Government has banned 14 FDCs after recommendations of the Expert Committee which stated that there is no therapeutic justification for these FDCs and the FDCs may involve risk to human beings.
The Central Government in exercise of the powers conferred by section 26A of the Drugs and Cosmetics act 1940 (23 of 1940) prohibited the manufacture for sale, sale and distribution for human use of 14 drug FDCs (fixed dose combinations).
Prohibited FDCs involves:
Nimesulide plus paracetamol;
Amoxicillin and Bromhexine; Pholcodine + Promethazine;
Chlorpheniramine Maleate + Dextromethorphan + Guaiphenesin + Ammonium Chloride + Menthol;
Chlorpheniramine Maleate + Codeine Syrup;
Ammonium Chloride + Bromhexine + Dextromethorphan;
Bromhexine + Dextromethorphan + Ammonium Chloride + Menthol;
Dextromethorphan + Chlorpheniramine + Guaiphenesin + Ammonium Chloride
Paracetamol + Bromhexine + Phenylephrine + Chlorpheniramine + Guaiphenesin
Salbutamol + Bromhexine;
Chlorpheniramine + Codeine Phosphate + Menthol Syrup;
Phenytoin + Phenobarbitone Sodium;
Ammonium Chloride + Sodium Citrate + Chlorpheniramine Maleate + Menthol (100mg + 40mg + 205mg + 0.9mg), (125mg + 55mg + 4mg + lmg), (1 lOmg + 46mg + 3mg + 0.9mg) & (130mg + 55mg + 3mg + 0.5mg) per 5ml syrup
Salbutamol + Hydroxyethyltheophylline (Etofylline) + Bromhexine
The Expert Committee recommended that “there is no therapeutic justification for this FDC and the FDC may involve risk to human beings. Hence, in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26A 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."
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.
