Even as the inclusion of Schedule Y-1 on clinical trials sector is pending for notification, the Health Ministry is now planning to incorporate another schedule, Y-2, to the Drugs and Cosmetics (D&C) Rules on making the registration of Ethics Committees mandatory.
The office of the Drugs Controller General of India (DCGI) has already issued notice to make the registration of ethics committees attached to the clinical trial organizations mandatory for conducting trials. However, by bringing a new schedule, the ministry wants to make it as part of the D&C Rules for strict adherence, sources said.
Apart from the registration, the rules pertaining to the quantum of compensation in case of trial related injury or death to be decided by Ethics Committee will also be included under the Schedule. In this regard also, the DCGI had issued guidelines already. The proposal had been cleared by the Drugs Technical Advisory Board (DTAB), sources said.
With Schedule Y, with sections of 1 and 2 in place, the entire gamut of clinical trial activities would be streamlined under rules. At present, the sector is regulated by the instructions and guidelines issued by the DCGI. The amendment to the D&C Rules will make them statutory laws. The rules will also be framed to give full authority to CDSCO for inspections and take administrative actions including cancellation of the approval, among other things.
A draft notification, issued by the CDSCO in August 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.”
Meanwhile, the inclusion of Schedule Y-1 is still pending, after the Minister published the draft rules inviting suggestions from the stakeholders. The Ministry then constituted a committee having balanced representation of all stakeholders to finalise the rules.
The main feature of the amendment is the insertion of Schedule Y1 which covers 'all organisations, individuals, institutions, and companies that take the responsibility of conducting clinical trials including those who seek permission for clinical trial from licensing authority'.