European regulator bans drugs from GVK’s Hyderabad plant

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.