EU ban on GVK-tested drugs from August 21

The 700-odd products that underwent clinical studies here include those from six Indian firms

European Commission, executive body of the European Union (EU), has accepted the European Medicines Agency (EMA)’s recommendation for an EU-wide ban on 700-odd drugs that underwent bio-equivalence studies at Hyderabad-based GVK Bio Sciences’ facility.

While several of the 28-member countries have already suspended these drugs, the European Commission’s move will mandate every member to follow suit.

In a statement posted on its website, Germany’s drug regulator, the Federal Institute for Medicines and Medical Products, said the EU-wide ban will kick in from August 21. The medicines figured on the list of EMA will lose their validity for use in the EU from that date and  should no longer be distributed or sold by pharmaceutical companies, wholesale dealers, drug stores and other outlets, it added.

A GVK Bio spokesperson said: “Despite all the evidence and data presented, the European Commission has moved ahead with the EMA recommendation. 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.”

Medicines figuring in the list of EMA will lose their validity for use in the EU from that date and should no longer be distributed or sold by pharmaceutical companies, wholesale dealers, drugs stores and other outlets, the German regulatory agency said in a press statement on Thursday.
 
Even before the EMA came out with its recommendation in January, four European nations — Belgium, France, Germany and Luxemburg — had suspended the  cited drugs in December 2014, after the French Regulatory Agency, ANSM, raised data integrity issues at  GVK Bio’s Hyderabad facility.

ANSM said it had found evidence of manipulation of electrocardiograms of people linked to the studies on some of these generic medicines at the facility in its May 2014 audit. Following this, EMA launched a formal investigation and came up with a provisional recommendation for suspension of these drugs, followed by a final confirmation in May.

While most of the suspended drugs belong to global generic players, including Teva and Mylan, at least a dozen were made and marketed by Indian firms and their subsidiaries, including Dr Reddy’s Laboratories, Ranbaxy Laboratories, Lupin, Torrent Pharma, Alembic Pharma and Glenmark.

In the UK market, the anti-epileptic drug Levetiracetam, anti-diabetic drug Pioglitazone among other drugs of Dr Reddy's Laboratories, ulcer drug Pantoprazole of Lupin, Alendronic acid of Ranbaxy, a product used to treat bone diseases, anti-hypertension drug Irbesartan by Torrent Pharma were a part of the list of medicines recommended for suspension by EMA.

Similarly, some of these products and other types of drugs that were also found in the markets of other European countries including Romania, Sweden and the Netherlands.

“As Europe is a small market for many of these Indian companies such as Dr Reddy’s and Lupin, the suspension of drugs from the markets of individual European countries will not have any significant impact on the revenues,” Sarabjit Kour Nangra of Angel Broking, who tracks the pharmaceutical sector, had told Business Standard  earlier.

Dr Reddy’s said it would not be impacted by the EMA decision. The anti-epileptic drug marketed in Germany by the company's German subsidiary Betapharm has also been figured in the list.