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REVISED PROCEDURAL STEPS TO PROCESS OF THEPROPOSALS FROM THE INDUSTRIES by RCGM

 

     
Steps
Time in days
Image
A)
Application Processing by RCGM
90
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B)
Examination of data by the DCG(I) Advisory Committee (Scientific Biosafety and Ethical Issues)
Clearance for Phase I clinical trial by DCG(I)
60
Image
C)
Examination of phase I clinical trial data by DCG(I)
Clearance for Phase II trials by DCG(I)
30
Image
D)
Examination of Phase II clinical trial data by DCG(I)
Clearance for the Phase III clinical trials by DCG(I)
30
Image
E)
Examination of Phase III clinical trial data by DCG(I) in consultation with GEAC
Clearance for manufacturing activity by DCG(I)
90
Image
F)
GEAC/DCG(I)/State Drugs Controller
Clearance for manufacturing activity