India's CDSCO board recommends Phase III drug trial waivers for 'well-regulated' therapies

SINGAPORE--India's Central Drugs Standard Control Organization (CDSCO) has recommended new guidelines for Phase III trial drug trial waivers via the Drugs Technical Advisory Board. The organization said waivers could be granted for therapies approved for marketing in "a well-regulated country"--such as the U.S. or those in the European Union--so long as a four-year post-marketing surveillance plan was also approved.

The CDSCO would obtain input from experts in the therapeutic area prior to any waiver for which the drug is indicated.

The board's recommendation is along the lines of suggestions made by an earlier committee that was tasked with overhauling the drug regulatory system in India. At the time, India's Health Ministry countered that such a waiver should be limited to national health emergencies and for drugs targeting rare diseases.

- here are the meeting minutes