India’s MedTech industry has strongly refuted the claims made by the United States Trade Representative (USTR) in its 2025 National Trade Estimate (NTE) report, calling the criticisms misleading and one-sided. The USTR highlighted barriers to US medical device exports to India, including tariffs, pricing regulations, and unclear rules on importing refurbished equipment. However, industry experts argue that these points ignore the larger context of India’s healthcare needs and policy goals.
India’s Medical Devices Policy 2023 was introduced to reduce the country’s overwhelming 70% dependence on imports—much of which comes from the US. The policy aims to boost local manufacturing through initiatives like production-linked incentives (PLI), medical device parks, and regulatory reforms under CDSCO, BIS, and Legal Metrology. It also supports MSMEs and encourages innovation and fair competition in the domestic market.
Despite this, US multinational corporations often dominate the market through monopolistic practices—buying local firms, limiting component supply like x-ray tubes, and driving up costs. The COVID-19 crisis exposed India’s reliance on foreign suppliers and the resulting supply chain risks. Yet, the USTR continues to label India’s policies as protectionist, overlooking India’s efforts to ensure self-reliance, patient safety, and healthcare security.
India has also restricted imports of refurbished and second-hand devices to promote local manufacturing and uphold safety standards. New high-end equipment is still available for those who can afford it, but the broader goal is to build a resilient, competitive domestic industry. India’s large population and limited purchasing power mean affordability, accessibility, and consistent supply are key priorities.
The USTR’s objections to India’s 7.5% tariff on medical devices are seen as exaggerated. The Indian industry has even called for an increase to 10–15% to further support domestic production.
The USTR also criticizes price controls on coronary stents and knee implants, despite the fact that some states reimburse US-made stents at nearly double the rate of Indian ones, thanks to unethical marketing tactics. This undermines affordability and access for Indian patients.
India’s regulators, including CDSCO and BIS, have undertaken significant reforms, yet the USTR continues to raise concerns about regulatory complexity, customs delays, and intellectual property norms. In reality, Indian Customs has improved clearance times, and India’s IP policies are designed to protect public health through mechanisms like compulsory licensing.
The USTR also takes issue with local content requirements, which are essential to India’s ‘Make-in-India’ push. Ironically, the US follows a similar Buy American policy that restricts Indian companies from accessing American public procurement. The USTR’s stance on India’s data privacy regulations, product standards, and market exit rules fails to acknowledge their importance in ensuring patient safety and system stability.
India’s medical device sector also faces global challenges. In regions like West Asia and North Africa, Chinese dumping undercuts prices, while the EU’s costly and time-consuming CE certifications block market access. Japan’s weak yen and Indonesia’s local preference further restrict India’s exports. Domestically, CDSCO’s delays in issuing licenses and Free Sale Certificates are preventing higher-class device makers from going global.
Low import duties (0–7.5%) and misclassification of goods by importers to reduce customs charges discourage domestic production. Private hospitals also favor high-margin foreign brands, often pricing them with inflated MRPs. As a result, consumers don’t benefit from the low tariffs.
To address these issues, the Global Tender Exemption (GTE) list must be revised by removing 119 devices already being produced in India. Some multinational firms exploit government tender rules by demanding USFDA/CE certification to sideline Indian manufacturers. GeM’s current policy even allows relabelled imports with under 20% local content, with little scrutiny. Enforcing stricter local value addition requirements is key to leveling the playing field.
India must push back against the USTR’s misrepresentations while prioritizing support for its domestic industry during trade negotiations. Reducing dependence on costly imports will lower prices, improve access, and help build a robust healthcare infrastructure. With the right policies, India can become a global medical device manufacturing hub, ensuring affordable and quality care for all.
