The Indian drug industry could lose around $ 1 to 1.2 billion worth of exports due to the latest decision of the European Union to ban 700 generic drugs, an estimate of the Pharmaceutical Export Promotion Council (Pharmexcil) says.
The EU last week announced the ban on the marketing of these generic medicines for alleged manipulation of clinical trials conducted by the Hyderabad-based pharmaceutical research company GVK Biosciences.
The Union Ministry of Commerce is expected to review the implications of this decision and discuss necessary steps to be taken during its meetings over the next two days, the Director-General of Pharmexcil, PV Appaji told Business Line.
The largest EU-wide suspension of sales and distribution of generic drugs ordered by the European Commission will come into effect on August 21 and it will be applicable to all 28 member nations, according to Germany's drug regulator, the Federal Institute for Medicines and Medical Products (BfArM).
Medicines affected by the sales ban will lose their validity for use in the EU from that date and they should no longer be distributed or sold by pharmaceutical companies, wholesale dealers, drugs stores and other outlets, the agency based in Bonn said in a press statement on Thursday.
Meanwhile, the CEO of GVK Bio, Manni Kantipudi said they were disappointed with the decision. “Despite all the evidence/data presented, the European Commission has moved ahead making the EMA recommendation. Even after multiple appeals, a deeper scientific dialogue was not undertaken. We will continue to work with the Government of India and our customers to help resolve this.”
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. The CEO also said there were no moves to exit the clinical trial business from the company.