Fitch - India Medical Devices Report 2022

Q1 2022
www.fitchsolutions.com
India
Medical De
Devic
vices
es R
Report
eport
Includes 5-year forecasts to 2025
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India Medical Devices Report | Q1 2022
Contents
Key View............................................................................................................................................................................................ 5
Medical Devices Key View ......................................................................................................................................................................................................... 5
India Medical Devices Covid-19 Impact .............................................................................................................................................................................. 6
SWOT .................................................................................................................................................................................................. 7
Medical Devices SWOT ............................................................................................................................................................................................................... 7
Industry Forecast........................................................................................................................................................................... 8
Medical Devices Forecast .......................................................................................................................................................................................................... 8
Consumables Forecast.............................................................................................................................................................................................................11
Diagnostic Imaging Forecast .................................................................................................................................................................................................15
Dental Forecast ...........................................................................................................................................................................................................................19
Orthopaedics & Prosthetics Forecast.................................................................................................................................................................................22
Patient Aids Forecast.................................................................................................................................................................................................................25
Other Medical Devices Forecast ...........................................................................................................................................................................................28
Medical Devices Monthly Imports .......................................................................................................................................................................................31
Medical Devices Annual Imports..........................................................................................................................................................................................32
Medical Devices Monthly Exports ........................................................................................................................................................................................39
Medical Devices Annual Exports...........................................................................................................................................................................................40
Industry Risk/Reward Index ....................................................................................................................................................45

Asia Pacific Medical Devices Risk/Reward Index............................................................................................................................................................45
Market Overview..........................................................................................................................................................................53
Medical Devices Overview.......................................................................................................................................................................................................53
Healthcare Overview.................................................................................................................................................................................................................55
Industry Trends And Developments .....................................................................................................................................65

Medical Devices Industry Trends And Developments .................................................................................................................................................65
Regulatory Development ..........................................................................................................................................................67

Medical Devices Regulatory Development ......................................................................................................................................................................67
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Medical Devices Pricing And Reimbursement................................................................................................................................................................74
Competitive Landscape.............................................................................................................................................................77
Medical Devices Production...................................................................................................................................................................................................77
Medical Devices Manufacturing ...........................................................................................................................................................................................78
Medical Devices National Manufacturers .........................................................................................................................................................................82
Medical Devices Multinational Manufacturers................................................................................................................................................................94
Medical Devices Multinational Activity ........................................................................................................................................................................... 101
Medical Devices Market Access......................................................................................................................................................................................... 105
Medical Devices Methodology.............................................................................................................................................. 108
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Key View
Medical Devices Key View
Key View: India's medical device market will continue to record solid growth, despite a hardened stance on pricing for
essential devices. Recovery is expected to continue in 2022 as vaccine rollout efforts proceed. Government initiatives to improve
healthcare accessibility and provide universal healthcare over the long term, and the rising healthcare expectations of the
expanding middle class that support further development of the private sector will be primary growth drivers. The increasingly
competitive operating environment and expanding market share for low-cost, domestically-produced products will limit growth in
some sectors. The government will continue to take measures to reduce high import dependency through the Make in
India initiative.
INDIA - PROJECTED MEDICAL DEVICE MARKET (2020-2025)
2020 2021f 2022f 2023f 2024f 2025f
Total (USDmn) 4,170.8 4,929.4 4,703.6 5,159.5 5,596.0 5,945.2
Per Capita (USD) 3.0 3.6 3.4 3.6 3.9 4.1
Total (Local
309,057.4 363,788.6 359,827.9 402,444.0 449,586.0 499,394.1
Currency mn)
Per Capita (Local

224.0 261.1 255.8 283.5 313.9 345.6
Currency)
Exchange Rate
(Local Currency/ 74.1 73.5 75.5 78.0 80.3 84.0
USD)
f = Fitch Solutions forecast. Source: National Statistics, Fitch Solutions
Latest Updates And Key Forecasts
• A shift towards a more unified government in India will bode well for medical device market growth, compared to heavily
fragmented administrations previously. The Make In India initiative will be a long-term driver of local medical device
manufacturing and will boost exports as well as a production linked incentive scheme. Dental products and patient aids will be
the most dynamic product areas registering low double-digit CAGRs in local currency terms throughout the forecast period.
• Medical device import performance will likely moderate in the face of a slowing economy hindered by weak private
consumption. Imports have maintained an upward trajectory in local currency terms over the past decade, recording mainly high
single-digit to double-digit year-on-year growth. In 2020, imports fell by 16.1% to INR253.7bn. Imports grew at a 2015-2020
CAGR of 5.1%.
• With the exception of 2015, exports have recorded positive growth since 2011, reflecting the expanding domestic medical
device industry, particularly in the consumables product area, which accounts for a disproportionately large share of total
exports. We expect the export share of consumables will decline as other product areas grow in importance. In local currency
terms, exports grew by 15.3% to INR117.1bn in 2020. This compares to slower growth than in 2019 and 2018. The 2015-2020
CAGR was 11.1%.
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India Medical Devices Covid-19 Impact

Key View: India's cases of Covid-19 have plateaued following a peak in Q121 and early Q221. Vaccine efforts have continued,
reaching 1bn doses. However, ongoing concerns surrounding the scale if the country's vaccine rollout are resulting in a bleak
outlook for recovery with many yet to receive their first dose.
Country-Specific Impact
• India's cases of Covid-19 have plateaued following a peak in Q121 and early Q221. Vaccine efforts have continued, reaching 1bn
doses. However, ongoing concerns surrounding the scale if the country's vaccine rollout are resulting in a bleak outlook for
recovery with many yet to receive their first dose.
• While some products are seeing a maintained increase in demand (such as personal protection equipment and ventilators),
there is reduced uptake of most other medical devices, due to the pressure placed on healthcare resources by Covid-19 and the
accompanying decline in economic activity.
• Though medical device imports will benefit from the country's increasing budget allocations for the health sector and ongoing
healthcare development projects, the pandemic will put a strain on trade and medical device supply chains continuing
throughout 2021, moderating import performance. India's production and export of medical devices will be restricted by the
outbreak with the country likely seeking to restrict the export of medical products it sees as critical in containing the spread of
Covid-19.
• India's medical device market is expected to weather the storm of the impact from Covid-19 with signs of recovery.
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SWOT
Medical Devices SWOT
SWOT Analysis
Strengths • World's largest democracy.
• Fastest growing major Asian economy with low-cost but skilled English-speaking labour force.
• A huge population in excess of 1.3bn set to overtake China by 2027.
• Potentially huge market with an increasing middle class.
• Medical device market outperforming Asia Pacific region.
Weaknesses • Large coalition government complicates policymaking.

• Uneven healthcare policy implementation by 35 state governments and union territories.
• Low per capita health expenditure and low health insurance uptake.
• Vast regional disparities in healthcare coverage.
• Healthcare infrastructure remains underdeveloped, particularly in rural areas.
Opportunities • Policy continuity following governing NDA's decisive victory in April-May 2019 elections.
• Likely pick-up in reform momentum, improving business environment.
• Public health expenditure gradually increasing, although level remains low.
• Populist FY2019/20 union budget including double-digit rise in public health spending.
• National Health Protection Scheme which, if fully implemented, would be the world's largest government-
funded health protection programme.
• National Urban Health Mission will expand primary healthcare network.
• Reduced timeframe to implement AIIMS projects will increase access to tertiary care.
• Foreign investment to improve the healthcare infrastructure.
• High quality, high-tech products are sought by the private sector.
• Relaxation of FDI rules to encourage foreign ownership of domestic manufacturers as part of Make in India
programme
• Industry initiatives to establish manufacturing joint ventures and technology sourcing.
• National Medical Devices Promotion Council to coordinate medical devices policy.
• Participation in more free trade agreements.
Threats • The BJP's continued push of its Hindu nationalist agenda stoking domestic tensions and posing downside
risks to policymaking.
• A weaker economic growth outlook on the back of softer private consumption.
• Weakening rupee, making imports more expensive.
• Inadequate resources could hinder efforts to improve healthcare access.
• Uncertainties over incentives for private sector investment in smaller cities.
• Ongoing ambiguity over the management of medical device regulation.
• Government reimbursement policy favours cheaper locally produced products where available.
• Price monitoring and 10% annual price increase cap for 19 notified devices.
• Pressure to extend price controls to more medical device groups.
• Public Procurement Order giving preferential market access to domestically produced products in tenders
below INR5mn (USD75,000).
• Withdrawal from the RCEP.
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Industry Forecast
Medical Devices Forecast
Key View: We maintain our forecast CAGR and project that the medical devices market will grow at a 2020-2025 CAGR of 11.8% in
local currency terms and 9.1% in US dollar terms, which will take the markets value to INR499.4bn (USD5.9bn). The market will
continue to benefit from India remaining one of the fastest growing economies in the region, but the country's economic growth
will slow due to the Covid-19 outbreak posing risks to the short-term outlook. India, under Prime Minister Narendra Modi, has
continued to shift towards protectionism. While a large domestic market will continue to support long-term economic growth, the
lack of external competition will hamper productivity growth. Growing fiscal constraints will also limit the government's ability to
shore up growth when faced with economic challenges.
Latest Updates
We have revised slightly upwards our forecast CAGR in local currency terms and project that the medical devices market will grow at
a 2020-2025 CAGR of 11.8% in local currency terms, which will take the markets value to INR499.4bn. The market will continue to
benefit from India remaining one of the fastest growing economies in the region, but the country's economic growth will slow due
to the Covid-19 outbreak and a more aggressive global economic downturn, as well as tightening of global financing conditions, will
pose further headwinds to the growth outlook.
The market will see low double-digit growth over the forecast period. Government initiatives to improve healthcare accessibility and
provide universal healthcare over the longer term, coupled with the rising healthcare expectations of the expanding middle class,
supporting further development of the private sector, will be primary growth drivers. The increasingly competitive operating
environment and the outbreak of Covid-19 will limit growth in some sectors.
Medical Device Market, Local Currency

(2015-2025)
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We maintain our forecast CAGR in US dollar terms and now project that the market will register a 2020-2025 CAGR of 9.1%, which
will take the value to USD5.9bn. We expect the Indian rupee to remain on a broad deprecatory path against the US dollar due to the
currency's overvaluation, higher inflation versus the US and an increasingly precarious global growth outlook. This will result in high
single-digit growth over the forecast period.
Medical Device Market, US Dollar

(2015-2025)
Structural Trends
The market will benefit from key drivers:
• Strong Fundamentals: The world's largest democracy; policy continuity and likely pick-up in reform momentum following the
governing NDA's decisive victory in April-May 2019 elections; one of the fastest growing major economies in Asia, despite a
weaker economic growth outlook; an expanding middle class of around 300mn people with rising healthcare expectations; a
low-cost, but skilled English-speaking workforce; and well-established trade links with Western Europe and the US.
• Healthcare Drivers: A huge population in excess of 1.3bn people, set to overtake China by 2027, including around 85mn
elderly; growing urbanisation and adoption of sedentary lifestyles fuelling chronic disease prevalence; increasing health
insurance cover, including new National Health Protection Scheme which, if fully implemented, would be the world's largest
government-funded health protection programme; populist FY2019/20 union budget including double-digit rise in public
health spending; a National Urban Health Mission scheme to expand primary healthcare network; healthcare infrastructure
developments supported by foreign investment; and an expanding private hospital sector aiming to attract health tourists.
• Market Drivers: A medical device market outperforming Asia Pacific region; an expanding middle class supporting further
development of the private sector, which seeks high quality, high-tech products; improving medical device regulation with the
launch of a new regulatory framework in January 2018; further efforts to expand regulatory framework to all medical devices
within three to four years; relaxation of FDI rules, which will encourage foreign ownership of domestic manufacturers as part of
the Make in India programme; the new National Medical Devices Promotion Council, which will coordinate medical devices
policy; and participation in more free trade agreements, although India's withdrawal from the RCEP represents a setback to
economic liberalisation efforts.
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The market will be constrained by:
• Weak Fundamentals: A large coalition government, which complicates policymaking at national level; wide variation in the
competence of state governments, which are responsible for public healthcare provision in their territories; and the influence of
special interest groups contributing to opaque business practices.
• Healthcare Barriers: Low per capita health expenditure; low health insurance uptake; payment delays to private hospitals from
government-backed insurance schemes; patchy public healthcare provision; underdeveloped healthcare infrastructure,
particularly in rural areas, which will hinder efforts to improve healthcare access; and uncertainties over incentives for private
sector investment in smaller cities.
• Market Barriers: A weakening rupee, making imports more expensive; ongoing ambiguity over the management of medical
device regulation; uncertainty over medical device pricing for some high value devices, with pressure to extend price controls to
more medical device groups following introduction of price caps for coronary stints in Q117 and artificial knee joints in Q317,
together with price monitoring and a 10% annual price increase cap for 21 other notified devices; preferential procurement
policy favouring domestically produced products, including 2017 Public Procurement Order prioritising products with 25-50%
minimum local content in tenders below INR5mn (USD75,000); a fragmented medical device industry and withdrawal from
the RCEP.
INDIA - MEDICAL DEVICE MARKET BY PRODUCT AREA, 2015-2025 (USDMN)

2015 2016 2017 2018 2019 2020 2021f 2022f 2023f 2024f 2025f
CONSUMABLES 696.0 728.9 874.2 999.8 1,315.7 907.7 1,085.9 1,100.3 1,208.9 1,306.8 1,387.1
DIAGNOSTIC IMAGING 1,171.2 1,198.0 1,374.9 1,595.4 1,750.7 1,262.4 1,607.8 1,607.3 1,750.8 1,887.4 1,998.9
DENTAL PRODUCTS 143.5 157.8 194.9 205.7 227.2 139.7 128.6 128.4 144.2 159.8 173.3
ORTHOPAEDICS &
284.8 314.0 336.2 372.0 416.5 227.7 198.4 197.0 222.9 248.8 271.4
PROSTHETICS
PATIENT AIDS 315.6 332.1 390.6 442.6 450.8 413.3 562.0 278.9 297.7 315.9 335.9
OTHER MEDICAL DEVICES 985.2 1,053.3 1,155.4 1,297.6 1,419.9 1,220.0 1,346.7 1,391.7 1,535.1 1,677.3 1,778.6
TOTAL 3,596.3 3,784.1 4,326.2 4,913.1 5,580.7 4,170.8 4,929.4 4,703.6 5,159.5 5,596.0 5,945.2
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Consumables Forecast
Key View: We maintain our forecast CAGR in local currency terms and project that the consumables market will grow at a
2020-2025 CAGR of 12.9% in local currency terms and 10.1% in US dollar terms, which will take the value to INR116.5bn
(USD1.4bn). The market will continue to benefit from India remaining one of the fastest growing economies in the region as well as
the increased demand for consumables products in the short term, but the country's economic growth will slow due to the
Covid-19 outbreak posing risks to the short-term outlook. However, a strong recovery is expected.
Latest Updates
We maintain our forecast compound annual growth rate (CAGR) in local currency terms and project that the consumables market
will grow at a 2020-2025 CAGR of 12.9% in local currency terms, which will take the value to INR116.5bn. The market will continue
to benefit from India remaining one of the fastest growing economies in the region as well as the increased demand for
consumables products in the short term, but the country's economic growth will slow due to the Covid-19 outbreak posing risks to
the short-term outlook. However, a strong recovery is expected.
The market will see low double-digit growth driven by population increase, improved healthcare access and rising consumer buying
power. However, we anticipate growth rates will moderate from 2021, reflecting an increasingly competitive operating environment
and expanding market share for lower cost domestically produced products in some sectors.
Consumables Market, Local Currency

(2015-2025)
will take the value to USD1.4bn. We expect the Indian rupee to remain on a broad depreciatory path against the US dollar due to the
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Consumables Market, US Dollar

(2015-2025)
e/f = Fitch Solutions estimate/forecast. Source: National Statistics, Fitch Solutions
Structural Trends
• Healthcare Drivers: Large elderly population, rising urbanisation and adoption of sedentary lifestyles fuelling increasing
chronic disease prevalence, which support demand for a broad range of consumables; the rising incidence of venous disorders,
diabetes (world's second largest population of diabetic sufferers with 70mn adult cases) and chronic inflammatory disorders,
which are contributing to the increased use of medical dressings to treat leg ulcers and other persistent wounds; multinational
investment in nurse training programmes to enhance knowledge of advanced wound care techniques; the growing number of
surgical procedures exceeding 18mn per annum, which supports the use of suturing materials and surgical gloves; the
increasing outpatient rate, supporting the use of syringes, needles and catheters; increasing rates of colorectal and prostate
cancer (with 75,000 new colorectal cancers and 22,000 new prostate cancers each year), together with increasing prevalence of
inflammatory bowel disease, which will increase demand for currently limited ostomy care; and an increased focus on infection
control that encourages the use of surgical gloves.
• Market Drivers: A low rate of per capita spending, with high growth potential driven by rising disposable incomes and
increasing awareness of more advanced products; higher growth in biological dressings; the growing use of absorbable sutures;
the development of user-friendly smart syringes; more attractive product packaging for first-aid boxes; and well established
domestic production for basic products with higher import dependency for more advanced products.
• Imports: Supply less than half the market. The EU supplied around a third of imports in 2018 and the US one sixth. Singapore,
China, Malaysia and Japan are the principal Asian suppliers.
• Domestic Production: Is well established in a number of sectors. Hindustan Syringes and Needles is the leading indigenous
producer of syringes and needles, while Sutures India is the leading manufacturer of sutures. Other notable local producers
include Poly Medicure and SURU International for IV sets, catheters and other plastic medical disposables, and Prowess for
ostomy products. Multinationals with a manufacturing presence include B. Braun for sutures and IV sets, Becton Dickinson for
disposable syringes and needles and Johnson & Johnson Ethicon for sutures.
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Bandages & Dressings
We forecast that the market for bandages and dressings will grow at a US dollar 2020-2025 CAGR of 6.4%, taking expenditure to
USD114.3mn. Adhesive dressings will grow at a higher rate than non-adhesive dressings.
Due to the existence of a sizable local manufacturing base producing basic dressings, less than 15% of the market is supplied via
imports. China supplied over 32% pf the total followed by he US which supplied 15.5%.
Suturing Materials
We forecast that the market for suturing materials will grow at a US dollar 2020-2025 CAGR of 8.4%, taking expenditure to
USD44.0mn. The market will see high single-digit growth from 2022.
Imports supply around a quarter of the market. The US accounted for 52.1% of imports followed by Australia with 14% of the total.
Syringes, Needles & Catheters
Syringes, needles and catheters will remain the largest sector of the consumables market. We forecast a US dollar 2020-2025 CAGR
of 10.5%, which will increase the market to USD945.6mn. Syringes will grow at the highest CAGR.
Imports supply around half the market. 20.9% came from Singapore in 2020 and a similar amount from the US.
Other Consumables
We forecast that the market for other consumables, including blood-grouping reagents, first-aid boxes and kits, ostomy products
and surgical gloves, will grow at a US dollar 2020-2025 CAGR of 10.8%, which will increase expenditure to USD283.3mn. Surgical
gloves will see the fastest growth.
Imports supply around a quarter of the market. Surgical gloves account for nearly two-thirds of imports of other consumables and
these are mainly sourced from Malaysia and Sri Lanka in 2020.
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INDIA - CONSUMABLES MARKET, 2015-2025 (USDMN)

2015 2016 2017 2018 2019 2020 2021f 2022f 2023f 2024f 2025f
CONSUMABLES 696.0 728.9 874.2 999.8 1,315.7 907.7 1,085.9 1,100.3 1,208.9 1,306.8 1,387.1
BANDAGES & DRESSINGS 78.0 78.7 84.4 92.1 94.0 89.9 91.7 93.6 101.3 108.5 114.3
Medical dressings (adhesive) 15.3 15.2 16.9 17.2 17.8 14.3 10.5 10.5 11.5 12.5 13.3
Medical dressings (non-

62.7 63.5 67.5 74.9 75.5 75.6 81.2 83.1 89.8 96.0 101.0
adhesive)
SUTURING MATERIALS 32.7 34.3 40.8 44.8 40.8 28.0 32.6 32.5 36.5 40.5 44.0
SYRINGES, NEEDLES &

488.3 511.0 627.8 730.1 783.2 593.4 732.7 737.3 816.3 886.8 945.6
CATHETERS
Syringes (with/without
65.4 65.8 74.1 90.1 91.6 92.6 123.9 124.4 135.0 145.0 153.0
needles)
Tubular metal needles/needles

72.5 82.6 95.2 101.9 101.3 86.2 105.4 105.5 116.3 126.6 135.3
for sutures
Other needles, catheters,

350.3 362.5 458.4 538.0 590.3 414.6 503.4 507.4 565.0 615.2 657.3
cannulae etc
OTHER CONSUMABLES 97.0 104.9 121.2 132.9 397.7 196.5 228.9 237.0 254.9 271.0 283.3
Blood-grouping reagents 3.7 3.7 6.8 7.0 7.6 5.3 5.7 6.0 6.6 7.1 7.5
First-aid boxes & kits 2.3 2.9 3.2 3.2 2.9 3.2 3.4 3.4 3.7 3.9 4.1
Ostomy products 38.1 40.2 44.8 47.4 299.9 77.1 83.6 90.8 99.8 108.2 114.9
Surgical gloves 52.9 58.0 66.4 75.2 87.4 110.9 136.2 136.7 144.7 151.8 156.8
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Diagnostic Imaging Forecast

Key View: We maintain our forecast CAGR in local currency terms and project that the diagnostic imaging market will grow at a
(USD2.0bn). Diagnostic imaging will become one of the fastest growing medical device product areas. The market will continue to
benefit from India remaining one of the fastest growing economies in the region, but the country's economic growth will slow due
to the Covid-19 outbreak posing risks to the short-term outlook. However, a strong recovery is anticipated.
Latest Updates
We maintain our forecast compound annual growth rate (CAGR) in local currency terms and project that the diagnostic imaging
market will grow at a 2020-2025 CAGR of 13.5% in local currency terms, which will take the value to INR167.9bn. Diagnostic
imaging will become one of the fastest growing medical device product areas. The market will continue to benefit from India
remaining one of the fastest growing economies in the region, but the country's economic growth will slow due to the Covid-19
outbreak posing risks to the short-term outlook. However, a strong recovery is anticipated.
Rising private consumption will support further expansion of the private health sector which, together with new technology
acquisition, will be the main growth driver in the market. Expanding domestic production and intensifying competition will lower
prices, which will limit growth rates.
Diagnostic Imaging Market, Local Currency

(2015-2025)
will take the value to USD2.0bn. We expect the Indian rupee to remain on a broad deprecatory path against the US dollar due to the
currency's overvaluation, higher inflation versus the US and an increasingly precarious global growth outlook. This will result in
mainly high single-digit growth over the forecast period.
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Diagnostic Imaging Market, US Dollar

(2015-2025)
Structural Trends
• Healthcare Drivers: Rising urbanisation and adoption of sedentary lifestyles fuelling increasing chronic disease prevalence
including cardiovascular, cancer and CNS diseases, which supports demand for diagnostic imaging scans; expanding private
sector and government investment in tertiary care, which supports demand for more technologically advanced equipment; the
increasing use of interventional radiology and image-guided surgical procedures; and new diagnostic imaging applications.
• Market Drivers: Below average per capita spending, with moderate growth potential particularly in less developed areas (some
market saturation in major cities), driven by increasing use for diagnosis and treatment; continued technological innovation to
offer faster scan times, improved image quality and enhanced data analytics to enable more accurate diagnosis; design
ergonomics to improve user functionality and develop more patient-friendly systems, such as the development of quiet MRI
systems; the development of smaller more affordable equipment for use in less developed areas; the reduction of radiation dose
to improve patient safety; the increasing use of ultrasound for therapeutic purposes; a growing market for refurbished
equipment; expanding domestic production; and high import dependency for more technologically advanced products.
• Imports: Supply nearly three-quarters of the market. The US and China supply around half of imports. The EU supplies a further
third of imports, led by Germany and the Netherlands. Japan supplies around 10% of imports.
• Domestic Production is expanding. Indigenous producers include BPL Medical Technologies for ECGs and patient monitoring
systems, Cura Healthcare for radiology equipment, MediRay HealthCare for X-ray equipment, Panacea Medical Technologies for
mammography and radiotherapy systems, Prognosys for digital radiology system, Skanray Technologies for X-ray apparatus and
ECGs, and Trivitron for a broad range of diagnostic imaging equipment. Multinationals with manufacturing operations include GE
Healthcare, Philips HealthTech and Siemens Healthineers.
Electrodiagnostic Apparatus
We forecast that the market for electrodiagnostic apparatus, including ECGs, ultrasonic scanning, MRI imaging, scintigraphic
apparatus and other electrodiagnostic apparatus, will grow at a US dollar 2020-2025 CAGR of 8.5%, taking expenditure to
USD676.0mn. Scintigraphic apparatus will lead growth.
There is an established market for refurbished products. Small-scale centres and hospitals tend to use refurbished high-field MRIs,
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while some high-end centres and large hospitals are opting for refurbished high-field MRIs instead of new low-field MRIs.
Imports supply two-thirds of the market. The import share is higher for MRI and scintigraphic apparatus and lower for ECGs and
other electrodiagnostic apparatus. China, the EU and the US each supply around a quarter of all imports. The Netherlands and
Germany each account for around a third of all EU shipments.
The domestic manufacturing industry is growing in size and sophistication, supported by investment from multinationals. National
producers of ultrasound apparatus include Triviton, which has a joint venture with Hitachi Aloka. GE has a joint venture with Wipro
for the production of ultrasound scanners and other electrodiagnostic apparatus, while Philips produces the ClearVue range of
ultrasound systems for the Indian market and in April 2014 launched the Visiq, a low-cost compact, miniaturised ultrasound device,
designed for use in remote areas. National producers of patient monitoring systems include BPL Medical and Opto Circuits.
Radiation Apparatus
We forecast that the market for radiation apparatus will grow at a US dollar 2020-2025 CAGR of 11.0%, taking expenditure to
USD492.5mn. Within the CT market, growth trends include focusing on CT scanners with more applications, upgrading existing CT
scanners, using nuclear medicine combined with CT technologies, reducing radiation doses and increasing patient throughput.
Price, however, remains a key factor.
Imports account for around three-quarters of the market, though this rises to over 90% for high-tech equipment. Imports are
primarily sourced from the EU, the US and China. China has overtaken the US as the leading supplier of CT scanners. The US was
the leading supplier of other medical X-ray apparatus in 2019 but has been overtoken by the UK as the leading supplier of A, B, C ray
apparatus.
The domestic production industry is well established with local producers such as Kiran Medical Systems, MediRay HealthCare and
Trivitron, as well as multinationals such as GE, Philips and Siemens. Samsung India launched digital radiology equipment under the
Geo brand in June 2013, while Hitachi Medical has established an office in India, and Canon has made plans to strengthen its
presence in India. National producers of CT scanners include MediRay HealthCare. Additionally, Sanrad Medical Systems,
headquartered in Mumbai with offices located in Bangalore, Bhopal, Coimbatore, Calicut, Mangalore and Pune, specialises in
refurbished CT scanners, particularly refurbished Toshiba CT scanners imported from Japan.
Imaging Parts & Accessories
We forecast that the market for imaging parts and accessories will grow at a US dollar 2020-2025 CAGR of 12.3%, taking
expenditure to USD830.3mn. Contrast media will see the highest growth.
Imports supply around three-quarters of the market. The US is the leading supplier accounting for more than a fifth of imports in
2020, followed by China, which is the dominant supplier of contrast media. The EU supplied a third of imports in 2020, led
by Germany. Japan is the leading supplier of X-ray film.
fitchsolutions.com
INDIA - DIAGNOSTIC IMAGING MARKET, 2015-2025 (USDMN)

2015 2016 2017 2018 2019 2020 2021f 2022f 2023f 2024f 2025f
DIAGNOSTIC IMAGING 1,171.2 1,198.0 1,374.9 1,595.4 1,750.7 1,262.4 1,607.8 1,607.3 1,750.8 1,887.5 1,998.9
ELECTRODIAGNOSTIC
441.6 429.9 506.1 567.4 662.5 482.6 559.5 571.1 611.2 648.0 676.0
APPARATUS
Electrocardiographs 14.6 19.7 21.1 23.4 39.2 33.8 56.3 54.9 58.8 62.1 64.7
Ultrasound 126.8 130.8 149.8 177.8 197.3 158.5 206.2 202.9 218.6 233.2 244.7
MRI 116.0 119.1 149.3 155.3 151.7 102.6 70.3 70.5 76.9 83.3 88.6
Scintigraphic apparatus 2.7 5.7 5.1 8.6 7.0 2.7 2.0 1.6 1.9 2.2 2.4
Other electrodiagnostic
181.5 154.6 180.8 202.4 267.3 185.0 224.8 241.4 255.0 267.1 275.7
apparatus
RADIATION APPARATUS 303.9 283.1 343.6 449.6 441.7 295.2 399.0 384.8 423.5 461.1 492.5
CT scanners 102.1 73.7 90.3 131.0 122.4 91.0 113.6 112.0 121.9 131.3 138.9
Other medical X-ray apparatus 182.4 183.3 227.8 283.8 289.5 170.6 229.3 218.9 242.8 267.3 288.2
A, B, C ray apparatus 19.4 26.1 25.4 34.8 29.8 33.6 56.1 54.8 58.9 62.6 65.5
IMAGING PARTS & ACCESSORIES 425.6 485.0 525.3 578.4 646.5 484.6 649.3 651.4 716.1 778.4 830.3
Contrast media 39.8 39.7 43.9 49.7 63.6 36.4 49.8 49.6 55.7 61.8 67.0
Medical X-ray film (flat) 75.8 77.6 81.1 88.8 91.7 76.1 88.3 86.3 95.8 105.1 113.0
Medical X-ray film (rolled) 17.7 10.4 7.9 10.9 6.6 7.5 7.8 7.2 7.2 7.0 6.8
X-ray tubes 71.7 72.8 80.7 98.6 139.8 95.7 114.8 116.1 125.6 134.5 141.5
Other imaging parts &

