In a way, it is almost surprising that it had not happened earlier. A country like India, with its huge population often desperate for medication of any kind and with socio-legal conditions that provide at best haphazard and at worst non-existent consideration of the rights of patients, is obviously ideal ground for expanding the business of clinical testing of pharmaceutical drugs and other medical devices.
 
Indeed, situations of extreme poverty have driven people in our country to do much worse than simply agree to be part of medical experiments or tests. We are all familiar with the sale of human organs, such as kidneys, which had become a major export before they were banned and are still probably traded illegally in large numbers. In such a context, the possibility of earning income through volunteering for straightforward medical tests would seem an alternative infinitely preferable to that of trading organs. And since such tests would come so much cheaper for the drug companies, the "comparative advantage" of India in this rather peculiar form of service activity would appear to be a foregone conclusion.
 
This would in fact mean high savings for multinational drug companies, since clinical trials of drugs are estimated to account for up to one-third of the total costs of developing a new drug. Most of this money is typically spent on trials undertaken in the penultimate phase just before seeking regulatory approval and being able to file patents, and that usually requires large number of human rather than animal subjects.
 
Because of the greater ease in getting people to agree to be part of such tests and the lower requirements in terms of payment or information to such human guinea-pigs, such clinical trials in countries like India are likely to be much cheaper and faster. In addition, the sheer size and diversity of the Indian population in particular means that virtually all the known diseases, disorders and illnesses (those of the poor and of the rich) can be found here with sufficiently large numbers of cases.
 
Until a few years, ago, however, rather stringent medical regulation in the countries of the developed world that are still the biggest consumers of drugs, had limited the possibility of relocating such testing to India and similar countries. However, in 1997 the United States, Japan and the European Union agreed on common standards for running clinical drug trials, which meant that trials conducted anywhere in the world would be acceptable as long as they conformed to these standards.
 
This then cleared the way for a move by contract-research organisations (which are companies specifically directed towards conducting clinical trials and providing related services to pharmaceutical companies) to enter developing countries. Recently, the trend appears to have accelerated.
 
Thus, a recent report in the London Economist magazine suggests that the real move to increase such medical testing in India is only now becoming evident. A number of major US-based contract-research organisations have entered into joint ventures with Indian partners, such as Quintiles Transnational and Covance.
 
Indian companies like Nicholas Piramal and Max India have signed up with other foreign concerns to undertake such testing here on a contract basis. The potential return on investment in such activities in India is being described as "tremendous".
 
Obviously, it cannot and should not be argued that there should be no research in the form of clinical drug trials conducted on human beings. Such research is essential for the development of new drugs, and therefore for enhancing human health and well-being. It is now generally acknowledged, however, that clinical research on drugs, as well as evaluations of newly developed diagnostic agents, medical instruments and related material, should follow certain basic guiding principles. Thus, the benefits of intervention should far outweigh the risks ; the adverse effects should be minimal and transitory; and they should disappear on withdrawal of the drug.
 
The Indian Council of Medical Research (ICMR) has identified the following main pillars of ethics in biomedical research : (1) essentiality of the proposed research - that is, that valid information would not become available otherwise, (2) voluntariness of the subject, informed consent, confidentiality of the identity/personal data of individual subjects, (3) non-exploitation of subjects' situational or circumstantial position, treatment of research subjects with respect and dignity, (4) professional competence of the investigator(s) or medical team, (5) accountability and transparency of all transactions between the researcher(s), research institution and the volunteer, and finally (6) the public domain, that is, the findings should be made public for the benefit of the society. If these criteria were always observed, there would be no problem in allowing for a huge expansion in medical testing in India. But in that case, it would not be very much cheaper than similar tests in the highly regulated developed countries, and perhaps companies would find it less attractive in terms of returns on investment and cutting costs. Unfortunately, there is often a strong economic or material filter through which ethical issues are viewed, and this area is clearly an example.