WASHINGTON - More counterfeit drugs are turning up with traces of actual active pharmaceutical ingredients (APIs) as counterfeiters try to stay ahead of anticounterfeiting efforts.
“Twenty years ago most counterfeit medicines did not contain any medicinal ingredients,” said Jeffrey Gren, director of the Office of Health and Consumer Goods at the U.S. Department of Commerce. “They had ground up dry wall, sawdust, anything to make the product look real.”
Now, in some cases, counterfeit drugs contain some of the actual ingredients, in others, completely different drugs altogether.
“Even if it’s an exact duplicate,” Gren said, “there are no chemical trials or tests to make sure the drug works how it’s supposed to” so they shouldn’t be considered safe. Some of the most counterfeited are erectile dysfunction drugs, anti-malarials, cardiovascular drugs, and HIV medications. Gren referred questions about specific numbers to the U.S. Food and Drug Administration.
The problem is partially due to increased API production in countries with less chemical regulation, Gren said during a presentation on the Commerce Department’s involvement in anticounterfeiting activities at the Global Forum on Pharmaceutical AntiCounterfeiting and Diversion in Washington on Wednesday.
“Thirty years ago most API were actually made in Europe,” Gren said. Italy and the U.S. were also major producers. Now China and India are the largest producers, Italy is a distant third, and 80 percent of APIs in U.S. medicines come from outside of the country.
The ingredients for many popular APIs are located in those areas, so chemical companies are able to produce them more economically. The regulatory regimes are not as rigorous, which means growth in counterfeits and substandard APIs and availability to counterfeiters, he said.
It’s not clear whether the APIs are coming from legitimate factories or rogue players looking to turn a profit.
In China, the state food and drug administration is often unaware of these chemical producers and don’t have regulatory power over them unless the chemical is declared for medicinal use.
“It is clearly something we are trying to get more information on and we’re working very cooperatively on this problem with China’s state food and drug administration and other regulatory authorities around the world,” Gren said.
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