Indian
Medical Device Industry: Integrating Market, Technology,
Innovation And Ecosystem
|
Dr.
Jitendar Kumar Sharma
Head, Division of Healthcare Technology & Director,
WHO Collaborating Centre for Priority Medical Devices
& Health Technology Policy, National Health Systems
Resource Centre, Ministry of Health & Family Welfare,
Govt. of India |
Highlights of Presentation
made by Dr. Jitendar Kumar Sharma during the 13th National
Conference and Technology Display Exhibition on Indian
Medical Devices & Plastics Disposables / Implants Industry
2016, Ahmedabad.
Dr. Jitendar Sharma started
his presentation by giving the overview of Medical Devices
Sector. He said, “Medical devices Sector are complex
knowledge driven field. It is not like producing microwave
or transistor or fridge. It is so knowledge dependent that
any lapse in knowledge can lead to adverse events.” He
expressed happiness for the fact that the conference was
jointly participated by Universities and Industries. He
appreciated the formation of Orthopaedic Implant
Manufacturers Association (OIMA) explaining that unless
there is a critical mass of people thinking together in
the same way, no job can be done. He also mentioned that
all the manufacturers will be benefitted by this.
Introducing Division of
Healthcare Technology in National Health System Resource
Centre which is at NHSRC under ministry of health, he
explained that it is the technical secretariat not for
regulation but for service delivery and industry
promotion. During the presentation he elaborated on major
issues of importance to the Indian Medical Device Industry
namely – Quality, Infrastructure, Cost Reduction,
Compliance and Reporting.
Quality
He introduced the new quality
assurance scheme, “Indian Certification of Medical Device
Scheme (IC-MED)” - a joint initiative of Association of
Indian Medical Device Industry (AIMED), Quality Council of
India (QCI) & National Accreditation Board for
Certification Bodies (NABCB). Explaining more he said
that, “This IC-MED mark is a voluntary certification. It
is not the replacement to what the regulators do; it is
focused quality improvement strategy to improve medical
device manufacturing processes. There are many standards
in the IC-MED mark right from product manufacture,
realization, process to safety to standardization etc.” He
suggested the industry to work together to make “IC-MED
mark” a success. He also suggested the industry to have a
joint training program so that QCI can offer an
orientation program to understand & prepare the company
for getting “IC-MED”.
Infrastructure
Emphasizing on the importance
of Cost Reduction for the industry, Dr. Sharma explained
that for both, safety & cost reduction, it is essential to
have right quality of infrastructure. Explaining the need
for Medical Device Testing Laboratories in India, Dr.
Sharma mentioned that two such laboratories are under
process of implementation and will be in operation
shortly- one in Noida for testing of electrical &
electronic devices and second in Vadodara for biomaterials
and implants testing.
He explained the quality of
such laboratories abroad and emphasized the need for
certified Medical Device Testing Labs. In order to guide
the industry, Dr. Sharma informed that Division of
Healthcare Technology has prepared reports on establishing
and operationalising medical devices testing laboratories.
The reports have been made available at the WHO website as
well.
Medical Device Parks In
India
Dr. Sharma informed that two
Medical Device Industry parks are announced in India. He
explained at length the benefits of such parks and
mentioned that it will reduce the cost of manufacturing
and make the indigenous products economical and
affordable. In particular he informed that Govt. of Andhra
Pradesh has decided to establish country’s first Medical
Technology Manufacturing Park at Vishakhapatnam. The
creation of such as park 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. A park 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 park would have all such facilities
in-house to reduce manufacturing process costs, the
Andhra Med Tech Zone at Visakhapatnam would be located
in an area which is well connected with Railways,
Roadways, Waterways and Airways with near presence of
Industrial Corridors, Port and Harbor to reduce logistical
costs. The park will provide for all capital intensive
common manufacturing facilities required by medical device
manufacturers and modern state of art 100-150 independent
manufacturing units, each of a built-in ready to use area
of 1 to 2 acres.
Materiovigilance Program
He explained the
materiovigilance program designed on the line of
Pharmacovigilance for medical devices. He further
mentioned that 10 institutions are identified for
reporting of adverse events. He emphasized the need of
having a medical device safety officer in each company who
can get feedback of adverse events from market so that
necessary improvements can be made at product level which
would help improve product credibility and profits.
Innovation
Emphasizing on the need for
innovation, Dr. Sharma introduced the National Health
Innovation Portal which carries out evaluation of the
innovative medical technology innovation and provides
report on whether the innovation is suitable to public
health needs. The evaluation is carried out by Division of
HCT and then approved by a committee appointed by Ministry
consisting of distinguished scientists as members which
makes recommendation for uptake of innovative
technologies. Dr. Sharma also explained the proposed
‘Auction Program’ by government under which patents and
prototypes that have been invented at research
institutions would be auctioned to the industry thereby
leading to transfer of manufacturing rights. Revenue thus
generated could be shared with the institutions for
carrying out further research and could also be used for
supporting medium and small scale manufacturers obtain
necessary quality certifications for their products.
Summarizing his presentation,
Dr. Sharma strongly suggested the industry to appoint an
officer for implementation of “IC-MED” in organization as
well as for tracking adverse events. He mentioned that
doing this voluntarily will help the industrial progress
in a major way. He reiterated that the Govt. will create
testing labs as well as Med Tech manufacturing parks which
will provide manufacturing space with common facilities at
substantially low cost. He also repeated his appeal to the
industry to share knowledge on the National Health
Innovation Portal.
Dr.
Jitendar Kumar Sharma is Head of Healthcare
Technology Division and Director of WHO Collaborating
Centre for Priority Medical Devices & Health
Technology Policy, at National Health Systems Resource
Center, the technical support institution under
Ministry of Health & Family Welfare, Government of
India. He is also Adviser (Health & Medical
Technology) to the Hon’ble Chief Minister of Andhra
Pradesh and nodal officer for Andhra Med Tech Zone
Project. He is a key designer and coordinator of
several health technology programs in India and a
faculty for courses on health technology policy &
assessment in several countries. He is referred as the
“Med Tech Man of India” for his contributions to the
field of medical technology policy & programs. He
earlier served at Sri Sathya Sai Institute of Higher
Medical Sciences, later as consultant to World Bank
and then as Consultant to the World Health
Organization, Geneva. He is Clinical Faculty at
University of Adelaide, Australia and program director
for Health Technology Assessment (HTA) fellowships in
India. He has been an adviser at Health Technology
Innovation Centre, IIT Madras and serves as faculty
for National Accreditation Board for Hospitals (NABH)
in India for Medical Devices. He has contributed
through several research papers, seven books on health
technologies & assessments, and six compendiums on
technical specifications for medical technologies and
has been contributor to several reports on health
technologies by International agencies including WHO. |
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