220.6 284.6 311.7 330.4 344.9 269.0 388.6 392.2 431.8 470.0 502.0
accessories
fitchsolutions.com
Dental Forecast
Key View: We maintain our forecast CAGR and now project that the dental products market will grow at a 2020-2025 CAGR of 5.9%
in local currency terms and 3.2% in US dollar terms, which will take the market value to INR14.6bn (USD173.3mn). Dental products
will be supported in the long term by government strategies to include healthcare provision and will benefit from India remaining
one of the fastest growing economies in the region. However, the country's economic growth will slow due to the Covid-19
outbreak posing risks to the short-term outlook but a strong recovery is anticipated.
Latest Updates
We maintain our forecast CAGR and now project that the dental products market will grow at a 2020-2025 CAGR of 5.9% in local
currency terms, which will take the market value to INR14.6bn. Dental products will continue to be the fastest growing medical
device product area and will continue to benefit from India remaining one of the fastest growing economies in the region. However,
the country's economic growth will slow due to the Covid-19 outbreak posing risks to the short-term outlook but a strong recovery
is anticipated.
The market will continue to see double-digit growth driven by population increase, the growing incidence of oral diseases, improved
access to dental care, rising consumer buying power and new technology acquisition.
Dental Products Market, Local Currency

(2015-2025)
We also maintain our forecast CAGR in US dollar terms and now project that the market will register a 2020-2025 CAGR of 3.2%,
which will take the value to USD173.3mn. We expect the Indian rupee to remain on a broad deprecatory path against the US dollar
due to the currency's overvaluation, higher inflation versus the US and an increasingly precarious global growth outlook. This will
result in high single-digit to low double-digit growth over the forecast period.
fitchsolutions.com
Dental Products Market, US Dollar

(2015-2025)
Structural Trends
• Healthcare Drivers: Population increase and growing incidence of oral diseases, which supports demand for dental treatment;
rapid expansion of dental services, underpinned by a steady increase in the number of dentists, which contributes to investment
in dental technology; advances in less invasive treatment procedures; the growing popularity of cosmetic dentistry with dental
tourism boosting domestic demand; expansion of dental college training programmes to address shortages of dental
technicians; and the increasing use of dental implants due to better aesthetics, supported by enhanced CAD/CAM technologies
to improve product customisation.
• Market Drivers: A very low rate of per capita spending, which indicates high growth potential driven by rising disposable
incomes and growing consumer awareness of dental care; the acquisition of new dental equipment; continued technological
innovation; the replacement of analogue dental X-ray with digital systems; the adoption of new 3D scanning dental
manufacturing techniques to improve the quality of artificial teeth; expanding domestic production of dental instruments and
supplies; and high import dependency for more technologically advanced products.
• Imports supply around three-quarters of the market. The EU supplies around a third of imports, led by Germany. South Korea
was the leading country supplier in 2018, accounting for more than 15% of imports. China, Switzerland and the US are the other
notable suppliers, each contributing 10-15% of imports in 2018.
• Domestic Production is expanding. MediRay HealthCare and Skanray Technologies produce dental X-ray systems and
MediRay also produces dental chairs. Narang Medical produces dental instruments, while Anand Medicaids' Dental Lab India
subsidiary manufactures a range of dental fittings and Dental Products of India produces dental filling materials.
Capital Equipment
We forecast that the capital equipment market will grow at a US dollar 2020-2025 CAGR of 2.1%, taking expenditure to USD22.2mn.
Dental chairs will see the highest growth.
Imports supply more than three-quarters of the market. The EU supplied over 30% of imports in 2020 primarily from Italy and
Finland. Korea was the leading country supplier, accounting for over 30% of the import total in 2020. In second place, China
contributed over one quarter of the total.
fitchsolutions.com
Instruments & Supplies
Instruments and supplies will remain the largest sector of the dental market, growing at a US dollar 2020-2025 CAGR of 3.4% to
reach USD151.1mn. Other dental fittings will see the highest growth.
Imports supply nearly three-quarters of the market, apart from artificial teeth where local products predominate. Korea was the
leading supplier in 2020, accounting for nearly 14% of imports. The EU supplied 25% of imports, led by Germany.
INDIA - DENTAL PRODUCTS MARKET, 2015-2025 (USDMN)

2015 2016 2017 2018 2019 2020 2021f 2022f 2023f 2024f 2025f
DENTAL PRODUCTS 143.5 157.8 194.9 205.7 227.2 139.7 128.6 128.4 144.2 159.8 173.3
CAPITAL EQUIPMENT 19.0 21.0 32.8 27.7 28.6 17.9 16.6 17.3 19.0 20.7 22.2
Dental drills 1.3 1.3 1.5 1.5 1.5 0.5 0.4 0.5 0.6 0.7 0.7
Dental chairs 13.0 13.4 18.4 14.4 13.5 10.2 9.3 9.8 10.6 11.4 12.0
Dental X-ray 4.7 6.2 12.9 11.8 13.6 7.3 6.9 7.0 7.8 8.7 9.4
INSTRUMENTS & SUPPLIES 124.5 136.8 162.1 178.0 198.6 121.7 112.0 111.1 125.2 139.1 151.1
Dental cements 27.8 30.9 32.7 41.9 46.4 27.5 23.8 23.5 26.1 28.7 30.8
Dental instruments 50.6 56.8 70.2 79.9 84.3 49.0 45.0 45.2 50.2 55.8 60.7
Teeth & other fittings 46.2 49.2 59.2 56.1 67.9 45.3 43.4 43.1 48.8 54.6 59.6
Artificial teeth 7.2 7.0 7.8 9.3 11.0 9.1 8.6 8.7 9.5 10.2 10.8
Other dental fittings 38.9 42.2 51.4 46.8 56.9 36.2 34.8 34.4 39.4 44.4 48.8
fitchsolutions.com
Orthopaedics & Prosthetics Forecast

Key View: We maintain our forecast CAGR and now project that the orthopaedics and prosthetics market will grow at a
(USD271.4mn). The market will continue to benefit from India remaining one of the fastest growing economies in the region, but
the country's economic growth will slow due to the Covid-19 outbreak posing risks to the short-term outlook. However, a strong
recovery is anticipated.
Latest Updates
We maintain our forecast compound annual growth rate (CAGR) in local currency terms and now project that the orthopaedics and
prosthetics market will grow at a 2020-2025 CAGR of 5.9% in local currency terms, which will take the value to INR22.8bn. The
market will continue to benefit from India remaining one of the fastest growing economies in the region, but the country's
economic growth will slow due to the Covid-19 outbreak posing risks to the short-term outlook. However, a strong recovery is
anticipated.
The market will continue to be driven by population increase, an increasingly chronic epidemiological profile, improved healthcare
access, rising consumer buying power and technological advances. On the downside, an increasingly competitive operating
environment, expanding market share for lower cost domestically produced products and government-imposed price cuts in some
sectors will hinder growth.
Orthopaedics & Prosthetics Market, Local Currency

(2015-2025)
will take the value to USD271.4mn. We expect the Indian rupee to remain on a broad deprecatory path against the US dollar due to
the currency’s overvaluation, higher inflation versus the US and an increasingly precarious global growth outlook. This will result in
high single-digit growth over the forecast period.
fitchsolutions.com
Orthopaedics & Prosthetics Market, US Dollar

(2015-2025)
Structural Trends
• Healthcare Drivers: Population increase and adoption of sedentary lifestyles, which are fuelling rapid rise in musculoskeletal
disorders, particularly osteoarthritis and osteoporosis in post-menopausal women, increasing demand for replacement joint
surgery and artificial limbs boosted by Non-Resident Indians returning to India for joint surgery; a high incidence of cataracts,
increasing demand for intra-ocular lenses; a large elderly population with a growing prevalence of arterial and valvular heart
diseases, which is increasing demand for arterial grafts and heart valves; and development of minimally invasive techniques such
as transcatheter aortic valve replacement (TAVR).
• Market Drivers: A very low rate of per capita spending, which indicates high growth potential driven by rising disposable
incomes and greater consumer awareness of treatment options; technological developments, including new biomaterials and
improvements to implant design; development of advanced heart valves to improve clinical outcomes and reduce
complications; development of accommodating, multifocal and trifocal IOLs; well established domestic production for fixation
devices; and high import dependency for technologically advanced products.
• Imports account for nearly three-quarters of the market. The EU and the US each supply around a third of imports. Switzerland
and Singapore are the other notable suppliers with an import share of 15.0% and 10.0% in 2018.
• Domestic Production is focused on fixation devices. Domestic producers include ASCO, Atlas Surgical, INOR, Narang Medical
and Ormed Medical Technology. Orthovasive, a division of Biorad Medisys, is one of the few Indian companies manufacturing
artificial joints. Endolite India, a joint venture between New Delhi-based Prime Group and UK-based Chas. A. Blatchford & Sons,
produces artificial limbs and orthotics. Smith & Nephew produces trauma products through its Sushrut-Adler acquisition.
Fixation Devices
We forecast that the market for fixation devices will grow at a US dollar 2020-2025 CAGR of 1.2%, taking expenditure to USD62.0mn.
The market will see single-digit growth from 2021.
Imports only supply around a third of the market due to the growing number of local producers active in this sector. Nearly 50% of
imports were sourced from the US in 2020, with China the other major supplier.
fitchsolutions.com
Artificial Joints
We forecast that the market for artificial joints will grow at a US dollar 2020-2025 CAGR of 4.3%, taking expenditure to USD81.1mn.
The market will see single-digit growth from 2021. The previously dynamic market lost momentum in 2018 but contracted in 2021.
Imports dominate the market, over 35.0% of which were sourced from the EU in 2020, while the US supplied around a fifth of
imports. Switzerland and Germany are the other notable suppliers, each contributing over 15% of imports in 2020. Local producers
include INOR Orthopaedics and Ormed Medical Technology.
Other Artificial Body Parts
Other artificial body parts will grow at a US dollar 2020-2025 CAGR of 1.9% to reach USD128.3mn. This will be the slowest growing
sector of the orthopaedics and prosthetics market.
Imports supply over 70% of the market, nearly 40% of which came from the US in 2020. The EU supplied a third of imports in
2019. Switzerland was the other notable supplier, contributing nearly 15% of imports.
INDIA - ORTHOPAEDICS & PROSTHETICS MARKET, 2015-2025 (USDMN)

2015 2016 2017 2018 2019 2020 2021f 2022f 2023f 2024f 2025f
ORTHOPAEDICS &
284.8 314.0 336.2 372.0 416.5 227.7 198.4 197.0 222.9 248.8 271.4
PROSTHETICS
FIXATION DEVICES 44.7 45.2 53.0 57.5 75.9 60.0 47.9 48.3 53.3 58.0 62.0
ARTIFICIAL JOINTS 98.3 128.0 132.9 120.4 141.5 61.0 56.1 55.3 64.1 73.1 81.1
OTHER ARTIFICIAL BODY PARTS 141.8 140.8 150.3 194.0 199.1 106.7 94.3 93.4 105.5 117.7 128.3
fitchsolutions.com
Patient Aids Forecast

Key View: We maintain our forecast CAGR in local currency terms and now project that the patient aids market will grow at a
(USD335.9mn).The market will continue to benefit from India remaining one of the fastest growing economies in the region, but the
country's economic growth will slow due to the Covid-19 outbreak posing risks to the short-term outlook. However, a strong
Latest Updates
We maintain our forecast CAGR in local currency terms and now project that the patient aids market will grow at a 2020-2025 CAGR
of 14.1% in local currency terms, which will take the value to INR28.2bn. The market will continue to benefit from India remaining
one of the fastest growing economies in the region, but the country's economic growth will slow due to the Covid-19 outbreak
posing risks to the short-term outlook. However, a strong recovery is anticipated.
The market will see low double-digit and high single-digit growth over the forecast period driven by population increase, an
increasingly chronic epidemiological profile, improved healthcare access, rising consumer buying power and technological
advances. However, market growth will continue to be negatively impacted by the government-imposed price cuts on coronary
stents originally introduced in Q117 and Q118, as well as expanding market share for lower cost domestically produced products.
Patient Aids Market, Local Currency

(2015-2025)
We maintain our forecast CAGR in US dollar terms and project that the market will register a 2020-2025 CAGR of 11.2%, which will
take the value to USD335.9mn. We expect the Indian rupee to remain on a broad deprecatory path against the US dollar due to the
fitchsolutions.com
Patient Aids Market, US Dollar

(2015-2025)
Structural Trends
• Healthcare Drivers: A large elderly population, which supports the use of hearing aids and other aids for the disabled; an
increasingly chronic epidemiological profile with a particularly high incidence of heart disease, which drives the use of
pacemakers and other portable aids such as stents; the growing number of interventional cardiologists which supports
procedure growth; the rising incidence of muscular disorders and the interest in sports and fitness, which benefit the use of
mechano-therapy apparatus; a high prevalence of respiratory diseases such as COPD and asthma, which supports demand for
therapeutic respiration apparatus.
• Market Drivers: A very low rate of per capita spending, which indicates good growth potential, although some sectors such as
stents will be hindered by government imposed price caps; the reduced stigma of hearing aids due to more innovative and
aesthetically pleasing designs; technological advances that make pacemakers cheaper and less invasive; technological advances
such as increased battery life for ICDs, which result in fewer expensive surgeries; technological advances that have made
mechano-therapy apparatus easier and safer to use; the growing use of home respiratory care; and high import dependency for
technologically advanced products.
• Imports supply over 90% of the market by value, but this is likely to fall in the wake of government-imposed price caps for
stents and potentially other implantable devices. Around 40% of imports came from the EU in 2018, of which half from the
Netherlands. The US and China are the other major suppliers, each contributing around a sixth of imports in 2018.
• Domestic production is focused on portable aids, notably stents. Domestic producers include Opto Circuits, Relisys Medical
Devices and Sahajanand Medical Technologies.
Portable Aids
Portable aids will remain the largest sector of the patient aids market, despite seeing only moderate growth at a US dollar
2020-2025 CAGR of 1.5%, which will take the value to USD227.9mn.
Imports supply nearly 90% of the market. Over half of all imported products are sourced from the EU, principally Denmark and
Austria for hearing aids, Belgium, the Netherlands and Germany for pacemakers and the Netherlands and Ireland for other portable
aids. Singapore supplied around 12% and the US supplied around 10% of imports in 2020.
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Therapeutic Appliances
We forecast that the market for therapeutic appliances will grow at a US dollar 2020-2025 CAGR of 19.6%, taking expenditure to
USD108.0mn. Therapeutic respiration apparatus will grow at a higher rate than mechano-therapy apparatus.
Imports supply around 95% of the market with China and the US the leading suppliers, each contributing around 36% and 9.3% of
the total respectively in 2020. The EU supplied a quarter of imports in 2020, led by Germany.
INDIA - PATIENT AIDS MARKET, 2015-2025 (USDMN)

2015 2016 2017 2018 2019 2020 2021f 2022f 2023f 2024f 2025f
PATIENT AIDS 315.6 332.1 390.6 442.6 450.8 413.3 562.0 279.0 297.7 315.9 335.9
PORTABLE AIDS 190.5 199.5 225.1 247.8 250.5 213.7 184.0 182.8 199.3 215.0 227.9
Hearing aids 42.9 42.4 46.2 54.3 46.4 31.3 27.0 26.9 30.0 33.0 35.7
Pacemakers 23.3 24.6 28.1 35.7 43.8 27.0 24.2 23.4 25.1 26.7 27.9
Other portable aids 124.3 132.5 150.8 157.9 160.3 155.4 132.8 132.5 144.2 155.3 164.4
THERAPEUTIC APPLIANCES 125.0 132.6 165.6 194.8 200.4 199.6 378.0 96.2 98.4 100.9 108.0
Mechano-therapy apparatus 44.5 38.3 51.1 54.1 56.6 40.7 59.0 56.5 58.1 60.5 65.7
Therapeutic respiration
80.5 94.4 114.5 140.6 143.7 158.9 319.0 40.0 40.3 40.5 42.3
apparatus
fitchsolutions.com
Other Medical Devices Forecast

Key View: We maintain our forecast CAGR in local currency terms and project that the market for other medical devices will grow at
a 2020-2025 CAGR of 10.9% in local currency terms and 9.1% in US dollar terms, which will take the value to INR149.4bn
(USD1.8bn). The market will continue to benefit from India remaining one of the fastest growing economies in the region, but the
country's economic growth will slow due to the Covid-19 outbreak posing risks to the short-term outlook. However, a strong
Latest Updates
We maintain our forecast CAGR in local currency terms and project that the market for other medical devices will grow at a
2020-2025 CAGR of 10.9% in local currency terms, which will take the value to INR149.4bn. The market will continue to benefit
from India remaining one of the fastest growing economies in the region, but the country's economic growth will slow due to the
Covid-19 outbreak posing risks to the short-term outlook. However, a strong recovery is anticipated.
The market will see low double-digit growth over the forecast period driven by population increase, an increasingly chronic
epidemiological profile, improved healthcare access, rising consumer buying power and new technology acquisition. We anticipate,
however, that growth rates will moderate, reflecting an increasingly competitive operating environment and expanding market
share for lower cost domestically produced products in some sectors.
Other Medical Devices Market, Local Currency

(2015-2025)
We maintain our forecast CAGR in US dollar terms and project that the market will register a 2020-2025 CAGR of 9.1%, which will
take the value to USD1.8bn. We expect the Indian rupee to remain on a broad depreciatory path against the US dollar due to the
The broad other instruments & appliances subcategory will continue to represent more than 70% of the market with dialysis
fitchsolutions.com
apparatus and endoscopy apparatus the leading identifiable product segments. All product segments will record high single-digit
CAGRs, apart from UV/IR apparatus.
Other Medical Devices Market, US Dollar

(2015-2025)
Structural Trends
• Healthcare Drivers: Population increases and an increasingly chronic epidemiological profile; a growing elderly population
with mobility needs, which supports the use of wheelchairs; a high incidence of eye diseases, and the ageing population with
sight defects and age-related eye diseases, which drive the use of ophthalmic instruments; the rising incidence of ophthalmic
surgery, which benefits ophthalmic instruments; the increasing incidence of hospital acquired infections, which supports the use
of sterilisers; investment in hospital infrastructure, which supports demand for hospital furniture; new therapeutic applications for
UV/IR apparatus; and the rising number of surgical procedures exceeding 18mn per annum, which supports demand for a broad
range of surgical devices.
• Market Drivers: A low rate of per capita spending, which indicates good growth potential driven by new technology acquisition;
the development of smaller more affordable equipment for use in less developed areas; technological innovation incorporating
enhanced features for higher-end equipment; established domestic production for low technology products; and high import
dependency for technologically advanced products.
• Imports supply around three-quarters of the market. A third of imports come from the EU, notably Germany, plus Italy for
sterilisers. The US is the leading supplier overall, accounting for nearly a quarter of imports in 2018. China contributed 15% of
imports in 2018 and was the leading supplier of wheelchairs and hospital furniture.
• Domestic Production focuses on low technology products. Domestic producers of surgical instruments include ASCO, Atlas
Surgical, Kayco, Narang Medical, Pace devices, Ribbel International and SISCO. ASCO, Atlas Surgical, Kayco and Narang Medical
also manufacture hospital furniture and sterilisers. Nipro of Japan produces dialysis apparatus, while Terumo produces blood
transfusion apparatus.
fitchsolutions.com
INDIA - OTHER MEDICAL DEVICES MARKET, 2015-2025 (USDMN)

2015 2016 2017 2018 2019 2020 2021f 2022f 2023f 2024f 2025f
OTHER MEDICAL DEVICES 985.2 1,053.3 1,155.4 1,297.6 1,419.9 1,220.0 1,346.7 1,391.7 1,535.1 1,677.3 1,778.6
WHEELCHAIRS 27.4 35.2 39.7 49.5 49.6 60.4 54.3 53.3 57.5 61.2 64.1
Wheelchairs, not mechanically

21.1 28.5 32.7 43.3 41.3 51.4 46.0 45.2 48.6 51.7 54.2
propelled
Wheelchairs, mechanically
6.2 6.6 7.0 6.2 8.3 9.0 8.2 8.2 8.8 9.5 9.9
propelled
OPHTHALMIC INSTRUMENTS 175.0 171.5 177.2 194.0 190.9 104.5 98.0 99.0 120.8 145.6 170.7
HOSPITAL FURNITURE 43.7 48.1 54.0 58.7 59.5 58.5 68.5 73.6 80.3 86.7 91.9
MEDICAL, SURGICAL
35.3 48.6 51.8 52.6 51.5 55.4 68.0 71.2 78.7 86.2 92.9
STERILISERS
ULTRA-VIOLET OR INFRA-RED
1.3 1.5 1.7 3.4 3.9 2.7 3.0 3.2 3.4 3.6 3.8
RAY APPARATUS
OTHER INSTRUMENTS &

702.6 748.5 830.9 939.4 1,064.4 938.5 1,055.1 1,091.5 1,194.4 1,293.9 1,355.3
APPLIANCES
Blood pressure monitors 18.1 19.1 21.5 23.8 24.4 26.3 29.3 31.1 33.6 36.0 37.9
Endoscopy apparatus 47.6 48.2 52.5 56.1 68.4 62.8 65.1 64.0 64.0 63.4 61.8
Dialysis apparatus 28.1 35.6 47.5 64.4 66.4 70.7 67.9 67.0 72.4 77.2 81.0
Transfusion apparatus 22.8 25.4 31.8 31.6 50.9 54.8 60.7 61.6 64.5 67.1 69.0
Anaesthetic apparatus &

10.1 17.7 21.9 27.9 28.6 30.3 32.6 33.0 35.6 37.9 39.7
instruments
fitchsolutions.com
Medical Devices Monthly Imports

Key View: Medical device import performance remained mostly positive in 2019, with imports estimated to have grown by 4.7% in
the 12 months to December 2019.
The latest monthly trade data reveal that imports grew by 9.6% y-o-y to USD982.8mn in the three months to December 2019.
Orthopaedics and prosthetics was the strongest performing product area and dental was the weakest, recording a low single-digit
US dollar growth.
In the 12 months to December 2019, imports grew by 4.7% to USD3.6bn. Diagnostic imaging remained the largest product area.
INDIA - MONTHLY MEDICAL DEVICE IMPORTS BY PRODUCT AREA, YEAR ENDING DECEMBER 2019 (USD'000)
CONSUMABLES DIAGNOSTIC DENTAL ORTHOPAEDIC PATIENT OTHERS Total
IMAGING AIDS
Quarter to Dec-18 124,415 317,454 42,816 52,403 112,304 247,671 897,063
Quarter to Dec-19 146,122 328,575 44,063 77,037 117,500 269,535 982,832
Qtr % +/- 17.4 3.5 2.9 47.0 4.6 8.8 9.6
Year to Dec-18 467,068.0 1,170,216.0 152,326.0 269,612.0 402,877.0 977,781.0 3,439,880.0
Year to Dec-19 514,065.0 1,196,942.0 155,942.0 302,385.0 397,863.0 1,035,869.0 3,603,066.0
12 months % +/- 10.1 2.3 2.4 12.2 -1.2 5.9 4.7
Source: Directorate General of Commercial Intelligence & Statistics, Fitch Solutions
fitchsolutions.com
Medical Devices Annual Imports
Latest Updates
Imports have maintained an upward trajectory in local currency terms over the past decade, recording mainly high single-digit to
double-digit year-on-year growth. In 2020, imports fell by 16.1% to INR253.7bn. Imports grew at a 2015-2020 CAGR of 5.1%.
Medical Device Imports, Local Currency

(2010-2020)
Source: ITC, Fitch Solutions
In US dollar terms, imports have recorded positive growth in all years apart from 2020. In 2020, imports fell by 20.3% to USD2.9bn.
This marked a change from mid single-digit growth after consecutive years of single- to double-digit growth, following mainly low
single-digit rises recorded in the preceding four years when a weakening of the rupee against the US dollar hindered performance.
Imports grew at a 2015-2020 CAGR of 2.2%.
fitchsolutions.com
Medical Device Imports, US Dollar

(2010-2020)
Structural Trends
Diagnostic imaging is the largest product area accounting for over a third of total imports, followed by other medical devices, patient
aids, consumables, orthopaedics & prosthetics and dental products.
Other medical devices and consumables were the best performing product areas in 2020, recording the smallest contractions of
around 13% and 19% respectively in local currency terms. All product areas registered y-o-y double-digit contractions.
Patient aids, consumables and diagnostic imaging have been the strongest product areas over the past five years, recording the
largest 2015-2020 CAGRs in local currency terms and single-digit rises in US dollar terms. Other product areas registered positive
CAGRs exclusing orthopaedics & prosthetics.
Leading Suppliers
China is the leading supplier of medical devices to India with shipments worth USD605.5mn, equal to around one fifth of the total in
2020. China dominates in most product areas and is particularly strong in the supply of patient aids, where it contributed a quarter
of imports in 2020.
The US is the number two supplier, accounting for 17.3% of imports in 2020. The US performs well in most product areas and is
particularly strong in the supply of orthopaedics and prosthetics, where it contributed over a quarter of imports in 2020.
The EU-27 supplies nearly a third of imports, with shipments valued at USD856.4mn in 2020. Germany is the dominant EU-27
supplier accounting for 11.3% of the import total in 2020, making it the third largest country supplier. The Netherlands, Belgium,
Switzerland (prior to leaving the EU), France and Italy are smaller suppliers with import shares ranging from 2-7% in 2020.
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INDIA - TOP 20 MEDICAL DEVICE SUPPLIERS, 2020 (USD'000)
2020 % Total
China 605,553 20.8
US 503,588 17.3
Germany 329,483 11.3
Japan 168,873 5.8
Singapore 164,652 5.7
Netherlands 163,865 5.6
Belgium 147,080 5.1
Switzerland 100,995 3.5
South Korea 88,566 3.0
UK 82,155 2.8
Hong Kong 78,436 2.7
France 59,678 2.1
Malaysia 52,087 1.8
Italy 49,949 1.7
Vietnam 30,248 1.0
Australia 24,657 0.8
Denmark 22,937 0.8
New Zealand 20,936 0.7
Israel 20,393 0.7
Ireland 17,729 0.6
Subtotal 2,731,860 93.9
Others 177,395 6.1
Total 2,909,255 100.0
Note: Includes territories and special administrative regions. Source: ITC, Fitch Solutions
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INDIA - DETAILED MEDICAL DEVICE BY PRODUCT AREA, 2016-2020 (USD'000)
2016 2017 2018 2019 2020
CONSUMABLES 321,340 393,429 469,171 516,397 398,209
BANDAGES & DRESSINGS 27,727 28,683 29,912 31,208 35,633
Medical dressings (adhesive) 11,292 12,039 12,335 12,649 9,954
Medical dressings (non-adhesive) 16,435 16,644 17,577 18,559 25,679
SUTURING MATERIALS 8,625 9,496 12,661 15,061 8,304
SYRINGES, NEEDLES & CATHETERS 258,580 325,454 392,961 426,658 307,731
Syringes (with/without needles) 35,297 39,709 56,516 61,505 60,611
Tubular metal needles/needles for sutures 43,058 51,107 55,721 54,123 42,185
Other needles, catheters, cannulae etc 180,225 234,638 280,724 311,030 204,935
OTHER CONSUMABLES 26,408 29,796 33,637 43,470 46,541
Blood-grouping reagents 3,532 6,496 6,714 7,209 5,093
First-aid boxes & kits 286 191 89 535 49
Ostomy products 2,835 4,128 5,210 4,207 5,614
Surgical gloves 19,755 18,981 21,624 31,519 35,785
DIAGNOSTIC IMAGING 866,524 977,179 1,176,730 1,221,285 947,912
ELECTRODIAGNOSTIC APPARATUS 293,223 337,529 373,097 388,434 317,062
Electrocardiographs 8,264 8,486 7,802 7,954 11,871
Ultrasound 107,379 131,406 162,280 171,780 141,431
MRI 110,364 134,687 137,225 132,006 90,569
Scintigraphic apparatus 5,239 4,776 8,396 6,778 2,552
Other electrodiagnostic apparatus 61,977 58,174 57,394 69,916 70,639
RADIATION APPARATUS 187,653 235,613 357,131 326,466 235,041
CT scanners 69,080 82,299 122,623 115,628 87,680
Other medical X-ray apparatus 93,703 130,377 202,350 181,594 114,805
A, B, C ray apparatus 24,870 22,937 32,158 29,244 32,556
IMAGING PARTS & ACCESSORIES 385,648 404,037 446,502 506,385 395,809
Contrast media 31,186 35,543 40,133 54,537 30,579

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2016 2017 2018 2019 2020
Medical X-ray film (flat) 76,664 79,268 88,292 91,035 75,476
Medical X-ray film (rolled) 10,357 7,861 10,777 6,586 7,474
X-ray tubes 25,839 24,313 31,806 55,819 46,173
Other imaging parts & accessories 241,602 257,052 275,494 298,408 236,107
DENTAL PRODUCTS 114,479 147,104 153,036 159,992 89,683
CAPITAL EQUIPMENT 15,604 27,297 21,402 22,767 13,455
Dental drills 732 1,003 900 573 349
Dental chairs 9,022 13,580 8,857 8,965 5,921
Dental X-ray 5,850 12,714 11,645 13,229 7,185
INSTRUMENTS & SUPPLIES 98,875 119,807 131,634 137,225 76,228
Dental cements 25,635 26,077 32,481 35,172 19,385
Dental instruments 45,202 56,457 64,444 65,269 37,173
Teeth & other fittings 28,038 37,273 34,709 36,784 19,670
Artificial teeth 801 1,034 1,455 1,291 401
Other dental fittings 27,237 36,239 33,254 35,493 19,269
ORTHOPAEDICS & PROSTHETICS 255,460 251,424 269,393 305,289 133,169
FIXATION DEVICES 15,015 17,480 17,811 21,566 15,717
ARTIFICIAL JOINTS 124,452 125,475 111,036 131,219 52,175
OTHER ARTIFICIAL BODY PARTS 115,993 108,469 140,546 152,504 65,277
PATIENT AIDS 307,322 362,098 406,128 406,141 476,837
PORTABLE AIDS 179,909 202,815 220,085 212,484 162,174
Hearing aids 41,339 44,583 52,257 44,972 30,370
Pacemakers 21,787 24,941 31,929 39,937 25,015
Other portable aids 116,783 133,291 135,899 127,575 106,789
THERAPEUTIC APPLIANCES 127,413 159,283 186,043 193,657 314,663
Mechano-therapy apparatus 36,451 48,761 50,738 53,918 37,735
Therapeutic respiration apparatus 90,962 110,522 135,305 139,739 276,928
OTHER MEDICAL DEVICES 800,543 858,437 981,372 1,040,081 863,445
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2016 2017 2018 2019 2020
WHEELCHAIRS 12,893 14,194 18,461 21,435 12,782
Wheelchairs, not mechanically propelled 6,593 7,783 13,021 14,742 8,608
Wheelchairs, mechanically propelled 6,300 6,411 5,440 6,693 4,174
OPHTHALMIC INSTRUMENTS 154,923 158,529 173,046 168,336 88,978
HOSPITAL FURNITURE 32,153 35,686 39,978 43,617 37,413
MEDICAL, SURGICAL STERILISERS 36,497 35,401 37,029 41,103 45,895
ULTRA-VIOLET OR INFRA-RED RAY

