The country’s drug controller is planning to waive local clinical trial of drugs meant to treat certain type of cancer, AIDS, hepatitis and rare blood disorders if the drugs are cleared in “well-regulated” countries like the US, Australia, Canada, Europe…
Government looks to fast-track approvals for clinical trials
As the government reviews an overhaul of the drug regulatory process, rules related to clinical trials may be further eased and timelines for approvals shortened to four to six months from around six to eight months now. The central drug…
CDSCO LAUNCHED ONLINE APPLICATION FOR GCT (Global Clinical Trials
notice-dated05-10-2016 CDSCO has published notice that online application for Global Clinical Trial application is live and effective 24 Oct 216, it is mandatory to file application online. Although at present hardcopies of application also needs to be submitted along with…
Report of Committee to examine the issues relating to the essentiality of Coronary Stents
The report of committee under the chairmanship of Prof. Y.K.Gupta has been published by CDSCO. There were three meeting held among the committee members and the committee has also met with the stents manufacturers and associations of stents manufacturers. In…
DCGI Office Lashes to FDC Pharma companies
DCGI office lashes to FDC(Fixed Dose Composition) Pharma companies who has not submitted the phase IV study protocol to be reviewed by Expert Committee. It is good to see that DCGI office is becoming stringent where they were suppose to…
CDSCO launches GCP Inspection checklist
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…
