Indian medical device manufacturers are sensing an opportunity to replace Chinese suppliers and expand exports to lucrative US market, however, some players are citing challenges in scaling up rapidly, as well as procedural barriers in accessing the US market.
The ongoing tariff war between US and China has pushed the Trump tariffs on Beijing to cover nearly all goods including medical devices, substantially eroding China’s cost arbitrage with Indian medical devices. In an attempt to capitalize on gap that has now been created, some of the India medical devices companies have started working on regulatory filings and paperwork, to ensure that they do not miss out on a business opportunity.
“China does a lot of syringe exports to US market at lower prices, with the tariffs in place, we have an opportunity,” Rajiv Nath, Managing Director, Hindustan Syringes & Medical Devices Ltd and Forum Coordinator for the Association of Indian Medical Device Industry (AIMED) said.
Nath’s company HMD is among the world’s leading manufacturer of syringes and exports surgical blades to US, and already possesses 510(k) registration with USFDA for syringes, but couldn’t export due to market conditions. Rajiv Nath said the company is considering reviving its 510(k) filing with an aim to export syringes to US.
Dr GSK Velu, Chairman & Managing Director of Trivitron Healthcare, a leading medical devices manufacturer said that the global trade environment is evolving, and it would take at least 3-6 months for clarity to emerge. Velu said the tariffs are also positive for the radiation protection business and he expects traction in orders from US healthcare providers operating in this space.
Trivitron had acquired US-based The Kennedy Company, that makes aprons, shields, gloves, eyewear and storage systems, protecting patients and workers from radiation in X-ray, CT scanners and nuclear medicine rooms.
The industry players believe India has the capability to become a potential alternative supplier to China, especially in manufacturing lower-cost, high-volume items such as consumables, disposables, select surgical instruments and IVD reagents. Companies like Poly Medicure already have a strong export base, however, for the full range – especially high-end technology – the manufacturer still relies heavily on imports.
America is a Major Market
US is the top export market for Indian medical device manufacturers, and has gained momentum in the post pandemic years. In FY24, India exported medical devices worth Rs 5,667 crore ($700 million), consisting of electronic equipment (46% export share), consumables (34%), disposables (7%), implants (7%), with the rest being IVD reagents and surgical instruments.
India’s share of exports dwarfs in comparison with China, which exported $14.05 billion worth of medical equipment in 2023 alone, according to US trade data, with some estimates pegging the actual Chinese exports to be around $20 billion.
Challenges Before India
Indian medical device makers claim that penetrating US market is not easy for them due to non-tariff barriers like high filings costs, lengthy timelines for approvals, and regulatory hurdles. Certain devices would require clinical trials too, exacerbating the cost.
For example, according to Hindustan Syringes’ Rajiv Nath, to register a product as basic as a bandage, it costs about Rs 8 lakh and a month’s time. For devices like pulse oximeters, catheters, syringes, and infusion pump, the registration costs go from Rs 14 lakh to 29 lakhs and takes about 9-24 months. To register high-risk products like cardiac stents, valves and ventilator with US, the costs can go up to Rs 1 crore to Rs 4.5 crore, and may take about 18-30 months.
To overcome the complexity of market entry and technology barriers, Indian companies are increasingly looking to acquire or collaborate with foreign firms. Recently Zydus Lifesciences acquired France-based orthopedic implant maker Amplitude Surgical in a deal valued at €256.8 million (over Rs 2,400 crore), while Meril acquired Maxx Medical, an established US-based orthopedic devices company.
The other challenge for India is that the country is not a major supplier of components such as semi-conductor chips, sensors, actuators, displays, that go into manufacturing of medical devices. China has emerged as powerhouse of component supplies, making it critical part of supply chain.
“It’s not possible to build component manufacturing eco-system, if we don’t make finished products,” Hindustan Syringes’ Rajiv Nath said.
To add to that, India manufacturers are also worried about China devaluing its currency yuan to make it more competitive or re-routing its exports via third countries to US.
