New Delhi: The Drugs Technical Advisory Board (DTAB) has given its nod to a proposal to amend the New Drugs and Clinical Trials (ND & CT) Rules, 2019 to do away with two-step issuance of certificate for registration of ethics committee for biomedical and health research considering that better systems are in place in the Department of Health Research (DHR) for the process.
The Board, however, refused another proposal to amend the Rules to include the fee payable for registration and re-registration of ethics committees, observing that the activity of the ethics committee is not like a business entity.
As per the provisions of the ND&CT Rules at present, the ethics registry in the DHR issues provisional and final certificate in CT-03 form to each ethics committee who apply for Naitik portal for EC registration.
The rule 17 related to registration of ethics committee related to biomedical and health research, suggests that applications should be submitted form CT-01 to register with the authority in the DHR for approval and under sub-rule (3) of this rule, on receipt of the application, the authority shall grant provisional registration which shall remain valid for a period of two years.
Under sub-rule (4), after the grant of provisional registration under sub-rule (3), the authority designated under sub-rule (1) shall scrutinise the documents and information furnished with the application, and if satisfied that the requirements of these rules have been complied with, grant final registration to Ethics Committee in Form CT-03. It also adds that if the authority is not satisfied, shall reject the application, for reasons to be recorded in writing and the final registration in Form CT-03 shall supersede the provisional registration granted under sub-rule (3).
The DTAB, in its latest meeting held in August, considered an amendment to these sub rules. Both certificates are issued after review of applications, which is valid for two and five years consecutively.
It observed that now a system is in place in DHR for review, scrutinize the documents of all ethics committees, and review at both provisional and final stages of registration leads to duplication of efforts and resources which can be removed and only final certificates can be issued to the ethics committees directly.
The proposal is to delete the sub-rules (3) and (4) of the Rule 17, and modify it as “On receipt of application in Form CT-01 under sub-rule (1), the authority designated under sub-rule (1) shall scrutinise the documents and information furnished with the application, and if satisfied that the requirements of these rules have been complied with, grant final registration to Ethics Committee in Form CT-03; or if not satisfied, reject the application, for reasons to be recorded in writing.”
The Board, after deliberating the matter, agreed with the proposed amendment under ND & CT Rules, 2019.
However, it did not agree to another proposal to incorporate provision for inclusion of fee, which shall be chargeable in respect of application for registration, re-registration of ethics committee relating to clinical trial, bioavailability and bioequivalence study.
The fee payable for registration and re-registration of ethics committee is not mentioned in the ND & CT Rules, 2019 and the proposal was to make provision for inclusion of fee which shall be chargeable as per Sixth Schedule. The proposal was to impose Rs. 50,000 as fee for any other application not specified in the existing provisions, in respect of application for registration or re-registration of independent ethics committee relating to clinical trial, bioavailability and bioequivalence study, exempting institutional ethics committee of government institutes.
“DTAB deliberated the matter and did not agree with the proposed amendment under ND & CT Rules, 2019 as ethics committee discharge its duty to ensure rights, safety and wellbeing of the trial participants and it is not like as business entity,” said the Board in the minutes of the meeting.
However, it recommended for inspection of Ethics Committees along with experts under rules.
