In a major blow to the credibility of contract research operations, the U.S. Food and Drug Administration (FDA) has rejected all in vitro bioequivalence studies conducted by Navi Mumbai-based Raptim Research Ltd, citing “significant data falsification.”
Following an inspection conducted between April 24 and April 28, 2023, along with subsequent data analysis, the FDA uncovered falsified data involving “multiple subjects/samples across multiple studies.” In a strongly worded communication, the agency stated that it has “no reason to believe that any in vitro data” generated by Raptim Research is trustworthy.
As a result, the FDA has informed an undisclosed number of pharmaceutical companies that none of the in vitro studies carried out at Raptim Research can be accepted as valid scientific evidence. This directly affects drug approval processes that relied on those studies to demonstrate bioequivalence—an essential requirement for generic drug approvals.
“All study data from all in vitro studies conducted at Raptim must be rejected,” the FDA declared in its letter. The regulator added that companies using Raptim’s services must now repeat the studies at a different, FDA-compliant research facility.
This move has significant implications for global pharmaceutical supply chains, especially for companies that had outsourced their research to Raptim Research for regulatory submissions. The situation also raises serious concerns about the oversight of CROs operating in the generic drug manufacturing ecosystem, particularly in markets like India that play a critical role in supplying affordable medicines worldwide.
