NPPA revises ceiling price of Asthma Inhaler Combination

The Asthma Inhaler in question is a dry powder inhaler (DPI) containing formoterol 6 mcg and budesonide 400 mcg.

May 25, 2024

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Last Updated on June 9, 2024 by The Health Master

Asthma

In a move to ensure accurate pricing of essential medications, the National Pharmaceutical Pricing Authority (NPPA) has implemented a “suo moto correction” for a specific asthma inhaler combination.

Suo moto means “on its own motion” and empowers the NPPA to rectify errors in drug pricing notifications even after they are published.

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The Affected Inhaler Combination

The Asthma Inhaler in question is a dry powder inhaler (DPI) containing formoterol 6 mcg and budesonide 400 mcg.

This combination is used to manage chronic obstructive pulmonary disease (COPD) and asthma.

Initial Price Fixation and Discrepancies

In February 2024, the NPPA set a ceiling price of Rs. 6.62 per dose for this specific DPI combination.

However, several pharmaceutical companies, including the following submitted representations to the NPPA:

Zydus Healthcare,
Glenmark Pharma, and
Mankind Pharma.

These representations highlighted that the initial price calculation might have included an error.

Mankind Pharma’s Clarification and Data Discrepancies

Mankind Pharma, in particular, clarified that they only offered two product variations: a metered dose inhaler (MDI) and the relevant DPI.

They pointed out that the initial price might have mistakenly included their MDI data in the DPI price calculation.

Additionally, they requested a correction in the DPI pack size.

NPPA’s Investigation and Revised Price

Following these representations, the NPPA sought clarifications from both Mankind Pharma and Pharmatrac, the agency that provides market data to the NPPA.

This investigation revealed that Mankind Pharma actually had two DPI SKUs (Stock Keeping Units).

However, there were discrepancies in the reported pack size.

After considering all the available information, the NPPA implemented a suo moto correction and set a revised ceiling price of Rs. 6.95 per dose for the formoterol 6 mcg + budesonide 400 mcg DPI combination.

This revised price factors in the impact of the Wholesale Price Index (WPI) revision effective from April 1, 2024.

Transparency and Market Considerations

The NPPA’s decision highlights its commitment to transparent and accurate drug pricing.

The authority also clarified that even discontinued products with low market share might be considered for price calculations if they appear in market data from recent periods.

This ensures a comprehensive approach to price setting.

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