EU recommends withdrawing drugs approved on unreliable data
Indian firm Micro Therapeutic Research Labs accused of misrepresenting clinical data and documentation deficiencies
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’.