NPPA panel fixes retail price of Alkem marketed Amoxicillin, Clavulanate FDC

New Delhi: The National Pharmaceutical Pricing Authority (NPPA) panel has fixed the retail price of each 5ml of the reconstituted suspension containing Amoxicillin in Trihydrate plus Potassium Clavulanate diluted manufactured by Alkem Health Science and marketed by Alkem Laboratories.

The retail price of each 5mI of the reconstituted suspension containing Amoxicillin Trihydrate IP eq. to Amoxicillin 600 mg and Potassium Clavulanate Diluted IP eq. to Clavulanic Acid 42.9 mg for Alkem Healthscience (manufacturer) and Alkem Laboratories Ltd (marketer) has been set at Rs. 3.36 per ml excluding GST.

This recommendation came during the 37th meeting of the Multidisciplinary Committee of Experts held on November 25, 2021, where the issue of retail price fixation of each 5mI of the reconstituted suspension containing Amoxicillin Trihydrate IP eq. to Amoxicillin 600 mg and Potassium Clavulanate Diluted IP eq. to Clavulanic Acid 42.9 mg for Alkem Healthscience (manufacturer) and Alkem Laboratories Ltd (marketer) under Para 5 of the DPCO, 2013 was deliberated.

The combination of amoxicillin and clavulanic acid is used to treat certain infections caused by bacteria, including infections of the ears, lungs, sinus, skin, and urinary tract. Amoxicillin is a penicillin derivative used for the treatment of infections caused by gram-positive bacteria, in particular streptococcal bacteria causing upper respiratory tract infections.

Clavulanic acid is a beta-lactamase inhibitor that is frequently combined with Amoxicillin or Ticarcillin to fight antibiotic resistance by preventing their degradation by beta-lactamase enzymes, broadening their spectrum of susceptible bacterial infections.

At a recent Multidisciplinary Committee of Experts meeting, the panel noted that as per the provisions of DPCO 2013, the retail price of each 5ml of the reconstituted suspension containing Amoxicillin Trihydrate IP eq. to Amoxicillin 600 mg plus Potassium Clavulanate Diluted IP eq. to Clavulanic Acid 42.9 mg for  Alkem Healthscience (manufacturer) and  Alkem Laboratories (marketer) is required to be calculated based on the" market data for the month of February 2021.

The Committee further noted that data of the formulation is not available in Pharmatrac database for the month of February 2021, however, the data of the formulation started appearing from April 2021.

The Committee also noted that the applicant company has claimed retail price of Rs. 4.00 per ml excluding GST.

The Committee deliberated upon the matter in detail and decided to fix the retail price of the subject formulation by calculating as per thé formula provided in DPCO 2013 for calculating retail price of new drugs based on April 2021 data as available in Pharmatrac database.

Accordingly, the Committee recommended the retail price of each 5mI of the reconstituted suspension containing Amoxicillin Trihydrate IP eq. to Amoxicillin 600 mg+ Potassium Clavulanate Diluted IP eq. to Clavulanic Acid 42.9 mg for Mls Alkem Healthscience (manufacturer) and M/s Alkem Laboratories Ltd (marketer) at Rs. 3.36 per ml excluding GST.