New Clinical Research Rules To Speed Up Trials Rate In India - ACRI India

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New Clinical Research Rules To Speed Up Trials
Rate In India
With India being the second largest populated
country in the world, and the first on the list
of countries with disease burden, only 1.2 of
clinical trials being held here seems to be a
very poor number. But, with the new rules that
have been set for clinical trials that are likely
to come into effect by March 2019, the scenario
is expected to change for the better.
It has been revealed that the new rules include a
regulation wherein if an Indian company does not
hear from the drug regulator on their proposal
for clinical trials and research in 30 days, the
proposal should be considered as approved. This
will clearly speed up the approval process to
less than a month, where it earlier took
somewhere between 3-6 months! (Note Where the
approval period for Indian companies would be 30
days, the same would be 90 days for a
multinational company.) This seems to be a very
major decision! India has always been considered
as a country that is low on innovation and
generics, as compared to other advanced
countries. But, this new rule will encourage
Indian companies to innovate. The new clinical
trial rules are said to come into effect by the
coming month, which is expected to bring, if not
big, then at least a small rise in the number of
clinical trials in India. The tightening of
clinical trials rules in the past years had
lowered the percentage of clinical trials being
held in India, which is all set to change now.
India is home to a largely ethical and
genetically diverse population, suffering from a
variety of ailments. Moreover, it is also home to
6 out of 7 genetic varieties of human races that
are largely treatment-naive and are looking for
a cure. Thus, we need to encourage research on
such patients to ensure that we have drugs
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that work on our population. Taking the example
of the drug that is now the gold standard for
treatment in heart failure, but came much later
to India because of the time it took to have its
trial conducted in India, we can see how our
population fails to get the best treatment mainly
because of the lack of time management. Thus,
with the new rule that allows companies to wait
only for a month before taking approval as
granted, it seems that the Indian population is
now set to receive better treatments to ailments
that have not yet received a cure yet. With the
Indian clinical research industry now moving
towards positivity and success, you can also set
up your career in the field to have a bright
future with the hope of helping your fellow
country mates fight diseases like never before!
And, for this, you need to get top clinical
research training in Bangalore from a reputed
institute like Avigna Clinical Research
Institute, where you can learn from experienced
professionals and also gain 100 placement and
internship assistance guaranteed after completing
your course.