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In an email to Robertson, the whistleblower Sunny described how Ranbaxy used hidden areas of the plant to store and cover up testing machines that were not connected to the company’s main computer network. He was referring to the crucial high-performance liquid chromatography (HPLC) machines, the workhorses of any good testing laboratory. The bulky machines looked like a stack of computer printers. Once a drug sample is mixed with a solvent, injected into the machine, and pressed through a column filled with granular material, the machine separates out and measures the drug’s components, including impurities. It displays them as a series of peaks on a graph called a chromatogram. In a compliant laboratory, HPLC machines would be networked with the main computer system, making all their data visible and preserved. During a recent inspection, Sunny wrote, the unauthorized HPLC machines were kept in two ancillary labs: “Ranbaxy creates small such hidden areas where these manipulations can be done.” Sunny estimated that some thirty products on the U.S. market did not pass specifications and advised Robertson that the agency needed to raid Paonta Sahib and Dewas, just as it had done in New Jersey, to find the evidence. He warned, “The move has already started in Ranbaxy to share such details of problematic products personally and not on emails or letters.” But because the U.S. Attorney had no jurisdiction in India, the FDA couldn’t execute a search warrant there. Robertson felt thwarted: “People said, ‘You need to go to India.’” But her response was, “What am I going to do [over there], knock on people’s doors and hope they talk to me? I don’t have authority over in India. It’s all a voluntary, good-faith system.” The case had crashed like a wrecking ball into the overtaxed agency, exposing the fact that the FDA had no effective way to police a foreign drug company.
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