CDSCO

Is India Ready For Phase I Studies?

Tuesday, August 15, 2006

India has come a long way as a center for clinical drug trials, but is the country ready for Phase I studies? I think the short answer – and others would agree – is “no”. Take, for instance, recent comments by Ashwini Kumar, the Drug Controller General of India (DCGI), who spoke recently at the Drug Information Association’s (DIA) Annual Meeting in Philadelphia. Kumar, head of the Central Drug Standard Control Organization (CDSCO), India’s regulatory agency, said that India needed to create an environment for the best quality assurance before embarking on phase I studies…

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