Centre Bans 16 Fixed-Dose Combination Drugs After Safety Review, Cites Lack Of Medical Justification

The Government of India has imposed an immediate nationwide ban on 16 fixed-dose combination (FDC) medicines following a detailed scientific review that found the formulations lacked medical justification for continued use. The decision was notified under Section 26A of the Drugs and Cosmetics Act, 1940.

In its official announcement, the Union Health Ministry stated that the “manufacture for sale, sale, distribution and supply” of the identified 16 FDCs for human use has been prohibited with immediate effect across the country.

The banned drugs span several therapeutic categories, including antibiotics, pain management combinations, antispasmodic drugs, and dermatological formulations.

Among the prohibited combinations are drugs such as Acetyl Salicylic Acid with Ethoheptazine; combinations of Dicyclomine, Paracetamol and Clidinium Bromide; and multi-drug formulations including Dicyclomine, Paracetamol, Clidinium Bromide and Chlordiazepoxide.

Other restricted products include Gliclazide with Chromium Picolinate and Paracetamol with Lignocaine.

The order also targets multiple antibiotic combinations, including Amoxicillin with Serratiopeptidase, Amoxicillin with Cloxacillin, and combinations involving Lactobacillus Sporogenes and Serratiopeptidase.

Additionally, Cefadroxyl with Probenecid and Cefuroxime with Serratiopeptidase have been banned.

Certain dermatological and skincare FDCs containing Aloe Vera or Aloe Extract combined with ingredients like Vitamin E, Jojoba Oil, Tea Tree Oil, and D-Panthenol have also been prohibited.

The action follows a comprehensive review of FDC medicines initiated after directions from the Supreme Court.

The Drugs Technical Advisory Board formed an expert committee to evaluate existing combinations and identify those deemed irrational, unsafe, or lacking therapeutic value.

The ministry clarified that fixed-dose combination drugs contain two or more active ingredients in fixed proportions, but the banned formulations were found to have no adequate therapeutic rationale or benefit compared to associated risks.

The government stated that the decision is aimed at safeguarding public health, ensuring rational drug use, and strengthening evidence-based prescribing practices.

It also directed state drug regulators and enforcement agencies to implement the ban, while manufacturers and distributors must comply immediately with corrective measures.