National Medical Products Administration announced 8 typical cases of drug violations.
Since 2023, drug supervision and management departments at all levels have thoroughly implemented a series of decisions and arrangements made by the CPC Central Committee and the State Council on strengthening drug safety, solidly promoted the consolidation and promotion of drug safety, continuously strengthened drug safety supervision, severely cracked down on illegal and criminal activities in the drug field, and investigated and dealt with a number of major cases according to law, effectively protecting people’s health and drug safety. Eight typical cases of illegal activities in the pharmaceutical field are hereby announced as follows.
1. The case of Shandong Jingyutang Pharmaceutical Co., Ltd. producing and selling inferior drug lactase tablets.
In August, 2022, Shandong Drug Administration conducted on-site inspection on Shandong Jingyutang Pharmaceutical Co., Ltd. according to the clues of complaints and reports, and conducted on-site sampling on two batches of raw lactase tablets in the company’s inventory. After inspection, the "content determination" of the sampled drugs did not meet the requirements. After investigation, the value of the above two batches of raw lactase tablets was 122,900 yuan, and the amount of products sold was 37,500 yuan.
The company’s production and sale of the inferior drug Lactobacillus raw tablets violated the third paragraph of Article 98 of the Drug Administration Law of People’s Republic of China (PRC). In January, 2023, Shandong Drug Administration imposed an administrative penalty of confiscating the drugs involved, confiscating the illegal income of 37,500 yuan and fined 1,352,200 yuan according to the first paragraph of Article 117 of the Drug Administration Law of People’s Republic of China (PRC).
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2. Hainan Kangwei Pharmaceutical Co., Ltd. violated the quality management standard of pharmaceutical business.
In July 2022, Hainan Provincial Drug Administration conducted an on-site inspection of Hainan Kangwei Pharmaceutical Co., Ltd. according to the clues of other departments. After investigation, the company has made out illegal acts such as purchasing invoices for Chinese herbal medicines and selling invoices for Chinese herbal pieces. The person in charge of the company failed to perform relevant management duties, and the person in charge of quality was part-time and attached to the Licensed Pharmacist Registration Certificate.
The company violated the Quality Management Standard for Pharmaceutical Trading and the first paragraph of Article 53 of the Drug Administration Law of People’s Republic of China (PRC). In September 2023, according to Article 126 of the Drug Administration Law of People’s Republic of China (PRC), Hainan Provincial Drug Administration imposed an administrative penalty on the company, which was ordered to suspend business for one month and fined 500,000 yuan. The legal representative Chen Moumou and the responsible person Lu Moumou were banned from engaging in drug production and operation for ten years; According to the provisions of Article 34 of the Measures for the Administration of Licensed Pharmacists Registration, Guo, the quality director of the company, was punished for revoking the Licensed Pharmacist Registration Certificate and refusing to register within three years.
III. Case of illegal drug purchase in Haohong Pharmacy, Wanzhou District, Chongqing
In August, 2022, Chongqing Wanzhou District Market Supervision Administration conducted a daily inspection of Haohong Pharmacy in Wanzhou District, Chongqing. After investigation, the pharmacy did not purchase drugs such as Huangkui Capsule, Songling Xuemaikang Capsule and Maixuekang Capsule from drug marketing license holders or enterprises with pharmaceutical production and business qualifications, and the product value was 143,700 yuan.
The above behavior of the pharmacy violated the provisions of Article 55 of the Drug Administration Law of People’s Republic of China (PRC). In August, 2023, Chongqing Wanzhou District Market Supervision Administration imposed an administrative penalty of confiscation of illegal income of 143,700 yuan and a fine of 431,100 yuan on the pharmacy according to Article 129 of the Drug Administration Law of People’s Republic of China (PRC).
Iv. Yibin Hekang Hospital Co., Ltd. purchased and sold preparations from medical institutions without approval.
In August 2023, the Xuzhou District Market Supervision Administration of Yibin City, Sichuan Province conducted an on-site inspection of Yibin Hekang Hospital Co., Ltd. according to the clues of complaints and reports. After investigation, the company purchased and sold 20,240 bottles of four kinds of medical institution preparations, including Quyu Huoluo liniment, Tongbi Huoluo Pill, Eucommia Yaobi Pill and Jianiu Zhuanggu Pill, from other medical institutions, with a sales amount of 518,600 yuan.
The above behavior of the company violated the provisions of Article 55 of the Drug Administration Law of People’s Republic of China (PRC). In October 2023, according to Article 129 of the Drug Administration Law of People’s Republic of China (PRC), the Market Supervision Administration of Xuzhou District of Yibin City ordered the company to correct the above-mentioned illegal acts, and imposed administrative penalties such as confiscation of illegal drugs, confiscation of illegal income of 518,600 yuan and fine of 519,900 yuan.
