Centre bans 16 irrational drug combinations to ensure patient safety
The central government has prohibited the manufacture, sale, and distribution of 16 fixed-dose combination (FDC) medicines with immediate effect, after expert panels determined that these combinations lacked therapeutic justification and scientific evidence. The decision, announced by the health ministry on Friday, was taken under the Drugs and Cosmetics Act, following a Supreme Court-mandated review of FDCs available in the country.
The Drugs Technical Advisory Board (DTAB) constituted an expert committee to examine whether these drug combinations were scientifically justified and safe for patients. Based on the committee's recommendations, the government concluded that the 16 combinations were irrational, and their continued use presented potential risks that outweighed any benefits.
The banned products include antibiotics such as amoxicillin, cefuroxime, and cefadroxyl, combined with enzymes like serratiopeptidase; medicines for pain relief and abdominal cramps; and several aloe vera-based dermatological preparations. Specific prohibited combinations include Amoxicillin + Serratiopeptidase, Amoxicillin + Serratiopeptidase + Lactobacillus Sporogenes, Cefuroxime + Serratiopeptidase, Cefadroxyl + Probenecid, Dicyclomine + Paracetamol + Clidinium Bromide + Chlordiazepoxide, and a number of aloe vera skin formulations.
According to the health ministry, the expert committees found that the available scientific data did not support the use of these combinations. The government stated that the move aims to ensure that only safe, effective, and scientifically validated medicines are available to the public, reinforcing ongoing efforts to promote rational drug use and strengthen patient safety.
State drug regulators have been directed to enforce the ban strictly across the country. Officials said that the action is part of a continuing effort to eliminate unscientific drug combinations from the market, protecting patients from unnecessary exposure to potentially harmful or ineffective medicines.
