The clash between the government and multinational device manufacturers has intensified after some top companies decided to withdraw high-end stents from India market. With the Department of Pharmaceuticals citing its power to stop companies from pulling out stents, the industry has come out in the open with arguments to back its withdrawal move.
Medical Technology of India (MTAI), an association of multinational device makers, in a strongly-worded statement on Tuesday, said the government should not have a problem with companies exiting India if it feels all stents are the same. MTAI was referring to the government’s measure to cap stent prices at Rs 29,600, irrespective of their make or origin.
“If all drug eluting stents are the same, the industry should have some freedom in deciding which stents to market, as long as a broad range still stays available,’’ the statement said. It added that if on hindsight, the authorities feel that some drug eluting stents are better than others, there is a case for categorization. That, the association said, was the main point which it made to the committee overseeing the National List of Essential Medicines (NLEM), and that it maintained its stand.
While the Department of Pharmaceuticals had on February 22 invoked section 3(i) of the Drug Price Control Order 2013 to stop companies from withdrawing their stents soon after the price cap on stents, the latest bone of contention between the two sides is withdrawal of high-end stents by companies such as US-based Abbott and Ireland-headquartered Medtronic a few days ago.
Both Abbott and Medtronic have filed applications with the National Pharmaceutical Pricing Authority (NPPA) for withdrawing their high-end stents from India market, while pointing out that the government’s price order had made the high-end stents unviable in the country.
The government has the option to stop companies from withdrawing stents for a six-month period that ends in August. Officials said that the government would wait till August before taking a further decision on whether to extend the section 3(i) provision. The DoP may use its discretionary powers and extend the order by a few months, it is learnt. At the moment, stent makers can be prosecuted if they try to withdraw their stents with or without a notice to the National Pharmaceutical Pricing Authority (NPPA).
According to the February 22 order, stent makers need to submit weekly report of production and distribution of stents in India. This includes import of stents. In February, the Department of Pharmaceuticals had also decided to blacklist stent makers who try to sell above the ceiling price fixed by the NPPA or try to create a shortage of quality stents in the market.
Stents were brought under the National List of Essential Medicines last year. Subsequently, it was brought under the schedule 1 of the Drug Price Control Order (DPCO) 2013. After that, NPPA fixed the price of all drug eluting stents at Rs 29,600 despite significant opposition from stent makers.
When the NPPA had fixed the price of all drug eluting stents at Rs 29,600, multinational stent makers had argued that it would become unviable for them to market their latest generation stents. The NPPA’s counter-argument was that the ‘next generation’ stents did not show any kind of superiority over other stents.