Flawed Indian studies spur EU regulator to back drug suspensions
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London: The European Medicines Agency recommended suspending a number of medicines that were tested in India, after an inspection of the site found “substitution and manipulation” of the study samples.
Hundreds of mostly generic medicines from companies including Novartis AG’s Sandoz unit, Teva Pharmaceutical Industries Ltd. and Mylan Inc., and smaller Indian companies like Lupin Ltd. have been recommended for suspension, according to an EMA statement on Friday. Drugs currently being evaluated using studies from the Semler Research Centre Pvt. site in Bangalore shouldn’t be authorized until alternate data is provided, the agency said.
So far, there is no evidence of unexpected harm or lack of effectiveness in these medicines, the EMA said.
The EMA review follows an inspection by the US Food and Drug Administration which identified issues at the bioanalytical site. The World Health Organization had also raised “serious concerns” regarding data integrity and manipulation of study samples after its own inspections of Semler’s bioanalytical and clinical sites.
The regulator’s recommendation for suspension will be sent to the European Commission for a legally binding decision valid throughout the European Union.
The agency last year had recommended the suspension of market authorizations secured using clinical studies done by another Indian company, GVK Biosciences Pvt., after inspections showed a pattern of electrocardiogram manipulations. Bloomberg