Pharma Regulator Revises Coronary Stent Rates a Year After 85% Cut in Cost

NPPA has increased the price of bare metal stents to Rs7,660 from Rs7,260 and reduced the price of drug-eluting and biodegradable stents to Rs27,890 from Rs29,600.

New Delhi: Almost a year after it slashed rates of coronary stents by up to 85%, the government on February 12 revised the ceiling prices of bare metal stents and drug-eluting ones.

In the 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, the price of drug-eluting stents (DES) has come down to Rs 27,890 from Rs 30,180.

The revised prices will be effective from February 13, the national pharmaceutical pricing authority (NPPA) said in a notification.

The ceiling prices shall also be applicable to all the stocks of coronary stents available for sale in the trade channel, it added.

The NPPA said it has been decided that there is no case for subclassification of DES in the light of lack of enough clinical evidence to support the superiority of one DES or other.

The regulator said after intensive deliberations on all the issues and available information/market statistics at its disposal, it was of the unanimous view that “cardiac stents being an essential drug under Schedule I of DPCO, 2013 and part of NLEM, 2015 having paramount importance on public health needs to continue to be kept under price regulation in larger public interest”.

The manufacturers may add Goods and Services Tax (GST) and no other charges in the calculation of MRP, if they have actually paid such taxes or if it is payable to the government on the ceiling price specified, it added.

The notification also said wherever institutions such as hospitals, nursing homes and clinics performing angioplasty procedures using coronary stents are billing directly to the patients, they shall be required to comply with the ceiling prices notified and follow the applicable provisions of the DPCO, 2013.

The regulator also directed all the manufacturers to continue to ensure the availability of all the brands of coronary stents and ensure that no disruption is caused in the supply chain because of printing new MRPs.

The ceiling prices as specified in the order are inclusive of 8% maximum permissible trade margin which is sacrosanct and no additional charge shall be levied on the consumer/patient except applicable GST, if any, paid or payable, it added.

The ceiling price fixed shall be applicable till March 31, 2019, unless revised by another notification, the notification said.

Providing a major relief to lakhs of cardiac patients, the government had cut prices of life-saving coronary stents by up to 85% in February 2017.

A coronary stent is a tube-shaped device placed in the arteries that supply blood to the heart. It keeps the arteries open in the treatment of coronary heart diseases.

The NPPA also said that based on available data from the official sources and manufacturer/importer, the trade margins for the supply of cardiac balloon catheter is as high as 405% over the import cost.

It was 292% for a cardiac drug-eluting balloon or cutting balloon, it added.

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