861 1,021 2,789 3,413 1,968
APPARATUS
OTHER INSTRUMENTS & APPLIANCES 563,216 613,606 710,069 762,177 676,409
TOTAL 2,665,668 2,989,671 3,455,830 3,649,185 2,909,255
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INDIA - DETAILED MEDICAL DEVICE SUPPLIERS BY PRODUCT AREA, 2020 (USD'000)
China US Germany Japan Singapore EU27
CONSUMABLES 42,465 67,444 10,049 16,163 68,027 96,212
BANDAGES & DRESSINGS 11,741 5,533 148 2,698 2,814 3,963
SUTURING MATERIALS 45 4,326 11 0 12 1,980
SYRINGES, NEEDLES & CATHETERS 29,225 56,945 9,876 13,459 64,392 84,322
OTHER CONSUMABLES 1,454 640 14 6 809 5,947
DIAGNOSTIC IMAGING 234,723 183,842 113,930 98,731 30,953 262,052
ELECTRODIAGNOSTIC APPARATUS 92,742 60,617 26,099 18,257 16,904 70,177
RADIATION APPARATUS 58,382 38,100 34,763 15,876 3,386 67,685
IMAGING PARTS & ACCESSORIES 83,599 85,125 53,068 64,598 10,663 124,190
DENTAL PRODUCTS 13,245 10,831 9,535 6,875 133 20,781
CAPITAL EQUIPMENT 3,534 420 1,688 112 3 3,918
INSTRUMENTS & SUPPLIES 9,711 10,411 7,847 6,763 130 16,863
ORTHOPAEDICS & PROSTHETICS 5,716 35,986 14,514 50 5,343 53,178
PATIENT AIDS 120,688 53,770 35,748 248 23,110 151,518
PORTABLE AIDS 7,429 12,858 6,484 0 15,958 95,885
THERAPEUTIC APPLIANCES 113,259 40,912 29,264 248 7,152 55,633
OTHER MEDICAL DEVICES 188,716 151,715 145,707 46,806 37,086 272,633
TOTAL 605,553 503,588 329,483 168,873 164,652 856,374
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Medical Devices Monthly Exports

Key View: Medical device export performance remains robust, registering double-digit growth in both local currency and US dollar
terms.
The latest monthly trade data reveal that exports grew by 12.5% y-o-y to USD1.6bn and rose by 10.3% y-o-y to USD0.4bn in the
three months to December 2019. Dental products was the strongest performing product area and diagnostic imaging the weakest.
All product areas register positive growth y-o-y to December 2019, with only diagnostic imaging registering a contraction in the
three months to December 2019.
MONTHLY MEDICAL DEVICE EXPORTS BY PRODUCT AREA, YEAR ENDING DECEMBER 2019 (USD'000)
DIAGNOSTIC PATIENT
CONSUMABLES DENTAL ORTHOPAEDIC OTHERS Total
IMAGING AIDS
Quarter to Dec-18 121,883 150,061 7,716 28,624 8,064 71,692 388,040
Quarter to Dec-19 132,453 140,793 10,442 30,592 11,595 101,947 427,822
Qtr % +/- 8.7 -6.2 35.3 6.9 43.8 42.2 10.3
Year to Dec-18 482,876.0 489,941.0 30,491.0 100,336.0 28,494.0 282,490.0 1,414,628.0
Year to Dec-19 530,819.0 512,162.0 39,147.0 113,128.0 37,226.0 359,254.0 1,591,736.0
12 months % +/- 9.9 4.5 28.4 12.7 30.6 27.2 12.5
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Medical Devices Annual Exports
Latest Updates
With the exception of 2015, exports have recorded positive growth since 2011, reflecting the expanding domestic medical device
industry, particularly in the consumables product area, which accounts for a disproportionately large share of total exports. We
expect the export share of consumables will decline as other product areas grow in importance.
In local currency terms, exports grew by 15.3% to INR117.1bn in 2020. This compares to slower growth than in 2019 and 2018. The
2015-2020 CAGR was 11.1%.
Medical Device Exports, Local Currency

(2010-2020)
Source: National Statistics, Fitch Solutions
In US dollar terms, exports fell by 1.8% to USD1.6bn in 2020. This marked the first contraction in USD terms since 2015. The
2015-2020 CAGR was 7.9%.
With the notable exception of consumables, India maintains a balance of trade deficit in all major product areas. As a result, the
overall trade deficit decreased to USD1.3bn in 2020.
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Medical Device Exports, US Dollar

(2010-2020)
Structural Trends
Consumables and diagnostic imaging are the two largest product areas, reflecting the strengths of the domestic manufacturing
industry. These two product areas each account for around a third of the export total. Other medical devices is the third largest
product area accounting for a fifth of the export total in 2020, followed by orthopaedics and prosthetics, dental products and
patient aids.
Diagnostic imaging was the best performing product area in 2020, recording a rise of more than 40% in local currency terms and
35% in US dollar terms. Patient aids and orthopaedics and prosthetics had slightly lower growth, followed by dental products,
consumables and other medical devices.
Orthopaedics & prosthetics and patient aids both recorded double digit 2015-2020 CAGRs in both currencies.
Leading Destinations
The US is the leading destination in all product areas, receiving exports valued at USD331.2mn in 2020, equal to more than one fifth
of the total. Diagnostic imaging accounted for more 35% of shipments to the US in 2020.
China and Germany were the other leading destinations in 2020, although they each received less than 10% of the total, with
diagnostic imaging comprising the majority of shipments.
The EU-27 was the destination for less than a quarter of exports at a value of US364.4mn in 2020, led by Germany and France.
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INDIA - TOP 20 MEDICAL DEVICE DESTINATIONS, 2020 (USD'000)

2020 % Total
US 331,152 21.0
China 116,911 7.4
Germany 109,465 6.9
Singapore 65,987 4.2
France 58,416 3.7
Brazil 41,930 2.7
Turkey 36,311 2.3
Belgium 32,307 2.0
Spain 30,088 1.9
Italy 27,984 1.8
Netherlands 27,165 1.7
Nepal 27,151 1.7
Iran 25,902 1.6
Sri Lanka 24,562 1.6
UAE 24,100 1.5
UK 24,024 1.5
Russia 22,447 1.4
Poland 20,788 1.3
Japan 20,410 1.3
Bangladesh 19,689 1.2
Subtotal 1,086,789 68.8
Others 492,890 31.2
Total 1,579,679 100.0
Note: Includes territories and special administrative regions. Source: ITC, Fitch Solutions
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INDIA - DETAILED MEDICAL DEVICE EXPORTS BY PRODUCT AREA, 2016-2020 (USD'000)
2016 2017 2018 2019 2020
CONSUMABLES 383,161 418,446 484,325 534,575 526,113
BANDAGES & DRESSINGS 48,203 47,396 54,478 57,695 56,879
SUTURING MATERIALS 21,859 30,143 30,900 27,434 23,513
SYRINGES, NEEDLES & CATHETERS 275,088 308,646 362,442 407,883 384,442
OTHER CONSUMABLES 38,011 32,261 36,505 41,563 61,279
DIAGNOSTIC IMAGING 372,239 362,932 494,246 517,264 483,285
ELECTRODIAGNOSTIC APPARATUS 127,881 123,248 180,731 220,894 202,573
RADIATION APPARATUS 44,177 53,820 73,258 58,248 55,528
IMAGING PARTS & ACCESSORIES 200,181 185,864 240,257 238,122 225,184
DENTAL PRODUCTS 24,692 25,300 30,625 40,058 32,849
CAPITAL EQUIPMENT 3,587 2,675 2,942 3,837 3,055
INSTRUMENTS & SUPPLIES 21,105 22,625 27,683 36,221 29,794
ORTHOPAEDICS & PROSTHETICS 69,586 79,249 100,853 115,914 117,425
PATIENT AIDS 19,379 21,781 28,659 36,289 51,091
PORTABLE AIDS 13,049 14,144 17,725 25,422 37,053
THERAPEUTIC APPLIANCES 6,330 7,637 10,934 10,867 14,038
OTHER MEDICAL DEVICES 256,999 256,490 283,181 364,648 368,916
TOTAL 1,126,056 1,164,198 1,421,889 1,608,748 1,579,679
na = not available. Source: ITC, Fitch Solutions
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INDIA - DETAILED LEADING MEDICAL DEVICE DESTINATIONS BY PRODUCT AREA, 2019 (USD'000)
US China Germany Singapore France EU27
CONSUMABLES 49,865 22,739 24,449 3,836 12,487 115,709
BANDAGES & DRESSINGS 15,290 181 8,079 128 935 15,653
SUTURING MATERIALS 1,062 278 248 110 235 13,768
SYRINGES, NEEDLES & CATHETERS 31,921 22,247 11,147 3,136 10,880 72,044
OTHER CONSUMABLES 1,592 33 4,975 462 437 14,244
DIAGNOSTIC IMAGING 172,993 67,387 31,359 52,255 35,482 99,346
ELECTRODIAGNOSTIC APPARATUS 101,093 14,903 13,183 21,321 2,789 37,554
RADIATION APPARATUS 9,633 468 2,048 505 1,678 10,715
IMAGING PARTS & ACCESSORIES 62,267 52,016 16,128 30,429 31,015 51,077
DENTAL PRODUCTS 9,261 76 1,581 105 545 6,130
CAPITAL EQUIPMENT 605 0 541 5 53 725
INSTRUMENTS & SUPPLIES 8,656 76 1,040 100 492 5,405
ORTHOPAEDICS & PROSTHETICS 14,435 450 5,064 1,759 1,170 28,315
PATIENT AIDS 2,496 3,181 2,140 952 40 10,121
PORTABLE AIDS 1,679 2,760 1,545 496 17 8,607
THERAPEUTIC APPLIANCES 817 421 595 456 23 1,514
OTHER MEDICAL DEVICES 82,102 23,078 44,872 7,080 8,692 104,731
TOTAL 331,152 116,911 109,465 65,987 58,416 364,352
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Industry Risk/Reward Index

Asia Pacific Medical Devices Risk/Reward Index
Key View
• The Asia Pacific region remains the second most attractive region for medical devices, with some of the world's fastest growing
markets, despite significant regulatory and operational risks.
• Developed markets led by Japan top our Medical Devices Risk/Reward Index, offering a high-reward, low-risk profile.
• Bangladesh and Pakistan languish at the bottom of the index, with high risks outweighing relatively low rewards.
• China and Malaysia represent some of the best market opportunities in the region through a mix of high rewards and
manageable risks, while India offers the most potential as a fast-growing market with an improving regulatory environment,
offset by a hardened stance on medical device pricing.
Asia Pacific High Potential

Asia Pacific - Medical Devices Risk/Reward Index Heat Map
Note: Includes territories and special administrative regions. Scores out of 100; higher score = lower risk. Source: Fitch Solutions Medical Devices Risk/Reward Index
Main Regional Features And Latest Updates
• Asia Pacific is the second most attractive region in our Medical Devices Risk/Reward Index (RRI), outperforming the global
scores for both Rewards and Risks. The region benefits from the presence of two of the world's five largest markets and more
than half the world's population, including an elderly population of 300mn.
• Developed markets outperform emerging markets on most Rewards and Risks components, driven by a high rate of
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urbanisation, superior access to healthcare, more robust regulatory frameworks and lower operational risks. Emerging
markets have the edge in terms of overall population size, population growth and market growth, indicating higher long-term
potential that counterbalances the considerably higher risks that these markets pose.
• As Asia Pacific's largest market, Japan ranks first in the region, heading the scores for Rewards and Industry Risks, followed by
South Korea and AustrAustralia
alia. China ranks first among emerging markets, with strong Industry Rewards factors offset by below
average scores for Country Rewards and Industry Risks. Malaysia is the second most attractive emerging market, offering a
balance of relatively high Rewards and comparatively low Risks. In 10th place, India offers considerable potential, ranking third
for Industry Rewards, but much lower for other components of the RRI.
• Pakistan and Bangladesh are the least attractive markets, limited by small market sizes, large rural populations, poor access to
healthcare services, weak regulatory systems and unfavourable operating environments.
Asia Pacific High Potential

Asia Pacific - Medical Devices Risk/Reward Index
Japan Remains Most Attractive Market In The Region
• Japan occupies the top position in our Asia Pacific Medical Devices RRI and the third position globally. The country is bolstered
by a particularly strong score for Industry Rewards and Industry Risks. The Industry Rewards score reflects the market size - the
second largest in the region - and high level of per capita spending, despite strong emphasis based on cost-containment, while
the Industry Risks score is enhanced by excellent healthcare access and a robust regulatory environment. The overall Rewards
score is further boosted by a large urban population and rapidly ageing demographics.
• South Korea occupies second place and fifth position globally, supported by strong its Industry Risk score, as a result of the
country's excellent healthcare access and the strength of its regulatory environment. South Korea's above-average Industry
Rewards score is supported by having the third largest market, per capita spending well above the regional average and a strong
domestic industry.
• Australia takes third place regionally and ninth position globally. The country's high rank is largely supported by its low Industry
Risk score as a result of the country's excellent healthcare access and robust regulation.
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Japan Driven By High Industry Rewards And Low Industry Risks

Japan & Asia Pacific Average - Medical Devices Risk/Reward Scores
Note: Scores out of 100; higher score = lower risk. Source: Fitch Solutions Medical Devices Risk/Reward Index
China And Malaysia Head Emerging Asia
• China is the top emerging market and fifth in the overall region. China ranks second highest for Industry Rewards, having the
largest market in the region, which is seeing renewed growth after a period of weakness, supported by the Healthy China 2030
strategic plan, making health a national political priority, as well as its 14th Five Year Plan. However, the drive to reduce import-
reliance means rising demand for medical devices will primarily benefit domestic producers. A strong Industry Rewards
performance is offset by the below average scores for Country Rewards reflecting patchy access to medical services, particularly
in rural areas and the absence of a comprehensive pricing and reimbursement framework.
• Malaysia is the second most attractive emerging market, and the eighth Asia Pacific-specific, offering a balance of relatively
high rewards and comparatively low risks. The market is one of the largest in South East Asia, which supports a strong Industry
Rewards score. Within Country Rewards, the highly urbanised and fast growing population offsets the small elderly population,
meaning a comparatively smaller burden posed by chronic diseases associated with old age, which limits demand for medical
devices. The country's relatively new medical device regulations have increased the attractiveness of the market for
multinationals, which continue to invest in local industry, contributing to the development of Malaysia as a high value-added
manufacturing hub, supporting an above average score for Industry Risks. Economic stability and a business-friendly
environment underpin the above average Country Risks score, which has improved on the back of a more positive stance on
foreign investment.
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China And Malaysia Offer High Rewards With Manageable Risks

China, Malaysia & Asia Pacific Average - Medical Devices Risk/Reward Scores
India Offers Long-Term Potential
• India sits below the average Asia Pacific Medical Devices RRI score, despite being in joint-fourth place for Industry Rewards on
account of its relatively large market, and above average market growth. The large rural and predominantly young population
contributes to a Country Rewards score that is below the regional average. India remains a difficult place to do business with
significant structural risks including internal security threats, corruption, excessive bureaucracy and weak utilities infrastructure,
which lowers the score for Country Risks. The overall position is further dragged down by a particularly low Industry Risks score,
reflecting poor access to healthcare for the majority of the population, vast regional disparities in healthcare coverage and a
weak regulatory environment. While moves to regulate all medical devices will strengthen the regulatory
framework going forward, access to specialist care will remain limited. Additionally, a more proactive stance on medical device
pricing, including pricing controls on high cost implantable devices such as coronary stents and artificial knee implants, poses
further downside risks.
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India A High Reward, High Risk Market

India & Asia Pacific Average - Medical Devices Risk/Reward Scores
Pakistan And Bangladesh Low Reward, High Risk Markets
• Pakistan is the least attractive market in our Asia Pacific Medical Devices RRI. The country occupies bottom position for Industry
Rewards, Industry Risks and Country Risks hindered by very low per capita spending, limited production geared to export and a
poor operating environment. Pakistan also scores below average for Country Rewards despite its large and rapidly expanding
population due to the fact that less than 40% of inhabitants reside in urbanised areas, leaving the market highly fragmented with
poor access to healthcare services.
• Bangladesh has the second lowest position in our Asia Pacific Medical Devices RRI. The country has the smallest market in the
region and lowest per capita spend. The Country Rewards score is also below average, hindered by the large rural population and
the predominantly youthful demographic profile. Poor healthcare access, a weak regulatory system and a poor
operating environment hinder the Industry and Country Risk scores.
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Japan, South Korea, Australia And Hong Kong Score In Global Top 15
Asia Pacific - Medical Devices Risk/Reward Index
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Japan, China And South Korea Offer Highest Rewards

Asia Pacific - Medical Devices Rewards Scores
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Pakistan And Bangladesh Pose Highest Risks

Asia Pacific - Medical Devices Risks Scores
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Market Overview
Medical Devices Overview
• Among the top 20 largest markets by overall size, but very low per capita expenditure.
• Ratio of spending on medical devices to GDP remains low.
• Diagnostic imaging and other medical devices account for the largest market shares.
• The market is seeing relatively high growth by global standards underpinned by a strong economy.
• Growing middle class population fuelling demand for high quality private healthcare.
• The private sector accounts for two-thirds of hospitals and 75% of advanced medical technology.
• Public sector is under-resourced and infrastructure is woefully inadequate.
• Import dependency has started to reduce and will fall further as domestic production expands under the Make in India initiative.
• Local domestic producers focus mainly on low-tech medical devices; higher end devices tend to be manufactured by
multinationals.
• Regulatory oversight is increasing, including a hardened stance on pricing for essential devices.
MEDICAL DEVICE MARKET, KEY RATIOS (2020)
2020
Market size (USDmn) 4,170.8
% health expenditure 3.7
% GDP 0.2
% world market 1.0
% supplied by imports 69.8
% projected CAGR 7.3
Per capita (USD) 3.0
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MEDICAL DEVICE MARKET, BY PRODUCT AREA (2020)
Per Capita
Total % Total Per Capita Total (Local
(Local
(USDmn) Market (USD) Currency mn)
Currency)
Consumables 907.7 21.8 0.7 67,260.9 48.7
Diagnostic imaging 1,262.4 30.3 0.9 93,541.1 67.8
Dental products 139.7 3.3 0.1 10,352.7 7.5
Orthopaedics & prosthetics 227.7 5.5 0.2 16,876.1 12.2
Patient aids 413.3 9.9 0.3 30,622.3 22.2
Other medical devices 1,220.0 29.3 0.9 90,404.3 65.5
Total 4,170.8 100.0 3.0 309,057.4 224.0
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Healthcare Overview
Health Status
India is the second most populous country in the world, accounting for around one sixth of the global population, with 1.4bn
inhabitants. Using data from the UN Population Division, we estimate that the population is growing at an annual rate of 1.0%, and is
on course to reach 1.5bn in 2030 and 1.6bn in 2050, with India set to overtake China as the world's most populous country by
2027. The population remains comparatively young with around half aged under 25. Though only 6.6% of the population is aged 65
and over, this still represents around 91mn elderly inhabitants in 2020. We estimate life expectancy at 68.7 years for men and
71.2 years for women in 2020.
Based on UN data, we estimate that:
• The birth rate fell at a 2025-2020 CAGR of 1.3%, but remains above the regional average at 17.4 per thousand population in
2020, equal to 24.1mn births.
• The mortality rate has remained relatively stable over the past five years at 7.3 per thousand population in 2020, which is around
the regional and global average.
• The infant mortality rate fell at a 2015-2020 CAGR of 3.7%, but remains high at just under 30 deaths per thousand live births.
The rise in unhealthy lifestyles with decreasing physical activity, increasing stress levels and increasing intake of saturated fats and
tobacco is fuelling the incidence of non-communicable diseases. The country also has the world's highest prevalence of metabolic
syndrome and obesity: 20mn Indians are obese with the number projected to rise to 70mn by 2025.
India has seen a sharp rise in the prevalence of heart disease, cancer and diabetes, which are the main contributors to the country's
disease burden:
Heart disease is now the leading cause of disease burden and mortality in India, while stroke is the fifth leading cause. According to
the India State-level Disease Burden Initiative, there were 54.5mn cases of cardiovascular disease in 2016, including 23.8mn cases
of ischaemic heart disease and 6.5mn stroke cases.
There are 1.2mn cases of cancer each year, representing 6.4% of the worldwide total of 18.1mn cases in 2020, according to the
International Agency for Research on Cancer. The number of new cancer cases is forecast to grow at a CAGR of 2.3% to reach
1.9mn by 2040.
According to the International Diabetes Federation, India had 72.9mn adult diabetes sufferers in 2017, the second-highest number
in the world after China and equal to a prevalence in adults of 8.8%, which is above the global average. National prevalence is
forecast to grow to 11.4% by 2045, which amounts to over 134mn diabetic patients. In addition, we highlight that the number of
undiagnosed patients remains high in India with an estimated 42mn in 2017.
The government has initiated several measures to tackle the increasing burden of non-communicable diseases including a free
door-to-door screening programme for early detection of cancer, heart disorders and diabetes.
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Healthcare System
Organisation
The Ministry of Health and Family Welfare is responsible for health policy at national level. Under a reorganisation implemented in
August 2014, the Ministry of Health and Family Welfare comprises the Department of Health and the Department of Health
Research. The Department of Health is responsible for healthcare matters, immunisation campaigns, preventive medicine and
public health. Bodies under the administrative control of the Department of Health include the National AIDS Control Organisation,
the Medical, Dental and Pharmacy Councils of India, the Indian Nursing Council and the Central Drugs Standard Control
Organisation. The Department of AYUSH responsible for traditional Indian Medicine has been made a separate ministry.
The Directorate General of Health Services (DGHS) is attached to the Department of Health and has subordinate offices throughout
the country. The DGHS renders technical advice on medical and public health matters and is involved in the implementation of
various health schemes. Various colleges, institutes, teaching hospitals and training centres operate under the DGHS, along with a
variety of research establishments.
National Health Policy
The National Health Policy of 2015, which updates the previous policy published in 2002, seeks to establish the framework for
health sector development over the next decade. It aims to take account of the country's changing burden of disease profile and
the rising incidence of catastrophic healthcare expenditure, which is judged to be one of the major contributors to poverty. In this
context, the commitment to ensure universal access to affordable healthcare services is cited as an important catalyst for framing a
new health policy. However, the target of providing universal healthcare access is ambitious.
The 2015 Health Policy outlines the following six key objectives:
• Improve population health status through concerted policy action in all sectors and expand preventive, curative, palliative and
rehabilitative services provided by the public health sector;
• Achieve a significant reduction in out of pocket expenditure due to healthcare costs and reduction in proportion of households
experiencing catastrophic health expenditures and consequent impoverishment;
• Assure universal availability of free, comprehensive primary healthcare services, as an entitlement, for all aspects of reproductive,
maternal, child and adolescent health and for the most prevalent communicable and non-communicable diseases in the
population;
• Enable universal access to free essential drugs, diagnostics, emergency ambulance services, and emergency medical and
surgical care services in public health facilities;
• Ensure improved access and affordability of secondary and tertiary care services through a combination of public hospitals and
strategic purchasing of services from the private health sector giving preference to non-profit providers;
• Influence the growth of the private healthcare industry and medical technologies to ensure alignment with public health goals,
and enable contribution to making healthcare systems more effective, efficient, rational, safe, affordable and ethical.
On the question of healthcare delivery, the policy calls for a major overhaul of primary healthcare services in urban areas through a
strengthened National Urban Health Mission. Given the well established private sector in urban areas, the policy sees considerable
scope for developing sustainable models of partnership with for profit and not for profit sector for healthcare delivery. Addressing
the major prevalence of non-communicable diseases such as hypertension and diabetes through planned early detection, and
better secondary prevention would be an integral part of urban health strategy.
For secondary care services, the policy sets a target of one hospital bed per thousand population with the aim of giving access to
secondary care within one hour. This objective is to be achieved through strengthening the district hospital network supported by
Community Health Centres or sub-divisional hospitals. Care would be purchased from private hospitals to cover for gaps in public
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provision with a preference for non-profit hospitals prepared to work on cost recovery principals. Strategic purchasing is seen as an
opportunity to provide stewardship to the private sector, where purchase by the State would indicate where and what services have
critical gaps and encourage growth of the private sector in such areas.
Public Healthcare Providers
The provision of public healthcare services is the responsibility of the state governments. Public healthcare services include primary
healthcare provision through a network of health sub-centres, primary health centres (PHCs) and community health centres (CHCs).
At district level there are civil/district hospitals in the main district towns with an average of 150 beds, as well as a number of smaller
hospitals and dispensaries spread over other towns and villages.
Railway hospitals and those run by the large public sector undertakings (PSU) such as the Steel Authority and Nalco provide
services for their employees. These hospitals are generally well equipped, having generous budgets for equipment. Healthcare is
also provided by the Armed Forces Medical Service, which operates entirely outside the civilian system.
Some of the big industrial organisations in India provide hospital services, mainly for their employees. Tata Steel provides healthcare
facilities for its staff, including the 830-bed Tata Main Hospital (TMH) in Jamshedpur. TMH caters its services to around 60,000
employees of Tata Steel and their families, and also extends its facilities to patients from in and around Jamshedspur, as well as
associated and contractor companies. In May 2011, a new cancer centre, the Tata Medical Center, was opened in Kolkata. This not-
for-profit initiative is aimed at helping cancer patients from the east and northeast of India and also from Bangladesh.
Private Healthcare Providers
The private sector has grown rapidly in recent years and is now the dominant healthcare provider, particularly in urban areas. An
estimated 95% of all new hospital beds created in recent years have been in the private sector.
According to the Ministry of Health and Family Welfare, the private sector share of healthcare provision now covers around 80% of
outpatient care and around 60% of inpatient care. The private sector's dominance extends to medical education and training,
medical technology and diagnostics, pharmaceutical manufacture and sale, hospital construction and ancillary services, and
medical care. More than 75% of human resources and advanced medical technology are in the private sector, as are two-thirds of
hospitals and 37% of beds. The majority of facilities are in urban areas.
Private sector facilities range from 500-bed hospitals equipped to Western standards run by hospital groups such as Apollo
Hospitals and Fortis Healthcare to small hospitals with up to 40 beds run by independent doctors. These facilities provide private
healthcare in smaller towns where there are no large private hospitals. In the big cities they tend to specialise in gynaecology and
obstetrics, cardiac care, orthopaedics and minor surgery.
The majority of private healthcare providers in India are members of the Association of Healthcare Providers (India): a non-profit
organisation that represents the interests of the private healthcare industry.
Apollo Hospitals
Apollo Hospitals was founded by Dr Prathap C Reddy in 1989 and was listed on the Bombay Stock Exchange (BSE) in 1983 and the
National Stock Exchange of India (NSE) in 1996. Apollo Hospitals offers a full range of healthcare services, including hospitals,
diagnostic centres, pharmacies, health insurance, schools for nursing and paramedical training, preventive medicine and managed
care. Apollo Hospitals has a network of 71 hospitals across India with around 10,100 beds, of which 8,873 are in 64 owned hospitals
and 1,234 in seven managed hospitals. The group also operates 71 medical clinics, 74 dental clinics and 218 diagnostic centres.
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Apollo Hospitals has sought to remain at the forefront of medical technology. Firsts in India claimed by the company include a G4
Cyberknife robotic radiosurgery system, a 320-slice CT scanner, a 64-slice PET scanner and a full-field digital 3D mammography
system. In January 2019, Apollo Hospitals opened India's first proton therapy centre. The centre, equipped by Ion Beam Applications
of Belgium, is located in Chennai.
CARE Group
The CARE group of hospitals operates 15 hospitals with around 2,100 beds across a number of states. The group was founded in
1997 by cardiologist Dr B Soma Raju, who set up the CARE Heart Institute in the Hyderabad suburb of Nampally in Andhra Pradesh
state. The group has expanded into other states with hospitals in Nagpur, Pune, Raipur and Surat.
Cygnus Medicare
Founded in 2011 by four doctors, Delhi-based Cygnus Medicare claims to be one of the largest chains of multispecialty hospitals in
the National Capital Region. It has ten hospitals with over 1,000 beds located in tier II cities including Dwarka,
Nangloi, Pitampura, Rama Vihar and Safdarjung in Delhi and Bahadurgath, Karnal, Panipat, Rewari and Sonipat in Haryana. Cygnus
operates an asset-light model where it does not own its facilities, meaning its operating costs are much lower than those typically
incurred by larger hospital operators. The company is backed by Eight Roads Ventures (formerly Fidelity Growth Partners)
and Somerset Indus Capital Partners.
Fortis Healthcare
Fortis Healthcare was founded in 1996 on the vision of the late Dr Parvinder Singh, formerly chairman of Ranbaxy Laboratories.
Fortis Healthcare has around 45 healthcare facilities, of which 34 are hospitals, with 5,000 beds, including the New Delhi-based
Escorts Heart Institute, a leading cardiac care facility in the Asia-Pacific region. In November 2018, the Malaysian-Singaporean
private healthcare group IHH Healthcare acquired a 31% stake in Fortis. IHH subsequently launched an offer to acquire a majority
share in Fortis, but the deal has been blocked by India's Supreme Court. IHH has seven hospitals in south and west India with 1,600
beds.
HCL Healthcare
HCL Corporation, parent company of HCL Technologies, an IT services provider, is diversifying into the healthcare services market
with the establishment of HCL Healthcare. The new business will set up a network of multispecialty clinics as part of a technology-
led system targeting the 300mn urban middle class. HCL Healthcare has acquired a controlling stake in Bharat Family Clinic, a
primary healthcare provider, which runs two health and wellness clinics in Noida and Gurgaon, Delhi. HCL aims to employ 1,500
clinicians over the next five years and to treat 50,000 patients daily. In the longer term, it has ambitions operate across the entire
healthcare services spectrum, from clinics and hospitals to diagnostics and analytics.
Manipal Hospitals
Manipal Hospitals forms part of the Manipal Education and Medical Group (MEMG), which is active in the fields of education and
healthcare delivery. The focus at Manipal Hospitals is to develop an affordable tertiary care multispecialty healthcare framework
through its entire delivery spectrum and further extend it to homecare. The group has a network of 15 hospitals, of which 11 are
owned, and three primary clinics located across five states, predominantly in South India. The hospitals comprise a quaternary care
facility located in Bangalore, five tertiary care and nine secondary care facilities. Manipal Hospitals operates and manages around
5,100 beds and cares for around 2mn patients each year. There are plans to double capacity to 10,000 beds with hospitals
earmarked for Indore, Jaipur, Bhubaneshwar and Pune. Manipal also has a home care business run in partnership with
Portea Medical, which offers specialised nursing for post-operative care and long-term conditions, including cancer and
neurological disorders, as well as physiotherapy and rehabilitation services, doctor consultations and equipment rental.
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Max Healthcare
Founded in 2002, Max Healthcare (MHC) has grown from a small clinic in South Delhi to a network of primary care centres and 14
hospitals in North India with over 2,000 beds. Services are in three tiers, from primary to tertiary care, with an increasing focus on
high end tertiary care, including cancer care where MHC claims to have one of the largest pools of clinical talent in India. In
November 2014, South African healthcare operator Life Healthcare completed an investment of INR7.7bn (USD0.1bn) to increase
its stake in MHC, giving it an equal 46.4% share with venture partner Max India. The International Finance Corporation has also
bought additional equity in MHC to maintain its 7.5% stake in an expanded capital base. In March 2014, MHC signed an agreement
with GE Healthcare to set up a Centre of Excellence for cancer care at the Max Super Specialty Hospital in Saket, Delhi, which will
conduct collaborative research on cancer care and technology solutions. The two parties will also set up an oncology training
institute to advance oncology clinical skills and address the severe shortage of oncology specialists.
Narayana Health
Headquartered in Banglore, Narayana Health operates a network of hospitals across India with a particularly strong presence in
Karnataka state and Eastern India. The group has over 6,000 operational beds located in 23 hospitals, seven heart centres and 19
primary care centres in India, as well as an international hospital in the Cayman Islands.
Sterling Hospitals
Sterling Hospitals is a leading hospital group in the state of Gujarat, which is managed by Sterling AddLife India. The private equity
firm Actis holds a majority stake in the business. Sterling Hospitals operates six hospitals with around 1,100 beds. The largest facility
is a 300-bed hospital in Ahmedabad.
Healthcare Funding
Health Insurance
Health insurance uptake remains low. The 2012-2017 five year plan committed to the introduction of universal healthcare
coverage; currently only around 30% of the population is covered by some kind of insurance scheme, of which around three-
quarters are covered by a government-sponsored scheme. The government aims to increase this to at least 75%, but this will be
difficult to attain without the intervention of the private sector.
Public Health Insurance
There are a number of public health insurance schemes including:
• Central Government Health Scheme (CGHS) covering central government employees and members of their families, together
with various other public sector employees totalling over 20mn beneficiaries. Services are provided by accredited government
and over 750 private hospitals, clinics and diagnostic centres.
• Employees' State Insurance (ESI) Scheme for workers in establishments with 10 or more employees funded through employee
and employer contributions with state government support. Services are provided by dispensaries, diagnostic centres and
secondary level hospitals with the bulk of tertiary care referred to corporate super-speciality hospitals.
• Ex-Servicemen Contributory Health Scheme (ECHS), which healthcare services for retired armed forces personnel and their
dependents with a total of 4.3mn beneficiaries. The scheme operates some 400 polyclinics and has more than 500 empanelled
hospitals.
• Pradhan Mantri Jan Arogya Yojana (PMJAY), previously part of the Ayushman Bharat, which is replacing the Rashtriya Swasthya
Bima Yojana (RSBY), a government-run health insurance scheme for the Indian poor, now under the jurisdiction of the MoHFW.
Originally announced in the FY2016/17 budget as the National Health Protection Scheme, the renamed PMJAY scheme was
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officially launched in September 2018. The scheme aims to cover the entire 'below the poverty line' population with health
insurance for most diseases that require hospitalisation. Progress on implementation has been slow to date, but the scheme
received new impetus with the announcement in the FY2018/19 budget that it would be rolled out to around 100mn poor
families and up to 500,000 beneficiaries, or nearly 40% of the entire population. The scheme aims to provide healthcare
coverage of up to INR0.5mn (USD7,700) per family per year. The central government is expected to meet 60% of the cost with
the states responsible for financing the other 40%. The cost of full implementation is estimated at INR100-120bn
(USD1.4-1.7bn), based on a family premium of around INR1,100 (USD15). All public hospitals will be eligible to participate in the
scheme with private hospitals accredited on defined criteria.The government has established fixed package hospital rates for a
large number of interventions.
By the end of July 2018, more than 20 states and union territories had signed up to the PMJAY. Larger states including Assam, Bihar,
Madhya Pradhesh and Uttar Pradesh have opted to directly fund health services through a trust with services provided by
empanelled hospitals according to prices fixed by the government. Some smaller states have opted for an insurance-based model
where the state will appoint an insurance company to run the scheme on its behalf.
Private Health Insurance
India's private health insurance market is relatively small, but growing fast. In FY2015/16, 85.7mn people had private health
insurance, up from 50.6mn in FY2011/12, according to the Insurance Regulatory and Development Authority of India. This
represents around 6.5% of the population. Around two thirds of beneficiaries were covered by group plans and one third by
individual plans.
Health Expenditure
Based on data from the WHO, we estimate health expenditure at USD111.8bn in 2020, equivalent to 4.4% of GDP and USD81 per
capita. Private health expenditure represents around two-thirds of the total, primarily in the form of out-of-pocket spending. Public
health expenditure is comparatively low, accounting for the remaining third of the total. Current spending levels fall well short of the
ambitious target of doubling the level of public health expenditure to 2.5% of GDP under the 2012-2017 Five Year Plan. In the
longer term, the government accepts that to fully achieve the objectives of its National Health Policy would require increasing
public health expenditure to 4-5% of GDP.
The budget for the Ministry of Health and Family Welfare will increase to INR670.86bn (USD9.2bn) in FY2020/21, 97% of which will
go to the Department of Health and the remaining 3% to the Department of Health Research. This represents a 3.9% rise over the
FY2019/18 health budget and a 18.2% rise over actual spending in FY2018/19. We note that health expenditure since the
Modi government came to power in 2014 has risen at a CAGR of 15.5%, between FY2014/15 and FY2018/19, double the rate of
growth in the preceding four years, when the health budget was consistently underspent. That said, at less than 1.5% of GDP, public
health expenditure remains woefully inadequate to achieve any significant improvement in the country's current poor healthcare
provision.
The budget for the National Health Mission, one of the largest components, is set at INR324.0bn (USD4.5bn), a 5.6% increase over
the revised FY2018/19 expenditure of INR306.8bn (USD4.5bn). The budgetary allocation for Health is more generous than last
year’s increase, due in part to increased resources for the PMJAY public health insurance programme, which forms a key component
of the government's push to achieve universal healthcare. The PMJAY budget will rise by 167% to INR64bn (USD0.9bn) in FY2019/
20. However, this falls short of the INR100bn (USD1.4bn) sought by the National Health Authority responsible for implementing the
scheme.
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Further Health Spending Boost In FY2019/20 Budget

