India – CDSCO Creates Process for Companies That Lack Data Supporting Their FDCs

India’s Central Drugs Standard Control Organization (CDSCO) has established an authorization process for fixed-dose combinations (FDCs) that came to market despite lacking the required data. CDSCO’s process covers FDCs that require either a Phase IV trial or active surveillance to stay on the market.

In its assessment of hundreds of FDCs that came to market via a back door, India identified 278 drug combinations that may be rational but are supported by insufficient data. CDSCO originally planned to require all manufacturers of these FDCs to perform Phase IV clinical trials but, following feedback from industry, has since limited its requirements for some products to active surveillance…