AiMeD Lauds
Cabinet Decision To Approve National Medical Devices
Policy 2023
April 27,
2023
New Delhi
[India], April 27 (ANI): Extending gratitude to the Centre
for announcing a Medical Devices Policy, the Association
of Indian Medical Device Industry (AiMed) on Wednesday
said it was a long waited decision.
The
announcement was made following a meeting of the Union
Cabinet chaired by Prime Minister Narendra Modi. “At AiMeD,
we are delighted with the Cabinet’s decision of
announcing a Medical Device Policy to
fulfil PM Narendra Modi and India’s aspirations to be not
only Atmanirbhar Bharat but also a global key of top five
suppliers of Medical Device worldwide. This is a direction
that we had been keen for a long. It’s long awaited
decision,” Rajiv Nath, forum coordinator, AiMe, said.
He said the
policy will help traders and importers start investing in
factories and end the 70-80 per cent import dependency and
the ever-rising import bill (of Medical Devices), which
shot up by a steep 41 per cent to over Rs 63000 crores
last year.
The Medical
Devices policy is expected to facilitate an orderly growth
of the Medical Device Sector and help in meeting public
health objectives of access, affordability, quality and
innovation. (ANI)
https://www.aninews.in/news/national/general-news/longawaited-decision-aimed-lauds-cabinet-decision-toapprove-national-medical-devices-policy-202320230427025547/
Cabinet Approves The Policy
For The Medical Devices Sector
Six Strategies planned to tap
the potential of the Sector, with the Implementation
Action Plan Policy is expected to help the Medical Devices
Sector, grow from present $11 Bn to $50 Bn in next five
years.
Posted On: 26
APR 2023 7:35PM by PIB Delhi The Union Cabinet, chaired by
the Hon'ble Prime Minister Shri Narendra Modi, today
approved the National Medical Devices
Policy, 2023.
The medical
devices sector in India is an essential and integral
constituent of the Indian healthcare sector. The Indian
medical devices sector’s contribution has become even more
prominent as India supported the domestic and global
battle against COVID-19 pandemic through the large scale
production of medical devices & diagnostic kits, such as
Ventilators, Rapid Antigen Test kits, Real-Rime Reverse
Transcription Polymerase Chain Reaction (RT-PCR) kits,
Infrared (IR) Thermometers,
Personal Protective Equipment(PPE) Kits & N-95 masks. The
medical devices sector in India is a sunrise sector which
is growing at a fast pace. The market size of the medical
devices sector in India is estimated to be $11 billion
(approximately, ₹ 90,000 Cr) in 2020 and its share in the
global medical device market is estimated to be 1.5%. The
Indian medical devices sector is on a growth track and has
an enormous potential to become self-reliant and to
contribute towards the goal of universal health care. The
Government of India has already initiated implementation
of PLI Scheme for medical devices and support for setting
up of 4 Medical devices Parks in the States of Himachal
Pradesh, Madhya Pradesh, Tamil Nadu and Uttar Pradesh.
Under the PLI scheme for Medical Devices, till now, a
total of 26 projects have been approved, with a committed
investment of Rs.1206 Cr and out of this, so far, an
investment of Rs.714 Cr has been achieved. Under the PLI
scheme, total of 14 projects producing 37 products have
been commissioned and domestic manufacturing of high-end
medical devices has started which include Linear
Accelerator, MRI Scan, CT-Scan,
Mammogram, C-Arm, MRI Coils, high end X-ray tubes, etc.
Remaining 12 products will be commissioned in near future.
Five projects out of total 26 projects have been approved
recently, under Category B, for domestic manufacturing of
87 products / product components.
Building upon
these measures, a holistic policy framework to accelerate
this growth and fulfil the potential of the sector is the
need of the hour. While various Departments of the
Government have undertaken programmatic interventions to
encourage the sector, the current policy aims to put in
place a comprehensive set of focus areas for growth of the
sector in a coordinated manner. Secondly, in view of the
diversity and multi-disciplinary nature of the sector, the
regulations, skilling trade promotion of medical device
industry are spread over several departments in the
Government both at the Centre and State levels. There is a
need to bring together the range of interventions in a
coherent manner that would facilitate focused and
efficient support and facilitation for the sector by the
respective agencies. The National Medical Devices Policy,
2023 is expected to facilitate an orderly growth of the
medical device sector to meet the public health objectives
of access, affordability, quality and innovation. This
sector is expected to realize its full potential, with the
strategies viz, building an enabling ecosystem for
manufacturing along with a focus on innovation, creating a
robust and streamlined regulatory framework, providing
support in training and capacity building programs and
promoting higher education to foster talent and skilled
resources in line with the industry requirements.
