Regulator mandates full review of globally unapproved drugs

New Delhi: Pharma companies cannot use the participation of Indian subjects in global clinical trials as a shortcut to get local marketing permission for new drugs that are not approved anywhere in the world.

Technical Panel

India's central drug regulator said any new drug not yet approved anywhere in the world must undergo the full regulatory process here, regardless of whether Indian patients participated in the global trial. In a circular dated August 10, the Central Drugs Standard Control Organisation (CDSCO) observed a rise in applications from companies to import and market new drugs that are either still under review by foreign regulators or have completed phase III global clinical trials with Indian subjects participating.

The matter was examined by CDSCO's internal technical committee, and after detailed deliberations, it opined that such investigational new drug (IND) applications, which are under review by foreign regulatory authorities, are required to be processed by the IND division of the CDSCO, the regulator said.

"The drug will have to go through the full regulatory process, the same scrutiny applied to any new drug seeking entry into the Indian market. The clarification sets a clear boundary. Companies cannot use the participation of Indian subjects in a global trial as a shortcut to market approval in India," said an official. "These applications require a comprehensive evaluation of non-clinical and clinical data in accordance with the provisions of the NDCT Rules, 2019," the regulator said.

It said all such applications will be examined and processed by the IND division under the New Drugs and Clinical Trials Rules, 2019. This move means any new drug cleared through this route must be thoroughly evaluated for safety and efficacy before reaching Indian shores, rather than being approved based on trials conducted elsewhere, the same official said.