The most costly part of new drug discovery is the three phase clinical research lasting for three to four years involving thousands of human volunteers and investigators in multi locations. Any of these potential drug candidates can be abandoned during the trial period if their adverse drug events are beyond the acceptable limits. It is certainly a high risk activity involving millions of dollars and pharmaceutical companies usually make sure that trial reports reaching the regulatory authorities are favourable. No new drug can be approved for marketing without submission of trial reports and their scrutiny by the regulatory authorities. Because of these reasons, the whole operation of clinical research is highly secretive. Apart from top MNCs like Pfizer, GSK, Novartis and Novo Nordisk, there are a large number of contract research organizations engaged in clinical trials in India for the last ten years. As thousands of human subjects are recruited for each drug trial, the regulatory authorities have a responsibility to monitor the trial locations. And it is for this purpose, the Schedule Y of the Drugs & Cosmetics Act stipulates the existence of an ethics committee at each trial site. But for many years, ethics committees have not been existing or non functional in India. It is this ineffectiveness of ethics committees that embolden the CROs and MNCs to carry out trials illegally endangering the lives of illiterate and ignorant volunteers.
The decision of the Drug Technical Advisory Board to make registration of ethics committees mandatory at its meeting early last month is in consideration of this state of affairs. There has been several complaints about the non functioning of ethics committees at most of the trial sites. It is this situation that has led to a sharp rise in the number of cases of trial related deaths and injuries in the country during the last five years. Currently, ethics committees are constituted by the pharma companies or CROs intending to conduct trials but they are not required to be registered. For starting any clinical trial, the approval of the ethics committee is necessary as without which the DCGI do not permit the study in the country. But the ethics committees are not found to be responsible once the approval is given. No periodic meetings with investigators are called and no critical assessment of data is made. And there is no monitoring of the functioning of the ethics committee by the office of DCGI. The need to streamline activities of ethics committees is extremely urgent considering the growing number of clinical trials taking place in the country. Making registration of ethics committees is an extremely critical step and needs to be strictly enforced without any delay.