NPPA Panel fixes retail price of antibiotic FDC marketed by Abbott, details

The retail price of each modified release tablet containing Cefixime IP as trihydrate eq. to Anhydrous Cefixime 200 mg (in immediate release form) plus Dicloxacillin Sodium IP eq. to Dicloxacillin 500 mg (in modified release form) plus Lactic Acid Bacillus 2.5 billion spores (appropriate overages of lactic acid bacillus spores added) for Akums Drugs & Pharmaceuticals (manufacturer) and Abbott Healthcare (marketer) has been set at Rs 18.24 per tablet excluding GST.

This recommendation came during the 39th meeting of the Multidisciplinary Committee of Experts held on February 25, 2022 where the issue of retail price fixation of each tablet containing cefixime, dicloxacillin sodium and lactic acid bacillus billion spores manufactured by Akum Drugs and marketed by Abbott Healthcare under Para 5 of the DPCO, 2013 was deliberated.

Cefixime, an antibiotic, is a third-generation cephalosporin like ceftriaxone and cefotaxime. Cefixime is highly stable in the presence of beta-lactamase enzymes. Cefixime binds to specific penicillin-binding proteins (PBPs) located inside the bacterial cell wall, causing the inhibition of the third and last stage of bacterial cell wall synthesis.

Dicloxacillin is a penicillin used to treat penicillinase-producing bacterial infections that are susceptible to the drug. The bactericidal activity of dicloxacillin results from the inhibition of cell wall synthesis and is mediated through dicloxacillin binding to penicillin binding proteins (PBPs).

Tablet containing Cefixime plus dicloxacillin belongs to a class of drugs called antibiotics used to treat several bacterial infections of the urinary tract, ears, nose, throat, chest and lungs.

Lactic Acid Bacillus is a probiotic used to treat diarrhoea caused due to infections, antibiotics etc. It is also used to relieve symptoms of digestive disorders such as irritable bowel syndrome, inflammatory bowel disease, stomach ulcers, constipation, indigestion etc.

At a recent Multidisciplinary Committee of Experts meeting, the panel noted that as per the notice SO.2458(E) dated 24.09.2009, it was decided that for each 10 million spores or part thereof of Lactic Acid Bacillus Rs 0.017 shall be added or subtracted. Accordingly, for 2.5 billion spores of Lactic Acid Bacillus, it comes to Rs 4.25 [ 2.5 billion= 2500 million, ie Rs 0.017/10x2500]

Furthermore, the panel also added, "In the notification number 2458(E) dated September 24 2009 it was mentioned that for each 10 million spores of Lactic Acid Bacillus Rs 0.017 to be added. Accordingly, it is assumed that the retail margin has already been included."

Finally, after detailed deliberation the committee recommended that the retail price of the modified released tablet containing cefixime as trihydrate eq to anhydrous cefixime 200mg (in immediate-release form), dicloxacillin sodium eq to dicloxacillin 500mg (in modified release forum), and lactic acid bacillus billion spores(appropriate overage to lactic acid bacillus added) has been set as 18.24 per tablet excluding GST as detailed below.