"Unethical clinical trials" head for India

A Netherlands-based global health advocacy group which monitors clinical trials in developing countries claims that lack of regulation, accountability, cheap operating costs and easy access to volunteers are the reasons that research-based drugmakers are basing studies in India. Jacob Sijtsma, a spokesman for the WEMOS group, claimed at a bioethics conference in Bangalore, India, that, of 22 documented unethical clinical trials operating in 2006, eight were in India.

The advocacy group also claims that "documented illegal trials" were reported in both the UK and the USA, the Inter Press Service news agency said. However, a spokesman for the Association of the British Pharmaceutical Industry told the Marketletter that he was unaware of any drug company-related clinical trial in the UK in 2006 that was "unethical or illegal." In addition, he explained that, although it is a voluntary requirement, the ABPI expects its members to make information about all clinical trials publicly available, either on their own corporate web sites, or via the ABPI itself.

Although the campaigners admit there have been regulatory improvements in recent years, including an on-line clinical trial registry administered by the Indian Council of Medical Research, enforcement issues remain.