CDSCO has issued circular dated 03 Aug 2016 regarding “Requirement of NOC from DCGI for addition of new clinical trial site or investigator”wherein they have stated that just notification of addition of site/investigator to DCGI is required. However the respective Ethics Committee approval is essential.
This is yet another remarkable decision which will surely be welcomed by Industry and will give shot to improve number of clinical studies in India
NOC from DCGI for addition of Clinical Trial site or Investigators
CDSCO has issued another circular which indicates that CDSCO is making Rules and Regulations more Industry Friendly