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Little Changed in China Since Counterfeit Heparin Debacle

Filed August 29th, 2012 Laurie

China has a history of producing substandard and counterfeit drugs. Beijing promised to make sweeping changes after 149 Americans died after receiving contaminated Chinese supplies of the blood-thinner Heparin. A Reuters investigation, however, found that unregulated Chinese chemical companies making active pharmaceutical ingredients (API) are still selling them on the open market with few or little checks.

Through interviewing more than a dozen API producers and brokers, Reuters found that drug ingredients continue to enter the global food chain with no oversight from China’s State Food and Drug Administration, and with no Good Manufacturing Practice (GMP) certification.

The lack of oversight may be putting lives at risk, particularly in poor countries where there are few pharmaceutical controls. Faulty active ingredients or the wrong dose can contribute to drug-resistant strains of dangerous diseases like malaria. Additionally, unlicensed Chinese chemical firms advertise substances that have been pulled from western markets for safety reasons.

Chinese officials are trying to use technology to help them in their battle against counterfeit drugs. By 2015, China hopes to be able to electronically track different types of drugs from their production to end-market to prevent counterfeit and substandard drugs from being placed on the market, but it will only apply to products traded within the country.

The U.S. and Europe are also working to tighten regulations to control API quality better. The U.S. government recently approved the Generic Drug User Fee Amendments.
Inspections of foreign and domestic generic drug manufacturing facilities will be required to take place every two years.

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