GUWAHATI: The Union Ministry of Health and Family Welfare has prohibited the manufacture, sale and distribution of 16 Fixed Dose Combination (FDC) drugs for human use with immediate effect, citing lack of therapeutic justification and potential risks to public health.
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The prohibition has been issued under Section 26A of the Drugs and Cosmetics Act, 1940, as part of the Centre’s efforts to promote rational use of medicines and ensure that only scientifically validated drug formulations remain available in the market.
The decision follows directions issued by the Supreme Court for a comprehensive review of FDC drugs marketed across the country. In compliance with the directive, the Drugs Technical Advisory Board (DTAB) constituted an expert committee to evaluate various combinations and identify formulations considered irrational, medically unjustified or potentially harmful.
Following scientific assessment by the committee, the government concluded that the continued use of the identified 16 FDCs did not offer sufficient therapeutic benefit when weighed against associated health risks.
According to the ministry, the prohibited combinations belong to multiple therapeutic categories, including dermatological preparations, analgesic and antispasmodic medicines, and antibiotic-based formulations.
The ministry stated that the latest action aligns with previous regulatory measures against irrational drug combinations and reflects the government’s commitment to patient safety and evidence-based healthcare practices.
With the notifications taking effect immediately, all State Drug Controllers, regulatory authorities and enforcement agencies have been directed to ensure strict implementation of the order nationwide.
Manufacturers, importers, distributors and other stakeholders have also been instructed to take corrective measures and comply with the applicable legal provisions.
Among the banned formulations are:
1.Acetyl Salicylic acid + Ethoheptazine
2. Aloe Extract + Allantoin + Alphatocopherol Acetate +D-Penthenol + Vitamin A
3. Aloe Extract +Vitamin E + Dimethicone + Glycerine
4. Aloe Vera +Jojoba Oil +Vitamin E
5. Aloe vera + Orange oil
6. Aloe vera + Jojoba oil + Wheat germ oil + Tea tree oil
7. Aloe vera + Vitamin E + Herbal
8. Dicyclomine + Paracetamol + Clidinium Bromide
9. Dicyclomine +Paracetamol + Clidinium Bromide + Chlordiazepoxide
10. Gliclazide + Chromium Picolinate
11. Paracetamol + Lignocaine
12. Amoxicillin + Serratiopeptidase+ Lactobacillus Sporogenes
13. Amoxicillin + Cloxacillin + Lactic acid bacillus + Serratiopeptidase
14. Amoxicillin + Serratiopeptidase
15.Cefadroxyl + Probenecid
16.Cefuroxime + Serratiopeptidase