Clinical research is perhaps the most expensive and critical phase of drug development process in pharmaceutical industry. Without a three phase human trials, no new drug can be approved for marketing. It is expensive as it involves participation of thousands of subjects and investigators in multi locations for nearly ten years. And new molecules may have to be abandoned at any point of time during the trial period if ADRs of the new molecule are beyond the acceptable limits. For these reasons, the whole operation of clinical research is dangerously secretive. Of late, there is a sudden spurt in clinical research activity in India on account of two reasons. Firstly, the cost of clinical trials has become prohibitively expensive in developed countries whereas it is far cheaper in India and other developing countries. Increased awareness of the risks involved in testing of drugs under development has also led to a sharp drop in the number of human volunteers available in developed countries. Secondly, a stringent regulatory system governing clinical research is not in place in India yet. Thus, MNCs like Pfizer, GSK, Novartis and Novo Nordisk are already conducting human trials on a big scale. Apart from these giants, there are a large number of Indian and foreign CROs conducting human trials in different locations in the country.

In India, the government has been allowing only phase II and phase III trials of new molecules so far. The phase I trials are allowed in India only if phase I trials are already done in a different country and submitted the data here. Now there are reports to the effect that the phase I is also going to be allowed in India soon. MNCs, supported by leading industry associations have been putting pressure on the government for this relaxation for some time. Phase I trials are conducted on a small group of healthy volunteers for a short period. If the government thinks by allowing phase I trial can bring a lot more foreign exchange, it is fine. Before that the rules and the framework to regulate clinical research in the country should be in place. Otherwise, India could turn into a place of large scale human rights violation in the name of clinical trials. Already surreptitious trials are being conducted in various parts of the country by a large number of small time CROs on illiterate youngsters from slum areas. Many of these volunteers are either dying or seriously falling sick after a few months of trial. There is no system of tracking down these illegal operators and stopping them as they are operating with the support of certain unscrupulous medical practitioners. Ethics committees are either non existing at these clinical trial sites or are not functioning. What is shocking is the extreme slow pace at which the Union health ministry is moving to enact the law for clinical trials in the country. The ICMR Ethical Guidelines for Biomedical Research on Human Subjects has been with the ministry since the year 2000.