List Of Banned Antibiotic FDCs

Contributed by Dr R Surendran

The Govt. of India has banned 328 Fixed Drug Combinations in a recent notification which prohibits the manufacture for sale or distribution for human use with immediate effect, based on DTAB’s (Drugs Technical Advisory Board) recommendation that there is no therapeutic justification for the ingredients. The list includes syrups, suspensions, tablets, creams, ointments etc. The full list can be accessed online here.

Following antibiotic tablet FDC formulations are banned

Serial Number - FDC Name (Notification Number)

1. Amoxicillin + Cefixime + Potassium Clavulanic acid (757)
2. Amoxicillin + Dicloxacillin (753)
3. Amoxicillin 250 mg + Potassium Clavulanate diluted 62.5 (754)
4. Amoxicillin + Dicloxacillin + Serratiopeptidase (771)
5. Amoxycillin + Tinidazole (764)
6. Azithromycin + Cefixime (752)
7. Azithromycin + Cefpodoxime (772)
8. Azithromycin + Levofloxacin (755)
9. Azithromycin + Ofloxacin (763)
10. Cefixime + Levofloxacin (766)
11. Cefixime + Linezolid (756)
12. Cefpodoxime Proxetil + Levofloxacin (759)
13. Cefuroxime + Linezolid (774)
14. Clindamycin + Clotrimazole + Lactic acid bacillus (854)
15. Clindamycin + Telmisartan (786)
16. Combikit of Azithromycin + Secnidazole + Fluconazole (760)
17. Combikit of Azithromycin + Fluconazole + Ornidazole (769)
18. Diethyl Carbamazine + Chlorpheneramine + Guaifenesin (938)
19. Diethyl Carbamazine Citrate + Cetrizine + Guaifenesin (892)
20. Diethyl Carbamazine + Cetrizine + Ambroxol (923)
21. Diphenoxylate + Atropine + Furazolidone (768)
22. Doxycycline + Serratiopeptidase (765)
23. Furazolidone + Metronidazole + Loperamide (844)
24. Levofloxacin + Ornidazole + Alpha Tocopherol Acetate (761)
25. Metronidazole + Norfloxacin (776)
26. Metronidazole + Tetracycline (779)
27. Nimorazole + Ofloxacin (762)
28. Norfloxacin + Metronidazole + Zinc Acetate (847)
29. Ofloxacin + Metronidazole + Zinc Acetate (767)
30. Ofloxacin + Nitazoxanide (758)
31. Ofloxacin + Ornidazole + Zinc Bisglycinate (775)

Amazing how these irrational preparations were permitted for decades, very good news for the ID community indeed! Hopefully the ban will help reduce skyrocketing antimicrobial resistance in the country.