- Dozens of drugs are facing market suspensions in Europe after regulators determined an Indian facility responsible for clinically testing the medications had been submitting faulty data for four years.
- The European Medicines Agency (EMA) opened a review of Micro Therapeutic Research Labs following investigations early last year that raised concerns over the quality of bioequivalence data coming out of the Chennai, India-based contract research organization (CRO). The agency found data collected between June 2012 and June 2016 at two sites was "unreliable" and therefore couldn't be used for the drugs' market applications.
- Novartis' generics business Sandoz, Aurobindo Pharma and Mylan's French subsidiary are just a few named on a 32-page list of drugmakers and products affected under a potential suspension.
In spite of the inadequate data, "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," the EMA said in a March 24 statement.
The agency also noted companies can submit alternative data from other testing sites to avoid having their medications locked down. A handful of drugmakers, including Kenya-based Dawa Ltd. and Czech Republic-based SVUS Pharma, have already submitted such data for about 10 products.
The EMA conducted its review of the Micro Therapeutic Research Labs sites in December. The agency plans to submit its list of suspension recommendations to the European Commission, which will have final say on what drugs can stay on the market.
Notably, the agency advocated EU member countries retain the right to hold off suspending vital drugs that have few, if any, alternatives.
"National authorities in the EU will consider how critical individual medicines recommended for suspension are in their countries and make final decisions on whether to suspend or allow them to remain available, while new data are generated," the EMA said in the statement.
Though lengthy, the EMA's list is not all that shocking. European and U.S. regulators have increasingly found quality control and good manufacturing practice violations at many facilities throughout Asia, namely those in India and China. Just last week, for example, the Food and Drug Administration put a Divi's Laboratories facility located in Andhra Pradesh, India, on the import ban list.