This week, the European Medicines Agency recommended the suspension of more than 300 generic drug approvals and applications, after they uncovered “unreliable” tests conducted by Micro Therapeutic Research Labs.
The India-based contract research firm is part of the country’s drug-testing industry, which has faced problems with international regulators in recent years.
European officials have reportedly been investigating Micro Therapeutics and the company’s compliance with good clinical practice since Feb. 2016, when Austrian and Dutch authorities raised concerns.
“The inspections identified several concerns at the company’s sites regarding misrepresentation of study data and deficiencies in documentation and data handling,” the agency said, according to Reuters.
The European regulatory agency’s recommendation to suspend medicines tested by Micro Therapeutics will be sent to the European Commission for a legally binding decision that will be valid throughout the E.U.
There is no evidence that the medicine is harmful or doesn’t work as intended, the news outlet reported. Among the pharmaceuticals that would be impacted by the suspension are generic versions of blood pressure pills and pain-relievers.
Pharmaceutical companies often carry out drug-testing at Indian contract research organizations but in the wake of trial data scandals, some drugmakers are bringing their clinical trial programs to the U.S. and Europe, according to industry consultants.
In 2015, Europe banned 700 medicines that were approved based on data provided by India’s massive contract research organization, GVK Biosciences. Regulators have also identified smaller groups as falling short of standards.
Material from Reuters was used in this report.
