16 drug combinations banned by Centre over safety concerns

NEW DELHI: The Centre has banned 16 fixed-dose combination (FDC) medicines, including certain antibiotic, pain-relief and skin-treatment products, after expert panels found that they lacked therapeutic justification and were not supported by scientific evidence.The health ministry on Friday prohibited the manufacture, sale and distribution of these medicines with immediate effect under the Drugs and Cosmetics Act.The action follows a Supreme Court-directed review of fixed-dose combinations sold in the country. As part of the exercise, the Drugs Technical Advisory Board (DTAB) set up an expert committee to examine whether such drug combinations were scientifically justified and safe for patients.Based on the committee’s recommendations, the government concluded that 16 combinations were irrational and that their continued use was not considered beneficial in relation to the potential risks involved.The banned products include combinations containing antibiotics such as amoxicillin, cefuroxime and cefadroxyl, medicines used for pain relief and abdominal cramps, and several aloe vera-based dermatological preparations.Among the combinations prohibited are Amoxicillin + Serratiopeptidase, Amoxicillin + Serratiopeptidase + Lactobacillus Sporogenes, Cefuroxime + Serratiopeptidase, Cefadroxyl + Probenecid, Dicyclomine + Paracetamol + Clidinium Bromide + Chlordiazepoxide, and a number of aloe vera-based skin formulations.According to the ministry, expert committees found that the available scientific evidence did not support the use of these combinations. The government said the move is aimed at ensuring that only safe, effective and scientifically validated medicines remain available to the public.Officials said the latest action is part of a continuing effort to promote rational use of medicines and strengthen patient safety. State drug regulators have been directed to ensure strict implementation of the ban across the country.