Encouraging domestic investments and production of medical
devices complements the Government’s ‘Atmanirbhar Bharat’
and ‘Make in India’ programs. Salient Features of National
Medical Devices Policy, 2023:
Vision:
Accelerated growth path with a patient-centric approach
and to emerge as the global leader in the manufacturing
and innovation of medical devices by achieving 10-12%
share in the expanding global market over the next 25
years. Policy is expected to help the Medical Devices
Sector grow from present $11 Bn to $50 Bn by 2030.
Mission:
Policy lays down a roadmap for accelerated growth of the
medical devices sector to achieve the following missions
viz, Access & Universality, Affordability, Quality,
Patient Centred & Quality Care, Preventive & Promotive
Health, Security, Research and Innovation and Skilled
manpower.
Strategies to
Promote Medical Device Sector:
Medical
devices sector will be facilitated and guided through a
set of strategies that will be cover six broad areas of
policy interventions:
Regulatory
Streamlining: In order to enhance ease of doing research
and business and further to balance patient safety with
product innovation measures such as creation of a Single
Window Clearance System' for Licensing of Medical Devices
coopting all the stakeholder departments / organizations
such as AERB, MeitY, DAHD, etc, enhancing the Role of
Indian Standards like BIS and designing a coherent pricing
regulation, will be followed.
Enabling
Infrastructure: The establishment and strengthening of
large medical device parks, clusters equipped with world
class common infrastructure facilities in proximity to
economic zones with requisite logistics connectivity as
envisioned under the National Industrial Corridor Program
and the proposed National Logistics Policy 2021 under the
ambit of PM Gati Shakti, would be pursued with the State
Governments and Industry for better convergence and
backward integration with medical device Industry
Facilitating
R&D and Innovation: The policy envisages to promote
Research & Development in India and complement the
Department’s proposed National Policy on R&D and
Innovation in the Pharma- MedTech Sector in India. It also
aims at establishing Centres of Excellence in academic and
research institutions, innovation hubs, ‘plug and play’
infrastructures and support to start-ups.
Attracting
Investments in the Sector: Along with resent schemes and
interventions like Make in India, Ayushman Bharat program,
Heal-in-India, Start-up mission, the policy encourages
private investments, series of funding from Venture
Capitalists, and also Public-Private Partnership(PPP).
Human
Resources Development: In order to have a steady supply of
skilled work force across the value chain such as
scientists, regulators, health experts, managers,
technicians, etc., the policy envisages:
• For
skilling, reskilling and upskilling of professionals in
the medical device sector, we can leverage the available
resources in Ministry of Skill Development and
Entrepreneurship
• The policy will support dedicated multidisciplinary
courses for medical devices in existing institutions to
ensure availability of skilled manpower for futuristic
medical technologies, high-end manufacturing and research,
to produce future-ready MedTech human resources and to
meet the evolving needs of the Sector
• To develop partnerships with foreign academic/industry
organizations to develop medical technologies in order to
be in equal pace with the world market.
Brand
Positioning and Awareness Creation: The policy envisages
the creation of a dedicated Export Promotion Council for
the sector under the Department which will be an enabler
to deal with various market access issues:
Initiate
studies and projects for learning from best global
practices of manufacturing and skilling system so as to
explore the feasibility of adapting such successful models
in India.
Promote more
forums to bring together various stakeholders for sharing
knowledge and build strong networks across the sector. The
policy is expected to provide the required support and
directions to strengthen the medical devices industry into
a competitive, self-reliant, resilient and innovative
industry that caters to the healthcare needs of not only
India but also of the world. The National Medical Devices
Policy, 2023 aims to place the medical devices sector on
an accelerated path of growth with a patient-centric
approach to meet the evolving healthcare needs of
patients.
https://pib.gov.in/PressReleaseIframePage.aspx?PRID=19199
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