Don’t violate FDC ban, chemists warned

New Delhi: State drugs controllers have directed chemists and traders not to sell the 14 fixed dose combination (FDC) drugs banned by the central drug regulator and warned that failure to uphold it will invite strict action.

The Union government has prohibited the sale and manufacturing of these 14 drugs including Nimesulide+ Paracetamol tablets citing the absence of therapeutic justification and “risks” to human beings.

FDC drugs are those which contain a combination of two or more active pharmaceutical ingredients (APIs) in a fixed ratio. Last week, the Union government said that it is necessary to prohibit the manufacture, sale or distribution of 14 FDCs under section 26 A of the Drugs and Cosmetics Act, 1940 as their use is “not justifiable”.

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.

In 2016, the central government had banned the manufacture, sale and distribution of 344 drug combinations after the government expert panel suggested that these drugs were being sold to patients without scientific data. However, the government order was challenged by the manufacturers in court. The 14 banned cocktail drugs are part of the 344 combination drugs.