US gets to the heart of matter, flags concerns on stent prices

Against the backdrop of looming reciprocal tariffs by the Trump administration, the United States Trade Representative (USTR) raised concerns over India's decision to cap pricing of coronary stents, saying such measures dissuade American companies from serving the market. It also flagged concerns of US companies being unable to import their medical devices into India since April last year.

In February 2017, the National Pharmaceutical Pricing Authority had cut average stent prices by as much as 80% and set price caps for all drug-eluting stents and bioresorbable vascular scaffolds, prompting the USTR to write to the then commerce minister and principal secretary to the Prime Minister blaming India's "pricing policy" for causing "serious problems" for US stent makers in India, urging New Delhi not to extend caps to other devices.

In its report, USTR renewed concerns of American companies noting that the price controls have not been increased in line with inflation and do not differentiate on the basis of the cost of production or technological innovation. This, it said, dissuades US companies from serving the Indian market.

The 2025 National Trade Estimate (NTE) Report released by the USTR on Monday highlighted that India maintains very high basic customs duties-in some cases exceeding 20%-on drug formulations, including life-saving drugs and finished medicines listed on the WHO's list of essential medicines. The US market accounts for 30% of overall exports for India's pharma sector.

The annual report, which evaluates trade policies of countries across the world and their impact on US exports, investments, and trade, has around 15 pages on India's policies.

It said the Indian government took advantage of tariff flexibility in the 2019-2020 budget by raising tariffs without any notice or public consultation process on about 70 product categories, including those covering key US exports in the agricultural, information and communication technology, medical devices, paper products, chemicals, and automotive parts sectors. The report also highlighted issues around refurbished medical devices, stating that the absence of guidelines to issue licences and clear import processes under the Medical Device Rules has historically caused delays and uncertainty, limiting US exports.

"US companies report that they have been unable to import their devices into India since April 2024, when India's regulator (Central Drugs Standard Control Organisation or CDSCO) suspended approvals of existing and new applications for import licenses," the report said.

The USTR flagged a range of concerns over India's trade practices that it believes harm its interests. On patents, it said India's overall IP enforcement remains "inadequate" with US brand owners continuing to report excessive delays in trademark opposition proceedings and a lack of quality in examination.