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“goes beyond what pills
and scalpels can ever do.”
We believe that Stem cells
would be a major branch
of medical treatments
and would be a standard
of cure and practice in
the years to come. Stem
Cells will be available as
off-the-shelf product soon
for treating various unmet
medical needs.
As we mentioned earlier,
the DCGI has approved
three products recently.
Stempeucel® will be
available off the shelves in
2018. The average product
development period for
42
BioVoiceNews | April 2017
the novel therapeutics
is about 10-15 years, so
we are just in the cusp of
witnessing more product
approvals soon in India.
We will see at least five
new products on the
shelves in the next two to
three years’ time.
The DCGI’s limited
approval to
Stempeucel® in 2016
is being seen as a
boost to the company.
What has been the
progress so far?
As mentioned earlier,
we have received
manufacturing and
marketing approval in
Form 46 from DCGI this
year. This is a historic
moment in the world of
drug discovery in India
with DCGI granting
marketing approval to
Stempeucel®-India’s
FIRST biologic drug
made using stem cells.
This is the key mile stone
achieved by Stempeutics
in the last 10 years. The
company has successfully
put India on the global
map for cutting edge drug
discovery in the area as
Stempeucel® is only the
4th off-the-shelf stem cell