The European Medicines Agency (EMA) wants to suspend around 300 marketed generic meds and applications coming out of Indian CRO Micro Therapeutic Research Labs due to concerns over “misrepresentation of study data and deficiencies in documentation and data handling.”
The EMA said in a statement that, while there is “no evidence of harm or lack of effectiveness of the medicines,” it wants those marketed meds and applications, which total around 300, to be suspended.
The EMA said this is because the studies for these drugs are “unreliable,” namely because of problems in the way data and documents were managed at the sites in India.
The suspended drugs (PDF) include generic versions of many meds, such as blood pressure tablets and painkillers.
A year ago, Austrian and Dutch authorities inspected the sites and came away concerned that the company was not accurately describing study data and was causing problems with its paper work and handling of trial data.
The EMA, acting on these reports, conducted its own review, and said that data from studies, which were made at the sites between mid-2012 and to the summer of 2016, “are unreliable and cannot be accepted as a basis for marketing authorisation in the EU.”
The EMA’s report will be sent on to the European Commission, which will have a final say on whether the meds and apps should be suspended, a process that typically takes several months but usually follows the advice of the EMA.
The agency noted that these suspensions “can be lifted once alternative data establishing bioequivalence are provided.”
Some of the meds have in fact already been vindicated with these alternative supporting data, and the European regulator said that those can remain on the market (PDF).
The suspension comes two years after Europe banned around 700 drugs approved on data out of GVK Biosciences, which had been India’s largest CRO. It also comes amid charges that other, smaller Indian CROs have also been seen as falling short on commonly held standards.