All ongoing clinical trials of medicines to be made public: RegulatorMarch 13th, 2009 - 3:56 pm ICT by IANS
Ahmedabad, March 13 (IANS) The office of the Drug Controller General of India is preparing a list of all the clinical trials currently being carried out by contract research organisations (CROs) across the country and plans to make them available online, an official said here.
The registration of the CROs will become mandatory by June once the guidelines for adhering to the standard norms of conducting trials are approved by the Drug Control Committee and Drug Technical Advisory Board, Drug Controller General of India Surinder Singh said Thursday.
“In our audits carried out at several CROs in India, it was found that they are not adhering to the standard global practices on conducting clinical trials. We have decided to take stern action against such organisations,” he said while attending an exhibition of pharmaceutical products at the Gujarat University Convention Hall here.
Singh said not just the CROs but their sponsors and clinical research associates would also face action if they are not found to be adhering to standard global practices while conducting clinical trials.
India is the fourth largest market for clinical trials globally, he added.
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