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The
Medical Devices Sector in India; Task Force
Recommendations
Background
Medical
devices’ industry is a multi-product industry, producing
wide range of products. Manufacturing and trade in medical
devices is also growing quite steadily. Double digit
growth rates indicate its importance in health care.
Medical devices’ industry mostly depends on imports. Most
hi- tech innovative products and technology originate from
a well developed eco-system and innovative cycle which
needs to be developed in India to promote indigenous
industry and to reduce our dependence on imports.
The ‘Make
in India’ campaign of Hon’ble Prime Minister Narendra
Modi’s government has a mandate to boost the medical
device manufacturing sector in India for all types of
medical devices and equipments used in manufacturing of
Pharmaceuticals. To implement the initiative a Task Force
was constituted under the chairmanship of the Secretary,
Department of Pharmaceuticals (DoP) to address issues
relating to the promotion of domestic production of high
end medical devices and pharmaceutical manufacturing
equipment in the country. The Terms of Reference (ToR) for
the Task Force is given in the detailed report.
The need to
address various basic concerns facing the industry
including human resources, finance, market, ease of doing
business, promotion of R&D and innovation etc was
identified. Specific issues that have to be deliberated
upon intensively were identified and more focused
sub-groups were formed to address these issues including :
Sub-group 1: Sector overview
Sub-group 2: Policy & Infrastructure
Sub-group 3: Regulatory
All the
recommendations from different sub-groups were reviewed,
collated and a concise actionable set was created. However
participation of the industry / stakeholders from
manufacturing equipment used in pharmaceutical was lacking
and the Task Force did not receive inputs from them
despite all attempts.
.An
overview of the device industry and the different elements
required to build the envisioned harmonized ecosystem is
given below.
Medical
Devices Sector Overview
Medical
devices sector in India is very small by size as compared
to the rest of manufacturing industry, though India is one
of the top twenty markets for medical devices in the world
and is the 4th largest market in Asia after Japan, China
and South Korea. Although accurate data is not available,
an educated guess would place the retail market at Rs.
60,000-70,000 Crores.
Segments
The Medical
Devices market can be classified into two major
categories:
• Devices
that do not require any external energy source.
• Devices that require external energy source to be
operational (powered).
Powered
devices are further divided into three product categories:
a.
Equipments,
b. Implants, and
c. Disposables.
a.
Equipments
Equipments
account for the largest share of the total market followed
by medical implants and disposable segments respectively.
This segment is also the fastest growing and is largely
dependent on imports currently.
This can be
further segmented into the following categories -
• Surgical
Equipments :
Prominent
factors that drive demand are advancements in surgery and
surgical device designs, availability of high skilled
surgeons, growing breed of corporate hospitals and
advanced surgical facilities like advanced robotics,
minimally invasive
surgical techniques and imaging.
•
Diagnostics:
Increase in
the prevalence of diseases, their complexity and the need
for quick diagnosis has created a high demand for
diagnostic services and devices like Cardiac imaging, CT
scans, X-ray, Molecular Imaging, MRI and
Ultrasound-imaging including hand - held devices.
• Life
Support:
As life
support technologies evolve and improve, use of equipments
like ventilator and automated external defibrillator
outside of the hospital environment has increased. Also,
as consumer spending power increases demand for such
systems is expected to grow.
b.
Implants
The market
for implants is witnessing some amount of innovations in
terms of catering to large unmet needs in certain
disabilities e.g. blindness. A microchip retina implant is
under trial which will allow blind patients to read
letters & recognize foreign objects.
c.
Disposables
Medical
disposable products for medical electronic equipment are
used by all hospitals and private nursing homes in the
country, including diagnostic and pathological
laboratories. The market is becoming increasingly
competitive due to low entry barriers (for MNCs),
increasing number of players and an expanding consumer
base. Examples include disposable medical and electronic
probe assemblies for minimally invasive applications,
disposable catheter cables, disposable EEG sensors/lead
wires, disposable SpO2 sensors, panel mount receptacles,
etc.
Present
status
During the
period 2011-12 to 2014-15 both import and export of
medical devices have grown at more than 10% rates.
Import as
well as export of Medical Electronics and Hospital
Equipment has been the highest amongst all the devices in
terms of value. Along with surgical instruments they form
more than 50% of total sales with majority being imported
(87.4%)
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