China NMPA Drug Inspection - Shanxi Fenhe Pharmaceutical Co., Ltd. - Tortoise shell glue

The Inner Mongolia Food and Drug Administration announced the results of its 2016 drug quality sampling inspections on March 2, 2017. Out of 3,000 drug batches inspected across production, distribution, and usage stages, 449 (15%) were found to be unqualified. Notably, all 100 specifically highlighted substandard drugs were Chinese medicinal herbs and prepared slices. Issues were most prevalent in the usage stage (56%) and distribution stage (43%), with only 1% identified during production.Major violations centered on misrepresentation and adulteration of traditional Chinese medicines. These included passing off non-pharmaceutical products as drugs, selling low-priced items at higher prices, mixing similar products, using non-medicinal plant parts, and deliberate adulteration. Specific examples from the detailed list included poor appearance, incorrect identification, and non-compliance with content determination. Additionally, some batches of traditional glues (Deer Antler Glue, Tortoise Shell Glue) were found to contain unlisted bovine or donkey hide components, indicating substitution with cheaper materials.The regulatory framework for these inspections was the "2016 Autonomous Region Drug Sampling Inspection Implementation Plan" and standards like the Chinese Pharmacopoeia. In response, relevant municipal and prefectural food and drug departments have investigated the implicated manufacturers, distributors, and users, implementing control measures. Future actions require continued rigorous sampling, strengthened quality management, standardized procurement, and strict acceptance processes to safeguard public health.