India, US To Increase Engagement To Address Issues In Medical Devices Trade

Both sides also emphasised their mutual interest in furthering public health discussions to ensure safe and effective medical products

India and the US on Friday agreed to increase engagement to resolve various issues that could negatively impact the trade in the medical devices sector.

The issue came up for discussion during the 14th Trade Policy Forum (TPF) meeting here. It was co-chaired by US Trade Representative Katherine Tai and Commerce and Industry Minister Piyush Goyal here.

According to a joint statement, both ministers acknowledged the need to ensure patient access to affordable medical devices, including through the Trade Margin Rationalization (TMR) approach.

"They also emphasised the importance of enhancing engagement to address measures that could negatively impact the ongoing trade in the sector, such as standards and pricing issues for medical devices, including for cardiac stents and knee implants," it said.

The two sides also noted that this engagement would facilitate access to cutting-edge medical technology for patients.

The ministers shared concerns related to the over-dependence and lack of diversity in Active Pharmaceutical Ingredients (APIs) within the global pharmaceutical supply chain and welcomed the opportunity to collaborate to de-risk and diversify with a focus on key starting materials.

They also emphasised their mutual interest in furthering public health discussions to ensure safe and effective medical products.

"India emphasised the need to increase the number of inspections by the US Food and Drug Administration (US FDA) in India to facilitate trade and continue to reduce the backlog," the statement said, adding the US appreciated India's remarks, noting that the US FDA has increased staffing to increase pharmaceutical inspections conducted by the agency.

India flagged the issue as the US is a key market for domestic pharma exports.

The statement also said that the two countries agreed to establish a pathway in which India and the US will mutually recognise results from accredited conformity assessment bodies utilising International Laboratory Accreditation Cooperation (ILAC) and International Accreditation Forum (IAF) on a bilateral basis whenever possible.

This will allow labs and conformity assessment bodies to certify that products are compliant with certain standards.

The move would eliminate duplicative testing requirements and reduce compliance costs for trade in high-quality goods, it said.

"The Ministers committed to identify priority sectors of mutual interest for implementation and establish a Joint Facilitative Mechanism (JFM) for the same, the terms of reference of which will be finalised at the earliest," the statement said.

To promote trade in marine products, the two countries welcomed the finalisation of the Turtle Excluder Device (TED) design developed with the technical support of the National Oceanic and Atmospheric Administration (NOAA).

"The collaboration between India and the US to expedite the TED demonstrations will confirm that the TED design effectively minimizes the impact of commercial shrimp trawl operations on sea turtle populations," it said.

The NOAA has scheduled its visit to India for February 2024 to carry out field demonstrations with the newly designed TED and conduct workshops for stakeholders.

The move would help in increasing exports of wild-caught fish and shrimps from India to America.

"Both sides acknowledged that the timely completion of the field demonstrations could contribute to the sustainable management and protection of marine and coastal ecosystems, thereby fostering enhanced seafood trade between the two countries," it added.

They agreed to provide sufficient opportunities for stakeholder consultations on the issue and ensure that relevant domestic standards align with international standards to the extent feasible.

On intellectual property rights (IPRs), the US appreciated India's efforts to modernise its patent system and registration processes across its IP offices, particularly through recently proposed amendments to the patent rules, which aim towards streamlining compliance requirements and easing the process of patent filing and granting.

Further, the US welcomed India's decision to reduce the timeline for reaching 20 per cent ethanol blending with petrol from 2030 to 2025 and for the launch of the Global Biofuels Alliance as well as the India-US Biofuels Task Force.

"They offered to explore ways that the US can supplement ethanol supply in India for fuel blending in the event that stocks in India fall short of demand. The Indian side noted the United States' request for cooperation in this regard," it said.

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