EMA Requests Suspending Sales of Hundreds of Drugs Due to Flawed Data from Indian CRO
The EMA is recommending that the European Commission suspend the sales of more than 300 generic drug formulations that were approved from flawed bioequivalence studies conducted at two of Micro Therapeutic Research Labs’ facilities in India.
The EMA is calling for the suspension of sales after inspections of the two facilities by Austrian and Dutch authorities showed that — between June 2012 and June 2016 — the company mispresented study data and failed to manage data and documentation appropriately.
The suspension could affect several drugmakers, including Sandoz, Sanofi and Aurobindo Pharma, and the availability of generic versions of treatments such as Merck’s diabetes drug Januvia and Sanofi’s blood pressure medicine Avapro.
However, the EMA recommended that dozens of generic drugs approved from studies conducted at the facilities remain on the market, because Micro Therapeutic Research Labs provided alternative data to confirm their bioequivalence.