What Has Made India A Favorable Destination For Clinical Trials? - ACRI - PowerPoint PPT Presentation

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What Has Made India A Favorable Destination For Clinical Trials? - ACRI

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India is a large patient pool with more people looking forward to opt for clinical trials. Moreover, the costs of such trials in India and the approval times are low; making India a favourable clinical research destination. – PowerPoint PPT presentation

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Title: What Has Made India A Favorable Destination For Clinical Trials? - ACRI


1
What Has Made India A Favorable Destination For
Clinical Trials?
Clinical research is one of the most important
industries in the medical field today, where
trials are conducted to ensure the safety and
efficacy of new drugs. There are a set of
standard guidelines that have to be followed to
make successful reports of trials. Clinical
research in India was introduced more than a
decade ago, but there was a downfall in the
number of clinical trials in the country after
2010 due to multiple uncertainties and
unfavorable regulations. Looking at this, the
Indian government took initiatives in 2013 to
standardize the regulatory guidelines and
enforced rules to maintain ethical issues. These
were monitored and altered by a team of several
regulatory bodies involved in pharmaceutical
regulation in India. These include the DCGI,
DBT, CDL, DTAB, CLAA, ICMR, and GEAC. Keeping in
mind that a successful clinical trial can only
be possible when there is a balance of highly
skilled healthcare professionals, timeliness,
and cost effectiveness, the regulatory bodies
came up with many successful changes. The three
most important factors that have led to India
again becoming a favorable clinical trial
destination include
2
  • There is a large patient pool in India which has
    made it one of the reasons that has made the
    country one of the most favorable destinations
    for clinical trials. India constitutes almost 20
    of the total world population, having 1/5th of
    the global burden of disease. There is an
    increasing prevalence of communicable and
    non-communicable diseases like TB, HIV, malaria,
    cancer, diabetes, cardiovascular diseases, etc.
    Moreover, it has a record of the highest toll on
    maternal, neonatal, and child deaths in the
    world. These diseases levy heavy cost burden on
    healthcare expenditure. Also, India consists of a
    diverse talent pool with a large number of
    healthcare professionals including doctors,
    nurses, researchers, clinical practitioners, and
    laboratory technicians. In addition, there are a
    large number of skilled professionals in the
    field of information technology and other
    sciences related to clinical trials.
  • Furthermore, the cost for conducting clinical
    trials in India is only 1/10th that of the costs
    in
  • USA. This is why many pharmaceutical companies
    are relocating or outsourcing the clinical trial
    processes to India. This in turn has
    exponentially increased the research and
    development expenditure in the pharmaceutical
    industry.
  • Moreover, the regulatory bodies in India have
    also set new timelines that ensure trial
    applications to be approved in a relatively
    shorter span of time. The DCGI gives its first
    approval for conducting clinical trials within 45
    days, whereas for conducting a bio- equivalence
    study, it takes 28 working days. Additionally,
    any approval of investigational new drug by
    referral bodies or experts will take 12-14 weeks
    more. Finally, the completion of process will
    take another 45 days in case of any discrepancies
    in the applications that will be sent back for
    review.
  • All of this has made India a favorable
    destination again in the list of countries for
    clinical trials. Looking at this success, more
    and more candidates want to take up clinical
    research as a career option to help find
    innovations to eliminate all forms of diseases
    from the country. If you are one of them, you
    need education from Avigna Clinical Research
    Institute, one of the top clinical research
    institutes in Bangalore, where you can attain
    quality information from highly qualified
    professionals online, right from the comfort of
    your home.
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