Some European Union states have suspended the approvals of drugs tied to a data falsification scandal at CRO GVK Biosciences, and the European Medicines Agency is investigating whether to recommend a continental halt.
According to the EMA, irregularities at GVK's Hyderabad lab have cast doubts on bioequivalence data used to support the approval of an undisclosed number of drugs, and some countries have yanked their marketing authorizations until sponsors redo the studies. Without providing details, the agency said it is still in the midst of its own investigation into just how many products are affected by the issue and plans to hand down a recommendation on what to do about the drugs by January.
The issue began in May, when investigators from France's Agency for Medicines and Health Products Safety examined 9 trials conducted at GVK's Hyderabad facility and discovered that the CRO's workers repeatedly switched out patient ECG scores with those of healthy volunteers.
GVK said it complied with regulators' requests and provided evidence that all of the other aspects of bioequivalence testing--like dosing, blood sampling and processing--were handled properly. Still, the agency's Committee for Medicinal Products for Human Use (CHMP) found "an element of doubt" in the results, the company said.
"We at GVK BIO believe that the studies conducted are in accordance with the GCP guidelines while we honor the conclusion made by CHMP and are working with our clinical development customers to provide new data that meets all regulatory requirements," the company said in a statement.
The issue could be a significant setback for GVK, which has been expanding its operations throughout and beyond India over the past year. The fast-expanding CRO has quickly transitioned from a local player into an international force, making its way into the U.S. through a buyout of California's Aragen Bioscience earlier this year. Among the CRO's clients are Astellas, Bayer, Endo Health Solutions ($ENDP), Onconova ($ONTX) and the FDA.
- read the EMA release (PDF)
- here's GVK's statement