20 generic drugs taken off Portuguese market amid clinical trial concerns

Twenty generic drugs have been withdrawn from the Portuguese market following concerns raised by the European Medication Agency (EMA) about clinical trials carried out by Indian drug maker GVK Biosciences, Portugal's National Medication and Healthcare Products Authority (Infarmed) said in a statement issued Wednesday.

The EMA published last Friday a list of hundreds of generic drugs manufactured by GVK Biosciences with the recommendation that their sale be suspended in European markets.

The recommendation followed an inspection of GVK Biosciences' premises in India, which found irregularities in the company's clinical trials methods.

The inspection of the Indian company found manipulation of results of electrocardiograms during clinical trials.

A total of 64 drugs on the list have been or are currently sold in Portuguese pharmacies. Of those, Infarmed said additional information that proves the safety of the generic drugs was not available for 24, of which only 20 are currently being sold.

"Despite not having information on evidence, they are putting public health at risk. While awaiting a final decision from the European Commission, based on the principal of precaution, Infarmed requests holders of the market authorizations voluntarily to remove the 20 medications sold in Portugal," the statement said.

The withdrawn medications include analgesics, antidepressants, anti-allergy drugs, as well as drugs to treat angina, schizophrenia, bipolar disorder, Parkinson's disease, osteoporosis and Alzheimer's disease. Endit