The Centre has prohibited 16 fixed-dose combination (FDC) medicines, including certain antibiotic, pain-relief and skin-treatment products, after expert panels determined that they lacked therapeutic justification and were not supported by scientific evidence.
Immediate Ban Under Drugs and Cosmetics Act
The health ministry on Friday banned the manufacture, sale and distribution of these medicines with immediate effect under the Drugs and Cosmetics Act.
This 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.
Expert Committee Findings
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.
List of Prohibited Combinations
- Amoxicillin + Serratiopeptidase
- Amoxicillin + Serratiopeptidase + Lactobacillus Sporogenes
- Cefuroxime + Serratiopeptidase
- Cefadroxyl + Probenecid
- Dicyclomine + Paracetamol + Clidinium Bromide + Chlordiazepoxide
- Several aloe vera-based skin formulations
Government's Rationale and Future Steps
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 stated that 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.
