CDSCO asks stakeholders to submit data on rationality, safety, & efficacy of older FDCs

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.

List of pre-1988 permitted Fixed Dose Combinations (FDCs)

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