Abstract
Over the last decade pharmaceutical and biotechnology companies have entered a
period where they have become confronted by a variety of complex issues
affecting their operational efficiency and profitability. It has now become
generally acknowledged that the current business models have become both
economically unsustainable and operationally unsuited to act quickly enough to
produce the types of innovative treatments that will be demanded by global
markets. Major issues confronting both the pharmaceutical and biotechnology
market are: the requirement to reduce the escalating costs and risks
associated with drug development; and reduce clinical trial timelines by
improving patient recruitment and improving the efficiency of clinical trial
results analysis and reporting. The biopharmaceutical industry has recognized
the opportunities and advantages that exist by conducting clinical trials in
what are referred to as the emerging markets. This report identifies market
dynamics and key regulatory changes, and analyzes the implications and factors
which need to be taken into consideration when conducting clinical trials in
India.
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