EU recommends withdrawing drugs approved on unreliable data

Several hundred formulations of various generic medicines face suspension from sale across Europe (or delays in receiving approval) following ‘unreliable’ studies conducted by an Indian contract research organisation (CRO).

The European Medicines Agency (EMA) concluded that data from bioequivalence studies conducted by Micro Therapeutic Research Labs at its two sites in Tamil Nadu, between June 2012 and June 2016, are ‘unreliable and cannot be accepted as a basis for marketing authorisation in the EU’.

The recommendation, which will be passed to the European Commission for a legally binding decision, covers products from large and small manufacturers across the world – including Aurobindo, Sandoz, Sanofi and Mylan. Some other formulations tested by Micro Therapeutic Research are covered by data from alternative sources, so will be unaffected.

The agency began its review after inspections by Austrian and Dutch authorities in February 2016 ‘identified several concerns at the company’s sites regarding misrepresentation of study data and deficiencies in documentation and data handling’.

The EMA says there is no evidence that the medicines themselves are unsafe, and can continue to be used where there is a critical need. The marketing authorisations will be reinstated once appropriate alternative data is presented.

The move follows a similar case in 2015, where hundreds of products were withdrawn after data from Indian CRO GVK Biosciences was judged to be fraudulent.