Indian Medical Device Industry Pushes Back Against Zero-Duty Imports Under EU-India FTA

New Delhi, Sep 24 (KNN) As the India-EU Free Trade Agreement (FTA) negotiations progress, tensions have emerged between domestic medical device manufacturers and the government over the proposed zero-duty imports for medical devices.

The Association of Indian Medical Device Industry (AiMeD), representing the country’s medical device makers, has strongly opposed the proposal, citing concerns over unfair competition and safety loopholes.

India currently relies on imports for 70 per cent of its medical devices, with Germany and the Netherlands ranking among its top suppliers.

Over the past four years, imports from Germany surged from Rs 4,742 crore in FY20 to Rs 7,490 crore in FY24, while imports from the Netherlands rose from Rs 2,329 crore to Rs 3,815 crore over the same period.

In a letter dated September 21, AiMeD Forum Coordinator Rajiv Nath expressed strong opposition to the zero-duty proposal, addressing key government officials, including Arunish Chawla, Pharma Secretary, and Nitin Yadav, Joint Secretary, Department of Commerce (Medical Devices).

Nath emphasised that the EU regulatory system allows companies to label themselves as legal manufacturers without making the products themselves, leading to what he described as "pseudo-manufacturing."

He claimed that this practice creates a loophole, as EU regulations do not require the country of origin to be listed on the labeling of medical devices, unlike in the US and India.

“This has allowed pseudo-manufacturing to thrive in the EU, as ‘country of origin’ is not insisted upon on medical device labels in Europe and the UK,” Nath wrote.

He added that AiMeD had previously received assurances regarding the UK-India FTA, ensuring that medical devices not genuinely manufactured in the UK would not qualify for zero-duty benefits.

AiMeD raised concerns that if the zero-duty provision were enacted under the EU-India FTA, devices produced in China and Taiwan could enter the Indian market via Europe, further undercutting domestic manufacturers.

The association urged the government to focus on Mutual Recognition Agreements (MRAs) for regulatory approval and the Quality Management System (QMS) certification for Indian exports.

Nath also recommended factory inspections by Indian regulators, such as the Bureau of Indian Standards (BIS) and the Central Drugs Standard Control Organisation (CDSCO), to ensure compliance with Indian regulations and protect local manufacturers.

As trade talks continue, the domestic industry hopes these concerns will shape the final agreement, ensuring fair competition and safeguarding patient safety.

(KNN Bureau)