Centre bans 14 fixed dose combination drugs citing risks to patients
The decision was taken on the basis of the recommendations of an expert committee and the Drugs Technical Advisory Board, the health ministry said.
The Centre on Friday banned 14 fixed dose combination drugs, including nimesulide and paracetamol dispersible tablets, which are prescribed to relieve pain and reduce fever.
Fixed dose combinations comprise two or more active drugs in a single dosage form.
The government banned the drugs after an expert committee found that there was no therapeutic justification for these medicines and that they may pose risks to patients.
The combination drugs that have been banned include nimesulide and paracetamol dispersible tablets; chlopheniramine maleate and codeine syrup; pholcodine, promethazine, amoxicillin and bromhexine and bromhexine dextromethorphan, ammonium chloride, menthol; paracetamol with bromhexine and phenylephrine, chlorpheniramine, guaiphenesin; and salbutamol and bromhexine.
The Union Ministry of Health said that the decision was taken on the basis of the recommendations of the expert committee and the Drugs Technical Advisory Board.
“Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this under section 26 A of the Drugs and Cosmetics Act, 1940,” the ministry said. “In view of the above, any kind of regulation or restriction to allow for any use in patients is not justifiable.”