|GVK CEO Manni Kantipudi|
A few months ago, the European Medicines Agency followed through on a threatened continental marketing halt affecting about 700 drugs in Indian CRO GVK Biosciences' generic lineup due to allegations of manipulated trial results. Now, Germany's regulators have suspended another 54 drugs tested by GVK in accordance with the EMA's recommendations.
The scandal began late last year as several European Union states began suspending the drugs' approvals, and by the middle of 2015, France, Germany, Belgium and Luxembourg had halted the sale of a number of GVK-related drugs.
In the latest move, Germany's Federal Institute for Medicines and Medical Products published the new list based on investigations of bioequivalence trials from GVK between 2004 and 2014, according to an article from the Business Standard. The list is to be regularly updated.
And GVK has suffered, losing millions and large contracts after years of rapid international expansion. Among its partners are Astellas, Bayer, Endo Health Solutions ($ENDP), Onconova ($ONTX) and the U.S. FDA. The EU ban put an estimated $1 billion worth of Indian exports at risk--it's no surprise the country pushed back, defending the CRO and threatening to sue and ultimately take the issue to the World Trade Organization.
Earlier this month, another Indian CRO, Spira Labs, came under fire from the FDA for control issues dating back to 2009, joining GVK and Quest Life Sciences in alleged data mishandling.
The German regulators are offering partners of GVK a chance to reverse the decision with new clinical trial data within the span of a year, according to the Business Standard. And any challenges from the affected companies must be brought in a European court, not a German one, since the decision is based on the EU recommendations.
- here's the story from the Business Standard