The Ministry of Health and Family Welfare has banned 156 fixed-dose combinations (FDCs) medicines which include commonly used antibiotics, antiallergy medication, painkillers and multivitamins.
The decision comes following an expert group appointed by the central government and recommendations by the Drug Technical Advisory Board (DTAB). The gazette notification stated, “The said Expert Committee considered this FDC as irrational.”
The gazette notification further stated, “There is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended.”
Following this advisory, the central government has decided to prohibit the combination “with immediate effect as the said drug is found to have no therapeutic justification and may involve risk to the human beings.”
Sharing his opinion on the government’s decision, Sudarshan Jain, Secretary General, Indian Pharmaceutical Alliance stated, “The discussion on FDC is going on over a period of time with the recommendation from Kokate committee and Nilima Kshirsagar committee. This is the right step in the interest of patients and all aspects have been taken into consideration.”
The list of the banned FDCs includes:
- Amylase + Protease + Glucoamylase + Pectinase + Alpha Galactosidase + Lactase + Beta-Gluconase + Cellulase + Lipase + Bromelain + Xylanase + Hemicellulase + Malt diastase + Invertase + Papain
- Antimony Potassium Tartrate + Dried Ferrous Sulphate S.O.3286 (E) 12.08.2024
- Benfotiamine + Silymarin + L-Ornithine L-aspartate + Sodium Selenite + Folic acid + Pyridoxine hydrochloride
- Bismuth Ammonium Citrate + Papain
- Cyproheptadine HCl + Thiamine HCl + Riboflavine + Pyridoxine HCl + Niacinamide
- Cyproheptadine Hydrochloride + Tricholine Citrate + Thiamine Hydrochloride + Riboflavine + Pyridoxine Hydrochloride
- Rabeprazole Sodium (As enteric coated tablet) + Clidinium Bromide + Dicyclomine HCl + Chlordiazepoxide
- Fungal Diastase + Papain + Nux vomica Tincture + Cardamom Tincture + Casein Hydrolysed + Alcohol
- Mefenamic Acid + Paracetamol Injection
- Omeprazole Magnesium + Dicyclomine
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