DGCI has certified three FDCs comprising cefixime and cefadroxil as reasonable

The Drugs Controller General (India) has approved the three fixed dose combinations (FDCs) cefixime+cloxacillin, cefaxime+cloxacillin+lactobacillus, and cefadroxil+clavulanic acid as reasonable under specific situations.

FDCs of cefixime+cloxacillin and cefixime+cloxacillin+lactobacillus can be deemed reasonable if cloxacillin is given in a sustained-release form in twice-daily dosages and the FDC’s prescription is limited 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 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.

 

Medically Speaking

Recent Posts

ANTIBIOTIC MISUSE IN INDIA: HOW IT’S MAKING INFECTION TREATMENT MORE CHALLENGING

Antibiotic use has surged globally, leading to a rise in antibiotic resistance, especially concerning in…

6 hours ago

CHILD DIES FROM CHOKING ON CANDY: HOW TO SAFEGUARD AGAINST CHOKING HAZARDS IN YOUNG CHILDREN

Choking is a leading cause of injury and death in young children, particularly those under…

8 hours ago

Video: How Hard Water Leads to Hair Fall and Expert Tips to Combat It

Hard Water (Khara Pani) Leading To Hair Fall Hard water is rich in minerals and…

9 hours ago

“How High Blood Pressure During Pregnancy Is Rising: What Every Expectant Mother Should Know”

Discover how the rise in high blood pressure during pregnancy is impacting maternal and fetal…

9 hours ago

“Revitalize Your Weight Loss Journey: 6 Powerful Homemade Drinks to Naturally Melt Away Fat!”

"Discover the transformative power of six delicious homemade drinks that can help you naturally melt…

9 hours ago

“Revitalize Your Weight Loss Journey: 8 Powerful Fat-Flushing Drinks to Boost Your Results!”

"Transform your weight loss routine with these eight delicious fat-flushing drinks that not only hydrate…

10 hours ago