The European Medicine Agency (EMA) has recommended the suspension of over 300 approvals and applications for generic drugs that underwent bioequivalence studies by Micro Therapeutic Research Labs, an Indian based CRO. The EMA stated that there were concerns regarding the reliability of bioequivalence studies that took place in the two sites owned by Micro Therapeutics.
The concerns were identified by Austrian and Dutch authorities regarding the company misrepresenting data in addition to deficiencies in documentation and data handling. Although these drugs face suspension within the EU, they are currently still on the market as recommended by the Committee of Medicinal Products for Human Use due to provided supporting data.
The Committee of Medicinal Products for Human Use concluded that “there was no evidence of harm or lack of effectiveness of medicines” but they were facing suspension due to the basis of studies on the site. In the statement released by the EMA, they stated that these suspensions can be lifted as soon as Micro Therapeutics Research Lab can provide alternative data to establish bioequivalence.
This announcement is significant since the model has dramatically changed over the last decade, with pharmaceutical companies increasingly outsourcing. In light of this case, it is speculated whether this will have an impact on where companies choose to outsource.