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.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”