New Delhi: The EU Friday defended the banning of around 700 generic drugs tested by India's GVK Biosciences, asserting it was based on "scientific and not trade considerations" and voiced hope that a solution will be found after India deferred FTA talks with the bloc over the issue.
The EU delegation here said the drugs were banned on the ground of inaccuracy in data and that there was no evidence of harm or lack of effectiveness in the medicines.
It said conditions for lifting of the ban have already been prescribed by the concerned authorities which include submission of required clinical data and some of the medicines may remain in the market in some European countries if they are considered to be of critical importance for patients.
"The decision concerning a ban on 700 generic drugs was based on scientific and not trade considerations and in accordance with the advice of the scientific Committee of the EMA (European Medicines Agency)," said Cesare Onestini, acting Head of Delegation of the European Union to India.
On India's decision to defer the talks, she said the EU remained committed to continue working towards conclusion of the FTA and hoped that a solution will be found to the "current deferral" of negotiations.
The EU delegation said, "Decision constitutes a suspension of medicines for which there were no supporting data from other data sources available. This does not mean that these medicinal products will be recalled or 'taken off the shelf'. Many of them are still available for the time being."
It said some of the medicines may remain on the market in some countries if they are of critical importance for patients as alternatives cannot meet patients' needs.
"The decision on whether a medicine is critical for patients lies with the national authorities of EU Member States. For medicines that are considered critical, companies are given 12 months to submit additional data," it said.
On banning of the drugs by the 28-member bloc, Onestini said the relevant Scientific Committee noted that there was no evidence of harm or lack of effectiveness in the medicine.
"However, this does not address the issue of inaccurate data provided. Data integrity is an indispensable element in the EU marketing authorisation system."
The Delegation said marketing authorisation holders have to conduct new studies and in some cases it may have already initiated/completed so that the suspension for some will not be required because "marketing authorisation holders may have successfully completed the required bioequivalence study".
Justifying the action, Onestini said, "Similar necessary suspensions occurred in the past in different countries. Such procedures do not question the reputation of the company nor the countries concerned, nor of generic medicinal products. They are an integral part of a rigorous scientific assessment process."
The medicines affected by the EU action are those for which clinical studies had been done at GVK Biosciences in Hyderabad.
The EU delegation said it was not an action against GVK nor against the Indian pharmaceutical industry as a whole but deals with issues identified for one particular clinical trial site.
On FTA talks, he said EU remained committed to continue working towards conclusion of the FTA.
After a gap of about two years, chief negotiators of India and the EU were scheduled to resume talks here on August 28 on the FTA officially dubbed as Broadbased Investment and Trade Agreement (BTIA). India on Tuesday deferred the talks following EU's decision to ban the drugs.
The trade talks, which were launched in June 2007, remain stuck as both sides are not satisfied with each other's offers.
"The EU remains committed to continue working towards conclusion of an agreement between India and the EU that will be acceptable to both sides. For this reasons, the EU hopes that a solution will be found to the current deferral," Onestini said.
The EU official said the purpose of the meeting at Chief Negotiators level was to explore the possibility of resuming the FTA talks, and was not meant to constitute in anyway a "full-fledged" negotiation round.
