Central Government Prohibits Manufacture, Sale, and Distribution of 16 Irrational Fixed Dose Combinations

Through Gazette Notifications S.O. 3068(E) to S.O. 3083(E) dated 11 June 2026, the Central Government prohibited the manufacture, sale, and distribution of 16 Fixed Dose Combinations (FDCs) intended for human use. The banned FDCs include: 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 + Alphatocopherol Acetate + D Panthenol + 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; Cefadroxyl + Probenecid; and Cefuroxime + Serratiopeptidase. The decision was taken under Section 26A of the Drugs and Cosmetics Act, 1940, following reviews by the Expert Committee, DTAB Sub-Committee, and Drugs Technical Advisory Board, which concluded that these FDCs lacked therapeutic justification, were unsupported by adequate scientific evidence, and posed potential risks to public health despite the availability of safer alternatives.