The European Medicines Agency has started a review of medicines whose studies have been conducted at either of the two sites of Micro Therapeutic Research Labs in India, following concerns about the CRO's data integrity.
The review process (PDF) initiated this month was based on a good clinical practice inspection carried out jointly by Austrian and Dutch authorities in February 2016, when concerns were raised about study data used by the company’s two labs in Chennai and Coimbatore, both in the Indian state of Tamil Nadu, for applications of some medicines in the EU.
“The findings reported during the inspection cast serious doubts on the reliability of the data of bioequivalence studies (clinical and bioanalytical part) conducted at the sites inspected,” according to a notification sent to the Committee for Medicinal Products for Human Use (CHMP), which will also be responsible for carrying out the re-examination.
As the notification shows, the findings reported include ECG recordings inconsistencies, which the joint inspection force concluded to be intentional misrepresentation of data; in different cases, source data were generated retrospectively, or raw data were overwritten; noncompliant issues like deficient procedures on verification of subject identity are also mentioned.
This put in question marketing authorizations of medicines assisted by those two labs in EU members within a wide range of periods from June 2012 to June 2016, which included more than 440 items (PDF), some of the same product in different strengths, or of the same one in different countries.
All together 18 countries were involved, which signed and submitted requests to the EMA to assess the impact. Medicines which are currently being evaluated for authorization and which use studies performed at these sites will also be under review.
The Indian CRO is expected to submit its responses to CHMP about those concerns by Feb. 9, 2017. CHMP will then adopt an opinion and forward it to the European Commission, which will issue a final legally binding decision applicable in all EU member countries.