The New Drugs And Clinical Trials Rules In India For The Year 2019- ACRI

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On 19th March 2019, the Union Ministry for Health
and Family Welfare declared the new Drugs And
Clinical Trials Rules 2019, which aim to promote
clinical research in India through transparent
and faster approval processes. These new rules
are applicable to all new drugs intended for
clinical trials, bioequivalence study, and human
use. The rules bring about more clarity in terms
of clinical trials of new drugs in and outside
India, post- trial access of new drugs, drugs
importing, compensation, monitoring, and orphan
drugs. Let us take a look at each segment in
detail.
Clinical trials of new drugs in and outside
India Any drugs discovered in India will be
deemed approval for clinical trials within 30
working days by the Central Licensing Authority.
If no communication has been received from
this governing body to the applicant, it should
be considered that the permission to conduct
trials has been granted. In addition, for the
drugs developed out of India, which have already
been approved and marketed in another country,
the limit for approval is set to 90
days. Post-trial access of new drugs For the
patients who require access to drugs for the
first time, the sponsor is supposed to provide
the investigational drug to the trial subject for
free if the clinical trial is being
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conducted for a condition that has no other
alternative therapy, and for which the new drug
has been found to be beneficial to the trial
subject. Drug importing If certain new drugs
are permitted to be imported for sale and
distribution in India, local clinical trials for
these drugs are spared, so that early access can
be provided to patients for drugs that have
already been approved in other countries.
However, the condition here should be that there
is no major unexpected serious adverse events
reported for the drug, and that the applicant
agrees to conduct Phase IV clinical trial to
establish safety and effectiveness of the new
drug. Compensation and monitoring Every
clinical trial subject must be monitored well,
and in case of any injury to the subject during
the trial, medical management should be provided
as long as required, as per the opinion of the
investigator. However, if it is established that
the injury is not related to the clinical trial,
the medical management may be ceased. In
addition, in cases of death or permanent
disability, compensation to the trial subject
will be decided by the Drug Controller General
of India. Orphan drugs Orphan drugs are those
that are intended to treat the rarest of
conditions, like those which affect not more than
5 lakh people in India. No fee will be charged in
respect of application for conduct of clinical
trials for orphan drugs. Furthermore, local
clinical trials for orphan drugs permitted to be
imported for sale or distribution in India have
been exempted. With all these new clinical trial
rules, the ethical and quality standards of
clinical trials in India will be improved, which
will further benefit patients. Early access to
drugs will be made possible to patients with
these new rules that reduce the approval period,
and eliminate local trials, wherever possible
and not necessary. This changing scenario is set
to boost the Indian clinical trial industry in
the future for sure. If you are willing to set up
a career in this booming industry, you must have
yourself enrolled for top clinical research
training in Bangalore from a reputed institute
like Avigna Clinical Research Institute. The
institute is a well-recognized one, which is
known as the market leader in innovation for its
curriculum, and who has the best placement record
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