America’s Drug regulator US FDA is in talks with Indian drug regulator-The Drug Controller General Of India for co-operation on various regulatory parameters.
This alliance between Indian and American drug regulator reveals the global influence that Indian drug manufacture have.The world’s most stringent regulatory authority US FDA is in alliance plans with Drug Controller General Of India to work on most important issues considering drug investigative parameters.
More than 200 Indian drug units presently supplying generic category medicines to the Indian states which are already authorized by USFDA. Moreover Indian drug regulation is to be deeply understood by US regulator consequently better equipped US FDA will supervise Indian manufacturing units.
It furthers helps DCGI’S office in getting full exposure to current features of investigation, drug evaluation and approval processes.
USFDA is planning a risk evaluation and mitigation plans for several vital drugs globally in turn Indian drug regulators are being benefitted from such keen moves.
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5 comments:
WOUNDER FULL DRAFT BUT i have one doubt ,till now we dont have any phase 1 permination ? in india
In the past, Phase I trials were allowed only for Indian discovery molecules . This was done to stop Indians becoming “guinea pigs” for foreign companies. Phase II and onwards was allowed for other MNCs wanting to do a clinical study in India. Foreign companies did begin to do Phase 3 trials in India where this country became a part of the worldwide trials.The expertise for approval of phase 1 studies need to be built whether the molecule is indian or global.
Thanks for this post.
Thanks for this great post......
Thank you for this good post!!!!!!!!!!!!!!!!!!!!!!!
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