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European Pharmaceutical Contractor
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| With India fast becoming a new pharmaceutical frontier, Ed J Brennan at IndiPharm
explains why outsourcing here makes sense in order to achieve lower cost clinical trials
Western pharmaceutical and biotech companies need to
increase productivity, decrease costs and shorten the time-tomarket
for new drugs. The costs of clinical trials needed to gain
regulatory approval represent roughly two-thirds of the typical
billion-dollar cost of developing a single new chemical entity
(NCE). There is, therefore, a critical need for conducting
clinical trials that provide lower cost and faster recruitment
without compromising the quality of the research.
WHY INDIA?
India provides a number of significant advantages as a
destination for clinical trials. It offers a large patient population,
low per-patient trial costs, and a highly qualified professional
medical community (many of them Western-trained), as well as
global quality hospitals and clinical research facilities.
Furthermore, with a highly developed IT and data collection
capability and no language barrier, India has become an
increasingly attractive destination for clinical trials.
THE BACKGROUND
Until recently, there were few clinical trials conducted in India by
Western pharmaceutical and biotech companies, primarily
because of regulatory hurdles. Recognising the significant
advantages that India offers to multinational companies and the
potential benefits of conducting clinical trials in India, the
Government made major changes in 1999 with the amendments
to Schedule Y of the Drugs and Cosmetics Act. These changes
formalised the definition and conduct of clinical trials; specified
the responsibilities of the sponsor, the investigators, and the
Ethics Committees; developed guidelines and procedures for
importing drugs for clinical trials; instituted required compliance
with GCP; specified the requirements for informed consent; and
defined the structure, content and formats of clinical study
reports. In addition, the Indian Government provided increased
protection for intellectual property (IP). |
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