In a major blow to India’s pharmaceutical research reputation, the U.S. Food and Drug Administration (FDA) has rejected all in vitro bioequivalence study data generated by Navi Mumbai-based contract research organisation (CRO), Raptim Research Ltd, citing widespread data falsification.
According to a letter issued by the FDA and accessed by regulatory sources, the agency has determined that “data from all in vitro studies conducted at Raptim Research must be rejected” due to evidence of fabricated results across multiple studies and subjects.
The FDA’s stern action follows an on-site inspection conducted between April 24 and April 28, 2023, followed by rigorous post-inspection data analyses.
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The investigation revealed “nearly identical concentration profiles between different donors in different studies for different sponsors” — a red flag indicating scientific misconduct.
The FDA concluded that the company submitted falsified information related to the measurement of drug bioavailability and bioequivalence with reference listed drugs.
In an email dated March 27, 2025, the FDA informed Rajen Shah, Owner and Director of Raptim Research, that the company had failed to offer any “legitimate, scientifically valid explanation” for the anomalies. Despite earlier communications — including a General Correspondence Letter sent in August 2024 — and subsequent responses from the company in September and October 2024, the agency noted that Raptim’s replies failed to “adequately address” concerns or outline “specific corrective action plans.”
The FDA has warned all pharmaceutical companies relying on Raptim’s data that such studies will no longer be accepted as evidence of bioequivalence. The companies have now been instructed to repeat their in vitro studies at alternate research facilities.
The development has stirred concerns across the global pharma community, especially among companies with pending or approved applications based on Raptim’s data. Experts believe the incident may lead to delayed drug approvals, increased regulatory scrutiny, and loss of credibility for contract research firms in India.
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This case underscores the critical importance of data integrity and ethical compliance in pharmaceutical research, particularly when lives depend on the safety and efficacy of drugs tested using such studies.
As of now, Raptim Research has not issued an official public statement addressing the FDA’s findings.
