STOCK MARKET BSE NSE

GVK Bio Under European Drug Watchdog's Lens

Published: 02nd October 2014 06:00 AM  |   Last Updated: 01st October 2014 11:04 PM   |  A+A-

HYDERABAD: GVK Biosciences Pvt Ltd has come under the scanner of the European Medicines Agency (EMA) for alleged violation of manufacturing norms.

It may be noted that recently, French medicines agency ANSM had initiated an inspection raising concerns over the study data used by GVK Biosciences to support the marketing authorisation applications of generic medicines.

According to EMA, it has started a review in connection with findings of alleged non-compliance with good clinical practices at a facility owned by GVK Biosciences, a contract research organisation.

“The review will cover nationally authorised medicines whose marketing authorisation applications included clinical data from studies conducted by GVK Biosciences Pvt Ltd, Hyderabad...The review of medicines for which studies have been conducted by GVK Bio has been initiated at the request of the European Commission”, it said. 



Comments

Disclaimer : We respect your thoughts and views! But we need to be judicious while moderating your comments. All the comments will be moderated by the newindianexpress.com editorial. Abstain from posting comments that are obscene, defamatory or inflammatory, and do not indulge in personal attacks. Try to avoid outside hyperlinks inside the comment. Help us delete comments that do not follow these guidelines.

The views expressed in comments published on newindianexpress.com are those of the comment writers alone. They do not represent the views or opinions of newindianexpress.com or its staff, nor do they represent the views or opinions of The New Indian Express Group, or any entity of, or affiliated with, The New Indian Express Group. newindianexpress.com reserves the right to take any or all comments down at any time.

flipboard facebook twitter whatsapp