DCGI directs pharma companies to submit information of pre-1988 permitted FDCs on their safety and efficacy

The DCGI notice on FDCs has been sent to the Indian Drug and Pharmaceuticals Associations and also uploaded on the website of CDSCO for information and necessary action by the concerned stakeholders.

The Drugs Controller General of India (DCGI) has directed pharma companies to submit information of certain pre-1988 permitted Fixed Dose Combinations (FDCs) on their rationality, safety and efficacy in the prescribed format along with relevant supporting documents.

The Supreme Court of India in its past judgments dated December 15, 2017 and February 14, 2019 had passed an order that the Central Government may, if it so chooses, carry out an inquiry as to whether FDCs licensed prior to 1988 should be the subject matter of a notification under Section 26A of the Drugs and Cosmetics (D&C) Act, 1940 (23 of 1940).

In pursuance of the same observations, an Expert Committee has been constituted by the Central Government under 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 website of CDSCO for information and necessary action by the concerned stakeholders.

Format for submission of information on FDC to Expert Committee  includes name and address of the applicant name of the FDC, copy of product manufacturing license composition of the FDC, indication, international status, rationality (to be submitted with reference to FDC only, not on individual ingredients), brief on safety and efficacy data (along with published data published in peer reviewed journal with reference to FDC only, not on Individual ingredients 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.