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Background

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 organisations for establishing clinical research facilities has been well recognized and a number of Contract Research Organizations (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 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 University--KBC Research Centre (AU-KBC) and Apollo Hospitals Educational and Research Foundation (AHERF) have jointly come forward with this program.

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