CDSCO asks stakeholders to submit data on rationality, safety, & efficacy of older FDCs
New Delhi: In order to assess the status of fixed dose combination drugs licensed prior to 1988, the Directorate General of Health Services, Central Drugs Standard Control Organization (CDSCO) expert committee has invited concerned stakeholders to submit information on the rationality, safety, and efficacy of such fixed dose combinations (FDCs) in the specified format.
The list contains 19 FDCs for which CDSCO asked for details. The list includes Nimesulide plus Paracetamol dispersible tablets, Paracetamol, Phenylephrine, Caffeine combination, Pholcodine and Promethazine combination, lmipramine and Diazepam combination, Salbutamol and Bromhexine combination, etc.
This comes in line with the Honorable Supreme Court of India's judgments dated 15.12.2017 and 14.02.2019, which stated that the Central Government may, if it so chooses, conduct a de novo inquiry into whether fixed dose combinations licensed prior to 1988 should be the subject matter of a notification under Section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940).
Section 26A of the Drugs and Cosmetics Act, 1940, empowers the Central Government to regulate, restrict, or prohibit the manufacture, etc., of drugs and cosmetics in the public interest.
Section 26A of the Drugs and Cosmetics Act, 1940, stated, "Without prejudice to any other provision contained in this Chapter, if the Central Government is satisfied that the use of any drug or cosmetic is likely to involve any risk to human beings or animals, or that any drug does not have the therapeutic value claimed or purported to be claimed for it or contains ingredients and in such quantity for which there is no therapeutic justification and that in the public interest it is necessary or expedient so to do, then, that Government may, by notification in the Official Gazette, regulate, restrict or prohibit the manufacture, sale or distribution of such drug or cosmetic."
In pursuance of the above observations, the matter has been duly considered by the Central Government. Accordingly, an Expert Committee has been constituted under the Chairmanship of Dr. M.S. Bhatia, Professor & Head, D/o Psychiatry, University College of Medical Sciences, New Delhi to examine these FDCs.
In this regard, a meeting of the expert committee was held and the committee desired that the concerned stakeholders submit information on the rationality, safety, and efficacy of these FDCs as per the prescribed format, which is enclosed along with the list of these FDCs.
Accordingly, through the recently issued notice, the Directorate General of Health Services, Central Drugs Standard Control Organization has asked all the concerned stakeholders to submit the information in the prescribed format along with relevant supporting documents in hard copy as well as soft copy (i.e. in C.D. Form) to this office latest by 25th August 2021 till 5:00 PM.
Format for submission of information on FDC to Expert Committee
Submit all the information including full text of references as hard copy as well as soft copy
Name and Address of the Applicant
Name of the FDC
Copy of Product manufacturing license
Composition of the FDC
Rationality (to be submitted
w.r.t. FDC only, not on individual ingredients)
Brief on Safety and Efficacy Data (along with published data published in peer reviewed journal w.r.t FDC only, not on Individual ingredients)
Presentation Copy (PPT maximum 10 slides)
List of pre-1988 permitted Fixed Dose Combinations (FDCs)
Nimesulide +Paracetamol dispersible tablets
Paracetamol + Phenylephrine + Caffeine
Amoxicillin + Bromhexine
Pholcodine + Promethazine
lmipramine + 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
Chlorpheniramine Maleate + Ammonium Chloride + Sodium Citrate