EMA Calls to Suspend More Than 300 Drugs due to Unreliable Studies From Indian CRO

Regulatory News | 24 March 2017 | By Zachary Brennan

The European Medicines Agency (EMA) on Friday announced it is recommending the suspension of more than 300 approvals and applications for generic drugs for which bioequivalence studies were conducted by Chennai, India-based contract research organization (CRO) Micro Therapeutic Research Labs.

The review of the CRO by EMA’s Committee for Medicinal Products for Human Use (CHMP) concluded that data from studies conducted at two sites between June 2012 and June 2016 “are unreliable and cannot be accepted as a basis for marketing authorisation in the EU. However, there is no evidence of harm or lack of effectiveness of medicines authorised and being evaluated in the EU on the basis of studies at the sites.”

EMA’s list of drugs it’s recommending suspension covers just about every EU member state, including: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Norway, Portugal, Spain, The Netherlands and the UK.

Generic drugs included those with the active substances bupropion, voriconazole, betahistine, amlodipine/valsartan, tadalafil and naproxen, and sponsored by marketing authorization holders and applicants including Novartis’ Sandoz, Aurobindo Pharma, Strides Arcolab and Bluefish Pharmaceuticals, among others.

Several medicines which were approved based on studies conducted at Micro Therapeutic Research Labs can remain on the market in the EU, EMA added, noting that during its review, alternative data were provided for some medicines. Here’s the list of medicines EMA recommended to remain on the market.

CHMP’s review was initiated last December after inspections to check compliance with good clinical practice by Austrian and Dutch authorities in February 2016 identified concerns at the company’s sites on misrepresenting study data and deficiencies in documentation and data handling.

The European Commission will now make a legally binding decision. National authorities can temporarily postpone a suspension in the interest of patients, EMA said, noting that member states should decide whether recalls of the affected medicines are necessary.

EMA