5. The case of using imported drugs without obtaining drug approval documents in Xiaoshan Hongning Road Medical Beauty Clinic of Hangzhou Liancheng Yimei Hospital Management Co., Ltd.
In November, 2022, Xiaoshan District Market Supervision Administration of Hangzhou, Zhejiang Province conducted a daily inspection of Xiaoshan Hongning Road Medical Beauty Clinic of Hangzhou Liancheng Yimei Hospital Management Co., Ltd. After investigation, the clinic used lidocaine local anesthetic plaster marked in Korean and English, which belongs to imported drugs without obtaining drug approval documents, and the product value was 1450 yuan.
The above-mentioned behavior of the clinic violated the second paragraph of Article 124 of the Drug Administration Law of People’s Republic of China (PRC). In July, 2023, the Xiaoshan District Market Supervision Administration imposed an administrative penalty of confiscation of the drugs involved and a fine of 500,000 yuan on the clinic in accordance with the first and second paragraphs of the first paragraph of Article 124 of the Drug Administration Law of People’s Republic of China (PRC).
Six, Yang Rongmao Chinese medicine clinic illegal purchase of drugs, the use of inferior drugs.
In October, 2022, Taiyuan Municipal Market Supervision Administration of Shanxi Province conducted an on-site inspection of Yang Rongmao’s comprehensive clinic of traditional Chinese medicine according to the notification from other departments.
After investigation, it was found that the clinic did not purchase Herba Schizonepetae and other Chinese herbal pieces from drug marketing license holders or enterprises with pharmaceutical production and business qualifications, and the value of the products was 4,510 yuan, which violated the provisions of Article 55 of the Drug Administration Law of People’s Republic of China (PRC). The clinic uses Chinese herbal pieces without product batch number and any label, Bupleurum injection and sodium chloride injection that have exceeded the shelf life, and the missing pediatric cough syrup with product batch number, production date and expiration date information torn on the outer packaging, which violates the provisions of Item 3, Item 4 and Item 5 of Paragraph 3 of Article 98 of the Drug Administration Law of People’s Republic of China (PRC).
In June, 2023, Taiyuan Municipal Market Supervision Administration imposed an administrative penalty of warning, confiscation of drugs involved and a fine of 500,000 yuan on the clinic in accordance with Articles 117, 119 and 129 of the Drug Administration Law of People’s Republic of China (PRC).
Seven, Ai Moumou sold compound diphenoxylate tablets without permission.
In July, 2023, the Yili Prefecture Market Supervision Administration of Xinjiang Uygur Autonomous Region, together with the public security organs, conducted on-site inspection on the vehicles driven by Ai Moumou according to the clues handed over by other departments, and seized 500 bottles of compound diphenoxylate tablets in the trunk.
After investigation, the parties concerned bought 2,000 bottles of compound diphenoxylate tablets through online shopping and other channels, and sold them through WeChat and other channels. The value of the products was 62,000 yuan, and the illegal income of the sold products was 750 yuan. The above-mentioned behavior of the parties violated the first paragraph of Article 51 of the Drug Administration Law of People’s Republic of China (PRC).
In September, 2023, according to Article 115 of the Drug Administration Law of People’s Republic of China (PRC), the market supervision administration of Yili Prefecture ordered the parties concerned to stop the illegal sale of drugs, and imposed administrative penalties such as confiscation of drugs involved, confiscation of illegal income of 750 yuan and a fine of 2.55 million yuan.
Eight, Wang Moumou illegally purchased drugs.
In March 2023, Beijing Fengtai District Market Supervision Administration conducted an on-site inspection of Wang’s drug business premises according to the clues transferred by the public security organs.
After investigation, from August 2020 to March 2021, the parties bought 63 kinds of drugs such as Tongxinluo Capsule and Songbai Suxiao Jiuxin Pill from individuals around Fengtai District of Beijing in the form of cash transaction and settlement on the spot. The above-mentioned behavior of the parties violated the provisions of Article 22 of the Measures for the Supervision and Administration of Drug Circulation.
In June, 2023, Beijing Fengtai District Market Supervision Administration imposed an administrative penalty of confiscation of the drugs involved and a fine of 1.5 million yuan on the parties concerned in accordance with Article 115 of the Drug Administration Law of People’s Republic of China (PRC) and Article 43 of the Measures for the Supervision and Administration of Drug Circulation.
Information: Popular Science China
Original title: "National Medical Products Administration public exposure! 》
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