NPPA allows companies to withdraw stent from market

New Delhi: Drug price regulator NPPA said it has decided not to stop any coronary stent manufacturer from withdrawing products from the Indian market.

The National Pharmaceutical Pricing Authority (NPPA) said however that the companies will have to follow the mandatory requirement of informing it six months in advance as prescribed under Drugs Prices Control Order (DPCO), 2013, while also following the ceiling price.

"In this connection, it is informed that NPPA has in-principle decided not to disallow any application submitted for withdrawal of stents from the market by stent manufacturer/importers," NPPA said in an office memorandum.

Under DPCO 2013, a manufacturer is required to inform NPPA at least six months prior to the intended date of discontinuation and also "follow ceiling price in such a manner and till such a time prescribed the government".

Last week, the government had revised ceiling prices of bare metal stents and drug-eluting ones, almost a year after it slashed rates of coronary stents by up to 85 percent. In case of bare metal stents (BMS), the government has increased the prices from current Rs 7,400 to Rs 7,660. On the other hand price of drug-eluting stents (DES) has come down to Rs 27,890 from Rs 30,180.

Read also: Govt Revision of Stent prices: Industry woes but Consumers Rejoice

In April last year, the NPPA had rejected applications by multinational firms Abbott and Medtronic to withdraw their advanced coronary stents from India while asking them to maintain supplies of the products.

Read also: Govt rejects Abbott, Medtronic applications to withdraw stents

The authority had asked the companies to consider options for price revision before deciding to withdraw their products from the market.

Prior to that, the NPPA had brought stents under price control and capped ceiling price of coronary stents at Rs 7,260 for bare metal variety and Rs 29,600 for drug-eluting ones.

Read also: Stent Prices Capped at Rs 29,600, profits slashed

Below is the attached notification.