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 The National Pharmaceutical Pricing Authority (NPPA) has released the revised calculation sheet for the ceiling price of azithromycin 250 mg tablet following a review order from the Department of Pharmaceuticals (DoP) in favour of Cipla Ltd.
The new calculation sheet works out the ceiling price of azithromycin 250 mg tablet at Rs. 11.67 per tablet, as against the current ceiling price of Rs. 11.65 per tablet notified on March 26, 2024. The calculation sheet has listed the price of Azee 250 mg tablet 6's, following the review order.
There are 15 companies with more than one per cent market share of the formulation. While the total Moving Annual Turnover (MAT) of the formulation is Rs. 222.13 crore, the sum of MAT value considered for the price calculation is around Rs. 193.23 crore.
The review authority, in an order issued on October 4, 2024, referred back the matter of ceiling price fixation of the formulation following an application from pharma major Cipla Ltd.
The company at the review authority, argued that its product Azee 250 mg tablet 6's had a market share of nearly 2.3 per cent of the scheduled formulation for the period from August 2021 to July, 2022, and despite representations with supporting documents within the prescribed timelines, the Authority did not consider its brand in calculation of ceiling price.
It argued that the calculation of the ceiling price of the formulation azithromycin 250 mg is incorrect and must be rectified after adding the brand pack size Azee 250 mg tablet 6's.
NPPA informed the review authority that while the company filed the Form II for Azee pack of 6's and 10's, on May 2, 2022 with revised PTR of Rs. 9.38 per tablet, Pharmatrac database of July, 2022 has been considered for calculation of ceiling prices and the brand was not reflected in the database for the period of August, 2021 to July, 2022.
Pharmatrac, after rechecking the data, informed NPPA that the pack of 6 was discontinued in October, 2019 and the value was zero in the current database. However, it later found that the stock keeping unit was relaunched in the month of March, 2021 and in the final data submitted in July, 2023, the details of the pack size was also included for being considered in averaging of PTR.
Observing that the company filed the Form II within the time limits and considering the anomalies in Pharmatrac database and their requisite corrections by the NPPA, the ceiling price of the formulation requires revision.
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