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The report, released just ahead of the US’s April 2 deadline for implementing reciprocal tariffs, has also cited high tariffs and price caps — which have not increased in line with inflation — as key obstacles for US businesses.
In the case of refurbished medical devices, the report stated that the absence of guidelines to issue licences and unclear import processes under the Medical Device Rules has historically caused delays and uncertainty, limiting US exports.
It added that US companies have been unable to import their devices into India since April 2024, after the Central Drugs Standard Control Organisation (CDSCO) suspended approvals of existing and new applications for import licences.
This comes after the drug regulator stopped imports of all high-end refurbished medical devices such as magnetic resonance imaging (MRI) scanners and robotic-assisted surgery (RAS) systems, citing patient safety concerns.
Valued at around Rs 1,500 crore, the pre-owned medical equipment market currently constitutes around 10 per cent of the total medical equipment industry in India.
Pavan Choudary, chairman, Medical Technology Association of India (MTaI), said that if President Trump’s aggressive posture prompts broader negotiations that ultimately lower tariff and trade barriers, it could paradoxically contribute to a more open economic landscape.
Raising concerns over price caps on devices such as coronary stents and knee implants by India’s National Pharmaceutical Pricing Authority (NPPA), the report stated that the price controls have not been increased in line with inflation.
It further noted that India maintains very high basic customs duties — in some cases exceeding 20 per cent — on drug formulations, including life-saving drugs and finished medicines listed on the World Health Organisation’s (WHO) list of essential medicines.
The USTR report comes even as domestic medical devices manufacturers have raised concerns over tariff structures.
Domestic manufacturers’ body, the Association of Indian Medical Device Industry (AIMED), emphasised the importance of continued dialogue and balanced trade practices between India and the US in the strategic healthcare sector.
Rajiv Nath, forum coordinator of AIMED, said that the global medical device market requires cooperative and fair trade practices, with equal attention given to both tariff and non-tariff barriers to ensure the sustainability of the industry in both India and the United States.