The Indian Medical Devices Market
The Indian Medical Devices Market
The Indian Medical Devices Market
TH E M T
M A R K E
E V I C E S
D
I N D I A
IN
FLANDERS INVESTMENT & TRADE MARKET SURVEY
THE INDIAN MEDICAL DEVICES
MARKET
Juli 2018
1
1 OVERVIEW OF HEALTHCARE SECTOR IN INDIA
The Indian healthcare sector is one of the fastest growing industry and one of India’s largest
sector - both in terms of revenue and employment. The total industry size is expected to touch
USD 280 billion by 2020.1 Healthcare comprises of hospitals, medical devices, clinical trials,
outsourcing, telemedicine, medical tourism, health insurance and medical equipment. “The
growing demand for quality healthcare in India and the absence of matching delivery mechanisms
poses a great challenge to all stake holders and an even greater opportunity for different service
providers”.2 As there exists immense scope for enhancing healthcare services penetration in India,
it presents ample opportunity for development of the healthcare industry.3
The demand for healthcare services, in India will get a major boost owing to:
Increasing income levels
ageing population
growing health awareness and
changing attitude towards preventive healthcare4
“Conducive policies for encouraging FDI, tax benefits, favourable government policies coupled
with promising growth prospects have helped the industry attract private equity, venture capitals
and foreign players”5.
The peculiar thing in India is the wide gap between the rural and urban population in its health
care system. “A staggering 70 per cent of the population still lives in rural areas and has no or
limited access to hospitals and clinics. Around 80 per cent of specialists live in urban areas”.6
Healthcare sector in India needs serious modernization. Due to lack of availability of proper
budget and funds from the Indian government, the Indian government-operated hospitals are
very inadequate in providing good medical treatment. The private sector saw an opportunity in
this segment and has taken initiatives to provide modern and efficient medical treatment – but
at a certain price. The private sector has a strong presence in India’s healthcare.
“The public health care system is patchy, with underfunded and overcrowded hospitals and clinics,
and inadequate rural coverage. Several public health insurance systems exist, such as state-level
employee insurance for industrial workers and the central government’s health care plan for civil
servants”. 7
A major thrust area is to extend employee coverage in private sector through economical health
plans.
2
1.1 NATIONAL HEALTH POLICY
The Indian government has announced a new Health Policy called the “National Health Policy –
NHP – 2017”. The policy focuses on the National Health Mission by systematically rectifying the
prevalent deficiencies. The policy is ‘inclusive’ to the masses. Thus far, the government employees
were covered by the Central and State government health schemes. The employers of organized
private sector provided the “medical insurance” to cover the medical expenses of the workers and
their family members.
Now, the Indian government would tie-up with the insurance companies and the third-party
administrators (TPAs) by allocating budget for this purpose. Under this scheme, private hospitals
will be extending health services to everyone – and not limited to the riches.
Under NHP, the Indian government is also laying a lot of emphasis on the Make in India policy to
manufacture substantial number of medical devices in India to usher in import substitution which
is almost 70% as of 2017. Since the requirement of medical devices will be huge, it is unlikely that
so much private investments will flow in for manufacture in India. Import of medical devices will
have to be continued to meet the increasing demand for medical devices.
More details about the policy can be obtained from the link below.
http://cdsco.nic.in/writereaddata/National-Health-Policy.pdf as seen on 24.05.2018
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3 MEDICAL DEVICE MARKET IN INDIA
“The medical device market in India is certainly smaller than the other overseas markets”.8
Considering the large size of the country and its huge population, large potential in this segment
is apparent but the will power in the Indian government to give greater importance to the
healthcare sector is lacking. The demand certainly is huge in the private sector.
“The Indian market is currently growing at a healthy CAGR of around 15%, significantly higher
than global industry growth of 4-6%, most recent studies indicate that medical devices
expected to be a USD 25-30 billion industry in India by 2025”.9
According to estimates by Association of Indian Medical Device Industry (AIMED) 70% of the
devices are imported.
The following table shows the basic classification and their share of imports in the medical device
sector.
Imported Items
Share in Medical
Devices
Reagents Implants
Source: Recommendation of task force on medical device sector in India-2015 as seen on 22.12.2017
“The Indian market is dominated by international players such as 3M, Abbott Vascular, GE Health
Care, Phillips Health Care, Medtronic, Johnson & Johnson, Siemens, Baxte, Stryker, Zimmer Holdings
and many more. The Indian Medical Devices sector is now welcoming the international companies
to set up manufacturing base by either direct investment or by acquiring existing players. Recently,
direct setups were by 3M in Pune, Becton Dickinson's in Haryana, Hollister in India and Philips’s
acquisition of Medtronics & Alpha X-Ray Technologies”.10 Government of India is encouraging
8
http://www.skpgroup.com/data/resource/skp_the_medical_device_industry_in_india_.pdf as seen on 26.04.2018
9
https://gita.org.in/Attachments/Reports/Medical%20Devices%20Making%20in%20India%20-
%20A%20Leap%20for%20Indian%20Healthcare.pdf as seen on 26.04.2018
10
http://ficci.in/sector/76/Project_docs/Medical_Devices_and_Equipment_Sector_profile.pdf as seen on 26.04.2018
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domestic manufacturing of medical equipment by proposing Medical Technology Parks, in
addition to the existing parks.
