By Marc Kaufman
Washington Post Staff Writer
Sunday, June 17, 2007; A01

India and China, countries where the Food and Drug Administration rarely conducts quality-control inspections, have become major suppliers of low-cost drugs and drug ingredients to American consumers. Analysts say their products are becoming pervasive in the generic and over-the-counter marketplace.

Over the past seven years, amid explosive growth in imports from India and China, the FDA conducted only about 200 inspections of plants in those countries, and a few were the kind that U.S. firms face regularly to ensure that the drugs they make are of high quality.

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Analysts estimate that as much as 20 percent of finished generic and over-the-counter drugs, and more than 40 percent of the active ingredients for pills made here, come from India and China. Within 15 years, they predict, as much as 80 percent of the key ingredients will come from those countries -- which are quickly becoming attractive to brand-name drugmakers, too.

William Hubbard, a former FDA associate commissioner, called the situation dire and deteriorating."

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Private inspectors hired by U.S. companies to check out foreign plants report finding very good ones but also some without walls and that are open to dust and pests, chemical equipment crowded in ways that could lead to cross-contamination, and one plant that had a hornet's nest atop a drugmaking vat. One frequently cited case involves the intravenous antibiotic gentamicin, which was supplied by a company in China and linked to deaths in the United States in the late 1990s. Tests by German researchers found a wide range in quality and effectiveness in what were supposed to be uniform dosages of the drug, leading the scientists to write that "it was assumed" the deaths "were related to faulty manufacture."