China NMPA Drug Inspection - Changchun Bio-pharmaceutical Co., Ltd. - Rheumatoid Arthritis Tablets

The State Food and Drug Administration (SFDA), now the National Medical Products Administration (NMPA), issued Announcement No. 5 on February 14, 2015, following nationwide special supervision and sampling inspections of Rheumatoid Arthritis Tablets and Traumatic Injury Pills. The inspections identified serious quality management deficiencies across seven pharmaceutical enterprises.Shanxi Wanglong Shennong Pharmaceutical Co., Ltd. was found to have two batches of its Die Da Wan (Traumatic Injury Pills) adulterated with Sudan I and Sudan IV. These Sudan Red dyes are toxic and illegally used in substandard medicinal materials. Additionally, Die Da Wan produced by Jilin Tongyao Pharmaceutical Group Co., Ltd. and Jilin Huaqiao Pharmaceutical Co., Ltd., along with Rheumatoid Arthritis Tablets from Changchun Yinnuoke Pharmaceutical Co., Ltd., Jilin Hongshi Pharmaceutical Co., Ltd., Jilin Kuahai Biochemical Pharmaceutical Manufacturing Co., Ltd., and Shenyang Dongxin Pharmaceutical Co., Ltd., contained abietic acid, a component of rosin used to illegally adulterate medicinal ingredients. While the direct health impact of abietic acid is under review, its presence signifies a clear breach of quality standards.The SFDA mandated stringent actions. Affected companies were ordered to immediately recall and destroy all substandard drug batches and suspend production until the root causes were identified and comprehensive rectification completed. Local food and drug administrations were instructed to launch investigations, impose severe legal penalties, and trace the source of any illegally obtained raw materials. Cases suspected of criminal activity were to be referred to public security organs. Provincial regulatory bodies were also tasked with overseeing recalls, ceasing sales of affected products, and enhancing market supervision of traditional Chinese medicines to safeguard public health and medication safety.