“Most Indian players consist of small and medium companies primarily focusing on their R&D
efforts and manufacturing capabilities for affordable medical devices such as disposables, medical
supplies and small equipment - which come under low-price, high-volume market segments.”11 The
requirement for high-end medical equipment and consumables is met largely by imports.
Over the past two years India has seen a major change in import figures for medical devices.
There has been an increasing trend of cheap medical devices imports from China. This is giving
competition to US and Germany particularly for stents and cardiac catheters.
Some Indian companies which are manufacturing these devices are also facing stiff competition
due to cheap imports from China. For more detail about imports from China please refer to the
article below.
http://timesofindia.indiatimes.com/business/india-business/domestic-med-devices-hit-by-cheap-
imports/articleshow/58920364.cms as seen on26.04.2018
Import statistics
Import
statistics_Medical Devices from Belgium.docx
The Indian government has identified the medical device sector as a sun shine sector for the Make
in India national initiative (http://www.makeinindia.com/about). The Indian medical device sector
is now open with tremendous opportunities for manufacturers of all sizes.
http://www.business-standard.com/content/b2b-pharma/india-can-be-among-world-s-top-5-medical-devices-
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5
Belgian companies in medical devices sector looking to explore the Indian market may initially
acquire/need a distributor to market their products. Whereas other companies may set
up/acquire a manufacturing plant, to take advantage of low-cost manufacturing for exports to
the neighbouring countries.
Vermeiren India Rehab Private Ltd., a wholly-owned subsidiary of Belgium-based Vermeiren Group,
has set up a manufacturing unit, with a localisation levels of around 50-60 % at present, in the
State of Andhra Pradesh, Sri City. The company has invested Rs. 400 Million for setting up the
plant and its current focus is to marketing the products at reasonable cost. The group is looking
at selling around 40,000 wheelchair units in India by 2020 and is planning to cater to Middle East,
Far East and European market in a phased manner over next five years. The company also has
plans to open a research and development (R&D) centre in the facility, which would work with
the global R&D team for both global products and also India specific projects.
The company selected Sri City for manufacturing considering its accessibility to various ports,
airports and national highways, apart from the proximity of the automobile hub in Chennai, which
can offer components. 12
While the large sized multinationals can afford Greenfield Investments or through brownfield the
new entrants or the smaller players may initially prefer entering alliances with domestic
companies and then scaling up eventually with direct investments. Ultimately the decision of
Greenfield entry, Brown field entry, Strategic alliance will depend on the Belgian firm’s global
strategy, market for Belgian company’s product portfolio in India, cost –benefit Analysis…etc.
India is currently dependent on imports (70-80%) for medical devices. Major portion of its import
is coming from the USA, followed by China. Other countries such as Germany, France, Japan, UK
and the others also have a share in it
It has been noticed that following areas in the medical field have scope for improvement and the
potential for the acquisition of better techniques and equipment for safe medical treatment.
Following are the areas in which potential exists:
• X-Ray equipment
• MRI imaging
• Medical scanning equipment, Diagnostic Kits, Hand- held diagnostic equipments
• Reagents
• Ultrasound
• Dentistry equipment
• Operation theatre equipment
• Equipment for physiotherapy & Pathology
• Products for orthopaedic treatment
• Equipment for eye surgery
• Equipment for ENT treatment and surgery
• Equipment for Neurology treatment and surgery
12
http://www.business-standard.com/article/companies/wheelchair-maker-vermeiren-to-expand-sales-in-india-
116091301070_1.html as seen on 20.12.2017
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• Products for the treatment of burns and post-injury skin treatment
• Hospital furniture (bedding, operation table, stretchers, storage cupboards for patients,)
• Anaesthetic equipment and products
• Ambulance with emergency medical attention facilities
• Equipment for dialysis, etc.
• Machinery for the manufacture of medicines and drugs
• Hand- held diagnostic equipments ( like blood sugar testing/ blood pressure testing..)
There are quite a few manufacturers of medical devices in India too – as India is now trying to
usher in “import substitution” as far as possible and make the cost of healthcare service affordable
to everyone through the supply of medical devices at reasonable costs. The efforts through “Make
in India” and “Start-up India” are in this direction. Though the Indian manufacturers of medical
devices are open to the idea of import and distribution.
