China NMPA Drug Inspection - Hubei Minkang Pharmaceutical Co., Ltd. - betel nut

The National Medical Products Administration (NMPA) of China announced on November 2, 2018, findings from inspections identifying 47 batches of drugs from 23 enterprises that failed to meet regulatory standards. Major issues included: 24 batches of Doxepin Hydrochloride Tablets from Taicang Pharmaceutical Factory failed for weight variation; 11 batches of areca nuts from ten companies, including Hebei Liankang Pharmaceutical Co., Ltd. and Harbin Pharmaceutical Group Shiyitang, showed non-compliant moisture content and aflatoxin levels; 10 batches of chicken gizzard lining products from ten manufacturers, such as Anguo Juyitang Pharmaceutical Co., Ltd. and Shanxi Guotai Traditional Chinese Medicine Pieces Co., Ltd., failed on extractives; Anhui Tongtai Pharmaceutical Co., Ltd.'s Ganoderma lucidum capsules exceeded microbial limits; and Shanxi Wanhui Pharmaceutical Co., Ltd.'s Qingwei Huanglian Pills exhibited issues with identification (thin-layer chromatography, microscopic identification) and fill weight uniformity. These violations were assessed against the Pharmacopoeia of the People's Republic of China (2015 Edition) and relevant Ministry of Health drug standards. In response, regulatory authorities implemented immediate control measures, including sealing, seizing, suspending sales, product recalls, and mandating rectification. Provincial drug regulatory bodies are required, under Articles 73, 74, and 75 of the Drug Administration Law of the People's Republic of China, to investigate these enterprises for producing and selling non-compliant drugs. Investigations must conclude within three months, with results made public, underscoring the NMPA's commitment to drug quality and safety.