Access to fetal tissues by chronic villus sampling and amniocentesis became quite easy. This immediately led to this technology being used for diagnosis of fetal sex in couples who had many daughters and no son. This practice became wide-spread in Punjab and Maharashtra (Verma, 1992; Patel, 1995). It was common to see advertisements in newspapers by the laboratories displaying that they can diagnose fetal sex. The persuasive argument they used was "spend Rs. 500 now and save Rs. 500,000 to be spent as dowry. "This resulted in a large number of abortions of female fetuses. There were fears that the already decreasing sex ratio of females as compared to males would worsen further. The Government had therefore to act and show its commitment. There were people, including scientists and doctors, who argued that we should allow prenatal diagnosis of sex for couples with 2-3 daughters. However, due to large scale female foeticide in the cities the Government of India passed the Prenatal Diagnostic Techniques (Regulation & Prevention of Misuse) Act, 1995. The Act requires that all prenatal diagnostic centers should be registered and that records be maintained of all prenatal diagnostic procedures performed. The indication for carrying out the test is to be specified and recorded in each case. It lays heavy penalties for misuse. But it has been only partially successful. Recently a report appeared in a prominent national daily "The Statesman" entitled "Calcutta doctor conducting fetal sex tests on the sly". Legislation to end deep-rooted cultural practices and preferences are not very effective in practice, especially when the machinery to enforce and monitor compliance is weak.
Ethics of Genome Research
India offers an ideal setting for genome studies - a vast population, a large number of castes and communities (4635), eight religious categories, and 325 languages (Singh, 1992). Consanguineous marriages occur in large parts of India. South India has about 40% of couples among all religious groups marry consanguineously. In North India consanguineous marriages are mostly among Muslims. These families provide an ideal setting to search for new genes by the technique of "homozygosity mapping". Families in China, which also has a large population, have only 1-2 children and are thus no longer attractive for such studies. Africa has families with large number of children but paternity problems invalidate linkage studies. Thus India has become the hunting ground for such studies (Verma, 1997). Since laboratories with facilities for identifying new genes are very few in India, samples of these interesting families are being sent to scientists in western counties. Many argue that this represents a loss of "genetic resource". Already the Indian Government has shown great concern at the biological resources in the country being plundered by foreign companies and scientists (Jayaraman, 1997). A draft legislation has been drawn up to protect its biological resources from being exploited by foreigners without sharing the benefits with local people. Indian scientists who transfer commercially valuable research material to foreign nationals without official approval will be punished. With this background the Government of India had issued a memorandum that permission of Indian Council of Medical Research (ICMR) would be required before samples are sent abroad, either for research or for diagnostic purposes (ICMR,1992). More recently these rules have been liberalized (Memorandum, 1997). The exchange of material for diagnostic or therapeutic purposes for individual cases has been permitted, if this exchange is considered necessary by the doctor concerned. No permission is required from any authority for this purpose. Where exchange of material is envisaged as part of a collaborative research project, the project proposal as a whole must be routed through the appropriate authority for evaluation and clearance. The exchange of human material should be an integral part of a collaborative project, which should have been approved by the institutional review and ethical committee. In order to protect the rights of the Indian study subjects as well Indian scientists and organizations, memoranda of understanding and/or agreements on material transfer should be entered into between the collaborating partners covering all aspects such as purpose of transfer, research to be carried out, filing of patents, arrangements for future commercial exploitation etc. Premier and national medical institutions in the country have been given the authority to approve the sending of samples abroad. However, ICMR has to be informed and this organization will maintain a register of all such joint projects and permissions. In case of involvement of smaller or private institutions the application for approval has to be routed through the ICMR. Hopefully these rules would allow foreign collaboration as well as ensure that the country will get its due when these samples are sent abroad.
Regarding genome diversity studies, their benefits are obvious - one learns about the origin and inter-relationship of the ethnic groups, one can identify resistance / susceptibility genes for infections like tuberculosis or malaria etc. However for the local community there is inconvenience and loss of time. Does the community get any real benefit ? In most countries like USA, Canada and Australia the aboriginal tribes have refused to participate in these studies saying "our forests and lands have been taken away and now you want to take our blood". These communities mistrust the motives of the investigators as there have been numerous attempts to patent "natural resources and plants" of these areas.
