China’s State Food and Drug Administration has issued a directive to the makers of heparin and heparin-related products to purchase supplies from only registered suppliers and to strengthen quality control standards. The safety of the raw ingredients has come under fire lately, prompting many recalls around the world, including the United States.
The initial response of the Chinese government was that it is the responsibility of the receiving country, not China’s, to make sure the heparin being shipped was safe.
Tainted heparin has led to hundreds of allergic reactions and no less than 19 deaths in the US alone. The US Food and Drug Administration (FDA) has identified oversulfated chondroitin sulfate in the recalled products although it is not an ingredient used to make heparin. Instead, it looks like the active ingredient in heparin under chemical analysis but it does not produce the anti-blood-clotting effect for which heparin is prescribed. There have been no conclusions drawn as to whether or not the oversulfated chondroitin sulfate did, in fact, cause the allergic reactions and the deaths but it is a contaminant in the product nevertheless.
Baxter International, the Wisconsin-based maker of the recently recalled heparin, gets its raw ingredients from another US-based company, Scientific Protein Laboratories (SPL). SPL, in turn, imports the ingredients from its factory in China, Changzhou SPL.
Changzhou SPL buys its raw ingredients from a system of consolidators who buy the ingredients from thousands of small, unregulated, producers, which are often family-operated, home-based businesses. Tests conducted by SPL indicate the contaminant was in the crude heparin before it was sold to the Changzhou factory.
The active ingredient in heparin is made from pig intestines which are dried in homes and small factories before sending it further along the supply line. China is the world’s largest supplier of this ingredient.
Most of the shops that produce the crude heparin are not licensed or regulated by the State Food and Drug Administration. The Chinese government considers them chemical companies, not drug makers, and therefore not subject to meeting the standards for making drugs in China. The current directive from the agency, strengthened by a similar announcement from the Chinese Ministry of Commerce, calls for the development of a system capable of tracking the raw ingredients from the initial workshop all the way up the supply line to the factory.
Meanwhile, the heparin recalls continue. On Friday, B. Braun Medical recalled 23 lots of heparin infusion bags that contained heparin that could be traced back to the Changzhou factory. The infusion bags are used when a hospitalized patient needs the drug for an extended period of time. No reports of ill effects have been reported but one lot of the bags tested positive for the contaminant.
Source: New York Times
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