NIAID ClinRegs – India

The NIAID ClinRegs website provides an online database of country-specific clinical research regulatory information designed to enable users to explore regulations within a country and compare requirements across countries. ClinRegs also provides links to official regulations and other key resources related to international clinical research to facilitate independent analysis. Link… Continue reading

Apex Committee turns down DCGI’s proposal on trial approval for FDCs, subsequent new drugs, vaccines

Ramesh Shankar | PharmaBiz.com | Mumbai | 10 November 2014 The Union health ministry’s Apex Committee, headed by Union health secretary, has turned down a proposal by the Drugs Controller General of India (DCGI) to dispose of clinical trial proposals of new drugs already approved in other countries, fixed dose… Continue reading