The proposed India–European Union Free Trade Agreement (FTA) has the potential to reshape India’s pharmaceutical and medical devices landscape, but industry leaders caution that its success will depend on how fairly it balances market access, regulatory alignment and domestic manufacturing interests.

Welcoming the strategic opportunity offered by the agreement, Rajiv Nath, Forum Coordinator of the Association of Indian Medical Device Industry (AiMeD), said the FTA must ensure a level playing field for Indian manufacturers. He emphasised that while deeper integration with the European market could unlock high-value collaboration and innovation, appropriate safeguards are critical to protect domestic industry from unfair competition.

“The India–EU FTA must ensure a level playing field for India’s medical device manufacturers. With fair regulatory alignment and safeguards against predatory imports, especially from third countries, this agreement can unlock high-value collaboration, boost domestic manufacturing, and support India’s ambition to become a top-five global MedTech hub,” Nath said.

India’s pharmaceutical and medical devices sectors have emerged as key pillars of the country’s manufacturing and export ecosystem, supplying affordable medicines and devices to global markets. The EU, meanwhile, represents one of the world’s most regulated and high-value healthcare markets. Industry stakeholders believe that improved access to Europe could accelerate India’s move up the value chain, particularly in complex devices, diagnostics and specialty pharmaceuticals.

However, Nath cautioned that regulatory convergence must be designed carefully. He highlighted the need for a Mutual Recognition Agreement (MRA) anchored in globally accepted ISO standards, ensuring quality, transparency and patient safety while avoiding duplicative compliance burdens for Indian manufacturers. Such an approach, he said, would promote trust and smoother market entry without compromising regulatory oversight.

The concern over predatory imports routed through third countries has also gained prominence in FTA discussions. Industry representatives argue that without adequate safeguards, Indian manufacturers—especially MSMEs—could face pricing pressure from subsidised imports that do not reflect true manufacturing costs or regulatory parity.

Beyond trade in goods, the agreement is expected to influence investment flows, technology transfer and joint research initiatives. Experts believe that a well-structured FTA could attract European investment into Indian manufacturing clusters, supporting capacity expansion, skill development and innovation in both pharmaceuticals and medical technology.

Nath added that the industry is keenly awaiting the detailed provisions of the agreement. “The goal should be mutual growth anchored in quality, transparency and patient safety. We look forward to reviewing the fine print and the follow-on cooperation discussions,” he said.

As negotiations move forward, the pharma and medtech sectors will closely watch how the final agreement balances market openness with domestic industrial priorities, determining whether the India–EU FTA becomes a catalyst for sustainable and inclusive growth.