Medical Devices and US Exports: Opportunities and Challenges for Indian Manufacturers

Medical Devices and U.S. Exports: An Emerging Industry Opportunity

Medical devices are primarily being targeted by Indian manufacturers looking to capitalize on the Trump tariffs that have significantly impacted Chinese suppliers. The ongoing tariff war presents a unique chance to expand exports to the U.S. market, with companies beginning to file necessary regulatory paperwork. Rajiv Nath, Managing Director of Hindustan Syringes & Medical Devices Ltd, highlights the potential to replace Chinese syringe exports, given the favorable tariff conditions.

Challenges in the U.S. Market

• High costs associated with FDA approvals.
• Lengthy timelines for obtaining necessary regulations.
• High-risk product registrations can cost up to ₹4.5 crore.

The Growing Demand for Medical Devices

As Trivitron Healthcare's Dr. GSK Velu notes, the evolving global trade environment suggests an increase in orders from the U.S. healthcare sector. Historically, India's exports in medical devices have been modest compared to the immense volume from China, which totaled $14.05 billion in 2023. However, the potential exists for Indian manufacturers to flourish under the shifting market dynamics, with exports hitting ₹5,667 crore ($700 million) in FY24.

Strategic Collaborations to Overcome Barriers

Indian firms are increasingly opting for partnerships and acquisitions to enhance their capabilities. Notably, Zydus Lifesciences’ acquisition of Amplitude Surgical underscores the trend toward utilizing foreign expertise to navigate regulatory landscapes.

As companies prepare to engage with the U.S. market, they must tackle the inherent challenges, including navigating complex regulations and a lack of component supply that can set them back in competition with China.