Indian Clinical Trial Rules Modified To Bring In More Sponsors - ACRI India

1
Indian Clinical Trial Rules Modified To
Bring In More Sponsors
The World Health Organization had written to the
Indian government that stringent rules of the
clinical research industry would push away
pharmaceutical companies from conducting clinical
trials in India, while also hampering WHOs
work. Taking this into consideration, the BJP-led
NDA government is all set to remove a clause
from the final version of the clinical trial
rules that authorizes compensation in case of
death or injury during a clinical trial.
The clinical trials rules that were released in
February 2018 included a provision stating that
if a clinical trial participant died or suffered
permanent disability during the course of the
trial, the sponsor will pay an interim
compensation upfront, amounting to 60 of the
compensation, payable within 15 days of the
opinion of an Ethics Committee. The remaining 40
was to be paid within 30 days of the order. It
was stated that any organization intending to
conduct biomedical and health research should
have an Ethics Committee in place to oversee the
conduct of the research, which would consist of 7
members including medical scientists, non-
medical scientists, legal experts, non-scientific
experts, one lay member, and a woman member. The
purpose of this committee was to ensure that the
medical research and experiments being done were
carried out in compliance with ethical concerns
and requirements, which would be reviewed and
approved to a clinical trial protocol by the
committee.
2
But, on June 19, the deputy director general of
the World Health Organization, Mr. Sowmya Swami
Nathan wrote to the Union health secretary to
have the Indian government reconsider the
compensation clause as it would drive away drug
companies and would also hamper the WHOs work
with India. He wrote that if the draft becomes
final, sponsors may not consider conducting
clinical trials in India. He added that as a part
of WHO, he himself would not act as a sponsor as
it is a public health priority to conduct
clinical trials on a particular condition in
India. The Indian Council of Medical Research
also agreed with these objections, as the
director general, Mr. Bal ram Bhargava wrote to
the Healthy Ministry that some provisions in the
draft rules would negatively affect the future
of clinical trials in India. Looking at all of
this, it was decided to eliminate this clause
from the clinical trials rules list, as it could
prove to be too difficult for companies and
sponsors to run clinical trials in India, while
being bound by this provision. With this
modification, it can be confirmed that India is
definitely going to see a huge expansion of the
clinical research industry in the near future,
which will in turn make clinical research
careers one of the most sought after ones soon.
If you are interested in such a career, and want
to be able to stand upright in this field and
achieve success, you need to get the best
possible education about the field. Avigna
Clinical Research Institute is who you can
approach them to provide you with the finest
quality online clinical research courses in
Bangalore. Here, you can learn from experienced
professionals right from the comfort of your
home, and earn a legitimate certification to help
you get the best jobs across the globe!