Govt cracks whip, no stent can be withdrawn for now

The government has invoked special powers under the law to prohibit stent makers from withdrawing their products from the market for the next six months.

Am id reports that several manufacturers, including Abbott and Medtronics, are seeking to withdraw premium, high-priced stents from the Indian market on account of the price cap imposed by National Pharmaceutical Pricing Authority (NPPA), the government has directed companies to maintain production, import and supply of coronary stents to a void any shortage.

Besides, the companies have also been directed to submit a weekly report on coronary stents produced and distributed, along with the production plan for the next week to the NPPA and the Drugs Controller General of India (DCGI). The department of pharmaceuticals (DoP) said it had come across reports regarding shortage of coronary stents in the market and in hospitals. “After due deliberations on the current situation and the alternatives available with the government to resume normal supply of the coronary stents, it has been decided to invoke the powers of Section 3 (i) of DPCO, 2013…,” the DoP said in a letter issued to Abbott Healthcare.

Sources said similar letters had been sent to all stent manufacturers.

Section 3(i) of the Drugs Price Control Order empowers the government to direct companies to maintain or increase production “in case of emergency, or in circumstances of urgency or in case of non-commercial use in public interest”.

The DoP said the order would be valid for the next six months, and the NPPA and the DCGI would recommend its withdrawal or extension, as the case may be, two weeks before the expiry of the peri od.

The NPPA and the DCGI are also empowered to extend these directions to any other producers of coronary stents in India during three-month period, the letter said. Abbott and Medtronic – two major player in the segment – have submitted applications with the NPPA seeking to withdraw some of their premium stents. Other multinational companies are also contemplating similar moves, sources said.

Abbott, which has sought to pull out its premium dissolvable stent Absorb and Xience Alpine from India, cited “commercial unsustainability” as the reason. Medtronic said its “decision to withdraw or introduce products is made only after taking into consideration all guidelines and norms set by the government”.

In February, NPPA capped prices of bare metal stents at Rs 7,260, whereas MRP of both drug eluting stents (DES) and biodegradable stents were fixed at Rs 29,600. Besides capping the MRP, the regulator has also imposed stringent norms on trade margins, discounts and other offers that companies often used to push sales of their products, particularly the high-end expensive ones.

Source- healthworld

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