Scenario of Clinical Research In India

The prospects of clinical research, especially delivering the market

driven worldwideclinical research trails, including international
bioequivalence studies, started as a pleasant dream in India in the
early 2000s. It was ascertained by many experts that by 2012,
India would be all set emerge as a global center of excellence for
clinical trial.
After implementation of the product patent in India, almost all
MNCs have started large clinical trialshere. India provided an
increased access to treatment of ingenuous subjects in cancer,
asthma, diabetes, BP, tropical infections and degenerative
diseases by listing a huge number of sites outside of major
markets. Another important factor is an enormous cost saving
through economies of scale and cost of labor. Another important
requirement is skilled investigators and assisting manpower in
trials and IT management, the former being well-trained in good
clinical practice and other good practices norms in India.

Until the year 2009, it was a pleasant dream and somewhat smooth in
nature, but ever since then there has been a rude wakening to the fact that
since then there has been a dramatic fall in successfully conducting and
delivering the international CTs outsourced to India. According to some
statistics, this drop is up to about 50% in last 4 years.
For a effective conduct of trials, one requires competent, well trained and
experienced investigators and resourceful sites. Every individual
associated with a clinical trial say it be investigators, supervisors, trial
designers, all need a formal training on the required subjects and areas.
Unfortunately, there is a big gap in India between theory and practice for
success in all these areas.
The lapse in ethics in India though not very frequent, but it should be
emphasized for many reasons. Recently Supreme Court of India has
criticized the government for being negligent about CT deaths and
unauthorized trials and also banned new molecular entity trials under
certain conditions .

The apex court further instructed that the government come up with a
new regulatory regime for Clinical trials that would reflect the concerns
of all stakeholders, including subjects who volunteer to be part of the
tests at the risk of adverse health effects and even death.
The good news is that even as this proposal is evolving , recently the
Central Drugs Standard Control Organization (CDSCO) has cleared
trial licenses for 50 Clinical Trials such that the industries doesnt
come to a standstill.
There are two main reasons why the current system of regulation and
control in India is not working very well:
Firstly lack of an evidential and competent review system of new drug
applications (NDAs), investigation new drugs (INDs) and abbreviated
NDAs (ANDAs). Yet none has seen a first class review report for any
submitted NDA or ANDA in India. Whereas in countries such as USA
or Canada a review report of an NDA is comparable with an article in a
journal of impact factor of say 25.

Developing a review system is not a childs act. A couple of

hours of an NDA meeting participated by a group of even
competent experts cannot deliver a quality of document and
review thereof. If written-first-class reviews are not produced
for each dossier, no long-term credibility and validity of
regulatory mechanism will be established.
Secondly, thorough address of issue of quality and
documentations. In recent inspections by US-Food and Drug
Administration, it was found that Indian sites could have built
in better quality in their clinical trials had they been paying
more attention to some particular areas. But there is one
major advantages in India is that of a high rate of patient
recruitment, sometimes the investigation sites focus less on
documentation. This need to be corrected as proper
documentation is significant in keeping records.

A lot of work needs to be carried out for worldwideclinical

studiesto flow into India again and to grow to the level of the
developed
countries.
The
industry,
academia,
ethics
committees, sponsors and all other stakeholders are ready to be
in pace with the government.
In the race of many organizationsCRB Tech Solutionshas a big
name in offering trainings onClinical Research.

...Thank You...
Clinical Research Review of clinical Research training instituteis
enough to make you consider and take up a career in this field.
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