The Ministry of Health and Family Welfare (MoHFW) has implemented an immediate ban on 156 fixed-dose combinations (FDCs), including drugs commonly used for treating colds, fever, bacterial, and fungal infections. These FDCs have been deemed irrational and potentially hazardous to human health, particularly when safer alternatives are available.
The Drugs Technical Advisory Board (DTAB) reviewed these FDCs and concluded that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may pose a risk to human health. Therefore, in the public interest, it is necessary to prohibit the manufacture, sale, or distribution of this FDC under Section 26A of the Drugs and Cosmetics Act, 1990.”
Based on the DTAB’s recommendation, the Ministry has mandated the prohibition of the manufacture, sale, and distribution of these drugs for human use in the country.
Examples of the banned FDCs include:
- Amylase + Protease + Glucoamylase + Pectinase + Alpha Galactosidase + Lactase + Beta-Gluconase + Cellulase + Lipase + Bromelain + Xylanase + Hemicellulase + Malt diastase + Invertase + Papain
- Antimony Potassium Tartrate + Dried Ferrous Sulphate
- Benfotiamine + Silymarin + L-Ornithine L-aspartate + Sodium Selenite + Folic acid + Pyridoxine hydrochlorid
- 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 HCl
For further details, please refer to the Notification attached herewith for your ease of reference.
Source: Ministry of Health and Family Welfare
