The Drug Controller General of India (DCGI) has initiated a nationwide effort to tackle unapproved Fixed Dose Combinations (FDCs). A letter has been circulated to state and Union Territory drug controllers, urging them to assess 90 FDCs based on their generic names to determine whether they have received the necessary approvals. Among the questionable drugs listed are multivitamins, folic acid preparations, syrups, Paracetamol, Clotrimazole, Betamethasone Cream, Diclofenac Potassium, and Dicyclomine Hydrochloride Tablets.

Concerns Over Public Health and Compliance with Regulatory Standards

The letter cites findings from the SUGAM lab testing data for the year 2025, detailing that a significant number of FDC samples have been flagged as unapproved and categorized as ‘New Drugs.’ The communication emphasizes that no new drug can be manufactured for sale unless it has been sanctioned by the Licensing Authority, in accordance with Rule 3 of the New Drugs and Clinical Trial Rules, 2019. Additionally, Rule 80 mandates that any entity wishing to manufacture a new drug must submit an application to the Central Licensing Authority, accompanied by the pertinent fee as outlined in the Sixth Schedule.

Call for Regulatory Action Against Non-Compliant Manufacturers

The presence of these unapproved drugs in the supply chain raises serious concerns about public health and safety. It highlights violations of the Drugs and Cosmetics Act of 1940 and corresponding rules. The DCGI letter calls for immediate investigations and regulatory actions to be taken against the manufacturers and marketers involved, emphasizing the need for strict monitoring and enforcement to prevent the manufacture, sale, and distribution of such unapproved drugs.

Urgent Request for Compliance and Reporting

In light of the implications for public interest, the drug regulator has classified the situation as a significant concern. The letter requests that, should manufacturers have submitted any New Drug permissions as required by Rule 83 of the NDCT Rules, 2019, a copy of such documentation should be provided. Furthermore, regulatory bodies are instructed to submit an action taken report (ATR) to the DCGI’s office at the earliest possible opportunity. The matter has been designated as a top priority to safeguard public health.

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