It was recently reported in Le Monde that the Indian Government had invited pharma companies to conduct trials in India, even where the safety of those drugs had not been demonstrated in humans. The newspaper stated that trials cost up to 40-60% less in countries such as India and that the financial inducements offered by companies were attractive to poorer people, who were more likely to participate in such research.
 
A Right to Information request by Rahul Verma, founder of an NGO, Uday, in India revealed that 49 infants have died during clinical trials for pharmaceutical companies at the All India Institute of Medical Sciences (AIIMS) in New Delhi since January 2006. Does the Commission consider that such infant deaths were a result of natural causes, or whether these multinationals conducting clinical trials in India should be held responsible?
 
Those who defend the use of infants in clinical trials argue that infant mortality rates in India are higher than the deaths that occurred among those in the trials. However, these clinical trials target children of low socio-economic status whose parents do not comprehend what the study entails. During the period of investigation, 4,142 infants entered into a total of 42 clinics of which 2,2728 were less than a year old.

Can the Commission give its opinion on whether the practice of using infants like guinea pigs for drug testing is at all ethical?
 
Experts forecast that human clinical trials will become a multi-million dollar industry in India by 2010; both GlaxoSmithKline and Johnson & Johnson have been involved in 22 trials each, testing new drugs in India over the last year.
 
The international community should address this serious issue within the lucrative, multi-million dollar drug industry. Does the Commission agree that such unethical treatment should be stopped?
 

Signature(s): Kathy Sinnott                                                                                                                                                 
Date:  5.09.2008