India’s CDSCO Issues Compliance Deadline to Fixed Dose Combination Manufacturers

Posted 03 July 2013 | By Ansis Helmanis 

India's Central Drugs Standard Control Organization (CDSCO) issued a notice on 1 July 2013 to State Drug Controllers ordering all manufacturers of new fixed dose combination (FDC) products licensed locally before October 2012 without CDSCO permission to submit safety and efficacy data prior to 30 August 2013.

Manufacturers that fail to submit the data by the deadline run the risk of having their products banned from the market, CDSCO said. The notification is the second yet made to India's State Drug Controllers, who were first informed on 15 January 2013 that they needed to inform local FDC manufacturers that data must be submitted to CDSCO. However, "hardly any such manufacturers" have complied with CDSCO's request thus far, the regulator wrote. The new deadline would provide CDSCO with the more time to assess the data, it added.

CDSCO Notice on FDCs

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