The medical devices industry has welcomed the successful conclusion of UK-India Free Trade Agreement, though pointing out certain aspects regarding the country of origin of the products to be kept in focus while proceeding with the engagement.
Medical Technology Association of India (MTaI), the association of research-based medical technology companies, said that the agreement should be followed through with rigour and vision.
""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 polarized global landscape. If followed through with rigour and vision, it could set a template for high-trust MedTech trade between developed and emerging economies,” said Pavan Choudary, chairman of the Association.
“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,"" he added.
The CDSCO is duty bound to implement this provision rigorously, honestly and consistently and 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, added Choudary.
While welcoming the initiative, The Association of Indian Medical Device Industry (AiMeD), the umbrella organisation of Indian medical devices manufacturers, has raised concerns about the potential impact on India’s medical device sector, emphasizing the need for safeguards to protect domestic manufacturing from unfair competition.
Rajiv Nath, forum coordinator of AiMeD, said, ""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 Department 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 third country,"" he said.
""We are not afraid of competing with UK made products. We had sought Department of Commerce to ensure that goods coming under UK FTA benefits to India needed to have over 35% 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” he averred.
Prime Minister Narendra Modi and Prime Minister of the United Kingdom Sir Keir Starmer on May 6, announced the successful conclusion of a mutually beneficial India – UK FTA, and the Government of India has said that this is a modern, comprehensive and landmark agreement which seeks to achieve deep economic integration along with trade liberalisation and tariff concessions.
The FTA ensures comprehensive market access for goods, across all sectors, covering all of India’s export interests, said the ministry of commerce and industry. India is expected to gain from tariff elimination on about 99% of the tariff lines covering almost 100% of the trade value offering huge opportunities for increase in the bilateral trade between India and the UK.
The FTA is also designed to provide a positive impact on manufacturing across labour and technology intensive sectors and opens up export opportunities for sectors such as textiles, marine products, leather, footwear, sports goods and toys, gems and jewellery and other important sectors such as engineering goods, auto parts and engines and organic chemicals. This will substantially improve Indian goods competitiveness in the UK vis-a-vis other countries.
The Ministry said that India has ensured that non-tariff barriers are suitably addressed to ensure free flow of goods and services and that they do not create unjustified restrictions to India’s exports. The FTA seeks to promote good regulatory practices and enhance transparency that are in sync with India’s own focus on domestic reforms to enhance the ease of doing business.