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India Drafts Guidelines To Require CRO Registration Of Trials

This article was originally published in PharmAsia News

Executive Summary

India is considering a requirement that clinical research companies in the country register both themselves and the trials they run. The nation's health ministry has drafted guidelines for registration, intended in part to prevent unethical experiments on humans. Drug Controller General of India Surinder Singh said the draft, being reviewed by an internal committee, was drawn up in part with the World Health Organization and volunteering companies. The next step is for the guidelines to be presented to the Drugs Technical Advisory Board for approval, with the new rules expected to be in place before the new year. (Click here for more
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