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 combinations (FDCs), subsequent new drugs, vaccines, etc by the DCGI office.

According to sources, the Apex Committee in its 17th meeting held on October 15, 2014 decided to continue the present system of evaluation of all kinds of clinical trial proposals including proposals of New Chemical Entities (NCEs), Global Clinical Trials (GCTs), clinical trial of new drugs already approved in other countries, FDCs, subsequent new drugs and vaccines through a three-tier system of Subject Expert Committee (SEC), Technical Committee and then Apex Committee.

Read full article

Bookmark the permalink.

Comments are closed.