India-UK FTA draws mixed reactions from medtech leaders amid hopes for trade, innovation, and regulatory clarity

Rajiv Nath , Forum Coordinator, AiMeD:

“While this a path breaking initiative,  FTAs in past have been detrimental to medical devices sector and only made us more important dependent and less Atmaribhar – we had explained our concerns to Department of Pharma and Dept Of Commerce. 

Our concerns had been that for this to be a mutually beneficial deal we needed fast track regulatory approval based on ICMeD – ISO certification to over come non tariff measures put in by UK and to safeguard Indian manufacturers from rerouted products from China etc via UK as purportedly made in UK or UK country of Origin products even if wholly made by a “UK based legal “ (and not actual manufacturer ) manufacturer in a 3 rd country. We had sought Dept Of Commerce to ensure that goods coming under UK FTA benefits to India needed to have over 35 per cent value added in UK with change of tariff heading of inputs to qualify as manufactured in UK- we welcome UK medical devices into India as long as these do not undermine make in India of medical devices in India  .We are seeking finer details to enable us to make an informed comment.”

Pavan Choudary, Chairman of the Medical Technology Association of India (MTaI): 

“Though we are still going through the fine print, strategically, the FTA reflects a geopolitical maturity: two democracies choosing to collaborate on healthcare innovation in an increasingly polarised global landscape. If followed through with rigour and vision, it could set a template for high-trust MedTech trade between developed and emerging economies.

One essential caveat: every FTA, including this one, must mandate clear disclosure of the actual site of manufacture for all imported products as mandated by India’s Central Drugs Standard Control Organisation (CDSCO) which requires separate registration of both the legal and actual manufacturers. The CDSCO is duty bound to implement this provision rigorously, honestly and consistently. This is critical to prevent trans-shipment from third countries or undisclosed locations. Some geographies lack such regulatory rigour, and even within a country, manufacturing plants can vary greatly in standards. Transparent, unambiguous disclosure ensures legal compliance, protects patient safety through true traceability, and upholds a level playing field for all companies and especially  those which adhere to high level of regulatory compliance.”

Ganesh Sabat, Co-Chair FICCI Medical Devices Committee & Non-Executive Director, SMT: 

“Heartiest congratulations to Hon’ble Prime Minister Narendra Modi ji on the historic India-UK Free Trade Agreement (FTA) and the Double Contribution Convention, a landmark achievement amid global trade uncertainties. At SMT, we applaud this much awaited  ambitious trade deal that is set to significantly strengthen economic ties between India and the UK, unlocking new opportunities for the medical devices sector through enhanced collaboration, innovation, and streamlined trade processes.

The FTA addresses key challenges in the MedTech sector by reducing customs tariffs on critical medical devices, such as consumables, implants, and diagnostic equipment, which previously faced duties of up to 7.5 per cent in India and 4.2 per cent in the UK. It also harmonises non-tariff barriers, including prolonged regulatory approval processes in the UK, which have historically limited India’s medical device exports. A Mutual Recognition Agreement (MRA) framework is introduced to expedite market entry for Indian devices certified by the Central Drugs Standard Control Organisation (CDSCO) or the Indian Certification of Medical Devices (ICMED), reducing compliance costs and delays.

The agreement fosters innovation by promoting joint R&D initiatives and public-private partnerships, aligning with India’s National Medical Device Policy 2023. It facilitates technology transfer and the establishment of Centres of Excellence in India, enabling the development of affordable, high-quality medical devices tailored to both markets. 

Additionally, the FTA supports the UK’s Design for Life programme, encouraging sustainable practices like reuse and remanufacturing in MedTech supply chains.

By easing bilateral trade barriers, the deal empowers businesses to export, import, and invest in a more diverse and affordable range of healthcare products.

Indian MedTech exports, valued at $3.8 billion in 2023-24, particularly to the UK, are poised for growth, while UK firms gain improved access to India’s $12 billion medical devices market, projected to reach $50 billion by 2030. This FTA not only strengthens the MedTech ecosystem but also sets a template for India’s trade negotiations with other developed nations, driving economic growth and healthcare accessibility.”