Bilcare, a Pune-based company that provides research, clinical and packaging services to the pharmaceutical industry, has launched the Indian chapter of the US-headquartered Association of Clinical Research Professionals (ACRP) and inaugurated its first academic centre in partnership with ACRP.
The initiatives, which confirm the fast-growing international interest in India as a clinical trial centre, as well as the reciprocal need to build capacity and professional expertise to international standards, is part of a wider effort to “uplift the clinical research infrastructure in the Asian region,” said Mohan Bhandari, chairman and managing director of Bilcare Research.
The ACRP is forging a similar path to the UK-based Institute of Clinical Research, which earlier this year appointed its first country manager for India. According to Bilcare, the new ACRP chapter will serve as a gateway to quality clinical research training in Asia.
The company had previously announced its plans to open up 30 academic centres across India and other parts of Asia, with an initial investment of 200 million rupees ($4.9 million) and a goal of training at least 5,000 quality clinical research professionals by 2010.
The first Bilcare Research Academy was inaugurated in the company’s home base of Pune, with links to Bangalore Diabetic Hospital and nine other hospitals across India. A second centre should be launched shortly in Bangalore, while Bilcare expects its first academy outside India to be up and running in Singapore before year-end.
Speaking at the inauguration, Thomas Adams, president and chief executive officer of ACRP, predicted that the forthcoming presidential elections in the US could give further momentum to India’s $200 million clinical trials sector, which currently accounts for just 1% of the world market.
The Democrats in the US “are keen to empower the government to negotiate drug prices directly with pharmaceutical companies as well as to provide for re-importation of drugs,” Adams noted. “If accomplished, these measures could reduce the profitability of big pharma, which would impact their resources for inventing new drugs. In such a scenario, pharmaceutical companies would be forced to offshore their clinical trials to cost-effective regions, particularly to India.”
At the same time, the Indian authorities are at pains to emphasise that any economies from outsourcing of clinical research will not come at the expense of quality and safety. “We will not compromise on any clinical trials and research that are being conducted in the country,” insisted M Venkateshwarulu, Drug Controller General of India, at the inauguration.
The proposed Central Drug Authority bill, which would be tabled during the forthcoming monsoon session of Parliament, included a five-year prison sentence and a 2 million rupees fine for anyone found violating clinical trial norms, he pointed out.