The QMN Weekly Bulletin
Pharmaceuticals / Regulatory Affairs / Submissions and Approvals

India Takes Steps to Control Flood of Unapproved FDC Products

Jan. 3, 2014

India’s Parliamentary Standing Committee on Health and Family Welfare is taking the next step in its effort to regulate the more than 5,000 unapproved fixed dose combination (FDC) products on the market in the country, calling for recommendations from technical experts.

Earlier this year, makers of unapproved FDCs were asked to provide India’s Central Drugs Standard Control Organization (CDSCO) proof of safety and efficacy within 18 months or face withdrawal from the market.

Following the notice, the Drug Controller General of India received a flood of responses and many were found to have little-to-no therapeutic justification for being marketed.

In answering the standing committee’s call for help, India’s Drug Technical Advisory Board has urged the formation of a sub-panel that will be headed by B. Suresh, president of the Pharmacy Council of India, to suggest ways Indian authorities can bring unapproved drug products into compliance or remove them from the market altogether.

The standing committee’s call builds on newly published guidelines for manufacturers and importers of FDCs, creating four categories and providing information drugmakers should include in their product applications.

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