The European drug regulator has recommended suspension of around 300 medicines on which bioequivalence studies were conducted by Chennai-based Micro Therapeutic Research Labs, citing unreliability of data.
bioequivalence studies are usually the basis for approval of generic medicines.
The European Medicines Agency (EMA) said that the suspension has been ordered for all drugs for which the bioequivalence studies were conducted by Micro Therapeutic Research Labs at two sites in India.
“The review, by EMA’s Committee for Medicinal Products for Human Use (CHMP), concluded that 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 EU,” 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 studies at the sites.
Aurobindo Pharma, Zydus, Sandoz, Sanofi and Mylan are among the major pharmaceutical firms that will be affected by the suspension.
Micro Therapeutic Research Labs is a contract research organisation (CRO) which conducts analytical and clinical parts of bioequivalence studies, some of which are used to support marketing authorisation applications of medicines in the EU, it added.
Comment from Micro Therapeutic Research Labs could not be obtained.
The regulator also recommended that medicines not yet authorised but which are being evaluated on the basis of studies from the two sites should not be authorised until bioequivalence is demonstrated using alternative data.
The review of medicines studied by Micro Therapeutic Research Labs was started after inspections to check compliance with good clinical practice by Austrian and Dutch authorities in February 2016, EMA said.
“The inspections identified several concerns at the company’s sites regarding misrepresentation of study data and deficiencies in documentation and data handling,” it added.
“The CHMP’s recommendation concerning these medicines will now be sent to the European Commission for a legally binding decision valid throughout the EU”, EMA said.
The regulator, however, said that some of the medicines which have been recommended for suspension may be of critical importance in certain EU member states. Therefore, national authorities can temporarily postpone the suspension in the interest of patients.“Member States should also decide whether recalls of the affected medicines are needed in their territories,” EMA said.