As of 15 June, all clinical trials conducted in India will have to be logged in the clinical trials registry set up by the Indian Council of Medical Research (ICMR).

The new rule is aimed at improving the transparency and accountability of clinical research in India at a time when the sector’s headlong growth has been soured by allegations of lax supervision and questionable practices by sponsors, investigators, contract research organisations and ethics committees.

Previously the Directorate General of Health Services only recommended that clinical trial applicants should register their studies online with the Clinical Trials Registry-India (CTRI) at before they started enrolling patients.

Explaining the shift to mandatory registration in a letter to the ICMR last month, Drugs Controller General Dr Surinder Singh cited the “accelerated growth” in the number of clinical trials run in India over the last five years “because of several inherent advantages available in the country”.

Logging studies in a publicly accessible registry was “very important as it improves the accountability of the stakeholders and also ensures that key information about the clinical trial is made available to the public”, he said.

Launched in July 2007, the ICMR’s clinical trial registry was developed by the Council’s National Institute of Medical Statistics in collaboration with the World Health Organization (WHO) and the Indian Department of Science and Technology.

It incorporates the 20 items endorsed by the WHO International Clinical Trials Registry Platform (WHO-ICTRP) and the International Committee of Medical Journal Editors (ICMJE), as well as more nationally specific criteria such as ethics committee approval status and regulatory clearance by the Office of the Drugs Controller General.