DCGI directs manufacturers of FDCs to manufacture, market certain FDCs based on Bombay HC directive

Drugs Controller General of India (DCGI) has directed all the manufacturers of Fixed Dose Combinations (FDCs) – Cefixime + Cloxacillin, Cefixime + Cloxacillin + Lactobacillus and Cefadroxil + Clavulanic acid to manufacture and market these FDCs as per the indication approved as per the directions of Bombay High Court (HC), Nagpur Bench, Maharashtra.

With regards to the FDC- Cefadroxil + Clavulanic acid, manufacturers have been directed to submit the protocol for conducting in-vitro study to prove the efficacy of this combination to this office for approval.

While reviewing the directions of the Bombay HC, Nagpur bench on following FDCs which are already approved by the DCGI in specific dosage forms and strengths, Drugs Technical Advisory Board (DTAB) in its meeting held on August 27, 2019 also referred these FDCs to the Prof. Kokate Committee.

As per the report of DTAB dated April 13, 2021 and recommendations of the subcommittee of DTAB as approved, the specified FDCs have been considered as rational with certain conditions.

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.

As regard to the FDC of Cefadroxil + Clavulanic acid, firms should prove the efficacy of the combination by conducting in-vitro study in Good Laboratory Practice (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 also in FDC form. Accordingly, the study protocol should be submitted for approval within 3 months of the notification.

The copy of the notice has also been sent to the Central Drugs Standard Control Organisation (CDSCO) Zonal and Sub-Zonal offices, Drug Manufacturing Associations like İDMA, OPPI, IPA, CIPI, FOPE, Indian Drug and Pharmaceuticals Association Forum.