FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

India to Waive Required Clinical Trials for Drugs Approved in ICH Countries

Jan. 31, 2017
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India’s Drugs Technical Advisory Board agreed to two conditions that would allow sponsors to waive the necessary local clinical trials for drugs that have already been approved in countries included in the International Council for Harmonisation, covering the U.S., Europe and Japan, among others.

The board is requiring that India’s Central Drugs Standard Control Organization perform inspections of batches manufactured for regulatory approval.

Additionally, bioavailability and bioequivalence studies of the new drugs, including of parenteral preparations manufactured for the first time in India, will be required. It may also be confirmed that the drug is being marketed in its country of origin, according to minutes from the board’s meeting.

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