EU recommends suspending many drugs tested by India firms
Vendor support news service:
LONDON: 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 theEuropean 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.
