Labeled by the U.S. Government as the largest drug-safety settlement to date with a generic drug manufacturer; Ranbaxy Laboratories has just pled guilty to three felony counts under the Food, Drug, and Cosmetic act, and four felony counts of of providing false statements to the United States Food and Drug Administration.
The company failed to conduct proper safety and quality tests of several drugs that were manufactured in the Indian plants. These generic drugs were manufactured in Paonta Sahib, and Dewas India. The major drugs involved in this case were the generic versions of Gabapentin, Sotret, and Ciprofloxacin. This is a great cause for concern because compared to the plants in the United States which are inspected by the F.D.A. once every two years, plants over seas are inspected about once every seven to thirteen years. It has been proven between June and August of 2007, certain batches of medications had tested positive for “unknown impurities” and had unreliable shelf lives. Ranbaxy waited two months until October of that year to report these impurities.
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