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

The Sichuan Provincial Food and Drug Administration (NMPA) issued an announcement on December 28, 2017, summarizing findings from drug quality sampling inspections conducted throughout 2017. These inspections, initiated under the 2017 Provincial Drug Sampling Inspection Work Plan, aimed to bolster drug supervision and ensure the safe and effective use of pharmaceuticals across drug production, operation, and use units. The announcement identified 13 batches of substandard drugs. Key manufacturers implicated include Chengdu Zhengkang Pharmaceutical Co., Ltd., Sichuan Qianfang Traditional Chinese Medicine Pieces Co., Ltd., Sichuan Zhongchuang Pharmaceutical Co., Ltd., Sichuan Fengyi Traditional Chinese Medicine Pieces, and Beichuan Ante Natural Pharmaceutical Co., Ltd. The primary violations involved non-compliance with quality standards, particularly those outlined in the Chinese Pharmacopoeia (2010 and 2015 editions). Issues ranged from incorrect content determination (e.g., for Pediatric Relief and Cough Relief, Mangiferin, and Star Anise) to inadequate physical properties and identification failures for various traditional Chinese medicine pieces. Local food and drug administrations are required to investigate these non-compliances in accordance with Articles 73, 74, and 75 of the "Drug Administration Law of the People's Republic of China." They must publicly disclose the investigation results within three months and report all relevant findings to the provincial bureau.