Germany's drug regulator has suspended the sale of 54 clinically proven drugs for pharmaceutical research company GVK Biosciences India in the implementation of the ban in the European Union (EU) 's in about 700 generic drugs.
The Federal Institute for Drugs and Medical Products (BfArM) in Bonn, said on Friday issued a new list of drugs that are taken out of the supply chain here on the basis of the largest EU-wide suspension of the sale and distribution of generic medications ordered by the European Commission last month. The decision of the commission was in response to a recommendation of the drug regulator of the EU, the European Medicines Agency (EMA) in January that the marketing authorization for these medicines should be stopped because they are based on clinical trials Hyderabadbased allegedly manipulated by the company.
BfArM A spokesman told PTI that the agency added several new drugs to the list as required by the decision of the commission, which was based on the results of investigations of the bioequivalence studies conducted by GVK Bio during the period between 2004 and 2014.
An early list of generic drugs banned by the Agency in December and updated regularly in recent months covered only medicines undergoing clinical trials for the contract research company from 2008 to 2014, said the spokesman.
Pharmaceutical companies affected by the suspension of the marketing authorization have the possibility to challenge it before a European court as the agency decision is based on the order of the European Commission, the spokesman said.
The Federal Institute for Drugs and Medical Products (BfArM) in Bonn, said on Friday issued a new list of drugs that are taken out of the supply chain here on the basis of the largest EU-wide suspension of the sale and distribution of generic medications ordered by the European Commission last month. The decision of the commission was in response to a recommendation of the drug regulator of the EU, the European Medicines Agency (EMA) in January that the marketing authorization for these medicines should be stopped because they are based on clinical trials Hyderabadbased allegedly manipulated by the company.
BfArM A spokesman told PTI that the agency added several new drugs to the list as required by the decision of the commission, which was based on the results of investigations of the bioequivalence studies conducted by GVK Bio during the period between 2004 and 2014.
An early list of generic drugs banned by the Agency in December and updated regularly in recent months covered only medicines undergoing clinical trials for the contract research company from 2008 to 2014, said the spokesman.
Pharmaceutical companies affected by the suspension of the marketing authorization have the possibility to challenge it before a European court as the agency decision is based on the order of the European Commission, the spokesman said.
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