China NMPA Drug Inspection - Tonghua ZhongSheng Pharmaceutical Co., Ltd. - Cough-relieving capsules

The Hubei Province Drug Quality Bulletin (Issue 2, 2016), released on October 31, 2019, details the outcomes of a province-wide drug quality sampling inspection conducted in the second quarter of 2016. This inspection, overseen by the Hubei Provincial Food and Drug Administration, cited 52 batches of drugs from numerous manufacturers and suppliers for non-compliance. Companies implicated include Hubei Qingda Traditional Chinese Medicine Slices Co., Ltd., Hubei Sian Pharmaceutical Co., Ltd., Hubei Jurui Traditional Chinese Medicine Pieces Co., Ltd., and various others from Hubei and other regions. Main violations encompassed failures to meet quality specifications outlined in the Chinese Pharmacopoeia (2010 and 2015 editions) and national drug standards. Specific issues included discrepancies in content determination, incorrect physical properties, identification failures (e.g., thin-layer chromatography), and non-adherence in tests for total ash, moisture content, weight variation, and dissolution. A significant number of products were also identified as "not produced by the indicated enterprise," indicating serious mislabeling or suspected counterfeiting. The regulatory framework requires city and prefecture food and drug administrations to investigate these issues, intensify follow-up sampling and testing, and for counterfeit products, trace supply channels. Cases with criminal suspicion are to be referred to public security departments for legal action.