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NPPA rejects stent withdrawal applications of Abbott, Medtronic

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Stating that the “statutory Form IV” attached with their “request letter” has not been “duly signed”, the National Pharmaceutical Pricing Authority (NPPA) has rejected the applications of Abbott Healthcare and India Medtronic to withdraw their latest stents from the Indian market.medtronic-abbott

The pricing regulator has advised both the companies “to be more cautious and responsible in taking such business decisions in the light of government’s commitment to ensure affordability and availability of all essential drugs to the people”. Moreover, the regulator advised the companies “to explore the options of price revision” as per provisions of Drug Prices Control Order, 2013 (DPCO, 2013) before “exercising an exit route”.

On Wednesday, the NPPA reminded the firms that as per the order of February 21, 2017, which was passed under Para 3 of the DPCO, 2013, all companies have to maintain uninterrupted supplies of all its stents for six months. Therefore, as powers under Para 3 has been invoked, “no request under Para 21(2) can be considered during the period of restriction”. Abbott Healthcare and India Medtronic did not respond to specific queries of The Indian Express.

On April 21, Abbott Healthcare had filed two applications to withdraw ‘Absorb GT1-Bioresorbable Vascular Scaffold (BVS)’ stents and ‘Xience Alpine Medical Device (cardiac stent)’, respectively. On April 3, India Medtronic had filed the application to withdraw ‘Resolute Onyx Zotarolimus Eluting Coronary Stent System’. Both the companies filed their applications — under Para 21(2) of the DPCO, 2013 — on the ground of “commercial unviability post fixation of ceiling price”.

 

On February 13, the NPPA capped the prices of coronary stents. The ceiling prices of bare metal stents were fixed at Rs 7,260 per piece and that of drug eluting and biodegradable stents were fixed at Rs 29,600 apiece. On March 31, the price caps were increased by NPPA to Rs 7,400 and Rs 30,180, respectively.

 

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