India bans 16 fixed-dose drug combinations over safety concerns

The Government has prohibited the manufacture, sale, and distribution of 16 fixed dose combinations (FDCs) of drugs including antibiotics and topical and cosmetic combinations with immediate effect after experts found then irrational and concluded that none of these combinations carry any therapeutic justification.

The government invoked Section 26A of the Drugs and Cosmetics Act, 1940. The ban follows a multi-year review process in which an Expert Committee, the Drugs Technical Advisory Board (DTAB), and a DTAB Sub-Committee collectively found them to be lacking therapeutic justification.

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The review initiated in 2021 found that peer-reviewed scientific evidence did not support the rationality of any of the 16 combinations.

While the manufacturers and stakeholders were given an opportunity to present data in their defence through public notices but the Sub-Committee after examining all submissions, submitted its final report on December 28, 2024, recommending a ban on all 16 in the larger public interest.

The antibiotic combinations that came under heavy scrutiny include combination of Amoxicillin + Serratiopeptidase + Lactobacillus Sporogenes which was banned on the grounds that the concurrent use of Amoxicillin and Serratiopeptidase is irrelevant with no sound clinical evidence supporting their combined use and no endorsement from standard therapeutic guidelines.

The same reasoning was applied to Amoxicillin + Serratiopeptidase, a two-ingredient version of the same irrational pairing. Likewise, Amoxicillin + Cloxacillin + Lactic Acid Bacillus + Serratiopeptidase was banned for the reason that the inclusion of Serratiopeptidase alongside antibiotics has no clinical justification. Two other antibiotic combinations-Cefuroxime + Serratiopeptidase were declared pharmacodynamically irrelevant and contrary to standard treatment guidelines. Cefadroxyl + Probenecid was banned due to the absence of pharmacokinetic data to justify the addition of Probenecid to Cefadroxyl or to determine appropriate dosing.

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The antispasmodic combinations also drew strong objections from the expert committee. Dicyclomine + Paracetamol + Clidinium Bromide + Chlordiazepoxide was found irrational because Dicyclomine already possesses potent anticholinergic and smooth muscle relaxant properties, making the addition of another anticholinergic agent, Clidinium, therapeutically unjustified. The three-ingredient version, Dicyclomine + Paracetamol + Clidinium Bromide, was banned for the same reason.

Among the topical and cosmetic combinations-Aloe Extract + Allantoin + Alphatocopherol Acetate + D-Panthenol + Vitamin A, Aloe Extract + Vitamin E + Dimethicone + Glycerine, Aloe Vera + Jojoba Oil + Vitamin E, Aloe vera + Orange oil, and Aloe vera + Vitamin E + Herbal were all prohibited.

“Some of these combinations drew additional criticism as the formulation was found to be poorly defined and inadequately characterised making it even more problematic from a regulatory standpoint,” said an expert on the condition of anonymity.

The combination of Paracetamol + Lignocaine were also banned as no therapeutic justification could be established and the Sub-Committee flagged a possibility of risk associated with this pairing.

Gliclazide + Chromium Picolinate used in the context of Type 2 diabetes management was prohibited because neither national nor international standard treatment guidelines recommend the use of Chromium Picolinate in diabetes care rendering its combination with Gliclazide entirely without basis.