China NMPA Drug Inspection - Inner Mongolia Fangkangyuan Pharmaceutical Co., Ltd. - earth dragon

The Inner Mongolia Autonomous Region Food and Drug Administration announced findings in April 2016 from drug quality inspections conducted throughout 2015. From 3,147 drug batches sampled across various manufacturers, distributors, and healthcare facilities, 13.7% were found to be substandard. A total of 130 specific problematic drugs were identified, overwhelmingly Traditional Chinese Medicine (TCM) decoction pieces, which represented over 90% of these non-compliant products. Issues were detected across all operational stages: 13.8% during production, 28.5% in distribution, and a substantial 57.7% during the usage phase. Common violations included failure to meet established quality parameters, such as incorrect physical properties, excessive sulfur dioxide residues, unacceptable total ash content, and microbial contamination in certain medical preparations. These deficiencies indicated non-compliance with the Chinese Pharmacopoeia (primarily the 2010 edition), Inner Mongolia Traditional Chinese Medicine Standards (1988 edition), and national Mongolian Medicine drug standards. Regulatory authorities have launched investigations, implemented control measures for affected drugs, and mandated prompt corrective actions from all responsible entities. The administration plans to enhance market surveillance on Chinese medicinal products, enforcing rigorous adherence to quality management systems, procurement controls, and acceptance procedures to ensure public health.