India-US Medical Device Trade: Balancing Access & Self-Reliance

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To counter the potential impact of US tariffs on Indian exports and strengthen trade negotiations, the Indian government is considering offering easier market access to US medical device firms. According to sources, the commerce ministry recently discussed this strategy and asked export promotion councils to identify medical devices that could benefit from improved access to the US market. The proposal includes reducing tariffs, possibly to zero. However, industry stakeholders have raised concerns over the impact on domestic manufacturers.

Industry Voices Concern Over Self-Reliance

As reported by ET, the move has sparked resistance from industry experts who fear it could hinder India’s goal of self-reliance. “If the government keeps lowering duties and allows US manufacturers easier access, how will India ever become ‘atmanirbhar’?” an industry expert questioned. Currently, India imposes a 5-10% import duty on medical devices from the US, whereas the US does not charge any duty on Indian medical device imports.

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Another industry executive pointed out that the US already dominates the Indian medical device market, enjoying negligible non-tariff barriers and low duties. “If we continue easing access, American firms will capture an even larger share of the Indian market,” the executive warned.

Call for Reciprocity in Trade

Industry leaders argue that if India lowers trade barriers for US firms, the US should reciprocate by easing its stringent regulatory norms for Indian medical device exporters. The US Food and Drug Administration (FDA) imposes high regulatory hurdles, making it costly for Indian manufacturers to enter the US market.

“While approvals in India cost almost nothing, obtaining a USFDA certification requires hundreds of thousands of dollars, discouraging Indian manufacturers from expanding into the US,” an industry representative stated.

Another executive expressed frustration over the government’s approach, saying, “Instead of supporting domestic manufacturers, the government is pushing us into an unfair competition.”

Current Import Trends in Medical Devices

At present, India imports around 70% of its medical devices, with the US being the largest supplier. Imports from the US reached ₹12,562 crore in FY24. China is the second-largest contributor, exporting ₹11,506 crore worth of medical devices to India, up from ₹5,101 crore in FY20.

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Some of the key medical devices India imports from the US include:

  • MRI machines
  • Artificial joints
  • Gas analysis apparatus
  • Computed tomography (CT) scanners
  • X-ray and radiography equipment
  • Radiotherapy machines
  • Orthopedic and fracture appliances
  • Surgical forceps and clamps

In addition to the US and China, India also imports medical equipment, consumables, implants, and surgical instruments from Germany, Singapore, and the Netherlands.

Ongoing Trade Negotiations

To prevent the implementation of reciprocal US tariffs expected to take effect in April, the Indian commerce department has been actively engaging with stakeholders. Commerce Minister Piyush Goyal recently visited Washington to negotiate trade terms and ease tensions.

While the government seeks to balance trade relations, the industry remains divided on whether easing access for US firms will boost cooperation or weaken India’s push for self-reliance in medical manufacturing.