EU says drug ban not trade related, hopeful of solution

The EU today 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".