Centre Bans 16 Drug Combinations Amid Public Health Concerns

NEW DELHI: The Centre has banned the manufacture, sale and distribution of 16 fixed-dose combination (FDC) drugs, stating that they “lack therapeutic justification” and are not beneficial in relation to the risks involved. FDC drugs contain two or more active pharmaceutical ingredients in a fixed ratio. The banned formulations include combinations such as acetyl salicylic acid with ethoheptazine; dicyclomine, paracetamol and clidinium bromide; dicyclomine, paracetamol, clidinium bromide and chlordiazepoxide; gliclazide with chromium picolinate; and paracetamol with lignocaine.

Several antibiotic-based combinations have also been prohibited, including amoxicillin with serratiopeptidase, amoxicillin with serratiopeptidase and lactobacillus sporogenes, amoxicillin with cloxacillin, lactic acid bacillus and serratiopeptidase, cefadroxyl with probenecid, and cefuroxime with serratiopeptidase.

The list also covers dermatological and skincare formulations combining aloe vera or aloe extract with ingredients such as vitamin E, jojoba oil, orange oil, wheat germ oil, tea tree oil, allantoin and D-panthenol.

The health ministry said the ban aims to promote rational drug use and ensure only scientifically validated medicines reach the public. State drug controllers and enforcement agencies have been directed to implement it strictly, while manufacturers, importers and distributors must comply.

The decision follows a Supreme Court-directed review by an expert committee under the Drugs Technical Advisory Board, which identified irrational or potentially harmful FDCs. The notification was issued under Section 26A of the Drugs and Cosmetics Act, 1940, to strengthen patient safety.