Drug Wars

The U.S. Department of Justice has accused $1.6 billion (sales) Ranbaxy Laboratories, India's largest pharmaceutical firm, of selling adulterated drugs. In a motion filed July 3 in federal court in Maryland, the Justice Department alleged that Ranbaxy, one of the world's biggest generic drug makers, has engaged in a "pattern of systematic fraudulent conduct," including false and fabricated information submitted to the Federal Drug Administration, as well as attempts to conceal from the FDA "violations of current good manufacturing practices regulations." The motion alleges that Ranbaxy fabricated data to support applications with regulators to sell generic drugs in the U.S. and anti-retroviral medicines bought by the U.S. for use abroad, especially in Africa. The motion is in support of a court order to force Ranbaxy to turn over audits of its plants by a third-party consultancy. Ranbaxy had refused to do so, arguing that the audits were protected by attorney-client privilege. As to the motion, Ranbaxy has denied the allegations and has agreed to provide all documents sought by the Justice Department. Ranbaxy's troubles started in February 2006. After an FDA inspection of a plant in Paonta Sahib in India, the agency imposed a "compliance hold" on approval of new drug applications originating from that plant because of "significant deviations from current good manufacturing practices." In February 2007 federal agents raided the company's U.S. headquarters in New Jersey. Last month Japan's Daiichi Sanyo agreed to acquire the billionaire Singh brothers' entire 34.8% stake in Ranbaxy for $4.6 billion. Both companies say the deal is still on track, despite Ranbaxy's legal troubles. Now, Democratic leaders of the U.S. House Committee on Energy and Commerce are looking into whether the FDA knowingly allowed drugs suspected of being fraudulently manufactured to continue being sold by Ranbaxy in the U.S. The company makes anti-infectives, cardiovascular medicines, anti-expectorants, analgesics and gastrointestinal products. By Ms.Bobby Aanand, Metropolitan Jury.

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