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BfArM

Germany has banned 80 generic drugs that had clinical trials performed by GVK Biosciences in India and found to be substandard.

The ban by Germany’s Federal Institute for Drugs and Medical Devices (BfArM) emerged after it suspended marketing authorisation of 17 generic drugs manufactured by five companies last week.

BfArM’s decision follows investigation reports that clinical trials undertaken at the GVK Biosciences facility in Hyderabad had ‘substantial deficiencies.’

The reports also questioned the validity of data presented by the facility to support marketing authorisation applications.

The German regulator reviewed 178 drugs manufactured by 28 companies and suspended marketing authorisations for 80 of them. Suspension will be in effect until the companies submit results of fresh bio-equivalence studies.

France, Belgium and Luxembourg banned 25 drugs related with the facility.

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Germany’s decision affected 16 pharmaceutical companies including Stada, Dr Reddy’s Laboratories, Mylan Laboratories, Torrent Pharmaceuticals, Lupin Pharmaceuticals and Zydus and Teva.

A statement by BfArM said that considering the serious and systematic deficiencies, bio-equivalence studies carried out by the Indian company to establish that generic versions have the same effect on the human body as original branded versions, cannot be accepted as a basis for marketing approval.

Bio-equivalence studies were undertaken to establish that generic versions of the drugs are as effective as their branded counterparts.

"The German regulator reviewed 178 drugs manufactured by 28 companies and suspended marketing authorisations for 80 of them."

Clinical trials related to generic drugs for high blood pressure, depression, migrane, epilepsy and Parkinson’s disease, among others.

Concerns were raised about anomalies found in the way electrocardiograms (ECG) were monitored.

GVK said in a statement: "We are disappointed that despite providing detailed clarifications, unfortunately Committee for Medicinal Products for Human Use (CHMP) has concluded that though the "check-out" ECGs may have no direct relevance to the quality of the testing of drugs, the fact that the same employees were involved in other critical activities, left an element of doubt on the bio-equivalence results.

"Hence authorities have concluded that BE studies conducted at our Hyderabad clinic are not sufficient to support Marketing Authorisation Holders (MAHs) for the products approved.

"We expect the Marketing Authorisation Holders will need to repeat the studies in the next 12-15 months."


Image: The Federal Institute for Drugs and Medical Devices in Bonn has reviewed 178 drugs manufactured by 28 companies. Photo: courtesy of BfArM.