Chinese regulators are looking into whether antibiotic manufacturers there incorporated recycled food grease called "gutter oil" into APIs.
Citing various Chinese news reports, in-PharmaTechnologist says the central government in Jiaozuo has accused a subsidiary of Joincare Pharmaceutical Group of buying 16,200 tons of gutter oil from Huikang Grease and then turning it into intermediate 7-aminocephalosporanic acid (7 ACA). Joincare, which Pharmalot says, denies the report, is one of the largest suppliers of the API in China.
Not everyone is appalled by the suggestion that the putrid cooking oil scraped from gutters behind restaurants may be making its way into Chinese APIs. Stan Abrams, a Beijing-based intellectual property and IT lawyer and professor, jumped to the companies' defense in his blog, pointing out that antibiotics are obtained from bacteria isolated from fungi and mold. "We're already squarely in the realm of putrescent slime," he says, saying authorities should understand that.
Citing a story in the Shanghai Daily, Abrams says a long list of Chinese API makers has now been accused of using the cheaper gutter oil to replace the traditional soybean oil. He names Qilu Pharmaceutical, Charoen Pokphand Group, and two Shenzhen-listed forage makers, Beijing Dabeinong Technology Group and Tangrenshen Group.
The Shanghai Daily says the companies were identified during the trial of Henan-based Huikang Grease, which was being prosecuted for selling "swill oil." It says Huikang sold more than half of the 30,000 tons of gutter oil it processed to Jiaozuo Joincare Biological Product Co. for 145 million yuan ($22.9 million).
With China and India now accounting for an estimated 70% to 80% of APIs used in the pharmaceutical industry, there is a lot of concern about the largely unregulated nature of the industry. China has been trying to rein in some of the problems, recently arresting a host of alleged drug counterfeiters and closing down their operations, as well as attacking gelatin makers who used industrial-grade gelatin in capsules. Still, with many of the APIs coming from chemical companies, which are not regulated by the State Food and Drug Administration (SFDA), there is a big gap in who gets inspected and who does not.
- here's the Shanghai Daily story
- read the in-PharmaTechnologist story
- get more from Pharmalot
- here's Abrams' blog post
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