China NMPA Drug Inspection - Sichuan Gukang Pharmaceutical Co., Ltd. - Oyster

On October 22, 2020, the Chongqing Municipal Drug Administration released an announcement regarding 45 batches of traditional Chinese medicine (TCM) that failed to meet regulatory quality standards. The non-compliant products were traced to 28 different manufacturers, including Chengdu Jiankang Pharmaceutical Co., Ltd., Sichuan Qianfang Traditional Chinese Medicine Co., Ltd., and Beijing Tongrentang (Bozhou), as well as various vendors within the Chongqing Traditional Chinese Medicine Professional Market.

Following tests conducted by several regional drug inspection institutes, the products were found to have several significant violations. The primary issues included inaccurate levels of active ingredients, failures in correctly identifying the medicinal materials, and poor physical properties such as mold growth and insect damage. Some batches also failed testing for extractives and purity, indicating potential issues with the harvesting season, processing techniques, or the quality of raw materials used.

The inspections were carried out under the regulatory framework of the Chinese Pharmacopoeia (2010 and 2015 editions) and local provincial processing standards. To address these safety risks, the Chongqing Municipal Drug Administration has instructed relevant bureaus to take immediate action, including sealing and seizing the defective batches, suspending all sales, and initiating formal product recalls. The involved parties will face further legal and administrative handling in accordance with national drug regulations.