The National Pharmaceutical Pricing Authority (NPPA) has updated the maximum allowable price for atorvastatin 10 mg, a medication used to lower cholesterol, following a directive from the Department of Pharmaceuticals’ review body. On October 4, the review panel approved a reconsideration request submitted by pharmaceutical giant Abbott Healthcare.
The revised price cap, derived from July 2022 data, is now set at Rs. 4.97 per tablet, slightly higher than the previously set limit of Rs. 4.94 per tablet notified on March 26, 2024.
The Department of Pharmaceuticals, in their October mandate, instructed the NPPA to reassess the price cap for three formulations, including Clarithromycin 250 mg, streptomycin 1000 mg per vial injection, and atorvastatin 10 mg, adhering to the regulations set forth by the DPCO, 2013.
Abbott, in its appeal, expressed that while presenting the draft worksheet for ceiling prices listed in the National List of Essential Medicines (NLEM) 2022 on November 25, 2022, they submitted evidence indicating updated Price to Retailer (PTR) for certain brands. Despite this, the NPPA did not incorporate the revised PTR.
Specifically, Abbott pointed out that for atorvastatin 10 mg tablets, the new PTRs for brands such as Atchol from Aristo Pharma, Avas from Micro Labs, and Lipikind from Mankind Pharma were overlooked during the price ceiling establishment.
The company further highlighted that according to the NPPA’s 105th meeting on December 15, 2022, any amendments in draft calculations of ceiling prices must be made public on their website for ten working days to solicit feedback.
In the absence of feedback or once all objections to the revised worksheets are resolved, the findings are submitted to the Authority for final decisions. For cases where data has been verified by Pharmarac, prices will be adjusted based on the revised figures, leading to potential new price notifications, notes NPPA minutes.
Abbott contended that delays in adapting to revised MRPs or PTRs due to the impact of the Wholesale Price Index (WPI) should not be misinterpreted as failure to implement such revisions. Furthermore, discrepancies or delays in updating PTR within market-based data provided by Pharmarac shouldn’t be misconstrued as non-implementation, especially when supporting evidence is submitted.
The NPPA responded that information related to WPI-based price updates should be submitted by May 15, which is a 15-day period from the date of revision. Aristo Pharma submitted their atorvastatin brand revisions in April 2022, while Micro Labs delayed Form II and submitted Form V in July 2022. Mankind Pharma submitted Form V in May and Form II in June.
The NPPA observed no contestations based on the Pharmarac database worksheet posted online within the 10-day policy window, thereby not considering the revised PTR.
Recognizing that the necessary forms under DPCO had been duly completed for the brands in question, the review authority stated, “Not responding within ten days to the NPPA-fixed ceiling price shouldn’t strip the applicant of rightful pricing of the manufactured drugs.”
Consequently, the review authority has redirected the NPPA to recalculate the pricing for the specified formulations.