Germany suspends more drugs tested by GVK Bio

Germany on Friday put one more nail on the stalled EU-India free trade talks by suspending the sale of 54 drugs manufactured by Indian generic drug manufacturer GVK Bio, in line with an EU regulatory prescription to block the sale of 700 generic drugs tested by GVK Biosciences.

The European Union action banning 700 generic drugs tested by GVK Biosciences has closed all possibilities of India continuing its free trade talks with the European Union.

India has decided to call off all ongoing negotiations with the European Union for a free trade agreement with the 28-member group after the EU regulators refused to withdraw a ban on the sale of over 700 good quality generics drugs tested by GVK Biosciences.

India's commerce minister Nirmala Sitaraman said there is no scope at the moment to mend bilateral economic relations with the EU as the latter has refused to withdraw the ban on Indian pharma products.

The ban imposed by Germany's drug regulator on 54 medicines clinically tested by India's pharmaceuticals research company GVK Biosciences is compliance with the EU's ban on around 700 generic drugs.

The Federal Institute for Medicines and Medical Products (BfArM) in Bonn said yesterday that it published a new list of medicines taken out of the supply chain in this country on the basis of the largest EU-wide suspension of sales and distribution of generic medicines ordered by the European Commission last month.

The commission's drug regulator, the European Medicines Agency (EMA), had in January, recommended suspension of marketing authorisation of these drugs on the grounds that they were based on clinical trials allegedly manipulated by the Hyderabad-based company.

The German regulator, BfArM, is reported to have added several new medicines to its earlier list as required by the commission's decision, which was based on the results of investigations into bio-equivalence studies conducted by GVK Bio during the period between 2004 and 2014.

An earlier list of banned generic medicines published by the agency in December covered only 26 medicines subjected to clinical trials by GVK Bio from 2008 to 2014.

Pharmaceutical companies affected by the suspension of marketing authorisation can challenge it only in a European court as the agency's decision is based on the European Commission's order.

BfArM is reported to have offered to reverse its decision if these drug companies provide new clinical trial data. Drugs manufacturers have one year to furnish the results of fresh bio-equivalence studies of their medicines.

Medicines affected by the commission's marketing ban have lost their validity for use in the EU from yesterday and they should no longer be sold or distributed by pharmaceutical companies, wholesale dealers, drugs stores or other outlets, the agency said in a press statement.

However, the ban on certain medicines could be lifted on the basis of the outcome new clinical trial data provided by their marketing authorisation holders. Several drug manufacturers have already availed of this opportunity, the statement said.

Despite the ban, the German regulator said it has no information so far that the medicines subjected to clinical trials by GVK Bio posed any health risks to patients who continued to use them.