EMA looks to suspend 331 drugs due to ‘misrepresentation of study data’ at Indian CRO

The European Medicines Agency’ Committee for Medicinal Products for Human Use (CHMP) recommended the suspension after identifying concerns surrounding the misrepresentation of study data and deficiencies in documentation and data handling at two sites rub by Indian contract research organisation (CRO) Micro Therapeutic Research Labs.

Products marketed by Sandoz, Aurobindo and Strides Arcolab are among the 331 nationally approved medicines for which the CRO conducted bioequivalence studies. The full list of suspended products can be found here​.

“The review of medicines studied by Micro Therapeutic Research Labs was started after inspections to check compliance with good clinical practice (GCP) by Austrian and Dutch authorities in February 2016,”​ the EMA said in a press release.

“The inspections identified several concerns at the company’s sites regarding misrepresentation of study data and deficiencies in documentation and data handling.”​

Micro Therapeutic Research Labs was not contactable for comment at the time of publication.

The EMA had begun reviewing drugs tested by Micro Therapeutic Research Labs back in December​.

Misrepresentation of study data​

Anders Fuglsang – an advisor to regulatory agencies and private companies, and a consultant and inspector for the World Health Organisation (WHO) – while not commenting specifically on the CRO in question told this publication the EMA’s actions follow a similar approach to data issues at fellow Indian CRO GVK Bio in January 2015​ when it recommended suspension for more than 700 products, and last year​ at Bangalore-based Semler.

“CHMP's public explanation for the current action is stated as ‘concerns at the company’s sites regarding misrepresentation of study data and deficiencies in documentation and data handling,’”​ he said.

 “Deficiencies in documentation and data handling can be anything big or small, but when regulators decide to use the term 'misrepresentation' the problem is of another order of magnitude, and there is usually a justified reason for concern.”​

He added European patients should be grateful that agencies have competent inspectors who can and do identify such issues.

“This is especially so at this time when many MA holders and dossier developers are doing what they can to cut down on their vendor oversight budgets. The responsibility for integrity in an approved dossier rests with the MA holder's, not with the agency and not with a subcontractor.”​

The Agency said there is no evidence of harm or lack of effectiveness of medicines, but called on Marketing Authorisation Holders (MAH) to provide alternative supporting data to lift the suspension. Some alternative data have already been provided for a number of products which will remain on the market (see here​).