More than 300 generic drugs pending approval flagged by the European Medicines Agency.
The European Medicines Agency (EMA) has recommended the suspension of over 300 approvals for generic drugs based on "bioequivalence studies" conducted by a Chennai-based company Micro Therapeutic Research Labs – a contract research organization that conducts analytical and bioequivalence studies. The EMA said it recommended suspension after inspections identified concerns relating to study data and deficiencies in documentation and data handling at the firm's sites in Chennai and Coimbatore.
The drugs whose approvals have been suspended include painkillers, anti-diabetic drugs and blood pressure medications. EMA added that there was no evidence of unexpected harm or lack of effectiveness with the medicines approved on the basis of the studies conducted by Micro Therapeutic. Bioequivalence studies are conducted to demonstrate that a generic medicine has the same physiological and pharmacological behavior as the original pharmacological compound.
The EMA's panel for medicinal products for human use said the data from studies conducted at the sites in Chennai and Coimbatore between June 2012 and June 2016 were "unreliable and cannot be accepted as a basis for marketing authorization in the EU ( European Union)." This is the latest blow to India's drug-testing industry, which has run into a series of problems with international regulators in recent years. Europe banned approximately 700 medicines in 2015 that were approved based on clinical trial data provided by GVK Biosciences, India's largest contract research organization at that time. Other smaller Indian organizations have also been found to have fallen short of required standards.
This suspension means EU member states, where the drugs have been approved, could decide to recall the affected medicines. According to a regulator, some of the medicines on the suspension list may be of critical importance because of lack of available alternatives in certain member states and so authorities may postpone the recommended suspension for the best interest of patients. The regulator said the suspensions can be lifted once alternative data establishing bioequivalence are provided.
In the wake of such trial data scandals, many large drugmakers have been shifting more critical trials back to the U.S. and Europe over the last three years, according to consultants and industry executives.