India - Union Budget Health Expenditure (FY2009/10-FY2019/20)
Source: Ministry of Finance, Union Budget, Fitch Solutions
Healthcare Resources
Infrastructure
The private sector is the dominant healthcare provider, particularly in urban areas, and is the major end-user of medical equipment.
We estimate that the number of private hospitals has grown at a 2015-2020 CAGR of 6.2% to 48,136. We estimate the number of
public hospitals at 15,692 in 2020. Three-quarters of public hospitals are located in rural areas.
We estimate the number of hospital beds at 1.2bn in 2020, equal to 0.9 beds per thousand population. Provision is well below
average for the Asia-Pacific (APAC) region. The National Health Policy 2015 set a target of one hospital bed per thousand population
with the aim of giving access to secondary care within one hour. At current population growth rates, this would require increasing
bed capacity to 1.4bn. In 2017, there were 710,761 beds in public hospitals, of which 279,588 were in rural hospitals and 431,173 in
urban hospitals. Provision in the public sector is as low as 0.1 beds in some of the more populous and underdeveloped states, with
Bihar state having over 8,600 inhabitants per government hospital bed in 2017.
Tertiary Care Expansion
The government is funding an expansion of tertiary care in the public sector to address the rising costs of largely private sector
tertiary care. This includes strengthening 58 medical colleges, upgrading 58 district hospitals to become medical colleges and
expanding the number of medical education and research facilities along the lines of the All India Institute of Medical Sciences
(AIIMS) with the ultimate aim of having at least one AIIMS in each state. The policy acknowledges that there is a need for further
expansion of infrastructure for speciality and super-speciality services at state level. In addition to expanding its own network, the
government will purchase selected tertiary care services from empanelled private hospitals.
The BJP made an election pledge to convert more district colleges to medical and post graduate medical colleges, through public or
private participation, with a target of 75 colleges by 2022 and one medical college or post graduate medical college in every district
by 2024.
In November 2018, the cabinet of the state of Bihar approved a project to redevelop Patna Medical College & Hospital (PMCH) at a
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cost of INR55.4bn (USD758.9mn). Established in 1925, PMCH is Bihar’s oldest medical college and teaching hospital. The
redeveloped PMCH will have 5,462 beds making it India's largest hospital. Bihar Medical Services & Infrastructure Corporation, a
government agency, will carry out the redevelopment on a turnkey basis. The project will be executed in three phases. The agency
will aim to complete the project within five years, down from an original time frame of seven years. The project will have an
equipment budget of INR8.8bn (USD120mn).
The UK is collaborating on a GBP1.0bn (USD1.5bn) project to provide multi-speciality hospitals and medical colleges in 11 states
under a 2015 agreement signed by Prime Ministers, Narendra Modi and David Cameron. The first three will be located in New
Chandigarh, Punjab state; Hyderabad, Telangana state; and Amaravati, the new capital of Andhra Pradesh state. The others will be set
up in the states of Gujarat, Rajasthan, Karnataka, Uttar Pradesh, West Bengal, Maharashtra, Madhya Pradesh and Haryana.
Private Sector Investment
The government is seeking a substantial increase in private sector investment in healthcare services and has said that it will give
land and viability gap funding to support private investment in tier 2 and tier 3 cities. However, there was no mention of these
incentives in the FY2019/20 budget. In addition to income tax breaks, healthcare providers are calling for medical equipment
purchases for these hospitals to be exempted from Goods and Services Tax.
Medical Technology
The provision of medical technology is low, lagging behind that of other countries with large populations such as China. According
to GE Healthcare, there are around 3,500 CT scanners used in Indian hospitals, equal to just 3 systems per million population.
According to Varian, India only has 400 radiotherapy machines for a population of more than 1bn.
Healthcare Activity
We estimate that the number of inpatient admissions has grown at a 2015-2020 CAGR of 3.6% to 70.2mn, equal to a rate of
51 admissions per thousand population in 2020. This is one of the lowest rates within the APAC region. We estimate that outpatient
activity has increased at a 2015-2020 CAGR of 2.1% to 3.4bn outpatient visits in 2020, equal to a rate of 2,438 visits per thousand
population. This rate is also below average for the region.
Healthcare Personnel
We estimate that India has 0.8 doctors per thousand population in 2020, a rate that is below the APAC regional average. The
number of nurses is growing at a higher rate, with a 2015-2020 CAGR of 4.5% equal to 2.4 nurses per thousand population in 2020.
We estimate that the number of dentists remains very low at only 0.3 per thousand population, although the number is increasing
at more than four times the rate of the number of doctors. Trained healthcare personnel are concentrated in urban, rather than rural
areas.
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KEY HEALTHCARE DATA, 2015-2020

Health Status 2015 2016 2017 2018 2019 2020 CAGR
Population (mn) 1,310.2 1,324.5 1,338.7 1,352.6 1,366.4 1,380.0 1.0
Population growth (%) 1.1 1.1 1.1 1.0 1.0 1.0 -2.4
% of population aged 65+ 5.6 5.8 6.0 6.2 6.4 6.6 3.2
Live Births ('000) 24,414.4 24,296.6 24,220.9 24,164.4 24,116.0 24,067.8 -0.3
Per '000 population 18.6 18.3 18.1 17.9 17.6 17.4 -1.3
Deaths ('000) 9,425.9 9,531.1 9,652.5 9,785.0 9,926.0 10,073.5 1.3
Per '000 population 7.2 7.2 7.2 7.2 7.3 7.3 0.3
Infant mortality/'000 live births 35.2 33.8 32.5 31.3 30.2 29.1 -3.7
Male life expectancy at birth 67.5 67.8 68.0 68.2 68.5 68.7 0.4
Female life expectancy at birth 69.8 70.1 70.4 70.7 71.0 71.2 0.4
Healthcare Funding 2015 2016 2017 2018 2019 2020 CAGR
Health Expenditure (USDbn) 82.4 86.5 92.8 98.5 105.6 111.8 6.3
Per capita (USD) 62.9 65.3 69.3 72.8 77.3 81.0 5.2
Health expenditure % of GDP 3.8 3.8 3.5 3.6 3.7 4.4 2.9
Public % of health expenditure 30.5 32.3 27.5 27.2 27.3 25.5 -3.5
Social security % of public na na na na na na na
Private % of health expenditure 69.5 67.7 72.5 72.8 72.7 74.5 1.4
Out of pocket % of private 87.1 86.6 86.0 86.1 na na na
Private insurance % of private 6.0 6.9 6.9 6.9 na na na
Exchange rate, national currency/USD 64.2 67.2 65.1 68.4 70.4 74.1 2.9
Healthcare Resources 2015 2016 2017 2018 2019 2020 CAGR
Hospitals 49,717.0 52,287.0 55,207.0 57,846.0 60,672.0 63,828.0 5.1
Public 14,045.0 14,379.0 14,768.0 15,040.0 15,343.0 15,692.0 2.2
Private 35,672.0 37,908.0 40,439.0 42,806.0 45,329.0 48,136.0 6.2
Beds 1,061,263.0 1,092,049.0 1,123,727.0 1,152,472.0 1,185,123.0 1,220,898.0 2.8
Per '000 population 0.8 0.8 0.8 0.9 0.9 0.9 1.8
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Healthcare Activity 2015 2016 2017 2018 2019 2020 CAGR
Inpatient admissions ('000) 58,805.8 60,999.0 63,273.9 65,634.0 68,081.9 70,205.7 3.6
Per '000 population 44.9 46.1 47.3 48.5 49.8 50.9 2.5
Average length of stay (general care-

7.0 7.0 7.0 7.0 7.0 7.0 -0.1
days)
Surgical procedures ('000) 17,643.5 18,301.5 18,984.1 19,692.0 20,426.4 20,567.2 3.1
Outpatient visits ('000) 3,039,064.6 3,106,072.1 3,172,837.0 3,244,701.0 3,317,356.3 3,364,246.7 2.1
Per '000 population 2,319.6 2,345.1 2,370.1 2,398.8 2,427.8 2,437.9 1.0
Healthcare Personnel 2015 2016 2017 2018 2019 2020 CAGR
Physicians 960,233.0 1,005,281.0 1,041,395.0 1,076,135.0 1,110,915.0 1,152,271.0 3.7
Per '000 population 0.7 0.8 0.8 0.8 0.8 0.8 2.6
Nurses 2,639,229.0 2,778,248.0 2,878,182.0 2,998,758.0 3,156,612.0 3,285,437.0 4.5
Per '000 population 2.0 2.1 2.2 2.2 2.3 2.4 3.4
Dentists 156,391.0 197,734.0 251,207.0 290,774.0 333,203.0 387,599.0 19.9
Per '000 population 0.1 0.1 0.2 0.2 0.2 0.3 18.7
Pharmacists 960,233.0 1,005,281.0 1,041,395.0 1,076,135.0 1,110,915.0 1,152,271.0 3.7
Per '000 population 0.7 0.8 0.8 0.8 0.8 0.8 2.6
na = not available/applicable. Source: UN, WHO, National Statistics, Fitch Solutions
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Industry Trends And Developments

Medical Devices Industry Trends And Developments
India's Medical Device Market To Be Supported In Long Term Through Reform And Infrastructure
A shift towards a more unified government in India will bode well for medical device market growth, compared to heavily
fragmented administrations previously. The Make In India initiative will be a long-term driver of local medical device manufacturing
and will boost exports as well as a production linked incentive scheme. Dental products and patient aids will be the most dynamic
product areas registering low double-digit CAGRs in local currency terms throughout the forecast period.
India’s recent shift to a more unified government through the Bharatiya Janata Party’s dominance will bode well for medical device
market growth. Previous large coalition governments and fragmented administrations have complicated policymaking at its centre
as outside parties pursue their own agendas with competence varying significantly across India’s 28 states and eight union
territories. A stronger majority will increase the pace of structural reform momentum and bode well for India’s business
environment, providing tailwinds for growth.
Private Sector Will Bolster India's Medical Device Performance But Risks Of Vaccine Hesitancy Could Impede
Recovery
India's medical device market will continue to record solid growth, with a good recovery expected following Covid-19, boosted by
government initiatives. Healthcare expenditure increased in 2020 with expectations this trend will continue throughout our forecast
period but public percentage of health expenditure has fallen. Vaccine hesitancy in the country will provide headwinds to the
recovery outlook despite India's involvement in the Covax scheme and nationally developed vaccines.
India's medical device market performance remains robust, supported by government initiatives to improve healthcare accessibility.
We expect 2022 will bring rising healthcare expectations of the expanding middle class alongside further development of the
private sector which will provide tailwinds to the growth outlook for India's medical device market. India's government will continue
to reduce its high import dependency through the Make in India initiative. The main obstacle from the interruption of the pandemic
for this initiative will be extended disruption to supply chains as a result of the fallout of Covid-19 but the funding schemes are
expected to continue without issue.
India's Medical Device Market Growth Will Continue As New Covid-19 Cases Slow
India's medical device market will continue to record double-digit growth. The country's medical device market will register growth
by continued increased demand due to the continuing spread of Covid-19. As of Q420, Covid-19 cases in the country are beginning
to level off following a peak. India remains the country with the second largest number of people who have been infected with
Covid-19.
India's medical device market will continue to record strong growth over the 2020-2025 forecast period despite the ongoing spread
of Covid-19. We at Fitch Solutions forecast that the medical devices market will grow at a compound annual growth rate (CAGR) of
11.8% in local currency terms over 2020-2025, which will take the value to INR499,394.1mn. We forecast that other medical
devices will register the highest CAGR in local currency terms at 12.1%, closely followed by dental products at 11.2% with
orthopaedics predicted to growth the slowest at 9.1% in local currency terms.
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India's Medical Device Market Will Weather Impact Of Covid-19
India's medical device market will continue to record solid growth over the forecast period despite a hardened stance on pricing for
essential devices, though 2020 and 2021 were tough due to the outbreak of Covid-19. Covid-19 will support medical device exports
for India's medical device market and reflect the expanding industry. India's management of Covid-19 and healthcare inequalities
suggest further opportunities for medical device manufacturers. We at Fitch Solutions forecast that the medical devices market will
grow at a compound annual growth rate (CAGR) of 11.8% in local currency terms over the forecast period, which will take the value
to INR499,394.1mn. The market will continue to benefit from India remaining one of the fastest growing economies in the region,
but the country's economic growth will slow due to the Covid-19 outbreak and a more aggressive global economic downturn.
Tightening of global financing conditions will pose further headwinds to the growth outlook, as will India's management of the
pandemic.
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Regulatory Development
Medical Devices Regulatory Development
Competent Authority
The Medical Devices and Diagnostics Division of the Central Drugs Standard Control Organisation (CDSCO) is responsible for
medical device regulation. Prior to the implementation of new medical device rules, CDSCO was mainly focused on drugs. CDSCO
has strengthened its number of personnel trained specifically for medical devices. The organisation, however, has been judged as
inefficient on a number of occasions dealing with drug approvals.
In July 2019, a Medical Devices Technical Advisory Group (MDTAG) was established to advise CDSCO on matters relating to medical
devices regulation. The 22-member committee includes representatives from industry including the Association of Indian Medical
Device Industry (AIMED), the Medical Technology Association of India (MTaI), the Federation of Indian Chambers of Commerce &
Industry (FICCI) and the American Chamber of Commerce in India (AMCHAM India).
Regulation
India continues to take measures to regulate more medical devices. In April 2019, the Drugs Technical Advisory Board accepted the
recommendations of a Ministry of Health and Family Welfare (MOHFW) medical devices committee report that all medical devices
should be regulated under the Drugs and Cosmetics Act in a phased manner as follows:
• Phase 1: all manufacturers and importers of non-regulated medical devices should register their medical devices on the
SUGAM online portal. Registration will be voluntary during the first 18 months following the official notification for registration
and will become mandatory thereafter. Companies must adhere to the Materiovigilance Programme of India (MvPI) and report
serious adverse events.
• Phase 2: after the 18-month voluntary registration period, licencing under the Medical Device Rules, 2017 (MDR 2017) will
become mandatory for all Class A and Class B devices within 12 months.
• Phase 3: after the 18-month voluntary registration period, licencing under the MDR 2017 will become mandatory for all Class C
and Class D devices within 24 months.
Under this regulatory roadmap, it was proposed that CDSCO set up a medical device vertical to handle the new regulatory
requirements, headed by an Additional Drugs Controller (Medical Devices), assisted by four Joint Drugs Controllers, with
responsibility for invasive medical devices, non-invasive medical devices, in-vitro diagnostics and materiovigilance. The committee
also recommended that five medical device testing laboratories be set up within five years. It is proposed to employ an extra 785
staff in total, comprising 449 regulatory officials, 305 laboratory personnel and 31 experts and specialists.
In February 2020, India's CDSCO expanded the scope of products falling under medical device regulation in the country as well as
an expedited registration route for some devices.
Specific introductions include:
• Creation of a new statutory body under the jurisdiction of the Directorate General of Health Services with specialist expertise to
regulate medical devices;
• Establishment of a National Register of Medical Devices and introduction of a unique device identification number to improve
product traceability;
• Requirements for companies to undertake post-marketing surveillance and report adverse events; and
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• Introduction of penalties for failure to comply with conformity regulations and compensation for patients suffering from the
adverse effects of faulty medical devices.
Medical Device Rules
Previous medical device regulations took effect in January 2018, initially for notified devices only. The new rules have been drawn up
in conformity with the Global Harmonisation Task Force (GHTF) framework and broadly follow best international practices.
According to the Ministry of Health and Family Welfare, the MDR 2017 seek to remove regulatory bottlenecks to Make in India and
facilitate ease of doing business, while ensuring availability of better medical devices for patient care and safety. A Ministry of Health
and Family Welfare statement highlights that the new regulations, coupled with other recent measures are expected to provide
incentives for firms to become more efficient, innovative and competitive. According to Finance Minister Arun Jaitley, the core aims
of the new rules are to attract investment and lower the cost of devices.
Medical devices will be classified according to four internationally recognised levels of risk. Low risk Class A and low moderate risk
Class B devices will be licensed by State Licensing Authorities, while higher risk Class C and Class D devices will be regulated by the
Central Licensing Authority (CLA). The rules envisage a system of third party conformity assessment and certification through
Notified Bodies accredited by the National Accreditation Board for Certification Bodies. Class A devices will be subject to self-
certification by the manufacturer, although a post approval audit of the manufacturing site by an accredited Notified Body to
ascertain conformity with ISO 13485 will still be required. Imports of all medical devices will continue to be regulated by the CDSCO.
In July 2019, CDSCO expanded the number of Notified Bodies registered under MDR 2017 to six as follows:
• BSCIC Certifications, Faridabad

• BSI Group India, New Delhi
• DNV GI Business Assurance India, Mumbai
• Intertek India, New Delhi
• TÜV Rheinland India, Bangalore
• TÜV SÜD South Asia, Mumbai
These organisations will undertake on-site audit of the quality management systems of medical device manufacturers of lower risk
Class A and Class B devices and may be called upon to help in the verification of higher risk Class C and Class D devices. The
government also intends to set up a central medical device testing laboratory.
Clinical testing of new medical devices will be subject to clinical investigation provisions, which will be less onerous than the four
phase system for drug clinical trials to support medical device innovation, while ensuring patient safety. CDSCO will be responsible
for regulating clinical investigations.
Uniquely, there will be no requirement for periodic renewal of licences under the new rules, with manufacturing and import licences
remaining valid until suspended, cancelled or surrendered. The entire regulatory process will also be processed through the SUGAM
online electronic licensing platform.
In July 2017, CDSCO put out to consultation a draft guidance document entitled 'Essential Principles for Safety and Performance of
Medical Devices' covering fundamental design and manufacturing requirements in accordance with Rule 6, Chapter II of the new
regulations. Section four of the document outlines the following seven key safety and performance requirements that apply to all
medical devices:
• Medical devices should be designed and manufactured to ensure they perform as intended without compromising patient or
user safety, other than acceptable risks when weighed against the benefits to the patient.
• Device design and manufacturing solutions should conform to state-of-the-art safety principles and should adopt risk reduction
principles to control potential hazards including risks associated with foreseeable misuse to eliminate risks as far as reasonably
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practicable and inform users of any residual risks.

