National, March 23: The Drug Controller General of India has initiated a nationwide review of 90 fixed-dose combinations (FDCs) suspected to be unapproved, directing regulators across states and Union Territories to verify their legal status and take necessary action.
The identified formulations include widely used products such as multivitamins, folic acid supplements, cough syrups, paracetamol-based combinations, clotrimazole and betamethasone creams, as well as diclofenac potassium with dicyclomine hydrochloride tablets.
The directive follows an analysis of 2025 data from the SUGAM portal, which revealed that several FDC samples were being classified as “new drugs” despite lacking mandatory central approval. Under the New Drugs and Clinical Trial Rules, 2019, such products cannot be manufactured or marketed without clearance from the Central Licensing Authority.
Authorities have asked state and UT regulators to examine whether any approvals were granted at the local level and to launch investigations against manufacturers and marketers found violating norms.
Officials have raised concerns over the continued presence of unapproved drug combinations in the supply chain, warning that it poses significant public health risks and may breach provisions of the Drugs and Cosmetics Act, 1940.
Regulatory bodies have been instructed to immediately halt the manufacture, sale, and distribution of such drugs and submit action taken reports at the earliest, as the matter has been accorded top priority.
