Europe’s medicines regulator has recommended the suspension of more than 300 generic drug approvals and drug applications due to “unreliable” tests conducted by Indian contract research firm Micro Therapeutic Research Labs.
The decision, announced by the European Medicines Agency (EMA) on its website, is the latest blow for India’s drug-testing industry, which has run into a series of problems with international regulators in recent years.
Nobody at the Chennai-based company was immediately available to comment.
The EMA said European officials had been investigating Micro Therapeutic’s compliance with good clinical practice after Austrian and Dutch authorities raised concerns in February 2016.
“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.
However, there is no evidence of harm or lack of effectiveness of the medicines, which include generic versions of many common prescription pharmaceuticals, including blood pressure tablets and painkillers.
The EMA’s recommendation on the suspension of the medicines tested by Micro Therapeutic will now be sent to the European Commission for a legally binding decision valid throughout the European Union.
Drug tests carried out at Indian contract research organizations (CROs) have been key in getting a huge array of generic medicines approved for sale around the world over many years.
In 2015, Europe banned around 700 medicines that had been approved based on clinical trial data provided by GVK Biosciences, then India’s largest CRO. Other smaller Indian CROs have also been found to have fallen short of required standards.
In the wake of such trial data scandals, many large drugmakers have been shifting more critical trials back to the United States and Europe over the last three years, according to consultants and industry executives.