In a fresh sign of quality-control problems in the Indian pharmaceutical industry, the Food and Drug Administration decided that a Sun Pharmaceuticals facility failed to comply with a legal mandate to correct serious shortcomings. As a result, the company has halted exports from the plant to the United States.
At issue is a facility Sun bought eight years ago from Ranbaxy Laboratories, which was a poster child for lax manufacturing standards in India. In 2012, Ranbaxy paid a $350 million fine to U.S. authorities as part of a settlement that saw the company plead guilty to charges of violating drug safety laws, including by falsifying manufacturing data. The company also paid $150 million to settle civil claims.
The episode rattled regulators and policymakers, given that Ranbaxy was one of the largest purveyors of generic medicines, which account for approximately 90% of all prescriptions written in the U.S. The settlement also included a consent decree, which required the company to follow strict procedures for maintaining necessary manufacturing practices at its facilities.
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