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In
California, the leaderships and R & D manpower of the
Medical Device Companies comprise of Indian Talent in
a big way. People of Indian Origin are rare resource
and creators of Intellectual Property (IP) for their
Companies and Employers. Companies holding such IP can
multiply revenues 5 to 10 folds.
The
work is companies like GE or Siemens in India is owned
by Companies in Germany or Netherlands or US but the
people of Indian Origin work whether, it is in India
or those Countries. Why in next 10 years, some similar
work not be performed by Indian engineers working for
of that work can not be the property of Indian
Companies ?
Some of
the Indian Clients are already doing similar work .
One such western medical device Company has already
completed designing with the help of Indian Engineers
and Scientists for a Medical Product to be launched in
China market, which is roughly 10 times the size for
that particular product category than that of the
Indian Market. The Market. The Company would not have
been successful if they had done the work in the West.
The Company cannot do this work in China because of
apprehension of protection of IP.
Another
leading US Company is working for Health related
product for Latin American market. They do not find it
economical to do so in US and hence they are hiring
Indian Engineers to do the Innovations for Brazil,
Argentina and other Latin American Markets.
There
are many such examples of world class work is
happening right here in this country.
Based
on the capability of India for Innovations and ability
to create value for the day-to-day requirements
,requirements, there is a need in India for instant
T.B. Diagnostics possibility where one can take blood
from the patient and decide within seconds whether the
patient has T.B. or not. It’s India’s need unlike
America.
Similarly, Lots of diabetics are present in India. We
need to have a way to test the blood sugar that costs
pennies, not the kind of solutions that you see from
the west that you give away Glucometer but the patient
needs so much money on the strips.
It is
possible to find such solutions right in India and for
this market is not limited to India. And beyond
serving India, India, these products could be sold in
Africa, Africa, Latin America, America, Middle East
though may not be in regions with rich people like
North America, Japan etc.
Such
Innovations can far more effectively be served by
Indian Engineers than those working in the West. It
also provides opportunities to Indian Companies.
Such
opportunities are far bigger and far more immediate
and hence it is better for Indian Companies to look at
them rather than waiting for Government of India to
change this rule or that rule.
We need
to work with Global minds. We need to have more “Tata
Nano”s coming out from the Medical Device Business.
We see
success coming only from Innovative Companies, focused
on manufacturing . When this happens in big way, you
will see far bigger achievement than what we saw with
IT business where it is “TCS” and “Wipro” leads. In
Medical Device Business, there is much greater
opportunity.
Like
“Taiwan” and “Korea” has done in Electronics , Indian
Companies can do for medical device market globally
Global market and create far more value and far more
market capitalization than what we have seen till
today.
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Another
example is of “mobile “ phone business with an example
of a California based Company, “QUALCOMM” which has
built its entire business employing tens of thousands
of people basically around Patents. They do not
manufacture products without their own IP. Yet each of
us has probably a device where in “QUALCOMM” is being
paid because you buy that handset.
There
is tremendous value in creating Intellectual Property
which in the long run would serve India very well.
Snippets
Indian Institute Of
Science And National Centre For Biological
Sciences Collaborates With Industries For The
Early R&D Of Combination Products Like Pre-Filled
Drug Delivery Devices
Indian medical devices companies have upheld US
Food and Drug Administration (FDA) regulation on
the current good manufacturing practice (cGMP)
requirements applicable to combination products
that would be enforced from July 22, 2013.
Indian Institute of Science and National Centre
for Biological Sciences have collaborated with
industries for the early R&D of combination
products like pre-filled drug delivery devices.
As
per US FDA, in a combination product the
constituent parts retain their regulatory status
as a drug or device, after they are combined.
Hence the cGMP requirements that apply to each of
constituent parts continue to become relevant even
when they are combined to make combination
products.
The
FDA published a proposed rule in the Federal
Register of September 23, 2009 (74 FR 48423) on
current good manufacturing practices for
combination products. The proposed rule merely
provided that all such constituent parts must be
manufactured in accordance with cGMP requirements
that would apply to them if they were not part of
a combination product, said the Regulatory
authority.
The
compliance with either the cGMP regulations for
drugs at parts 21 CFR parts 210 and 211 or the
quality system (QS) regulation for devices at part
820 which are 21 CFR part 820 will satisfy many,
though not all, of the cGMP requirements
applicable to both drug and device constituent
parts, said the regulatory authority.
Ref:
http://pharmabiz.com/NewsDetails.aspx?aid=73404&sid=1 |
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Nipro Sets Up India's First Dialyser Manufacturing
Facility
Nipro Corporation, a
Japan based maker of life saving medical devices,
consumables, pharmaceutical glass products has set
up a facility at Shirwal near Pune which will
manufacture the first made-in-India artificial
kidney (dialyser).
The
company has made investment of Rs 700 crore for
this facility and it has been given mega project
status by the State Government.
Also, the project has been accorded approval by
the Atomic Energy Regulatory Board of the Bhaba
Atomic Research Centre to introduce in-house Gamma
technology for sterilising devices for the first
time in the country.
Nipro has been operating in India since 1995, and
notches an annual turnover of Rs 500 crore.
Commenting on this development, Milind Pappu,
managing director, Nipro India Corporation said, "NIPRO
India Corporation expects to achieve Rs 350 crore
turnover in 2013.
The
Pune Factory currently provides employment
opportunity to 800 people and expects to double it
by end of 2013. Nipro India’s Facility for
manufacturing Artificial kidneys from synthetic
fibers is the country’s most ambitious project in
the Medical Device Industry.
The
growing importance of Indian Healthcare market
gives this country a central position in Nipro
Corporation’s global strategy. We entered the
Indian Market in 1995 and started our trading
activity in the country."
According to Pappu, Nipro products will bring down
the cost of dialysis and increase the reach.
Currently, In India, only 10 per cent of patients
can afford dialysis treatment. Initially, it will
make six million dialysers per annum, which can be
ramped-up and it plans to export 90 per cent of
its production in the beginning. |
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