China’s food and drug regulatory body has revoked the certifications of 81 manufacturers of traditional Chinese medicine (TCM) products after detecting irregularities in the companies’ production, quality control, and inventory processes, according to a recent inspection report.
The China Food and Drug Administration (CFDA) last year withdrew 172 drugs from the market — 81 of which were classified as TCM products — because their manufacturers did not meet so-called good manufacturing practice (GMP) standards. Some of the inspections were unannounced.
The CFDA found irregularities in the extraction of Chinese herbs during production, ultimately affecting their concentrations in the medicines. Some producers had falsified their supply records, as well as fabricated data on raw materials, according to the report. Other companies did not have enough personnel to adequately carry out quality control checks, resulting in batches of untested drugs being sold, it said. The report did not identify any companies by name.
Industry insiders claim the issue is bigger than the infractions uncovered by the CFDA. Yan Xijun, chairman of Tasly Holding Group, which runs TCM clinics outside of China, told The Paper, Sixth Tone’s sister publication, that 50 to 60 percent of TCM enterprises with GMP certificates have problems of some kind.
Xu Haoming, a deputy pharmacist at the Shanghai Municipal Hospital of Traditional Chinese Medicine, told Sixth Tone that the poor test results for TCM drugs can be attributed in part to the same standards being used to test Western and Chinese medicines. Because TCM uses natural ingredients instead of synthetic ingredients, the contents of the products will vary, he said. But he also noted that farmers’ use of chemical fertilizers could mean some potentially harmful residue ends up in medicines.
Xu also pointed to the GMP certificate, which was once quite easy to obtain, making the barrier for entry into the industry low. But standards have since become stricter, he added.
“The GMP certificate does not last a lifetime; rather, it requires re-evaluation every five years,” Xu said. “So those companies that did poorly and still got lucky the first time won’t survive the recheck after five years, especially with today’s tighter regulations and standards for TCM and GMP qualification.”
In order to achieve better oversight of quality and revitalize the TCM industry while at the same time promoting its globalization, the Chinese government issued its first white paper on traditional Chinese medicine last year. It said that the state had “improved standards for the quality and safety of TCM services.”
TCM, a multibillion-dollar industry that constitutes 28 percent of China’s pharmaceutical revenue, is never far from controversy. Last year, the death of a young Chinese actress who opted to treat cancer with TCM instead of chemotherapy ignited a debate around the effectiveness of the former method. TCM is also often criticized for its use of animal parts, some of which come from endangered species. Though China officially banned the practice in 1993, wild animals are still killed for their supposed medicinal qualities. Last year, a draft law on how to regulate the industry led to a dialogue about whether China would promote unscientific practices going forward.
Nevertheless, TCM is experiencing something of an international boom. Chemist Tu Youyou won a Nobel Prize for creating an anti-malaria drug derived from traditional Chinese methods, and athletes at last year’s Olympic Games in Rio de Janeiro showed up to events with their bodies covered in dark, wine-colored circles from traditional cupping treatments.
Additional reporting: Qian Zhecheng; editor: Kevin Schoenmakers.
(Header image: An employee weighs ingredients and portions out prescriptions of traditional Chinese medicine at a pharmacy in Beijing, May 9, 2008. Zhang Kaixin/VCG)