Tuesday, April 21, 2009

Full Details are Required for Indian Clinical Trials

According to this article in outsourcing-pharma.com CROS and drug companies that are conducting clinical trials in India will now be required to record full details of all their research including the funding source.

Up until now, registration on Indian Council of Medical Research (ICMR) website was done voluntarily, but now that will all change come this June. Last summer 49 infants died in clinical trials in India, and an infant that died in October should have never been part of the trial because the baby had existing heart problems. As a result of this, the committee wants to be able to regulate and monitor all patients before they are enrolled.

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