The Central Drugs Standard Control Organisation (“CDSCO”) has issued a Circular highlighting concerns regarding certain Fixed Dose Combination (“FDC”) drugs that were licensed for manufacture, sale, and distribution without prior evaluation of their safety and efficacy, as per the provision of New Drugs and Clinical Trial Rules (“NDCT”) 2019 under the Drugs and Cosmetics Act 1940. In view of public health and safety, the Authority has directed all State/ Union Territory (“UT”) Drugs Controllers to ensure that the unapproved / cancelled FDCs mentioned in the Annexure to the Circular (attached) are not allowed for manufacture, sale, and distribution in the Country.
The State/UT Drug Controllers have further been requested to review their approval process for such FDC’s and ensure strict compliance with provisions of the Act and Rules. Further, they have been urged to conduct investigation and take necessary action against violators, as per provision of New Drugs and Clinical Trial Rules (“NDCT”) 2019 under the Drugs & Cosmetics Act 1940.
Source: Central Drugs Standard Control Organisation
