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The European Union’s ban on 700 generic drug products based on data integrity issues would impact exports worth at least $ 1 billion from India, according to the Pharmaceutical Export Promotion Council of India (Pharmexcil).
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While products being manufactured and marketed directly by Indian pharmaceutical companies constitute around 30 per cent of this estimated value, those carrying the rest of the value are being sourced by global generic players from India, estimates Pharmexcil.
While products being manufactured and marketed directly by Indian pharmaceutical companies constitute around 30 per cent of this estimated value, those carrying the rest of the value are being sourced by global generic players from India, estimates Pharmexcil.
“We have estimated the value of the products banned by the European Union to be between $ 1 billion and $1.2 billion. These products are being sourced from India by global majors. Therefore, the EU decision impacts our pharmaceutical exports to the extent of around $1 billion,” Pharmexcil director general P V Appaji said here today.
According to Appaji, the Union commerce ministry is reviewing the situation arising out of the EU decision and has asked Pharmexcil for the necessary feedback on the impact.
He said the ministry was unhappy with the blanket ban since the French regulator, ANSM, which had found discrepancies in the ECG reports in its May 2014 audit itself stated that the findings should not be extrapolated beyond the clinic part of the facility.
However, Appaji did not directly respond to a question on whether the commerce ministry was planning to approach the EU with any fresh representation on this matter.
The Government of India and clinical research firm GVK Biosciences Pvt Ltd, which had conducted the bioequivalence studies on these products at its Hyderabad facility, opened dialogue with various regulatory agencies in Europe and presented more data from cardiologists as well as from the company’s internal investigations following the recommendation for suspension of these products by the European Medicines Agency (EMA) in January this year.
