Nation

IIE DIGITAL DESK : In a major move aimed at strengthening drug safety in India, the central government has officially banned the manufacture, sale, and distribution of 35 fixed-dose combination (FDC) drugs. The decision comes after a thorough review by an expert committee which found that these combinations lack therapeutic justification and could pose serious health risks to the public.

Fixed-dose combinations refer to two or more active pharmaceutical ingredients combined in a single dosage form. While they are often prescribed for convenience, many have not undergone sufficient clinical trials or safety assessments. The recently banned drugs include commonly used medications in categories such as pain relief, anti-diabetic treatment, and nutritional supplements.

According to the notification issued by the Union Health Ministry, these FDCs were approved by various state licensing authorities without proper evaluation from the Central Drugs Standard Control Organisation (CDSCO). The ministry has acted on the recommendation of an expert panel that reviewed the safety, efficacy, and therapeutic rationale of these combinations.

Officials emphasized that this ban is part of an ongoing effort to ensure that only scientifically vetted and safe medications remain in circulation. The ministry has instructed all state drug controllers to withdraw the licenses issued for these FDCs and ensure compliance at manufacturing and retail levels.

Healthcare professionals have been advised to stop prescribing these combinations and instead recommend safer, approved alternatives. Patients currently on these medications should consult their doctors immediately for guidance and alternate treatment plans.

This step reflects the government’s commitment to strengthening regulatory oversight in the pharmaceutical sector and protecting citizens from irrational and potentially dangerous drug combinations.