The Drugs Controller General of India (DCGI) has directed pharma providers to submit information and facts of particular pre-1988 permitted Fixed Dose Combinations (FDCs) on their rationality, security and efficacy in the prescribed format along with relevant supporting documents.
The Supreme Court of India in its previous judgments dated December 15, 2017 and February 14, 2019 had passed an order that the Central Government could, if it so chooses, carry out an inquiry as to no matter if FDCs licensed prior to 1988 must be the topic matter of a notification below Section 26A of the Drugs and Cosmetics (D&C) Act, 1940 (23 of 1940).
In pursuance of the very same observations, an Expert Committee has been constituted by the Central Government below the Chairmanship of Dr M S Bhatia, Professor and Head, Department of Psychiatry, University College of Medical Sciences (UCMS), New Delhi to examine these FDCs.
The DCGI notice on FDCs has been sent to the Indian Drug and Pharmaceuticals Associations and also uploaded on the site of CDSCO for information and facts and required action by the concerned stakeholders.
Format for submission of information and facts on FDC to Expert Committee contains name and address of the applicant name of the FDC, copy of item manufacturing license composition of the FDC, indication, international status, rationality (to be submitted with reference to FDC only, not on person components), short on security and efficacy information (along with published information published in peer reviewed journal with reference to FDC only, not on Individual components and a Presentation Copy in PPT format of maximum 10 slides.
List of pre-1988 permitted FDCs are Nimesulide +Paracetamol dispersible tablets, Paracetamol + Phenylephrine + Caffeine, Amoxicillin + Bromhexine, Pholcodine + Promethazine, Imipramine + Diazepam, Chlorpheniramine maleate+ Dextromethorphan+ Dextromethorphan + Guaifenesin + Ammonium chloride + Menthol , Chlorpheniramine Maleate +Codeine syrup, Ammonium Chloride + Bromhexine + Dextromethorphan, Bromhexine +Dextromethorphan +Ammonium Chloride +Menthol, Dextromethorphan +Chlorpheniramine + Guaifenesin +Ammonium Chloride, Caffeine + Paracetamol +Phenylephrine + Chlorpheniramine, Paracetamol + Bromhexine +Phenylephrine +Chlorpheniramine + Guaifenesin, Salbutamol + Bromhexine, Chlorpheniramine +Codeine phosphate +Menthol syrup, Phenytoin + Phenobarbitone sodium, Paracetamol + Propyphenazone + Caffeine, Ammonium Chloride + Sodium Citrate + Chlorpheniramine Maleate + Menthol , Salbutamol + Hydroxyethyltheophylline (Etofylline) + Bromhexine and Chlorpheniramine Maleate + Ammonium Chloride + Sodium Citrate.