Stay
order
Two days after the
National Pharmaceutical and Pricing Authority (NPPA) said that they will ensure
all stent brands would be available in the market, they have rejected the
requests of MNCs Abbott and Medtronic to withdraw their latest generation
cardiac stents from the market.
Abbott wanted to withdraw its stents Absorb and Alpine while Medtronic
wanted to withdraw drug eluting stent Onyx from the market. MNCs including
Abbott, Medtronic, Meril Lifesciences and Boston Scientific have around 60 per
cent market share.
The companies are required to give NPPA a six-month warning
before withdrawing their stents from the market. Boston Scientific has written
to NPPA as well, a decision on which is still awaited. NPPA while rejecting the
applications for withdrawal said that the request letters of the companies had
not been duly signed, making their applications technically null and void.
Invoking the Drugs Prices Control Order (DPCO) 2013 the
government said that the two companies would have to maintain an uninterrupted
supply of the stents in the market for the next six months. The companies have
also been asked to send the NPPA weekly reports about the production and
distribution of the stents in the country. “Status check from the Monitoring and
Enforcement Division reveals that the company has not been complying with the
directions of the government,” said the NPPA in its order.
The regulatory agency
said that there is no provision that allows the stents to be immediately
withdrawn from the market as Abbott had done with its Alpine and Absorb stents.
The companies have been informed that they could resubmit their requests within
the next two weeks.
Source: DNA-27th April, 2017
