Concern over Indian drug trials highlights global challenges

By recommending that hundreds of drugs tested by a Hyderabad-based company be suspended, European regulators have shone a light into a complex network of research and commerce, says Salla Sariola.

This May, the European Medicines Agency, which oversees regulation of medicines in Europe, confirmed its recommendation that 700 generic drugs that had undergone clinical trials at a contract research organisation called GVK Biosciences, based in Hyderabad, India, should be suspended. Because CROs, like others in the pharmaceutical business, are extremely cagey about their financial, operational and collaborative details, it is difficult to assess the scale of this move. Suspending 700 drugs at once, however, would be unprecedented.

The EMA’s decision followed a September 2014 inspection by the French medicines agency, which reported that GVK Biosciences had not complied with good clinical practice. After an initial ruling in January, the EMA reaffirmed its original judgement after reviewing the company’s operations and data.