Early this month, a leading financial daily reported the Union health ministry’s inquiry into the ways in which pharmaceutical giants are conducting clinical trials in India. The probe revealed that these companies have not given compensation to majority of the volunteers who died during the course of trials. Of the 671 deaths recorded during trials in 2010, the ministry has evidence of just three cases of offering compensation. The ministry has 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. Therefore, they are not bound to pay any compensation. MNCs and CROs know very well that there are no competent consumer action groups and well informed judiciary to take them to task on such offences. Responses from them are not totally unexpected as the ministry has no records to counter their stand. The basic problem with the clinical research in the country is that it is not at all effectively regulated. The health ministry has been  working for last ten years to put in place a set of comprehensive rules to regulate clinical research with huge flow of contract research jobs into the country. But that has not happened yet. India only has a set of guidelines after amendment of the Schedule Y of Drugs & Cosmetics Act and they are not notified. That emboldens the MNCs and CROs to conduct trials as they do it now.

ICMR's Ethical Guidelines for Biomedical Research on Human participants, 2006 have specified the need for a provision for compensation to participants for research related injuries. In October 2008, ICMR had invited comments from the experts on the draft guidelines as a step before notifying them. The draft guidelines apply to all kinds of clinical research, whether sponsored by the pharmaceutical or medical devices industry, government or academia or individual investigators. As per the guidelines, compensation should be provided to the research participants when temporary or permanent injury occurs in the clinical research and also when injury is caused by a procedure which has been undertaken to manage an adverse reaction occurring during the research. The guideline proposes compensation to the participants irrespective of whether injury was foreseeable, predictable or not. How long the government will take these guidelines to notify them as law is some thing to be seen. In the meanwhile what needs to be done immediately is to activate monitoring of trials. Currently, monitoring of  trials at various sites in the country is hardly done once the permission for conducting trials is granted. This is a critical area of neglect on the part of the office of DCGI. All trial sites are expected to have ethics committees to oversee the trials. But hardly the ethics committees have any control on the trial centres or on the sponsors. Therefore, unless operations of ethics committees are strictly monitored, avoidable deaths and injuries during trials are bound to continue.