The Union Health Ministry has banned the manufacture, sale, and distribution of 16 fixed-dose combination (FDC) drugs for human use with immediate effect. The ban, notified by the Department of Health, cites a lack of therapeutic justification and potential risk to patients. It has been imposed under Section 26A of the Drugs and Cosmetics Act, 1940, following a prolonged regulatory review process spanning several years.
Banned Combinations Include Common Painkillers, Antibiotics, and Skin Products
The list of banned combinations includes widely used painkillers, antibiotics, and skin products. Among them are: acetyl salicylic acid + ethoheptazine; aloe vera + jojoba oil + wheat germ oil + tea tree oil; amoxicillin + serratiopeptidase + lactobacillus sporogenes; dicyclomine + paracetamol + clidinium bromide + chlordiazepoxide; amoxicillin + serratiopeptidase; aloe extract + allantoin + alpha-tocopheryl acetate + D-Penthenol + vitamin A; aloe extract + vitamin E + dimethicone + glycerine; aloe vera + jojoba oil + vitamin E; aloe vera + orange oil; aloe vera + vitamin E + herbal; dicyclomine + paracetamol + clidinium bromide; paracetamol + lignocaine; gliclazide + chromium picolinate; amoxicillin + cloxacillin + lactic acid bacillus + serratiopeptidase; cefadroxil + probenecid; and cefuroxime + serratiopeptidase.
Expert Panel Found No Scientific Support for Combinations
The issue of FDCs came under scrutiny when an expert panel examined them in 2021 and concluded that available data and peer-reviewed scientific evidence did not support the rationality of these combinations. For amoxicillin-serratiopeptidase-based combinations, including those with lactobacillus sporogenes and cloxacillin, the committee found the pairing “pharmacodynamically irrelevant,” stating there was no sound clinical evidence for concurrent use of the antibiotic and the enzyme, and that the combination did not follow standard therapeutic guidelines. This FDC has been used for bacterial infections, with amoxicillin working as an antibiotic and serratiopeptidase helping to reduce swelling and pain.
The same reasoning was applied to cefuroxime (a broad-spectrum, second-generation cephalosporin antibiotic used for respiratory infections) combined with serratiopeptidase.
Dicyclomine Combinations Deemed Unjustified
For dicyclomine-based combinations, the committee noted that dicyclomine already has potent anti-cholinergic and smooth-muscle relaxant properties, making its combination with another anti-cholinergic agent such as clidinium bromide unjustified. Dicyclomine is used to address irritable bowel syndrome (IBS) and intestinal pain.
Regarding gliclazide + chromium picolinate, used in Type 2 diabetes management, the committee said neither national nor international standard treatment guidelines recommend the use of chromium picolinate.
Lack of Pharmacokinetic Data for Cefadroxil + Probenecid
For cefadroxil + probenecid (an FDC used for bacterial infections), the committee found no pharmacokinetic data to justify adding probenecid for dose titration and said further studies would be needed to determine appropriate dosing, which it did not recommend pursuing. Pharmacokinetics refers to how the body interacts with an administered substance.
For several aloe-based topical formulations, the committee additionally noted that the products were “not defined as well as characterised” and lacked scientific support.
DTAB and Sub-Committee Process Led to Ban
The recommendations of the expert committee were examined by the Drugs Technical Advisory Board (DTAB) of the Health Ministry, which is the apex statutory body that informs the government on drug-related policy issues. The board agreed with the recommendations and asked its sub-committee to examine all irrational FDCs in detail. The sub-committee gave manufacturers and stakeholders an opportunity to submit data through public notices before submitting its final report on December 28, 2024, recommending prohibition in the larger public interest. The DTAB accepted this recommendation, after which the Central Government concluded a ban was necessary and expedient in the public interest. The order prohibits the manufacture, sale, and distribution of these fixed-dose combinations for human use across India.
