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India Eyes Japanese Tech
For Med Devices
NEW DELHI : India is seeking
to leverage its partnership with Japan to manufacture
medical equipment as part of a five-year $42 billion
investment and financing package agreed by prime ministers
Fumio Kishida of Japan and Narendra Modi in March.
Such equipment may include
patients monitoring systems, cardiac catheters, dialysers,
speciality needles, thermometers, glucometers and personal
weighing scales.
The matter was further
discussed during Modi’s visit to Japan in May.
India’s department of
pharmaceuticals now plans to invite large Japanese MNCs to
use India as a global manufacturing supply hub as part of
their China-plus policy.
The department has sought
suggestions for investment from stakeholders such as the
Indian Pharmaceutical Alliance (IPA), Indian Drugs
Manufacturing Association (IDMA), Bulk Drug Manufacturers
Association India (BDMAI), Association of Diagnostics
Manufacturers of India (ADMI) and Association of Indian
Manufacturers of Medical Devices (AiMED).
“At AiMeD, we have suggested
targeting 1,200 Indian ventures for ₹25 crore each with
foreign technical collaboration from countries like Japan
who have the know-how but may not have the organizational
capabilities to set up their own factories in India or
their own sales organizations. And then we can target 200
joint ventures where the foreign partner may be willing to
coinvest in factories of ₹50 crore each and also invite
large MNCs (including from Japan) to use India as a global
manufacturing supply hub in their supply chain as part of
China-plus policy whereby they consider derisking their
investments and dependence on their Chinese factories,"
said Rajiv Nath, Forum Coordinator, AiMeD.
He added that a target of 50
investments of over 200 crore each is feasible.
“We currently import many
basic devices like thermometer, glucometer, personal
weighing scales and more sophisticated technologies like
patients monitoring systems, cardiac catheters, dialysers,
specialty needles etc which may no longer be of strategic
importance to Japanese manufacturers for making in Japan
but that technical knowledge can reap benefits for them in
India," Nath said.
According to pharma industry
experts, India, which is over 80% import dependent has a
potential for ₹50,000 crore of investments in the medical
devices sector. They said that Japan is one of the leading
manufacturers of medical devices and most of the
production is by MSME companies that have specialised and
created niche products.
Darra Patel, General
Secretary, IDMA noted it has disseminated the information
to their member companies. “We have sought comments and
suggestions from our member companies in this regard and
we are hoping that they will soon share their ideas."
(
https://www.livemint.com/industry/manufacturing/india-eyesjapanese-tech-for-med-devices-11654705992525.html
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IPC Launches MvPI
Internship Course To Strengthen
Medical Device Adverse Event Reporting In India
In a bid to strengthen
medical device adverse event reporting in the country, the
Indian Pharmacopoeia Commission (IPC), the national
coordination centre (NCC) for Materiovigilance Programme
of India (MvPI) has launched internship programme for
pharmacy, medical, dental, and allied health science
professionals. The programme will enhance the knowledge of
the professionals on importance of materiovigilance
programme and medical device adverse event reporting.
Talking about the importance
of the MvPI internship programme, Dr Vivekanandan
Kalaiselvan, senior principal scientific officer, IPC
said, “Rapid growth in the use of medical devices has
drawn attention to gaps in the systematic monitoring of
medical deviceassociated adverse events in India. There
are medical device adverse events which can not be
reported through conventional medical device adverse event
reporting mechanisms. To address this gap, IPC has come up
with an MvPI internship programme. The internship course
will help professionals gain valuable research experience,
develop and refine medical device adverse event reporting
skills.”
The candidates pursuing or
completed pharmaceutical sciences such as B. Pharm, M.
Pham, Pharm D, Ph. D; medical sciences such as MBBS, MD,
DM; dental sciences such as BDS, MDS, Ph. D; engineering
such as BE/ME/B. Tech/M.Sc./MSc/MS/Ph. D in biomedical
engineering, medical electronics, clinical engineering,
electronics, instrumentation & related courses; nursing
such as ANM, GNM, DNA, BSc/M.Sc. Nursing and allied health
science courses, can apply for short-term or long-term
projects which could be an exclusive learning experience
for them.
The duration of internship
shall be preferably: three months (short-term), six months
(long-term), one year (long-term).
Interested candidates can
fill the following google link:
https://docs.google.eom/forms/d/e/lFAIpQLSedMo_gD8gv01DGIKxQkSLJ7r4MMSu6XHDNTWdlysMukUoLCQ/viewform
They can also send their
updated resume to
shatrunjay.ipc@gov.in
Applications will be accepted
throughout the year. Students are required to apply
directly (via google link/e-mail) of their interest at
NCC-MvPI, IPC with an updated resume. Students shall
submit a recommendation letter from the head of the
department / head of the institute from their
college/university/institute indicating the requirement of
training and duration as necessary for the fulfilment of
their degree.
In 2017, the government of
India issued the Medical Devices Rules 2017 for regulating
medical devices used throughout the country. The rules
came into effect on 1 January 2018.
As per the MDR, the devices
are classified, based on degree of risk associated with
Class A (low risk), Class B (low moderate risk), Class C
(moderate high risk) and Class D (high risk).
As per the MDR, G.S.R. 78,
Chapter 4, Section 26 (ii) the adverse events reporting
associated with medical devices to the relevant authority
is mandatory; the license holder shall inform the state
licensing authority or central licensing authority, as the
case may be, of the occurrence of any suspected unexpected
serious adverse events and take necessary action thereon
including any recall within 15 days of such event coming
to the notice of license holder.
Although medical devices
adverse events reporting is compiled by law, the reporting
to the authority and its surveillance system are a grave
concern. Therefore, besides the MDR, in order to promote
the culture of adverse events reporting, the health
ministry had launched Materiovigilance Programme of India
(MvPI) in order to monitor and assure the safety of
medical devices used in the country in 2015.
The MvPI aims to collect,
collate and analyze the voluntarily reported adverse
events associated with medical devices and thus arriving
at meaningful or evidence-based information that is being
recommended to the regulatory authority and general public
for promoting the safe use of medical devices.
In order to facilitate
adverse events reporting from the region, a structured
programmatic approach has been made by recognizing medical
colleges/hospitals/other related institutions as Medical
Devices Adverse Events Monitoring Centres (MDMCs) across
the country.
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