Disappointed by the European Union action of banning 700 pharma products, New Delhi has decided to defer the India-EU free trade talks.
A Commerce and Industry Ministry statement issued here on Wednesday said: “The decision has been taken as the Government is disappointed and concerned by the action of EU in imposing illegally binding ban on the sale of around 700 pharma products clinically tested by GVK Biosciences, Hyderabad.”
The India-EU trade talks, formally known as the Broadbased Investment and Trade Agreement, were launched in 2007, but have consistently missed deadlines with consensus not emerging on various issues. The negotiations were scheduled to resume this month after almost two years.
Following this, in January, the European Medicines Agency (EMA) recommended that drugs for which authorisation in the EU were primarily based on studies conducted at the GVK facility should be suspended. New Delhi had challenged these allegations and kept engaging with both the EMA and ANSM. But these efforts yielded nothing and on July 25, the German drug regulator, the Federal Institute for Medicines and Medical Products, announced a ban on marketing of the 700 generic medicines.
The ban will affect India’s annual exports of $15 billion. According to industry estimates, it could lose $1-1.2 billion worth of exports. The ban is to come into effect from August 21 and will apply in all the 28 member-nations.
“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 and, therefore, the government will examine all options in this regard,” the Commerce Ministry statement said.
“It is pertinent to mention that most of these drugs are already in the EU market for many years without any adverse pharmacovigilance report from any member-state,” it added.