CSDCO calls meeting of makers of 19 older FDCs to examine their rationality

Stakeholders must give information on the rationale, safety, and efficacy of such Fixed-Dose Combination FDCs in the suggested format for the aforesaid conference to assess the status of Fixed-Dose Combination medications.

There are 19 FDCs on the list for which CDSCO has requested information. Nimesulide with paracetamol dispersible pills, Paracetamol, Phenylephrine, Caffeine combination, Pholcodine and Promethazine combination, imipramine and Diazepam combination, Salbutamol and Bromhexine combination, are among the medications on the list.

This is in line with the Supreme Court of India's judgments dated 15.12.2017 and 14.02.2019, which stated that the Central Government may, if it so desires, conduct a de novo investigation into whether fixed-dose combinations licensed before 1988 should be the subject of a notification under Section 26A of the Drugs and Cosmetics Act, 1940. (23 of 1940).

The Pharmaceuticals and Cosmetics Act of 1940, Section 26A, gives the Central Government the authority to regulate, restrict, or prohibit the manufacture, distribution, and sale 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."

Earlier the CDSCO had also asked the companies to submit data on rationality of these older FDCs

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

In follow-up the CDSCO has now planned a meeting of the stakeholders. According to the fresh notice, if the stakeholder does not appear for the meeting, the committee has the right to make its decision based on available information. As per the annexure, participation in the conference should be confirmed through mail at fdc@cdsco.nic.in along with a PowerPoint presentation, mobile number, email id, serial number of the FDC, before the 24th of this month.