In India tribal communities, who are the likely subjects for diversity studies, live in remote areas, are often illiterate and suffer from nutritional and parasitic disorders. Extensive studies are planned by the Department of Biotechnology, Government of India. In the numerous studies performed by the author these were linked with health care benefits for the community (Verma, 1997). For example members of the Kondh tribe in Orissa were studied for sickle cell disease, and a local centre for diagnosis and management of this disorder was established. The negrito tribes of Andaman islands were evaluated to find the cause for their demographic decline as the onges number only 100. This was linked with providing them the necessary medical care and reproductive advice during the study. Studies among such isolated and illiterate tribes have raised ethical concerns. The Department of Biotechnology, as a safeguard for such studies, requires "informed consent" of the subjects. Objectives of the study are to be explained in the local language, there has to be voluntary participation, there showed be compensation for loss of time and loss of wages, and consent must be obtained from the individual and the community, either written or tape-recorded.
Improving Ethical Practices in Medicine
Correct ethical practices are ensured through numerous professional councils such medical, dental, nursing etc. (Verma et al., 1997). These councils recognize medical colleges and courses, ensure code of medical ethics and take disciplinary action when necessary. The Medical Council of India (MIC) has been charged with the responsibility of setting minimum standards for medical education. It has not prescribed a separate curriculum in medical ethics. However, curriculum in Forensic Medicine includes one to two formal lectures on some of the ethical issues. At the All India Institute of Medical Sciences, ethics is being taught and assessed as part of the Forensic Medicine curriculum. Kasturba Medical College, Manipal has a series of sessions touching upon ethical issues and several other medical colleges similarly have 6 to 8 sessions on the subject. Christian Medical College, Vellore has been a leader in this area and uses case studies during internship to inculcate ethical thinking in future doctors. These sessions are attended by lawyers and experts in medical ethics who give their opinion regarding the issues discussed.
St. Johns Medical College in Bangalore has however set an example that should be followed by the MCI and every medical school in the country and region (Francis,1996). Since the inception of the college in 1963, St. Johns has paid particular attention to the teaching of this subject. They are perhaps unique amongst medical institutions in having a department of medical ethics. This department has four faculty members headed by a professor. Their teaching program for medical ethics extends as a continuum throughout the undergraduate period and is reinforced during both internship and residency by clinical case oriented sessions. Since 1992 this pioneering medical college has also instituted monthly clinico-ethical conferences held during the weekly hospital meetings.
The consortium of nationally important medical institutions comprising of All India Institute of Medical Sciences (AIIMS), New Delhi; Christian Medical College Vellore, Jawaharlal Institute of Postgraduate Medical Education & Research, Pondicherry, Institute of Medical Sciences, Banaras Hindu University, Varanasi formulated inquiry-driven strategies for innovations in medical education with financial support from WHO in 1989 (Verma et al. 1992, 1995). A number of instruments were used for identifying curricular deficiencies during the inquiry. One of the important findings of the above enquiry was, that the ethical, moral and humanistic aspects of the disease are neither taught nor assessed. Consortium proposed modification of the existing undergraduate curriculum based on the results of the inquiry. It was proposed to have a formal course in medical ethics. The course contents and teaching-learning methodology has been finalized. It has been largely drawn from the course being followed at St. Johns Medical College, Bangalore. It has been stressed that this course should be taught preferably by case examples, case discussions and role models rather than as lectures. However, it has yet to be introduced by most of the medical colleges in the country.
Ethical Guidelines for Research
Ethical guidelines have been formulated for research in India, by the three main organizations for research-Indian Council of Medical Research (ICMR), Research/ Department of Science and Technology, Department of Biotechnology and Council of Scientific & Industrial Research . ICMR has recently revised its guidelines, having drawn heavily on those prepared by World Health Organization and Nuffield Council of Bioethics. These guidelines have been calculated to 500 prominent persons in diverse fields, doctors and scientists for their comments. Regional discussions will take place before the document is accepted for national implementation . A recommendation has been made for having an ethical committee in very medical institution.
I am a great admirer of Dr. Halfden Mahler, a former Director General of WHO. He said "Is it realistic to expect rational ethical decisions in this world. We are asking for rational decisions in an irrational world, honesty in a dishonest world, generosity in a greedy world, altruism in an egoistic world, intelligence and humility in an arrogant world". I leave you with these thoughts.
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