Government has banned 14 fixed-dose drugs as they have been found to lack therapeutic justification and may pose risks to health. A government notification on Friday said it is necessary to prohibit the manufacture, sale and distribution of the fixed dose medicines in larger public interest. An Expert Committee recommended that there is no therapeutic justification for the ingredients contained in these Fixed dose Combinations and the FDCs may involve risk to human beings.
FDC drugs contain a combination of two or more active pharmaceutical ingredients in a single form. They are usually manufactured in a fixed ratio and distributed. The 14 FDCs include combinations such as Nimesulide Paracetamol dispersible tablets, Amoxicillin Bromhexine and Pholcodine Promethazine. The drugs are used for treating cough, common infections, fever and body ache.