China NMPA Drug Inspection - Tianma (Anhui) Traditional Chinese Medicine Pieces Technology Co., Ltd. - Amomum villosum

An announcement from the State Administration for Market Regulation, published on December 29, 2017, reported significant quality control failures in traditional Chinese medicine. Investigations by institutions like the China National Institutes for Food and Drug Control identified 38 batches of decoction pieces from 29 enterprises as unqualified. Key companies involved included Anhui Yiyuantang Traditional Chinese Medicine Decoction Pieces Technology Co., Ltd. and Beijing Bencao Fangyuan Pharmaceutical Co., Ltd., among numerous others. Main violations stemmed from substandard product quality, particularly concerning appearance, identification, and content determination for products like Bletilla striata, Amomum villosum, Codonopsis pilosula, and Eupolyphaga sinensis. These issues violated standards outlined in the Pharmacopoeia of the People's Republic of China and relevant provincial processing specifications. In response, provincial food and drug administrations were mandated to implement control measures, including product sealing, seizure, sales suspension, and recalls. Operating under the "Drug Administration Law of the People's Republic of China," these departments are required to investigate the illegal production and sale, impose severe penalties on responsible manufacturers, and publicly disclose resolution outcomes within three months, emphasizing a strong commitment to drug quality and safety.