New Delhi: A February order by India’s drug price regulator slashing the price of coronary stents has prompted US healthcare giant Abbott to withdraw its premium stents from the country.
On Monday, the drug giant’s Indian unit Abbott Healthcare Pvt. Ltd received permission to withdraw its premium metallic stent Xience Alpine, less than a week after it was allowed to withdraw its dissolving stents.
The company will have to continue supplies for one year, though.
The drug price watchdog National Pharmaceuticals Pricing Authority (NPPA) allowed the withdrawal after Abbott said it has become commercially unviable to sell these stents.
A stent is a small tube placed inside clogged blood vessels to improve blood flow. In February, the NPPA slashed stent prices by as much as 83% to Rs 29,600 from a maximum retail price of Rs 1.80 lakh.
An Abbott Healthcare spokesperson said, “While we are aligned with the government’s intent for broad access to healthcare, we’re disappointed that advancements among stent generations have not been recognized, which could restrict future investments and innovations that benefit patients. The NPPA has accepted our application to withdraw our latest drug eluting stent technology Alpine. The ceiling price that has been set unfortunately makes it an unsustainable business to continue to provide Alpine, given our cost of manufacture and other associated costs.”
The NPPA order found Abbott’s claim baseless “because there are enough margins to support its sales here,” but still allowed it to withdraw the product.
“The authority after examining the legal status of application and taking into account the fact that department of pharmaceuticals has not accepted the request of NPPA to exercise government powers under Para (3) of the DPCO, 2013 and extend the restriction on the stent manufacturers from withdrawing, NPPA is left with no option but to allow formal withdrawal,” the order added.
Normally, NPPA allows products to be withdrawn after six months; however, in this case, the regulator invoked a “public interest” clause that would prevent Abbott from discontinuing the life-saving device for another year to ensure adequate supplies.
The company will have to maintain “uninterrupted supply” of Alpine equivalent to the average imports for the brand between June and August 2017. From the seventh month, it can begin reducing supplies by 15% until it completely withdraws it.
Abbott will also have to issue a public notice to withdraw Alpine. “It was found that these brands have a sizable market share and its withdrawal will create sudden shortage of stents which will not be in the interest of public health safety,” the order stated.
The Abbott spokesperson added: “We support patient access and will continue to make our Xience stents available, which are the gold standard and account for the vast majority of Abbott stents used every year in India”.