Ban on GVK drugs due to ‘inadequate data’: EU regulator

Clarifying the reasons for the ban imposed on some 700 drugs clinically tested by Hyderabad-based GVK Biosciences, the European Union on Friday said the move had neither to do with the efficacy of those drugs nor was it against the Indian pharmaceutical industry. The ban, it said, was imposed due to "inaccurate data provided".

"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). Such procedures do not question the reputation of the companies or countries concerned, nor of generic medicinal products. These are an integral part of a rigorous scientific assessment process," Cesare Onestini, acting head of the European Union's delegation to India, said.

He added that the scientific committee concerned had noted there was no evidence of harm or lack of effectiveness in the medicines. However, the committee believed GVK Biosciences provided "inaccurate data".

"This procedure is necessary for both ensuring patient safety and retaining the credibility of the robust EU marketing authorisation system… Similar necessary suspensions have occurred in different countries in the past," Onestini said.

He added that the EU was keen to continue work towards a successful conclusion of its proposed free trade agreement (FTA) with India.

On India deferring the talks between chief trade negotiators, Onestini said EU hoped "a solution will be found to the current deferral".

 The issue concerns an inspection of GVK Biosciences' site at Hyderabad in January this year, when French medicine agency (ANSM) had found "data manipulations of electrocardiograms (ECGs) during the conduct of some studies of generic medicines, which appeared to have taken place over a period of at least five years", according to an EMA press release.

Apparently, the EU did not plan to recall the medicinal products, many of which were still being sold in the European markets, another EU official said.

The decision on whether a medicine is critical for patients is taken by the national authorities of EU member states. For medicines considered critical, companies are given 12 months to give additional data.

The EU official, however, said the ban could only be lifted after a fresh round of inspection on the basis of a bioequivalence study conducted vis-à-vis the EU Reference Medicinal Product.

"This means marketing authorisation holders have to conduct new bioequivalence studies, which many have already completed, so that the suspension for some will not be required, because marketing authorisation holders may have successfully completed the required bioequivalence study and therewith fulfill the conditions for lifting of the suspension.

This is about reliability of some of the clinical records performed at one particular clinical trial site," the official said.

India on Thursday said it was deferring the talks on FTA with the EU because the 28-nation bloc had pointed a finger at the country's robust pharmaceutical industry.

As a result, the talks that were supposed to be held here this month were indefinitely suspended.
While the government has maintained that this was a negotiation round, the EU has said it is only aimed at taking stock of the negotiations that began in 2007.