Clinical Trials In India
India has been in focus
as a hub of clinical trials. Many Indian cities and villages have
centres which do clinical trials. There are two questions :
1) Do India need
to allow the clinical trial
2)ethical issues
3) Is there heavy
exploitation in name of clinical trial.
The clinical trials are
done by mostly big pharma companies. It is difficult for these
companies to get permission in their respective nations for the
trials. The pharma companies have a great opportunity to have their
trials in India due to high population/ lesser activism against
trails/ more persons willing to take trials (lack of alternative)
The heavy exploitation
where the middle men in India
( agencies/doctors/outsourced
companies) bag the money while the person who takes the trial getting
a pittance is another sad side. There are complaints that people are
brought into the trial through half-truths about the interventions
they are to undergo.
source: padisysmobileclinicaltrials.wordpress.com |
Why india is a favoured destination?
India has diversity in
population and also all diseases. The poor people and easy access to
people due to lack of proper health care. All diseases –
communicable and non communicable are present in large numbers in
india. India has lot of patients who cannot afford medical care. They
are lured into the drug trials since they have no other option for
treatment.
How is clinical trial conducted in India?
The company has to get
the clearance from DGCI and the clinical trial is conducted under
scheduleY of drug and cosmetic rules. The pharmaceutical companies
deploys CROs(contract research organisations) for conducting
researches. The permission of local ethics committee has be acquired
before conducting clinical trial.
Is the present system
sufficient?
The DGCI's monitoring
system is flawed. There is not enough staff or enough expertise to
check the plan design or the impact of clinical trial.
Time and over again
NGO's/ journalists/ social media have questioned the ease with which
many companies got permission for the trials. The incidence where 5
persons undergoing trials at Khamman Andhrapradesh died turned focus
on the safeguards of the trials. The SC had also come heavily against
the unethical trials. (click
here).
The Ranjit Roy report
has recommendations for betterment of the system.
Download Ranjit
Roy Report (only the recommendations part needed). Read the
action taken by government regarding the report.
The links to the recent
updates can be found here (click
here)
The Action taken report
(Click here)
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