China NMPA Drug Inspection - Inner Mongolia Tengyitang Pharmaceutical Co., Ltd. - Typha pollen

In June 2017, the Inner Mongolia Autonomous Region Food and Drug Administration announced the results of targeted sampling inspections focusing on traditional Chinese medicinal materials and processed herbs. These inspections revealed significant quality issues, with 17 batches of Typha orientalis pollen and 15 batches of Lygodium japonicum pollen failing to meet established standards. The identified violations spanned several categories, including the misrepresentation of non-pharmaceutical items as drugs, the practice of selling low-priced products at inflated prices, the mixing of similar products, the use of non-medicinal plant parts, and deliberate adulteration. Specifically, issues with Typha orientalis batches included excessive total ash, acid-insoluble ash, and the presence of Auramine O, while Lygodium japonicum batches showed deficiencies in their physical properties and total ash content. These findings were assessed against the criteria outlined in the Chinese Pharmacopoeia 2010 Edition, Part I, and supplementary drug inspection approvals.

Following these findings, relevant municipal and prefectural food and drug administration departments initiated investigations into the implicated manufacturers, distributors, and users, implementing control measures for the substandard drugs. The administration mandates ongoing specialized market rectification efforts, increased sampling and testing, and strict supervision of manufacturers and distributors to ensure adherence to quality management systems, standardized procurement, and rigorous acceptance and review processes, ultimately safeguarding public medication safety.