CDSCO decides on fate of 3 antibiotic FDCs including Cefixime, Cloxacilli

This comes in line with the earlier DTAB report and recommendations.

Further, regarding the Cefadroxil and Clavulanic acid FDC, CDSCO has asked all State and UT Drugs Controllers to direct manufacturers to submit the protocol for conducting an in-vitro research to prove the efficacy of this combination to this office for approval.

Cefixime plus Cloxacillin is an antibiotic drug combination that acts by blocking the formation of bacterial protective coatings, which are necessary for germs to survive in the human body.

The FDC drug containing Cefixime, Cloxacillin and Lactobacillus is used in the treatment of bacterial infections. Lactobacillus is a live microorganism that helps to restore the balance of good bacteria in the intestine, which can be disrupted by antibiotic use or infections.

In the case of Cefadroxil plus Clavulanic acid FDC, Cefadroxil is an antibiotic that works by blocking the c of the bacterial protective coating, whereas Clavulanic Acid is a beta-lactamase inhibitor that prevents the inactivation of cefadroxil by enzymes generated by bacteria. The addition of clavulanic acid decreases resistance and improves Cefadroxil's antibacterial effectiveness.

Earlier, the Medical Dialogues Team had reported that as per the direction of the High Court of Maharashtra, Nagpur Bench, the 84th DTAB committee held on 27.08.2019, had suggested that in the case of three FDCs, namely Cefadroxil + Clavulanic acid, Cefixime + Cloxacillin, and Cefixime + Cloxacillin + Lactobacillus, it might be necessary to refer to Prof. Kokate Committee, which was already looking into similar FDCs.

In continuation, as per the report of DTAB dated 13.04.2021 and recommendations of the subcommittee of DTAB as approved, the said FDCs have been considered as rational with certain conditions.

Accordingly, in the latest issued notice, it is stated,

"As regard to the FDC of Cefixime + Cloxacillin and FDC of Cefixime + Cloxacillin + Lactobacillus, these have been considered as rational if cloxacillin is in sustained release form in twice daily doses schedule. The indication of the FDC should be restricted to skin and soft tissue infections."

The notice further added,

"As regard to the FDC of Cefadroxil + Clavulanic acid, firms should prove the efficacy of the combination by conducting in-vitro study in GLP complied laboratory for all the approved indications with respect to the infections caused by susceptible microorganisms including S. aureus. The study should compare cefadroxil alone and in FDC. Accordingly the study protocol should be submitted for approval within 3 months of the notification."

In light of the foregoing, the Directorate General of Health Services has requested all State/UT Drugs Controllers to instruct all manufacturers of the above FDCs to only manufacture and market Cefixime + Cloxacillin and FDC of Cefixime + Cloxacillin + Lactobacillus for the above-mentioned indication.

In addition, the Directorate General of Health Services has requested that manufacturers submit the protocol for conducting an in-vitro study to prove the efficacy of the FDC Cefadroxil with Clavulanic acid to this office for approval.

To view the official notice, click the link below: