Indian Government Bans 14 Fixed-Dose Combination Drugs
The Indian government has recently banned 14 fixed-dose combination drugs, including nimesulide and paracetamol dispersible tablets and chlorpheniramine maleate and codeine syrup. The Union Health Ministry issued a notification stating that there is “no therapeutic justification” for these medicines and that they may involve “risk” to people.
Which drugs have been banned?
The banned drugs include those for treating common infections such as cough and fever, including combinations such as nimesulide + paracetamol dispersible tablets, chlorpheniramine maleate + codeine syrup, pholcodine + promethazine, amoxicillin + bromhexine, and bromhexine + dextromethorphan + ammonium chloride + menthol, among others.
The move comes after recommendations by an expert committee, which stated that there is “no therapeutic justification for this FDC (fixed dose combination) and the FDC may involve risk to human beings.” Therefore, in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of the Drugs and Cosmetics Act, 1940.
What are FDC drugs?
FDC are drugs which contain a combination of two or more active pharmaceutical ingredients (APIs) in a fixed ratio. Back in 2016, the central government announced the ban on 344 drug combinations after an expert panel said they were being sold to patients without scientific data, and the order was challenged by the manufacturers in court. The currently banned 14 FDCs are a part of these 344 drug combinations.
The Indian government’s decision to ban these drugs is a step towards ensuring the safety and well-being of its citizens. The ban will prevent the use of potentially harmful drugs and encourage the development of safer alternatives.
(With inputs from agencies)
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