Usually, the industry is not part of trade negotiations, as these are conducted on a government-to-government basis.
“In case of medical devices the Commerce Ministry consults the Department of Pharmaceuticals (DoP) and the Pharmaceutical Exports Promotion Council (Pharmexcil) through which key industry associations come into the picture,” Rajiv Nath, forum coordinator, Association of Indian Medical Device Industry (Aimed) said.
Pavan Choudary, Chairman of the Medical Technology Association of India (MTaI) clarified that while a formal advisory body for FTAs has not yet been established, there is an informal framework in place through which industry shares relevant information with the government as needed.
Harsh Mahajan, chair of FICCI–Health and Services and founder of Mahajan Imaging Labs, added that such a body would help the government consider the concerns of private manufacturers, as only they can highlight the exact pain points of the industry.
“It is a must to have such a committee, as it would empower our government to actually speak about our pain points and our expectations from the countries with which an FTA is being made,” he added.
This comes after India and the United Kingdom (UK) concluded talks over an FTA between the two countries.
Choudary added that there should actually be an unified government industry FTA advisory body, where no point of discussion should be missed.
Calling the FTA a path-breaking initiative, Nath said FTAs in the past have been detrimental to the medical devices sector, making India more import-dependent. According to public data from the DoP, India currently imports around 80 to 85 per cent of its medical device requirements.
While welcoming the deal’s finalisation, medtech associations are also wary that tariff reductions could lead to re-routing and dumping of low-quality medical devices from China or other European countries into India via the UK.
Mahajan commented that some substandard products, presented as UK- or US-made, but priced much lower, could severely affect India’s domestic manufacturing market.
Nath added that for the FTA to be mutually beneficial, there is a need to fast-track regulatory approval based on ICMeD–ISO certification to overcome non-tariff measures and safeguard Indian manufacturers from re-routed products from China via the UK.
“We had requested the Commerce Department to ensure that goods coming under FTA benefits to India must have over 35 per cent value addition in the UK to qualify as manufactured in the UK,” he added.
The 35 per cent value addition requirement is likely a rule-of-origin criterion, which ensures that the product undergoes sufficient transformation in the country of origin to be considered a product of that country.
Choudary pointed out that the issue of substandard products is not limited to China. “Even in developed regions such as the UK or Europe, there are countries, cities, or facilities where manufacturing standards may fall short,” he said.
To address this risk, companies have asked for Central Drugs Standard Control Organisation (CDSCO) regulations mandating full disclosure of real manufacturing sites should be strictly enforced.
“Overlooking such regulatory safeguards, whether due to oversight or moral lapse, jeopardizes both patient safety and product traceability. That is simply unacceptable”, Choudary added.
Last year, imports of medical devices from the UK stood at ₹2,295 crore, a 36 per cent rise from ₹1,682 crore in FY2022–23. Major devices imported into India include diagnostic instruments and reagents, needles, ophthalmic consumables and oxygen therapy equipment.
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