Phase III clinical trials for drugs will now be an exception rather than the norm, with more emphasis on post-marketing surveillance, Drug Controller General of India Dr G N Singh has said.
“If a drug is approved in the US, Europe, Australia, Canada or Japan, then phase III clinical trials will have to be done only in cases where there is a specific requirement… Phase IV, that is the pharmacovigilance programme, will go on as usual. Earlier, phase III was waived in some cases, now it will have to be done in some cases. Why should Indians be deprived of the latest drugs that are being developed and marketed in countries where the regulatory system is known to be robust,” Singh said.
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