Ministry of Health prohibits 16 irrational Fixed Dose Combinations for human use

The Ministry of Health and Family Welfare has issued a series of notifications under the Drugs and Cosmetics Act, 1940 prohibiting the manufacture, sale and distribution of sixteen Fixed Dose Combinations (“FDCs”) for human use with immediate effect, i.e., from 15^th June 2026. The prohibitions have been issued based on recommendations of Expert Committees, the Drugs Technical Advisory Board (“DTAB”) and its Sub-Committee, which concluded that the identified FDCs lack therapeutic justification, are not supported by adequate scientific evidence and may pose risks to human health despite the availability of safer alternatives.

Key Highlights:

1. The Central Government has prohibited the manufacture, sale and distribution of 16 FDCs for human use with immediate effect in the interest of public health.
2. The prohibited FDCs were found to be irrational, lacking therapeutic justification and not aligned with established scientific evidence and standard treatment guidelines.
3. State Drug Controllers, regulatory authorities and enforcement agencies have been directed to ensure strict implementation of the notifications and compliance by manufacturers, importers, distributors and other stakeholders.

4. The following FDCs have been prohibited:

• Acetyl Salicylic Acid + Ethoheptazine
• 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 + Jojoba Oil + Wheat Germ Oil + Tea Tree Oil
• Aloe Vera + Vitamin E + Herbal
• Dicyclomine + Paracetamol + Clidinium Bromide
• Dicyclomine + Paracetamol + Clidinium Bromide + Chlordiazepoxide
• Gliclazide + Chromium Picolinate
• Paracetamol + Lignocaine
• Amoxicillin + Serratiopeptidase + Lactobacillus Sporogenes
• Amoxicillin + Cloxacillin + Lactic Acid Bacillus + Serratiopeptidase
• Amoxicillin + Serratiopeptidase
• Cefadroxyl + Probenecid
• Cefuroxime + Serratiopeptidase

Source: E-Gazette