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Medicines imported from overseas and safety worries

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There's a big problem with "recent lapses" in quality at a handful of pharmaceutical firms, according to a February 14, 2014 New York Times article by Gardiner Harris, "Medicines Made in India Set Off Safety Worries," because India is the second-largest exporter of over-the-counter and prescription drugs to the United States. Safety lapses is an issue. India’s pharmaceutical industry supplies 40 percent of over-the-counter and generic prescription drugs consumed in the United States.

The issue is not just about imported medicines. The NY Times article mentions that 80 percent of the seafood consumed in the United States, 50 percent of the fresh fruit, 20 percent of the vegetables and the vast majority of drugs are coming from outside the USA. The average consumer would ask why aren't more medicines made in the USA? One answer is because imported items might be cheaper because they're generic.

Most American consumers of prescription drugs, generic medicines, and over-the-counter remedies didn't know how large a percentage of these medicines are imported from India

And American regulators are bringing to media attention data about falsified drug test results and selling fake medicines, the NY Times article reports. But the FDA can't inspect factories all over the world.

Does the FDA even have the staff, resources, and money, let alone time to look at factories in the USA, such as what's going into the food supply here? Is the real problem lack of money? Or is the problem more about oversight, hindsight, insight, or foresight?

The news is that FDA investigators are inspecting Indian drug plants

Who's financing the inspections? Some of the money comes from approximately $300 million in annual fees from generic drug makers collected as part of a 2012 law requiring increased scrutiny of overseas plants.

The agency inspected 160 Indian drug plants last year, three times as many as in 2009, says the NY Times article. Check out the piece. The question is whether the scrutiny will bring about changes because people who buy medicines in the USA want to know more about who is in charge of the quality, how many medicines are inspected, and what standards are being met.

Recently, news about the FDA export bans of generic versions of popular medicines — like the acne drug Accutane, the pain drug Neurontin and the antibiotic Cipro became news available to the average shopper. In those cases, the FDA found the medicines were adulterated

What the public is afraid of is whether cheaper imports are the issue or whether the FDA's inspections go far enough in making sure what's on the label is what's in the container, and what's in the container is of high enough quality and safe. But does the FDA really have the time, money, and staff to inspect everything that ends up in the hands of average shoppers in the USA? Check out the recent interview with an Indian newspaper, mentioned in the NY Times article.

The World Health Organization estimated that one in five drugs made in India are fakes. A 2010 survey of New Delhi pharmacies found that 12 percent of sampled drugs were spurious, says that NY Times article. The article mentions a widely used antibiotic found to contain no active ingredient after being randomly tested in a government lab.

The test was kept secret for nearly a year while 100,000 useless pills continued to be dispensed, according to the NY Times article. So who's watching the watchers? And is it ultimately left up to the average shopper to scrutinize the flood of medicines, foods, and other products people use every day?



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