January 20, 2019
When Drugs Go Global

When Drugs Go Global

by Berkeley Wellness  

Concerns about generic medications grew in November 2012 when Ranbaxy Pharmaceuticals, a leading generics manufacturer in India, had to halt production of its version of the cholesterol-lowering drug atorvastatin (brand name Lipitor) because tiny particles of glass were found in some lots. This was just the latest in a series of manufacturing problems by Ranbaxy.

It’s estimated that 80 percent of all active ingredients and 40 percent of finished drugs sold in the U.S. are now imported. The biggest drug companies are still located in North America, Europe and Japan, but India and China are striving to catch up. They have a big advantage to offer—lower prices.

Drugs made in the U.S. are regulated according to strict standards, and manufacturing facilities undergo periodic Food and Drug Administration (FDA) inspections; Canada and the European Union have their own standards. But this is not generally true in other countries. The FDA does inspect foreign plants that make drugs exported to the U.S., but they have had limited resources to do so. The disparity has been greatest for generic drugs: the FDA inspects foreign manufacturers once every 10 years, on average, compared to every two years for domestic plants.

A law passed by Congress in 2012 requires the generic drug industry to pay fees so that the FDA will be better able to ensure the safety and quality of generics. Among its many benefits, the law will enable the FDA to inspect foreign generic manufacturing facilities every two years. It will take time, however, for the FDA to catch up.

“Imported” is not necessarily a dirty word, for brand-name or generic medication. We just need better quality control.