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The report noted the “non-availability” in India and Latin America of validation methods, stability data, and bioequivalence reports. In short, Ranbaxy had almost no method for confirming the content of drugs in those markets. For example, the data collected by Thakur’s team showed that of the 163 drug products approved in Brazil since 2000, almost all had been filed with phony batch records and stability data that did not exist. The report noted that in a majority of regulatory filings, Ranbaxy had “intentionally misrepresented” small research and development batches (some two thousand doses) as exhibit batches one hundred times the size, and then deceptively performed crucial tests for bioequivalence and stability on the smaller, easier-to-control batches. The result was that its commercial-sized batches had not actually been tested before being sold, putting millions of patients at risk.
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