The European Medicines Agency on Friday recommended suspending the sale of dozens of generic medicines — many of which are sold by Novartis and Teva Pharmaceuticals — over concerns about “flawed” studies that were conducted by an Indian clinical research organization.
The move comes three months after the US Food and Drug Administration alerted an untold number of drug makers of problems at the Semler Research Center, which is located in Bangalore. An inspection last fall found “significant instances of misconduct and violations of federal regulations, including the substitution and manipulation of study subject samples.”
Two weeks earlier, the World Health Organization had issued a notice to Semler for the same reasons. As we wrote previously, the global health agency had examined company computer servers and found a spreadsheet file containing detailed instructions for manipulating drug samples that were used in clinical trials for its clients. The WHO inspections were conducted early and late last year.
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Yet another example of reaping the ‘rewards’ we deserve for outsourcing to places that we KNOW do not have quality standards that are anywhere close to our own. Pharma, where is your conscience? Left it at the bank, perhaps?