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In yet another boost to clinical research in India CDSCO has published two circulars wherein they have withdrawn two pre-conditions for approving clinical studies which was imposed in year 2013.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…
Dynamic and different L&D prospect for Pharma marketers and teams
Mark Lawson, sales and marketing director at Lundbeck and member of the Executive Steering Committee, said: “Taking part in the competition is superb development for marketers. It tests their analytical capability, understanding of strategy and tactics and most importantly it…
Sponsors 62% more likely to engage CROs than 5 years ago
A recent survey by Worldwide Clinical Trials reveals that 62% of respondents are more likely to engage a CRO partner for clinical research than they were five years ago, demonstrating the increasingly vital role that CROs are playing in modern drug development,…
Top three therapy areas dominate pipelines
The world’s top three therapy areas accounted for 68 percent of the overall pharmaceutical industry pipeline as of Q1 2016, according to business intelligence provider GBI Research. The company’s Innovation Tracking Factbook 2016 states that oncology is by far the…
CDSCO Updates
CDSCO came hard on applicant firms who are not attending the scheduled meeting of Subject Expert Committee. Failing to attend meeting by applicants moving forward will be treated as APPLICATION WITHDRAWN and the matter will be closed. Notice-Not attending SEC…
