China NMPA Drug Inspection - Anhui Qingchuntang Pharmaceutical Co., Ltd. - Codonopsis pilosula

On September 22, 2021, the Hubei Provincial Drug Administration published its second drug quality bulletin of the year, detailing the results of routine inspections conducted across drug production, distribution, and use units. The inspections identified 13 batches of non-compliant drugs, primarily focused on traditional Chinese medicine components. Key manufacturers named in the report include Hubei Qingda Traditional Chinese Medicine Pieces Co., Ltd., Yueyang Tianxiang Traditional Chinese Medicine Pieces Co., Ltd., and Anhui Qingchuntang Pharmaceutical Co., Ltd., among others.

The main violations involved failures to meet the standards established by the 2015 and 2020 editions of the Chinese Pharmacopoeia. Specific issues included substandard physical appearance, excessive moisture and total ash content, sulfur dioxide residues, and incorrect microscopic identification. Significantly, several manufacturers claimed the sampled drugs were not produced by their facilities, suggesting potential counterfeit products or unauthorized sourcing.

Following the regulatory framework for drug safety, the administration has ordered immediate control measures, including the sealing, seizure, and recall of all non-compliant batches. Provincial departments are currently investigating the manufacturers and distributors involved. For products with untraceable origins or suspected criminal elements, cases are being referred to public security organs for prosecution to ensure the safety and integrity of the pharmaceutical supply chain.