more-in The European drug regulator has recommended suspension of around 300 medicines on which bio-equivalence studies were conducted by the Chennai-based Micro Therapeutic Research Labs (MTRL), citing unreliability of data. Bio-equivalence studies are the basis for approval of generic medicines. The European Medicines Agency (EMA) said the suspension has been ordered for all drugs for which the bio-equivalence studies were conducted by MTRL at two sites in India. ‘Data can’t be accepted’ “The review, by the EMA’s Committee for Medicinal Products for Human Use (CHMP), concluded that the data from studies conducted at the [two] sites between June 2012 and June 2016 are unreliable and cannot be accepted as a basis for marketing authorisation in the European Union,” the EMA said in a statement. It, however, said there is no evidence of harm or lack of effectiveness of medicines authorised and being evaluated in the EU on the basis of the studies at the sites. Aurobindo Pharma, Zydus, Sandoz, Sanofi and Mylan are among the major firms that will be affected by the suspension. MTRL is a contract research organisation which conducts analytical and clinical parts of bio-equivalence studies, some of which are used to support marketing authorisation applications of medicines in the EU, it added. MTRL was not available for comment. The regulator also recommended that medicines not yet authorised but which are being evaluated on the basis of the studies from the two sites should not be authorised until bio-equivalence is demonstrated with alternative data.

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