NPPA allows Abbott Healthcare to withdraw its latest stents

On September 8, 2017, Abbott Healthcare requested the NPPA to let it withdraw Absorb and Absorb GT1 brands of Bioresorbable Vascular Scaffold from the Indian market as “it is stopping the manufacturing” of these two brands globally because of “low commercial uptake”.

The National Pharmaceutical Pricing Authority (NPPA) on Thursday permitted Abbott Healthcare to withdraw two of their latest generation coronary stents — Absorb and Absorb GT1 brands — from the Indian market.

On March 31 this year, Abbott Healthcare partially removed these latest generation stents from the European Union (EU) market as studies found them to be increasing the risk of major cardiac events. In March itself, the drug regulators of various countries including the US and Australia also issued safety alerts against these stents. Following this, on April 7, the drug regulator issued a medical device alert asking the doctors and patients to report any adverse events related to the use of these two stents of Abbott Healthcare.

On September 8, 2017, Abbott Healthcare requested the NPPA to let it withdraw Absorb and Absorb GT1 brands of Bioresorbable Vascular Scaffold (BVS) from the Indian market as “it is stopping the manufacturing” of these two brands globally because of “low commercial uptake”. A stent is used to open a narrowed or blocked artery to improve blood flow.