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Articles by Rajiv Nath
India’s Needs For Dedicated Medical Devices Act: One Regulatory Framework For Challenges
When India unveiled the Draft Drugs, Medical Devices & Cosmetics Bill, 2026, expectations were high. With import dependence in medical devices hovering at 70–80 per cent and the domestic market presenting a significant opportunity for local manufacturing and exports, the legislation could have marked an important step towards positioning India as a global medical device hub.
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Pacemakers to syringes: Why India needs fair pricing for medical devices Medical devices cannot be regulated like medicines.
Budget 2026: A defining moment for India’s medical devices and life sciences industry
The Union Budget 2026 marks one of the most strategically consequential policy statements for India’s life sciences and medical devices sector in recent years. At a time when global supply chains are being rearchitected and nations are competing fiercely to attract biopharma and MedTech investments, India has signalled, with unusual clarity, its ambition to become a globally competitive innovation and manufacturing hub.
India–EU FTA: A Defining Opportunity To Elevate India’s Medical Devices Sector - BW Healthcare World
The India–EU Free Trade Agreement (FTA) marks a pivotal moment for India’s medical instruments, appliances and vital supplies sector. Built on advanced manufacturing, precision engineering, and a rapidly expanding innovation ecosystem, the industry is poised to benefit significantly from the elimination of tariffs of up to 6.7 per cent across 99.1 per cent of trade lines.
The Rise Of Lifestyle Diseases Among Young Indians: The Road Ahead For Treatment
India’s greatest strength its youth now faces a silent epidemic that threatens to erode our demographic dividend. Lifestyle diseases once associated with middle age diabetes, hypertension, obesity, cardiac illnesses, and even mental health disorders are increasingly being diagnosed in people in their twenties and thirties. Our epidemics have moved on from communicable diseases to non-communicable lifestyle diseases at all age groups. This is not just a health challenge. It is a developmental one.
USTR claims vs India's medical device policy
The United States Trade Representative (USTR) has highlighted issues in its 2025 National Trade Estimate (NTE) report about barriers to exporting medical devices to India. These concerns include high tariffs, price controls, and unclear guidelines for importing refurbished medical devices. The USTR earlier expressed concerns about the lack of adjustments in price caps for essential medical devices such as coronary stents and knee implants.
Medical device makers need a booster shot
As India breaks into the ranks of the top economies of the world, the time is right to seize every available opportunity to make domestic industry thrive. One neglected segment, though, is medical device manufacturing — despite it having stepped up during Covid-19, when global supply chains were disrupted and there was a call for an atmanirbhar (self-reliant) Bharat.
Digital MedTech: Unlocking New Revenue Streams for Hospitals
By Rajiv Nath, Forum Coordinator, AIMED (Association of Indian Medical Devices Industry) Traditional hospital revenue is challenged by lower reimbursements, rising costs, shifting patient expectations, and competition. CEOs are increasingly concerned about shrinking profits.
Medical Devices Industry Will Expand Exponentially In 2024
As India strives to enhance its position as a global player in the healthcare sector, the medical devices industry is likely to witness continued expansion, offering significant opportunities for growth, investment, and technological innovation during FY2024-25 Photo Credit : Shutterstock, Print this article Font size -16+ The prospects of the medical devices industry in India appear promising in 2024 as the sector continues to undergo significant advancements and growth the expected...
Medical Devices Industry Outlook In 2023 Cautiously Optimistic
Sadly, after over two years of PM Narendra Modi’s call for self-reliance Aatmanirbhar Bharat, India’s trade deficit with China is still on high rise and widened to a record USD 72.9 billion in 2021-22.
Volunteering for a vaccine trial
Bharat Biotech launched its Phase 3 clinical trials in late-November and in my town, Faridabad, at the ESI Medical College. The invitation received from ESI via the Faridabad Industry Association office was circulated at our manufacturing plants. I was surprised to learn from the human resources department that the initial response was lukewarm, especially from our office staff, though some workers were keen to volunteer.
High-level quality check: India needs to bring in a quality culture
During Covid-19, India faced hurdles in weeding out substandard medical products flooding the markets. By Rajiv Nath To become a dependable manufacturer of high-quality medical devices and the second global factory of the same, India needs to bring in a quality culture.
Mission Aatmanirbhar Bharat: COVID-19 crisis shows that Indian medical devices sector can rise to the challenge
Prime Minister Narendra Modi’s call for self-reliant Aatmanirbhar Bharat envisions India emerging as a manufacturing superpower. The government has approved setting up of an empowered group of secretaries and project development cells for attracting investment in India.
Medical devices: Why we need a strong local ecosystem
The focus needs to shift from chasing investment value by foreign brands and onto creating an ecosystem for making in India. By Rajiv Nath Amid growing Indo-China tensions, India has to address every issue linked to national security. Healthcare being the most critical, India has to evolve imaginative policies and usher in reforms that will accelerate its economic revival. Developing our own domestic medical industry is the best way forward.
Govt must consider trade margin rationalisation for medical devices import; Here's why
Businesses need profits to grow and serve their clients adequately, but profiteering should be a strict no-no for healthcare delivery. (Representative image) By Rajiv Nath The United States has reportedly asked India to do away with price controls on high-end and premium medical devices. The American medical devices industry has been asking India to do away with price caps on all medical devices.
