On the 26th, the National Medical Products Administration (NMPA) released an official statement revealing that 28 batches of medications manufactured by 23 companies were found to be substandard following evaluations conducted by nine drug testing facilities, including the Anhui Institute for Food and Drug Control. Key findings include:
- The Anhui Institute identified 8 batches of Acyclovir Eye Drops from Shijiazhuang Gerui Pharmaceutical Co., Ltd., Jiangsu Yuanheng Pharmaceutical Co., Ltd., and Guangdong Hengjian Pharmaceutical Co., Ltd. as non-compliant due to the presence of visible foreign particles.
- The Tibet Autonomous Region Institute flagged 1 batch of Glycerin Enema from Jingzhou Jinfeng Pharmaceutical Development Co., Ltd. for failing to meet standards, citing issues with acrolein, glucose, and ammonium salts.
- The Dalian Drug Inspection and Testing Institute reported 1 batch of Benproperine Phosphate Oral Solution from Shaanxi Guanai Pharmaceutical Co., Ltd. as non-compliant due to related substances.
- The China National Institutes for Food and Drug Control found 1 batch of Econazole Nitrate Cream from Jiangxi Yaodu Renhe Pharmaceutical Co., Ltd. to be substandard due to fill volume discrepancies.
- The Shanxi Testing and Inspection Center identified 1 batch of Cold and Fever Relief Granules from Shaanxi Baiyun Pharmaceutical Co., Ltd. as non-compliant due to moisture levels and fill volume variations.
- The Yunnan Institute for Food and Drug Control reported 1 batch of Nuan Wei Shu Le Tablets from Jilin Junhong Pharmaceutical Co., Ltd. as failing microbial limit tests.
- The Anhui Institute flagged 1 batch of Licorice Tablets from Jiangxi Xinjian Pharmaceutical Co., Ltd. for content determination issues.
- The Shanxi Testing and Inspection Center found 1 batch of Trichosanthes Kirilowii from Anhui Yiquan Traditional Chinese Medicine Co., Ltd. to be non-compliant due to characteristics and total ash content.
- The Henan Medical Devices and Pharmaceutical Inspection Institute identified 8 batches of Safflower from multiple manufacturers, including Hangzhou Kanglun Traditional Chinese Medicine Pieces Co., Ltd. and Hubei Tianji Pharmaceutical Co., Ltd., as substandard due to characteristic discrepancies.
- The Zhejiang Institute for Food and Drug Control reported 1 batch of Albizia Julibrissin Flower from Anhui Yishengyuan Traditional Chinese Medicine Pieces Technology Co., Ltd. as non-compliant due to impurities, and 2 batches from Bozhou Yonggang Traditional Chinese Medicine Pieces Factory Co., Ltd. and Jiangxi Zhangshu Chengfang Traditional Chinese Medicine Pieces Co., Ltd. for content determination issues.
- The Guangdong Drug Inspection Institute flagged 2 batches of Sophora Tonkinensis from Bozhou Shenghai Traditional Chinese Medicine Pieces Co., Ltd. and Hunan Songlingtang Traditional Chinese Medicine Pieces Co., Ltd. for content determination problems.
In response to these findings, the NMPA has mandated that the involved companies and units implement risk control measures, including halting sales and initiating recalls. They are also required to investigate the root causes of the non-compliance and take corrective actions.
Furthermore, the NMPA has directed the relevant provincial drug regulatory authorities to investigate potential legal violations by these companies and units under the "Drug Administration Law of the People's Republic of China," with the outcomes to be disclosed publicly as per regulatory requirements.