The European Medicines Agency is recommending its member states stop selling drugs tied to improprieties at a GVK Biosciences facility in India.
The EMA examined data on more than 1,000 marketed drugs that came through GVK's site, finding about 300 with enough third-party results to support their approvals. For the rest, the agency is recommending suspension of marketing authorization until companies can replicate the questionable data, making an exception for medicines of critical importance.
The recommendation now goes before the European Commission and, if approved, would apply to all EU member states, following the lead of France, Germany, Belgium and Luxembourg, which suspended a number of GVK-related drugs late last year.
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. Those irregularities have cast doubts on bioequivalence data used to support hundreds of European approvals.
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| GVK CEO Manni Kantipudi |
And the fallout has had a marked effect on GVK's business. Earlier this month, GVK CEO Manni Kantipudi told Economic Times that the company has suffered about 50 crore rupees ($7.8 million) in cancellations since the problems first came to light in August, and the CRO has struggled to win new orders.
Before the issue came to light, GVK had been rapidly expanding its operations throughout and beyond India. The fast-growing company has quickly transitioned from a local player into an international entity, making its way into the U.S. through a buyout of California's Aragen Bioscience earlier this year. Among the CRO's clients are Astellas, Bayer, Endo Health Solutions ($ENDP), Onconova ($ONTX) and the FDA.
- read the EMA's release (PDF)
- here's the list of affected drugs (PDF)