USTR flags barriers for med device export to India ahead of Apr 2 deadline

Move comes even as domestic medtech manufacturers lobby asked GOI to work towards a fair deal

Ahead of the April 2 rollout of its reciprocal tariff plan, the United States Trade Representative (USTR) has raised concerns over barriers to medical device exports to India in its 2025 National Trade Estimate (NTE) Report on foreign trade barriers.

 

The report, released on March 31, highlighted high tariffs, price caps that have not kept pace with inflation, and delays caused by the absence of guidelines for importing refurbished medical devices as major hurdles for American businesses.

 

It stated that the Government of India increased tariffs without notice or public consultation on approximately 70 product categories in the 2019–20 Budget. These included key US exports such as medical devices and chemicals.

 

 

Raising specific concerns over price controls on coronary stents and knee implants imposed by India’s National Pharmaceutical Pricing Authority (NPPA), the report said these caps had not been revised in line with inflation. “These caps do not differentiate on the basis of the cost of production or technological innovation, which dissuades US companies from serving the market,” it said.

 

The report also noted that India maintains high basic customs duties—exceeding 20 per cent in some cases—on drug formulations, including life-saving medicines and those listed on the World Health Organisation’s (WHO) essential medicines list.

 

In the case of refurbished medical devices, the USTR cited the absence of clear licensing guidelines and import procedures under India’s Medical Device Rules as a source of delay and uncertainty, limiting US exports. It added that American companies have been unable to import such devices since April 2024, after the Central Drugs Standard Control Organisation (CDSCO) suspended approvals for existing and new import licences.

 

The CDSCO move halted imports of high-end refurbished devices such as magnetic resonance imaging (MRI) scanners and robotic-assisted surgery (RAS) systems, citing patient safety concerns. India’s pre-owned medical equipment market, valued at around Rs 1,500 crore, constitutes about 10 per cent of the country’s overall medical equipment industry.

 

The USTR also noted that US firms have faced extensive inspections and seizures of imports that appear unrelated to risk. “India’s customs authority generally requires extensive clearance documentation, often in electronic and paper format, which is duplicative and leads to lengthy processing delays,” the report said.

 

The report also raised concerns about India’s quality control mechanisms, particularly those issued by the Bureau of Indian Standards (BIS). “Since 2019, India has made a number of BIS standards mandatory for quality control purposes in an increasing number of sectors, including chemicals, medical devices, batteries, electronics, food, and textiles,” it said.

 

The USTR report added that these standards are not fully aligned with international norms, do not provide clear means of establishing conformity, and often impose burdensome requirements without stakeholder consultation. It also flagged unclear timelines for transition and validity of licences.

 

Domestic lobby seeks fair terms

 

The USTR report coincides with growing concerns among domestic medical device manufacturers over India’s own tariff regime.

 

Last month, the Association of Indian Medical Device Industry (AIMED) urged the Centre to reconsider recent discussions on reducing import duties on medical devices from the United States.

 

According to data from the Department of Pharmaceuticals, India imports 80 to 85 per cent of its medical device requirements, with the US being the largest supplier. In the financial year 2023–24 (FY24), India imported devices worth Rs 12,552 crore from the US, a significant increase from Rs 7,547 crore in FY20.

 

Key imports include mass spectrometers, gas analysis apparatus, MRI machines, and other analytical and diagnostic equipment.

 

“Currently, India imposes basic customs duties (BCDs) ranging from zero per cent to 7.5 per cent on medical devices imported from countries like the United States,” AIMED said.

 

The association called on the government to ensure reciprocity in trade agreements and enforce tighter controls on maximum retail prices (MRPs) and trade margins, particularly for essential medical consumables and implants such as stents.