Indian subjects in clinical trials are vulnerable lot
The government of India enacted a new rule that allows foreign pharmaceutical companies and other interested parties to conduct trials of new drugs in India during the same time that trials of the same phase are being conducted in other countries. But even under the new rule, phase 1 trials will not normally be permitted in India. The old rule was designed to protect Indians from being used as guinea pigs in the testing of unproved drugs of foreign origin.
The change was made in response to vociferous demands from multinational drug companies and in the light of WTO agreement where India is playing a major role as a stakeholder. In recent timesit has become increasingly difficult to test drugs in Western countries, with their strict regulations, elaborate safety and compensation requirements, and small populations, all of which make the recruitment of research subjects slow and expensive. The move is made to outsource some of their trials to Third World countries such as China, Indonesia, Thailand, and India.
India is particularly an attractive site for such trials because of its genetically diverse population of more than 1 billion people who have not been exposed to many medications but have myriad diseases, ranging from tropical infections to degenerative disorders. Virtually every Indian doctor speaks English, and many have acquired postgraduate qualifications abroad, primarily in Britain or in the United States. Added to these attractions are cheap labor and low infrastructure costs, which can reduce expenditures for clinical trials by as much as 60 percent.
Contrary to these, although the country has more than half a million practicing doctors, fewer than 200 investigators have been trained in good clinical practice. Among some 14,000 general hospitals, no more than 150 have the adequate infrastructure to conduct trials, and there are fewer than a dozen pathology laboratories that meet the criteria for compliance with good laboratory practice. Only about half of the large hospitals have institutional review boards, and even these boards have not yet formulated standard operating procedures — and they, too, often lack the expertise with which to evaluate protocols. Information about conflicts of interest is neither sought nor voluntarily provided by investigators.
Prevailing sorry state of the apparatus for reviewing proposals, the greatest concern about clinical trials in India, from the vantage point of both Indians and ethicists, is illegal and unethical trials, a number of which have attracted adverse coverage in the media in recent years. All these trials have taken place in the past without regulatory approval.
These studies were of course conducted by Indian organizations, but in the past, Western pharmaceutical companies have conducted similarly unethical trials.Moreover, the sponsors of many such trials engage in practices that are currently legal yet ethically dubious. Widespread illiteracy makes it particularly easy to sidestep the standard methods of obtaining informed consent. Investigators frequently enroll patients in trials as if their participation were a necessary next step in their care. And no protocol has promised to continue to supply the studied medication free of charge after completion of the trial, if it is found to be beneficial.
There have, of course, been some ethical and successful drug trials of immediate relevance to India and other developing countries in the past. But opponents argue that India itself would not benefit greatly from these studies what is aimed to benefit the foreign country’s patients. These trials do not cover the drug related to tropical disease such as kala-azar, Tuberculosis, Malaria, Filaria, Dengue, Chucken Gunea, which are the major problems of the third world countries. Arguable no one disputes that researchers should be encouraged to conduct Indian trials of new drugs for diseases that are endemic to this country. But to our knowledge, hardly any trials involving such new drugs have taken place in India; globally, only 1 percent of the new drugs discovered in the past 25 years have been for tropical diseases.
The earning potential which is shown to open up a new door of opportunities looks some what meager in terms of other opportunity India is riding through. As per the projection, India would earn somewhere $200 million by 2008. Given the situation, even with relaxed rules, India makes as much in one week by exporting computer software, and clinical Trials can in a year by offering up its citizens as study subjects. And that too, software offers no direct risk to anyone's health. Therefore, many of the industry experts are in opinion that it would not benefit India. The much-hyped earning potential is likely to remain a distant dream.
One more aspect which bothers experts that the sponsors do not guarantee the new drugs tested in India will be made available locally at an affordable prices. Recent examples suggest that new-patented drugs will cost so much that most of the Indians will not be able to buy them.
Moreover, even before such a limited form of "liberalization," or opening of the economy, occurs, adequate safeguards must be put in place to protect participants. Such safeguards might range from a procedure for the proper review of study protocols by the DCGI to the registration of trials and their results on publicly accessible Web sites to requirements for insurance and appropriate compensation of subjects in whom the drugs under study have adverse effects.
Real informed consent should be obtained from participants in the presence of an objective third party. Trials should be conducted only by investigators trained in good clinical practice at designated research hospitals. Truly independent institutional review boards should be formed, and a system should be created to enable these boards to share information about trials they have rejected and their reasons for doing so.
Among India’s population, a large proportion of the subjects in any trial will inevitably be disadvantaged persons. It is therefore of paramount importance to protect the most vulnerable — women, children, the poor, and the illiterate — by making sure that their enrollment in trials is truly voluntary and that their consent is genuinely informed. They should have access to the drug after the trial if it is found to be effective, and they should not only be treated and compensated for injury but also be compensated for any resultant loss of income. These things can be done only when the government strengths its regulatory system to safeguard the rights of patients and protecting them from exploitation.