India Drug Regulator Takes New Step In Adding To Approval Procedure
This article was originally published in PharmAsia News
Executive Summary
The Drug Controller General of India has selected six laboratories it intends to rely on to test drugs before they are allowed on the Indian market. The DCGI said it is considering the system for making the review process work, including a public-private partnership arrangement. The agency is considering adding the testing procedure instead of relying solely on clinical trial data submitted by drug makers as an additional guarantee of quality. The six government labs have been identified as capable of providing the testing envisioned. (Click here for more