The Union Health Ministry is working towards introducing a statute for the biomedical research in the country soon. The Indian Council of Medical Research (ICMR) has almost finalised the draft on the 'Biomedical Research Human Subjects Promotion and Regulation Bill'.

According to experts, this was the most opportune time for the bill to be introduced as India is increasingly being considered by global pharma companies for clinical studies.

The draft proposes to prevent the pharma companies from conducting the clinical studies without prior approval from an accredited Ethical Committee, said a panel of experts comprising DA Prasanna, managing director & founder, Ecron Acunova, Dr Ferzaan Engineer, CEO Quintiles India and Dr Navaneetha Rao, vice president clinical research and development, Vicus Therapeutics.

At a panel discussion during the Bangalore India Bio 2010 on the subject “Meeting the challenges & actualizing the potential in clinical trials,” the experts pointed out that partnership and networking were vital for clinical trials. Asia is projected to become the world’s largest pharma market in five years primarily because India and China were the driving growth.

The value of the Indian clinical research industry is estimated at Rs 8,000 crore ending fiscal 2010-2011. The industry which was valued at Rs 1,200 crore in 2006 grew to Rs 6,500 crore in 2009-10.

According to the Ecron Acunova managing director & founder, India is engaged in clinical research for the last 15 years because of the population size, English communication, diseases burden, naive patient’s advantages, and western medical education.

Eastern Europe has more clinical trials registered compared to India, hence the country has a lot of ground to cover in this area, he said. Ending December 2009, the number of clinical trials registered in India was 1,256 as against Poland which is 2,328. Conformity to EU and US laws, strengthening therapy areas and going up the value-chain to conduct phase III studies were the only way forward.

Presently, there is no apex body to accredit investigators to clinical trials but FDA recognition to doctors acting as investigators was there. In fact over 70 per cent of accredited investigators are from South India and 30 per cent from Karnataka.

To attract more clinical trials to India we should provide information, which includes international data acceptance by USA & EU, build therapy area competence by providing special expertise and knowledge in clinical studies in the area of oncology. There is also the impending need for drug safety specialists to conduct clinical trials along with strict adherence to quality, credible regulatory authority and support infrastructure to build an ecosystem required to face the challenges in human studies, he added.

It is said that the new models of business are emerging and there is geographic shift from west to east. Therefore, India’s clinical research industry needs to adapt, evolve and change. There is a need for potential to reverse from outsourcing to innovation in the pharmaceutical industry. India started conducting clinical trials which was mostly outsourced work, said Dr Ferzaan Engineer, CEO Quintiles.

There is a decade of change. The environment is now different due to rising cost in research and development, increasing regulatory scrutiny and complexity. While China was ahead in R&D, India was strong in clinical drug development and information technology. Hence, both India and China complement each other and need to work together, added Dr Engineer.

Dr Navaneetha Rao, vice president clinical R&D, Vicus Therapeutics, USA, said that the potential of clinical trials is crucial for developing products that are safe, effective and affordable.