India Government Drafting Human Research Regulation Bill

India's government is drafting legislation to regulate research on humans, according to news reports.

The possibility that India may impose regulation is important because the country is seen as an inviting resource for clinical trials with its large population of "treatment naive" people who haven't been exposed to medication, and a workforce that includes some 500,000 physicians.

In January 2004, Ajay Piramal, chairman of Nicholas Piramal India, the country's second largest drug maker, told Dow Jones at the annual World Economic Forum, that US and European drug companies should consider India as a site for conducting drug trials on humans because of potential savings from $200 million to $900 million on the development of a drug, a cost that is pegged at some $1 billion to $1.7 billion.

According to India's Business Standard publication, the human research regulation bill, which is likely to be introduced in the next session of parliament, draws heavily on ethical guidelines issued by the Indian Council of Medical Research and would provide for a regulatory agent to enforce ethical practices in scientific research on humans, including all clinical trials, and for research ranging from genomics to stem cells. Presently, India's drug controller-general (DCGI) regulates clinical trails.

The DCGI agency recently announced that it would create a website, slated for operation in the first quarter of 2006, to provide information about clinical trials in India including the name of the pharma sponsoring organizations, the contract research organizations involved, the number of volunteers, the clinical endpoints of the trials, and contact details. Additionally, the DCGI, with World Health Organization support, will seek to begin random inspection and audits of clinical trials in January with a team of 30 inspectors focusing good clinical practices.

According to the DNA India publication, there are about 350 Indian companies and 100 global firms presently involved in clinical trials in India with some 3,500 drugs under development and 4,000 new drugs applications reported.

The current India clinical trials market is estimated at $35 million, and predicted to grow to some $300 million by 2010, according to the India Times