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Manufacturing Medical Devices In India
How Do
We Balance Between Compliance, Quality And Innovation?
With these
together, the chances of success for the cluster are much
better. He also mentioned about Ahmedabad, Gandhinagar as
another perfect locations for a cluster alongwith Delhi.
There are many other locations. Since India is a very
large country, we should not be worried about how many
clusters come up.
Coming back
to balancing between Compliance, Quality and Innovations,
he mentioned that along with satisfying the regulators, we
have to be absolutely sure that the patient safety is not
compromised; new innovations take place for the patients
to benefit from newer treatments. How do we do that?
He shared
the example of his company which very closely interacted
with Regulators resulting in knowledge sharing and benefit
to both, the Company as well as the regulating agency. He
also lauded efforts by Indian regulatory authorities to
enhance the sectorial knowledge.
He further
gave the example of very good low cost innovation carried
out in India by institutes like Stanford India Biodesign
located in the premises of All India Institute of Medical
Sciences (AIIMS) in New Delhi which he visited recently.
The students in the institute work closely with Doctors,
healthcare professionals and patients to understand
problems faced by them. Explaining how they achieve
development of low cost medical devices, he said they look
at the need and determine critical quality requirements.
More and more of such institutes are required in our
country at different locations. Ahmedabad may be one such
location.
More Mr. C
Padmakumar strongly recommended the delegates to go
through a report on, “Understanding Barriers to Medical
Device Quality” , prepared as a result of an initiative
launched by the United States Food and Drug Administration
(FDA), Centre for Devices and Radiological Health (CDRH),
as part of an effort to assess and understand gaps in
medical device quality. Mr Padmakumar mentioned that this
introspection by USFDA was in response to the criticism by
the Industry. They interacted with Medical Device Industry
professionals at various levels and also to Doctors as
well as USFDA officers. He shared the important outcome of
the report (summary of the said report is covered under
the column “Global Trends” in this issue).
He
mentioned that European Regulators provide mentoring and
hand holding to SMEs in the Medical Device Sector who can
not afford resources like large companies. However, they
have innovative approaches, more ideas, large no of young
minds and hence they need help. And hence, the US FDA is
looking forward to implementing the findings of the report
very seriously.
He
suggested that the Indian regulators should look at the
approach by the European Regulating agencies as well as
the encouraging efforts being made by USFDA.
Mr.
Padmakumar shared his experience of working with both
Japanese as well as American companies over a period of
time. He mentioned that Americans obviously have a very
different philosophy from that of Japanese. They have been
trying to adopt both cultures. However, he explained how
the mindsets of Japanese and American principals have
changed about India now. Initially, the US Company was not
expecting much from Indian Company. However after visiting
India and looking at the Terumo quality standards and
products , meeting customers , talking to Doctors ,
talking to regulators and various other stakeholders ,
they realised that they can trust and just take Terumo
products and sell them. It is simply too costly to make
either in America or Japan. The American and Japanese
counterparts have now realised that the opportunity in
India is not just low cost but also very high power
scientific and engineering talent including design talent.
They also hold major innovation summit in Trivandrum. The
Japanese and American principals are now looking very
seriously at investing more in India and taking advantage
of the capabilities in India.
Mr.
Padmakumar also mentioned that they have given proposal to
Kerala Government for developing a cluster.
Mr.
Padmakumar concluded his presentation, with following
remarks:
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Over a
period of 29 years of his business career, he has been
fortunate to have passed through different phases.
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When they
started, there was no ecosystem for medical device
manufacturing. There was no availability of components, no
good quality fabrication work, and no availability of most
of the supplies. Almost everything was imported.
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Things have
changed dramatically over the last 29 years. Most of the
supplies are available in India.
-
For
Terumo’s new blood bag factory in Vietnam, most of the
pharma equipments are going from India and not from the
sources of the principals. There are lots of changes.
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He however
mentioned about non-availability of precision plastic
components as a big problem. Good components are not
available in India and have to be imported. He hoped this
situation will change shortly and mentioned that there is
good opportunity to take up medical components
manufacturing in India..
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