The U.S. Food and Drug Administration (FDA) has notified an unspecified number of drug companies that data from all in vitro bioequivalence studies conducted by the Navi Mumbai-based contract research organisation (CRO) Raptim Research Ltd “must be rejected” due to data falsification. The letter mentions that the FDA had identified data falsification for “multiple subjects/samples across multiple studies”.
The FDA had inspected the company between April 24 and April 28, 2023, and also carried out post-inspection data analyses.
The letter further says that because Raptim Research has been “responsible for the creation of false in vitro study data”, it has “no reason to believe that any in vitro data that Raptim [Research] has produced are reliable”. Hence, the FDA has “determined that all study data from all in vitro studies conducted at Raptim [Research] must be rejected”. The drug regulator has told the companies that the data generated by Raptim Research will not be sufficient to support a bioequivalence finding. The companies have been asked to reconduct the in vitro studies at an alternate study site besides Raptim Research.
In an email dated March 27, 2025, the FDA told Rajen Shah, Owner and Director of Raptim Research, that “significant objectionable conditions” were observed during the inspection and data analyses. As per the email, the FDA had sent a General Correspondence Letter (GSL) on August 6, 2024, asking the company to provide specific responses to the concerns raised by it about the falsified data that were submitted. The FDA had observed “nearly identical concentration profiles between different donors in different studies for different sponsors”.
Regarding FDA’s concerns about data falsification, it said “in vitro study conduct resulted in the submission of false information to FDA regarding the measurement of the bioavailability of a drug product or the demonstration that a drug product is bioequivalent to a reference listed drug”.
The September 4, 2024, and October 17, 2024 responses by the company had failed to “adequately address FDA’s concerns or substantively explain what caused the significant data anomalies” in the studies, leading to the FDA sending the letter on March 27, 2025. The FDA’s email to Raptim Research also mentions that the company failed to “provide a legitimate, scientifically valid reason why the evidence of falsification of data discussed in FDA’s GCL should not call into question all in vitro study data generated by your firm”. The company also failed to provide “specific corrective action plans that fully address the identified pattern of in vitro and in vivo issues”.
Published – April 05, 2025 08:34 pm IST