Regulators urged to share data on drug ingredients
Hepeng Jia/ Beijing, China
Drug industry figures have urged regulators in different countries to work more closely together to ensure the safety of active pharmaceutical ingredients (APIs), after contaminated heparin was linked to at least 81 deaths and hundreds of allergic reactions in the US.
The tainted batches of the blood-thinning drug were made by the US pharmaceutical firm Baxter Inc. But the raw heparin, extracted from pig intestines, was supplied by the Chinese subsidiary of the US API producer Scientific Protein Laboratories (SPL) - Changzhou SPL.
The US Food and Drug Administration (FDA), and later China’s State Food and Drug Administration (SFDA), have identified the contaminant chondroitin sulfate in raw heparin exported to Baxter. FDA commissioner Andrew von Eschenbach has since told a US Senate hearing that the heparin-like chemical was probably introduced because it was cheaper to make than real heparin. ’It was apparently, we suspect, done by virtue of economic fraud,’ he said.
SPL says the contaminant was in the material before it reached their Chinese subsidiary. However, the case is the latest in a string of accidents caused by exported Chinese pharmaceutical and food chemicals.
Luo Jiali, vice president of business development for Zhejiang Province-based Hisun Pharmaceutical - China’s leading API maker - says the heparin case would not impact exports of most APIs, which tend to be small molecules subject to strict regulation by Chinese authorities and by agencies in the importing country. But Changzhou SPL - though an FDA approved provider of APIs - is not registered as a pharmaceuticals maker in China, and so is not under the jurisdiction of Chinese regulators.
Li Kechun, general manager of drug intermediates producer Chiral Quest, agrees that it is difficult for US-based drug regulators to control the quality of ingredients shipped in from abroad. A further complication in the heparin case, he adds, is that intestines were probably bought from thousands of small pig farms in Chinese villages.
Both Li and Luo believe that it is vital that Chinese and US drug regulators exchange information on API suppliers and on the side effects of drugs based on the same source of material.
The US FDA has announced it plans to set up eight full time permanent positions at the US embassy in China to better monitor the quality of pharmaceutical products produced for US firms.
But a Chinese pharmaceutical Good Manufacturing Practice(GMP) expert, who refused to be identified, said that the small team of FDA officials could not hope to monitor all of China’s API producers. ’Instead, this should be seen as a chance for better and closer cooperation between drug regulators,’ he said.