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Re: DewDiligence post# 10178

Wednesday, 11/11/2015 3:46:02 PM

Wednesday, November 11, 2015 3:46:02 PM

Post# of 30493
India makes it easier to approve new drugs already approved elsewhere:

http://health.economictimes.indiatimes.com/news/pharma/india-eases-testing-norms-for-new-drugs/49743892

India has taken a series of steps that eases norms for testing and clinical trials needed for introduction of drugs already approved in other countries.

The move places greater responsibility on the Ethics Committees - that vets clinical trials - and is expected to cut timelines for launch of new medicines, including biologics.

The Central Drug Standard Control Organization, through a Nov. 10 circular, said if a new drug was already approved outside India after conducting pre-clinical/toxicological studies on animals, such studies are not required to be repeated while approving their proposal for import or manufacture in India unless some specific concerns are raised.

This is a pretty big deal for multinational drug/biotech companies, IMO.

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