India’s sound knowledge in information technology has been a key growth driver of the clinical research industry said Ashis Mukherjee, senior director Hospitals & Oncology BU and Corporate Hospitals, sanofi aventis.

Although the clinical research industry started off in India in 1992, it gained momentum from 2004 and the last three years have seen an exponential growth. An important factor for such fast paced activity in the sector is the sound IT and English skills supported by qualified doctors, trained medical personnel including investigators, research-hospital infrastructure, economies-of-scale and access to recruiting large number of patients. There is huge disease burden the country from cancer, diabetes, tropical fevers to genetic disorders.

The installation of EMR (electronic medical records) by hospitals in the country have also proved as a major attraction for international clinical research organizations (CROs) and multinational companies to off load human studies to India, said Mukerjee in key note address at the inauguration of the two-day Clinicon 2010 which is being held in Bangalore.

In a lucid presentation on ‘Challenges and Prospects of Clinical Research in India,’ Mukherjee said the country’s 100 CROs, 80 hospitals and 150 investigators with US FDA registration have contributed to the clinical trial management capacity and productivity. According to the Ernst & Young Report, clinical research industry in 2010 will be valued at US$ 1,000 million.

There is a steep rise in the global demand for world class clinical trial management for which opportunities in IT specific to clinical trial industry are on the cards. These include data management and medical writing which have widened the scope for outsourced clinical research business to India, said Mukherjee.

On similar lines of several multinational companies, like Pfizer, GSK, Eli Lily, sanofi-aventis too has in India has strengthened its clinical research in the last few years. It manages 220 sites and is keen to team up directly with hospitals for conduct of human studies in specific areas of cardiology, oncology, diabetes, Thrombosis and central nervous system disorders.

The hospital infrastructure and medical expertise have facilitated smooth conduct of phase-III and phase-IV human studies. However, India needs to look at conducting phase-I trials immediately. The expertise in phase-III and phase-IV have given the country much of the recognition to become a hub in clinical research. In order to grow the clinical research industry here, phase-I needs to be taken on, he said.

The challenges of this industry in India is that the knowledge of product patent is low. There has been no focus on drug development till 2005. Despite the presence of large and young team of clinical research professionals, they lack training on Good Clinical Practices (GCP) and Good Lab Practices (GLP). Other issues are that medical education curriculum in India does not have a component on research methodologies and there is no standardized training on clinical research. In addition, there is also a need for accreditation of hospitals on similar lines of NABH for sites selected to carry out human studies, said Mukherjee.