• Medical devices should be designed, manufactured and packaged to achieve the intended performance under normal
conditions of use.
• Safety and performance of a device should not be adversely affected to such a degree that the health or safety of the patient or
user are compromised during the device lifetime due to stresses of normal use when the device has been properly maintained
according to the manufacturer's instructions.
• Transport and storage conditions such as fluctuations of temperature and humidity should not adversely impact a device's
characteristics or performance taking into account instructions and information provided by the manufacturer.
• A manufacturer should minimise all known and foreseeable risks, and any undesirable effects which should be acceptable when
weighed against the benefits of the intended performance of a device under normal conditions of use.
• Every device requires clinical evidence appropriate for its intended use and classification to demonstrate compliance with the
applicable provisions of the essential principles. The clinical evaluation should review clinical data in the form of any clinical
investigation reports, literature reviews or clinical experience to establish that a favourable benefit-risk ratio exists for that device.
Additional design and manufacturing requirements apply to particular types of device such as protection against mechanical risks
and protection against radiation, along with issues relating to infection and microbial contamination, devices incorporating
medicinal products or biological materials and devices incorporating software and standalone medical device software.
The document specifies that the manufacturer will select which of these design and manufacturing requirements are relevant to a
particular medical device, documenting the reasons for excluding the others.
In April 2021, the CDSCO announced the delay of implementation of implantable devices and other medical products for which
manufacturers or importers have already applied for licenses under the Medical Device Rules 2017. According to a recent CDSCO
order, establishing regulation of the following medical devices will be delayed until at least September 2021:
• Implantable medical devices

• CT scan equipment
• MRI equipment
• Defibrillators
• PET equipment
• Dialysis machines
• X-Ray machines
• Bone marrow cell separator devices
Notified Devices
A growing number of so-called notified devices are now regulated as drugs under Section 3 (b) (iv) of the 1940 Drugs and
Cosmetics Act. Notification allows CDSCO to regulate the import, manufacture and sale of these devices, which are subject to
mandatory registration. Committees have been set up to evaluate and monitor quality of devices and to ensure
GMP compliance. Importers and retailers are required to obtain appropriate sale licences from the State Licensing Authorities.
At present, 23 medical device categories are notified and have to comply with the MDR 2017. A further 11 medical devices and one
IVD device were notified in December 2018. According to the notification orders, these devices were meant to comply with the
MDR in 2020, but an official announcement in the Gazette of India, dated December 27 2019, extended the deadline for nebulisers,
blood pressure monitoring devices, digital thermometers and glucometers from January 2020 to January 2021. The remaining
devices will likely also receive a 12-month extension from April 2020 to April 2021.
On October 16 2019, the Ministry of Health and Family Welfare notified ultrasound equipment as drugs with effect from November
2020.
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On May 15 2019, CDSCO issued a notice outlining the risk classifications for the 11 medical device categories and one IVD device
notified in 2018, according to classification criteria outlined in MDR 2017 Rule 4, Chapter II. Most will be classified as moderate to
high risk Class C, with three classified as low to moderate risk Class B as follows:
• CT scan equipment (Class C)

• MRI equipment (Class C)
• Defibrillators (Class C)
• Dialysis machines (Class C)
• PET equipment (Class C)
• X-ray machines (Class C)
• Bone marrow cell separators (Class B)
• Nebulisers (Class C)
• Blood pressure monitoring devices (Class B)
• Digital thermometers (Class B)
• Glucometers (Class C IVD)
• Organ preservation solutions (Class C)
In December 2018, CDSCO proposed to include surgical gowns and drapes under the MDR 2017 regulatory framework.
In August 2018, CDSCO published revised classification lists for 383 notified devices in 17 notified medical device categories
(including contraceptives and disinfectants), along with 247 IVD devices.
On July 9 2014, CDSCO published a list of 13 notified medical device categories and one IVD device category. Ablation devices were
added in January 2016.
MEDICAL DEVICES CLASSIFIED AS DRUGS

Device Category Notification Number Date Of Notification
Disposable hypodermic syringes GSR 365 (E) 17.03.1989
Disposable hypodermic needles GSR 365 (E) 17.03.1989
Disposable perfusion sets GSR 365 (E) 17.03.1989
IVD devices for HIV, HBsAg and HCV GSR 601 (E) 27.08.2002
Cardiac stents S.O. 1468 (E) 06.10.2005
Drug eluting stents S.O. 1468 (E) 06.10.2005
Catheters S.O. 1468 (E) 06.10.2005
Intraocular lenses S.O. 1468 (E) 06.10.2005
IV cannulae S.O. 1468 (E) 06.10.2005
Bone cements S.O. 1468 (E) 06.10.2005
Heart valves S.O. 1468 (E) 06.10.2005
Scalp vein stents S.O. 1468 (E) 06.10.2005
Orthopaedic implants S.O. 1468 (E) 06.10.2005
Internal prosthetic replacements S.O. 1468 (E) 06.10.2005
Ablation devices S.O. 237 (E) 25.01.2016
Source: CDSCO, Fitch Solutions
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In addition, other sterile materials that are regulated as drugs include surgical dressings, sutures and staplers and blood bags.
In September 2007, additional clarification of the guidelines for the import registration and manufacture of medical devices was
published. The clarification states that a pre-requisite for the registration of medical devices under the provisions of the Drugs and
Cosmetics Rules is a Free Sale Certificate in the country of origin, issued by the Ministry of Health/National Regulatory Authority.
Clarification with regard to the requirement of regulatory status of a medical device to be registered in India is as follows:
• For medical devices manufactured in the US, US FDA approval for the manufacture and free sale of the device in US is to be
submitted;
• For medical devices manufactured in Australia, Japan and Canada, approval for the manufacture and free sale in the respective
country of origin is to be submitted;
• For medical devices manufactured in European Countries, CE certification along with approval for manufacture and the Free Sale
Certificate from the respective country of origin is to be submitted;
• For medical devices manufactured in countries other than those specified above, approval for the manufacture and free sale in
the respective country of origin is to be submitted, together with approval from any one of the following: US FDA, TGA Australia,
Health Canada, Ministry of Health, Labour and Welfare Japan or CE Certification.
The clarification additionally states that:
• All peripheral stents are covered under the provisions of the Drugs and Cosmetics Rules and, as such need to be registered for
import and licences must be approved by the Central License Approving Authority (CLAA) for indigenous manufacture.
• All 'Cardiac Patches' and 'Occluders' used in interventional cardiology or for closing holes in the cardiovascular system are to be
considered as an 'Internal Prosthetic Replacement' (Medical Devices) and must be registered under the provisions of the Drugs
and Cosmetics Rules. The import of any cardiac patches and occluders requires a valid Registration Certificate and a Form 10
Licence with immediate effect.
The clarification also details the requirements for clinical trials with regard to the importation of stents. Where manufacturers wish to
import stents that are currently in use in countries outside India, a six-month clinical trial is required on 100 patients. In the case of
new stents that are not already in use outside India, a 12-month clinical trial on 100 patients is required.
Online Registration Portal
In February 2016, CDSCO launched an online portal for registrations of notified medical devices and import applications to speed up
market access. Authorised Indian agents and foreign companies with an Indian subsidiary can register on the portal. As well as
submitting registration applications, authorised agents can track the status of submitted applications, provide answers to raised
queries and upload essential documents for registration certificates, import licences and other related activities.
The online portal will speed up registration times, which typically take six-nine months if a Medical Device Advisory Committee
review is not required. The system only applies to a limited list of notified medical devices, which continue to be treated as drugs
under the Drugs and Cosmetics Act.
Guidance On Medical Device Clinical Trial Requirements
On July 3 2014, CDSCO issued guidance specifying that while there is no concept of conducting Phase I clinical trials to assess safety
and tolerability of medical devices due to their difference in nature, clinical trial requirements for medical devices will nonetheless be
similar to those in force for new drugs and vaccines in respect of approval process, and accreditation's of investigators, sites, ethics
committees and other conditions.
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Product Labelling
In March 2017, the National Pharmaceutical Pricing Authority (NPPA) issued a memorandum making it compulsory to display the
maximum retail prices on the packaging of notified devices.
A September 25 2014 notification amending a number of rules of the existing Drugs and Cosmetic Act, includes Rule 109A relating
to product labelling. This amendment makes labelling of medical devices mandatory stating that all the requisite details shall be
printed in indelible ink on the label or sticker on the shelf pack or on every outer covering in which the medical device is packed.
Specifically, the regulation states that the labelling shall provide the following:
• the proper name of the medical device;

• the details necessary for the user to identify the device and its use;
• the name of the manufacturer and address of the manufacturing premises where the device has been manufactured;
• the correct statement of the net quantity in terms of weight, measure, volume, number of units, as the case may be, and the
number of the devices contained in the package shall be expressed in metric system;
• the date of manufacture and date of expiry; alternately the label shall bear the shelf life of the product. In the case of sterile
devices the date of sterilisation may be given as date of the manufacture of the device, or if the device is made up of stable
materials such as stainless steel or titanium, and supplied non-sterile, date of expiry may not be necessary;
• to provide wherever required an indication that the device contains a medicinal or biological substance;
• to provide a distinctive batch number or lot number preceded by the word 'Lot No.' or 'Lot' or 'Batch No.' or 'B. No.';
• to indicate, wherever required, any special storage or handling conditions applicable to the device;
• to indicate if the device is supplied as a sterile product, its sterile state and the sterilisation method;
• to give, if considered relevant, warnings or precautions for the attention of the user of the medical device;
• to label the device, if the device is intended for single use;
• to overprint on the label of the container, the words 'FOR CLINICAL INVESTIGATION ONLY', if the device is intended for clinical
investigation;
• to overprint on the label of the device, the words 'Physician's Sample - Not to be sold', if a medical device is intended for
distribution to the medical professional as a free sample;
• to provide, except for imported devices, the manufacturing licence number by preceding the words 'manufacturing licence
number' or 'Mfg Lic No' 'ML';
• devices or in-vitro diagnostics which are not sold to customer or patient directly and are sold for use by hospitals or diagnostic
labs shall provide the information affixing additional label or sticker on outer shelf pack;
• to provide on the label, in case of imported devices, with the approval of the licensing authority mentioned in rule 21, the import
licence number, name and address of the importer and address of the actual manufacturing premises, date of manufacture (if
not already printed at the time of import).
The label may bear symbols recognised by the Bureau of Indian Standards or the International Organisation for Standardisation
(ISO) in lieu of text, provided the device safety is not compromised by a lack of understanding on the part of the user in case the
meaning of the symbol is not obvious to the device user.
Labelling of medical devices produced for export shall be adapted to meet the specific requirements of the law of the country to
which the device is to be exported, but the labelling is still required to show the name, batch number or lot number, the date of
expiry if applicable, the name and address of the manufacturer and address of manufacturing premises and the manufacturing
licence number. Custom made devices should be labelled custom made device. Mass produced devices that only need adapting to
meet the specific needs of the medical practitioner or other professional user shall be considered as custom made devices.
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GMP Compliance
In December 2014, CDSCO issued a revised Schedule M III. The 57-page document covers Good Manufacturing Practices (GMP) and
requirements of premises, plant and equipment for medical devices and in-vitro diagnostics (IVDs). It forms part of the government's
efforts to revise GMP for medical devices under the Drugs and Cosmetics Act, 1945, replacing the previous limited Schedule M III,
which only specified requirements for three categories of medical devices of the 14 notified under the Act: sterile disposable
perfusion and blood collection sets; sterile disposable hypodermic syringes and sterile disposable hypodermic needles.
The new legislation also aims to bring GMP requirements for medical devices in line with international standards. The medical device
industry had been demanding that GMP requirements for medical devices should be as per IS 15579 (ISO 13485) standards. To
achieve this, manufacturers will be required to develop a quality system in line with IS 15579/ISO 13485. In the case of combination
devices, the process of manufacture of the drug/biologics will be as per schedule M regulating pharmaceutical and biologic
products. However the process of loading the drug/biologics on to the device will be governed by the new schedule. No part of the
Schedule M will be applicable for the manufacture of medical devices or IVDs. This effectively addresses the concerns of the
industry association AIMED, which claims that even though the legislation clearly specifies Schedule M for pharmaceuticals,
Schedule M II for cosmetics and Schedule M III for medical devices, many officials insist on additional compliance to Schedule M as
well as Schedule M III, effectively imposing requirements for sterile pharmaceutical products on medical devices.
Local Medical Device Testing Laboratories
The Department of Pharmaceuticals has said it is planning to set up three dedicated medical device testing laboratories in the states
of Gujarat, Haryana and Uttar Pradesh to serve local medical device manufacturing clusters. The first is likely to be in Gujarat, where
the State Food and Drugs Control Administration (FDCA) has initiated a project to set up a medical device testing lab in Vadodara in
partnership with the Ministry of Health and Family Welfare. According to the Gujarat FDCA, it would be an affordable option for the
local medical device industry, which currently relies on international agencies to test products. The laboratory in Uttar Pradesh will
be set up at the Noida site of HLL Lifecare, a Government of India-owned corporation (PSU) active in a number of healthcare fields
including the manufacturing of consumables. The laboratories will receive technical support from the National Health Systems
Resources Centre within the Ministry of Health and Family Welfare.
Materiovigilance
The Ministry of Health and Family Welfare has initiated a materiovigilance programme (MvP) to formulate a system of reporting of
adverse events of medical devices. The MvP intends to enable safety data collection in a systematic manner so that regulatory
decisions and recommendations on safe use of medical devices for India could be based on data generated in the country. The
programme will monitor medical device-associated adverse events (MDAE)s, create awareness among healthcare professionals
about the importance of MDAE reporting in India, and monitor the benefit-risk profile of devices. It also intends to generate
independent, evidence-based recommendations on the safety of medical devices and to communicate the findings to all key
stakeholders. The programme will begin with the creation of MvP hubs in 10 medical colleges across the country and will be
coordinated by the Sree Chitra Thirunal Institute of Medical Sciences and Technology in Thiruvananthapuram. It will be run along
the lines of the existing pharmacovigilance and haemovigilance programmes currently in operation.
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Medical Devices Pricing And Reimbursement
Pricing
Competent Authority
The National Pharmaceutical Price Authority (NPPA) is responsible for price monitoring and pricing controls for products deemed
essential for public health. Until recently, the NPPA's remit was limited to monitoring the prices of prescription drugs and capping
the prices of essential medicines, as there was no regulation governing the price of medical devices prescribed to patients. However,
the government has begun to look at capping the maximum retail price of some medical devices supplied to patients, particularly
high cost implantable devices for hospital use. A number of implantable devices have been added to the National List of Essential
Medicines (NLEM), effectively bringing them under the price control regime in place for drugs, which has allowed the NPPA to
impose price caps on these devices.
Pricing Regulation
On February 11 2020, the Indian Government had gazetted a notification that brought all medical devices and medical equipment
sold in India under existing quality and safety regulatory framework by declaring them as 'drugs'. However, this notification has
exposed all medical devices to India’s drug price control regulation that was put in place to make drugs affordable and accessible as
well. So, from April 1 2020 (the effective date of the notification), all manufacturers and importers of medical devices and medical
equipment sold in India have to be careful to not increase the maximum retail price of their products by more than 10% within 12
months. They will have to make periodic trade-related filings with the Government in which they will have to submit price
information such as price to distributors, price to stockist, price to hospital and price to retailer. On top of all this, they will have to
operate under constant risk of price fixation at the hands of the government, like was done in the case of coronary stents and knee
implant systems in 2017.
In September 2018, the Prime Minister’s Office rejected a proposal by the government think tank Niti Aayog to implement a 65%
trade margin cap in the medical device supply chain. The trade margin cap was meant to replace the current price control
mechanism that has resulted in large price cuts for some regulated medical devices and was backed by the Medical Technology
Association of India (MTaI) representing multinational companies. However, the proposal attracted strong criticism from the local
industry because the cap was to apply from the distributor onward, and not from the landing cost, which domestic producers
claimed would have given foreign manufacturers a pricing advantage. For its part, MTaI has stated that using the ex-factory price for
locally manufactured products would create an uneven playing field for importers, as ex-factory prices, which include difficult to
audit costs such as R&D, marketing and administrative expenses, and taxes, could be highly manipulative. MTaI is now proposing that
any trade margin cap should be based on an equivalent of the landed cost for locally manufactured products, such as the standard
cost of manufacturing, which excludes sales and administrative costs.
In June 2018, the Central Drugs Standard Control Organization (CDSCO) announced its intention to classify all implantable medical
devices and other high-end equipment such as CT, MRI and PET scanners, X-ray equipment, defibrillators and dialysis machines as
drugs under Section 3 of the 1940 Drugs and Cosmetics Act. The initiative paves the way for the regulator to introduce pricing
controls on a much broader range of medical devices, including other implantables such as cochlear implants and pacemakers.
In February 2018, NPPA imposed further cuts on the price of more advanced drug-eluting and biodegradable stents, reducing their
price from INR29,600 to INR27,890, while the price of bare metal stents was marginally increased from INR7,260 to INR7,660.
In August 2017, the NPPA imposed price caps on artificial knee implants with price reductions averaging 60%-70%. The move came
after the NPPA published pricing data for knee implants, which shows average total trade margins ranging from 200% to 450%
depending on the type of implant with mark-ups for total replacement knee system averaging 313%.
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In June 2017, the FDA in Maharashtra state called on the government to add balloon and guiding catheters used in angioplasties
and intraocular lenses used in cataract surgery to the NLEM and cap prices following investigations into excessive price inflation.
The Maharashtra FDA has also investigated profit margins of up to 500% on routine medical instruments such as arterial catheter
sets, disposable syringes & needles, endotracheal tubes, oxygen masks and urinary bags.
In May 2017, the NPPA instigated price monitoring for 19 notified devices requiring all manufacturers, importers and distributors to
submit pricing information for said devices by May 31 2017, subsequently extended to June 9 2017.
In March 2017, the NPPA issued an order limiting the maximum price increase for notified devices, including heart valves, intraocular
lenses, orthopaedic implants and syringes, needles & catheters to 10% per annum. Companies wishing to raise prices beyond the
10% limit will have to seek permission from the regulator. They will also have to ensure that the maximum retail price for each
device is displayed on the product packaging.
In February 2017, the NPPA imposed price caps of INR7,260 for bare metal stents and INR29,600 for drug-eluting stents, after the
Department of Pharmaceuticals issued a notification including coronary stents on schedule-I of the Drug Price Control Order. The
initiative aims to curb the mark-ups imposed on devices by distributors, hospitals and healthcare professionals. Previously, these
mark-ups meant patients could end up paying up to ten times the ex-factory price of a device. The new pricing control mechanism
has meant substantial falls in the prices companies can charge for more advanced devices and this has prompted several
multinationals to seek permission to withdraw their most expensive stents from the Indian market.
Reimbursement
There is no comprehensive reimbursement system for medical devices in India. Medical device reimbursement is available under
various government health insurance schemes, such as the Central Government Health Scheme, but generally speaking there is no
or very little reimbursement with most expenditure financed out of pocket.
Health Technology Assessment
The 2015 National Health Policy commits to the development of health technology assessment capacity along the lines of the UK
National Institute of Clinical Excellence to enable informed technology choices based on scientific evidence, safety, cost
effectiveness and social values, as well as the development of standard treatment guidelines.
Procurement
In March 2018, the Department of Pharmaceuticals (DoP) released draft guidelines for implementaton of the provisions of
the Public Procurement Order (PPO), 2017 in respect of medical devices covering tenders valued at less than INR5mn (USD75,000).
The guidelines propose that in order to be eligible for public procurement, medical devices will need to have a minimum local
content ranging from 25% for instruments and equipment to 50% for consumables.
The DoP is collecting data regarding domestic production capacity of various types of medical device and based on these findings
may revise the local content percentage after one year or as soon as the relevant data becomes available. In line with the 2017 PPO,
preference will be given to local companies provided there is enough capacity and competition in India (at least two local suppliers
for each tender). Where a foreign manufacturer is the lowest bidder, domestic firms will be asked to match the lowest bid to supply
50% of the contract.
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MTaI has questioned the minimum local content requirement for different categories of medical devices as not reflective of the
reality of current production capacity. MTaI has also raised concerns over the decision to make Bureau of Indian Standards (BIS)
certification mandatory for public procurement where BIS standards exist rather than regulatory approval granted by established
national regulatory authorities such as the FDA.
Minimum Local Content Quotas To Support Make In India Agenda

India - Medical Devices Proposed Minimum Local Content For Small-Scale Tenders
Source: Department of Pharmaceuticals, Fitch Solutions
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Competitive Landscape
Medical Devices Production
We estimate medical device production at over USD2.0bn. Output is seeing double-digit growth in local currency terms and is
gradually increasing in sophistication.
Domestic manufacturers dominate the low tech, disposable equipment and supplies end of the market. Only a few companies have
moved to producing higher end products, leaving the high tech end of the market heavily dependent on imported products. More
advanced equipment is usually produced in joint ventures with European and US companies.
The market's strategic importance and the availability of a skilled, but relatively cheap, workforce have attracted multinationals to
produce within the country, though development is not on a scale of that taking place in China. Multinationals manufacturing in
India include Baxter, B. Braun, Becton Dickinson, Johnson & Johnson, Nipro, Philips, Siemens and Terumo.
India's budgets aim to introduce a number of provisions to boost local production and increase demand through more competitive
pricing. These provisions include:
• The application of zero excise duty and an exemption of customs duty on raw materials required for the manufacture of
coronary stents/ coronary stent systems which will lead to the availability of these products to cardiac patients at cheaper rates.
• The reduction of excise duty and customs duty on specified raw materials for the manufacture of syringe, needle, catheters and
cannulae which will make them available at cheaper rates.
• The reduction in excise duty and basic customs duty on parts of blood pressure monitors and blood glucose monitoring systems
which can be expected to drive demand.
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Medical Devices Manufacturing