MEDICAL TOURISM
Medical tourism has been gaining a lot of momentum in India from the past few years.
The main advantage of Medical Tourism in India is high quality healthcare standards, with low
treatment cost. Cost of surgery is one-tenth as compared to USA or Europe.
Secondly one gets opportunity to travel, get better and quicker treatment results than in their
home country. Some hospitals in India offer world-class facilities and Indian medics are renowned
for cosmetic surgery, Heart bypass surgery, dental care and coronary bypass. In the recent times,
the conventional Medicare such as Ayurveda is gaining acceptance. The most common surgical
procedure amongst international tourists in India is Kidney / Liver transplantation.
Many of the leading hospitals chains in India offers quality services and make use of advanced
technology, excellent medical services comparable to the developed world; coupled with
personalized care.
5 E-HEALTHCARE IN INDIA
India is on high adoption curve of online:
• medical consultation,
• medical records,
• medicine supply,
• pan-India exchange for patient information, etc.
The Ministry of Health and Family Welfare ( MOHFW) to support government in its digital drive
has taken initiative to and has a vision to deliver better health services in terms of access, quality
, affordability , efficient monitoring etc.
Details about the same are available in the following link.
https://www.nhp.gov.in/e-health-india_mty
There is enormous potential for improving the awareness about healthcare through digital media
and information technology.
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6 REGULATORY AUTHORITY IN INDIA
For long number of years, the regulatory task was undertaken by the “Drugs Controller General
of India”. As a result, all the medical related products (medical devices, pharmaceuticals,
consumables, etc.) came under the purview of “Drugs & Cosmetics Act – 1940 & Rules – 1945”. In
the year 2012, the “Central Drugs Standard Control Organization (CDSCO), was formed to control
and regulate the medical sector. Though the rules are being modified, the process is rather slow.
All issues related to registration, certification, labelling, etc. are being handled by the CDSCO.
At long last, the Indian government announced the “Medical Devices Rules 2017”. The rules
announced through this notification came into effect from 01 January 2018.
However, it should be noted that the “Medical Devices Rules 2017” have been announced with the
intention of going in for “import substitution” in gradual phases. Experts in the field of medical
healthcare opine that the Indian government will find it impossible to implement “import
substitution” as India is a very large country with a huge population and the requirement of
medical devices is huge. Through production of devices in India, the requirements will never be
met. Imports will remain an integral part of meeting the requirements. It is also felt that high
quantum of overseas investments and transfer of technology will not be coming into India for
manufacturing medical devices. Many companies will wish to hold on to their cutting edge in
high value technology and will not be interested in parting with it to India.
Other useful websites related to this subject are also given below:
• http://pib.nic.in/newsite/PrintRelease.aspx?relid=157955
• http://www.cdsco.nic.in/forms/list.aspx?lid=1580&Id=1
All the public-sector hospitals follow the system of calling for offers from suppliers through tender
procedure. After due comparison, the offer with most competitive price and matching quality
gains the order. The HSCC and AIIMS issue most number of tender notifications. Other public-
sector hospitals generally approach the Indian Ministry of Health and Family Welfare to arrange
for the supplies. Hence public tender notifications from the other public sector hospitals are not
seen in the website or in newspapers.
For private medical projects, direct negotiations can be undertaken for the supply of medical
equipment; whereas in the case of government medical projects, offers will have to be submitted
against international tender notifications issued by the Indian government entities.
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Private hospitals evaluate the products based on the technology, cost and price. Decision-making
is faster in the private hospitals.
Private hospitals make direct purchases usually keeping in view of the following points.
• Name and standing of the company, Companies like Siemens, Philips are well known
brands in India in Medical sector
• Local presence for easy contact
• Quality of the product and cost factor as India is a price sensitive market
• Availability of spare parts for machines and quick after-sales service in India
• “Upgrade” of the machines in lieu of purchase of new machines in short periods
The India Agent must maintain a drug store license (Forms 20B and 21B/C). The India Agent must
have relevant prior experience in the Medical Devices industry.
We have a dedicated person as ‘Customs Attache’ who can be approached for specific custom
related queries.
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List of devices which require registration in India?
Only certain products require registration in India, and most of these products are outlined in
the official List of Notified Medical Devices – See attached document for details:
Steps for
registration.docx
From 2018, medical device sector has been distinguished out from the pharmaceutical laws.
Automatic approval is granted on 100% FDI (Foreign Direct Investment) under both brownfield
and greenfield ventures.
The “Task Force” has also recommended preference to domestically manufactured medical devices
for government procurement. Additional preferences will also be given for medical devices
manufactured under the MSME (Micro, Small and Medium Enterprises).
