Global Counterfeiting Still Growing, U.S. Commerce Official Says
Foxhall, Kathryn, Drug Topics
Legitimate interests around the world are facing a battle with pharmaceutical counterfeiters, Jeffrey Gren, director of the Office of Health and Consumer Goods, Department of Commerce, said at a conference in Washington.
Drug counterfeiters, he said, "are very sophisticated, well organized, and right now they are winning the battle because every year there are more counterfeit medicines in the world than there were the year before."
Gren said about 40% of active pharmaceutical ingredients (API) manufacturing is done in India and China, and most industry experts expect that to rise to 80% over the next 15 years. By contrast, 20 years ago "most APIs in the world were manufactured in the United States and Europe. Many of the APIs were 'captive APIs,' were made in-house or under contract by innovative companies. And economics has driven much of the production overseas," he said.
For generics, Gren said, much of the manufacturing is done in India, China, Brazil, Russia, and Mexico. Nations of the Middle East and Southeast Asia are significantly increasing production. Those shifts away from developed markets clearly add to the problems of counterfeited drugs because standards established in those regions are much weaker than in the United States, Gren said.
Gren spoke at the Global Forum on Pharmaceutical AntiCounterfeiting, held in June and attended by about 100 people. It was sponsored by Reconnaissance International, a company in the United Kingdom that does publishing and consulting on product security.
Gren said that China's State Food and Drug Administration has authority to implement good manufacturing inspections on chemical producers only if they state their products are for medical use. If they do not claim medicinal use, that regulatory authority doesn't exist. "We have been trying to get the Chinese to close that loophole," he said. "The Chinese are taking this issue much more seriously."
Among signs of progress, Gren noted a recent investigation in which the Chinese government shut down some Web sites advertising APIs for medicinal use from companies not complying with manufacturing regulations. There are also plans for a U.S.-China joint counterfeit medicine seminar later this year, he said, and the United States has had or is planning seminars with a number of other nations.
The United States also has raised the API issue with India. …