The European Medicines Agency (EMA) has recommended the suspension of 100 generic drugs after uncovering data irregularities at an Indian CRO (Contract Research Organization), according to Endpoints News.
A CRO provides support to the pharmaceutical, biotechnology, and medical device industries. It may also provide services such as biopharmaceutical development, biologic assay development, commercialization, clinical development, clinical trials management, pharmacovigilance, and outcomes research. It basically runs tests for generic drugs.
Here, the CRO in question is Synchron Research Services, which is not the first to come under the scanner for data integrity failings.
Previously, the U.S. Food and Drug Administration (FDA) and EMA uncovered similar data integrity issues from several Indian CROs, including Semler Research and GVK Biosciences.
On Friday, the EMA said, “The recommendation comes after irregularities were found in how the CRO carried out bioequivalence studies, which raised serious concerns about the company’s quality management system and the reliability of data from that site.”
The EMA recommended the suspension of 100 generic drugs made by several companies, such as J&J, Sandoz, Teva, Viatris, Jubilant, Wockhardt, Accord, Aurora, and Strides, among others.
The European drug regulatory body warned member states that the drugs recommended for suspension “may be of critical importance (e.g. due to lack of available alternatives) in a given EU Member State. 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,” it added.
Last year, Synchron also came under fire from the FDA over similar data concerns.
In a 2019 inspection, the FDA body “found unusual and unexplainable study records demonstrating that you engaged in practices and processes that undermined the analytical methods used at your firm. Upon close review of study records from your firm, we conclude that those practices and processes resulted in the submission of falsified study data to the FDA.”
