Govt bans 14 fixed dose combination drugs (FDC) including

The Government of India has banned 14 fixed dose combination (FDC) drugs in the country. The Union Health Ministry has also issued a notification on this regard.

  • Earlier in 2016, the government had announced the ban on the manufacture, sale and distribution of 344 drug combinations. The current banned 14 FDCs are also part of those 344 drug combinations.

Key points

  • The government says that there is “no therapeutic justification” for these medicines and they may involve “risk” to people.
  • When two or more drugs are combined in a fixed ratio into a single dosage form, it is termed as fixed dose combinations (FDCs).
  • The move came following recommendations by an expert committee. As per the committee recommendations, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of the Drugs and Cosmetics Act, 1940.
  • These banned drugs included those used for treating common infections, cough and fever combinations such as: Nimesulide Paracetamol dispersible tablets, Chlopheniramine Maleate Codeine Syrup, Pholcodine Promethazine, Amoxicillin Bromhexine and Bromhexine Dextromethorphan Ammonium Chloride Menthol, Paracetamol Bromhexine Phenylephrine Chlorpheniramine Guaiphenesin and Salbutamol Bromhexine.

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