Draft rules scrap provisional ethics committee registration stage

Health Ministry proposes removing provisional registration for ethics committees, shifting to single-stage approval to streamline clinical research and cut regulatory delays

In a move aimed at simplifying the ease of doing business, the Union Health Ministry has proposed a draft amendment to eliminate the requirement of a provisional registration certificate for ethics committees involved in biomedical and health research. Earlier, all ethics committees were required to obtain a provisional registration certificate valid for two years, which was subsequently replaced by a final registration certificate after further scrutiny by the Department of Health Research (DHR).

 

The draft amendment to the New Drugs and Clinical Trials (NDCT) Act, 2019 proposes to omit the provisional certification and will allow ethics committees to skip the provisional certificate and straightaway go for a final registration, saving time and not allowing non-compliant committees to work even for a provisional period if they fail the scrutiny process.

 

 

“On receipt of application in Form CT-01, the designated authority 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 draft amendment stated.

 

Industry executives noted that the step removes the requirement of provisional registration for Ethics Committees under the Clinical Trial Rules and shifts the system from a two-stage approval process to a single, final registration after scrutiny.

 

“This provides for a clear regulatory transition to one application, one review, one decision,” an executive said.

 

The draft amendment will be taken into consideration on or after the expiry of a period of 30 days from the date on which the copies of the Official Gazette containing the draft rules are made available to the public.

 

Objections and suggestions that may be received from any person within the period will be considered by the Central Government, it added.

 

Rishi Agrawal, chief executive officer (CEO) and co-founder of software compliance firm Teamlease Regtech, said that the proposed amendment reduces procedural layering and lowers regulatory friction by bringing greater clarity to the framework.

 

“At the same time, compliance is now front-loaded, requiring Ethics Committees to demonstrate full regulatory capacity at the outset, with no interim operating window,” he added.

 

In the short term, this may slow the activation of trial sites and temporarily increase friction during the transition phase, as full verification must be secured upfront. “However, once approved, the regulatory position becomes stronger and more defensible, lowering downstream risk for sponsors and institutions,” Agrawal said.

 

The move comes at a time when the Centre has, in recent days, significantly modified the NDCT Act through various amendments regarding the manufacturing of small quantities of drugs intended for examination, research, or analysis purposes to reduce regulatory burden and promote Ease of Doing Business (EoDB).

 

It said that these amendments are aimed at simplifying regulatory processes, reducing approval timelines, and enabling faster conduct of clinical research and pharmaceutical development in the country.

 

Last week, the ministry proposed amendments categorising the post-approval changes of new drugs, both imported and manufactured in the country, based on the impact of the changes on the quality of the drug.

 

It also proposed changes in the rules to ease the process of approval for manufacturing of a new drug or investigational new drug for analytical and non-clinical testing, and to reduce the timeline for approval of manufacturing of a new drug or investigational new drugs for tests.

 

In another step to expedite clinical research, the requirement of obtaining prior permission for certain categories of low-risk bioavailability/bioequivalence (BA/BE) studies has been dispensed with. Such studies may now be initiated on the basis of a simple online intimation to the Central Drugs Standard Control Organisation (CDSCO), enabling faster commencement of studies, particularly for the generic pharmaceutical industry.