The fallout from a European Union-wide ban on more than 700 drugs that were bioequivalency-tested by India's GVK BioSciences could cost India at least $1 billion in exports by the end of the fiscal year in March 2016, the Economic Times reports.Pharmexcil Director General P.V. Appaji
The "majority of those 700 generic drugs are either produced or sourced by the domestic and multinational pharmaceutical companies in India," the director general of India's Pharmaceuticals Export Promotion Council (Pharmexcil), P.V. Appaji, said to reporters in the southern city of Hyderabad, according to the Economic Times.
"We estimate that the loss of exports could be $1-1.2 billion this fiscal." He added that India exported $15.2 billion of pharmaceutical products in the year ended March 31, 2015, with the European Union accounting for a fifth of that figure, or $3 billion.
Germany's Federal Institute for Medicines and Medical Products posted the notice of the ban in German on July 22, Business Standard reported. The notice showed the acceptance of a European Medicines Agency recommendation for an EU-wide ban on the drugs tested at GVK's Hyderabad, India, facility.
The ban will come into effect on Aug. 21 in a move that New Delhi had tried to head off with diplomatic efforts, the failure of which has apparently riled India's Commerce Ministry the Economic Times said.
"The commerce ministry is not happy with the latest development of the European Commission going ahead with ban even after series of consultations we had with the respective European agencies," a commerce ministry official told the Economic Times.GVK CEO Manni Kantipudi
"We are reviewing the situation and will decide shortly on the course of action."
Appaji separately told the newspaper that among the steps ahead are consultative discussions with stakeholders and a possible complaint to unspecific multilateral forums.
In another article, the Economic Times said GVK BioSciences may sell its clinical trials business.
Citing people familiar with the development, the newspaper said talks to sell the business, which it said accounts for 10% of the revenues of GVK BioSciences, are underway.