Amid the ongoing negotiations for the India-EU Free Trade Agreement (FTA), the Association of Indian Medical Device Industry (AiMeD) has urged the exclusion of medical devices from the trade list. In a letter addressed to the Ministry of Commerce, AiMeD highlighted a 68 per cent surge in imports of medical devices into India over the last four years, which has led to the country relying on imports for 70 per cent of its medical device needs.
Rajiv Nath, Forum Coordinator of AiMeD, emphasised that including medical devices in the FTA would endanger India’s medical security and undermine the domestic manufacturing sector. India already maintains low import duties on these products, ranging from 0.0 to 7.5 per cent. AiMeD is concerned that further liberalising imports under the FTA would increase dependence on foreign suppliers and weaken local industry.
Nath pointed out that previous FTAs have led to increased medical device imports. For example, after India signed the Japan-India Comprehensive Economic Partnership Agreement (JICEPA), imports from Japan jumped 19 per cent between FY20 and FY24, from Rs 1826 crore to Rs 3085 crore. Similarly, under the India–Singapore Comprehensive Economic Cooperation Agreement (ISCECA), medical device imports rose from Rs 4294 crore in FY20 to Rs 6779 crore in FY24.
Germany and the Netherlands, both EU nations, are already among the top five exporters of medical devices to India. AiMeD has called for a “Tit-for-Tat” approach in trade policy, requesting that Indian regulators enforce inspections of EU factories and compliance with Indian Medical Device Rules (MDR), similar to how the EU conducts rigorous inspections before importing from India.
The organisation also raised concerns about EU regulations that allow companies to label themselves as "Legal Manufacturers" without necessarily producing the devices, which could enable third-country exports to bypass proper scrutiny under the FTA.
Nath stressed the need for Indian regulatory agencies, such as the Bureau of Indian Standards (BIS) and the Central Drugs Standard Control Organisation (CDSCO), to inspect foreign medical device factories before allowing imports, to ensure compliance with local standards. AiMeD has called for a stricter approach to safeguard the domestic medical device sector, citing examples from countries like China, Japan, and Singapore that have benefitted from similar trade agreements.
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