USCC seeks trade margin rationalization for medical devices with India

US Chamber of Commerce (USCC) has called for trade margin rationalization for medical devices with India.

The recommendation of part of the comments filed by the US Chamber to the Federal Register Notice issued by the Office of the US Trade Representative on Reviewing and Identifying Unfair Trade Practices.

“Treat knee implants at par with other non-scheduled devices and retain them under Paragraph 20 of DPCO (providing an ability to take a 10% price increase per provisions of Paragraph 20 of DPCO) without an annual revision clause, “ the Chamber said.

The Chamber said there is uncertainty about bringing additional medical devices under price controls without a suitable mechanism separate from drugs and appropriate to medical devices.

“In 2017, the Indian government introduced price controls on cardiac stents and knee Implants, which were ultimately capped after being added to the National List of Essential Medicines (NLEM). American companies in this space now need to consistently navigate a lengthy and cumbersome price review process as part of the NLEM, creating significant uncertainty in the market. Since 2017, the industry has been plagued with multiple challenges, including supply chain disruptions caused by the pandemic, rupee depreciation, increased labor and freight costs, and inflation, among others,” the chamber said.

US Chamber of Commerce also noted that a licensing change in April 2024 has also meant that American medical device companies are now unable to import refurbished/reused medical equipment into India, despite the use of these products globally, including CT scanners and other advanced surgical systems, and despite India’s healthcare system already having adopted some of these products in Tier 2 and 3 cities.

“The change has prevented American companies from importing products for nearly a year despite its product being widely used across India and worldwide. Meanwhile, Indian and non-U.S. OEMs increase their market share,” it said.

US Chamber of Commerce sought a new policy for refurbished medical equipment that could be developed to allow for American companies to import their certified products, passing savings to Indian consumers and enhancing their choice options.
MB Bureau