Cipla's Azithromycin Price Battle: NPPA Increases Ceiling with New Revision
New Delhi: In a major win for Cipla Ltd., the National Pharmaceutical Pricing Authority (NPPA) has issued a revised calculation sheet for the ceiling price of Azithromycin 250mg tablets following a review order from the Department of Pharmaceuticals (DoP).
The review was prompted by an application from Cipla Limited, challenging the earlier price fixation of its product Azee 250 mg tablet 6's, the antibiotic used to treat a variety of bacterial infections.
The newly revised ceiling price for Azithromycin 250mg tablets now stands at Rs 11.67 per tablet, slightly higher than the previously notified ceiling price of Rs 11.65 per tablet issued on March 26, 2024. This revision incorporates data from Cipla's product "Azee 250mg tablet 6's," which was excluded in the earlier calculations.
The pricing analysis reveals that there are 15 companies with more than a 1% market share for the formulation, contributing to a total Moving Annual Turnover (MAT) of Rs 222.13 crore. However, only Rs 193.23 crore of MAT was considered for price calculation, reflecting adjustments to ensure accuracy.
The review order, issued on October 4, 2024, by the DoP, directed the NPPA to reexamine the ceiling price. Cipla argued that its product, "Azee 250mg tablet 6's," had a market share of 2.3% during the period from August 2021 to July 2022. Despite submitting representations with all required documents within prescribed timelines, Cipla claimed that the NPPA had excluded the product from its calculations, leading to an inaccurate ceiling price.
In its defense, the NPPA stated that while Cipla had filed Form II for "Azee 250mg tablet 6's and 10's" on May 2, 2022, with a revised Price to Retailer (PTR) of Rs 9.38 per tablet, the Pharmatrac database used for the calculations did not reflect sales data for the six-tablet pack between August 2021 and July 2022. Further investigation revealed that this pack had been discontinued in October 2019 but was relaunched in March 2021. Updated data from Pharmatrac in July 2023 confirmed the relaunch, warranting its inclusion in the price calculations.
The DoP concluded that Cipla had submitted all necessary filings within the required timelines and noted anomalies in the Pharmatrac database. These errors have since been corrected, leading the NPPA to revise the ceiling price to reflect the updated data.
Also Read: DoP orders NPPA to reassess price of Cipla's Advent, Synclar and Azee drugs
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