Drugs currently being evaluated using studies from the Semler Research Centre Pvt. 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. The EMA review follows an inspection by the US Food and Drug Administration which identified issues at the bioanalytical site. So far, there is no evidence of unexpected harm or lack of effectiveness in these medicines, the EMA said. 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.

Source: Mint July 22, 2016 12:45 UTC