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5 Key Challenges: US Tariffs Slam India’s Medical Device Sector

New Delhi recently voiced strong concerns over the US President’s announcement of a 25% trade tariff and additional penalties. Consequently, Indian medical device manufacturers call this move troubling and shortsighted. These new measures are set to significantly impact the nation’s healthcare landscape. [1]

Understanding the New US Tariffs on Indian Medical Devices

President Donald Trump, in a Truth Social post, declared that India will face a “25 per cent” tariff plus an additional “penalty” starting August 1. [1] He alleged that India imposes some of the highest tariffs globally and has strenuous non-monetary trade barriers. [1] Previously, tariffs on medical devices from India ranged between 0 and 6%, mostly near zero. [3, 5] Therefore, this new 25% tariff represents a sharp escalation. [3, 4] This measure pushes import duties on the Indian medical device industry to as high as 35%, including the existing 10% base duty. [1]

Significant Impact on India’s Medical Device Sector

India’s medical device sector relies heavily on imports, with approximately 80-85% of its total device requirements met through foreign sources. [1] US-based companies hold a substantial share of these imports. [1] For instance, in FY 2023-24, India exported $714.38 million worth of medical devices to the US, but imported more than double that amount, at $1,519 million. [1, 3, 4, 5, 7, 9] Consequently, the new tariff gravely impacts the cost-competitiveness of Indian MedTech exports, particularly affecting crucial low-value, high-volume consumables. [4, 5]

Industry Voices Decry US Medical Device Tariffs

Pavan Choudary, Chairman of MTaI, criticized the US decision, labeling it economically shortsighted and strategically misguided. [1] He emphasizes that such actions target partners, not rivals, potentially shifting Indo-US ties from cooperation to caution. [1] Furthermore, he stated that attempting to punish a sovereign nation’s independent choices through coercive trade measures is inappropriate and counterproductive. [1] Rajiv Nath, Forum Coordinator of AiMeD, an Indian device makers’ body, similarly suggests that these steep tariffs will protect US-based manufacturers. [1, 5] This could potentially reverse investments into the US for products where Indian players previously held a competitive advantage. [1]

Addressing Non-Tariff Barriers and Regulatory Hurdles

Beyond the direct tariffs, non-tariff barriers remain a significant challenge for Indian medical device exporters. [3, 5, 7, 8] The US Trade Representative (USTR) previously outlined certain compliance requirements in India as burdensome. [1, 10] Conversely, the US Food and Drug Administration (FDA) imposes stringent regulatory hurdles, making it costly for Indian manufacturers to enter the US market. [3, 5, 6, 7] FDA approval costs range from $9,280 to over $540,000, while US exporters face minimal costs in India. [5, 7] Therefore, addressing these imbalances through bilateral collaboration is crucial for fair trade. [5, 7]

Path Forward: Diplomacy and Domestic Strengthening

The Union Commerce Ministry has noted that the government is studying the implications of the US President’s statement on bilateral trade. [1] They will take all necessary steps to secure national interest. [1] Additionally, India and the US have engaged in multiple rounds of talks to discuss sectoral trade terms. [1] There is ongoing discussion about India potentially lowering tariffs on US medical devices in exchange for reciprocal treatment for Indian pharmaceutical products, including generics. [6, 10, 13, 14] Ultimately, the medical device industry in India requires governmental support in bilateral negotiations for a balanced approach to tariffs and regulatory policies to secure its global position. Explore pharmacy specialty courses.

References

  1. Med Device makers decry US Tariffs as Troubling, Shortsighted – ETHealthworld.
  2. USITC’s – US-India Trade Tensions and Medical Devices. U.S. International Trade Commission.
  3. Will US tariffs hit the medical device industry in India? Here’s decoding the ripple effect. The Indian Express. April 6, 2025.
  4. How US tariffs are going to affect MedTech industry in India. Mojo4Industry. May 3, 2025.
  5. Impact of reciprocal tariff levy on India’s medical device sector. Express Healthcare. April 3, 2025.