India defers EU trade talks as ban on GVK-tested drugs rankles

India has deferred planned trade talks with the European Union as a form of protest to a European Union-wide ban set to start this month on more than 700 drugs that were bioequivalency-tested by GVK BioSciences, India's LiveMint newspaper said.

The ban could cost India at least $1 billion in exports by the end of the fiscal year in March 2016.

India's Commerce and Industry Ministry was scheduled to meet with European negotiators on a broad-based investment and trade pact this month, but said it remained "disappointed and concerned" over the ban, Live Mint said.

Germany's Federal Institute for Medicines and Medical Products posted the notice of the ban in German on July 22, Business Standard reported at the time.

The notice showed the acceptance of a European Medicines Agency recommendation for an EU-wide ban on the drugs tested at GVK's Hyderabad, India, facility.

The ban will come into effect on Aug. 21 in a move that New Delhi had tried to head off with diplomatic efforts, the failure of which has apparently riled India's Commerce Ministry, the Economic Times said in a July story.

IPA Secretary General D.G. Shah

Live Mint, citing D.G. Shah, secretary general of the Indian Pharmaceutical Alliance (IPA), suggested the commerce ministry's move sends a strong message to European regulators who he said have "acted unfairly and without any proof."

The EMA issue began in May when investigators from France's Agency for Medicines and Health Products Safety examined 9 trials conducted at GVK's Hyderabad facility. The inspection found GVK employees repeatedly switched outpatient ECG scores with those of healthy volunteers.

It was followed by a separate stinging rebuke this month from the World Health Organization to CRO Quest Life Sciences over falsified ECGs in an HIV drug trial.

- here's the story from LiveMint

Read more on