25 generic drugs will be banned for sale from December 18, 2014, according to the new report from the National Medicines Safety Agency (ASNM). This decision was taken following the discovery of anomalies and as a precaution, because these irregularities are without risk for the health of the patients.
ANSM inspectors noted irregularities during a control visit to the site of the GVK Bio company in Hyderabad, India. These anomalies characterize a lack of respect for good clinical practices concerning these bioequivalence studies. “Even if the electrocardiograms, in themselves, are not used to demonstrate the bioequivalence of the generic drug, they allow the monitoring of subjects included in clinical trials of bioequivalence” reassures the Agency.
Pending the verdict of the European Medicines Agency (EMA), and the Committee for Medicinal Products for Human Use (CHMP), France has decided to suspend the Marketing Authorizations (AMM) of 25 generics.
“But this decision is taken as a precaution. To date, nothing has led to the establishment of a proven risk for human health or a lack of efficacy of these medications »Recalls the Agency in a press release. “These suspensions only affect certain specialties of the brands affected by these irregularities”.
Like France, Belgium, Germany and Luxembourg have taken an identical decision. The list of suspended medications is available on the ASNM website(these are, among others, Ibuprofen ZF 400 mg, and Tramadol paracetamol ZF 37.5 mg / 325 mg). But, there is no risk of interrupting treatment as these drugs are available under other brands in pharmacies.
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