Agencies

NEW DELHI: Global stent makers seeking higher prices for their new products in India or exemption from price control may have to wait until February for relief. The government is expected to hold discussions to decide on these requests only in February, a year after it first capped prices of these life-saving devices. Even if they want to discontinue supplies of stents, it is expected to take at least six months before they can do so.“Next February, stent prices as well as grievances and suggestions would be revisited through a consultative process,” a senior government official told ET on condition of anonymity.“At that stage, the government would have a year’s experience and (would be better placed to decide) what the new ceiling prices of stents should be and whether some stents need differential pricing.”The National Pharmaceutical Pricing Authority (NPPA), India’s drug pricing watchdog, slashed prices of coronary stents by over 80% in February and set ceilings for all drug-eluting stents and bioresorbable vascular scaffolds.During the past seven months, some companies approached the Prime Minister’s Office seeking exemption for their new, premium products from price control, two industry executives aware of the development said on condition of anonymity.“Companies have been in constant touch with relevant officials, including the PMO,” said one executive. “One of them has requested an exemption for some later generation brands.”“The import costs for some of these brands are now higher than their ceiling price and companies have provided this information to the government for consideration,” said a third executive who also did not wish to be identified.Some multinationals have tried proving the clinical superiority of their products to obtain a higher price for them. These applications have been rejected as well, according to industry executives. Prices of drug-eluting and bioresorbable stents have been limited to Rs 30,180 and bare-metal stents to Rs 7,400, excluding taxes.Before this move, some of these devices had maximum retail prices of as much as Rs 1.95 lakh. Global stent makers, which made up 70% of India’s Rs 1,400-crore stent market last year, are expected to be the most affected by the price caps.The Department of Pharmaceuticals (DoP), which gave NPPA the green light to cap stent prices, ordered companies to continue making and supplying all their products for six months to prevent sudden shortages. Multinational stent makers Abbott , Medtronic and Boston Scientific approached the NPPA in April with requests to withdraw their high-end stents, but their applications were rejected due to the DoP’s order.Companies cannot discontinue their products from the Indian market for at least six months after informing NPPA, according to the Drug ( Prices Control ) Order, 2013.Even then, the regulator has the authority to direct such companies to continue supplying stents in public interest for up to a year from the intended date of discontinuation. On Friday, Abbott globally announced its intention to stop sales of its bioresorbable vascular scaffold ‘Absorb,’ which sold at Rs 1.8 lakh in India before the price cap.The regulators here were told about the discontinuation, which was due to “low commercial sales,” an Abbott spokesperson told ET. NPPA confirmed that Abbot had applied to withdraw Absorb from India. Abbott has also submitted a new application to stop sales of its other premium stent ‘Xience Alpine,’ a government official told ET on condition of anonymity. Yet, it is not clear whether NPPA will allow Abbott to discontinue the products within six months.