The Indian medical device industry has raised objections to a potential reduction in import tariffs on medical devices from the US, arguing that such a move would provide an unfair edge to foreign manufacturers at the cost of domestic producers.
The Association of Indian Medical Device Industry (AiMeD) has urged the government to reconsider the proposal, following discussions within the Ministry of Commerce, which has asked the export promotion council to explore ways to improve market access for US medical device manufacturers.
Industry representatives have pointed out that India already maintains relatively low tariffs on imported medical devices, which has contributed to a heavy 70% reliance on imports. A further reduction in duties could worsen the situation, making it even harder for local manufacturers to compete.
Currently, basic customs duties (BCDs) on imported medical devices from countries like the US range between 0% and 7.5%, said Rajiv Nath, forum coordinator at AiMeD. Several high-tech diagnostic and analytical devices, such as mass spectrometers and gas analysis apparatus, are imported into India at zero duty, while US companies already hold a dominant market share in many segments.
Instead of only focusing on tariff reductions, AiMeD has urged the government to also factor in non-tariff barriers (NTBs) that significantly impact Indian exports to the US.
Indian medical device manufacturers face major hurdles in entering the US market, including high registration fees and expensive clinical trials required by the US FDA. These regulatory costs are often prohibitive, adding millions of dollars in expenses and causing delays that range from months to years.
For example, the cost of regulatory approval for Indian firms to sell their devices in the US varies between $6,000 and $540,000 per device, with approval times ranging from 1 to 30 months. In contrast, US companies can enter the Indian market at a much lower cost, with regulatory fees between $50 and $3,000 per device and a faster approval process of 3 to 6 months.
“If the US insists on imposing reciprocal tariffs, it must also acknowledge these non-tariff barriers that Indian manufacturers face when trying to access the US market,” an industry expert pointed out.
AiMeD has suggested that instead of merely lowering import duties, India should negotiate a fair trade agreement that ensures parity in both tariff and non-tariff regulations between the two countries.
“In the spirit of reciprocity, we urge the government to work towards a balanced trade arrangement where regulatory and tariff measures are uniform for both Indian and US medical device manufacturers,” said Rajiv Nath.
