Alleged manipulation of clinical trial results has led to a ban of approximately 700 generic drugs developed by GVK Biosciences. The ban on marketing, sales and distribution of the drugs in question will begin on August 21, 2015 and will apply to all member nations of the EU according to the European Commission and the Federal Institute for Medicines and Medical Products (BfArM), based in Germany.
P V Appaji, the director general of the Pharmaceutical Export Promotion Council of India (Pharmexcil) commented, “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.”
The decision to suspend sales of these generic medications was made following allegations made by the European Medicines Agency (EMA) of falsified clinical trial data based on bioequivalence studies and electrocardiogram (ECG) results by GVK Biosciences. Marketing Authorization of over 1,000 drugs was put under investigation after the French Medicines Agency (ANSM) inspected GVK’s Hyderabad facility in May 2014 and concluded the company showed “systematic manipulation of clinical trial data.”
“Their systematic nature, the extended period of time during which they took place and the number of member of staff involved, cast doubt on the integrity of the conduct of the trials at the site generally, and on the reliability of data generated,” the EMA said.
While the BfArM released a statement saying that GVK Biosciences may have the ability to appeal against the EMA’s decision, the ban will not immediately be lifted. GVK Biosciences and the Government of India have begun to provide multiple EU agencies with additional data from the company’s internal investigations.
- EU bans 700 generic drugs for manipulation of trials by GVK – http://www.business-standard.com/article/pti-stories/eu-bans-700-generic-drugs-for-manipulation-of-trials-by-gvk-115072500419_1.html
- EU-ban will impact $1 bn pharma exports from India: Pharmexcil – http://www.business-standard.com/article/companies/eu-ban-will-impact-1-bn-pharma-exports-from-india-pharmexcil-115072700653_1.html