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Indian Medical Device
Manufacturing Industry: Evolving Ecosystem
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Mr. Rajiv Nath
Managing Director, Hindustan Syringes & Medical
Devices Ltd. & Forum Coordinator,
Association Of Indian Medical Device Industry (AiMeD) |
This September has been a most
eventful month with come September bringing in the
formal announcement of the creation of Medical
Devices Export Promotion Council and shortly
followed up with the reconstituted Medical Devices
Promotion Council’s first meeting under the
chairmanship of the Secretary Dept. Of
Pharmaceuticals.
BIS sought a meeting with
Stakeholders and for discussing the SNAP (Standards
National Action Plan) for the next 5 years and
sought AiMeD’s inputs for domestic industry needs and
the deadline for compulsory licensing of October 1st
for all low-risk medical devices loomed.
The Parliamentary Standing
Committee on Health & Family Welfare headed by BJP MP
Prof Ram Gopal Yadav presented its report on
“Medical Devices Regulation & Control” to the
Rajya Sabha on 12 th Sep. which will help the
manufacturing of medical devices to thrive if most of
these recommendations are implemented.
All Medical Devices have still to
come under Regulations and are still under a
transitional stage. |
The Draft Notification for Resellers of
Medical Devices was released for public comment by MoH&FW
in Feb 2022 and now released on September 30th. It’s now a
simple registration process and not as cumbersome as is
for Resellers of Drugs which had more stringent storage
and warehousing conditions and needed a pharmacist - in
case of Medical Devices this will be related to nature of
products and on basis of guidance of manufacturers whose
products are being resold for any specific temperature /
storage condition, if any.
Since there are now no conditions like
keeping a refrigerator etc. to seek a Wholesale Drug
License a Reseller of ventilator or any oxygen therapy
equipment is free to store the goods anywhere if no
special environment conditions are prescribed in the IFU
(instructions for use) or as a specific condition under a
Distribution Sales Agreement with a Manufacturer.
Also, on 30th September vide Circular of
CDSCO the time to get a Manufacturing License from CDSCO
for a Class B Medical Device like a moderate risk oxygen
therapy equipment has been extended by 6 months if the
Manufacturer has already registered his product or applied
for the Manufacturing License. For Class C Medical
Devices, one has time till Oct 2023 to get a Manufacturing
License for making ventilators or other Class C high
moderate risk oxygen therapy equipment as detailed in
CDSCO Classification List. Similar is the case for Class D
high risk medical devices.
By default, this 6-month reprieve for
Class A & B manufacturers and importers gets extended to
even resellers of Class A&B Medical Devices (other than
for the 37 Medical Devices that were already Notified as
Drugs prior to February 2020) and they need to apply to
their State Licensing Authority on hard copy if online
registration system not launched by them.
For Non-Sterile, Non-Measuring Medical
Devices items like nonsterile surgical instruments,
orthopedic support & rehabilitation devices, spectacle
frames more diluted requirements are being Notified vide
Draft Notification Dt: 20th September 2022 which now no
more seek an audit for compliance to Schedule V Quality
Management System requirements that are along the lines
ofISO13485 and will provide relief to a number of affected
micro & small manufacturers.
Indian medical devices manufacturing
Ecosystem is evolving for the better
The Eco System of medical devices
manufacturing is evolving for the better with the
Parliamentary Committee on Health making the following
recommendation that will come as a delight for
manufacturers of Medical Devices and related shareholders.
Key Excerpts are reproduced below:
The Committee recommends that instead of
drafting a combined legislation for Drugs, Medical Devices
and Cosmetics, the Ministry should appreciate the
potential of the Medical Device industry and formulate
a separate legislation for Medical Devices.
The Committee recommends that the new
legislation should set up a new set of regulators at
different levels for regulating the Medical Devices
industry. Unlike the present structure, the proposed
regulator should license the manufacturing of all classes
of medical devices i.e., Class A, B, C, and D. This would
help harmonize the regulation process throughout the
country as it would do away with different regulating
procedures employed by different States. The Committee
feels that in the new legislation regulatory controls need
to be shared between Centre, State and Conformity
Assessment Notified Bodies in Law. There should be no
duplication of State and Central Government regulations.
There needs to be accountability fixed on State Regulator
to the Central Licensing Authority (or a National
Regulator) to ensure harmonious enforcement.
The Committee believes that with industry
growing by leaps & bounds, the government should not
afford regulation of medical devices by pharma experts
and its time that at ground level the medical device
regulations are dispensed with by qualified and
well-trained Medical Device Officers to give a fillip to
the Medical Device industry in the country.
The Committee recommends the Ministry to
introduce standards and certification process
(particularly for Class C&D products) comparable to global
standards. The Ministry, along with compulsory compliance
to Quality Management System as per schedule 5 of the MDR,
2017, should also allow cognizance to 3rd party
assurance schemes like ICMED 13485.
The Committee is of the considered view
that to encourage indigenous manufacturing, the Government
should provide incentives or encourage preferential
purchase for domestically manufactured products in
Government procurement. In this regard, the Department
should ensure that in all public procurement, the
preference must be given to Indian manufactured medical
devices having domestic content of at least 50%. Given
the size of Government's (both Central and State)
purchase, the Preferential Purchase Agreement would have a
significant pull for several medical devices companies to
manufacture medical devices in India. Also, the PLI scheme
should be broad based, and all the medical devices
should be covered under the scheme. Additionally, the
Committee recommends that PLI scheme should be expanded to
cover raw material and component manufacturing as well so
that India can become a hub for raw material for the
world.
To invigorate the culture of research and
development in medical devices in institutions like IITs,
NITs and other academic institutions the Committee
recommends the Department to start Research Linked
Incentive (RLI) Scheme in Line with PLI scheme. The
Department should facilitate academia- industry
partnership for undertaking research projects on industry
challenges and incentivize the successful outcomes.
The Committee expresses concern over the
fact that the highly technical medical devices industry,
having no synergy with the Ministry of Chemicals &
Fertilizers is being promoted by them instead of Ministry
of Health and Family Welfare. The Committee, therefore,
recommends that since the Ministry of Health and Family
Welfare is the key stakeholder and the medical devices'
being very diverse in range with respect to technology and
material sciences, inter-ministry co-ordination is
required between various departments, which should be done
by the Ministry of Health and Family Welfare only. The
Committee, accordingly, recommends that to nurture the
nascent medical devices industry, the government should
consider creation of a separate Department of Medical
Devices for playing the role of a policy maker,
facilitator as well as regulator.
The Dept of Pharma & Honourable Minister
Shri Mansukh Mandaviya announced it is organising a
large-scale India MedTech Expo 2022 event on
Medical Devices sector form 09-11th December 2022 at
Pragati Maidan, New Delhi with the focus to showcase
India’s journey and opportunities in the sector.
The event will create opportunities to
network and explore collaborations both for the sector’s
growth in India and its potential contribution globally,
duly bringing together all the stakeholders such as PLI
Participants, Start-ups, MSMEs, Innovative Entrepreneurs,
R&D Facilities, Incubators, Public and Private Hospitals,
etc.
The event will bring together industry,
academia, research institutions, investors, state
governments, MedTech parks and the Government bureaucrats
for taking the sector on a forward growth trajectory.
The Prime Minister is expected to inaugurate the Expo
and this will provide further impetus to this sector which
we hope one day will become one of the ToP5 manufacturing
hubs of Medical Devices worldwide. |
