Clinical research is being touted as a great business opportunity for India by most of the leading chambers of commerce and industry, international consultancy companies and country's pharma industry associations for some time now. These organizations are aggressively promoting the idea across the country through seminars and conferences. Such sustained business campaigns has not only attracted a stream of contract research organizations from the US and Europe but has also triggered mushrooming of a large number of local CROs in the country over the years. The shift of clinical trial business from the US and Europe to India and some other developing countries is not without reasons. Increased awareness of the risks involved in testing of drugs under development has led to a sharp drop in the number of human volunteers available there for this activity. This is despite huge sums of money offered by the MNCs and CROs to the volunteers. At the same, easy availability of human volunteers for trials at a far cheaper costs in India is a major attraction. Diversity of India's large patient pool is yet another attraction that pulls MNCs and CROs to this country. Besides all these, there is an overall increase in the number of compounds being tried on humans with the approval process of new molecules by US FDA becoming very stringent since 1996.
Clinical research is the most expensive and critical phase of drug development process for any pharmaceutical company. It is inevitable because without a three phase human trials, no new drug can be approved and it is expensive as it involves participation of thousands of subjects and investigators in multi locations for years. And new molecules may have to be abandoned at any point of time during the trial period if ADRs of a molecule are beyond the acceptable limits. For these reasons, the whole operation of clinical research is dangerously secretive. MNCs like Pfizer, GSK, Novartis and Novo Nordisk have been already conducting human trials for some years now. Apart from these, there are a large number of Indian and foreign CROs conducting human trials in India. As there is a perennial urgency to have a favourable trial report, pharma companies and CROs try to manage the same with the support of the medical practitioners. Each clinical trial site is expected to have a functioning ethics committee but it either hardly exists or functions. But what is shocking is surreptitious trials being conducted by a large number of small time CROs on illiterate youngsters from slum areas. Unethical and illegal clinical trials are most rampant in the country and are conducted without fear as there is no law to safeguard the interests of volunteers. 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. The government has to evolve a mechanism to detect such criminals in the country. The ICMR Ethical Guidelines for Biomedical Research on Human Subjects has been in place as early as 2000. It is not still made into a law. Now an attempt is being made to modify these Guidelines by adding two chapters. It is high time the government should have made the ICMR's Ethical Guidelines into an Act to commence an effective regulatory monitoring in this segment.