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European Union Suspends the Sale of 700 Generic Drugs Made in India

by Dr. Trupti Shirole on  July 28, 2015 at 4:22 PM Drug News   - G J E 4
An Indian firm, GVK Biosciences, tests for bio-equivalence, to see if the generic versions of drugs are identical in impact to the original. The company contracted by drug companies to test medications was found to have manipulated data. On-site verification last year at GVK Biosciences showed irregularities in each and every one of the nine trials inspected. Following this, the European Medicines Agency (EMA) recommended a suspension in May 2015. Therefore, the European Union (EU) nations have until August 20, 2015, decided to suspend the sale of some 700 generic drugs made in India, informed the EU's executive.
 European Union Suspends the Sale of 700 Generic Drugs Made in India
European Union Suspends the Sale of 700 Generic Drugs Made in India
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Several European nations, including France, Germany, Belgium and Luxembourg, did not wait for the EU to act. They blocked sales in December 2014 or earlier in 2015. The EMA said, "The broad scope of the problems, which stretched back years, highlights critical deficiencies in the quality system in place at GVK Bio's clinic in Hyderabad."

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Commission officials were quick to suggest that there was no reason to suspect the drugs, including some brands of common pain relievers such as ibuprofen had caused any health problems, or that suspending sales would create shortages. A spokesman said, "There is no evidence of harm or lack of effectiveness. Removing the medications from shelves has been important both for ensuring patient safety and for retaining the confidence in the EU marketing authorization system."

Francois Hebert, deputy head of France's National Agency for Medicines and Health Products Safety, which carried out the inspections said, "Specifically, GVK Bio was found to have manipulated electrocardiograms (ECGs). Even if ECGs do not provide the most essential data for testing bio-equivalence, GVK did not respect good practices."

Source: AFP
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