India's business loss arising from the European Union's ban on 700 generic drugs is likely to be around USD 1.2 billion, says industry body Pharmexcil.
"We estimate that exports worth USD 1-1.2 billion are likely to be affected if the cancellation of 700 generic drugs by the EU stands," said PV Appaji, director-general of the Pharmaceuticals Export Promotion Council, the apex industry body under the drug ministry, here today.
The EU action is "unjustified and unfair" he said, adding that it will not only adversely affect the GVK Biosciences but also the sector.
Last week, EU banned 700 generic medicines alleging manipulation of data in clinical trials of these drugs and formulations, which were conducted by GVK Biosciences.
According to Germany drug regulator Federal Institute for Medicines & Medical Products (BfArM), the largest EU-wide suspension of sales and distribution of generic drugs ordered by the EU will come into effect from August 21 and will be applicable to all 28 member-nations.
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, the Bonn-based agency had said in a press statement last Thursday.
Though the affected pharma companies can appeal the suspension of marketing approvals, it will have no immediate effect as the ban will remain in force, the statement added.
The EU took the decision in response to a recommendation by the EU drug regulator European Medicines Agency in January this year, marketing authorisation of these drugs should be suspended as they are based on clinical trial data allegedly manipulated by the Hyderabad-based company.
"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, including the Pharmexicl on the issue," Appaji added.
He said the country exports around Rs 20,000 crore worth of pharma products, which include both API as well as formulations to the EU.
