The European Union's ban on 700 generic drug products, based on data integrity issues found at an Indian clinical research facility where they were subjected to bioequivalence studies, would impact exports worth at least $1 billion from India, according to Pharmaceutical Export Promotion Council of India (Pharmexcil).

While the products being manufactured and marketed directly by Indian pharmaceutical companies constitute around 30 per cent of this estimated value, the products carrying the rest of the value were being sourced by global generic players from India, the Commerce Ministry agency estimates.

"We have estimated the value of the products banned by the European Union to be between $1-1.2 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. The products marketed in Europe by the domestic players would be 30 per cent of the total value of exports impacted by the decision, he added.

According to Appaji, the Union Commerce Ministry has been reviewing the situation arising out of the EU decision and asked the Pharmexcil for the necessary feedback about 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 Union Commerce Ministry was planning to approach the EU with any fresh representation on this matter.

The Government of India and clinical research firm GVK BIO Sciences, which had conducted the 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 data from the company's internal investigations following the recommendation for suspension of these products by the European Medicines Agency (EMA) in January this year.

Source:- business-standard.com