China NMPA Drug Inspection - Sichuan Pharmaceutical Co., Ltd. - alum

The State Administration for Market Regulation (now NMPA) issued Announcement No. 113 of 2017 on July 20, 2017, concerning 26 batches of unqualified Traditional Chinese Medicine (TCM) decoction pieces. Investigations conducted by the China National Institutes for Food and Drug Control identified products from 20 companies, including Anhui Hukun Traditional Chinese Medicine Decoction Pieces Co., Ltd. and Beijing Meikangtang Pharmaceutical Technology Co., Ltd., as substandard. The core violation was the detection of ammonium salts in alum. Provincial food and drug administrations took immediate control measures, such as sealing and seizing affected products, and mandated companies to suspend sales, recall non-compliant batches, and rectify issues. The State Food and Drug Administration, operating under Articles 73, 74, and 75 of the Drug Administration Law of the People's Republic of China, required provincial authorities to investigate these illegal acts and publicize the handling results within three months. Companies disputing product authenticity face rigorous investigation, with severe penalties for confirmed manufacturers of substandard drugs.