ICMR replaces old system with single window approval for medical studies

The Indian Council of Medical Research (ICMR) has overhauled the ethics approval process for multicentre medical studies by replacing a fragmented, site-by-site system-a significant change that could help reduce timelines and expand the reach of medical research across the country.

The previous process had caused months of delays in the process and kept large parts of the country and its most vulnerable populations out of large-scale research.

The new guidelines are effective immediately.


For years, multicentre research in India meant large studies running simultaneously at multiple sites, mostly institutional centres in Delhi, Mumbai and other metros, each with its own version of the protocol, ethics committee and little coordination with the others. The result was inconsistent data, duplicated paperwork and research that struggled to generate the kind of robust, population-level evidence India needs to shape health policy.

"Implementing single ethics review for multicentre research will bring a transformation in the research ethics ecosystem and contribute to the vision of a Viksit Bharat," ICMR Bioethics Unit head Roli Mathur said.

The reform, long demanded by the research and pharmaceutical industry, is expected to dramatically reduce approval timelines, lower compliance costs and make India a more competitive destination for global clinical research.

A multicentre study will now need just one ethics approval.

According to the new guidelines, a single committee based at the lead institution running the study will review the protocol and clear it for all participating sites. Every hospital involved will be bound by that decision.

"The research protocol must clearly provide detailed site-specific ethical considerations for protection of research participants and sensitivity to local requirements," Mathur said.

By streamlining processes, the initiative positions India to deliver what is required for its people: evidence-based solutions that improve health, strengthen public trust and contribute meaningfully to national development, said ICMR director-general Rajiv Bahl.

Community health centres, field sites and rural outreach locations which previously could not participate in multicentre research because they lacked their own ethics committees can now be included under the single approval. This opens the door to research that better reflects India's diverse population.

The council acknowledged the greater responsibility that the new model places on the designated ethics committee, which must now oversee research quality and participant safety across all sites.

Getting a medical study approved in India used to mean running the same paperwork through every hospital involved, sometimes dozens of committees, the same protocol reviewed repeatedly, often with different outcomes at each site.