MAHARASHTRA-On the Defensive

appear to be a populist issue of whether human trials are being conducted in the US as well. It is of course heartening that the premier medical research body is so very concerned with protecting Indian citizens from exploitation at the hands of the US medical establishment. Unfortunately, there is little reason to believe that the council is particularly concerned with the welfare of human subjects in trials conducted by the Indian medical establishment itself. It is of course a moot point whether merely by conducting human trials in the US as well the research proposal would become 'ethical'. As is evident from this case, there is no autonomous authority which monitors clinical research, including human trials in this country. The ICMR does have well formulated norms for human trials; however, these apply only when the council has been approached for directly funding the project or if the study is a large collaborative study requiring the government's (that is, the ICMR's) approval. This means small-scale experimentation involving human 'volunteers' is taking place in small and large institutions across the country without the ICMR ever knowing of it. Drug trials are to an extent covered by ICMR regulations under the Drugs and Cosmetics Act which require information to be given on trials for the licensing of new drugs or new uses of old drugs. However, the introduction of new surgical procedures, use of new equipment, new technologies and diagnostic aids is not monitored by any central autonomous authority. Speciality associations very occasionally take on this role of assessing procedures and monitoring their use, but not often. The entire responsibility of ethically assessing an experimental project and of monitoring it lies with the 'ethical committees' of the concerned institutions which, as has been pointed out, are more often than not dubious entities. The lack of ethical consideration in a project gets highlighted only if there is a failure or doubts are raised for other reasons.