The Centre has banned the manufacture, sale, distribution and supply of 16 fixed-dose combination (FDC) drugs across the country, citing a lack of therapeutic justification and concerns that the risks associated with their continued use outweigh any potential benefits.

The Union Health Ministry said the decision was taken to safeguard public health, promote the rational use of medicines and ensure that only scientifically validated and effective drugs remain available to consumers.

FDC drugs contain two or more active pharmaceutical ingredients (APIs) combined in a fixed ratio. The latest action follows a review of such formulations conducted in compliance with directions issued by the Supreme Court.

The Ministry said the Drugs Technical Advisory Board (DTAB) had constituted an expert committee to examine various drug combinations and identify those that were irrational, therapeutically 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.

It added that these combination drugs were found to "lack therapeutic justification" and were "not considered beneficial" with respect to the risks involved.

According to the Ministry, the prohibited formulations cover multiple therapeutic categories, including dermatological preparations, painkillers, muscle relaxants and antibiotic-based combinations.

Among the banned drugs are 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.

The government has also prohibited several antibiotic-based combinations, 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 banned list further includes a number of dermatological and skincare products containing combinations of 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 Ministry issued the notifications under Section 26A of the Drugs and Cosmetics Act, 1940.

It said the move forms part of the government's broader efforts to encourage the rational use of medicines and strengthen patient safety, noting that several irrational FDCs had been banned in previous years following detailed scientific assessments.

All state drug controllers, regulatory authorities and enforcement agencies have been directed to ensure strict implementation of the notifications. Manufacturers, importers, distributors and other stakeholders have also been asked to take necessary corrective measures to comply with the law.