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  • NPPA Panel fixes...

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

Dr. Divya ColinWritten by Dr. Divya Colin Published On 2022-03-15T18:17:02+05:30  |  Updated On 12 Oct 2023 12:38 PM IST
NPPA Panel fixes retail price of antibiotic FDC marketed by Abbott, details
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New Delhi: The National Pharmaceutical Pricing Authority (NPPA) panel has fixed the retail price of modified released tablet containing cefixime, dicloxacillin sodium and lactic acid bacillus billion spores manufactured by Akum Drugs and marketed by Abbott Healthcare under Para 5 of DPCO, 2013.

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.

Also Read:NPPA panel fixes retail price of Intas Pharma Normal Human Immunoglobulin 5% solution

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.


Sl.No

Company

Unit

PTR

Calculation(Rs)

1

M/s Mankind Pharma Ltd (asper Forum-V data submitted by the company) (for the formulation tablet containing Cefixime 200mg + Dicloxacillin 500mg)

10 Tablets

127.86

12.79

2

Add: Retailer margin@16%(16% of sl No.1)

2.05

3

Calculate Price of (tablet containing Cefixime 200mg + Dicloxacillin 500mg) based on submitted Forum-V by the companies (excluding GST) (sl.No.1 +sl.No.2)

14.84(Retail price per tablet ex.GST)

4

Price of Lacto acid bacillus 2.5billion spore

4.25

5

Worked out Retail Price (3+4)

19.09

6

Less:- 20% of the lowest of (3) and (4) as recommended in the Pronab Sen Committee report

0.85

7

Net Retail Price (5-6) [per tablet excluding GST

18.24

8

Retail Price claimed (per tablet excluding GST)

Rs.19.99 per tablet excluding GST

9

Recommended retail price (price tablet excluding GST)

18.24


Also Read: Cipla gets CDSCO panel okay to manufacture, market Metformin, Sitagliptin FDC


CefiximeDicloxacillinAkum Drugs and PharmaceuticalsAbbott healthcarenppalactic acid bacillus
Dr. Divya Colin
Dr. Divya Colin

    Doctor of Pharmacy

    Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

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