You can't pull stents out, regulator tells Abbott, Medtronic

NEW DELHI: Drug price regulator National Pharmaceutical Pricing Authority has refused permission to

Abbott

and

Medtronic

to withdraw immediately their high end stents from the Indian market. Citing a previous order, re ported by TOI, by the department of pharmaceuticals prohibiting

companies

from withdrawing stents from the market for six months to prevent any shortage, the

NPPA

said after examining the legal status of the applications, the authority is of the view that “once the government has invoked Para 3 of the DPCO, 2013“ no request for withdrawal can be considered.

Para 3 of the

Drugs Price Control Order

empowers the government to direct companies to maintain or increase production “in case of emergency , or in circumstances of urgency or in case of non-commercial use in public interest“.

Abbott and Medtronic -major players in the segment -had submitted applications seeking to withdraw some premium stents citing commercial unviability after the price cap was imposed by the regulator. While Abbott sought to pull out premium dissolvable stents `Absorb' and `Xience Alpine' from India, Medtronic wants to withdraw `Resolute Onyx'.

In the case of Absorb, NPPA suggested the company can make a fresh application seeking to withdraw the product citing “safety concerns“ if it fails to address concerns raised by various regulators.