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Indian drug industry faces setbacks in Europe and the US Posted 21/04/2017

The European Medicines Agency (EMA) has announced that they have recommended the suspension of generic drug approvals and drug applications of over 300 drugs. This is due to unreliable bioequivalence studies carried out by the Indian contract research firm Micro Therapeutic Research Labs.

It is reported that Austrian and Dutch authorities raised concerns over Micro Therapeutic’s compliance with clinical practice in 2016. Since then, officials have been investigating the company and have reported that studies done between June 2012 and June 2016 are unreliable. However, they also noted that there is no evidence of harm or lack of effectiveness of medicines authorized. Companies affected by this suspension include, Aurobindo Pharma, Mylan, Sandoz, Sanofi and Zydus, many producing lifeline pharmaceutical products.

EMA’s recommendation for suspension will now be sent to the European Commission for a legally binding decision to be made. This would be valid throughout the entire European Union (EU). This is not the first time that such recommendations have been made against Indian contract research organizations. In 2016, concerns were raised over the bioequivalence study data produced at the Semler Research Centre in Bangalore [1], and in 2015 approximately 700 medicines that had been approved based on clinical trial data provided by GVK Biosciences were banned in the EU [2].

On the other side of the pond, the Indian drug industry faces more setbacks. The American sales of Sun Pharmaceutical Industries and Dr Reddy's Laboratories' products are reported to have gone down by 15% during the last quarter of 2016. It is stated that these reductions are likely due to increased competition in the generics drugs market in the US. However, there are also speculated fears that, from now on, profits will only go down for foreign drug manufacturers with the implementation of the current US president’s protectionist vision for the future.

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1. GaBI Online - Generics and Biosimilars Initiative. EMA halts sales of unreliable generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Apr 21]. Available from: www.gabionline.net/Generics/General/EMA-halts-sales-of-unreliable-generics
2. GaBI Online - Generics and Biosimilars Initiative. EMA recommends suspending generics from GVK Bio [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Apr 21]. Available from: www.gabionline.net/Policies-Legislation/EMA-recommends-suspending-generics-from-GVK-Bio

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