There are around 800 companies producing medical devices, but only around 100 are significant producers. Additionally, only
around 5% of companies have revenues of INR1.0bn (USD16mn) or more, while 20% have revenues of INR100mn-500mn
(USD1.6mn-USD8.0mn), leaving the bulk of manufacturing to be performed by small companies with revenues of less than
INR100mn (USD1.6mn).
National Medical Devices Promotion Council
Union Minister of Commerce and Civil Aviation, Suresh Prabhu inaugurated the National Medical Devices Promotion Council
(NMDPC) during the fourth WHO Global Forum on Medical Devices hosted at the AMTZ on December 13-15 2018. The NMDPC will
operate under the Department of Industrial Policy and Promotion (DIPP) within the Ministry of Commerce and Industry. It will act as
a facilitating and development agency for the medical device industry and will coordinate medical device policy previously covered
under various Ministries and departments.
One of the NMDPC's prime objectives will be to drive a robust Preferential Market Access (PMA) policy by discouraging unfair trade
practices and pro-actively monitoring public procurement notices to ensure compliance with the DIPP's PMA guidelines. The
Medical Technology Association of India (MTaI), which represents research-based medical technology companies, has welcomed
the establishment of the NMDPC and pledged its support to expand domestic production of high-end devices. However, MTaI has
questioned the minimum local content requirement for different categories of medical devices outlined in the Department of
Pharmaceuticals' March 2018 Public Procurement Order (PPO) guidelines as not reflective of the reality of current production
capacity. MTaI contends that manufacturers are unlikely to be incentivised to produce higher risk devices locally until the
appropriate environment is in place, including access to quality local components, as well as a clear roadmap for the long term
development of the industry and greater certainty on pricing and other regulatory issues. In the meantime, AdvaMed representing
US multinational manufacturers advises the government to prioritise high volume, low-tech labour intensive manufacturing to
develop India as a global manufacturing hub rather than just focusing on import substitution for the domestic market.
For its part, the Association of Indian Medical Device Industry (AIMED) has criticised the preferential procurement policy for failing to
include measures to support the development of the local industry. AIMED had campaigned for the 2018-2019 union budget to
increase the basic customs duty on imported medical devices to promote domestic manufacturing, but this measure was not
included in the final budget proposal. AIMED is particularly concerned about the competitive threat posed by cheaper products
imported from China which the association says are often priced 10-20% lower than locally produced products.
FDI Investment
FDI in the medical device sector fell sharply in 2017 and 2018, down to INR4.7bn (USD67mn), according to data from the
Department of Industrial Policy and Promotion (DIPP). This marked a sharp reversal from 2016, when FDI investment nearly tripled
to INR29.4bn (USD439mn), following a decision to include medical devices on the FDI automatic route. The downturn came in the
wake of an increasingly aggressive stance on medical device pricing, which saw the imposition of drastic price caps on cardiac
stents in February 2017 and on artificial knee implants in August 2017. That said, medical device FDI has started to recover in 2019,
with investment amounting to INR7.6bn (USD108mn) recorded in H119, exceeding the annual total for 2018.
National Medical Device Policy
In June 2015, the government published a draft National Medical Device Policy, which aims to create a supportive framework for the
local medical device industry through a number of key measures. These include:
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• The creation of a National Medical Device Authority (NMDA) under the jurisdiction of the Department of Pharmaceuticals;
• A range of financial incentives for companies manufacturing medical devices in both Greenfield and Brownfield units;
• The creation of an institutional framework covering medical device testing centres, centres of excellence to support product
development and validation, and a skills development committee.
The NMDA will be responsible for co-ordinating medical device policy with the aim of reducing dependence on imported products,
as well as making India a global hub for medical device production and innovation. The NMDA will also make recommendations on
increasing fiscal and financial support for local medical device production. Potential incentives include tax concessions,
concessional power tariff for up to five-10 years, low cost funding for medium and small enterprises, direct government funding for
start-ups, and minimum/zero duty on the import of raw materials and equipment for manufacturing medical devices. This would
seem to address the concerns of local producers, who had campaigned for tax breaks on medical manufacturing and other
measures to support innovation and R&D to be included in the FY2015/16 budget.
Regarding the creation of an institutional framework, the government favours setting up medical device testing centres in the PPP
mode at major medical device manufacturing hubs. Agencies cited as having the required expertise to set up centres of excellence
include the Department of Electronics and Information Technology, the Bureau of Indian Standards, the Indian Institutes of
Technology in Delhi and Madras and the Indian Institute of Science in Bangalore.
The medical device policy also addresses the issue of affordability by raising the possibility of a pricing strategy for the sector
through the implementation of a Medical Devices Price Control Order. The government is also considering granting preferential
status for locally manufactured devices in government procurement with an additional preference for medical devices
manufactured by the micro, small and medium enterprises (MSME) sector. Finally, the policy also seeks to address the problem of
'dumping' of obsolete equipment through restrictions on the import of second-hand diagnostic devices and higher taxes for
imported second hand equipment that is more than five-seven years old.
Manufacturing Parks To Support Make In India Initiative
The government is setting up three industrial parks dedicated to the manufacture of medical devices as part of the Make In India
programme. The programme will be overseen by the Task Force on Promotion of Domestic Production of High End Medical Devices,
which groups together representatives from various government departments and industry associations. The parks are being set up
in Chengalpattu, Tamil Nadu state; Sanand, Gujurat state; and Vishakhapatnam, Andhra Pradesh state.
Chief Minister of Andhra Pradesh Nara Chandrababu Naidu inaugurated Phase 1 of the Andhra Pradesh Medtech Zone (AMTZ) on
December 13 2018. The AMTZ was launched in 2016 as a public private partnership between the Andhra Pradesh state
government and AIMED. Construction of Phase 1 was completed in under a year at a cost of INR4.5bn (USD61.6mn) and will see
around 80 manufacturing units operational in 2019. Phase 2 will be completed at a cost of INR1.1bn (USD15.1mn).
The 270-acre manufacturing park will eventually have the capacity to accommodate up to 240 manufacturing units along with
specialised development laboratories and testing facilities to allow production of high-end medical devices at a reduced cost. The
AMTZ also houses India’s first institute dedicated to medical technology. The Kalam Institute of Health Technology is funded by the
Department of Technology and will work to bring together academic research institutions and industry to help bring promising
innovations to market and address the gaps in the domestic industry’s capacity. According to Mr Chandrababu Naidu, the park has
the potential to create around 25,000 jobs and generate a turnover of INR250bn (USD3.7bn) to INR300bn (USD4.4bn). The aim is to
reduce medical device costs by around 40% by reducing reliance on expensive imports.
The Union Cabinet gave the go-ahead for the Chengalpattu Medipark in October 2016. The park will be set up on a 330-acre site by
Tamil Nadu Industrial Development Corporation in partnership with HLL Lifecare, a mini-ratna public sector unit under the Ministry
of Health and Family Welfare, Government of India. HLL will hold a majority share in the park with the state government supporting
the initiative through an equity participation of up to 10%. The project is aiming to attract investment of up to INR30bn
(USD450mn) and is expected to provide direct employment to 3,000 persons and indirect employment to 5,000 people.
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According to HLL, the park will focus on diagnostic devices to boost local manufacturing of high-end products at significantly lower
cost to reduce import dependency and provide quality healthcare solutions at affordable prices. It will be developed in phases over
a seven-year time frame. The physical infrastructure is expected to be put in place over two years with plots leased in year three,
initially at a subsidised rate to attract investors. The park will be developed as a 'one-stop' facility. In additional to logistical support
and training and development facilities, the park will offer regulatory compliance, licensing and other legal services to assist
companies with faster market access. We note that Chengalpattu has emerged as a fast growing industrial location and already
forms a manufacturing base for the automobile and consumer electronics industries. Additionally, B. Braun's principal
manufacturing facility in India, specialising in sutures, is based in Chengalpattu, while Indian company Cura Healthcare has a
manufacturing facility for digital radiography systems in the nearby Madras Export Processing Zone.
A third medical device park is being set up in Gujarat. The Gujarat state government has allocated land for the project at Sanand
near Ahmedabad, which is already the site of an expanding car manufacturing industry. Gujarat is already a well-established
manufacturing location for medical device companies. The National Institute of Pharmaceutical Education and Research (NIPER) in
Ahmedabad will be developed as a national centre of excellence for medical devices to advance R&D in the area.
The creation of medical device parks is one of a number of recent initiatives to accord a higher profile to the long neglected medical
device domestic manufacturing industry after the Department of Industrial Policy and Promotion (DIPP) identified medical devices
as among the top five sectors having good investment potential in the domestic market, as well as the export market.
FDI Restrictions Eased To Encourage Foreign Investment
In February 2015, the Reserve Bank of India formalised the government decision to liberalise Foreign Direct Investment (FDI) policy
in the medical devices sector announced in December 2014. 100% FDI is now via the automatic route in medical device ventures in
both the greenfield (new ventures) and brownfield (existing companies) routes. The medical devices sector was previously treated
as a branch of the pharmaceutical industry, where 100% FDI requires approval by the Foreign Investment Promotion Board for
brownfield investments. FDI approval restrictions on the pharmaceutical industry will also be removed for medical devices. The
government hopes that easing restrictions on FDI policy will encourage foreign investment into the medical device sector with the
aim of increasing the share of the market held by domestically produced products.
MOU To Target Foreign Investment
In February 2017, AIMED and Invest India, the official investment promotion agency of the Government of India, signed a
memorandum of understanding aimed at making India a global medical device manufacturing hub. According to AIMED, the public-
private collaboration agreement will seek to facilitate investment by removing roadblocks for both Indian and overseas investors
and will focus on creating collaborations and joint ventures between mid-sized Indian companies and mid-sized foreign
manufacturers, as well as OEM partnerships with larger multinationals.
Specifically, the two parties will jointly work with various central and state government departments and agencies to establish
business friendly policies and an appropriate regulatory framework to promote medical device manufacturing similar to the
coordinated approach adopted for the cellular industry. Invest India will also reach out to large- and medium-sized companies in
other manufacturing nations in Asia such as Japan, South Korea and Taiwan, as well as companies in Europe, Israel and the US to
establish manufacturing joint ventures and technology sourcing. AIMED and Invest India plan to jointly host international roadshows
apprising potential investors of the opportunities available in the Indian medical device sector.
Enhanced Co-operation With Japan To Develop Local Industry
Japan will assist India in developing a world class medical device industry under a programme of enhanced co-operation agreed in
May 2017. Government officials, medical device regulators and industry representatives agreed the programme of enhanced co-
operation at the 2nd Japan-India Medical Products Regulation Symposium held in Tokyo in May 2017. The Japanese Pharmaceutical
and Medical Device Agency will work with the Indian the Central Drugs Standard Control Organisation (CDSCO) to develop an
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internationally harmonised medical device regulatory framework. Other key topics discussed included third party medical
certification systems, quality standards, GMP systems and development challenges.
It is our view that enhanced India-Japan co-operation in the medical device field will allow India to benefit from Japan's expertise as a
leading medical device producer and exporter in its quest to implement an internationally harmonised medical device regulatory
framework and boost the competitiveness of its domestic industry. We note that India and Japan have strong cultural and trade links
with Japan being the fourth largest FDI contributor to India. Under an agreement signed between Indian Prime Minister Narendra
Modi and Japanese Prime Minister Shinzo Abe, FDI from Japan is set to double by 2019. In the medical device sector, Terumo and
Nipro have well-established manufacturing operations in India.
Terumo, which produces blood transfusion apparatus through its Terumo BCT subsidiary, played a pivotal role in facilitating the first
India-Japan Medical Products Regulation Symposium which took place in New Delhi in May 2016, following the signing of a
memorandum of cooperation on medical products regulation in December 2015 between CDSCO and Japan's Ministry of Health
and Family Welfare.
Additionally, Osaka University is working with the All India Institute of Medical Sciences (AIIMS) to develop affordable medical devices
under a five-year partnership running from 2015. The collaboration will first focus on devices for minimally invasive surgery
including diathermy apparatus and semi disposable laparoscopic devices, the majority of which are imported. The aim is to adopt
Japanese technology to develop quality affordable devices for use in India as well as more advanced markets.
Meanwhile, Toshiba Medical Systems, now part of Canon, is partnering with the Indo UK Institute of Health's Medicity programme as
a preferred provider of diagnostic imaging products and services. In addition to providing products and services, Toshiba Medical's
commitment includes the sponsorship of a post-graduate training and education centre on the campus of one of IUIH's medicities
and a research collaboration in India to develop more effective and efficient patient pathways.
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Medical Devices National Manufacturers
Anand Medicaids
Overview: Founded in 1969, Anand Medicaids and its Suction India division is a market leader in suction equipment in India. Anand
exports its products to over 30 countries in Europe, Asia, Africa and the Middle East. The company also offers contract
manufacturing services. Also part of the Anand Group is Ampro, a company set up in 1993, which specialises in designing and
equipping dental colleges and laboratories on a turnkey basis. Its Dental Lab India unit manufactures a range of dental restoration
devices and cosmetic dentistry products, including crowns, bridges, inlays, onlays and veneers.
Product Portfolio: Products include suction units and related accessories, surgical disposables, UV sterilisers, foetal dopplers,
infection control systems, infant care products and breast feeding products.
Manufacturing: Products are produced in a 1,100sq m manufacturing facility in Bahadurgarh, Haryana state. Anand holds the
Indian Standards Bureau's ISI certification and has ISO 9001:2000 certification.
ASCO
Overview: Apothecaries' Sundries Manufacturing Co. (ASCO) was established in New Delhi in 1948, having migrated from Sialkot,
Pakistan. ASCO exports products to more than 40 countries around the world, including the US and Europe.
Product Portfolio: The company's product range includes hospital furniture, sterilisers, autoclaves, hospital hollowware, hospital
rubber goods, diagnostic instruments, microscopes, scientific and optical glass products, orthopaedic instruments/implants, suction
units, vacuum extractors, abortion sets, rehabilitation aids, surgical needles and surgical instruments.
Manufacturing: ASCO has ISO9001 certification.
Atlas Surgical
Overview: Atlas Surgical was established in 1951.
Product Portfolio: The product range covers hospital furniture, stainless steel hollowware, sterilising systems (sterilisers, hot air
ovens, incubators, autoclaves), laboratory equipment, microscopes, suction machines, orthopaedic products, laryngoscopes,
resuscitators, respiratory aids, diagnostic instruments and a range of disposables.
Manufacturing: The company holds ISO 9001 certification and is export oriented.
BPL Medical Technologies
Overview: BPL Medical Technologies specialises in patient monitoring and cardiac care products. The company was set up in 1969
by BPL, a company active in consumer electronic, power generation and telecom equipment. In 2013, BPL spun off its medical
device business into a separate entity. In May 2013, Goldman Sachs acquired a 49% stake in BPL Medical Technologies for INR1.1bn
(USD18.3mn) and subsequently became a majority stakeholder, providing funds to finance an expansion of the business into
imaging and neonatal care.
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Acquisition: In 2015, BPL Medical Technologies acquired the UK anaesthesia equipment manufacturer Penlon.
Financial Review: BPL Medical Technologies has annual turnover of INR3.5bn (USD50mn). Around 60% of revenues comes from
products manufactured in India. The company is targeting revenues of INR10bn by FY2021/22.
Product Portfolio: BPL Medical Tehcnologies' product range covers ECGs, patient monitoring systems, defibrillators and oxygen
concentrators. BPL Medical Technologies is also diversifying into mobile-based diagnostic products having developed
the LifePhonePlus, a personal healthcare device that records ECG, heart rate, blood glucose and physical activity, which can be used
with a mobile phone app to transfer data to a cloud server for remote consultation with a healthcare professional via SMS. The
acquisition of Penlon has added anaesthesia systems, laryngoscopes and vaporisers to the product range.
Manufacturing: Products are manufactured at an ISO 13485 certified facility in Palakkad, Kerala state.
R&D: The company has a research centre in Bangalore.
Distribution: BPL also distributes ultrasound scanners, X-ray systems, infusion and syringe pumps. It represents Alpinion of South
Korea and Ambu of the US. The company claims to have one of the largest indirect distribution networks in India with over 100
authorised sales and service dealers and a team of over 600 service personnel.
Carewell Mediproducts
Overview: Carewell Mediproducts was established in 1985 using technical knowledge and a plant purchased from Germany. The
company's objective is to manufacture and market medical disposables of international quality under GMP standards.
Manufacturing: Carewell Mediproducts commenced production of its Careject range of disposable needles and syringes in
January 1988 at its factory in Kashipur, Udham Singh Nagar District. The factory has the capacity to manufacture 60mn disposable
syringes and 300mn disposable needles per year.
Cura Healthcare
Overview: Cura Healthcare specialises in diagnostic imaging equipment. The company has evolved from an installer of mainly
imported equipment into a manufacturer with more than 250 employees. In 2012, Indian private equity firm Peepul Capital
acquired a majority stake in Cura Healthcare in exchange for an INR450mn investment. Peepul made a second investment in 2014.
In 2015, Cura Healthcare partnered with Oxford Instruments Healthcare, a service division of UK-based Oxford Instruments, to
provide high-end refurbished imaging equipment to emerging markets such as India and Bangladesh. In India, Cura Healthcare
plans to enter Tier II and III markets with high end MRI equipment. The initiative also plans to make India a hub for spare parts and
accessories.
Acquisitions: In 2016, Cura Healthcare acquired Bangalore-based Ives Healthcare, a diagnostic imaging equipment service
provider and supplier of refurbished equipment. In 2015, Cura Healthcare acquired a 49% stake in Tuscano Equipments, a medical
device R&D laboratory, and a majority stake in Adonis Medical Systems, which manufactures and services C-Arms with a production
facility in Mohali, Punjab state. In 2014, Cura Healthcare acquired Concept Integrations, a manufacturer of patient monitoring and
diagnostic tele-ECG systems with a turnover of INR80mn. In July 2014, Cura Healthcare acquired Chennai-based ultrasound
company DE Healthcare with a turnover of INR80mn. The acquisition marked Cura's entry into the ultrasound market. Founded in
1996, DE Healthcare is a distributor and service provider of ultrasound systems with a strong presence in South India, where it has
made over 600 installations. The company's ultrasound portfolio ranges from INR1.2mn to INR6.0mn. Cura Healthcare is seeking a
15-20% share of the ultrasound market, which it values at INR8.5bn.
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Financial Review: Cura Healthcare had estimated revenue of INR1.6bn (USD25mn) in FY2016/17. At the time of the partnership
with Oxford Instruments, the company was targeting revenue of INR5bn by 2018.
Product Portfolio: The radiology range includes digital radiography systems, mobile computed radiography systems, HF X-ray
systems, X-ray tables and accessories. The critical care range includes patient monitoring systems, defibrillators, ECG, Stress Test
systems and pulse oximeters. The Cura-DE Healthcare business focuses on ultrasound and colour Doppler systems.
Manufacturing: Cura Healthcare has a 50,000 sq ft manufacturing and R&D facility for radiology and critical care products in
Chennai, which is ISO 9001:2008 and ISO 13485:2003 certified. Cura also has a 30,000sq ft facility specialising in pre-owned high-
end diagnostic imaging equipment, including CT, MRI and mammography systems.
Endolite India
Overview: Endolite India is a joint venture between the Prime Group, a New Delhi-based technology company and UK-based Chas
A. Blatchford & Sons. It is a rehabilitation services company providing prosthetic and orthotic care at its centres nationwide. The
company headquarters are in New Delhi.
Product Portfolio: The product range covers prosthetic systems for lower and upper extremities, including feet, knees, limbs,
hands and elbows, as well as orthotic products.
Manufacturing: Endolite manufactures a wide range of artificial limb components.
Endo-Med Technologies
Overview: Founded in 2006, Delhi-based Endo-Med Technologies is a producer of minimally invasive devices for use in endoscopic
gastroenterology and endourology.
Product Overview: The product range includes catheters, dilators, guidewires, forceps, metal stents, needles and stone extraction
baskets.
Manufacturing: Products are produced at an ISO 13485 certified manufacturing facility.
Harsoria Healthcare
Overview: Harsoria Healthcare is a family-run company set up in 2002 for the production of IV catheters and other single use
medical devices. Products are supplied to markets in Europe, the Middle East and South East Asia.
Product Portfolio: The product range comprises IV cannulae, AV fistula needles, 3-way stop cocks, dialysis bloodlines, extension
tubes, flow regulators, injection stoppers and obturators.
Manufacturing: The company's factory in Gurgaon, Haryana state, is a 100% Export Oriented Unit registered with the Noida Export
Processing Zone. Products are produced and assembled in a Class 10,000 clean room. The company's facilities are ISO 13485
certified.
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HLL Lifecare
Overview: HLL Lifecare is a Mini Ratna public sector enterprise of the Ministry of Health and Welfare. Founded in 1996 as
Hindustan Latex Limited to manufacture condoms, the company has diversified into a multi-faceted healthcare company, which
manufactures a range of consumable products as well as diagnostic test kits and pharmaceuticals.
In 2008, HLL entered into a 50-50 joint venture with the US-based social venture capital fund Acumen operating under the name of
LifeSpring Hospitals, which operates small (20-bed) maternity hospitals for the urban poor. Lifespring operates 12 hospitals in the
city of Hyderabad, Andhra Pradesh providing maternity and paediatric care to around 3.5mn women. In the longer term, LifeSpring
plans to set up 100 hospitals across India.
Product Portfolio: The company also has three service divisions: Infrastructure Development, specialising in healthcare
infrastructure and facility management, Healthcare Services, specialising in outsourcing of diagnostic and pharmacy services and
Procurement & Consultancy, specialising in procuring medical devices, supplies and other health sector goods for its service users
and for central government agencies and some medical colleges on behalf of the Ministry of Health and Welfare.
Manufacturing: HLL Lifecare has seven manufacturing plants in India. The Akkulam Factory in Thiruvananthapuram (AFT), Kerala
state is dedicated to medical devices producing blood bags, surgical sutures, IUD devices and mesh implants. The AFT facility is
certified to international standards and produces in Class 10,000 and Class 100 clean room facilities. Products are exported to more
than 20 countries.
Hindustan Syringes And Medical Devices
Overview: Hindustan Syringes and Medical Devices (HMD) was established in 1957 to manufacture syringes and has grown to
become one of India's largest indigenous medical device manufacturers. The company has over 3,500 employees and claims to be
one of the top five syringe and needle manufacturers in the world as well as the leading manufacturer of Auto Disable (AD) syringes.
HMD has over 4,500 distributors in the Indian market where it claims a 60% share for disposable syringes and a 70% share for
disposable needles. HMD's products are also marketed in more than 90 countries covering Europe, the Middle East, South East Asia,
South America and the US. HMD has set up two international subsidiaries: HMD Healthcare in the UK and HMD Healthcare in the
US.
In 2012, HMD entered into a partnership with the Swedish company Vigmed to manufacture safety intravenous catheters in India.
HMD will market the products under the company's own brand, using SipClip to describe Vigmed's technology, and will focus on
markets in South Asia, Middle East and Africa. The first products were launched in April 2015. In January 2015, the Global Vaccine
Alliance designated HMD as a strategic partner for a multi-million dollar global initiative to promote injection safety around the
world, which aims to eliminate the practice of using re-usable syringes. HMD will act as a knowledge partner to promote the use of
AD syringes across India where implementation of AD has been inconsistent.
Financial Review: HMD has an annual turnover of more than INR6.7bn (USD95mn). Exports account for around 20% of HMD's
turnover, of which more than half goes to the US and Western Europe.
Product Portfolio: The company's major products are disposable syringes, disposable needles, IV cannulae, surgical blades and
blood collection kits.
Manufacturing: HMD has seven manufacturing plants in South Asia, including facilities at Ballabgarh and Faridabad. The latter is a
fully integrated plant spread over 1.0mn sq ft with an annual production capacity of more than 4.0bn units. Products are
manufactured to international standards and carry ISO 9001 and the CE Mark. HMD has also set up a second 200,000sq ft
manufacturing facility with an initial annual production capacity of 300mn syringes and 36mn IV cannulae.
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JBCPL
Overview: Founded in 1976, J. B. Chemicals & Pharmaceuticals (JBCPL) is a leading contract manufacturer as well as one of the top
three companies in the contrast media field in India. The company is headquartered in Mumbai.
Product Portfolio: JBCPL's contrast media products marketed in India include Cardiolek Injection
(iodixanol), Contrapaque (iohexol), Lek Pamidol (iopamidol), Magnilek Injection (gadopentetic acid), Trazogastro - Oral contrast
(diatrazoic acid) and Trazograf (diatrazoic acid). The company has also in-licensed the ultrasound contrast agent Definity (perflutren)
from US contrast media developer Lantheus Medical Imaging.
Financial Review: JBCPL had a turnover of INR15.4bn (USD225mn) in the fiscal year ended March 31 2019, including contrast
media sales of INR521mn (USD7.6mn), a y-o-y rise of 17%, representing 3.4% of total company revenues.
Manufacturing: JBCPL operates 17 manufacturing units.
R&D: JBCPL has a research centre.
Kayco
Overview: Delhi-based Kayco manufactures and exports medical instruments and appliances, and hospital furniture. The company
supplies healthcare institutions and clinical laboratories through a global network of direct importers. Kayco has been established
for more than 50 years.
Product Portfolio: The company's product range includes surgical instruments, laryngoscopes, stethoscopes, suction units,
autoclaves, orthopaedic implants, cannulae and hospital furniture.
Manufacturing: Kayco was the first Indian company to get ISO 13485:2012 certification for medical devices.
Lifeline Systems
Overview: Lifeline Systems was established in 1981 and claims to be one of India's leading suppliers of medical and surgical
disposables.
Product Portfolio: The product range covers disposables used in anaesthesia, dialysis, transfusion, general surgery, gynaecology,
urology, cardiology, cardiothoracic and vascular surgery, as well as general medical disposables.
Manufacturing: Lifeline has an ISO and CE accredited manufacturing facility located in Noida in the National Capital Region, which
is equipped with a Class 10,000 clean room.
MediRay HealthCare
Overview: Founded in 1992, MediRay HealthCare claims to be one of the largest manufacturers and suppliers of X-ray and C-arm
machines in India. It is headquartered in Delhi and has branch offices in all metro cities.
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Product Portfolio: The company's product range includes X-ray machines, X-ray tables, C-arms, dental X-ray, dental chairs, and
accessories.
Manufacturing: The manufacturing plant is located in Tronica City, near Delhi.
Narang Medical
Overview: Delhi-based Narang Medical, formerly Narang Enterprises, was established in 1989. The company manufactures and
exports a wide range of medical and surgical equipment to more than 80 countries.
Product Portfolio: The product range covers anaesthesia equipment, diagnostic equipment, disposables, general surgical
instruments, dental instruments, orthopaedic instruments and implants, surgical and medical rubber products, autoclaves and
sterilisers, suction units, rehabilitation aids, laboratory equipment, hospital/medical furniture, gynaecology and obstetrics products,
emergency medical products and cold chain equipment.
Manufacturing: The company's manufacturing are ISO accredited and many products are FDA and CE approved.
Opto Circuits
Overview: Bangalore-based Opto Circuits is a medical technology group specialising in primary, acute and critical care products for
the global market, which are marketed in more than 150 countries. It groups together several companies in the medical device
field.
Acquisitions: In 2007, Opto Circuits acquired Devon Innovations and Ormed Medical Technology. Ormed is now owned by Devon
Innovations and acts as its orthopaedic division. Opto Cardiac Care headquartered in Bangalore specialises in non invasive vital signs
monitoring and emergency cardiac care equipment. It groups together the activities of three US subsidiaries: Cardiac Science
Corporation, Criticare Systems Inc and Unetixs Vascular Inc. Opto Eurocor Healthcare was formed through the merger of Altron
Industries and Eurocor. Founded in 1994, Bangalore-based Altron Industries was acquired by Opto Circuits in 2006 and changed its
name to Opto Eurocor Healthcare in 2011. Bonn-based Eurocor was acquired by Opto Circuits in 2005.
Financial Review: Opto Circuits reported revenues of INR11.9bn (USD185mn) in FY2015 ending March 31 2015.
Product Portfolio: Founded in 1991, Devon Innovations specialises in devices for use in urology, gastroenterology and
gynaecology, including catheters, dilators, guidewires, introducers, needles and stents. Ormed Medical Technology specialises in
orthopaedic devices, including total hip prostheses, endernails, kirschner wires, wound drainage suction systems (Variodrains), intra-
operative suction devices (Klearsite cannula) and orthopaedic instrumentation kits. Opto Eurocor Healthcare specialises in
interventional cardiovascular and endovascular devices such as PTCA catheters and stents.
Manufacturing: Devon Innovations production facilities are based in Bangalore, and Parwanoo, Himachal Pradesh state, in
Northern India. Ormed's manufacturing facilities are based in Chennai, Tamil Nadu state. Opto Eurocor produces stainless steel and
cobalt chromium stents through its Kolkata-based subsidiary N.S. Remedies, a company acquired by Opto Circuits in 2010.
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Pace Devices
Overview: Established in 1992, Navi Mumbai-based Pace Devices was a distributor of surgical disposable instruments until 1996. In
1997, the company moved into the design and manufacture of endoscopy stone baskets and retrievals.
Product Portfolio: The product range covers baskets and retrieval products for urology, cardiology and gastroenterology, as well
as catheters and dilators.
Manufacturing: The company has its own manufacturing unit, an in-house R&D department and a distribution network. Pace
products are manufactured under the 'Xyster' brand name to international quality standards.
Panacea Medical Technologies
Overview: Founded in 1999, Bangalore-based Panacea Medical Technologies specialises in digital X-ray and radiotherapy
equipment. In 2015, the company celebrated the 10th anniversary of the Bhabhatron, a high-tech radiotherapy system developed
in collaboration with the Bhabha Atomic Research Centre.
Product Portfolio: Products include the Bhabhatron II digital telecobalt system, the Bhabhatron 3I image-guided gamma beam
therapy system, the Imagin flat panel radiotherapy simulator with advanced CBCT imaging capability and the Lilac digital
mammography system.
Manufacturing: Panacea develops and produces its products at its facilities in Whitefield, Bangalore, Karnataka state.
Poly Medicure
Overview: Founded in 1995, Poly Medicure began manufacturing medical disposables in 1997 and has developed into one of
India's leading producers of catheters and other consumables. The company is listed on the National and Bombay Stock Exchanges
and has over 1,900 employees. Products are sold in over 90 countries.
Acquisition: In June 2018, Poly Medicure's Dutch subsidiary Poly Medicure Netherlands entered into an agreement to acquire an
82% share in Plan Health 1, an Italian producer of infusion and long-term implantable vascular access devices, which will
complement Poly Medicure's own range of short-term vascular access devices. Poly Medicure subsequently acquired the remaining
18% stake, giving it 100% ownership.
Financial Review: Poly Medicure had consolidated revenues of INR6.3bn (USD89.2mn) in FY2019 ending March 31 2019,
including product sales of INR5.9bn (USD83.8mn), a 16.2% y-o-y rise, with EBITDA of INR1.5bn (USD21.2mn). Around 70% of
product sales come from exports. The company has been recognised as the leading Indian exporter of disposable plastic medical
devices for the past six years.
Product Portfolio: Poly Medicure produces over 125 consumable products covering the areas of infusion therapy, blood
management, surgery & wound drainage, urology, respiratory care, critical care, gastroenterology, dialysis and renal care.
Manufacturing: Poly Medicure has five manufacturing facilities in India, three in Faridabad and one each in Haridwar and Jaipur. All
facilities are CE accredited and one is US FDA audited. The company also has manufacturing facilities in Laiyang-Qindao, China and
Italy, as well as a 23% stake in a joint venture in Assuit, Egypt which operates under the name of Ultra Med. Manufacturing floor
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space covers over 400,000sq ft with around 100,000sq ft of clean rooms class 100,000 to class 10,000. Poly Medicure is planning to
further expand manufacturing capacity to meet growing domestic demand for import substitute products. Its third manufacturing
facility in Faridabad commenced manufacturing operations in February 2018, with the aim of becoming fully operational within 18
months.
R&D: Poly Medicure has an R&D facility located in Faridabad, which employs 50 engineers and technicians. The company has over
150 patents granted and has filed for an additional 400 patents in India and worldwide. R&D spending in FY2019 amounted to
INR101.5mn (USD1.4mn), equal to 1.6% of turnover.
Prognosys
Overview: Founded in 2004, Bangalore-based, Prognosys manufactures high-end digital radiology systems under the Prorad brand
name. Sister company Chayagraphics focuses on the distribution of medical imaging consumables.
Prognosys is the exclusive partner for Canon in India for assembling digital medical imaging products. The company also has
partnerships with radiology equipment manufacturers based in Spain and Italy. Prognosys has installed more than 50 digital
radiology systems and over 5,000 automatic film processors in India.
In June 2014, Prognosys Medical Systems received an investment of INR200mn (USD3.3mn) from Somerset Indus Capital Partners,
a healthcare focused PE firm in exchange for a minority stake. Prognosys plans to use the funds to set up a 30,000sq ft facility in
Bangalore.
Financial Review: Prognosys and Chayagraphics have a combined annual turnover of around INR800mn.
Product Portfolio: Products include high frequency X-ray systems, digital radiography systems, C-Arms, digital fluoroscopy
systems and accessories like automatic film processors. The company also has a telemedicine division providing a range of remote
monitoring products.
Manufacturing: The company's manufacturing facility in Bangalore is ISO 9001:2000 certified for radiology and imaging products.
Film processors are FDA and CE certified and are exported to over 17 countries.
Relisys Medical Devices
Overview: Hyderabad-based Relisys Medical Devices specialises in cardiovascular and peripheral vascular devices.
Product Portfolio: The product range covers coronary stents, including a drug-eluting stent developed in conjunction with
Cinvention, PTCA catheters, angiographic catheters, cardiac surgery disposables and critical care products.
Manufacturing: The company has a 160,000sq ft manufacturing facility with 35,000sq ft of Class 10,000 clean rooms. The factory
produces cobalt chromium and stainless steel stents, together with PTCA and angiographic catheters. There is also a drug coating
unit.
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Ribbel International
Overview: Ribbel International based in New Delhi, is an established manufacturer and exporter of disposable surgical blades,
which has recently diversified into respiratory care and urology products. The company exports its products to more than 85
countries including the US and Europe.
Product Portfolio: The company has three main product ranges: General Surgery including surgical blades, scalpels, stitch cutters
and post mortem blades; Respiratory Care including oxygen masks, nebuliser kits and nasal oxygen cannulae; and Urology including
foley catheters and urinary bags.
Manufacturing: Production facilities are based in Sonepat, Haryana state in the National Capital Region. In 2015, Ribbel
International doubled its manufacturing capacity for blade production to 50mn blades per annum to position itself as the largest
domestic producer in this sector. The company manufactures sterile surgical blades from both carbon steel and stainless steel and a
range of disposable scalpels with plastic handles. Manufacturing of respiratory care products started in 2013 and production of
urology products in 2014. The company holds ISO 9001, ISO 13485 and EC certification.
Sahajanand Medical Technologies
Overview: Established in 1997, Surat-based, Sahajanand Medical Technologies (SMT) is one of the world's largest manufacturers of
advanced coronary stents, having pioneered the development of coronary stents in South East Asia. SMT claims to be the largest
privately-held producer of coronary drug-eluting stents outside North America, with its stents sold in more than 40 countries.
Product Portfolio: The product range includes bare metal stents, drug eluting stents, PTCA balloon catheters and accessories.
Manufacturing: SMT uses high-precision laser technology and makes both drug-eluting and non-drug-eluting stents.
Skanray Technologies
Overview: Founded in 2007, Mysore-based Skanray Technologies is a manufacturer of diagnostic imaging systems and critical care
devices. Skanray has around 550 employees with operations in India, Italy and Brazil. The company is active in around 80 countries.
Acquisitions: In November 2012, Skanray Technologies acquired Larsen & Toubro's healthcare business, which provided Skanray
access to monitoring devices in the critical care, operation theatre and intensive care unit segments. In September 2013, Skanray
raised INR1.0bn (USD16.7mn) from private equity firm Ascent Capital to fund an expansion plan including setting up units in Brazil
and West Asia. In July 2014, Skanray acquired Italian X-ray tube maker Compagnia Elettronica Italiana (CEI). Skanray had previously
acquired a minority stake in the company and set up a joint venture, CEI-Skanray Radiology Devices based in Mysore, which is 51%
owned by CEI and 49% owned by Skanray.
Financial Review: Skanray has an annual turnover of INR1.2bn (USD20mn).
Product Portfolio: Radiology products include mobile X-ray units, C-Arms, high frequency RAD systems with Bucky table and intra
oral dental X-ray systems. Critical care products include ECGs and defibrillators. Skanray sells products under its own name and
supplies products on an OEM basis.
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Manufacturing: Skanray produces all of its products at its manufacturing facilities in India and Europe, which are FDA-compliant.
The company has two manufacturing facilities in Mysore, Karnataka state, which have ISO 13485 and ISO 9001 certification.
SISCO
Overview: South India Surgical Company (SISCO), based in Chennai, has been manufacturing surgical instruments for over 60
years. Products are exported to 30 countries worldwide, including the US, the UK, Germany, the Netherlands, Denmark, Spain and
Australia. SISCO also distributes products in India from a range of multinationals. The company has around 500 employees.
Product Portfolio: The product range covers laparoscopic and regular surgical instruments, disposable syringes and needles,
endotracheal tubes and other consumables.
Manufacturing: SISCO has factories in Chennai and Pondicherry, which are ISO and CE certified. Facilities include class 10,000
clean rooms for disposable products.
SURU International
Overview: SURU International is a medium sized company established in 1991 and based in Mumbai. The company's core
business is supplying quality disposable medical devices to customers in over 70 countries.
Product Portfolio: SURU International's product range includes sutures, surgical mesh and disposable products for infusion
therapy, central venous access, anaesthesia, urology, gastroenterology, blood management, surgery and wound care.
Manufacturing: SURU's production facilities located in Dahanu, Maharashtra state, have ISO 9001:2008 and ISO 13485:2003
certification and many products carry the CE mark.
Sutures India
Overview: Founded in 1992, Bangalore-based Sutures India is India's largest surgical sutures manufacturer, exporting to over 90
countries. The majority shareholder is private equity firm TPG Growth which initiated discussions in July 2017 to reduce its 73%
stake in the company and was subsequently reported to be seeking a full exit from the company. CX Partners is the other external
investor with a 12% stake.
Product Portfolio: The product range covers all types of surgical sutures, including absorbable sutures and non-absorbable
sutures, as well as surgical meshes, surgical gloves, surgical paper tapes, surgical skin staplers, suture needles, bone wax and Foley
catheters.
Manufacturing: The company has the capacity to manufacture about 20mn sterile sutures per annum at its facility located in
Bangalore, which has GMP, ISO 9001:2008, ISO 13485:2012 and CE certification.
In January 2013, the company commissioned its fourth plant at Sri City Special Economic Zone in Andhra Pradesh. The unit will
export its products to over 75 countries. The new facility is being set up to meet the demand for the company's products in ASEAN
and European markets. The plant has been set up at a cost of INR120mn (USD2.1mn). It will initially employ 50 people, rising to
around 200 people.
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Trivitron Healthcare
Overview: Founded in 1997, Trivitron Healthcare is headquartered in Chennai, with operations in the Middle East, South and South-
East Asia and Africa. Starting as a small medical equipment and instruments distribution company, Trivitron claims to have grown to
become the largest Indian med-tech company with more than 1,500 employees. In December 2013, Trivitron raised INR1.5bn
(USD26.7mn) from private equity firm India Value Fund Advisors (IVFA), which has taken a minority stake in the company. The
investment will fund Trivitron's investment plans aimed at strengthening the company's presence in the diagnostic imaging and
clinical diagnostic market. In October 2012, Fidelity Growth Partners India invested INR4bn (USD71mn) in Trivitron.
Acquisitions: In 2011, Trivitron acquired a minority stake in Mumbai-based Kiran Medical, which subsequently became a wholly-
owned subsidiary of Trivitron. Incorporated in 1976, Kiran Medical specialises in image enhancement accessories and radiation
protection products. It employs about 150 people in India. In November 2012, Trivitron acquired Finnish company, Labsystems
Diagnostics, specialising in neonatal screening, cardiac biomarkers, fertility and infectious disease testing analysers and kits. In
December 2012, Trivitron converted an existing JV established in 2006 with ETA Star Healthcare, an Al Ghurarir Group company, into
a wholly-owned subsidiary in Dubai. In 2013, Trivitron acquired Imaging Products India (IPI), a manufacturer and distributor of
contrast products in association with Bracco. In July 2016, Trivitron acquired a 60% stake in Bome Sanayi Urunleri, a Turkish product
of IVD devices based in Ostim, Ankara.
Financial Review: Trivitron had revenues in the region of INR7bn (USD100mn) in FY2018. More than half of revenues come from
international markets. Trivitron is targeting revenues of INR10bn (USD150mn), at which point founder and managing director GSK
Velu has indicated that the company will seek an IPO listing.
Product Portfolio: Trivitron's product range covers cardiology and implantable devices, diagnostic imaging, clinical diagnostics,
critical care and life support solutions and ophthalmology. The company has a strategic partnership with Hitachi Medical Systems
and also offers consultancy services for setting up hospitals, nursing homes, clinical laboratories and research centres. Kiran Medical
produces image enhancement accessories and radiation protection products, such as cassettes, screens, grids, shields and
computer radiography systems, and enjoys a leadership position in the US, Europe, Japan and Latin America. It also provides
accessories to some of the leading imaging product manufacturers like Fuji, Agfa and Kodak.
Manufacturing: Trivitron has three internationally accredited manufacturing facilities in Chennai, Mumbai and Pune, producing a
range of diagnostic imaging products including ultrasound and colour doppler machines, X-ray equipment, image enhancement
solutions and radiation protection apparels, cardiac diagnostics instruments, an entire range of operating room solutions, and in
vitro diagnostics (IVD) instruments and reagents. The Kiran Medical manufacturing facility in Mumbai covers 70,000 sq ft.
Trivitron has established the Trivitron Medical Technology Park, a 25-acre manufacturing facility located at Sriperumbudur, near
Chennai, which has the capacity to house some 15 medical technology manufacturing plants operated by Trivitron subsidiaries and
joint ventures. Manufacturing operations already installed in the park include Aloka-Trivitron Medical Technologies, a JV between
Hitachi Aloka and Trivitron Healthcare, which was established in 2010 to manufacture ultrasound and colour doppler units adhering
to ISO 13485 and CE certification for export to Japan. Annual output is more than 900 units, of which over 350 are exported to
Japan. A second joint venture with BioSystems SA of Spain has established an IVD reagents manufacturing facility in the park. A third
manufacturing unit for the production of Labsystems diagnostics IVD test kits was inaugurated in February 2016. According to
Trivitron the company has invested INR2.5bn (USD39.1mn) in these three production units. In March 2016, Trivitron announced
that it was seeking companies to collaborate on establishing a production unit for digital X-ray equipment, for which the company
has earmarked investment of INR1.0bn (USD15.6mn). Trivitron is also seeking technology to manufacture CT, MRI and digital
mammography equipment.
Trivitron Healthcare has also invested in Pune-based Vision Medicaid Equipments, a leading X-ray manufacturer and original
equipment supplier for various multinational companies and is working towards modernising and expanding two of its facilities for
the production of X-ray equipment and C-Arms. Trivitron is initiating R&D to manufacture a portable cathlab in the new facility.
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Wadia Group
Overview: The Wadia Group is a broadly diversified group of companies in India, encompassing the Bombay Burmah Trading
Corporation, the second oldest publicly listed company in the country. Three medical companies operate within the group:
• Instruments Orthopaedics (INOR), specialising in orthopaedic instruments and implants, being the first Indian company to
manufacture hip and knee joints, which has been awarded an import substitution award by the Indian government for its knee
implants.
• Dental Products of India (DPI), specialising in dental materials with a 10,000sq ft production facility, which claims to be the only
dental company in India that has the BIS (ISI) mark of quality for its major products.
• Medical Microtechnology, a collaboration with Micro Titanium of the UK, specialising in high precision forceps and needle holders
for ophthalmic surgery which are marketed by INOR Ophthalmics in India.
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Medical Devices Multinational Manufacturers
B. Braun
Overview: B. Braun's India subsidiary was incorporated in 1994 as a joint venture between B. Braun and a local company. B. Braun
Medical (India), headquartered in Mumbai, had 931 employees in 2018. In 2009, B. Braun entered into a Public Private Partnership
programme with the state of Andhra Pradesh to run 18 dialysis clinics. In 2014, B. Braun entered into a similar partnership with the
state of Bihar to set up 24 dialysis clinics in medical colleges and district hospitals.
Acquisition: In July 2018, B. Braun announced an agreement to acquire US-based NxStage Medical's bloodlines business.
Local acquisitions: In 2011, B. Braun Medical (India) acquired a controlling stake in Hyderabad-based Oyster Medisafe, an Indian
company specialising in safety infusion therapy. In 2012, B, Braun acquired a 75% stake in Ahlcon Parenterals, an OEM manufacturer
of parenteral products based in New Delhi and listed on various Indian Stock Exchanges. In 2014, B. Braun launched a delisting offer
to take full control of the company. Ahlcon Parenterals had 881 employees in 2018.
Product Portfolio: B. Braun operates four main divisions: Hospital Care, Aesculap for surgical products, Out-Patient Market and
Avitum for dialysis products and services. In India, the product portfolio focuses on IV sets, syringes & needles, diabetes care
products, dialysis disposables, sutures and surgical instruments.
Manufacturing: B. Braun's principal manufacturing plants are located in Chengalpattu and Hyderabad. The production facility at
Chengalpattu near Chennai in Tamil Nadu state was established by B. Braun Medical India in 2007. It employs 200 staff and
manufactures over 2,000 different types of surgical sutures with an annual output of over 20mn units. It is operationally integrated
with the B. Braun Centre of Excellence for Sutures in Spain. As a part of the Aesculap Division, it contributes significantly to the global
supply of B. Braun Surgical Sutures. The plant also produces IV sets and right heart catheters. Oyster Medisafe's manufacturing plant
in Hyderabad produces IV sets, syringes and cannulae. It is ISO 9001:2000, ISO 13485 and CE certified. Ahlcon Parenterals has
production facilities in Bhiwadi, Rajasthan. Following Braun's investment, these facilities have been expanded to make it a global
manufacturing hub for parenterals.
Baxter
Overview: Baxter International's subsidiary in India was set up in 1997 to provide critical therapies for people with life threatening
conditions. Baxter India is headquartered in Gurgaon and has offices across the country.
Acquisitions: In December 2019, Baxter announced the acquisition of Sanofi's Seprafilm surgical products unit for USD350mn. In
September 2019, Baxter signed an agreement to acquire Cheetah Medical, a provider of non-invasive haemodynamic monitoring
technologies, for USD190mn, with potential for an additional USD40mn based on clinical and commercial milestones.
Local Acquisition: In July 2002, Baxter India acquired Wockhardt Life Sciences' IV fluids business for an overall consideration of
USD40mn. The acquisition pushed Baxter into a leadership position in the Indian IV fluid market. The acquisition provided the
company with a significant position in the critical care market in India. In addition to market leadership, Baxter gained Wockhardt's
customer franchise, a country-wide marketing organisation of 165 people and two manufacturing units at Aurangabad and
Chennai with a combined capacity of 100mn bottles a year. The IV fluids market in India is valued at INR3.2bn, growing at over 12%
per year.
Product Portfolio: Baxter focuses on seven global business units. Renal Care includes sales of peritoneal dialysis (PD),
haemodialysis (HD) and additional dialysis therapies and services. Acute Therapies includes sales of continual renal replacement
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therapies (CRRT) and other organ support therapies focused in the intensive care unit (ICU). Medication Delivery includes sales of IV
therapies, infusion pumps, administration sets and drug reconstitution devices. Pharmaceuticals includes sales of premixed and
oncology drug platforms, inhaled anaesthesia and critical care products and pharmacy compounding services. Nutrition includes
sales of parenteral nutrition (PN) therapies. Advanced Surgery includes sales of biological products and medical devices used in
surgical procedures for haemostasis, tissue sealing and adhesion prevention. Other includes sales primarily from the company’s
pharmaceutical partnering business.
Manufacturing: Baxter operates a continuous ambulatory peritoneal dialysis (CAPD) fluid system manufacturing plant at Manesar,
near Delhi.
Becton Dickinson
Overview: Becton Dickinson (BD) has had a presence in India since 1989 and established a fully-owned subsidiary, BD India, in
1996, which is based in Gurgaon, Haryana state.
Divestiture: In September 2018, BD announced the sale of its Advanced Bioprocessing business to Thermo Fisher Scientific. In
March 2018, BD announced an agreement to divest its remaining stake in Vyaire Medical to funds managed by Apax Partners for a
transaction value of USD435mn.
Acquisitions: BD completed the USD24bn acquisition of Bard in December 2017, and the US12bn acquisition of CareFusion in
March 2015. Bard India Healthcare is based in Mumbai. CareFusion India is based in Chandigarh and operates as part of BD's Medical
division.
Product Portfolio: BD has three reportable segments since December 2017: Interventional, Medical and Life Sciences. The
majority of the Bard businesses will be reported under the new Interventional segment, which will have three units: Peripheral
Interventional, Surgery and Urology & Critical Care. Medical operates four main businesses: Diabetes Care, Medication Delivery
Solutions (rebranded), Medication Management Solutions and Pharmaceutical Systems. Life Sciences has three units: Biosciences,
Diagnostic Systems and Preanalytical Systems.
In December 2004, BD and Hindustan Latex (HLL), a Government of India enterprise, entered into an agreement to promote
injection safety in India through the introduction of auto-disable syringes; education and training of healthcare workers; and the
implementation of advocacy programmes with the Government of India.
Manufacturing: BD has a major manufacturing facility at Bawal near Rewari in Haryana. This facility is among the largest syringe
and medical device manufacturing plants in Asia, with capacity to manufacture over 1.0bn Class II and IIa disposable needles and
syringes using a highly automated process. Products include BD's Soloshot FX auto disable syringes. The plant has also been
recognised by the Haryana State Industrial Corporation.
Johnson & Johnson
Overview: Johnson & Johnson (J&J) has been active in India since 1947 and the company's Indian operations have more than 3,000
employees. Johnson & Johnson Medical India (JJMI) is one of the largest and most comprehensive medical devices companies in
India. JJMI encompasses well-known franchises in India, including DePuy, Ethicon and J&J Hospital Supplies.
Divestitures: In May 2019, Takeda announced that J&J’s Ethicon will buy TachoSil Fibrin Sealant Patch for USD400mn. In April 2019,
J&J completed the USD2.8bn divestiture of Advanced Sterilization Products (ASP), a division of Ethicon, to Fortive Corporation. In
October 2018, J&J completed the USD2.1bn divestiture of its LifeScan business, specialised in blood glucose monitoring products, to
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Platinum Equity. In June 2018, J&J announced the USD2.8bn binding offer from Fortive Corporation to acquire Advanced Sterilization
Products (ASP), a division of Ethicon. In October 2017, J&J completed the USD1.0bn divestiture of its Codman Neurosurgery
business to Integra LifeSciences. In October 2015, J&J completed the USD2.0bn divestiture of its Cordis business to Cardinal Health.
In 2014, J&J divested the Ortho-Clinical Diagnostics business.
Acquisitions: In December 2019, J&J announced an agreement to acquire the remaining stake in Verb Surgical from Verily. In May
2019, Takeda announced that J&J’s Ethicon will buy TachoSil Fibrin Sealant Patch for USD400mn. In April 2019, J&J announced that
Ethicon has completed the acquisition of robotics company Auris Health for USD3.4bn in cash and up to USD2.4bn in additional
contingent payments. In June 2017, J&J’s DePuy Synthes acquired Innovative Surgical Solutions.. In February 2017, J&J's Ethicon
announced a deal to acquire Torax Medical. In February 2017, J&J completed the USD4.3bn acquisition of Abbott Medical Optics
(AMO).
Product Portfolio: J&J is organised into three business segments: Consumer, Pharmaceutical and Medical Devices. The Medical
Devices segment includes a broad range of products used in the cardiovascular, diabetes care, diagnostics, orthopaedics (hips,
knees, trauma and spine & other), surgery (advanced, general and specialty) and vision care markets. The company's largest markets
are surgery and orthopaedics.
In July 2017, J&J presented Cerenovus, its new neurovascular business, which was expanded with the acquisitions of Pulsar Vascular
in December 2016 and Neuravi in April 2017. Cerenovus is part of DePuy Synthes Products, within the Medical Devices Companies
segment.
Manufacturing: Ethicon India claims to be the largest producer of absorbable and non-absorbable surgical sutures in India and a
market leader in the wound closure business. The first Ethicon plant was set up in the 1960s in Dharavi, Mumbai to manufacture
catgut sutures, while a new state-of-the-art manufacturing plant in Aurangabad became operational in 1991. This plant
manufactures sutures and needles. Many of the sutures are hand-assembled and packaged at the suture finishing facility, and
sterilised after assembly in the in-house facility. Suture needles are manufactured in-house from stainless steel wire.
A second state-of-the-art suture finishing facility was set up in May 2007 in Baddi, Himachal Pradesh state in North India. It houses
the manufacture of sutures & related medical requisites. All of the sutures are hand-assembled and packaged at the facility, and
sterilised after assembly in an outsourced facility in Delhi.
R&D: In July 2011, DePuy opened the DePuy Institute for Advanced Education and Research. The 30,000sq ft facility, the largest
DePuy facility of its kind outside the US, is located at Mahindra World City near Chennai, the capital city of Tamil Nadu. It serves as
one of the company's hubs for education training and research on subjects from non-surgical early intervention to complex surgery
in the areas of orthopaedics, spinal care, sports medicine, soft tissue repair, trauma and neurosciences.
Nipro Corporation
Overview: Nipro Corporation of Japan has been operating in India since 1995 Nipro has three subsidiaries in India; Nipro India
Corporation, which is responsible for the medical device business; Nipro Tube Glass, which manufactures and sells ampoules and
vials for injectables; and Nipro Glass India, which manufactures neutral borosilicate glass tubes for ampoules and vials at five sites in
India. Nipro employs over 2,000 staff in India.
Product Portfolio: Nipro operates Medical-Related, Pharmaceutical-Related and Glass-Related Businesses. The Medical-Related
Business specialises in Renal, Injection, Diabetic, Catheter, Infusion and Other Products.
Manufacturing: Nipro India Corporation opened a manufacturing facility in Shirwal near Pune City, Maharashtra state in December
2012. The production site manufactures artificial kidney dialysers and blood tubing sets, cannulae, intravenous catheters, arterial
venous fistulas and disposable syringes and needles. It will feature India's first in-house gamma sterilisation facility.
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Nipro has invested INR7.0bn in the facility, which has been accorded mega project status by the state government. Initial output will
be 6.0mn dialysers per annum, of which 90% will be exported. Around 80% of the raw materials will be imported with a gradual
switch to local sources of supply over time. There are also plans to ramp up production in the longer term with the aim of increasing
access to dialysis services in India by making the cost more affordable.
Philips
Overview: Philips India was incorporated in 1930 and is based in Gurgaon with branch offices in Ahmedabad, Bangalore, Chennai,
Hyderabad, Kolkata, Mumbai and Pune. The company has expanded its healthcare business through local acquisitions and more
recently through a dedicated manufacturing facility to develop products for the Indian healthcare market, as well as an innovation
centre in Bangalore.
Acquisitions: In July 2018, Philips completed the acquisition of EPD Solutions, an Israeli developer of cardiac imaging and
navigation systems for use in image-guided procedures to treat cardiac arrhythmia. In June 2018, Philips announced the acquisition
of the UK’s Remote Diagnostic Technologies to expand its position in the resuscitation and emergency care market. It also
announced the acquisition of EPD Solutions to expand its image-guided therapy portfolio. In 2017, Philips completed the USD2.2bn
acquisition of Spectranetics to strengthen its image-guided therapy business group, and the acquisition of CardioProlific, which
develops catheter-based thrombectomy products.
Local Acquisitions: In December 2008, Philips acquired Panvel-based Alpha X-Ray Technologies, a manufacturer of cardiovascular
X-ray equipment founded in 1989. Alpha had around 55 employees at the time of the acquisition. Alpha manufactured X-ray
systems including cardiac catheterisation laboratories with C arm DSA systems, and components for the economy segment of the
global CV X-Ray market. In March 2009, Philips acquired Mumbai-based Meditronics, one of India's largest manufacturers of
diagnostic and interventional X-ray equipment. Meditronics focused on low-cost diagnostic X-ray systems, high and line frequency
mobile surgical C-arm IITV systems, and mobile and portable radiography units. It had around 150 employees at the time of the
acquisition.
In 2017, Philips was planning to start investing in Indian healthtech startups via its venturing arm set up in 2016 to buy minority
stakes in healthtech startups across the world.
In October 2014, Philips announced it was partnering with Medwell Ventures Nightingales homecare unit based in Bangalore to
supply respiratory equipment such as non-invasive ventilators and oxygen concentrators to patients at home. Philips will provide
training to the company's respiratory therapists and specialist nurses. In 2016, Philips launched a home healthcare services business
in India specialising in cardio pulmonary care. The company is looking to tie up with hospitals to refer their cases. Philips is aiming to
provide home care to over 100,000 people by 2020.
Product Portfolio: Since January 2019, Philips has three main reporting businesses: Diagnosis & Treatment (diagnostic imaging,
ultrasound, healthcare informatics and image-guided therapy); Connected Care (monitoring & analytics, therapeutic care,
population health management and sleep & respiratory care); and Personal Health (personal care, domestic appliances, oral
healthcare and mother & child care).
Manufacturing: In June 2012, Philips opened its first Indian Development and Manufacturing Centre for imaging systems
incorporating the manufacturing activities of Alpha and Meditronics. Located at Chakan, near Pune, the facility focuses on
diagnostic and interventional imaging solutions, initially developed for the Indian market and then for global markets. To date, the
centre has developed four new X-ray systems: two interventional cardiovascular systems - the Allura FC and Allura Centron -, the BV
Vectra mobile C-Arm with orthopaedic applications and the Primary Diagnost entry level X-ray system. Products are aimed at the
value segment in India and abroad, including tier-two and tier-three towns and rural markets. Made in India products feature low
operating costs, energy-efficiency, easy serviceability and support for high patient volumes. In 2014, Philips changed the name of its
Chakan facility to the Healthcare Innovation Centre (HIC) as part of its plans to make the centre the global headquarters for its
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mobile surgery business. The HIC has around 400 employees. Around 70% of output is for the domestic market.
R&D: In addition to the Healthcare Innovation Centre in Chakan, which focuses on R&D in X-ray related products, Philips has an
Innovation Centre in Bangalore, which has transitioned from an innovation centre to a full-fledged product development centre,
with the focus on creating end-to-end high technology products and solutions for India and global markets. Philips is investing
more than EUR1.0mn a year in R&D in India and a large portion of the investment is in healthcare reflecting the country's increasing
importance as a global R&D centre for the group's healthcare business. About 80% of the Bangalore facility's activities focus on
healthcare and 20% on energy topics. Within healthcare these include: cardiology - early detection of disease and developing a
connected cath lab; perinatal care - solutions to improve the care of babies and mothers before, during and after delivery, including
solutions for the neonatal intensive care unit; oncology/women's health - solutions for cervical cancer screening, colposcopy and
treatment, and digital sequencing; The centre works with several research institutes, universities and hospitals for clinical
collaborations, including Divakar's Specialty Hospital, K.R. Hospital, Healthcare Global and Manipal Hospital. It also has partnerships
with the relevant business units of Philips. Healthcare products developed for the Indian market include the ClearVue range of
ultrasound systems and the Visiq miniaturised ultrasound system that is designed for use in remote areas.
Schiller Healthcare India
Overview: Founded in 1997, Schiller Healthcare India is a joint-venture between the Swiss Schiller AG and the Indian RR Group. It is
headquartered in Mumbai with offices in more than 33 locations, including major metro cities such as Chennai, Delhi, Kolkata and
Mumbai. It also has an office in Kathmandu, Nepal.
Product Portfolio: The company's diversified product range targets areas such as anaesthesia, cardiology, cardiopulmonary,
consumables, critical care, infusion pumps, pressure injectors, radiology, surgery and telemedicine. The main products are
ambulatory BP, portable CTs, defibrillators, ECGs, holters, patient monitors, pulse oximeters, robotic neurosurgery, spirometry
systems, standing MRI, stress test systems, surgical diathermy, telemedicine and ventilators. Schiller Healthcare India sells its own
products, products from Schiller AG and products from other companies.
Manufacturing: The company has a manufacturing facility at Pondicherry. It produces a range of equipment which is
'complementary' to Schiller AG's products in terms of functionality and pricing. The company also has an R&D team at Pondicherry.
Siemens Healthineers
Overview: Since March 2018, Siemens Healthineers is an independent listed company. In March 2018, Siemens raised EUR4.2bn
when it sold a 15% stake in Siemens Healthineers. Siemens owns the remaining 85% in Siemens Healthineers. Siemens' healthcare
operations in India were previously part of Siemens India, a company 75% owned by Siemens, which is listed on the National and
Bombay stock exchanges. In March 2016, Siemens transferred its Indian healthcare unit to its Siemens Healthcare subsidiary as part
of the global realignment of its healthcare business as a separately managed entity. In May 2016, the entity was rebranded as
Siemens Healthineers. It is based in Mumbai.
Divestitures: In FY2015, Siemens sold its hearing aid and hospital information businesses.
Acquisitions: In October 2019, Siemens Healthineers completed the USD1.1bn acquisition of US-based Corindus Vascular
Robotics. In November 2017, Siemens Healthineers closed the acquisition of Alere's point-of-care blood diagnostics subsidiary,
Epocal. In June 2017, Siemens Healthineers closed the acquisition of Medicalis to strengthen its Population Health Management
(PHM) offering.
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Product Portfolio: Siemens Healthineers is structured in three segments (Imaging, Advanced Therapies and Diagnostics), three
business horizontals (Digital Services, Enterprise Services and Customer Services) and three regions. The Imaging segment includes
MRI, CT, X-ray systems, molecular imaging and ultrasound. The Diagnostics segment specialises in laboratory, molecular and point-
of-care diagnostics. The Advanced Therapies segment includes products such as angiography systems and mobile C-arms.
Manufacturing: Following the realignment of its Healthcare business, Siemens is looking to expand its local manufacturing
operations to develop more products tailored to the local market. Siemens began to manufacture medical products in India in
1954. In 1996, the company opened a facility in Goa to manufacture mobile X-ray units for Siemens's worldwide requirements.
Siemens claims to have been the first medical engineering company to achieve ISO 9001 Certification in India, in 1998. The Goa
works encompasses around 86,200m2 of engineering and production space. It has 74 employees, with 70% of its activities
outsourced. The site is a global competency centre for the Multimobil 2.5/10 mobile X-ray generator and the Multimobil 5C image
intensifier, manufactures X-ray generators and is a RAD components centre for radiological tables. It is also responsible for a
portfolio of products for the Indian market, though the greater part of production is exported.
R&D: R&D for medical hardware products is conducted in Goa, while R&D for software products is undertaken by Siemens
Technology and Services (STS) headquartered in Bangalore. In the healthcare field, STS develops common platforms, PACS and
computer aided diagnosis solutions, for a broad range of modalities including angio/fluoroscopic/radiography, CT, MRI, molecular
imaging, ultrasound and oncology care systems, as well as new healthcare and radiological information systems. The company
employs around 1,100 software engineers.
Smith & Nephew
Overview: Prior to 2013, the Indian operations of Smith & Nephew (S&N) were confined to a representative office in Mumbai, but
the company is seeking to substantially increase its presence in India through local manufacturing and R&D.
Divestiture: In August 2016, S&N concluded the sale of its Gynaecology business to Medtronic.
Acquisitions: In July 2019, Smith & Nephew completed the acquisition of the Swiss optical tracking technology innovator Atracsys
Sàrl. In June 2019, Smith & Nephew completed the purchase of the Brainlab orthopaedic joint reconstruction business. In April
2019, Smith & Nephew completed the acquisition of Leaf Healthcare and the USD660mn acquisition of Osiris Therapeutics. In
January 2019, Smith & Nephew completed the USD105mn purchase of Ceterix Orthopaedics. In December 2017, Smith & Nephew
completed the acquisition of Rotation Medical. In January 2016, it completed the USD275mn acquisition of Blue Belt Holdings.
Local Acquisition: S&N gained a manufacturing base through its 2013 acquisition of Pune-based Adler Mediequip and with it, the
brands and assets of Sushrut Surgicals, a leader in mid-tier, orthopaedic trauma products. Set up in 1992, Adler Mediequip
pioneered the production of trauma implants in India and the acquisition has given S&N an entry point to India's trauma segment
with a well-established platform to provide and develop products for the mid-tier market in India and for export.
Product Portfolio: S&N operates two main divisions. Advanced Surgical Devices focuses on five product units (Orthopaedic
Reconstruction, Trauma and Extremities, Sports Medicine Joint Repair, Arthroscopic Enabling Technologies and Other) while
Advanced Wound Management on three product units (Advanced Wound Care, Advanced Wound Devices and Advanced Wound
Bioactives).
Manufacturing: Production of trauma products takes place in Sangameshwar, Maharastra state. The product range includes
primarily trauma implants and instrumentation that cater to internal and external fixation, as well as spine and limb salvage
portfolios.
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Terumo
Overview: Terumo manufactures blood bags in India through its subsidiary Terumo Penpol headquartered in Trivandrum, Kerala.
Penpol was incorporated in 1983 as Peninsula Polymers (Penpol) and became the first indigenous company to produce blood bags
in 1987 in partnership with the Sree Chitra Tirunal Institute for Medical Sciences and Technology. Terumo acquired a 74% stake in
1999 and the company was renamed Terumo Penpol.
Manufacturing: Terumo Penpol manufactures blood bags and offers a range of medical electronic products for use in blood
transfusion centres and blood banks. The company claims to be the largest producer of blood bags in India with a capacity to
produce approximately 24mn bags per year, and has 1,056 employees. Products are exported to some 80 countries.
R&D: Terumo Penpol also operates the Metabolic Disorders Research Center which was inaugurated in November 1998 and is
located in Jagathy, Trivandrum City. The centre aims to promote research into metabolic and genetic disorders, which are more
prevalent in Kerala than other parts of India, including chronic calcific pancreatitis, multinodular goitre, endomyocardial fibrosis and
mucoid vasculopathy. It is the only facility that screens newborns for genetic disorders in the state.
Distribution: In 2013, Terumo established a local sales subsidiary in India. Previously, Terumo conducted its sales in the Indian
market via distributors importing from its Dubai Branch. Terumo is also establishing a more timely logistics system with a new Indian
warehouse in Chennai.
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Medical Devices Multinational Activity

