Centre Bans 16 Fixed-Dose Drug Combinations Citing Public Health Concerns

The Union Health Ministry has prohibited the manufacture, sale and distribution of 16 fixed-dose combination (FDC) drugs, stating that they lack "therapeutic justification" and pose risks that outweigh any benefit to patients.

Fixed-dose combinations contain two or more active pharmaceutical ingredients in a set ratio. According to the Ministry, the ban is meant to safeguard public health and promote rational use of medicines, ensuring only scientifically validated drugs remain available to the public.

The decision follows a review carried out in compliance with Supreme Court directions. The Drugs Technical Advisory Board (DTAB) had set up an expert committee to assess various drug combinations and flag those found to be irrational, medically unjustified or potentially harmful.

"The manufacture for sale, sale, distribution and supply of the identified 16 FDCs for human use shall stand prohibited with immediate effect across the country," the Ministry said, invoking Section 26A of the Drugs and Cosmetics Act, 1940.

What's been banned

The prohibited list spans multiple therapeutic categories — painkillers, muscle relaxants, antibiotics and dermatological products.

Among the banned combinations are 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 formulations 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 further includes skincare combinations built around Aloe Vera or Aloe Extract paired with ingredients like Vitamin E, Jojoba Oil, Orange Oil, Wheat Germ Oil, Tea Tree Oil, Allantoin and D-Panthenol.

Part of a wider clean-up

The Health Ministry said the move is part of an ongoing effort to promote rational drug use and strengthen patient safety, noting that several irrational FDCs have been banned in previous years following similar scientific reviews.

State drug controllers, regulatory authorities and enforcement agencies have been instructed to ensure strict compliance with the notifications. Manufacturers, importers and distributors have also been advised to take corrective steps to fall in line with the law.