Govt must consider trade margin rationalisation for medical devices import; Here’s why
Businesses need profits to grow and serve their clients adequately, but profiteering should be a strict no-no for healthcare delivery. (Representative image) By Rajiv Nath The United States has reportedly asked India to do away with price controls on high-end and premium medical devices. The American medical devices industry has been asking India to do away with price caps on all medical devices.
Public policy on healthcare should not be part of trade discussions
The United States has asked India to do away with price controls on high-end and premium medical devices. The American medical devices industry has been putting pressure on the Indian government to do away with price caps on all medical devices ever since Prime Minister Narendra Modi visited the US in September last year and sought Trade Margin Rationalisation (TMR) on the basis of Price to Stockist by their Indian trading subsidiaries.
Will Union Budget 2020 address Indian medical device manufacturers’ woes?
Even though the year 2019 witnessed significant developments, there is an urgent need for the government to accelerate further reforms and supportive measures in 2020 to make India a global medical device manufacturing hub, reduce import dependency in this sector which is still at 80-90 percent, minimising outgo of foreign reserves, and making quality healthcare affordable and accessible to the masses at large.
India must rationalise trade margins on medical devices
There is a need to counter attempts to spread mis-information vis-à-vis any kind of government policy to control prices of medical devices By Rajiv Nath India is ranked 145 among 190 nations, lower than even Bangladesh, Sudan and Equatorial Guinea by the 2018 Global Healthcare Access and Quality Index. To change this landscape, we need to provide quality and affordable healthcare and reasonably priced medical devices.
Excessive pricing of medical devices is stifling India’s growth story
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Drug or device? Why India needs separate regulations for medical devices
The vast majority of India’s medical devices, a sector which is nearly 80 percent import dependent, are unregulated for quality and safety. While many of these products may have regulatory certifications in other countries, the reality is that a considerable number of them are being exported from countries that do not regulate their exports. The medical devices market in India is over $15 billion (Rs 105,000 crore) and projected to grow to $50 billion by 2025 and is the fourth-largest in Asia.
Medical devices need their own law
Medical devices have failed to attract investors to put up factories. By Rajiv Nath Thirty years have gone by since the first medical device was regulated as a drug. A comprehensive regulatory framework is nearly in sight with the Draft Medical Devices (Safety, Effectiveness & Innovation) Bill from NITI Aayog to be shortly proposed as a separate law. India currently imports 80-90% of medical devices, of which the vast majority is unregulated for quality and safety.
Why medical devices need their own law
By Rajiv Nath Thirty years have gone by since the 1st medical device was regulated as a drug but a comprehensive regulatory framework still remains elusive. India imports 70-90% of its medical devices of which the vast majority are unregulated for quality and safety. While many of these products may have regulatory certifications in other countries, the reality is that a considerable number of them are being exported from countries that do not regulate their exports.
Trade margin rationalisation
Government’s ambitious mission of making quality healthcare affordable and promoting ‘Make in India’ is in jeopardy The Global Healthcare Access and Quality Index (2018) ranks India at 145 among 190 nations, lower than Bangladesh, Sudan and Equatorial Guinea. It’s time that we change this landscape by ensuring affordable access to reasonably priced medical devices.
Calling for a policy dedicated to medical devices
India imports between 70 and 90 per cent of its medical devices. And while these products may have regulatory certifications in other countries, the reality is that a considerable number of them are not covered by a domestic regulation.For the over ₹30,000-crore imports of medical devices last year, there exists no local regulation or quality checks, save some products that are governed by the AERB (Atomic Energy Regulatory Board) for radiation safety.
Profit-making device
Rajiv NathThe Global Healthcare Access and Quality Index (2018) ranks India at 145 among 190 nations, lower than Bangladesh, Sudan and Equatorial Guinea. This ranking should drive the authorities and industry to change this landscape by ensuring affordable access to reasonably priced medical devices.Recent incidents have also brought to light unaffordable hospital bills arising from exorbitantly priced medical devices used in treatment.
Healthcare impasse | mydigitalfc
Is BJP government serious about making healthcare affordable in India? “If yes, then why is it killing its own messenger”. Why honest and upright officials working in favour of people and domestic medical products industry are being transferred jeopardising further progress?
‘Make in India’ for medical devices: A song with no lyrics
It brings little cheer that the World Economic Forum (WEF) ranked India among the Top 30 on a global manufacturing index. India would not have been ranked so had it not been for its sheer market size as the fifth largest in the world. The irony is that India is behind smaller countries like Czech Republic and Austria, both smaller than Gujarat in size, for example. When 'Make in India' was launched, there was a slogan and a vision. But this emotional connect now needs to be backed by a policy.
Wanted: a ‘Preferential Purchase Policy’ for medical devices
At long last, the critical amendment to Clause 153 of the General Financial Rules, pertaining to reserved items and other purchases by the Central government, has been undertaken by the Department of Expenditure. This paves the way for the much-needed ‘Preferential Pricing Policy’ (PPP) in the medical devices sector, a move that could boost domestic manufacturing under the ‘Make in India’ program. A PPP is neither discriminatory nor violative of WTO (World Trade Organisation) norms.
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