U.S. drugmaker Mylan ($MYL), Germany's Stada, India's Dr. Reddy's Laboratories and Unichem Laboratories are among 16 drugmakers who have had dozens of generic meds sidelined by German regulators who raised questions about bioequivalence tests.
Germany's Federal Institute for Drugs and Medical Devices (BfArM) Tuesday released the names of the 16 companies affected there by the recall, many of them German generic drug companies, as well as what it said were 80 drugs. That included different dose forms of many of the same drugs They include common generics like losartan and valsartan, as well as Dr. Reddy's generic of blood thinner Plavix and Mylan's ($MYL) copy of AstraZeneca's ($AZN) blockbuster heartburn med Nexium.
Last week, regulators in France, Belgium, Luxembourg as well as Germany, suspended 25 drugs saying their bioequivalence was suspect. The European Medicines Agency in a statement said inspectors found that a number of electrocardiograms were falsified by employees at India's GVK Biosciences as part of 9 different approval studies it had been contracted to perform. According to Reuters, GVK Bio has denied the claims. German officials said there have been no reports of adverse effects from the products removed from the market and warned patients to consult their doctors before they stop taking medications.
According to BfArM, another 96 other drugs had been evaluated and no problems were found. Of the 80 it banned, there were 17 from 5 companies where the license holder had already indicated they did not intend to keep selling the products in Germany. But none of the drugs will be allowed back on the market until the companies can show through other studies that they meet standards. Reuters was told by French officials that some drugmakers have already said they were willing to conduct new studies, and GVK Bio said it had set aside up to $6.5 million for new studies.
The revelations were another case in which the methods of India's drug industry have been called into question. A recent review of FDA documents by Bloomberg found that at least 12 drug companies with facilities in India were accused by the agency of failing to report data from tests designed to determine if a drug was safe and would work as designed. According to a November 2013 FDA internal document the news service obtained, agency computer forensics experts discovered that at one Sun Pharmaceutical Industries plant, employees had deleted 5,301 chromatography tests in which drug batches were found not to meet standards. The FDA has found that some companies often retest and report only those tests where batches make the required grade.
Sun is in the process of buying India's Ranbaxy Laboratories, which has four of its Indian plants banned from shipping to the U.S. for those kinds of issues, as well as others. The FDA this year also banned Sun plant where if found issues. In a recent interview at the CPhI conference in Paris, Indian regulators and industry officials argued that the FDA's testing approach to drug approval was at odds with European regulators, who were more concerned about the effectiveness of the finished product.
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