Home >Companies >German drug makers appeal drug suspensions linked to Indian data

Frankfurt: German drug makers including Stada Arzneimittel AG, Torrent’s Heumann Pharma GmbH and Dr. Reddy’s Laboratories Ltd’s Betapharm Arzneimittel GmbH have appealed a regulator’s decision to suspend approval of some drugs over concerns about clinical trials conducted by an Indian company.

Regulators in France, Germany, Belgium and Luxembourg this month suspended marketing approval for 25 drugs over the quality of trial data from India’s GVK Biosciences Pvt. Ltd.

Companies that have filed an appeal will be allowed to resume sales of affected products until their appeals are either approved or struck down, Germany’s Federal Institute for Drugs and Medical Devices (BfArM) said on Monday.

“We are reviewing the appeals thoroughly and quickly," a spokesman for BfArM said.

The regulator last week had published a list of 80 affected products that their manufacturers would not be allowed to sell until they had provided new clinical data.

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