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Semler Dirty Data: EMA Suspends Over 200 Products; Stings Indian CROs

 
• By Anju Ghangurde

Dirty data issues continue to plague Indian contract research organizations, denting the reputation of the beleaguered local industry and piling up challenges for marketing authorization holders. The European Medicines Agency (EMA) has now suspended close to 300 products that relied on flawed bioequivalence studies done by the Bengaluru-based Semler Research.

The EMA on July 22 recommended for suspension a long list medicines in various strengths based on a clutch of actives including erlotinib, saquinavir, celecoxib, eletriptan, duloxetine, amoxicillin and eprosartan for which bioequivalence studies were conducted at India's Semler Research Centre Private Ltd; marketing authorization holders for the suspended products include Sandoz NV, Teva Pharma Belgium NV, Mylan AB, Sanofi Aventis France, Zydus France, Ratiopharm GmbH and Glenmark.

But the Agency's action was not really entirely unexpected – both the FDA and the World Health Organization (WHO) had earlier

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