Joe and Terry Graedon have been teaching, writing, and broadcasting information to help people make informed decisions about their health for more than four decades. Joe is an adjunct assistant professor of pharmacy at the University of North Carolina. Terry has a PhD from the University of Michigan in medical anthropology. Together the couple write a popular syndicated newspaper column and are hosts of The People’s Pharmacy public radio program. They are authors of Simple Health Remedies, a monthly newsletter produced with Newsmax Health, and many books, including Quick & Handy Home Remedies.
Tags: pharmaceuticals | generics | FDA | China

Where Do Generic Drugs Come From?

By    |   Thursday, 14 May 2015 04:25 PM

When you shop for shoes or shirts, you can tell at a glance where they were made. When you look at your pill bottle, you won’t have a clue.

According to the FDA commissioner, up to 80 percent of the active pharmaceutical ingredients in our medicines come from other countries. India and China are two of the largest suppliers of these compounds.

The FDA has historically had tremendous problems inspecting manufacturing plants abroad.

Ranbaxy Laboratories, one of the largest Indian generic drugmakers, was fined $500 million in 2013 for selling subpar drugs and making false statements about its manufacturing practices.

Those plants were later banned from exporting drugs to the U.S.

But Ranbaxy isn’t the only company to get into trouble. According to an investigation by Bloomberg News (Dec. 3, 2014), Sun Pharmaceuticals systematically fudged and deleted data showing that drugs didn’t meet standards.

India has 600 drug companies that have registered with the FDA. But there are only 12 FDA inspectors to cover the entire country.

As paltry as that number is, it’s a big improvement over past years — and better than the ratio of inspectors to manufacturing plants in China.

In April 2014, the FDA had just two inspectors in that country. In the U.S., FDA inspectors can “pop in” on any company for a surprise inspection, but in China, India, and many other countries, inspectors must negotiate their visits months in advance, giving manufacturers plenty of time to tidy up.

The FDA has historically relied on the honor system with regard to drug quality. The agency needs to inspect every drug manufacturing plant in this country and abroad every two years.

These should all be unannounced visits. In addition, pill bottles on store shelves should be randomly analyzed for quality

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According to the FDA commissioner, up to 80 percent of the active pharmaceutical ingredients in our medicines come from other countries.
pharmaceuticals, generics, FDA, China
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2015-25-14
Thursday, 14 May 2015 04:25 PM
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