Curbs on drug trials

Published: Thursday 31 January 2002

all institutions in the country have been banned from carrying out clinical trials on a new drug without the permission from the Drugs Controller General of India (dcgi). This directive was issued by the government recently. It will cover both clinical investigations and clinical experiments. Trials, including those of private research organisations, are now under government control. The regulation aims to streamline and expedite approval procedures for the manufacture and import of new drugs. If an applicant fails to meet the conditions of approval, under the amended rules his permission can be revoked or suspended. The amendment also prescribes forms and approvals for making applications to get nod for trial of a new drug to the dcgi.

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