India is a strong base for the leading multinational companies. Some have set up local manufacturing bases, but nearly all have
established local offices and a growing number are undertaking R&D tailored to the local market. Major multinationals with no
manufacturing presence are listed below with their respective representation in the market.
Abbott
Overview: Abbott has been active in India since 1910. Abbott India headquartered in Mumbai was founded in 1944 and is listed on
the Bombay stock exchange. This subsidiary operates primarily as a pharmaceuticals business with pharmaceutical manufacturing
plants in Goa and Himachal Pradesh. Abbott India has around 3,500 employees.
Divestiture: In February 2017, Abbott completed the USD4.3bn sale of Abbott Medical Optics (AMO) to Johnson & Johnson.
Acquisitions: In January 2019, Abbott announced the purchase of Cephea Valve Technologies. In October 2017, Abbott closed the
USD5.3bn acquisition of Alere, which has strengthened Abbott's position in the point-of-care diagnostic market. In January 2017,
Abbott completed the USD25bn acquisition of St Jude Medical, which has positioned Abbott No. 1 or 2 across large and high-
growth cardiovascular device markets.
Product Portfolio: Medical Devices is one of the four main businesses that comprise Abbott. The Medical Devices business
focuses on Cardiovascular & Neuromodulation and Diabetes Care. The Cardiovascular & Neuromodulation product lines are
Rhythm Management, Electrophysiology, Heart Failure, Vascular, Structural Heart and Neuromodulation.
Boston Scientific
Overview: Boston Scientific India is headquartered in DLF Cyber City, Gurgaon, Haryana state. Boston Scientific is investing
significantly in its direct presence in India and undertakes distribution of its own products. Previously products were distributed by
Trivitron Healthcare.
Acquisitions: In June 2019, Boston Scientific closed the USD465mn acquisition of US-based Vertiflex. In March 2019, BTG
shareholders approved the USD4.2bn Boston Scientific’s acquisition of UK-based BTG. In January 2019, Boston Scientific completed
the USD325mn acquisition of Millipede. In 2018, acquisitions included Augmenix, Claret Medical, Cryterion Medical, NxThera,
nVision Medical and Veniti. In 2017, Boston Scientific acquired Apama Medical and Symetis. The USD1.6bn acquisition of the AMS
portfolio in March 2015 was Boston Scientific's largest deal since the acquisition of Guidant in 2006.
Product Portfolio: Boston Scientific specialises in three product categories: Cardiovascular (Interventional Cardiology and
Peripheral Interventions), Rhythm Management (Cardiac Rhythm Management and Electrophysiology) and Medsurg (Endoscopy,
Urology & Pelvic Health and Neuromodulation).
R&D: In July 2016, Boston Scientific opened an R&D Centre at its headquarters in Gurgaon. The centre will develop cardiovascular
and cardiac rhythm management products including stents, catheters and pacemakers for emerging markets in Asia Pacific, Middle
East and Africa. Boston Scientific plans to launch products from this facility by 2017. The 100,000sq. ft. centre will also serve as a
global product engineering site and will incorporate an advanced training facility to educate physicians in the use of minimally-
invasive surgical techniques. This facility will form part of the company's network of Institutes for Advancing Science.
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Fresenius Medical Care
Overview: Fresenius Medical Care (FMC) has been represented on the Indian market through distributors since the 1990s. The
company's Indian subsidiary, Fresenius Medical Care India (FMCI) based in New Delhi, is relatively small, but growing rapidly with 326
employees in 2018. FMCI is planning to open manufacturing facilities for some products as volumes grow. The acquisition of Sandor
Nephro Services has increased the likelihood that FMC will invest in manufacturing facilities under the Make in India initiative.
Acquisition: In February 2019, FMC announced the completion of its USD2bn acquisition of NxStage Medical.
In 2016, FMC acquired an 85% stake in Sandor Nephro Services, which is the second-largest provider of dialysis treatment in India
with more than 50 dialysis clinics. The acquisition will strengthen FMC's dialysis services business in India. Sandor will operate as part
of FMC's Nephrocare business. FMCI opened its first dialysis clinic in Jalandhar, Punjab, as joint venture with the Shrinath Kidney
Centre in December 2012 and was aiming to have 30 dialysis clinics by 2017, representing an investment of INR600mn
(USD10.7mn).
Product Portfolio: FMC is one of the four business segments operated by Fresenius. It focuses on products for haemodialysis,
peritoneal dialysis, further home therapies, acute dialysis, other blood cleansing procedures and dialysis drugs.
Medtronic
Overview: Medtronic has been directly represented in India for nearly 30 years. India Medtronic is headquartered in Mumbai, with
nine regional offices in Delhi, Baroda, Ahmedabad, Kolkata, Hyderabad, Kochi, Bangalore, Chennai and Pune. Its business region
extends to other South Asian countries namely Bangladesh, Sri Lanka and Nepal. The company employs more than 350 people in
India and is supported by over 200 distributors who are trained by India Medtronic. Medtronic has expanded its activities in India
through the acquisition of Covidien, which was completed on January 26 2015. Covidien's operations in India are headquartered in
Gurgaon, Haryana state where the company's Indian subsidiary Covidien Healthcare India is based.
Divestiture: In July 2017, Medtronic completed the sale of its Patient Care, Deep Vein Thrombosis (Compression) and Nutritional
Insufficiency businesses within the Patient Monitoring & Recovery (PMR) division of its Minimally Invasive Therapies Group (MITG) to
Cardinal Health for USD6.1bn.
Acquisitions: In June 2019, Medtronic completed the acquisition of Titan Spine. In January 2019, Medtronic announced the
acquisition of US-based EPIX Therapeutics to expand its cardiac ablation portfolio. In December 2018, Medtronic completed the
USD1.7bn acquisition of Israel-based Mazor Robotics. In August 2016, Medtronic acquired HeartWare International for USD1.1bn. In
February 2016, Medtronic acquired Italian haemodialysis treatment company Bellco. Overall, Medtronic has strengthened its global
position following the USD50bn acquisition of Covidien in January 2015.
Product Portfolio: Medtronic operates four business groups: Cardiac and Vascular Group (CVG), Diabetes Group, Restorative
Therapies Group (RTG) and MITG which represents 90% of Covidien's revenues. Covidien's Peripheral Vascular business has been
integrated into CVG, while Covidien's Neurovascular business has been integrated into RTG.
R&D: In February 2012, Covidien opened its first R&D centre in India. Known as the Covidien India Engineering Centre, it is located
in the DLF Cybercity Special Economic Zone in Hyderabad, Andhra Pradesh state. The 40,000sq ft R&D centre develops products for
the local market, speeds up delivery times and provides a range of engineering services for the company's medical products
business. There were plans to employ up to 350 staff within two years.
In October 2013, Medtronic entered into a collaboration with Apollo Hospitals Enterprise to bring to market an affordable and
portable haemodialysis (HD) system in India to help improve access to care for end-stage renal disease (ESRD) patients who need
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renal replacement therapy (RRT). Medtronic intends to develop and manufacture key components of this system in India, with an
investment of more than INR1.5bn (USD26.7mn). For the first time, Medtronic is establishing an R&D team that will focus on design,
development and manufacturing of key components of the system in India. The commercial launch of the product is slated for
2016.
India Medtronic has also set up the Health Heart for All programme in collaboration with the Maitrika Foundation. The programme
aims to make high quality cardiac care more readily available through various initiatives, including public awareness programmes,
free heart check-ups and telemedicine screening, as well as innovative financing options to increase patient access to the
company's cardiac products.
In November 2014, Medtronic announced that was partnering with CARE Hospitals to set up heart failure clinics for the prevention
and management of Congestive Heart Failure. The clinics will be set up by Medtronic's Healthcare Solutions division, which
collaborates with hospitals to improve the quality and efficiency of their service delivery, while ensuring affordable access to the
latest technologies and treatment options. It forms part of the company's drive to expand beyond medical devices into healthcare
services and solutions.
Stryker
Overview: Stryker India was incorporated in 2001 with a representative office in New Delhi.
Acquisitions: In November 2019, Stryker announced the USD5.4bn acquisition of US-based Wright Medical Group. In October
2019, Stryker completed the acquisition of US-based Mobius Imaging and its sister company Cardan Robotics for USD500mn. In
August 2019, Stryker announced the acquisition of TSO3, a Canadian-based company specialising in sterilisation technology for
medical devices for USD52mn. In March 2019, Stryker completed the acquisition of Israel-based OrthoSpace. In February 2019,
Stryker completed the purchase of US-based Arrinex. In 2018, key acquisitions included Entellus Medical, Hygia Health Services,
HyperBranch Medical Technology, Invuity, K2M and SafeAir. In 2017, Stryker completed the acquisition of Novadaq.
Product Portfolio: Stryker operates three main divisions: Orthopaedics, MedSurg and Neurotechnology & Spine. Orthopaedics
includes products such as hips, knees, robotics, trauma & extremities including foot & ankle, and orthobiologics & biosurgery.
MedSurg includes instruments (bone-cutting & surgical accessories and computer-assisted surgery), endoscopy (minimally invasive
surgical solutions and integration and connectivity), sports medicine, medical (beds, stretchers and emergency medical services
equipment) and sustainability solutions (reprocessing and remanufacturing). Neurotechnology and Spine includes spinal implants
and interventional spine products, neurovascular, neuro powered instruments and craniomaxillofacial products.
R&D: In 2006, Stryker opened an R&D centre at Gurgaon, Haryana state, which subsequently became the company's first Global
Technology Centre in the Asia Pacific region. The centre conducts R&D in all nine areas that the company operates, including joint
replacement, spine applications, neurological, endoscopic, communications and digital imaging systems. The Centre also operates
as a training centre for Indian surgeons and engineers. The centre employs over 250 staff.
Zimmer Biomet
Overview: Zimmer India was set up in 2005 and is headquartered in Gurgaon, Haryana state. Biomet Orthopaedic India is based in
Mumbai.
Product Portfolio: Zimmer Biomet focuses on six business areas: Knees; Hips; Surgical, Sports Medicine, Foot and Ankle,
Extremities and Trauma; Dental; Spine & Craniomaxillofacial; and Other.
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Strategic Partnership: In November 2016, Zimmer Biomet announced that IUIH had chosen the company as its preferred
orthopaedic partner to provide quality, affordable musculoskeletal healthcare for approximately 400mn people in India over the
next 20 years through IUIH's 11 Medicities to be created in major states across the country. The efficiencies created through the
long-term partnership are expected to significantly contribute to the delivery of affordable care in India by reducing the total cost of
orthopaedic care by approximately 25%. As part of the deal, Zimmer will supply large joint implants, trauma products and small
fixation devices for replacement surgery. The company has made an equity investment in UK Global Healthcare Limited, the parent
organisation for IUIH.
The partnership extends an initial collaboration with IUIH under which Zimmer Biomet committed to establishing a Zimmer Biomet
Institute of India medical training and education facility on the campus of King's College Hospital in Amaravati, Andhra Pradesh. The
Institute will train over 1,000 orthopaedic surgeons per year, with the curriculum including the effective use of Zimmer Biomet's
medical technologies. The company estimates it will invest over USD5mn in the King's College Hospital training and education
centre over three years, beginning in 2017. Since launching the inaugural Indian Zimmer Biomet Institute in 2008, it has trained
approximately 7,000 medical professionals.
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Medical Devices Market Access
Market Environment
Geographically, the country is vast, covering 3.3bn sq km and plagued by natural disasters. Hindu is the most widely spoken
language and the primary language of around 40% of the population, but English is the predominant language of both government
and commerce.
Administrative Divisions
India is a federal republic, consisting of 29 self-governing states and seven Union Territories. The administrative divisions can be
grouped into five regions: North, North-East, East, West and South. Generally speaking, the South and West regions are more
developed than regions in the North and East, but even within regions, there is considerable disparity in development. Around a
third of the population is urbanised, the major cities being the capital New Delhi with a population of 21.7mn, Mumbai (19.7mn),
Kolkata (15.3mn), Chennai (7.4mn) and Banglalore (7.1mn). Emerging cities include Ahmedabad, Chandigarh, Jaipur, Nagpur and
Pune to name but a few.
Infrastructure
The country's infrastructure has struggled to keep pace with economic development and lags behind countries like Hong Kong,
Singapore and Thailand in terms of logistics. Although India has one of the most extensive road networks in the world, much of this
network is not up to Western standards and only about a quarter of rail networks are electrified. Although India is moving forward
with a plan to turn 12 of the country's main harbours into integrated freight hubs, many of these lack the necessary rail and road
connections to handle the volume of container ships, meaning considerable investment in infrastructure will be needed to bring
the country up to developed world standards. In the meantime, poor infrastructure results in high transport costs.
Business Environment
India is one of the countries showing the most improvement in its business environment, having jumped 23 places to 77 in the
2019 edition of the World Bank's Doing Business report. Under its National Trade Facilitation Action Plan 2017-2020, India has
implemented several initiatives that have improved the efficiency of cross-border trade, reducing border and documentary
compliance time for both exports and imports. Other recent reforms include streamlining of the business incorporation process,
simplification of the tax regime and an easing of labour market regulations. Despite the improvement, India still trails behind South
East Asian economies such as Singapore, Thailand, Malaysia, Vietnam and Indonesia. Prime Minister Narendra Modi aims to take
India into the top 50 and this will require further reforms including revised tax rules and changes to land acquisition and labour
regulations. The 2019 Fiscal Budget proposed to reduce corporate tax to 25% from 30% for companies that have an annual
turnover of up to INR4.0bn (USD57mn).
Distribution
Companies serving the Indian medical market are increasingly setting up branch offices to liaise with potential clients, while the
larger multinationals have established local subsidiaries. The other main option is to appoint an agent or distributor. However, the
sheer size of the market requires a regional approach with multiple offices or agents needed to ensure the appropriate level of
representation within each region.
Medical devices are mainly imported via Indian distributors, or the subsidiaries of multinational companies. Potential exporters to
India need to appoint a local agent, or indeed several, dependent on the areas they intend to cover. Private hospitals and medical
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laboratories do not directly import medical equipment, but source it through agents or distributors. The distributor or agent benefits
hospitals by acting as a single contact for numerous items and can provide information from various countries.
Trade Agreements
The Indian government has become increasingly proactive in pursuing free trade agreements (FTAs) with major trade blocs and
global trade hubs - including the Common Market of the South (Mercosur), the Association of Southeast Asian Nations (ASEAN),
Japan and South Korea - while negotiations with China and the EU are underway. This improves the ease of trading with large
markets and key trade hubs, by lowering tariffs and other barriers to trade. FTAs have not yet been signed with some major trade
partners, including China and Gulf Cooperation Council (GCC) states, and tariffs and other barriers remain significant for trade with
these countries. FTAs with a moderate to high business impact are listed below:
• The Bay of Bengal Initiative for Multi-Sectoral, Technical and Economic Cooperation (BIMSTEC) was formed in June
1997 through the Bangkok Declaration. The objective of the alliance is to accelerate economic growth and social progress
among BIMSTEC members through collaboration and mutual assistance in areas of common interest. Areas of cooperation
include trade & investment, technology, energy, transport & communication, tourism, fisheries, agriculture, culture, environment
& disaster management, public health, people to people contact, poverty alleviation, counter-terrorism & transnational crime,
and climate change. The seven members of BIMSTEC are Bangladesh, Bhutan, India, Myanmar, Nepal, Sri Lanka and Thailand.
• The South Asian Free Trade Area (SAFTA) is the free trade arrangement of the South Asian Association for Regional
Cooperation (SAARC). It promotes and enhances mutual trade and economic cooperation among its member states, through
the exchange of concessions. SAFTA came into force in 2006, when the foreign ministers of the member states signed a
framework agreement to reduce the customs duties of all traded goods to 0-5% by 2016. SAFTA comprises eight members,
namely Afghanistan, Bangladesh, Bhutan, India, the Maldives, Nepal, Pakistan and Sri Lanka.
• The India-ASEAN Free Trade Area (AIFTA) was signed in August 2009 and came into force in 2010. The agreement will
gradually eliminate tariffs on 75% of traded goods over 10 years.
• India-South Korea Comprehensive Economic Partnership Agreement (IKCEPA) was signed in August 2009 and came
into force in January 2010. The agreement will gradually eliminate tariffs on trade goods over nine years, harmonise regulations,
liberalise trade in services, ease restrictions on foreign direct investments and increase bilateral cooperation in various sectors
including health and science and technology.
• India Mercosur Preferential Trade Agreement (India-Mercosur PTA) took effect in 2009. It is a limited free trade agreement
between India and the Mercosur bloc comprising Argentina, Brazil, Paraguay and Uruguay. The PTA is currently limited to 450
products but the two sides are in negotiation to increase this to around 3,000 products and to increase the margin of preference
as a further step towards establishing a full free trade area between the signatories. The move is in line with India’s aim of
strengthening ties with the Latin American region to diversify its trade beyond the EU and the US.
• India-Japan Comprehensive Economic Partnership Agreement (JICEPA) was signed in February 2011 and came into force
in August 2011. It will gradually eliminate tariffs on more than 90% of traded goods over 10 years, harmonise regulations,
liberalise trade in services, ease restrictions on foreign direct investments and increase bilateral co-operation in various sectors
including health and science and technology.
• In November 2019, India announced its withdrawal from the Regional Comprehensive Economic Partnership (RCEP).
Expectations had been for negotiations to conclude in 2019, paving the way for the agreement to enter force by late 2020. RCEP
negotiations without India may now be concluded in 2020, but the withdrawal of India represents a setback to attempts to
counter the growing wave of protectionism in the US and other parts of the world. RCEP will have broader and deeper
engagement with significant improvements over existing regional FTAs and agreement will need to be reached on politically
sensitive issues, including trade in services, investment rules and protection for intellectual property rights, as well as tariffs,
where the target is to remove trade barriers on at least 92% of products within 10 years. Formally launched in 2012, RCEP is a
China and ASEAN-led project that, before the withdrawal of India, involved 16 countries, namely the 10 ASEAN countries and the
ASEAN Free Trade Partners (Australia, China, India, Japan, South Korea and New Zealand). It would have been the world’s largest
trade pact covering nearly half the world’s population, one third of global GDP and around 29% of global trade.
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Trade Associations
• The Association of Indian Medical Device industry (AIMED) was set up in 2009 to represent the views of the entire medical
devices industry from a single platform. The association represents the interests of over 700 manufacturers covering all types of
medical devices from consumables and disposables to diagnostic equipment and implants. The association is based in New
Delhi, www.aimedindia.com
• The Medical Disposable Manufacturers' Association (MDMA) was set up in 1990 in Ahmedabad, Gujarat. It has over 40 members
supplying to central government for tender supply, other local markets and export markets. According to MDMA, its members,
which are small- and medium-sized manufacturing units in Gujarat, contribute approximately 60% of the country's production
and requirements of medical disposable products, such as IV and blood transfusion sets.
• The Medical Surgical And Healthcare Industry Trade Association (MSAHITA) represents traders, manufacturers, exporters,
importers and multinationals specialised in medical and surgical products.
• The Medical Technology Association of India (MTaI) is an association of research-based medical technology companies with
R&D / manufacturing investments in India, which was set up in 2016. Founding members include Boston Scientific, C R Bard,
Johnson & Johnson, Smith & Nephew, Terumo and Vygon. MTaI is based in Gurgaon, Haryana, www.mtaiindia.org
Trade Show
• Medical Fair India, an annual event focusing on diagnostics, medical equipment and medical technology, was held in Mumbai
on March 5-7 2020. Further information and future dates can be accessed at http://www.medicalfair-india.com
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Medical Devices Methodology

