The European Medicines Agency (EMA) had in January suspended a number of medicines approved for sale in the EU
India is examining whether to take up with WTO the EU’s suspension order for sale of about 700 generic drugs which were approved based on clinical trials by pharma major GVK Biosciences.
According to a PTI report, the European Medicines Agency (EMA) had in January suspended a number of medicines approved for sale in the EU which were based on clinical studies conducted by GVK Bio at its Hyderabad site.
The action flowed from findings from an inspection that allegedly red-flagged how GVK conducted studies at the Hyderabad site on behalf of marketing authorisation holders.
“The Commerce Ministry is internally analysing the issue. It is looking at the legal and WTO angle in it. Without gathering the complete information about the case, it will be difficult to discuss the matter even at a bilateral level with the EU,” a government source said.
The source said it is not “easy” to file a complaint with the WTO without doing a complete due diligence.
EMA’s Committee for Medicinal Products for Human Use had looked at over 1,000 pharmaceutical forms and strengths of medicines studied at the GVK site. Indian firms had faced similar issues in the past over generic drugs.
In 2011, some of the EU Customs authorities, mainly from the Netherlands and France, had confiscated several Indian off-patent generic drug consignments headed for Brazil via European ports and airports over alleged infringement of EU intellectual property rights (IPR).
After India voiced protest, the European Union members agreed not to seize Indian medicines passing through Europe.