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Imperfect clinical trials: Germany bans 80 generic medicines

Imperfect clinical trials: Germany bans 80 generic medicines

BERLIN: Germany’s drug regulator authority has banned the sale of 80 generic medicines of domestic pharma company GVK Biosciences because of frailty in the clinical trials.

The ban comes after regulators in Germany, France and Belgium last week suspended marketing approval of 25 generic drugs.

The list of banned drugs includes those for treating high blood pressure, depression, migraine and epilepsy, and are manufactured by Dr Reddy’s, Lupin, Micro Labs and Torrent, among others.

The regulator reportedly investigated 28 pharma companies after an inspection of GVK Biosciences’ facility in Hyderabad revealed “substantial deficiencies” in clinical trials of generic medicines.

Germany’s Federal Institute for Drugs and Medical Devices (BfArM) said recently it was investigating drug approvals based on clinical trials meant to show that the generic drugs were equivalent to the original versions, conducted by GVK between 2008 and 2014.

When contacted, Manni Kantipudi, CEO GVK BIO, said, “The regulatory authorities have themselves stated that the decision is taken out of precaution. No element at this stage has led to establish a true risk for human health or a lack of efficacy of these drugs.” He added the company will repeat the studies to help its customers continue their marketing authorizations in respective markets.

Recently, reports said that the European Union’s drug regulator, European Medicines Agency (EMA) had expressed concern on the same trials conducted at GVK Biosciences.

The banned drugs include Escitalopram (Micro Labs), Clopidogrel (Dr Reddy’s), Irbesartan (Unichem), Levetiracetam and Valsartan (Dr Reddy’s company, Betapharm), Cefpodoxim (Lupin) and Tacpan (Panacea Biotec). MNC companies facing the ban include Mylan.