Critics say that the
stem cell industry has
failed to take off and
this is the beginning
of its end in India. Do
you consider this as a
realistic assessment?
What opportunities
and trends do you see
in Indian stem cell
industry?
We believe stem cell
industry in India is
pointing up. World’s
first stem cell drug
“Prochymal® approved
in Canada in 2012 took
20 years for the product
development. Compared
to that, the progress made
by a decade old Indian
stem cell industry is
commendable. Thanks
to Ministry of Health,
recently Drug Controller
General of India (DCGI)
has given marketing
authorization for three
new drugs in the stem
cell therapy area.
Stempeutics’ has received
manufacturing and
marketing authorization
(Form 46) for its flagship
product, Stempeucel®
for the treatment of
Critical Limb Ischemia
due to Buerger’s (CLI)
disease in March 2017.
First allogeneic stem cell
drug to be approved by
DCGI and First allogenic
stem cell product to be
approved in the world
for the treatment of CLI.
This is a historic moment
in India’s nascent drug
development history.
This Novel Treatment is
a fruition of a decade of
development work wholly
done in India. This is truly
a remarkable “Made in
India” moment for the
Indian biopharmaceutical
industry.
This is just the beginning
of product approvals
for Indian stem cell
industries and this will
surely lead to many more
product approvals soon.
A few people who have
embraced failure for a
considerable period might
have expressed their
dismay in Indian stem cell
industry, but it is truly the
time to regenerate hope
and show our strength in
the global forum.
Do stem cells still
hold the promise of
future healthcare?
Why aren’t we seeing
more products off the
shelves?
Yes. India is already
seen as the world’s low
cost pharmacy as far as
conventional therapies
are concerned and the
recent economic and
epidemiological changes
present a lucrative
opportunity for the Indian
biotechnology industry
to replicate this success
in the field of novel and
innovative healthcare
therapies like stem cell
therapies. The hope that
stem-cell therapies will
repair and regenerate
diseased organs and tissue
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