China NMPA Drug Inspection - Hubei Kangyuan Pharmaceutical Co., Ltd. - Tortoise shell glue

The Inner Mongolia Autonomous Region Food and Drug Administration, in an announcement dated July 3, 2017, disclosed the findings of targeted quality sampling inspections of Chinese medicinal materials and processed medicinal herbs. These inspections, carried out by regional drug inspection institutes, identified significant quality deficiencies in 28 batches of products. Multiple manufacturers and suppliers were implicated, including entities like Hubei Kangyuan Pharmaceutical Co., Ltd., Hebei Dongru Ejiao Co., Ltd., and Jiangsu Kangmei Pharmaceutical Co., Ltd.

The main violations involved widespread adulteration and misrepresentation. Specific issues included the substitution of non-medicinal or lower-priced ingredients for authentic ones (e.g., animal hides in glues), the mixing of incorrect varieties, and the use of non-medicinal plant parts. Products also failed to meet quality standards regarding properties, identification, active content, or purity, with findings such as excessive ash content, unauthorized artificial dyes (like Acid Red 73 and Tartrazine) in safflower, and sulfur dioxide residues.

These findings were assessed against the Chinese Pharmacopoeia (2010 and 2015 editions) and approved supplementary inspection methods. In response, local food and drug administration departments have initiated investigations and implemented control measures for substandard drugs. Moving forward, continued special rectification efforts, intensified sampling inspections, and rigorous supervision are required to ensure manufacturers and distributors uphold stringent quality management systems, standardize procurement, and implement robust acceptance and review processes, thereby safeguarding public drug safety.