Credit: Kimberly Caesar

Procrit, a drug to treat anemia, is replaced with bacteria-contaminated tap water. Nearly 200,000 bottles of Lipitor, an anticholesterol pill, are recalled after patients complain of a bitter taste. Vials of Neupogen, a medication given to cancer patients, are found to contain saline.

The sale of such counterfeit drugs has skyrocketed in recent years. In some countries, nearly 25% of drugs on the market are fraudulent, according to the World Health Organization (WHO). Counterfeit drugs make up an estimated 10% of the Southeast Asian market, and Chinese authorities say more than 50% of certain products in that nation are fake. In a WHO survey of seven African countries, 20–90% of antimalarial drugs there failed quality testing.

In the US, the Food and Drug Administration (FDA)'s investigations on counterfeit drugs have increased to more than 20 per year from an average of 5 in the late 1990s, according to an interim report filed by the agency in October 2003.

The FDA, the WHO and other public health and regulatory agencies around the world are taking initiatives to fight this growing problem. In November 2003, the WHO and the governments of Cambodia, China, Laos, Myanmar, Thailand and Vietnam announced they would work together to strengthen inspection and postmarketing surveillance of drugs. In those countries, the products imitated most often are antibiotics, and drugs used to treat tuberculosis, malaria and HIV/AIDS.

The WHO is also conducting workshops in many African countries to help drug manufacturers upgrade their standards and assist officials in improving drug screening and testing practices. “It takes a lot to battle the problem,” says WHO spokesperson Daniella Bagozzi.

Pharmaceutical companies are taking their own steps to fight the problem. In December 2003, Johnson & Johnson and Pfizer—which manufactures Lipitor—told their wholesalers that they could only buy medicines directly from the company.

In the US, New York State congressman Steve Israel introduced legislation in October 2003 that would give the FDA the ability to recall counterfeit drugs and increase criminal penalties for counterfeiters.

Some nations are taking more extreme measures. In December 2003, the Indian government approved an amendment to its Drugs and Cosmetics Act, allowing lawmakers to seek the death penalty for people who manufacture or sell counterfeit drugs.

The FDA plans to take a multipronged approach to combat the problem. In its interim report, the agency recommends using authentication and track-and-trace technologies, implementing rapid-alert and -response systems, and increasing the awareness and education of health-care workers and consumers. Because the FDA does not regulate products bought from foreign countries through the Internet, the agency also suggests developing global standards for packaging, and international collaboration in law-enforcement efforts.

The FDA is also testing technologies such as radio-frequency chips, near-infrared spectroscopy and organic vapors to identify products. “The FDA is evaluating all available technologies,” says agency spokesperson Jason Brodsky. “There is no single 'magic bullet' solution to stay ahead of the counterfeiters.”

This material is part of Nature Medicine's 10 year anniversary series. For more content related to these special focus issues, please see http://www.nature.com/nm/special_focus/anniversary/index.html