DCGI approves 3 FDCs containing Cefixime & Cefadroxil as rational

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DCGI CDSCO

Last Updated on August 31, 2021 by The Health Master

Download DCGI’s latest Notices: The Drugs Controller General (India) has allowed three fixed dose combinations (FDCs) as rational with certain conditions.

These FDCs are cefixime+cloxacillin; cefaxime+cloxacillin+lactobacillus; and cefadroxil+ clavulanic acid.

As regard to FDC of cefixime+cloxacillin and cefixime+cloxacillin+lactobacillus, these can be considered as rational if cloxacillin is in sustained release form in twice daily doses schedule and the indication of the FDC should be restricted to skin and soft tissue infections.

Regarding cefadroxil+clavulanic acid, firms should prove the efficacy of the combination by conducting in-vitriol study in good laboratory practice 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 three months of the notification.

For the FDC cefixime+cloxacillin, it has requested the SLAs to direct manufacturers to submit the protocol for conducting in-vitro study to prove the efficacy of this combination to the CDSCO for approval.

For the other two FDCs, the SLAs were requested to direct all the manufacturers to manufacture and market these FDCs for the indication as directed by the CDSCO.

The decision was taken while reviewing the directions of the Nagpur Bench of Maharashtra High Court, related to the approval of these FDCs.

The DTAB in its meeting held on August 27, 2019 also referred these FDCs to the Prof. Mokate Committee and the decision by DCG(I) now is based on the report of DTAB, dated April 13, 2021 and recommendations of the subcommittee of DTAB.

DCGI-dt-27-08-2021-Procedure-for-regulation-of-FDCs-declared-as-rational-in-respect-to-294-FDCs-by-DTAB-which-were-licensed-to-manufacture-and-market-by-SLA-without-approval-of-DCGI

DCGI-dt-27-08-2021-Procedure-for-regulation-of-19-FDCs-declared-as-rational-in-respect-to-294-FDCs-by-DTAB-which-were-licensed-to-manufacture-and-market-by-SLA-without-approval-of-DCGI

DCGI-dt-27-08-2021-Manufacturing-and-marketing-of-certain-FDCs-as-per-directions-of-Honble-High-Court-Maharashtra-Nagpur-Bench

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