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Trial Registration Becomes Mandatory in India

Wednesday, June 17, 2009

All companies conducting clinical trials in India must now register those trials in a clinical trial registry set up by the Indian Council of Medical Research (ICMR).

The new rule, effective June 15, requires trial sponsors to register all trials in ICMR’s Clinical Trial Registry-India before they are initiated. Prior to this rule, it was only a recommendation that clinical trials be registered online with the Clinical Trials Registry (which launched in 2007) before patient enrollment began.

The Clinical Trials Registry was set up by the ICMR’s National Institute of Medical Statistics and funded by the Department of Science and Technology. It receives financial and technical support from the World Health Organization (WHO), WHO-SEARO (the WHO’s regional office for Southeast Asia) and the WHO India country office.

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