EU-wide ban starts Aug. 21 on 700-plus drugs tested by India's GVK Bio Sciences

A European Union-wide ban on more than 700 drugs that were bioequivalency tested by India's GVK BioSciences will come into effect on Aug. 21 in a move that New Delhi had tried to head off with diplomatic efforts.

Germany's Federal Institute for Medicines and Medical Products posted the notice of the ban in German on July 22, the Business Standard newspaper reported. The notice showed the acceptance of a European Medicines Agency recommendation for an EU-wide ban on the drugs tested at GVK's Hyderabad, India, facility.

The medicines, from both Indian and multinational companies, will lose validity in the EU on Aug. 21, and they cannot be distributed or sold by pharmaceutical companies, wholesale dealers, drug stores and other outlets, the notice said.

"Despite all the evidence and data presented, the European Commission has moved ahead with the EMA recommendation," a spokesperson for GVK told the Business Standard. "GVK Bio is disappointed with the fact that even after multiple appeals, a deeper scientific dialogue was not undertaken. GVK Bio will continue to work with the government of India and our customers to help resolve this."

The company declined to comment to FiercePharmaAsia on possible next steps.

Last week, New Delhi asked diplomats in Europe to avert fallout on any halt of medicines that had validation conducted by GVK Biosciences, the Financial Express reported.

The aim of the "diplomatic campaign," the Financial Express said, citing official sources, is to get regulators to reconsider and reverse their finding and restore the reputation of GVK Biosciences and Indian validation procedures.

The EMA issue began in May when investigators from France's Agency for Medicines and Health Products Safety examined 9 trials conducted at GVK's Hyderabad facility. The inspection found GVK employees repeatedly switched outpatient ECG scores with those of healthy volunteers.

It was followed by a separate stinging rebuke this month from the World Health Organization to CRO Quest Life Sciences over falsified ECGs in an HIV drug trial.

Several of the 28-member countries of the EU have already suspended these drugs, but the European Commission's move covers the entire bloc, the Business Standard said.

In January, Belgium, France, Germany and Luxembourg suspended cited drugs validated at the GVK facility after the French Regulatory Agency, ANSM, raised data-integrity issues with electrocardiograms in December of last year, Business Standard noted.

The suspended drugs include those sold by major global generics makers such as Teva ($TEVA) and Mylan ($MYL), Business Standard said, but at least a dozen were made and marketed by Indian drugmakers such as Dr. Reddy's Laboratories ($RDY), Ranbaxy Laboratories, Lupin, Torrent Pharma, Alembic Pharma and Glenmark.

In the case of the Indian companies, Business Standard said the drugs include antiepileptic drug Levetiracetam, antidiabetic drug pioglitazone among and ulcer drug pantoprazole from Lupin, as well as alendronic acid from Ranbaxy used to treat bone diseases and antihypertension drug irbesartan by Torrent Pharma.

Business Standard said that Dr. Reddy's has indicated that it would not be impacted by the EMA decision. The antiepileptic drug marketed in Germany by the company's German subsidiary Betapharm has also figured in the list.

- here's the story from Business Standard
- and the BfArM notice (German language)

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