“This decision has been taken as the Government of India is disappointed and concerned over the action of the EU in imposing a legally binding ban on the sale of around 700 pharma products clinically tested by GVK Biosciences,” read an official communiqué from the commerce & industry ministry.
Chief trade negotiators from both sides were expected to meet here on August 28 to resume the talks for the Broad-based Trade and Investment Agreement (BTIA), stalled since 2013.
The statement also said the government had been trying to pursue the matter across various regulatory bodies in the European Union (EU), and added the pharmaceutical industry was one of the country’s flagship sectors with a commendable reputation for sound research and safety protocols over the years.
“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 statement said. Therefore, the ministry added, the government would exercise all options on the matter.
When contacted, the delegation of the European Union in New Delhi said it had not received any formal communication on this matter from the commerce & industry ministry.
“As of now, we have not received any formal communication from the government or from the commerce ministry. For the time being, we have no further comments. The EU remains committed to continuing working towards conclusion of an agreement between India and the EU that will be acceptable to both sides,” it said.
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The official also said, for talks to proceed, India was even ready to take on from where the previous government had left.
Incidentally, EU Trade Commissioner Cecilia Malmstrom had on Tuesday said the meeting of the chief negotiators would focus on taking stock of negotiations and not resumption of the dialogue. However, India had always maintained the August 28 talks would restart the stalled process.
Negotiations for the FTA have failed to reach an agreement over issues pertaining to lowering of tariff on Indian automobiles and wines & spirits.
India, on the other hand, is unhappy with the offer it got on one of its main demands — increasing the EU’s immigration quota. Also, the EU has not given proper assurance to India on its demand to recognise the country as a ‘data secure’ nation.
The EU-wide ban on over 700 drugs was imposed last month and accepted by the European Medicines Agency (EMA). The ban is expected to be effective from August 21.
The medicines on the list of EMA will lose their validity for use in the EU from that date and will no longer be distributed or sold by pharmaceutical companies, wholesale dealers, drug stores and other outlets, according to German drug regulator Federal Institute for Medicines and Medical Products.
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