One of the major unethical practices existing in clinical research in the country today is the dubious way the subjects are procured for trials. For most of the trials, subjects are brought by agents engaged by the pharmaceutical companies or contract research organizations. Usually these subjects are illiterate and people living in slums and other backward  locations of urban and semi urban areas. These subjects are made to sign the consent forms by the agents without clearly conveying to them what is in the form. They are unaware about what kind of injuries they will be suffering during and after the trials and what compensation they are entitled for that. Ignorance of the trial subjects and  the ineffectiveness of the ethics committee at the trial sites have been helping  the companies and CROs to conduct clinical research without much hassles in the country. It is this situation that has caused several deaths and fatal injuries during trials during the last few years. An inquiry conducted by the Union health ministry in May 2011 half revealed that 671 deaths were reported during trials in 2010 and only in three cases, some compensation was given to the relatives of the victims. The ministry had then sought clarifications from 44 pharmaceutical companies on the compensation given by them for trial deaths. Top multinationals such as Eli Lilly, Novartis, Pfizer, Bayer, Merck, Johnson & Johnson, sanofi aventis and others who conduct clinical trials for some years have given the standard explanation that deaths were due progression of underlying diseases of the trial subjects.

While it is important that clinical trials need to be allowed in India, it has to be fair, transparent and least exploitive of the ignorant people. Now with a view to curb the practice of procuring illiterate subjects and making them sign the consent form, the Union health ministry is planning to amend the Schedule Y of the Drugs & Cosmetics Rules to make audio/video recording of the informed consent process in clinical trials mandatory. The amendment also seeks to ensure that the trial subjects are adequately informed about the failure of investigational products. The whole process is going to be made transparent and the investigator has to maintain it for record. The Drugs Technical Advisory Board has already given its approval to the proposal of the CDSCO to amend Schedule Y and to insert a new clause into the Schedule. The purpose of the amendment is to ensure proper care is taken to inform the subject about the pros and cons of the clinical trial and to place on record the participation of the subject is voluntary. As the comprehensive bill for Ethical Guidelines for Biomedical Research on Human participants is yet to be made into an Act, the CDSCO has to be vigilant enough to keep on bringing necessary amendments to D&C Act for protecting Indian public from exploitation by unscruplous business interests.