AU-KBC RESEARCH CENTRE
The Indian Pharmaceutical Industry is rated as one of the fastest growing
industrial segments in India.
However, its dominance so far has been as a supplier of generic drugs for the
Indian and global markets. With the advent of the post - 2005 TRIPS compliant
product patent regime, the Indian drug industry is moving into the challenging
phase of having to its own R&D work for the discovery and development of
new drugs. Drug discovery and development involves both extensive pre-clinical
and clinical investigations before the products are ready for marketing.
Clinical research is one of the most important, complex and expensive
components of drug development, which has so far been carried out in India
mostly to substantiate and validate already established drugs for the Indian
market. In recent times the advantages of setting up Indian organizations for
establishing clinical research facilities has been well recognized and a number
of Contract Research Organisations (CROs) have come up in India to carry out clinical research
not only for products of Indian origin, but
also for those originating from the global R&D based pharmaceutical
One of the most important components of clinical research is the conduct
of controlled clinical trials in patients after the candidate drug has been
subjected to pre-clinical studies to determine their safety and efficacy in
experimental animal models. Due to the availability of large patient
populations with diverse disease conditions, cultural variations and variations
in dietary habits, skilled clinical investigators and adequate analytical
facilities and resources, India
offers tremendous possibilities for the successful conduct of clinical trials.
In addition IT skills support these trials through the technologies of Clinical
Database Management (CDM), etc. Apart from these there are important cost
advantages when clinical trials are conducted in India, an important
consideration for reducing the overall costs of drug discovery and development
- over a quarter of the overall expenditure of developing a new drug from
concept to market is estimated to go into this activity alone, and cost saving
here can impact significantly on the business prospects.
Because of these reasons, as well as due to the passing of the Amendment
to Schedule Y of the Indian Drugs and Cosmetics Act in 2005, the Clinical
Research industry is poised for substantial growth in the country. It is
estimated that during the next three years the Clinical Research industry in
India would be worth about 2 billion dollars (2012), and the requirement of
personnel for the management of clinical trials in India alone could be around
50,000 in 2010 (McKinsey report). Given the rather inadequate number of quality
programs and facilities presently available for the training of such manpower
in India, it is obvious that
there is a need for established institutions to come forward to fill the gap
and help India
leverage this newly emerging global opportunity.
Given its complexity and the criticality of its consequences, Clinical
trials are coming under increasing public scrutiny, and instances have been
reported where improper procedures and practices have occurred, either by
design or by oversight-- once again highlighting the need for quality manpower
training programs in this domain. In this connection, the Clinical Trials
Registry- India (CTRI) has been set up by the ICMR's
National Institute of Medical Statistics (NIMS) and the mission of this is to
encourage all clinical trials conducted in India to be prospectively
registered before the enrollment of the first participant.
It is to help meet this national demand for quality manpower in this
domain that the Anna
Centre (AU-KBC) and Apollo Hospitals Educational and Research Foundation
(AHERF) have jointly come forward with this program.