European Commission Bans Generics Due to Flawed Studies

The European Commission is suspending sales and distribution of 700 formulations of more than four dozen generic drugs after determining that the bioequivalence testing on which their approvals were based included manipulated echocardiogram data.

The ban follows a report last year by France’s medicines authority that ECG data had been manipulated in each of nine studies it investigated that were conducted by contract research organization GVK Biosciences. The report was based on inspections of GVK’s Hyderabad, India, clinic.

The ban, which takes effect Aug. 21, applies to all member states. Countries may issue drugs on the list if they can show that the drugs are critical to meeting an unmet medical need.

The ban does not affect all drugs evaluated by GVK and sold in the EU. The agency looked at more than 1,000 drug forms and strengths at the GVK site and found sufficient evidence from other sources to support more than 300 of them, EMA spokeswoman Sophie Labbé tells Generic Line.

GVK has repeatedly maintained the drugs it assessed are safe.

GVK is disappointed that even after multiple appeals, a deeper scientific dialogue was not undertaken, says spokeswoman Dorothy Paul. The company will continue to work with the government of India and customers to help resolve the issue, she tells Generic Line.

Read the Commission’s decision here: www.fdanews.com/7-15-EC-GVK-Decision.pdf. An annex listing the affected drugs is at www.fdanews.com/7-15-EC-GVK-Annex.pdf. — Jonathon Shacat

 

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