In October last year, the Drugs Technical Advisory Board, had taken a significant decision to make registration of Ethics Committee mandatory for clinical trials in the country.  The DTAB's decision came in the wake of widespread complaints that the Ethics Committees at most of the clinical trial sites are not independent and also not active with no monitoring of trials. It is this situation that led to a steep rise in trial related deaths and injuries in the country during the last five years. 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, an Ethics Committee needs to be set up as without which the DCGI does not permit the trials 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. 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 insists on 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.

Now, early this month DCGI issued a notification making registration of Ethics Committee for conducting clinical trials mandatory in the country. The notification clearly states that no ethics committee shall review and accord its approval to a clinical trial protocol without prior registration of the committee with the licensing authority as defined in clause (b) of rule 21. The notification further says that an application for registration of ethics committee shall be made to the licensing authority in accordance with the requirements prescribed under Schedule Y-I. The licensing authority after being satisfied that the requirements of the rules having been complied with may grant registration subject to the condition stated therein. The registration of the ethics committee is valid for a period of five years from the date of issue. Proper functioning of ethics committees and their periodic monitoring is extremely urgent considering the growing number of clinical trials taking place in the country. Now what is required is regular supervision of the operations of ethics committees by the office of DCGI. Unless such a mechanism is in place, registration makes no sense.