NPPA Hikes Price of Cholesterol-Lowering Drug Atorvastatin

Published On 2024-11-25 12:53 GMT   |   Update On 2024-11-25 12:53 GMT
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New Delhi: The National Pharmaceutical Pricing Authority (NPPA) has recently revised the ceiling price of Atorvastatin 10 mg, a widely used cholesterol-lowering medication. Initially set at Rs 4.94 per tablet, the revised price, based on updated July 2022 data, has been marginally increased to Rs 4.97 per tablet, following a review order by the Department of Pharmaceuticals (DoP).

The DoP’s intervention was prompted by a review application filed by Abbott Healthcare challenging the methodology used in determining the price. The drugmaker contested that the NPPA had not accounted for updated Price to Retailer (PTR) data during its earlier price calculations. The review authority instructed the NPPA to revisit the ceiling price calculations for three drug formulations, including Atorvastatin 10 mg, in adherence to the Drug Price Control Order (DPCO), 2013.

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Abbott Healthcare argued that the NPPA did not consider the updated Price to Retailer (PTR) for certain brands while finalizing the ceiling price under the National List of Essential Medicines (NLEM) in 2022. Brands such as Atchol from Aristo Pharma, Avas from Micro Labs, and Lipikind from Mankind Pharma were cited as examples of omitted data. Additionally, Abbott pointed out procedural differences, such as the absence of a corrected worksheet being made available for stakeholder review, as outlined in the NPPA’s December 2022 meeting.

In response, the NPPA stated that manufacturers must submit price revisions based on the Wholesale Price Index (WPI) within 15 days of implementing changes. While some companies like Aristo Pharma complied, others, including Micro Labs and Mankind Pharma, delayed submissions. Consequently, the NPPA argued that it adhered to available data for price calculations. Despite this, the review authority noted that procedural gaps, such as the failure to consider legitimate updates, warranted the recalculation of the ceiling price.

Also Read: NPPA Revises Ceiling Prices for 6 Drugs Including Clarithromycin, Vitamin C, Details

Resultantly, NPPA has now released the revised ceiling price for the said formulation. The updated pricing formula incorporates several factors, including the market's Average PTR, retailer margins, and WPI adjustments. With an average PTR of Rs 3.82 and a 16% retailer margin added, the current ceiling price is set at Rs 4.43 per tablet before taxes. Adjustments for the WPI increase have further raised the final price to Rs 4.97 per tablet. The recalculation process highlighted significant variations in prices among various manufacturers, with the lowest priced unit at Rs 1.77 and the highest at Rs 4.87.

Notably, 17 companies hold a market share of 1% or above for this essential cholesterol-lowering medication. The top-performing brands, such as AztoR by Sun Pharma and Avas by Micro Labs, dominate the market, while smaller players contribute to the price disparity.

Also Read: Abbott's Plea Alleging NPPA Used Outdated PTR Data for Metoprolol Pricing Rejected by DoP

To view the DoP price revision order, click on the link below:

To view the NPPA notification (for the revised price), click on the link below:

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