After price cap, Abbot seeks to withdraw stents from India

Two months after the Indian government capped prices of coronary stents at Rs29,600, US manufacturer Abbott has filed an application with National Pharmaceutical Pricing Authority (NPPA) to withdraw two of its premium stents from the Indian market on the ground of "commercial unsustainability".

The company has sought to withdraw its revolutionary dissolvable stent, Absorb, priced at Rs1.9 lakh each before the cap. The other, Xience Alpine, introduced in 2016, was priced at Rs1.5 lakh till 14 February, when the NPPA ordered slashing of stent prices.

These stents were not exactly hot-sellers in India given their price tags, but a senior cardiologist told The Times of India the development could be an indicator that manufacturers would not bring latest generation stents to the Indian market.

Industry sources said Abbot's resorbable stent accounted for 1 per cent and Alpine for 7 per cent of the company's stent sales in India. Abbott is India's largest stent player as some of its earlier generation stents in the Xience series are still available at Rs25,000.

The withdrawal application was filed at the NPPA office in Delhi on Friday. The NPPA, which controls prices of pharmaceutical drugs in India, in its 14 February notification, capped prices of bare metal stents at Rs7,260 and drug-eluting stents at Rs29,600 (as per a 1 April notification, prices are now Rs7,400 and Rs30,180 respectively).

NPPA chairman Bhupendra Singh told TOI that he had not yet seen Abbott's letter. "There is, however, a provision under the DPCO (Drug Price Control Order) rules for companies to withdraw their products. They, however, have to follow a procedure," he said. NPPA's notification of 14 February said companies would have to give six months' notice to withdraw products.

"If the government believes we need the stents, it can invoke its restraint powers to stop them from being pulled out of the market," added Singh. Another official said there was a three-month deadline from February to prevent companies from seeking an exit.

The health ministry on 7 April issued an advisory about Absorb stents, asking patients and doctors to report adverse incidents with the dissolvable stent.

The advisory followed a European Union decision to stop open sale and only allow registry-based sale of Absorb stents over safety concerns.

"We have taken this step because of commercial unsustainability of Alpine and Absorb. The CDSCO medical device alert of 7 April does not restrict the use of Absorb in India," said an Abbott spokesperson in an email. He said all Abbott products continue to be available in the market "while the government reviews our application".