AU-KBC RESEARCH CENTRE
Background
of the Program
The Indian Pharmaceutical Industry is rated as one of the fastest growing
industrial segments not only in India,
but also in the global scene. So far the Indian drug industry had its dominance
as a supplier of generic drugs for the Indian and global markets. With the
advent of the post - 2005 TRIPS compliant patent regime, the Indian industry is
moving into the R&D space to meet global challenges 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
companies.
One of the most important components of clinical research is the conduct
of well 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.
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 CRO industry
is poised for substantial growth in the country. It is estimated that during
the next three years the CRO industry in India
would be worth about a billion dollars, and the requirement of personnel for
the management of clinical trials in India alone could be around 50,000.
Given the rather inadequate number of programs as well as 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.
It is to help fill this gap that the AU-KBC Research Centre is coming
forward with this program.
[Back]