Indian Government Bans 35 Fixed-Dose Combination Drugs

Raising red flags over patient safety, India’s top drug regulator has instructed state and union territory authorities to immediately halt the production and distribution of 35 unauthorized fixed-dose combination (FDC) drugs. These combinations, in general use nationwide, allegedly had no obligatory evaluation and central regulatory authority approvals.

The directive was released in April 2025 by the Central Drugs Standard Control Organisation (CDSCO) citing serious concern over the potential health dangers posed by these unapproved mixtures. The list in question includes commonly used medications that combine antidiabetics, antibiotics, antihypertensives, fertility drugs, multivitamins, and pain relief formulations.

In its official communication, the CDSCO emphasized that these FDCs were licensed for sale without prior examination of their safety or efficacy, a clear violation of the New Drugs and Clinical Trials (NDCT) Rules, 2019, and the Drugs and Cosmetics Act, 1940. The letter, issued by the Directorate General of Health Services (FDC Division) from FDA Bhawan, labeled the matter as “urgent and serious.”

Fixed-dose combinations are drugs that contain two or more active pharmaceutical ingredients in a set ratio. Though they can improve treatment outcomes and simplify dosing schedules, regulatory clearance is essential before such drugs can enter the market. The CDSCO emphasized that such products, when classified as "new drugs," need clear central approval before they can be manufactured.

Curiously, this is not a recent issue. As early as 2013, the Drugs Controller General of India (DCGI) had raised similar cases of unauthorized FDCs getting cleared by state licensing authorities without adequate scrutiny. In spite of various reminders over the years, most recently in February 2025, noncompliance continues to be a recurring problem.

After the recent order, CDSCO requested state and UT drug controllers to take prompt action: review their procedure for clearing FDCs, cancel licenses for the 35 unapproved formulations, make thorough investigations, and send detailed reports to the central office. The order also directs regional drug enforcement offices—zonal, sub-zonal, and port-level—to coordinate closely and ensure consistent implementation.

The circular stresses that patient safety is at serious risk due to the lack of scientific validation of these drug combinations. Adverse effects, harmful drug interactions, and unpredictable therapeutic outcomes are among the potential dangers cited. Dr. Rajeev Raghuvanshi, the DCGI at present, emphasized again that such failures in drug regulation erode public confidence and compromise health results across the country.

The companies that received show-cause notices have contended that their clearances were done by state governments, and thus they did not violate any legal procedures. The CDSCO, however, has indicated that such a defense pinpoints a wider issue: non-uniform application of national drug laws by states, which has enabled inconsistencies to remain.

To support accountability, a comprehensive annexure of the 35 unauthorized FDCs was appended with the notice. These combinations were either voluntarily withdrawn by manufacturers or had their licenses cancelled by State Licensing Authorities (SLAs) after regulatory intervention.

The agency has made it clear that moving forward, any FDC qualifying as a new drug will not be allowed into the market unless it undergoes comprehensive safety and efficacy evaluation by central authorities.

(Input from various sources)

(Rehash/Sai Sindhuja K/MSM)