Friday, September 12, 2008

Phase I Trial Outsourcing in India by 2010?

Outsourcing-pharma reports that Phase I outsourcing of trials to India may be allowed in 2010. Currently Phase I trials are not allowed in India, but the Central Drugs Standard Control Organisation (CDSCO) is considering changes stances.

Allowing Phase I trials to be outsourced to India would boost India’s thriving clinical outsourcing industry as well as offer pharma companies a cost-cutting route. These are some of the areas that the CDSCO will be focusing in on: fixed timelines of 2-6 weeks for each application, internet based new drug application (NDA) status and the recruiting subject experts and reviewers.

Will the recent new of infant deaths in India change the progress of this proposal?

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