China NMPA Drug Inspection - Tonghua Sway Pharmaceutical Co., Ltd. - Detox and Fat-Burning Tablets

The Sichuan Provincial Food and Drug Administration (NMPA) released its Drug Quality Bulletin (Issue 7, 2018) on September 13, 2018, following supervisory sampling inspections. This bulletin, initially announced on September 11, summarized findings from inspections conducted by municipal and prefecture-level food and drug administrations across various drug production, operation, and use units.

The inspections identified 21 batches of substandard drugs from numerous manufacturers. The primary violations included deficiencies in product properties, identification (such as microscopic characteristics, thin-layer chromatography, and specific salt identification), inaccurate content determination (for ingredients like Atractylodes, Qingteng alkaloid, Pueraria lobata, and Mongolian Flower), fill weight discrepancies, and the presence of impurities or residues like sulfur dioxide. These issues affected diverse drug forms, including granules, capsules, tablets, and traditional Chinese medicine pieces.

The regulatory framework underpinning these inspections comprised the National Drug Sampling Management Measures, the Drug Administration Law and its implementing regulations, alongside standards from the Chinese Pharmacopoeia (2010/2015 editions), the Ministry of Health Drug Standards, and national drug standards.

The Provincial Bureau mandated that local food and drug administrations investigate and prosecute the enterprises and units responsible for these illegal acts. They are required to publicly disclose the handling results within three months and promptly report relevant information to the Provincial Bureau, aiming to enhance drug supervision and ensure public health and drug efficacy.