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Pharma Regulator Calls For Immediate Reporting of Coronary Stent Shortage

These multinational companies had applied to withdraw their apparently latest generation coronary stents from the Indian market with Abbott leading the pack on April 22.

Aradhna Wal | News18.com

Updated:May 3, 2017, 12:21 PM IST

New Delhi: Hardening its stand against pharmaceutical giants Abbott, Medtronic and Boston Scientific, the National Pharmaceutical Pricing Authority has asked hospitals, doctors and patients at large to report on any shortage of coronary stents after these companies had tried to withdraw from India last month.

In an office memorandum dated May 2, the authority requested people to report back shortage of Medtronic’s Resolute Onyx Zotarolimus Eluting Coronary Stent System, Abbott’s Absorb GTI-Bioresorbable Vascular Scaffold (BVS) and Xience Alpine Medical Device, and Boston Scientific’s SYNERGY monorail Everolimus-Eluting Platinum Chromium Coronary Stent System and Promus PREMIER Everolimus- Eluting Coronary Stent System.

These multinational companies had applied to withdraw their apparently latest generation coronary stents from the Indian market with Abbott leading the pack on April 22.

Soon after the government had imposed price cap on stents, the companies had called it commercially unviable to bring the latest technology to India. However, on April 26, the NPPA denied Abbott and Medtronic permission to withdraw their stents from the country, stating the application was not duly signed. The NPPA had also ordered the companies, under the Drug Prices Control Order 2013, to ensure a steady supply of the stents in question and submit weekly reports on their availability.

Monday’s memorandum is another reminder to the industry to stop its posturing, as senior officials in the NPPA see it.

Speaking to News18 soon after Abbott’s announcement, Anand Kadkol the spokesperson for the company said that while the move did not mean there would be any shortage of stents in India, they could not bring their latest technology here. “Following the NPPA price ceiling decision, we have examined and reexamined whether there is a sustainable way to make available in India two of Abbott’s latest stent technologies, the Alpine drug eluting stent and the Absorb dissolving stent, considering their higher manufacturing costs and other associated costs. We have determined it is not sustainable, and we have applied to the NPPA to withdraw these two stents,” said Kadkol.

However, soon enough reports emerged in the media that Abbott’s Absorb, which the company sees as evolutionary technology, had raised safety concerns across the world, including in the US FDA, over adverse events. According to reports, there is no evidence that Absorb, which dissolves into the body over a period of time, has any benefits over the more commonly used metal stents. Sources monitoring the situation say these skeletons tumbling out of Absorb’s closet will damage any popularity it might gain in India.

On the other hand, the NPPA is clear that if Abbott wants to withdraw Absorb, then it has to go on record and address the safety concerns in application to the authority. They cannot, as sources said, kill two birds with one stone; exit the country without stating the real reason and damage the price cap measure by making the government look too controlling for industrial to function.

Absorb’s case is of the different nature. However, the authority isn’t too worried about other stents either. Abbott, echoing the rest of the industry, said it was “disappointed that the NPPA concluded there is no differentiation in coronary stent technology” and that innovation would suffer. The NPPA, however, has put the burden of proof on them, to show that different models of stents require different pricing, which the government’s expert committee of cardiologist — constituted while determining how price cap — found invalid. Abbott’s Alpine, too, has been found to be no different from its previous models that have been in the market longer.

Whether India truly loses out on latest innovations in technology remains to be seen. For now, the government is confident that the industry cannot hope to ignore the vast market it has in the country.

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| Edited by: Swati Sharma
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