NETHERLANDS – A scientific panel of the European Medicines Agency is set to suspend the use of approximately 100 generic medicines in Europe after reviewing evidence of irregularities at an Indian contract research organization (CRO).
Synchron Research Services, based in Ahmedabad, has come under fire following a US Food and Drug Administration inspection in 2019.
Concerning what the regulators are specifically concerned about, according to the FDA’s untitled letter to Synchron last year, an inspection from 2019: “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.”
The CRO in question, Synchron Research Services, is not the first to be scrutinized for data failures. The FDA and EMA have previously raised similar concerns about data findings from several India-based CROs, including Semler Research and GVK Biosciences.
Regulators are requiring drug sponsors to repeat their bioequivalence/bioavailability studies at an acceptable alternate study site in the case of Semler, as they did in the case of Synchron.
Companies with affected generic drugs include J&J, Sandoz, Viatris, Teva, Jubilant, Wockhardt, Accord Healthcare, Aurora Biofarma, and Strides Pharma.
Others include Tillomed Pharma, Orifarm Generics, Stada, Brillpharma, Micro Labs, ratiopharm, Bennet Pharmaceutica, Medicair Bioscience Laboratories, Pinewood Laboratories and more.
Companies that rely on Synchron Research Services data must provide alternative data demonstrating bioequivalence in order for the suspension to be lifted.
Other sources provided adequate bioequivalence data for a small number of authorized generic medicines (around 20), allowing these medicines to remain on the EU market.
With only a few exceptions where data from other sources is available, the majority of medicines being evaluated for authorization based on Synchron Research Services data will not be granted authorization in the EU.
A legally binding decision
The recommendation of the CHMP will now be forwarded to the European Commission, which will issue a legally binding decision in due course.
However, the EMA warned that some of the drugs recommended for suspension “may be of critical importance (due to a lack of available alternatives) in a given EU Member State.”
As a result, in the interest of patients, national authorities may temporarily postpone the suspension. Member States must also decide whether to recall the affected medicines in their respective territories.