German ban on generic drugs not applicable to 18 of them

Berlin, Dec 22, 2014 – Germany’s drug regulator has said that its ban on the sale of 80 generic medicines subjected to clinical trials by India’s GVK Biosciences will not be applicable for 18 drugs due to a legal challenge by their manufacturers.

The Federal Institute for Drugs and Medical Devices (BfArM) cannot implement its suspension of marketing authorisation given to these medicines until a decision is taken on the appeals filed by the companies, a spokesman for the agency told PTI on Tuesday.

Concerned medicines are allowed to continue their sales until further notice, the spokesman said.

Most of the drugs taken out of the sales ban are the products of betapharm, a leading German manufacturer of generic drugs, which was acquired by the Hyderabad-based Dr. Reddy’s Laboratories in 2006.

The regulator last week suspended the marketing authorisation given to 80 generic drugs made by 16 pharmaceutical companies and asked their manufacturers, wholesalers and medical stores not to sell or use these medicines any longer on account of “substantial deficiencies” in the clinical trials conducted by GVK Biosciences.

It had examined the marketing authorisation given to a total of 176 generic drugs by 28 manufacturers on the basis of the clinical data of bio-equivalence studies conducted by the Hyderabad-based contract research company during the period between 2008 and 2014.

The regulator came to the conclusion that there were “serious and systematic” deficiencies in these studies intended to establish that the generic versions have the same effect on the human body as the original branded versions and therefore the data provided by GVK Biosciences cannot be accepted as a basis for granting marketing approvals.

Medicines affected by the suspension of marketing authorisation will be allowed to resume sales if the companies furnish fresh clinical trial data, BfArM said.

Germany’s suspension of marketing authorisation of generic drugs was triggered by an inspection carried out by the French medicines agency at the GVK Biosciences facility in Hyderabad, which raised concerns about the reliability of studies conducted at the site between 2008 and 2014.

The European drug regulator, the European Medicines Agency (EMA) launched in September an investigation into the allegations of non-compliance with good clinical practice at the site and has been assessing its impact on medicines authorised on the basis of the studies conducted.

The EMA said it will make a recommendation in January on whether the marketing authorisation of the concerned drugs should be maintained, suspended or withdrawn across the EU.

It regards the suspension of marketing authorisation at the national level as “precautionary measures” until its review is completed.

Besides Germany, regulators in France, Belgium and Luxembourg also have suspended the marketing authorisation given to a number of generic drugs subjected to clinical trials by GVK Biosciences. PTI