Following recommendations by the European Medicines Agency (EMA) to suspend the marketing of around 300 generic drugs due to unreliable data from its bioequivalence studies conducted by a company in India, the Spanish Agency for Medicines and Health Products (AEMPS) has decided to ratify the European decision, withdrawing 18 medicines from the published list. The studies were conducted by Micro Therapeutic Research Labs at two of the company’s facilities in India.
It was in February 2016, following an inspection of good clinical practice (BPC) standards carried out by the Austrian and Dutch authorities, when there was evidence of non-compliance with these standards in the bioequivalence studies carried out in this company. Even so, the inspection showed doubts regarding data from studies and deficiencies in documentation and data management.
For this reason, in December of that same year, an arbitration proceeding initiated by 18 national drug agencies was initiated, among them the AEMPS. The CHMP review concluded that data from studies conducted at the two company sites between June 2012 and June 2016 are unreliable and can not be accepted as a basis for marketing authorisation in the European Union.Those affected drugs, not yet authorised but under evaluation, will not be authorised until alternative bioequivalence studies are available.
This is not the first time that Europe has made such suspension recommendations. In January 2015 it issued a recommendation to suspend the marketing of some 700 drugs in the EU whose marketing authorisations are based on clinical trials conducted by the Indian company GVK Biosciences.