Says the govt will examine all options in this regard
Stating that it was “disappointed and concerned” by the action of the European Union imposing legally binding ban on the sale of around 700 pharma products clinically tested by GVK Biosciences, Hyderabad, the Narendra Modi government on Wednesday said it has decided to defer the talks on the India-EU free trade agreement (FTA), officially called the broad-based bilateral trade and investment agreement.
“The government of India has taken a decision to defer the proposed talks between the chief negotiators on the India-EU broad-based Trade and Investment Agreement for the present,” an official statement said.
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, India will examine all options in this regard, it added.
Pointing out that the government was engaged on the GVK Biosciences issue with various EU regulators over the past eight months, the statement added, “It is pertinent to mention that most of these drugs are already in the EU market for many years without any adverse pharmaco-vigilance report from any member state.”
The chief negotiators were slated to meet by this month-end or early next month to resume the FTA talks. The talks have been stalled since May 2013 with New Delhi reluctant to accommodate the EU’s pitch for lower duties on wines, spirits and automobiles, and Brussels not relenting on India’s demands for a ‘data-secure nation’ status and easier movement of skilled Indian professionals in Europe.
India is keen to get the ‘data-secure nation’ tag because without it, Indian IT firms are finding it tough to get greater market access across EU member countries. India is also looking at increasing its exports of textiles and leather items to the EU. The FTA talks, to remove barriers to trade in goods and services and investment, began in June 2007 and 15 rounds of negotiations have been held so far.
The regulators, including the European Medicines Agency (EMA), France’s ANSM as well as their German, and their Belgian and Luxembourgian counterparts had suspended many ‘authorised’ medicines, whose “marketing authorisation applications included clinical data from studies conducted by GVK Biosciences at its Hyderabad site”. ANSM had initially “raised concerns on the reliability of the clinical part of bio-equivalence studies conducted between 2008 and 2014” by GVK Biosciences.
While the issue is restricted to the alleged flaws in GVK Biosciences’ studies, government sources in New Delhi apprehend that it could potentially lead to a clampdown on India’s pharmaceutical exports to the continent.