Govt rejects Abbott, Medtronic applications to withdraw stents

New Delhi: The government on Wednesday rejected applications by multinational firms Abbott Healthcare Pvt Ltd and India Medtronic Pvt Ltd to withdraw their advanced coronary stents from India while asking them to maintain supplies of the products.

In a notification on Wednesday, the national pharmaceutical pricing authority (NPPA) asked the companies to consider options for price revision before deciding to withdraw their products from the market. Last week Abbott had sought permission to withdraw its "alpine drug eluting" stent and "absorb dissolving" stent, while Medtronic had also sought to withdraw its Onyx Zotarolimus eluting stents in the wake of the government bringing the medical device under price control earlier this year.

On 21 February, the government had invoked emergency clause of DPCO 2013, citing public interest and asked stent manufacturers, distributors and suppliers to maintain supplies of their products for six months. In a notification on Wednesday, the NPPA said during the period no such request from the companies to withdraw their products could be entertained.

The NPPA said the companies would be "free to resubmit" their requests two weeks before the expiry of the restrictions, which are currently in operation. When contacted, an Abbott Healthcare spokesperson said that the company is reviewing the memorandum issued by the NPPA. The drug price regulator also asked the two companies to explore options of price revision provided under various rules before exercising "an exit route". It also asked Abbott and Medtronic "to be more cautious and responsible in taking such business decisions in the light of government's commitment to ensure affordability and availability of all essential drugs to the people".

The NPPA also said the two companies did not comply with the government's direction to give weekly reports on the availability of stents. In February, the NPPA had brought stents under price control and capped ceiling price of coronary stents at Rs7,260 for bare metal variety and Rs29,600 for drug-eluting ones. The corresponding average MRPs before the price control stood at Rs45,100 and Rs1.21 lakh, respectively. Last month, the drug price regulator increased price of stents by around 2% after taking into account the wholesale price index.