Companies, which will affected by the ban, would include Dr Reddy’s Laboratories, Ranbaxy
A ban imposed by the European Union on the sale of 700 generic drugs in 28 member countries due to alleged manipulation of clinical trials data conducted by GVK Biosciences will cost upto $1.2 billion for the Indian pharma industry.
Hyderabad: A ban imposed by the European Union on the sale of 700 generic drugs in 28 member countries due to alleged manipulation of clinical trials data conducted by GVK Biosciences will cost upto $1.2 billion for the Indian pharma industry.
Speaking at an event on Monday, Dr P.V. Appaji, director general, Pharm-excil, said, “The ban on these medicines will affect our exports and about 700 drugs may get affected by this ban. Which in turn means that about $1 billion to $1.2 billion of the total exports to EU will get affected.”
The companies, which will affected by the ban, would include Dr Reddy’s Laboratories, Ranbaxy, Cipla, Wockhardt, etc from India.
India’s pharma sector, which has a total exports worth approximately Rs 90,000 crore, has been growing at 18-20 per cent. Out of this, about Rs 20,000 crore is exported to the European Union.
On July 25, the European Union suspended marketing authorisation of these drugs on the recommendations of EU drug regulator European Medicines Agency in January, following the shortcomings the latter had found at GVK Bio.
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. Both the regulators had said the inspection raised serious concerns over whether the company’s studies complied with good clinical practices.
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 pharma companies, wholesale dealers, drugs stores and other outlets.
“For the first time there is a negative growth in pharma exports to the EU, which is affecting us. The commerce ministry is discussions with all the stakeholders,” Dr Appaji added.
( Source : deccan chronicle )
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