EU upholds massive drug ban over alleged CRO data manipulation
- In May 2014, when French regulatory representatives looked closely at clinical studies conducted by one contract research organization (CRO) in Hyderabad, India, GVK BioSciences, they discovered that there had been a trend of data manipulation involving electrocardiogram (ECG) data studies conducted by the firm.
- Therefore, the EMA chose to suspend close to 50 generic drugs, in January 2015, including drugs for diabetes, depression, hypertension and other medical conditions, due to flawed clinical studies conducted at a CRO in Hyperabad, India. The list of suspended drugs has increased considerably since then and now encompasses hundreds of drugs.
- Several drug makers approached the European Medicines Agency (EMA) to appeal the suspension—but they were unsuccessful, and the EU has upheld the ban.
The suspension of roughly 700 drugs will begin in August and could last up to two years. This debacle has been ongoing since last spring; however, it is all unfolding in the context of intense scrutiny of the Indian pharmaceutical industry, which has been plagued by quality concerns and major lapses in GMP adherence at various manufacturing facilities.
GVK Biosciences has reported a downturn in orders since all of this came to light, and has complained that the response was too harsh considering the "actual risk posed to human health." GVK has gone as far as posting a story on its web site in which the FDA allegedly inspected GVK and was not as concerned as the French regulators. That story, however, has been neither confirmed nor denied by the FDA.
Regardless, the suspension remains intact.