Govt banned 14 fixed dose drugs in view of involving risk to human beings

FDC drugs are those which contain a combination of two or more active pharmaceutical ingredients (APIs) in a fixed ratio.

The government in a notification issued on Friday said, “Hence, 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. In view of the above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under Section 26A is recommended.”

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.

“On the basis of the recommendations of the Expert Committee and the Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to regulate by way of prohibition the manufacture for sale, sale and distribution for human use of the said drug in the country,” said government notification.

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.

Updated: 03 Jun 2023, 06:53 PM IST

FDC drugs are those which contain a combination of two or more active pharmaceutical ingredients (APIs) in a fixed ratio.

The government in a notification issued on Friday said, “Hence, 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. In view of the above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under Section 26A is recommended.”

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.

“On the basis of the recommendations of the Expert Committee and the Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to regulate by way of prohibition the manufacture for sale, sale and distribution for human use of the said drug in the country,” said government notification.

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.

Updated: 03 Jun 2023, 06:53 PM IST