All new clinical trials of drugs or devices conducted in India must be registered through the Indian Council of Medical Research (ICMR), the Drugs Controller General of India said. The requirement applies to clinical trials that began after June 15, 2009.
Mandatory clinical trial registration was announced some time ago, Saurendra Das, India country head for Excel Life Sciences and director of operations, said.
The Clinical Trials Registry- India (CTRI) has been set up by the ICMR’s National Institute of Medical Statistics (NIMS) and is funded by the Department of Science and Technology (DST) through the Indian Council of Medical Research (ICMR). It also receives financial and technical support through the WHO, WHO-SEARO, and the WHO India Country office.