India’s Drug Regulator Proposes to Hasten Trial Approvals

June 5, 2018

India’s Central Drug Standard Control Organization (CDSCO) plans to approve new rules for clinical trials in a few months that will reduce the approval time for applications, a senior official said.

The new rules — which will speed up approval time for application reviews to between 30 to 60 days — are intended to stimulate clinical research in the country, which has slowed down in recent years, Ranga Chandrashekhar, a deputy drugs controller at CDSCO, said at a Mumbai pharmaceutical conference.

Chandrashekhar said CDSCO has already received comments from stakeholders on its draft and it expects to finalize the rules in about two months.

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