Indian Regulators Say Older Fixed-Drug Combinations Can Stick Around Under New Rules

India’s Central Drugs Standard Control Organization (CDSCO) has issued a notice exempting certain Fixed Dose Combination products (FDCs) from a requirement to submit data in support of safety and efficacy as long as they were licensed for marketing by State Licensing Authorities prior to 21 September 1988.  

The 5 June 2014 decision to exempt these FDCs from the scope of the CDSCO’s 15 January 2013 mandate was based on the fact that the products were licensed before the requirements governing new drugs were included in India’s Drugs and Cosmetics Rules. 

The decision effectively grandfathers such FDCs from the scope of the Drugs and Cosmetics Rules.

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