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Drug price regulator NPPA has said Abbott Healthcare has been allowed to withdraw latest drug eluting stent Xience Alpine from the Indian market with the Department of Pharmaceuticals not approving its request to block the move.
The company had earlier this month approached the National Pharmaceuticals Pricing Authority (NPPA) to discontinue Xience Alpine stent following capping of prices of medical devices by the drug price regulator.
NPPA said Abbott's request for discontinuation of the stent was considered at the 49th annual meeting of the authority on September 19.
The authority said it had requested the Department of Pharmaceuticals (DoP) to exercise government powers under para 3 of DPCO 2013, under which manufacturers can be directed to maintain adequate availability of drugs/medical devices in case of emergency, circumstances of urgency or non-commercial use in public interest.
"The authority, after examining the legal status of the application and taking into account the fact that the DoP has not accepted the request of NPPA to exercise government powers...NPPA is left with no option but allow formal withdrawal...," NPPA said in a notification.
It insisted that the import cost of Alpine brand was less than the ceiling price and adequate margins were there, "so the reason of unviability of sales in India is not understandable".
NPPA further said: "It was also 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."
When contacted, a spokesperson of Abbott said: "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 spokesperson further said the company would however continue to make its other Xience stents available, which account for the vast majority of Abbott stents used every year in India.
The company lamented that the capping of prices of medical devices has not taken into consideration cost involved in developing new technologies in the field.
"While we are aligned with the government's intent for broad access to healthcare, we are disappointed that advancements among stent generations have not been recognised, which could restrict future investments and innovations that benefit patients," the spokesperson added.
For the withdrawal of Alpine stent, the NPPA directed Abbott to issue a public notice on the same while continuing to maintain uninterrupted supply of the stent for a period of first six months, which will start from the date of publication and submission of a copy of the same to it.
NPPA further said from the seventh month onwards Abbott may start reducing supplies of the stent brand at the rate of 15 per cent every month for another five months and can withdraw the brand completely after the end of 12-month period.
During the period of one year, NPPA said Abbott must ensure uninterrupted supplies on demand made by patients, hospitals and distributors and no artificial barriers are created to hinder availability.
Abbott Healthcare is also required to submit monthly import inventory and sales details by 5th of every month starting from October 2017, NPPA said in its notification.