NPPA panel to examine price of antibacterial FDC Cefixime, Lactic Acid Bacillus

The issue of Fixed Dose Combination (FDC) of uncoated dispersible tablet containing Cefixime 200 mg and Lactic Acid Bacillus 60 million spores was extensively discussed during the 35th meeting of the "Multidisciplinary Committee of Experts," held on August 18, 2021.

Cefixime is a broad-spectrum, third-generation cephalosporin antibiotic derived semi-synthetically from the marine fungus Cephalosporium acremonium with antibacterial activity. Cefixime, like all beta-lactam antibiotics, binds to specific penicillin-binding proteins (PBPs) inside the bacterial cell wall, inhibiting the bacterial cell wall's last stages of synthesis. It is used to treat susceptible Gram negative and Gram positive bacterial infections.

The fixed dose combination of these two drugs, Cefixime and Lactic Acid Bacillus, is indicated for the treatment of bacterial infections, urinary tract infections, constipation, chronic bronchitis exacerbation, antibiotic associated diarrhea, gastro-intestinal disorders, gonorrhea, bacterial infections, otitis media, pharyngitis, and tonsillitis, among other conditions.

Regarding this combination, the NPPA panel noted that the Cefixime 200 mg tablet is a scheduled formulation and its ceiling price is fixed. The present applicable ceiling price is Rs. 9.62 per tablet, excluding GST.

However, the Committee further noted that various companies are manufacturing or marketing the Fixed Dose Combination (FDC) tablet containing Cefixime 200 mg and Lactic Acid Bacillus 60 million spores at a price which is much higher.

Additionally, the committee discovered that the unreasonably higher price is due to the addition of Lactic acid bacillus to the scheduled formulation of Cefixime 200 mg tablet which is not in the public interest.

In view of the above, after detailed deliberation, the committee decided that further examination may be undertaken in this regard.