China NMPA Drug Inspection - Shaanxi Ziguang Chenji Pharmaceutical Co., Ltd. - Qipi Pill

On June 15, 2018, the National Medical Products Administration (NMPA) of China announced that 11 batches of drugs from eight different pharmaceutical companies failed to meet regulatory standards. The inspections, carried out by five provincial drug testing institutions, identified various quality control deficiencies across these products.Key violations included issues with product appearance and weight variation in Compound Platycodon grandiflorus Cough Tablets from Tonghua Zhongchen Pharmaceutical Co., Ltd. and Guizhou Sanrentang Pharmaceutical Co., Ltd. Anyang Lude Pharmaceutical Co., Ltd.'s Cold and Fever-Reducing Granules exhibited non-compliant content uniformity. Three traditional Chinese medicine manufacturers, including Jiangxi Zhangshu Tianqitang Traditional Chinese Medicine Pieces Co., Ltd. and Jiangxi Zhihetang Traditional Chinese Medicine Pieces Co., Ltd., produced Chicken Gizzard Lining with inadequate extractives. Shaanxi Ziguang Chenji Pharmaceutical Co., Ltd.'s Qipi Pills failed content determination, while Jilin Hengxing Technology Pharmaceutical Co., Ltd.'s Erythromycin Stearate Capsules had non-compliant moisture levels and dissolution rates.In response, regulatory authorities implemented immediate control measures such as product recalls, sales suspensions, and seizure of affected batches, requiring companies to rectify the identified issues. The NMPA mandated provincial drug regulatory authorities to thoroughly investigate these firms for illegal activities concerning substandard drug production and sales, under Articles 73, 74, and 75 of the Drug Administration Law of the People's Republic of China. Investigations and public disclosure of results are required within three months.