1. Introduction:

Clinical research is now considered as one of the promising areas in the pharmaceutical field. This is one of the fastest growing disciplines in the Pharmaceutical industry. According to the Lead Discovery reports, the global clinical trials industry is currently about $10 billion and has the potential for fast growth in the future. The Indian clinical trial market has grown from $35 million in 2002 to $120 million in 2006. It was estimated that this market will grow to a large extent by 2010. Centre Watch expects it to be around US$ 250-300 million1, whereas McKinsey estimates a much higher figure of US$ 1.0-1.5 billion2. In 2002 40-50 clinical trials were conducted by 200-250 investigators and presently we have 700-1000 investigators in India. In USA 40000 investigators are conducting about 60000 trials.

In the recent past, there were several controversies noted that the existing legislature needed extensive changes for the safety of the patient, as well as to meet up the surrounding clinical trials and their procedures and it was needs of the clinical research industry in India. As a result, a number of regulations emerged and the existing Acts & Rules were amended. In the past Latin America and Eastern European countries like- Romania, Russia, Poland, Czech Republic, Hungary, Slovenia, Croatia etc. were preferred over India, but recently India is being considered as a global hub for clinical trials3. A report by Rabo says that India has the largest pool of patients with many diseases, including cancer and diabetes. This serves as a good volunteer base for clinical trials. (more…)