After amending the Drugs and Cosmetics (D&C) Rules to give clarity to the compensation issue and requirements of getting permissions for the trials, the Health Ministry will soon notify the rules to make advance registration of ethics committees mandatory.
The Government had already issued a draft notification sometime back and now the final notification would come soon to amend the D&C Rules and insert the required provisions in this regard.
Advance registration of ethics committees attached with the clinical trial organizations for conducting trails would stop the practice of sponsors setting up the panels with people of their own choice. Such committees, it has been reported in many cases, end up less active and not independent, thus affecting the quality of trials.
Though prior approval of the ethics committee is required to get the permission for the trials, the registration of the committees is not mandatory as per the existing rules. The notification is expected spell an active role to the ethics committees which will be forced to monitor the trials and hold inspections at the sites regularly.
According to the draft notification, issued by the CDSCO sometime back, “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 move to make the registration of ethics committee mandatory was taken way back in October 2011 by the Drugs Technical Advisory Board (DTAB), the highest decision-making body under the Union health ministry on technical matters.
As per the draft, an application for registration of ethics committee shall be made to the licensing authority in accordance with the requirements prescribed in Schedule Y-I. The licensing authority after being satisfied that the requirements of the rules have been complied with and the conditions of the registration will be observed, may grant registration subject to the condition stated therein.
The proposed rule would also make provisions for the CDSCO teams to inspect the ethics committee and issue warning letters or even cancelling the registration in case some violation of rules are found out during the inspections.