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NPPA revises ceiling price of atorvastatin 10 mg based on review order
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Gireesh Babu, New Delhi
November 23 , 2024
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The National Pharmaceutical Pricing Authority (NPPA) has released the recalculated ceiling price of cholesterol lowering drug atorvastatin 10 mg as per the instructions of the review authority under the Department of Pharmaceuticals (DoP). The review authority, on October 4, issued an order in favour of a review application filed by drug major Abbott Healthcare.
The revised ceiling price, based on data in July, 2022, is at Rs. 4.97 per tablet, compared to the current ceiling price of Rs. 4.94 per tablet, notified on March 26, 2024.
The DoP through its order in October, referred back the ceiling price calculation of three formulations - Clarithromycin 250 mg, streptomycin 1000 mg per vial injection, and atorvastatin 10 mg tablet to NPPA for recalculation of the prices as per the provisions of DPCO, 2013.
Abbott, in its review application, said that the draft worksheet of ceiling price under the National List of Essential Medicines (NLEM), 2022, was released on November 25, 2022 and the company had filed its representations stating that despite the company providing the pack shot of latest Price to Retailer (PTR) of certain brands for the formulation, the NPPA did not consider the revised PTR.
For atorvastatin 10 mg tablet, the company said that the revised PTRs of brand Atchol from Aristo Pharma, Avas from Micro Labs, and Lipikind from Mankind Pharma were not considered while fixing the ceiling prices.
The company added that according to the 105th authority meeting, held on December 15, 2022, in case of any revision in the draft calculation of ceiling prices, the corrected working sheet shall be uploaded on NPPA website for 10 working days for comments, if any.
In case of non-receipt of any comments or after addressing any issues received on the revised working sheets, the same shall be placed before the Authority for decision. In those cases, where the data has been verified and confirmed by Pharmarac, prices will be re-compounded based on revised data and a corrigendum or addendum or new price notifications shall be issued, says NPPA minutes.
The company argued that a delay in implementation of revised MRP or PTR based on Wholesale Price Index (WPI) impact should not be construed as non-implementation of WPI based revision, and non-reflection or delayed reflection of PTR in market-based data provided by Pharmarac should not be construed as non-implementation of revised MRP, especially when pack shots of relevant month are provided as documentary evidence in support of price revision.
NPPA argued that the information of price revision based on WPI impact should be submitted to the Authority latest by May 15, which is 15 days from the period of such price revision. The information on price revision from Aristo Pharma related to their atorvastatin brand were submitted in April, 2022, while Micro Labs did not submit their Form II and Form V was filed on July, 2022 and by Mankind Pharma in May (Form V) and June (Form II).
The Authority did not receive any representations regarding the draft worksheet based on the Pharmarac database uploaded on its website within 10 days, and hence, the revised PTR was not considered, it added.
Observing that the requisite forms under DPCO were filed for the subject brands with the NPPA, the review authority observed, "The failure to represent within ten days against the ceiling price fixed by NPPA, may not deprive the applicant of the legitimate prices of drugs manufactured by them."
In this backdrop, the review authority referred the case back to NPPA for recalculation of the prices of the formulations.
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