Registration of Ethics Committees becomes mandatory for clinical trials
August 07, 2012, 0800 IST – Source : Pharmabiz.com
Registration of Ethics Committees attached with the Clinical Trial Organisations (CROs) for conducting clinical trials has been made mandatory in the country by the Drugs Controller General of India (DCGI).
A draft notification, issued by the Central Drugs Standard Control Organisation (CDSCO), said, “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”.
Earlier in October last year, the Drugs Technical Advisory Board (DTAB), the highest decision-making body under the Union health ministry on technical matters, had taken the decision to make registration of Ethics Committees mandatory in the country for clinical trials. 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 the trials by the authorities.
So far, only the registration of clinical trials with the drugs controller general of India (DCGI) is mandatory in the country. Independent ethics committees are constituted by the individual companies and its registration is not mandatory. For starting any clinical trial, the approval of the ethics committee is crucial as without which the DCGI will not provide his sanction for beginning the study in the country.
As per the notification, 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 ethics committee will review and accord its approval to a clinical trial as per Schedule Y, the Good Clinical Practice Guidelines for Clinical Trials in India and other applicable regulatory requirements for safeguarding rights, safety and well being of the trial subjects.
The ethics committee shall allow inspectors/officials of CDSCO to enter the premises of the committee to inspect any record, data, document etc. related to clinical trial and provide adequate replies to any queries raised by the inspecting authority in relation to the conduct of clinical trial. The registration, unless it is sooner suspended or cancelled, shall be valid for a period of five years from the date of issue.
If the licensing authority is not satisfied, he shall reject the application and shall inform the applicant of the reasons for such rejection and the conditions which must be satisfied before the registration can be granted. If the ethics committee fails to comply with any of the conditions of registration, the licensing authority may after giving an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons therefore, suspended or cancel the registration of the ethics committee for such period considered necessary.
The ethics committee whose registration has been suspended or cancelled by the licensing authority may within ninety days of the receipt of the copy of the order by him prefer an appeal to the central Government and the central Government may, after giving an opportunity of being heard, confirm, reverse or modify such order, the draft notification said.