India Releases Guidelines for Approval of Fixed Dose Combinations
India's Central Drugs Standard Control Organization (CDSCO) has released guidelines governing the policy for approval of fixed dose combination (FDC) drugs.
The CDSCO had previously issued a notice on 1 July 2013 to State Drug Controllers alerting them that manufacturers of new FDC drug products licensed without CDSCO authorization before 1 October 2012 must submit safety and efficacy data to the CDSCO by 30 August 2013.
Manufacturers were warned that failure to submit the data by the set deadline could result in a ban on further manufacture and marketing of their products. The guidance now provides the information needed by FDC manufacturers as well as local regulators to comply with the CDSCO July notice.