NPPA fixes price of Cipla Synchrobreathe inhaler device; Details

New Delhi: Price of Synchrobreathe inhaler device manufactured by pharma giant Cipla has been set at Rs 67.20 after the National Pharmaceutical Pricing Authority (NPPA) gave its nod to the price rise in a recently held meeting.

This came after the apex pharma price regulator (NPPA) considered the application for grant of separate price/ special price for "Synchrobreathe inhaler device" under the provision of Para 11(3) or para 32(3) of DPCO 2013 submitted by Cipla.

Synchrobreathe is a breath-actuated inhaler, which helps overcome the co-ordination issues associated with the pressurized metered-dose inhaler (pMDI). It has an inbuilt dose counter which helps track the number of doses remaining. The simplicity of steps of usage makes it easy to use and the sleek design adds to the portability.

The application submitted by Cipla was placed before the Multidisciplinary Committee of Experts in its 14th meeting dated 04.12.2019. Two Pharmacoeconomic experts were co-opted in the Committee. The Committee noted that a separate price could be considered to promote incremental innovation. Accordingly, it recommended a special price of "Synchrobreathe Inhaler Device" for M/s Cipla Limited under para 11(3) of DPCO 2013.

Prior to this, in its 10^th meeting, the committee thought upon the details and documents submitted by the company. Cipla also provided a demonstration and presentation with respect to their product "Synchrobreathe inhaler device". However, due to some further clarification being queried by one member, the issue was transferred to the next meeting.

The Authority, in its 71st meeting dated 09.12.2019 deliberated upon the applications and accepted the recommendations of the Multidisciplinary Committee of Experts to give the separate price of "Synchrobreathe Inhaler Device" for Cipla under para 11(3) of DPCO 2013.

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It approved the additional price for 'Synchrobreathe inhaler device' of Cipla at Rs. 67.20 (excluding GST) on the ceiling price of the Inhalation having the formulation (a) Budesonide 200mcg+ Formeterol 6mcg per dose Inhaler 120 MDI and (b) Budesonide 400mcg+ Formeterol 6mcg per dose Inhaler 120 MDI, based on the recommendations of the Multidisciplinary Committee of Experts.

The Authority also decided that the additional price of Rs. 67.20 (excluding GST) of 'Synchrobreathe inhaler device' of Cipla on the applicable ceiling price of the Inhalation having the formulation (a) Budesonide 200mcg+ Formeterol 6mcg per dose Inhaler 120 MDI and (b) Budesonide 400mcg+ Formeterol 6mcg per dose Inhaler 120 MDI would remain fixed irrespective of the subsequent change in ceiling price of the Inhalation.

"The above-mentioned price of the device is applicable only to Cipla Ltd and subject to fulfillment of all the applicable statutory requirements as laid down by the Govt. under relevant statutes/ rules, including manufacturing license permission from the Competent Authority i.e. the Central/State Licensing Authority, as may be applicable, by the concerned manufacturer/marketing companies," read the NPPA order.

The Authority further ordered Cipla to issue a price list in Form–V from date of Notification as per paragraph 24 of the DPCO, 2013 to NPPA through IPDMS and submit a copy to State Drug Controller and dealers. As per para 24(4) of DPCO 2013, every retailer and dealer shall display price list and the supplementary price list, if any, as furnished by the manufacturer, on a conspicuous part of the premises where he carries on business in a manner so as to be easily accessible to any person wishing to consult the same.

Moreover, the company will have to furnish a quarterly return to the NPPA, in respect of production/import and sale of the device with the formulation as stated hereinabove in Form-III of Schedule-II of the DPCO, 2013 through IPDMS. Any manufacturer intending to discontinue production of above said scheduled formulation shall furnish information to the NPPA, in respect of discontinuation of production and/or import of scheduled the formulation in Form-IV of Schedule-II of the DPCO, 2013 at least six months prior to the intended date of discontinuation, the Authority added.

In case the price of the device is not complied with, as per instant price notification and notes specified, then Cipla will be liable to deposit the overcharged amount along with the interest thereon under the provisions of the DPCO, 2013 read with the Essential Commodities Act, 1955.

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