Government Bans 14 Fixed-Dose Drugs Due to Human Health Risks
The union health ministry on Saturday banned the manufacture for sale, sale and distribution for human use of 14 fixed dose combination drugs including the Nimesulide+ Paracetamol dispersible tablets citing “there is no therapeutic justification for these drugs and may involve “risk” to human beings.
FDC drugs are those which contain a combination of two or more active pharmaceutical ingredients (APIs) in a fixed ratio.
In a notification released on Friday, the government stated, “Considering the greater welfare of the public, it is imperative to forbid the production, sale, or distribution of this FDC (Fixed Dose Combination) in accordance with Section 26A of the Drugs and Cosmetics Act, 1940. In light of this, any form of regulation or limitation permitting its usage in patients cannot be justified. Hence, it is strongly advised to solely enforce the prohibition under Section 26A.”
These recommendations have been made by expert panel under Drugs Technical Advisory Board.
The banned drugs included those used for treating common infections, cough and fever. These drug combinations include: 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.