Aurobindo Pharma may face the brunt of suspension call

EMA recommends suspending 300 drugs or their applications of various firms

In a major setback to Aurobindo Pharma, the European drug regulator has recommended suspension of its 100 drugs, or their marketing applications, on which bioequivalence studies have been found to be “unreliable”. The European Medicines Agency (EMA) has recommended the suspension of total 300 drugs or their applications. It includes 100 drugs, 5 drugs and 4 drugs of Aurobindo Pharma, Strides Arcolab and Zydus Cadila, respectively. The bioequivalence studies, where the regulator found serious data integrity issues, for these 300 drugs were conducted by Micro Therapeutic Research Labs, a contract research organisation (CRO), at its two sites in Tamil Nadu.

Bioequivalence studies are usually the basis for approval of generic medicines as it proves that the drug, for which the application is being made, is similar to an already-approved drug in the market. After this recommendation of the EMA, the European Commission would take the final decision, which will be legally binding for all member-countries of European Union (EU). “The suspensions can be lifted once alternative data establishing bioequivalence are provided,” the EMA stated in its statement.

Aurobindo Pharma, Zydus Cadila and Strides Arcolab did not respond to the queries sent by The Indian Express. “The review of medicines studied by Micro Therapeutic Research Labs was started after inspections to check compliance with good clinical practice by Austrian and Dutch authorities 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 EMA stated.

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The review, by EMA’s Committee for Medicinal Products for Human Use (CHMP), concluded that data from studies conducted at the two sites between June 2012 and June 2016 are “unreliable and cannot be accepted as a basis for marketing authorisation in the EU”. However, the EMA stated that 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 these two sites.

“The CHMP’s recommendation concerning these medicines will now be sent to the European Commission for a legally binding decision valid throughout the EU,” the EMA stated in its statement. In 2015, the EU had banned the marketing of around 700 generic medicines, as it found manipulation of clinical trials conducted by GVK Biosciences, which is a Hyderabad-based CRO. “Some of the medicines which have been recommended for suspension may be of critical importance (e.g. due to lack of available alternatives) in certain EU Member States. Therefore, national authorities can temporarily postpone the suspension in the interest of patients. Member States should also decide whether recalls of the affected medicines are needed in their territories,” the EMA stated.

The EMA recommended suspension of four drugs of Zydus France, which is the French subsidiary of Ahmedabad-based Zydus Cadila. Five drugs — two in Italy, one on Spain and two in United Kingdom — of Strides Arcolab International Limited, which is a subsidiary of Bengaluru-based Strides Arcolab, have been recommended for suspension by the EMA.