New Delhi: After Abbott Healthcare Pvt. Ltd, another major multinational medical devices maker, Boston Scientific Corp., is considering withdrawing its high-end heart stents from India.
A person privy to the development said the company’s representatives met National Pharmaceutical Pricing Authority (NPPA) officials on Tuesday, seeking to withdraw its next-generation product “Synergy" stent from the market. The move comes three days after the regulator said that stent makers seeking revision in prices would have to wait until February.
Boston Scientific did not immediately respond to an email.
NPPA had slashed the prices of coronary stents by over 80% in February and set ceilings for all drug-eluting stents and bioresorbable vascular scaffolds (BVS).
The drug price regulator clarified last Friday that there would be “no mid-term" revision of stent prices.
The person cited above said on condition of anonymity that Boston Scientific representatives met NPPA officials to request that the company be allowed to withdraw its Synergy stents.
“The company is yet to file a withdrawal application before the NPPA but they had long discussion with the price regulator. The NPPA has asked the company to reconsider their decision of withdrawal," another person aware of the matter said.
Before the price cap, Boston Scientific’s Synergy stent used to cost Rs1.95 lakh each. The company had also approached NPPA in March, arguing that the landing cost (the company’s cost of manufacturing the stent in the country of origin) of Synergy was higher than the selling cost. It had asked NPPA to raise the price cap, citing Synergy’s superiority over other stents.
“The request was rejected as the drug pricing authority and the ministry of health and family welfare had not found any scientific data backing the company’s claims," said a senior official in the ministry of health and family welfare, requesting anonymity.
Another stent maker, Medtronic, had also sought to withdraw its Onyx Zotarolimus eluting stents but the NPPA rejected its application.
Stent makers have been engaged with the government since the price cap was announced in February. Recently, the manufacturers even approached the Prime Minister’s Office (PMO), seeking exemption from price caps for high-end stents. The stent manufacturers said selling their products in India at lower prices was not commercially viable for them.
Officials from the PMO met health ministry and pharmaceuticals department (under the ministry of chemicals and fertilizers) officials to seek suggestions on the stent makers’ representation. On Friday, however, the NPPA made it clear that there would be “no mid-term revision" of prices.
Abbott Laboratories, one of the biggest makers of coronary stents, recently halted global sales of its fully absorbable stent—Absorb bioresorbable vascular scaffold (BVS)—citing low “commercial sales". Absorb, was priced at Rs1.9 lakh each before the cap. Likewise, another stent-Xience Alpine, introduced in 2016, was priced at Rs1.5 lakh till 14 February, when NPPA slashed stent prices. Additionally, Meril Life Sciences—manufacturer of indigeneous BVS stents—has halted the launch of new stents in the market.
Boston Scientific did not respond to an email sent till the time of going to the press .