EU watchdog flags faulty generic drug data, backs sales halt

The European Medicines Agency (EMA) recommended suspending sales of some generic drugs after a review found that data collected by a contract research company in India for their approval was unreliable.

The EMA's list included drugs made by some of the top generic drugmakers, including Teva Pharmaceutical Industries Ltd, Mylan NV and Novartis AG's Sandoz.

The recommendation comes after the U.S. Food and Drug Administration and the World Health Organization raised concerns about substitution and manipulation of patients' clinical samples by Semler Research Center Pvt Ltd. (

The FDA asked drugmakers in April to repeat bioequivalence studies for drugs whose application used data obtained from tests conducted by Semler. (

Generic drugmakers have to prove to health regulators through bioequivalence studies that their cheaper copy-cat drugs are as effective as the drug that they try to mimic.

The EMA review expressed concerns about the bioequivalence of the suspended generics of cancer drug Tarceva, migraine treatment eletripan and anti-malarial drug Atovaquone/Proguanil.

The EU health regulator said it also recommended against approving those drugs whose applications used data from studies conducted at the research site.

The agency, however, allowed sales of those drugs where the manufacturing company provided data from alternate studies.

The European Commission will make a legally binding decision on these recommendations, the agency said.

Reporting by Vidya L Nathan in Bengaluru; Editing by Anil D'Silva

Fri Jul 22, 2016


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