India Defers Trade Talks With Europe
The government of India has decided to defer the proposed talks with the European Union on the Broadbased Investment and Trade Agreement.
At issue is the banning by the EU of some 700 generic pharmaceuticals manufactured in India.
“The government of India is disappointed and concerned by the action of EU in imposing a legally binding ban on the sale of around 700 pharma products…” said a government statement.
The trade talks negotiations have been underway since 2007, and cover market access for goods and services, public procurement, investment, intellectual property and competition, and sustainable development.
The European Commission recently formalized a recommendation from the European Medicines Agency to suspend the importation of medicines based on clinical studies conducted at GVK Biosciences. The recommendation was made on safety grounds, and arose from concerns of the French medicines agency, which found data manipulations of electrocardiograms during a site inspection.
The findings of the inspectors “cast doubt on the integrity of the conduct of trials at the site generally and on the reliability of data generated.”
“The pharmaceutical industry is one of the flagship sectors of India which has developed its reputation through strong research and safety protocols over the years,” said the government statement. “The government of India will examine all options in this regard. It is pertinent to mention that most of these drugs are already in EU market for many years without any adverse pharmaco-vigilance report from any member state.”
The government of India also noted that it “has engaged on the issue with various EU regulators over past eight months.”