Thursday, September 11, 2008

Indian government looking into regulation of Clinical Trials

According to this article at Sify Business, the Indian government is looking to allow CROs to conduct Phase 0 and Phase 1 clinical trials. This could begin occurring as soon as 2009 or 2010, after they've implemented an infrastructure to monitor the trials.

Presently, India only allows Phase I and Phase III trials if the company conducting the trial has gone to another country and conducted Phase O and Phase I trials there. But, new regulations could change this as well.

A recent gathering of Confederation of Indian Industry, those who are working with clinical trials took time to address current issues hindering the success of clinical trials in India. Some of these problems addressed were:
-Infrastructure
-Technical expertise
- Drug analysis
- Stringent clinical trial monitoring systems
- Mandatory regulations of CROs
- A way to keep track of patients so they don't participate in more than one clinical trial

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