In a major move aimed at strengthening patient safety and ensuring the rational use of medicines, the Ministry of Health and Family Welfare on Saturday prohibited the manufacture, sale and distribution of 16 Fixed Dose Combinations (FDCs) across India with immediate effect, citing potential health risks and lack of therapeutic justification.
The decision was announced through notifications issued under Section 26A of the Drugs and Cosmetics Act, 1940, marking another step in the government’s wider crackdown on irrational drug formulations circulating in the market.
This comes days after the government made it mandatory for people to have a doctor’s prescription before purchasing any syrup-based medicine, including cough syrups. The new rule means that these medicines can no longer be sold over the counter at pharmacies across the country.
According to the ministry, the prohibited combinations were found to be scientifically unjustified and their continued use was deemed to pose more risk than benefit to patients.
FDC helps contain two or more active drug ingredients combined into a single dosage form such as a single tablet, capsule, or syrup.
Supreme Court-led review triggered fresh action
The latest ban follows directions issued earlier by the Supreme Court of India, which had ordered a comprehensive review of fixed-dose drug combinations currently available in the country.
Following the court’s directive, the Drugs Technical Advisory Board (DTAB) constituted an expert committee to examine various FDCs and identify medicines that lacked therapeutic value, were irrational in composition, or could potentially endanger human health.
Based on the committee’s scientific assessment, the government decided to prohibit 16 combinations that failed to meet safety and efficacy standards.
Painkillers, antibiotics and skin formulations among banned medicines
The banned formulations cut across multiple therapeutic categories, including analgesics, antispasmodic medicines, dermatological products and antibiotic-based combinations.
Among the notable combinations prohibited are:
Acetyl Salicylic Acid + Ethoheptazine
Dicyclomine + Paracetamol + Clidinium Bromide
Dicyclomine + Paracetamol + Clidinium Bromide + Chlordiazepoxide
Gliclazide + Chromium Picolinate
Paracetamol + Lignocaine
Amoxicillin + Serratiopeptidase
Amoxicillin + Serratiopeptidase + Lactobacillus Sporogenes
Amoxicillin + Cloxacillin + Lactic Acid Bacillus + Serratiopeptidase
Cefadroxyl + Probenecid
Cefuroxime + Serratiopeptidase
The list also includes several aloe vera-based skin and wellness products containing combinations of Vitamin E, Jojoba Oil, Orange Oil, Wheat Germ Oil, Tea Tree Oil, Allantoin and Dimethicone, which regulators said lacked sufficient therapeutic justification.
Government says only scientifically validated medicines should reach consumers
The Health Ministry said that this was a part of government’s efforts to ensure that only safe, effective and scientifically validated medicines remain available to the public.
Nationwide implementation begins immediately
Following the notification, the manufacture for sale, distribution and supply of all 16 identified drug combinations for human use now stands prohibited across the country with immediate effect.
The Centre has directed all state drug controllers, regulatory bodies and enforcement agencies to ensure strict compliance with the order. Manufacturers, distributors, importers and other stakeholders have also been asked to take immediate corrective measures to comply with the new regulations.