Thursday, August 21, 2008

New Investigations in Deaths of Babies in Clinical Trials in India

India has become an attractive place for pharma companies to outsource their clinical trials to since on average it costs only 40 to 60 percent of what trials would cost in developed countries. AFP reports that India’s top medical facility will now investigate the deaths of 49 babies that occurred in clinical trials from the beginning of 2006 to the present.

A total of 4,142 babies were involved in clinical trials since January 1, 2006, and more than half of them were under the age of one. Shakti Kumar Gupta, head of administration for the state-run All-India Institute of Medical Sciences, mentions that he wants tougher and stricter regulations for clinical trials business in India, since it is now a 120 million a year industry growing at about 25 percent annually.

Health Minister Anbumani Ramadoss mentions:

"Earlier we had guidelines on how trials need to be conducted. Soon we will have a law."

A committee is expected to submit their findings later on next week. How will this affect partnerships with CROs in the future?

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