China NMPA Drug Inspection - Sichuan Pharmaceutical Co., Ltd. - Shilintong Granules

The National Medical Products Administration (NMPA) of China announced on May 10, 2018, findings from drug inspections revealing non-compliance in seven batches of drugs produced by six companies. These companies include Anguo Yuanguang Pharmaceutical Co., Ltd., Jiangxi Pengshi Guoyitang Pharmaceutical Co., Ltd., Hainan Guoruitang Traditional Chinese Medicine Pharmaceutical Co., Ltd., Sichuan Gukang Traditional Chinese Medicine Pieces Co., Ltd., Bozhou Xingrong Traditional Chinese Medicine Pieces Co., Ltd., and Sichuan Ziren Pharmaceutical Co., Ltd. The main issues identified involved quality control deficiencies across various drug products. Specifically, three batches of peppermint failed on appearance, microscopic characteristics, and thin-layer chromatography. One batch of ginseng exhibited unacceptable pesticide residue levels. Notopterygium incisum was non-compliant regarding its characteristic chromatogram, while two batches of Shilintong granules failed solubility tests. These violations indicate a failure to adhere to established quality standards, primarily outlined in the Pharmacopoeia of the People's Republic of China and relevant Ministry of Health drug standards. In response, regulatory authorities initiated immediate control measures, including the sealing, seizure, sales suspension, and recall of the affected products, along with mandates for rectification. Furthermore, the NMPA directed provincial drug regulatory authorities to investigate these companies for potential violations of the 'Drug Administration Law of the People's Republic of China,' specifically Articles 73, 74, and 75, concerning the production and sale of substandard drugs. These investigations are required to be completed, and results publicly disclosed, within three months from the receipt of inspection reports.