The department which seems to be dormant few months back are on toes with new zeal and motivation. The motivation is to make India number 1 destination for clinical studies. Everyday there is new announcement, notice, circulars coming from CDSCO…
Workshop on Online Application of CT – Minutes
The workshop on “Online Process for Grant of NOC for Clinical Trials” was conducted on 24 Aug 2016 was a great success. Dr. V.G.Somani (ADCGI) was present during the workshop. The workshop started at 11:00 am at CDAC office NOIDA…
Workshop Organised by CDSCO for Online Application of CT
CDSCO has published a notice dated 18 Aug 2016 wherein a hands-on workshop on “Online Process for Grant of NOC for Clinical Trials” has been organised on 24th August, 2016 between 11 A.M. – 4 P.M. at CDAC NOIDA premises…
CDSCO has amended the Import/Export Policy for Human Biological Samples
In line with various amendment which CDSCO has published in this month, the biological division of CDSCO has amended the Import/Export policy for Human biological samples for commercial purposes. The amended notification dated 04 Aug 2016, was published on 11…
SUGAM (Online Portal) for Application of CT – Meeting Updates
The meeting held at the DCGI office on 10th Aug 2016 was very informative. The objective of the meeting was to demonstrate the steps for registration and application for CT NoC through the portal on CDSCO website. There were around…
Services on “SUGAM”(Online Portal) launched by CDSCO is Extended for Clinical Trial Applications
CDSCO has launched an online portal “SUGAM” (www.cdscoonline.gov.in) on 14 Nov 2015. The portal is intended for filing applications for various services rendered by CDSCO. In the first phase, filling of application for import and registration of Drugs and Devices…
CDSCO has issued another circular which indicates that CDSCO is making Rules and Regulations more Industry Friendly
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…
Non-compliances Observed During Review of Applications for Registration and Import Licences of Medical Devices
CDSCO has come up with a presentation to support device industry for a common Non-Compliances observed during review of Applications for Registration and Import Licenses of Medical Devices. This is yet another step which indicates the support of CDSCO to…
CDSCO is determined to Boost Clinical Studies in India
In yet another boost to clinical research in India CDSCO has published two circulars wherein they have withdrawn two pre-conditions for approving clinical studies which was imposed in year 2013. Requirement of 50 bedded site to conduct clinical studies Restriction…
