A supervisory agency of the European Union has recommended suspending more than 300 generic drugs approved by Chennai-based Micro Therapeutic Research Labs. The European Medicines Agency has said that the Indian firm, which has run into problems with international regulators in the past, had conducted “unreliable” tests, Reuters reported.
To enforce a legally binding decision across the European Union, the recommendation will now be sent to the European Commission. The order will apply to all drugs on which bioequivalence studies had been conducted. European officials had been investigating the firm since Austrian and Dutch authorities had raised concerns last year regarding the tests it had conducted, the EMA said in a statement.
“The inspections identified several concerns at the company’s sites regarding misrepresentation of study data, deficiencies in documentation and data handling,” it said. However, the EMA clarified that there has been no evidence of harm caused by the medicines.
The list includes 100 drugs of Aurobindo Pharma, five of Strides Arcolab and four of Zydus Cadila. Other pharmaceutical companies that could be affected by the ban are Sandoz, Sanofi and Mylan.
The EMA has also recommended withholding approval for medicines that have not been authorised yet, but are being evaluated on the basis of bioequivalence studies, till alternative data is made available. Considering some of the drugs recommended for suspension may be of vital importance in some EU member states, the EMA has said that respective authorities can postpone suspending those drugs.
Tamil Nadu-based Micro Therapeutic is a contract research organisation that conducts the analytical and clinical legs of bioequivalence studies. Some of the studies are used to support marketing authorisation applications of medicines in the EU.
In 2015, Europe had banned more than 700 drugs approved by GVK Biosciences, then India’s largest contract research organisation, Reuters added.