The Indian government has banned 16 popular fixed-dose combinations (FDCs) of drugs, citing a lack of therapeutic justification and potential risks outweighing benefits. The Ministry of Health and Family Welfare issued notifications under Section 26A of the Drugs and Cosmetics Act, 1940, prohibiting the manufacture, sale, and distribution of these combinations for human use with immediate effect.
Government's Rationale
According to the Ministry, the decision is based on scientific assessment and recommendations from an expert committee. The prohibited FDCs were found to lack therapeutic justification, and their continued use was not considered beneficial given the potential risks involved. The move is part of the government's ongoing efforts to ensure only safe, effective, and scientifically validated medicines are available to the public.
Categories of Banned Combinations
The banned formulations span various therapeutic categories, including dermatological preparations, analgesics, antispasmodics, and antibiotic-based combinations. Previous actions against irrational FDCs have reinforced the government's commitment to patient safety and evidence-based healthcare.
Complete List of Banned Drug Combinations
- Acetyl Salicylic acid + Ethoheptazine
- Aloe Extract + Allantoin + Alphatocopherol Acetate + D-Penthenol + 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
The Ministry emphasized that this action aligns with the government's continuing efforts to promote rational use of medicines and safeguard public health. The ban is effective nationwide immediately.
