MDC To Seek Clarity On Licensing Requirement For Drug Device Combination

New Delhi: The Multidisciplinary Committee of Experts (MDC), which advices the National Pharmaceutical Pricing Authority (NPPA), will be seeking clarity from the central drug regulator on the licensing requirement of a drug device combination of Cipla in order to determine whether it should give a special pricing to the product based on the company’s application.

The Committee is seeking clarity on the regulatory requirement, on an application filed by Cipla for grant of separate price or special price for its Ciphaler inhaler device, a dry powder inhaler (DPI) device with an inbuilt dose counter. The applications were for approval of special prices for Ciphaler containing DPI formoterol fumarate 6 mcg + budesonide 200 mcg and formoterol fumarate 6 mcg + Budesonide 400 mcg.

While the NPPA earlier rejected a similar application from the company for a special price for the same product in September, 2021, the company filed a new application on February 15, 2024 for a special price claiming that the drug device combination is easy to learn and use, reduces training time, among others.

It claimed that the product has similar in vitro performance as compared to Turbuhaler, a product from AstraZeneca and provides better protection of the doses from moisture and temperature as compared to the rival drug. The company representatives also appeared before the MDC and made a detailed presentation about Ciphaler containing DPI formoterol fumarate 6 mcg + budesonide 200 mcg/400 mcg and two studies conducted by the company on Indian patients, with respect to their product.

“Accordingly, the Committee decided that clarification may be sought from CDSCO (Central Drugs Standard Control Organisation) with respect to the licensing requirement of the drug device combination and their applicability to the ‘Ciphaler’ i.e whether the company is required to take a fresh approval of the drug device combo from DCGI and State or the approval for drug only as provided by Cipla would be applicable in the instant case,” concluded the Committee after considering various aspects.

The company claimed that the Ciphaler device is an indigenously developed, breath-actuated, multi-dose (discrete), DPI device with an in-built dose counter which helps to reduce errors in the inhaler technique and helps patient to keep track of the number of doses remaining in the device. It also presented two studies which compares Ciphaler with a unit-dose DPI and efficacy and safety of the drugs delivered through the device.

It also argued that it was awarded special price for incremental innovation for its Synchro breath inhaler device (metered dose inhaler) in December, 2019, but for Ciphaler, 20 per cent of price for incremental innovation is low and does not adequately cover the costs of the product. It requested a price of Rs. 190-240 in addition to the DPI ceiling price, for the device containing the two formulations comprising a combination of formoterol fumarate and budesonide.

The MDC, in its latest meeting held in June, after hearing the company’s argument, observed that although two studies undertaken by the company show benefits of the device, they are not yet published in any journal. It also observed that the company has mentioned in its presentation that Ciphaler is a drug device combination.

The company got approval for the combinations from the central drug regulator in 2001 and 2002 and the State Licensing Authority in May 2017. However, these approvals are only in respect of the formulations and not in respect of the drug device combination as claimed in the company’s presentation, it observed while deciding to seek clarification from the drug regulator on the licensing requirement.

The MDC had earlier considered the application of Cipla for special price for the same product and observed that the claim of the company regarding efficacy of the product is yet to be validated and the report as submitted by the company was not based on its product. The Committee recommended rejection of the application and it was accepted by the NPPA in its meeting.

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