Pharmexcil sees $1.2-bn export hit from EU ban

The European Union has banned the marketing of around 700 generic medicines for alleged manipulation of clinical trials conducted by India’s pharmaceutical research company GVK Biosciences.

During the inspection at the GVK Bio site, German and French drug regulators reportedly found “anomalies” in the way electrocardiograms (ECG) were monitored during the bioequivalence studies. “Our estimate is that exports worth $1-1.2 billion are likely to be affected”.

This is for the first time that exports to EU is showing a negative growth. According to Germany’s drug regulator, the Federal Institute for Medicines and Medical Products, the ban will be applicable to all 28 member nations.

With this ban, 700 generic medicines will lose their validity for use in the EU and now they will not be distributed or sold by pharmaceutical companies, drugs stores, wholesale dealers and other outlets.

The European Commission is the executive body of the European Union (EU) responsible for proposing legislation and implementing decisions.

He said the company has already taken a hit in its business and the latest decision, which is only the completion of a process will not impact it further. In a note last week, the London-based EMA said during the re-examination, its arm, the Committee for Medicinal Products for Human Use, concluded that concerns about the reliability of the clinical studies remain and therefore maintained its recommendation of January 2015 to suspend medicines for which no supporting data from other studies were available. “This medicine is now no longer recommended for suspension”, the EMA added. “Despite all the evidence/data presented, the European Commission has moved ahead making the EMA recommendation into law”, a GVK Biosciences spokesperson said in a statement. GVK Bio had earlier claimed that the ministry too was disappointed by the decision of the European authorities and a ministry spokesperson, in a mail to the company, had said, “This action by the EU was one sided, highly disproportional and lacked scientific basis. GVK BIO will continue to work with the Government of India and our customers to help resolve this”.