Talks on regulatory issues are going on between the two countries in order to expand and strengthen technical co-operation on good manufacturing practices
India is engaging with EU to sort out regulatory issues and strengthen manufacturing practices following the 28-nation block’s ban on around 700 pharmaceutical products which were clinically tested by GVK Biosciences, government said.
“Currently India and EU are constructively engaged to sort out regulatory issues between the two countries and expand and strengthen technical co-operation on good manufacturing practices (GMP),” Hansraj Gangaram Ahir, Minister of State for Fertilisers, said in a written reply in the Lok Sabha.
He said the European Medicines Agency (EMA) had recommended suspension of about 700 pharma forms and strength of medicines for which authorisation in the EU was primarily based on clinical studies conducted at GVK Biosciences at Hyderabad.
The suspension of the products came 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, Ahir said. ..
“After the instruction of EU for withdrawal of these 700 products, the government had at that time temporarily deferred resumption of the talks on free trade agreement with EU,” he added.