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p However, a lot has changed in the clinical
research scenario since then.

p Today, clinical trials are conducted through a


regulated approach following certain guidelines
laid down by the International Conference on
Harmonization (ICH), which is spearheaded by
U.S.A., Europe and Japan
p The clinical research industry in India has been
growing rapidly. During the last 3 years it has
increased from Rs. 20 crores to Rs. 100 crores.
According to a recent McKinsey report, by the
year 2010 the industry is expected to grow up
to Rs. 5,000 crores.
¬ 
   
p India has become the preferred destination for
global clinical trials today. The unique criteria that
make India so attractive are:
1. India has a huge population base of more than 1 billion
(Indians represent about 15% of the global population)
2. This population is genetically, culturally and socio-
economically diverse
3. Asians have been seen to react differently to drugs as
compared to their Caucasian counterparts
4. India has the largest pool of patients (e.g. the highest number
of cancer and diabetes patients are found in India)
5. It is home to a wide variety of diseases ranging from
tropical infections to degenerative diseases
6. The patient population in India is mostly treatment naïve
Patient: doctor ratio is high
7. There is no dearth of professionals trained in the field of
medicine
8. India has a large pool of highly qualified and dedicated
scientists and clinical research professionals
9. The country is renowned for it¶s prowess in information
technology
10. English is a primary language of education and
communication among Indians
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p The use of Indians µfor the benefit of the
Western world¶ has extensively been criticized.
Before jumping into any ill-informed
conclusions, it would be worthwhile to
understand the benefits of clinical research.
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p Have access to the latest medication or treatment
modalities.
p Get free medical care, which includes costs of
investigations and medicine.
p Enter into the trial voluntarily after signing an informed
consent.
p Are not bound to continue to participate in the trial (The
consent can be withdrawn at any time).
p Receive more frequent and focused consultations leading
to an improvement in the quality of healthcare.
        

  
p Get first hand experience with the most recent drugs
p Get global recognition working on the same platform
as other international experts on the project
p Get extensive training in the internationally accepted
Good Clinical Practice (GCP) and Good Laboratory
Practice (GLP) guidelines
p Get an opportunity for publication
p Have access to the latest medicines for their patients
      
   


p Get infrastructural development

p Get global recognition


×        


p In spite of all the present pitfalls, the country is certainly
gearing up to attract more and more researchers from around
the world to conduct their clinical trial studies in India.
p The regulatory system is being polished.
p Laws are being amended to facilitate the entry of global
clinical trials.
p Massive and concerted efforts are on to train research
professionals and increase the base of investigators and
supporting staff.
p This will ensure the timely conduct and completion of the
clinical trials and at the same time generate high quality data
for international submission.
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CLINICAL TRIAL ACTIVITIES IN ASIA ALL STUDIES
www.clinicaltrials.gov-Snapshot: 7 Feb 2008
Countries with more than 100 studies listed
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  12,3 3,3
% 
  45 6234
7  ,53 ,,
8  ,6 ,33
%  65 252

  
   552 95
  53, 463
% 
& 8  32 93
  
3 453

 19 4555
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p ver the last five years India has become a preferred
destination for global trials.
p This globalization has brought challenge of compliance to
global regulatory and ethical norms.
p To meet this demand, Indian regulatory system had been on
an evolving mode for quite some time now.
p From an era of bureaucratic hurdles, delayed approval
timelines and lenient attitude towards misconducts, it is
rapidly moving to an era of fast- track approvals, active
inspection of sites and mandatory registration of Indian trials
in national trial registry in an attempt to meet global
regulatory expectations of stringency and transparency.
p The government is aggressively promoting India as a
location for clinical trials even before setting up the
structure to regulate the conduct of these trials.
p Clinical trials are conducted by contract research
organisations which are making inroads into small towns,
identifying trial sites in small private hospitals and
developing databases of potential trial participants.
p Medical professionals are given substantial incentives to
recruit their own patients into these trials thus creating a
major conflict of interest that threatens the well-being of
patients.
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p Another welcome initiative taken by the DCGI is to
conduct inspection of trial sites.

p Recently the DCGI inspectors had visited an Indian site


which reported death of an infant participating in a
vaccine trial by a foreign company and halted the trial
suspecting violation of regulatory norms.

p The DCGI, in collaboration with USFDA has recently


concluded an initial training session of 25 members to be
designated as potential inspectors.
p Indian regulatory system has started adapting itself to
the demands of quality, transparency and
accountability of global trials.

p The recent initiatives underscore the fact that our


national regulatory authority is in the process of
becoming more pro-industry, more vigilant and more
efficient, which translates to a more US FDA-like
regulatory system that by all means is the need of the
hour.
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In the year 2005, contract research in India


was estimated at $100-120m, growing all the
while at a rate of 20-25 per cent each year. By
the year 2010, it is estimated to hit a target
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p Clinical research holds tremendous scope and
opportunities not only for trained medical,
pharmaceutical and paramedical professionals,
but also for regulatory authorities, government
and the society at large
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