The companies are required to give NPPA a six-month warning before withdrawing their stents from the market
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The regulatory agency said that there is no provision that allows the stents to be immediately withdrawn from the market as Abbott had done with its Alpine and Absorb stents.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.
STAY ORDER
- NPPA tells Abbott and Medtronics they cannot withdraw their stents with "immediate effect"
- Decision on application of Boston Scientific is pending
- The companies have sought withdrawal of latest generation stents, not all products
- India's stent market is valued close to Rs 3,500 crore
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