Taking these medicines? Government bans 16 drug combinations over safety concerns

New Delhi: The Centre has banned the manufacture, sale, distribution and supply of 16 fixed-dose combination (FDC) drugs across the country, citing concerns over their safety and effectiveness.

The Union Health Ministry said the decision was taken after a scientific review found that the identified drug combinations lacked adequate therapeutic value and could pose potential health risks to patients.

"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.

According to the ministry, the prohibited combinations were found to "lack therapeutic justification" and were "not considered beneficial" with respect to the risks involved.

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

As part of the exercise, the Drugs Technical Advisory Board (DTAB) constituted an expert committee to examine various drug combinations and identify formulations that were irrational, therapeutically unjustified or potentially harmful.

The banned formulations span multiple therapeutic categories, including certain dermatological products, pain-relief medications, antispasmodics and antibiotic-based combinations.

Among the prohibited formulations 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.

Several antibiotic combinations have also been barred, 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 ban further covers a number of dermatological and skincare formulations containing Aloe Vera or Aloe Extract combined with ingredients such as Vitamin E, Jojoba Oil, Orange Oil, Wheat Germ Oil, Tea Tree Oil, Allantoin and D-Panthenol.

The ministry issued the prohibition orders under Section 26A of the Drugs and Cosmetics Act, 1940.

Officials said the move forms part of the government's broader efforts to promote rational use of medicines, strengthen patient safety and ensure that only scientifically validated and effective medicines remain available in the market.

The ministry also noted that several irrational FDCs had been prohibited in previous years following detailed scientific assessments.

State drug controllers and enforcement agencies across the country have been directed to ensure strict implementation of the ban. Manufacturers, importers, distributors and other stakeholders have also been advised to take necessary corrective measures to comply with the notifications.