China NMPA Drug Inspection - Shanxi Kangyi Hengtai Pharmaceutical Co., Ltd. - Stir-fried silkworm pupae

On August 18, 2023, China’s National Medical Products Administration (NMPA) released Announcement No. 36, detailing fourteen batches of pharmaceutical products that failed to meet national quality standards. Testing performed by various regional institutes identified deficiencies across eleven manufacturers. Key companies named in the report include Chifeng Wanzhe Pharmaceutical (producing on behalf of Shandong Ruian Pharmaceutical), Zhejiang Jianfeng Pharmaceutical, and several traditional medicine producers such as Hebei Runhua Pharmaceutical and Anhui Xusong Traditional Chinese Medicine Pieces Co., Ltd. The inspection revealed several quality control violations: Tacrolimus ointment failed due to the presence of impurities, Olopatadine hydrochloride eye drops failed because of incorrect fill volumes, and multiple Traditional Chinese Medicine products—including stir-fried silkworm pupae and jujube seeds—showed non-compliance regarding appearance, ash content, and moisture levels. Governed by the Drug Administration Law of the People's Republic of China, the NMPA has ordered immediate actions to mitigate public risk. The manufacturers must suspend the sale and use of these products and initiate comprehensive drug recalls. Furthermore, the companies are required to investigate the root causes of these failures and implement effective rectification plans. Provincial regulatory bodies will continue to investigate potential illegal activities and are expected to disclose the results of these inquiries publicly to ensure industry transparency.