cover story
Green signal to academic trials
raise hopes
The government’s move to allow trials for institutional research activities will
not only boost the new discovery efforts but also help in building confidence
among researchers
T
BY SAYONI RAUTELA
he recent Gazette notification on March 16,
2016 by the Ministry of Health and Family
Welfare regarding exemption given to
academic trials approved by the Ethics Committee
for a new indication, new route of administration,
new dose or new dosage form of approved drug
formulations, is expected to give a much needed
boost to institutional research being conducted
in India.
“Our academic and teaching institutions are engaged in
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BioVoiceNews | July 2016
path-breaking research that addresses the unique
health challenges of our country,” said Dr Shashwati
Pramanik, Chair, Regulatory Council, ISCR, “The work
they are doing is helping create not just new and better
treatment for diseases endemic to our region, but is
also making them more affordable and accessible to
patients. The recent amendment will significantly
reduce start-up timelines due to exemption from DCGI
approval while maintaining vigilance through Ethics
Committees. Thus, this will give a big fillip to these