Drug clinical trials may be outsourced to India

Pune: Clinical trials of drugs in India that currently accounts for one per cent of the world market could be the next step in outsourcing from the US.

Mr Thomas Adams, President & CEO of the Association of Clinical Research Professionals (ACRP), expressed the opinion while inaugurating its India chapter in association with Bilcare Research here.

'The US elections may trigger India's fledgling $200 million clinical trials industry. Democrats are keen to empower the government to negotiate drug prices directly with pharmaceutical companies and provide for re-import of drugs. If accomplished, these measures could reduce the profitability of big pharma, and impact resources for inventing new drugs,' Mr Adams said. 'The companies would be forced to offshore their clinical trials to cost-effective regions,' he added.

The Drug Controller General of India (DCGI), Mr M. Venkateshwarulu, emphasised the need for transparency and knowledge about the associated risk factors. 'There cannot be any compromise on clinical research and the trials that are being done in the country. The proposed Central Drug Authority Bill that envisages imprisonment of five years and a fine of Rs 20 lakh for those found violating norms of clinical trials, will be tabled during the monsoon session of Parliament.'

Training


In association with ACRP, the Bilcare Academy will impart training to hospitals, clinical research organisations and other intermediaries in the clinical research business in India and Asia. Bilcare has already tied up with Bangalore Diabetic Hospital and nine other hospitals across the country where customised programmes will commence shortly.

Mr Adams said, 'The first phase of our partnership will focus on programmes in India and Singapore followed by Thailand, Korea, Malaysia, Bangladesh, Sri Lanka, Indonesia and China in phases.'

Mr Mohan Bhandari, Chairman and Managing Director, Bilcare Research said, 'The ACRP-Bilcare academy will bridge the gap of a long awaited qualitative manpower requirement and practices in India and Asia.'

Bilcare proposes to open 30 academic centres across India and Asia with an initial investment of Rs 20 crore and aims to train at least 5,000 clinical research professionals by 2010.