However, there is no evidence of harm or lack of effectiveness of the medicines, which include generic versions of many common prescription pharmaceuticals, including blood pressure tablets and painkillers.
The EMA’s recommendation on the suspension of the medicines tested by Micro Therapeutic will now be sent to the European Commission for a legally binding decision valid throughout the European Union.
Drug tests carried out at Indian contract research organisations (CROs) have been key in getting a huge array of generic medicines approved for sale around the world over many years.
In 2015, Europe banned around 700 medicines that had been approved based on clinical trial data provided by GVK Biosciences, then India‘s largest CRO. Other smaller Indian CROs have also been found to have fallen short of required standards.
In the wake of such trial data scandals, many large drugmakers have been shifting more critical trials back to the United States and Europe over the last three years, according to consultants and industry executives.
