NPPA Seeks Clarity on Regulatory Requirements for this Inhaler Device

NPPA is seeking guidance from the CDSCO on the regulatory requirements for Cipla's Ciphaler inhaler device

NPPA National Pharmaceutical Pricing Authority
Picture: Pixabay

Last Updated on July 12, 2024 by The Health Master


The National Pharmaceutical Pricing Authority (NPPA) is seeking guidance from the Central Drugs Standard Control Organisation (CDSCO) on the regulatory requirements for Cipla’s Ciphaler inhaler device.

This innovative Dry Powder Inhaler (DPI) with an in-built dose counter aims to receive special pricing approval based on its unique features.

Cipla’s Application for Ciphaler with Formoterol Fumarate & Budesonide

Cipla submitted an application for a special price for Ciphaler containing two specific formulations:

  • DPI formoterol fumarate 6 mcg + budesonide 200 mcg
  • DPI formoterol fumarate 6 mcg + Budesonide 400 mcg

This application follows a previous rejection by the NPPA in September 2021 for a similar special pricing request.

Improved Usability and Patient Benefits

Cipla emphasizes several advantages of Ciphaler:

  • Easy to Use: The device boasts a user-friendly design that reduces training time for proper inhalation technique.
  • Dose Tracking: The built-in dose counter helps patients monitor remaining medication accurately.
  • Performance: Cipla claims Ciphaler’s in vitro performance matches AstraZeneca’s Turbuhaler device.
  • Enhanced Protection: The design reportedly offers better protection for medication against moisture and temperature fluctuations compared to competitors.

Supporting Evidence and Presentations

Cipla representatives presented detailed information about Ciphaler to the Multidisciplinary Committee of Experts (MDC).

This included:

  • Two Studies: Unpublished studies conducted by Cipla on Indian patients to demonstrate the device’s benefits.
  • Device Features: A presentation highlighting Ciphaler’s indigenously developed, breath-actuated, multi-dose design with a dose counter.
  • Comparative Analysis: Comparisons between Ciphaler and a unit-dose DPI in terms of efficacy, safety, and drug delivery.

Innovation Argument and Pricing Request

Cipla argues for special pricing due to the innovative features of Ciphaler.

They reference their successful application for a special price for their Synchro breath-actuated inhaler (metered dose inhaler) in December 2019, which received recognition for incremental innovation.

Cipla proposes a price range of Rs. 190-240 on top of the existing DPI ceiling price for the two Ciphaler formulations.

MDC’s Observations and Next Steps

While acknowledging the potential benefits of Ciphaler based on Cipla’s studies, the MDC noted the lack of publication in peer-reviewed journals.

Additionally, the committee observed a discrepancy in the application.

Cipla presented Ciphaler as a drug device combination, but their existing approvals from 2001-2002 (central drug regulator) and 2017 (State Licensing Authority) pertain only to the drug formulations, not the combined device.

Therefore, the MDC has decided to seek clarification from the CDSCO regarding the appropriate licensing requirements for Ciphaler as a drug device combination.

This will determine if Cipla needs a fresh approval for the combined product to qualify for special pricing.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.

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