Following eight key areas have been highlighted by the “Task Force” for special attention:
1. Policy Support
2. Infrastructure for the manufacture of medical devices
3. Creation of Validation Centre
4. Skill Development
5. Research & Development
6. Pricing Policy
7. Duty Structure – under this framework, the “Task Force” has recommended introduction
of a prohibition or stringent restrictions to stop the import of “second-hand diagnostic
equipment”.
8. Strong regulatory framework.
The aim of “Make in India” initiative is to gradually scale down the reliance on imported medical
devices through “import substitution”.
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The Indian Prime Minister, Mr. Narendra Modi, while addressing the oncologists in mid-2017 at the
Tata Memorial Hospital in Mumbai to mark 75 years of cancer treatment, invited “Start-up
Companies” to focus on research for innovative medical devices and use technology to make
healthcare more affordable. He emphasized that “India should manufacture its own medical
devices to bring down the cost of medical treatments”. Details are available in the website link of
the newspaper, Indian Express – Web: (Link).
“AMTZ ( Andhra Pradesh MedTech Zone) was incorporated in April 2016. AMTZ is an enterprise
under the Government of Andhra Pradesh, a 270 Acre zone, dedicated for Medical Device
Manufacturing. The objective behind this ‘One-Stop- Solution’ is not only to reduce the cost of
manufacturing up to 40% or to just simplify the end-to- end operations but also to reduce the
import dependency. AMTZ envisions to put India on the global map of high end medical equipment
production and make health care products affordable and accessible not only for India but for
world at large.
The creation of such a zone is based on the fact that medical devices manufacturing requires
certain high investment facilities which are too capital intensive for individual manufactures to
invest upon. The zone with in-house high investment scientific facilities would help manufacturers
reduce the cost of manufacturing by more than 40%-50%. Currently, due to lack of such centrally
located sharable facilities, either manufacturers do not undertake production of technologies
requiring them or send their products abroad for process up-gradation and value addition. While
the zone would have all such facilities in-house to reduce manufacturing process costs, it would
be in an area which is well connected with Railways, Roadways, Waterways and Airways with near
presence of Industrial Corridors, and Port to reduce logistical costs.”13
Information about make in India initiative particularly with reference to medical device is well
covered in the following report by Deloitte
https://gita.org.in/Attachments/Reports/Medical%20Devices%20Making%20in%20India%20-
%20A%20Leap%20for%20Indian%20Healthcare.pdf
13
https://amtz.in/ as seen on 26.04.2018
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The fair had lot of Chinese presence and in the visitors profile could find a lot of
consultants.
Few more fairs related to healthcare and Medical devices in Ayurveda, wellness etc.- which are of
regional nature are not listed here.
9 CONCLUSION
The medical device sector in India is expected to grow substantially, propelled by improved access
to health care facilities and a strong regulatory framework which would act as a catalyst for the
growth of this sector. The Government has allowed 100 percent FDI in this sector, which will
improve the competition and the standards which are presently under developed.
The current medical device sector is import dependent which is bound to change with the
Government’s new policies giving priority to “Make in India” initiative. Many MNCs have now set up
manufacturing plants in India following the Government’s holistic policy in this sector.
The competition in medical device sector is also bound to grow substantially with the
Government’s decision allowing 100% FDI, modern technologies being made available to domestic
players, and the cheap imports from China. There is still bright scope for quality products in this
sector.
10 LIST OF TENDERS
Herewith a list of some sample indications of tenders issued by hospitals and Government.
• http://www.hsccltd.co.in/index.php?option=com_tender&view=tender&Itemid=61&lang=en
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11 RELEVANT CONTACTS WITHIN HEALTHCARE SECTOR
Interested entities can obtain the full contact details of any of the below organizations /
hospitals / companies by writing to FIT New Delhi at [email protected]
Indian Radiology & Imaging Association (IRIA) / Indian College of Radiology & Imaging (ICRI)
www.iriaindia.com ; www.refindia.net/rindia/associations.htm
13
Confederation of Indian Industry (CII)
(Medical Equipment Division),
http://www.cii.in
Max Healthcare
www.maxhealthcare.com
14
Bharat Enterprises
http://www.biopluslifecare.com/
Medtech Devices
http://www.medtechdevices.net/
Meditech Electronics,
www.meditechelectronics.com ; www.ledotlight.com
Medtech Devices,
www.medtechdevices.net
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GPC Medical Ltd.
http://www.gpcmedicalltd.com/ ; http://www.gpcmedical.com
JSB Healthcare,
http://www.jsbhealthcare.co.in
Hindustan Syringes
Hindustan Syringes & Medical Devices Ltd. (HMD)
www.hmdhealthcare.com ; http://www.hmdhealthcare.com/asian/home1.htm
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