European Commission, executive body of the European Union (EU), has accepted the European Medicines Agency (EMA)’s recommendation for an EU-wide ban on 700-odd drugs that underwent bio-equivalence studies at Hyderabad-based GVK Bio Sciences’ facility.
While several of the 28-member countries have already suspended these drugs, the European Commission’s move will mandate every member to follow suit. In a statement posted on its website, Germany’s drug regulator, the Federal Institute for Medicines and Medical Products, said the EU-wide ban will kick in from August 21. The medicines figured on the list of EMA will lose their validity for use in the EU from that date and should no longer be distributed or sold by pharmaceutical companies, wholesale dealers, drug stores and other outlets, it added.
A GVK Bio spokesperson said: “Despite all the evidence and data presented, the European Commission has moved ahead with the EMA recommendation. GVK Bio is disappointed with the fact that even after multiple appeals, a deeper scientific dialogue was not undertaken. GVK Bio will continue to work with the government of India and our customers to help resolve this.”
The ban, EU 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 integral part of a rigorous scientific assessment process,” Cesare Onestini, acting head of the European Union’s delegation to India, told Business Standard.
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.
Source: Business Standard.