Trial Waivers May Trigger Early Indian Launch Of Sofosbuvir Copies
This article was originally published in PharmAsia News
Executive Summary
The Subject Expert Committee that evaluates clinical trial applications in India has looked favorably on a request to waive clinical trials for the breakthrough hepatitis C treatment sofosbuvir. The move, if cleared by the Drug Controller General of India, may see Indian generic companies vying for the market much earlier than expected.