European regulator bans drugs from GVK’s Hyderabad plant

24 Jan 2015

1

In a move that would come as a blow to GVK Biosciences, the European Medicines Agency (EMA) has banned the sale of medicines tested and approved on the basis of clinical trials conducted at GVK's Hyderabad plant, saying the testing was flawed and not up to international standards.

''These manipulations [of test results] appear to have taken place over a period of at least five years. Their systematic nature, the extended period of time during which they took place and the number of members of staff involved cast doubt on the integrity of the way trials were performed at the site generally and on the reliability of data generated at that site,'' said a statement issued by EMA.

The EMA reportedly tested 1,000 formulations and medicines and found just over 300 of them were supported by data from other sources. These will continue to be sold in the market. Earlier too, the EMA had expressed concern over clinical trials conducted at GVK Biosciences.

Business History Videos

History of hovercraft Part 3 | Industry study | Business History

History of hovercraft Part 3...

Today I shall talk a bit more about the military plans for ...

By Kiron Kasbekar | Presenter: Kiron Kasbekar

History of hovercraft Part 2 | Industry study | Business History

History of hovercraft Part 2...

In this episode of our history of hovercraft, we shall exam...

By Kiron Kasbekar | Presenter: Kiron Kasbekar

History of Hovercraft Part 1 | Industry study | Business History

History of Hovercraft Part 1...

If you’ve been a James Bond movie fan, you may recall seein...

By Kiron Kasbekar | Presenter: Kiron Kasbekar

History of Trams in India | Industry study | Business History

History of Trams in India | ...

The video I am presenting to you is based on a script writt...

By Aniket Gupta | Presenter: Sheetal Gaikwad

view more
View details about the software product Informachine News Trackers