India Mulls Laws To Accredit Ethics Committees To Streamline Clinical Trials
This article was originally published in PharmAsia News
The government is looking to tighten laws that would make ethics committees more accountable
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MUMBAI - Over the past decade, India's clinical research industry has grown at a compound annual rate of 64 percent, zooming up from just $12 million in 2001 to an estimated billion-plus dollars by next year. But that meteoric rise may be putting pressure on Institutional Review Boards entrusted with approval of clinical trials and some industry experts are now asking for better controls over IRBs, or ethics review boards
A rising number of enforcement actions by major drug regulators like the U.S. FDA is slowly making investors cautious about the longer term repercussions on earnings of Indian drug makers.
In a bold move, little known Indian drug firm Lee Pharma has applied for a compulsory license for saxagliptin in India, contending that AstraZeneca sells the diabetes drug at an exorbitant local price and that it is not being made sufficiently available. Lee also says that the originator has not responded to calls to collaborate.