U.S. FDA Slams India’s Wockhardt With Warning Letter For Failed Quality Systems, Data Manipulation
This article was originally published in PharmAsia News
U.S. FDA found Wockhardt sorely lacking in a robust quality management system at its India sites, and found the company manipulated crucial manufacturing data.
You may also be interested in...
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.
India’s top regulatory agencies are weighing up the findings from a study it had commissioned that looks at the clinical benefits of heart stents, with the possible aim of using the results to back the use of cheaper, locally-produced devices.