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Generics from India


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As reported yesterday by Bloomberg:

Drug Batch Tainted? Just Hit Delete and Ship It to the U.S.

A review of FDA documents by Bloomberg News found that similar actions on quality tests have happened at dozens of other companies' plants across India that make drug ingredients and pills for export to the U.S. While not as visible as the dead frogs and flies inspectors have found in other Indian labs, the pattern of data integrity breaches worries doctors in the U.S. and elsewhere. They say they fear prescribing generic drugs that may not do what they're supposed to.

The U.S. doesn't require tests of imported drugs as they cross the border. The FDA relies on factories themselves to conduct quality tests and report accurate results, only performing its own studies if it gets enough complaints about a medicine.

The agency has about a dozen staff members in India to police about 600 factories registered there with the U.S. This year, the FDA had conducted 97 inspections of drug manufacturers as of the end of October, said Tara Goodin, an agency spokeswoman.

Posted in comment section:

Old Tusan: A lot of our bulk drugs come from China,...,

You Don't Know Where Your Drugs Come From And Neither Does The FDA; U.S.Imports 90 Percent Of Its Antibiotics (And Vitamin A) From China

"China has surpassed the United States as the world's largest manufacturer of bulk drugs, vitamins and nutritional supplements and is now exporting a large portion of its production to the United States. Tens of millions of American consumers have no idea that the majority of the over-the-counter drugs they are purchasing now originate in China, where there are "relatively few regulations related to pharmaceutical exports in comparison to industrialized economies," according to a report commissioned by the U.S.-China Economic and Security Review Commission. The increasing dependence on China for active pharmaceutical ingredients and nutritional supplements "presents a range of issues for concern."

In 2008, China produced $25.7 billion worth of bulk drugs (up 23 percent from 2007), and exported $17.6 billion of that output (an increase of 30 percent over 2007). "For many years, China has been exporting more than half of its bulk drug products to nearly 200 countries," according to the study by NSD Bio Group. "As a result, China-sourced raw ingredients have a growing impact on the global pharmaceutical market."

The country is now the world's largest producer of acetominophen used in Contac, Benadryl, Excedrin, Sudafed, Theraflu and Vicks, among others. It is the world's major producer of Vitamin C, exporting 90 percent of its annual production of more than 100,000 tons..."

(There's a good check list for patients who take generic drugs on the People's Pharmacy website.)

(Advice: Stick to bud... preferably, sticky bud.)
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