Fixed Dose Combinations (FDCs)

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Fixed Dose Combinations (FDCs)

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Fixed Dose Combinations (FDCs) refer to pharmaceutical formulations that contain two or more active pharmaceutical ingredients (APIs) combined in a fixed ratio into a single dosage form (like a pill, capsule, or syrup).

The Union Ministry of Health and Family Welfare took decisive regulatory action by banning 16 major FDC drugs for human use with immediate effect. This step was taken under Section 26A of the Drugs and Cosmetics Act, 1940, following an extensive scientific review by an Expert Committee and the Drugs Technical Advisory Board (DTAB).

Section 26A of the Drugs and Cosmetics Act, 1940?

Section 26A of the Drugs and Cosmetics Act, 1940 is the statutory provision that empowers the Central Government to regulate, restrict, or completely prohibit the manufacture, sale, and distribution of specific drugs or cosmetics.

It serves as the primary legal mechanism used by the Ministry of Health and Family Welfare to ban irrational Fixed-Dose Combinations (FDCs) or hazardous drugs in the interest of public safety.

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