US prosecutors have alleged that generic drug maker Ranbaxy forged documents relating to an investigation into the quality of the company’s drugs sold in the this country. The allegations were revealed in a motion the Justice Department filed this month in federal court in Maryland.
The motion is part of a larger probe conducted by Justice Department and the Food and Drug Administration (FDA) into whether Ranbaxy made false claims and fabricated data to get FDA approval for its generic drugs. The investigation is also looking into allegations that Ranbaxy made weak or adulterated HIV drugs that were given to thousands of AIDS patients in Africa.
Based in India, Ranbaxy is one of the 10 largest generic-drug producers in the world and has been operating in the States since 1995. In February, federal agents raided the U.S. corporate offices of Ranbaxy in New Jersey, as well as a manufacturing facility in the state.
The raid – and criminal investigation – was prompted, in part, by problems uncovered in FDA inspections a year earlier at the company’s plant in Paonta Sahib, India. That inspection found inconsistencies in the company’s manufacturing processes and maintenance of data.
Ranbaxy was paid millions of dollars through U.S. government contracts to provide low-cost antiretroviral drugs under the president’s emergency plan for AIDS relief. Investigators at the Justice Department and the FDA allege that some of the drugs were poorly made, unstable or impotent. According to court filings Ranbaxy fabricated documents to cover up the substandard products.
The July 3 filing was intended to force Ranbaxy to release audits of its plants conducted by a consultant; the company had argued that the audits were privileged.
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