The Central Government has banned Fixed Dose Combination (FDC) drugs that gives quick relief. The banned drugs include widely sold drugs like paracetamol and nimesulide, these medicines give quick relief but they have a risk of harm, the Centre stated the reason of ban.
The decision has been taken by the Union Health Ministry after recommendations of an expert committee. The Ministry has also issued a notification banning these medicines.
The government constituted expert advisory committee had submitted its report in April last year. The Centre stated there is no medical justification for these medicines and involve high risk to the ones who consume it.
Fixed Dose Combination (FDC) drugs are those drugs that contains two or more active pharmaceutical ingredients (APIs) in a fixed ratio. These drugs are also known as cocktail medicines. In 2016, an expert panel constituted on the orders of the the Supreme Court viewed that these drugs were being sold to patients without scientific data.
During that period, the government had announced a ban on the manufacture, sale, and distribution of 344 drug combinations.
The list of drugs banned:
- 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
The expert committee said, there is no medical justification for FDC drugs and they can risk the human life, hence, in the larger public interest, the government has taken the necessary steps to prohibit the manufacturing, sale/distribution of the 14 FDC medicines. The ban has been imposed under section 26A of the 940 Drugs and Cosmetics Act.
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