Pharma body quashes firms’ request withdraw stents from market now

Govt can take six months to review market share, volume of stents before responding

The National Pharmaceutical Pricing Authority (NPPA) squashed the request of two leading international stent manufacturers — Abbott and Medtronics — to withdraw their latest generation of stents from the Indian market. The government regulatory agency that controls the prices of pharmaceutical drugs in India cited the notification released on February 21 which stated that production, import and supply of the coronary stents needed to be maintained for six months.

The NPPA is also examining stent manufacturing company Boston Scientific’s request to let them sell stents in India at “special prices” higher than Rs 30,000. Although the authority had, in February, capped the prices of coronary stents, section 11B of the Drug Price Control Act, allows companies to seek special category status.

NPPA chairman Dr Bhupendra Singh said that a letter was issued to both the companies on February 21 to ensure compliance of the price capping of coronary stents along with maintaining its uninterrupted supply. “This order will be valid for the next six months. But NPPA and Drug Controller General of India (DCGI) may recommend withdrawals or extensions two weeks before the validity expires,” the letter sent by Ministry of Chemicals and Fertilisers Department of Pharmaceuticals stated.

“Absorb, a bio-absorbable stent, was launched in 2016 and it was in the process of building market share. Secondly, using Xience Alpine — a drug eluting stent — needs a lot of special training and it’s not very popular in the country,” said an official

from Abbott. Absorb and Xience Alpine were worth Rs1.9 lakh and Rs1.5 lakh respectively before their prices were slashed.

Another company Medtronics too has written to the NPPA, asking permission to withdraw its drug eluting stent. “We have submitted an application for withdrawal of Resolute Onyx (latest generation drug eluting stent) under the provisions of Drug

Price Control Order. We will continue to supply Resolute Onyx till we get the required permissions,” said an official from Medtronics.

However, the February 15 notification also stated that the government would have six months to respond to such requests by the stent companies. During this period, the government could review the market share and volume of the stents.

On February 15, the government slashed stent prices in the country by nearly 75%. While the bare metal stents were capped at Rs7,260 per unit, the price of drug eluting stents and biodegradable stents has been fixed at Rs29,600 per unit.

This had upset international stent manufacturers who said it was not ‘commercially viable’ for them to sell the stents in India.