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Abstracts: Clinical trial may be defined as “A
systematic study of drug(s) in human subject(s) to
generate data for discovering and / or verifying the
clinical, pharmacological and /or adverse effects with
the objective of determining drug(s) safety and / or
efficacy”.
It is mandatory to conduct the pre clinical and clinical
trials for approval of drugs by any regulatory
authority. Most importantly the clinical trial data will
be accepted by the regulatory authority if it is been
conducted in a registered clinical trial centre.
Clinical trials were primarily conducted in the United
States. There was paradigm shift from the west to east
for conducting the clinical trials because of the cost
factor. Developing countries such as India, China and
South East Asian countries have tapped the very
potential clinical trial market. India has exploited the
potential for clinical research by attracting various
international and domestic pharmaceutical companies.
Scenario
India presently occupies only a small quiche of the
global market. The total numbers of clinical trials
conducted in India were 221 in 2007 and had increased to
just over 700 trials in 2008. Although there was an
increase of 65%, it associates to only single digit
percentage of the global clinical trial market. The
country is projected to conduct nearly 5% of the global
clinical trials by 2012. However, to achieve its goal of
becoming a global center of clinical trials, the country
has to overcome few challenges.
Clinical trials and research is now a major business in
India. Over 100 companies are currently conducting the
clinical trials in India. Top multinational
pharmaceutical companies like Pfizer, Glaxo Smith Kline,
Aventis, Novartis, Novo Nordisk, Astra Zenica, Eli Lilly
are conducting clinical trials in India apart from the
Indian companies like Dr. Reddys, Nicholas Piramal,
Cipla and Lupin.
Advantage India
India has an advantage of having huge population, well
equipped hospitals, trained doctors, government
initiatives and low cost. Population of over 1 billion
with a life expectancy of 65 years, large number of
patients who are suffering from various diseases,
heterogeneous and high enrolment rates provides
opportunity for clinical trial organization. More than
15000 hospitals provide the opportunity to select the
best with well trained doctors of over 500,000 and
nurses of 737,000. Increased awareness among various
health care professional regarding ICH–GCP (The
International Conference on Harmonisation-Good Clinical
Practice) guidelines for conduct of clinical trials.
Large pool of scientifically trained, English speaking
personnel who can be involved in clinical trials.
Government has taken initiatives like regulations in
data protection and data exclusivity. Import duty on
clinical trials is exempted. Availability of
infrastructure required for conducting clinical research
which includes connectivity with remote locations. It is
now possible to conduct meetings/training through strong
networking facilities provided by Information technology
sector. Overall cost of conducting clinical trials is
low in India when compared to US, it is estimated to be
half the cost (See Table 1). Cost of drug research and
development is high, hence, pharmaceutical companies are
attempting to reduce the Cost and time required to bring
a new drug to the market. Lower cost is a combination of
clinical researchers cost, nurses cost, doctors cost,
cost of infrastructure facilities and cost of subjects
recruited for clinical trials.
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