India orders nationwide review of 90 unapproved drug combinations

The Drug Controller General of India (DCGI) has directed a nationwide review of 90 fixed-dose combinations (FDCs) suspected to be unapproved, asking state and Union Territory regulators to verify their legal status and take action where necessary.

The list includes commonly used formulations such as multivitamins, folic acid preparations, cough syrups, paracetamol-based combinations, clotrimazole and betamethasone creams, and diclofenac potassium with dicyclomine hydrochloride tablets.

The move follows analysis of 2025 SUGAM portal data, which found a large number of FDC samples classified as “new drugs” without mandatory central approval. Under the New Drugs and Clinical Trial Rules, 2019, such products cannot be manufactured or sold without clearance from the Central Licensing Authority.

Regulators have been asked to determine whether any approvals were granted at the state or UT level and to initiate investigations against manufacturers and marketers found in violation.

The presence of unapproved drug combinations in the supply chain has been flagged as a serious public health concern, with authorities pointing to risks arising from non-compliance with the Drugs and Cosmetics Act, 1940.

Officials have been instructed to prevent further manufacture, sale and distribution of such drugs and to submit action taken reports at the earliest, as the issue has been given top priority.