Forecast Methodology
Fitch Solutions uses a wide definition of a medical device, similar to that used by the US FDA or EU EMA. In short, we define it as any
piece of equipment or apparatus used to treat or diagnose an illness that comes into direct contact with the patient.
Pharmaceuticals, IV diagnostics and laboratory equipment are not within the scope of our forecasts.
We have estimated national markets at ex-factory prices for the historical period in current local and USD terms. We have calculated
the markets using a trade-based approach, looking at imports, and then adding in domestic production, minus any exports. We have
sourced import and export data from national customs authorities, as compiled by the International Trade Centre (ITC).
We have estimated production data, considering factors such as the value of exports, taking into account re-exports, the known
presence of local and multinational manufacturers, sales data when available, and officially published estimates of production, again
when available.
We have forecast national markets at ex-factory prices for the forward period. First, we have calculated growth rates in local currency
terms for each product category using a linear regression method, and then converted the figures back to USD terms, using
average exchange rate projections.
We have calculated growth rates by looking at a number of factors: macroeconomic performance (private and government final
consumption), demographic and epidemiological trends, healthcare trends and expenditure levels, medical device trade trends and
medical device manufacturing size.
Trade Code Classifications
International trade is universally classified according to the Harmonised System (HS). This began to be used in the 1990s and is
overseen by the World Customs Organization. Medical devices are generally well-defined in the HS. There is one major code,
HS9018, named Medical Equipment, but there are a number of other codes for products with a specifically medical use. For the
majority of markets, it is not possible to provide a more detailed breakdown than this.
We have rearranged the data from their original code order to create six major product areas: Consumables, Diagnostic Imaging,
Dental Products, Orthopaedics & Prosthetics, Patient Aids and Other Medical Devices. We have sub-divided these into categories
and sub-categories. We have used them to analyse medical device market and trade data. Their relation to the trade codes is shown
on the following table.
REARRANGED HS TRADE CODES

Code Product
CONSUMABLES
BANDAGES & DRESSINGS
'300510 Medical dressings (adhesive)
'300590 Medical dressings (non-adhesive)
'300610 SUTURING MATERIALS
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Code Product
SYRINGES, NEEDLES & CATHETERS
'901831 Syringes (with/without needles)
'901832 Tubular metal needles/needles for sutures
'901839 Other needles, catheters, cannulae, etc
OTHER CONSUMABLES
'300620 Blood-grouping reagents
'300650 First-aid boxes & kits
'300691 Ostomy products
'401511 Surgical gloves
DIAGNOSTIC IMAGING
ELECTRODIAGNOSTIC APPARATUS
'901811 Electrocardiographs
'901812 Ultrasound
'901813 MRI
'901814 Scintigraphic apparatus
'901819 Other electrodiagnostic apparatus
RADIATION APPARATUS
'902212 CT scanners
'902214 Other medical x-ray apparatus
'902221 A, B, C ray apparatus
IMAGING PARTS & ACCESSORIES
'300630 Contrast media
'370110 Medical X-ray film (flat)
'370210 Medical X-ray film (rolled)
'902230 X-ray tubes
'902290 Other imaging parts & accessories
DENTAL PRODUCTS
CAPITAL EQUIPMENT
'901841 Dental drills
'940210 Dental chairs
'902213 Dental X-ray
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Code Product
INSTRUMENTS & SUPPLIES
'300640 Dental cements
'901849 Dental instruments
Teeth & other fittings
'902121 Artificial teeth
'902129 Other dental fittings
ORTHOPAEDICS & PROSTHETICS
'902110 FIXATION DEVICES
'902131 ARTIFICIAL JOINTS
'902139 OTHER ARTIFICIAL BODY PARTS
PATIENT AIDS
PORTABLE AIDS
'902140 Hearing aids
'902150 Pacemakers
'902190 Other portable aids
THERAPEUTIC APPLIANCES
'901910 Mechano-therapy apparatus
'901920 Therapeutic respiration apparatus
OTHER MEDICAL DEVICES
WHEELCHAIRS
'871310 Wheelchairs, not mechanically propelled
'871390 Wheelchairs, mechanically propelled
'901850 OPHTHALMIC INSTRUMENTS
'940290 HOSPITAL FURNITURE
'841920 MEDICAL, SURGICAL STERILISERS
'901820 ULTRA-VIOLET OR INFRA-RED RAY APPARATUS
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Code Product
'901890 OTHER INSTRUMENTS & APPLIANCES
10 digit Blood pressure monitors
10 digit Endoscopy apparatus
10 digit Dialysis apparatus
10 digit Transfusion apparatus
10 digit Anaesthetic apparatus & instruments
Sources
We have sourced historical and forecast political, macroeconomic, demographic and healthcare data, where indicated, from Fitch
Solutions.
We have analysed the medical device markets using, where possible, primary qualitative and quantitative data from local sources.
These include:
• national ministries (or departments) of health

• national statistical institutes
• national medical device trade associations
• national and multinational medical device companies
We may also make reference to a number of secondary sources, such as those listed below:
• Eurostat, http://epp.eurostat.ec.europa.eu/portal/page/portal/eurostat/home/
• Inter-American Development Bank (IDB), http://www.iadb.org
• International Trade Centre (ITC), http://www.intracen.org
• Organisation for Economic Co-operation and Development (OECD), http://www.oecd.org
• United Nations (UN), http://www.un.org
• World Bank (WB), http://www.worldbank.org
• World Customs Organization (WCO), http://www.wcoomd.org
• World Health Organization (WHO), http://www.who.org
• World Trade Organization (WTO), http://www.wto.org
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Risk/Reward Index Methodology
Our Medical Devices Risk/Reward Index (RRI) quantifies and ranks a market's attractiveness within the context of the medical
devices industry, based on the balance between the risks and rewards of entering and operating in different markets.
We combine industry-specific characteristics with broader economic, political and operational market characteristics. We weight
these inputs in terms of their importance to investor decision-making in a given industry. The result is a nuanced and accurate
reflection of the realities facing investors in terms of: 1) the balance between opportunities and risks, and 2) between sector-specific
and broader market traits. This enables users of the index to assess a market's attractiveness in a regional and global context.
The index uses a combination of our proprietary forecasts and analyst assessment of the regulatory climate. As regulations evolve
and forecasts change, so the index scores change providing a highly dynamic and forward-looking result.
The Medical Devices RRI universe comprises 75 markets.
Benefits Of Using Fitch Solutions' Medical Devices RRI
• Global Index: One global table, ranking all the markets in Fitch Solutions' universe for medical devices from least (closest to zero)
to most attractive (closest to 100).
• Accessibility: Easily accessible, top-down view of the global, regional or sub-regional risk/reward profiles.
• Comparability: Identical methodology across 75 markets for medical devices allows users to build lists of markets they wish to
compare, beyond the confines of a global or regional grouping.
• Scoring: Scores out of 100 with a wide distribution provide nuanced investment comparisons. The higher the score, the more
favourable the profile.
• Quantification: Quantifies the rewards and eisks of doing business in the medical devices industry in different markets around
the world and helps identify specific flashpoints in the overall business environment.
• Comprehensiveness: Comprehensive set of indicators, assessing industry-specific rewards and risks alongside political, economic
and operating risks.
• Entry Point: A starting point to assess the outlook for the medical devices industry, from which users can dive into more granular
forecasts and analysis to gain a deeper understanding of the market.
• Balance: Multi-indicator structure prevents outliers and extremes from distorting final scores and rankings.
• Methodology: It is a combination of proprietary Fitch Solutions forecasts, analyst insights and globally acceptable benchmark
indicators (for example, Transparency International's Corruption Perceptions Index).
fitchsolutions.com
Weightings Of Categories And Indicators
Source: Fitch Solutions
The RRI matrix divides into two distinct categories:
Rewards
Evaluation of an Industry's size and growth potential (Industry Rewards), and macro industry and/or market characteristics that
directly impact on the size of business opportunities in a specific industry (Country Rewards).
Risks
Evaluation of micro, industry-specific characteristics, crucial for an industry to develop to its potential (Industry Risks) and a
quantifiable assessment of the political, economic and operational profile (Country Risks).
Assessing Our Weightings
Our matrix is deliberately overweight on Rewards (70% of the final RRI score for a market) and within that, the Industry Rewards
segment (60% of final Rewards score). This is to reflect the fact that when it comes to long-term investment potential, industry size
and growth potential carry the most weight in indicating opportunities, with other structural factors (demographic, labour statistics
and infrastructure availability) weighing in, but to a slightly lesser extent. In addition, our focus and expertise in emerging and frontier
markets has dictated this bias towards industry size and growth to ensure we are able to identify opportunities in markets where
regulatory frameworks are not as developed and industry sizes not as big (in USD terms) as in developed markets, but where we
know there is a strong desire to invest.
fitchsolutions.com
MEDICAL DEVICE RRI INDICATORS - EXPLANATION AND SOURCES

Indicator Rationale Source
REWARDS
Industry Rewards
Denotes breadth of the medical device market. Larger markets score higher than smaller Fitch Solutions
Sales, USDmn
ones. Forecast
Sales Per Capita, Denotes depth of the medical device market. High value markets score higher than low Fitch Solutions
USD value ones. Forecast
5 Year CAGR, Denotes the projected performance of the medical device market. Markets with higher Fitch Solutions
USDmn CAGRs score better than those with lower CAGRs. Forecast
Denotes medical device production within the medical device market. Markets with larger Fitch Solutions
Production, %
production capabilities score better than those with lower production capabilities. Forecast
Country Rewards
Evaluates medical device demand associated to population size. Larger populations score Fitch Solutions
Population, mn
higher. Forecast
Evaluates long-term prospects associated to population growth. Fast-growing populations Fitch Solutions
Population, % y-o-y
suggest better long-term growth across the medical device industry and score higher. Forecast
Evaluates proportion of the population 65+ as an expenditure ratio. Ageing populations tend Fitch Solutions
65+ Years, %
to have higher per capita medical device expenditure and score higher. Forecast
Evaluates urbanisation as a proxy for development of medical facilities. Predominantly Fitch Solutions
Urban Population, %
urbanised markets score higher than rural markets. Forecast
RISKS
Industry Risks
Evaluates health policies, health insurance coverage, health expenditure and access to
Fitch Solutions
Healthcare Access health resources, activity and personnel. Markets with a good healthcare access score
Subjective Indicator
higher.
Evaluates the strength of the competent authority, national regulations and regulations Fitch Solutions
Regulation
aligned regionally, if existing. Markets with a strong regulation score higher. Subjective Indicator
Evaluates the level of government spending on medical devices and the attractiveness of
Fitch Solutions
P&R P&R policies. Markets with good government spending and friendly P&R policies score
Subjective Indicator
higher.
Country Risks
Takes into account the structural characteristics of economic growth, the labour market,
Long-Term Fitch Solutions
price stability, exchange rate stability and the sustainability of the balance of payments, as
Economic Risk Index Country Risk Index
well as fiscal and external debt outlooks for the coming decade.
Seeks to define current vulnerabilities and assess real GDP growth, inflation,
Short-Term Fitch Solutions
unemployment, exchange rate fluctuation, balance of payments dynamics, as well as fiscal
Economic Risk Index Country Risk Index
and external debt credentials over the coming two years.
Assesses structural political characteristics based on our assumption that liberal,

Long-Term Political Fitch Solutions
democratic markets with no sectarian tensions and broad-based income equality exhibit the
Risk Index Country Risk Index
strongest characteristics in favour of political stability, over a multi-year time frame.
Short-Term Political Assesses pertinent political risks to investment climate stability over a shorter time frame, Fitch Solutions
Risk Index up to 24 months forward. Country Risk Index
fitchsolutions.com
Indicator Rationale Source
Focuses on existing conditions relating to four main risk areas: Labour Market, Trade & Fitch Solutions
Operational Risk
Investment, Logistics, and Crime & Security. Operational Risk Index
Source: Fitch Solutions
fitchsolutions.com
Fit
Fitch
ch Solutions, 30 North C
Colonnade
olonnade,, Canary W
Wharf
harf,, L
London.
ondon. E14 5GN, UK
Tel: +44 (0)20 7248 0468
Fax: +44 (0)20 7248 0467
Web: www.fitchsolutions.com
IS SN: 2053-8243
ISSN:
Copy Deadline: October 2021

opy
© 20
2021
21 Fit
Fitch
ch Solutions Gr
Group
oup Limit
Limited.
ed. All rights rreserv
eserved.
ed.
All information, analysis, forecasts and data provided by Fitch Solutions Group Limited is for the exclusive use of subscribing persons or organisations (including those
using the service on a trial basis). All such content is copyrighted in the name of Fitch Solutions Group Limited and as such no part of this content may be reproduced,
repackaged, copied or redistributed without the express consent of Fitch Solutions Group Limited.
All content, including forecasts, analysis and opinion, has been based on information and sources believed to be accurate and reliable at the time of publishing. Fitch
Solutions Group Limited makes no representation of warranty of any kind as to the accuracy or completeness of any information provided, and accepts no liability
whatsoever for any loss or damage resulting from opinion, errors, inaccuracies or omissions affecting any part of the content.
This report from Fitch Solutions Country Risk & Industry Research is a product of Fitch Solutions Group Ltd, UK Company registration number 08789939 (‘FSG’). FSG is an
affiliate of Fitch Ratings Inc. (‘Fitch Ratings’). FSG is solely responsible for the content of this report, without any input from Fitch Ratings. Copyright © 2021 Fitch Solutions
Group Limited.


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Industry Risk/Reward Index ....................................................................................................................................................45

Industry Trends And Developments .....................................................................................................................................65

Regulatory Development ..........................................................................................................................................................67

Medical Devices Pricing And Reimbursement................................................................................................................................................................74

Medical Devices Methodology.............................................................................................................................................. 108

INDIA - PROJECTED MEDICAL DEVICE MARKET (2020-2025)

2020 2021f 2022f 2023f 2024f 2025f

Total (USDmn) 4,170.8 4,929.4 4,703.6 5,159.5 5,596.0 5,945.2

Per Capita (USD) 3.0 3.6 3.4 3.6 3.9 4.1

Per Capita (Local

f = Fitch Solutions forecast. Source: National Statistics, Fitch Solutions

Latest Updates And Key Forecasts

India Medical Devices Covid-19 Impact

Weaknesses • Large coalition government complicates policymaking.

Medical Device Market, Local Currency

f = Fitch Solutions forecast. Source: National Statistics, Fitch Solutions

Medical Device Market, US Dollar

f = Fitch Solutions forecast. Source: National Statistics, Fitch Solutions

The market will benefit from key drivers:

The market will be constrained by:

INDIA - MEDICAL DEVICE MARKET BY PRODUCT AREA, 2015-2025 (USDMN)

f = Fitch Solutions forecast. Source: National Statistics, Fitch Solutions

Consumables Market, Local Currency

f = Fitch Solutions forecast. Source: National Statistics, Fitch Solutions

Consumables Market, US Dollar

e/f = Fitch Solutions estimate/forecast. Source: National Statistics, Fitch Solutions

Bandages & Dressings

Syringes, Needles & Catheters

INDIA - CONSUMABLES MARKET, 2015-2025 (USDMN)

Medical dressings (non-

SYRINGES, NEEDLES &

Tubular metal needles/needles

Other needles, catheters,

f = Fitch Solutions forecast. Source: National Statistics, Fitch Solutions

Diagnostic Imaging Forecast

Diagnostic Imaging Market, Local Currency

f = Fitch Solutions forecast. Source: National Statistics, Fitch Solutions

Diagnostic Imaging Market, US Dollar

f = Fitch Solutions forecast. Source: National Statistics, Fitch Solutions

Imaging Parts & Accessories

INDIA - DIAGNOSTIC IMAGING MARKET, 2015-2025 (USDMN)

Other imaging parts &

f = Fitch Solutions forecast. Source: National Statistics, Fitch Solutions

Dental Products Market, Local Currency

f = Fitch Solutions forecast. Source: National Statistics, Fitch Solutions

Dental Products Market, US Dollar

f = Fitch Solutions forecast. Source: National Statistics, Fitch Solutions

Instruments & Supplies

INDIA - DENTAL PRODUCTS MARKET, 2015-2025 (USDMN)

f = Fitch Solutions forecast. Source: National Statistics, Fitch Solutions

Orthopaedics & Prosthetics Forecast

Orthopaedics & Prosthetics Market, Local Currency

f = Fitch Solutions forecast. Source: National Statistics, Fitch Solutions

Orthopaedics & Prosthetics Market, US Dollar

f = Fitch Solutions forecast. Source: National Statistics, Fitch Solutions

Other Artificial Body Parts

INDIA - ORTHOPAEDICS & PROSTHETICS MARKET, 2015-2025 (USDMN)

f = Fitch Solutions forecast. Source: National Statistics, Fitch Solutions

Patient Aids Forecast

Patient Aids Market, Local Currency

f = Fitch Solutions forecast. Source: National Statistics, Fitch Solutions