Title: What Has Made India A Favorable Destination For Clinical Trials? - ACRI
1What Has Made India A Favorable Destination For
Clinical Trials?
Clinical research is one of the most important
industries in the medical field today, where
trials are conducted to ensure the safety and
efficacy of new drugs. There are a set of
standard guidelines that have to be followed to
make successful reports of trials. Clinical
research in India was introduced more than a
decade ago, but there was a downfall in the
number of clinical trials in the country after
2010 due to multiple uncertainties and
unfavorable regulations. Looking at this, the
Indian government took initiatives in 2013 to
standardize the regulatory guidelines and
enforced rules to maintain ethical issues. These
were monitored and altered by a team of several
regulatory bodies involved in pharmaceutical
regulation in India. These include the DCGI,
DBT, CDL, DTAB, CLAA, ICMR, and GEAC. Keeping in
mind that a successful clinical trial can only
be possible when there is a balance of highly
skilled healthcare professionals, timeliness,
and cost effectiveness, the regulatory bodies
came up with many successful changes. The three
most important factors that have led to India
again becoming a favorable clinical trial
destination include
2- There is a large patient pool in India which has
made it one of the reasons that has made the
country one of the most favorable destinations
for clinical trials. India constitutes almost 20
of the total world population, having 1/5th of
the global burden of disease. There is an
increasing prevalence of communicable and
non-communicable diseases like TB, HIV, malaria,
cancer, diabetes, cardiovascular diseases, etc.
Moreover, it has a record of the highest toll on
maternal, neonatal, and child deaths in the
world. These diseases levy heavy cost burden on
healthcare expenditure. Also, India consists of a
diverse talent pool with a large number of
healthcare professionals including doctors,
nurses, researchers, clinical practitioners, and
laboratory technicians. In addition, there are a
large number of skilled professionals in the
field of information technology and other
sciences related to clinical trials. - Furthermore, the cost for conducting clinical
trials in India is only 1/10th that of the costs
in - USA. This is why many pharmaceutical companies
are relocating or outsourcing the clinical trial
processes to India. This in turn has
exponentially increased the research and
development expenditure in the pharmaceutical
industry. - Moreover, the regulatory bodies in India have
also set new timelines that ensure trial
applications to be approved in a relatively
shorter span of time. The DCGI gives its first
approval for conducting clinical trials within 45
days, whereas for conducting a bio- equivalence
study, it takes 28 working days. Additionally,
any approval of investigational new drug by
referral bodies or experts will take 12-14 weeks
more. Finally, the completion of process will
take another 45 days in case of any discrepancies
in the applications that will be sent back for
review. - All of this has made India a favorable
destination again in the list of countries for
clinical trials. Looking at this success, more
and more candidates want to take up clinical
research as a career option to help find
innovations to eliminate all forms of diseases
from the country. If you are one of them, you
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