China NMPA Drug Inspection - Henan Lihua Pharmaceutical Co., Ltd. - Children's Diarrhea Relief Granules

The State Administration for Market Regulation (now National Medical Products Administration) issued Announcement No. 10 of 2017 on January 19, 2017, disclosing that 16 batches of drugs from 11 pharmaceutical companies were found to be substandard. Companies involved included Shanxi Kangwei Pharmaceutical Co., Ltd., Shandong Kongshengtang Pharmaceutical Co., Ltd., Chengdu Di'ao Group Tianfu Pharmaceutical Co., Ltd., and several others. The primary issues identified across various drug batches involved deviations in critical quality attributes. These violations encompassed appearance defects, inaccurate content determination, elevated bacterial counts, inconsistencies in fill weight and overall weight variation, and failures in dissolution time and related substances tests. These findings indicate non-compliance with established quality control standards for pharmaceutical products. In response to these findings, the State Food and Drug Administration mandated provincial food and drug administrations to implement immediate control measures. These actions included sealing and seizing the affected products, ordering companies to cease sales and usage, and initiating product recalls. Furthermore, the regulatory framework, specifically the "Drug Administration Law of the People's Republic of China," requires investigations into the non-compliant manufacturers. These companies are compelled to conduct thorough investigations into the root causes of the deficiencies, implement comprehensive rectifications, and publicly disclose relevant information. This comprehensive regulatory response aims to ensure drug quality and public safety.