Over the weekend, a gazette notification was published by the Indian Government banning 14 fixed-dose combinations (FDC) medications that it determined lacked therapeutic efficacy.
The prohibited combinations include over-the-counter medications for infections, fevers, and coughs, despite claims from industry sources that some of these combinations aren't currently offered on the market.
The Central Drugs Standard Control Organisation (CDSCO) defines Fixed-Dose Combination (FDC) as products with one or more active components utilised for a particular indication or indications.
On Friday, the Union Health Ministry released a notification regarding this. A committee of experts concluded, as stated in the warning, that “there is no therapeutic justification for these FDCs and the FDCs may involve risk to human beings.”
The prohibition is immediately effective upon implementation of the expert committee's recommendations, which were created to evaluate the efficacy of various drug combinations.
Under section 26 A of the Drugs and Cosmetics Act of 1940, it is required to forbid the production, sale, or distribution of this FDC in the interest of the general public.
- Salbutamol + Hydroxyethyltheophylline (Etofylline) + Bromhexine
- Ammonium Chloride + Sodium Citrate + Chlorpheniramine Maleate + Menthol (100mg + 40mg + 2.5mg + 0.9mg) , (125mg + 55mg + 4mg + 1mg) , (110mg + 46mg + 3mg + 0.9mg) & (130mg + 55mg + 3mg + 0.5mg) per 5 ml
- Phenytoin + Phenobarbitone Sodium
- Chlorpheniramine + Codeine Phosphate + Menthol Syrup
- Salbutamol + Bromhexine
- Paracetamol + Bromhexine + Phenylephrine + Chlorpheniramine + Guaiphenesin
- Dextromethorphan + Chlorpheniramine + Guaiphenesin + Ammonium Chloride
- Nimesulide + Paracetamol dispersible tablets
- Amoxicillin + Bromhexine
- Pholcodine + Promethazine
- Chlorpheniramine Maleate + Dextromethorphan + Guaiphenesin + Ammonium Chloride + Menthol
- Chlorpheniramine Maleate + Codeine Syrup
- Ammonium Chloride + Bromhexine + Dextromethorphan
- Bromhexine + Dextromethorphan + Ammonium Chloride + Menthol
An expert panel established at the Supreme Court's request stated earlier in 2016 that 344 drug combinations were being sold to patients without scientific data. The government then announced the ban on their production, sale, and distribution, and the manufacturers successfully sued to overturn the decision. Of the 344 medication combinations, 14 FDCs that are now prohibited are included.
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