China Has No Fault for Bad Quality Heparin

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02/27/2008 - Commenting on an investigation into the recalled drug heparin, China’s State Food and Drug Administration declared Wednesday that it strictly controlled chemicals used in pharmaceuticals, but the importing countries should be the ones responsible for ensuring the imported products are safe.

The Chinese FDA said that it usually collaborated with foreign counterparts to supervise drug-ingredient production, but "safeguarding the legality, quality and safety of active pharmaceutical ingredients" is the responsibility of the importing country, The Wall Street Journal reports.

The blood thinner heparin, made by Baxter International, has been link to certain cases of illnesses and even deaths in US. Baxter International has recalled thousand of heparin doses after 350 patients reported allergic reactions.

Some of the raw ingredient for the drug was produced in a Chinese plant. In its defense statement, China’s FDA said that the Chinese manufacturer that produced the heparin is mostly owned by US and its production technology was supplied by an American company.

As Baxter produced most of the heparin on the market, APP Pharmaceuticals is developing a similar blood thinner to replace the heparin. Apparently, its active ingredient is also made in China, but the FDA has checked that plant.

According to US law, FDA is not required to inspect every foreign drug factory from which the country imports drugs. Laws regarding inspections actually request more frequent visits to domestic plants than to foreign ones.

A House committee investigating the issue reported that only 20 of the 700 Chinese plants producing drugs for US are inspected every year.

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