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

Harness the Power of Rice Water

Rice water, rich in inositol, antioxidants, vitamins, and minerals, protects hair from sunlight damage and…

13 hours ago

“8 Powerful Herbs and Supplements to Beat Bloating and Boost Your Gut Health Naturally”

Natural Remedies for Bloating: 8 Herbs and Supplements That Work Wonders for Your Gut Health…

13 hours ago

“Unlock the Power of Oil Pulling: Discover How This Simple Practice Improves Oral Health and Freshens Your Breath”

Benefits of Oil Pulling: Stops Bad Breath, Keeps Gums Healthy, But Can't Replace Brushing Oil…

13 hours ago

WHY DO YOU EXPERIENCE RUNNY NOSE AFTER EATING SPICY FOOD?

Spicy food – whether it’s a dash of chili in your curry, a spoonful of…

13 hours ago

“4 Simple Tests to Spot Adulterated Wheat Flour: Protect Your Health with These Easy Checks”

How To Identify Adulterated Wheat Flour? Try These 4 Easy Tests Wheat flour is a…

13 hours ago

“Unlock the Power of Jaggery: 10 Surprising Health Benefits of Eating It After Every Meal”

Reasons That Will Make You Eat Jaggery After Every Meal (Potential Health Benefits Inside) Jaggery,…

13 hours ago