New Delhi: The National Pharmaceutical Pricing Authority (NPPA) on Thursday permitted Abbott Healthcare Pvt Ltd to discontinue selling its premium metallic stent Xience Alpine Premium from the Indian market.
Rattled by the regulatory intervention on stent prices, the US healthcare giant had applied for withdrawal of its high-end stents last year.
“While we are aligned with the government’s intent for broader access to healthcare, we’re disappointed that NPPA has determined that there is no differentiation for advances among stent generations, which could restrict future investment and innovation that benefits patients. The ceiling price that has been set unfortunately makes it an unsustainable business to continue to supply Alpine given our cost of importation and other associated costs,” said Abbott’s spokesperson.
In August last year, Abbott had expressed its intent to discontinue the product. However, in September NPPA directed the drug giant’s Indian unit Abbott Healthcare Pvt. Ltd to discontinue the product after 12 months of issuing a public notice. Normally, NPPA allows products to be withdrawn after six months; however, in this case, the regulator invoked a “public interest” clause that prevented Abbott from discontinuing the life-saving device for a year to ensure adequate supplies.
“Abbott has fulfilled all the requirements to discontinue selling its XIENCE Alpine drug-eluting stent in India as of April 26. Abbott began notifying hospitals and healthcare providers of the planned discontinuation last year and has ample supply of our other XIENCE stents. Abbott is committed to ensuring patients in India have access to other products in its XIENCE line of drug eluting stents, which are among the most widely used stents in the world with a proven track record of quality and safety,” the spokesperson said.
Citing that the price cut will have a negative?effect?on the?industry’s ability to bring innovations to patients in India, in November Abbott Laboratories had also said that it would not introduce its latest stent Xience Sierra in India.
Last year’s price control on stents—mesh tubes placed in arteries to improve blood flow —led to a price cut of up to 85% and further capping this year prompted many multinational companies to withdraw their premium products from India.
Many multinational firms had demanded a new category of high-end stents, which could be kept out of price control. However, an eight-member health ministry sub-committee that met on 25 January found “no grounds” for the same as the firms did not “present adequate clinical evidence of superiority in terms of safety and benefit of their stents over currently available DES” and dismissed their plea.
Among stent makers and importers who made representations before the committee on 25 January were Boston Scientific India Pvt. Ltd, Abbott Healthcare Pvt. Ltd, India Medtronic Pvt. Ltd, Meril Life Sciences Pvt. Ltd. The companies said with a new category, quality and innovation would be rewarded and the segment kept viable.
Probir Das, chairman of industry lobby Ficci’s Medical Devices Forum and the Healthcare Federation of India’s Medical Technology Forum called the sub-committee’s decision “disappointing”, adding “given the current committee is too invested in their previous decision against stent categorisation, their latest decision is not surprising.” The industry wants the expert committee reconstituted to include private sector specialists, Das added.