The Union Health Ministry has banned the manufacture, sale and distribution of 16 fixed-dose combination (FDC) drugs for human use with immediate effect, citing lack of therapeutic justification and potential risk to patients.The ban, notified by the Department of Health, takes immediate effect and has been imposed under Section 26A of the Drugs and Cosmetics Act, 1940, following a prolonged regulatory review process through many years.The list of banned combinations includes fixed dose drug combinations that feature commonly used painkillers, antibiotics and skin products.The banned list includes: 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.The issue of FDCs came up earlier with an expert panel examining them in 2021 and finding that available data and peer-reviewed scientific evidence did not support the rationality of these combinations.For amoxicillin-serratiopeptidase based combinations, including with lactobacillus sporogenes and with 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. Amoxicillin works as an antibiotic and serratiopeptidase, the enzyme, helps reduce swelling and pain.The same reasoning as for the above FDC was applied to cefuroxime (a broad-spectrum, second-generation cephalosporin antibiotic used to address respiratory infections) + serratiopeptidase.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. For 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.WHAT’s FDCA medicine that combines two or more active drugs in a single dosage form such as tablet or capsuleFor 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 implies the study of 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.The above 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 of the experts 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.