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Regulatory News
29 March 2013
by Louise Zornoza

In Wake of Broader Concerns, India's DCGI Creates Panel to Investigate Drug and Trials Approvals

India's Drugs Controller General (DGC), in an order dated 26 March 2013, has convened a special committee to investigate allegations that the Central Drugs Standard Control Organization (CDSCO) did not adhere to "scientific requirements and … regulatory compliance" in four cases involving the approval of drugs and clinical trials. 

The order was issued at the request of the Parliamentary Standing Committee with oversight authority for the CDSCO. 

The committee's investigation is to focus on the approval of:

  • A fixed dose combination "not permitted in any developed country"
  • An appetite stimulant for children "without clinical trials and without consulting experts"
  • An oncology drug "without Phase II studies", and
  • Additional indications without deeming the product to be a new drug
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