EMA recommends to suspend of more than 300 generic drug approvals, drug applications due to ‘unreliable’ tests that were conducted by Indian contract research firm Micro Therapeutic.
Europe’s medicines regulator has recommended suspending of more than 300 drug applications and generic drug approvals due to “unreliable” tests that are conducted by Indian contract research firm Micro Therapeutic Research Labs.
European Medicines Agency (EMA) has announced the decision on its website. This will be the latest blow for India’s drug-testing industry, in which it has run into a sequence of problems with some international regulators in recent years.
Nobody is present over the Chennai-based company was immediately available to comment.
The EMA said that European officials have been investigating the Micro Therapeutic’s compliance with good clinical practice after that the two countries Austrian and Dutch authorities has raised few concerns in February 2016.
“The inspections of it have identified several concerns at the company’s sites regarding misrepresentation of study data and deficiencies in documentation and data handling,” the agency has said.
There will be no evidence of harm or lack of effectiveness of the medicines, which include generic versions of many of common prescription pharmaceuticals, including blood pressure tablets and painkillers.
Drug tests that had carried out at Indian contract research organisations (CROs) have yet been key in getting a huge array of generic medicines have been approved for sale around the world over many years.
In 2015, Europe banned all most of about 700 medicines that had approved based on clinical trial data provided by GVK Biosciences, then India’s largest CRO. Then the other smaller Indian CROs have also been found to have fallen short of some required standards.
Over the last three years many large drugmakers have been shifting more critical trials back to the United States and Europe, according to consultants and industry executives.