Source: LiveMint |Mar 02 2016, ECONOMY MARKET-PULSE
In order to strengthen technical co-operation on good manufacturing practices, Minister of State for Fertilisers Hansraj Gangaram Ahir has said that India is engaging with European Union’s (EU) to sort out regulatory issues following the 28-nation block’s ban on around 700 pharma products which were clinically tested by GVK Biosciences on the ground of inaccuracy in data.
Ahir has said that the 700 pharmaceutical products for which authorisation in the EU was primarily based on clinical studies conducted at GVK Biosciences at Hyderabad had suspension on the recommendation of the European Medicines Agency (EMA). This suspension of the products has come after an inspection at GVK Biosciences conducted by French Medicines Agency (ANSM) revealed data manipulations of electrocardiograms (ECGs) during the conduct of some studies of generic medicines.
Earlier in August 2015 India had deferred scheduled talks on free trade agreement (FTA) which was to resume after a gap of two years after the EU imposed a ban on around 700 generic drugs. During the same period, Prime Minister Narendra Modi had urged Chancellor of Germany Angela Merkel to use her influence in EU to remove the barriers for resumption of Free Trade Agreement talks with the 28-member bloc.