It is understood that after the Qiqihar drug fraud incident was announced, the Qiqihar police immediately took measures such as summonsing the main responsible persons in accordance with the law, and successively implemented control measures against 14 people involved in the company. On May 15, in accordance with the instructions of the Ministry of Public Security and the Heilongjiang Provincial Public Security Department, Qiqihar police handed over the counterfeit drug case file to the Guangzhou Municipal Public Security Bureau. On May 16, the Guangzhou Municipal Public Security Bureau launched a The case is filed for investigation. On May 16, many people involved in the case, including the company’s legal representative and deputy factory director, were criminally detained.
A few days ago, with the assistance of the Qiqihar police, the case investigators of the Guangzhou Municipal Public Security Bureau have completed the preliminary investigation and evidence collection and on-site inspection work and returned to Guangzhou, including the purchaser, general manager, deputy technical director, and deputy supply factory Five relevant persons in charge, including the director of the Changhe Laboratory, were also brought to Guangzhou for in-depth investigation.
NO.1 CCTV investigates Guangzhou
How were fake medicines and poisons discovered?
Patients who developed acute renal failure after being injected with fake "leupactin" concentrated on April 30 and experienced adverse reactions. On that day, Zhao Zhixin, an infectious disease doctor at the hospital, was doing rounds as usual. The abnormal reactions of some liver disease patients caught her attention. Zhao Zhixin said that during the examination, some patients were gradually found to have less urination. There were four cases at first. One of them had liver disease that was not serious. According to common sense, it is impossible to have hepatorenal syndrome. The next day, the number of liver disease patients with the same symptoms increased to 11. So the hospital immediately organized a multidisciplinary expert consultation and found that all the patients who had adverse reactions were injected with the same drug - Leucanthin Injection produced by Qiqihar Second Pharmaceutical Co., Ltd. This kind of leukomycin injection was only used in Zhongshan Hospital on April 19 this year. On May 2, this information was reported to the Guangdong Provincial Adverse Drug Reaction Monitoring Center.
The Provincial Food and Drug Administration’s inspection team immediately controlled the drugs involved and sent the samples to the Drug Testing Center for testing. Staff from the Provincial Drug Inspection Institute conducted inspection and analysis on the second batch of samples from Qi Pharmaceutical Company overnight. Xie Zhijie, director of the Provincial Drug Inspection Institute, said that among the prescription ratios provided by the manufacturers, there are two excipients with the largest dosage, one is propylene glycol and the other is polyethylene glycol 400. Propylene glycol is a frequently used excipient in injections, while polyethylene glycol and tetraethylene glycol are less commonly used. Therefore, we focused on the toxicity of polyethylene glycol-400. However, after five days and five nights of investigation, we found no evidence to prove the toxicity of polyethylene glycol 400.
By this time, it was May 7, and four patients with adverse reactions had died. Finally, after a day of hard work, 20 workers worked together to find possible degradation products of polyethylene glycol-400, which contained diethylene glycol, which can cause kidney poisoning. Polyethylene glycol 400 will produce trace amounts of diethylene glycol during the degradation process, but the content of diethylene glycol in the injection should not be higher than the content of polyethylene glycol 400. However, after testing, this batch of injection The content of diethylene glycol is higher than that of polyethylene glycol. This discovery opens a breakthrough for finally finding the cause of the disease. "At this time we suspect that diethylene glycol may have been used instead of propylene glycol."
Through further observation and analysis with an infrared spectrometer, on May 9, the Guangdong Provincial Institute for Drug Control finally determined that the Leupactin A injection produced by Qiyao No. 2 Factory contained a large amount of industrial raw material diethylene glycol, causing The patient died of acute renal failure. The State Food and Drug Administration issued an emergency notice to seal all drugs produced by Qi Er Yao.
NO.2 CCTV investigates Jiangsu
Who is the initiator of the fatal case?
After investigation by the Food and Drug Administration, it was confirmed that the industrial "diethylene glycol" in the "Leontozolin" injection produced by Qiqihar Second Pharmaceutical Co., Ltd. came from a man from Xuhe Town, Xuyi County, Taixing City, Jiangsu Province A man named Wang Guiping. Wang Guiping is currently under criminal detention. He admitted to selling counterfeit propylene glycol to Qiqihar Second Pharmaceutical Co., Ltd. The reporter rushed to the Taixing City Detention Center to interview Wang Guiping.
According to Wang Guiping, industrial propylene glycol is one to two thousand yuan cheaper per ton than medicinal propylene glycol. In January 2005, he sold a ton of industrial propylene glycol as medicinal propylene glycol to Qiqihar Second Pharmaceutical Co., Ltd.
This is his first business with Qiqihar Second Pharmaceutical Co., Ltd.
In September 2005, Wang Guiping’s second business with Qiqihar Second Pharmaceutical Factory was to sell a ton of lower-priced industrial raw material diethylene glycol as counterfeit propylene glycol to Qiqihar Second Pharmaceutical Factory. Glycol is strictly prohibited from being used in pharmaceutical production. The factory also uses diethylene glycol in the production of drugs such as Leucanthin Injection.
Diethylene glycol and propylene glycol have similar appearances, but their prices vary greatly. According to Wang Guiping, the price of diethylene glycol was only about 7,000 yuan per ton when he purchased it. Later, when it was sold to Qiqihar Second Pharmaceutical Co., Ltd., the price increased to 14,500 yuan per ton.
According to relevant regulations, when propylene glycol is used as a pharmaceutical excipient for sale in pharmaceutical factories, dealers must provide relevant qualifications to the pharmaceutical factory. It was verified by the Taixing Municipal Food and Drug Administration that the business license, drug registration certificate, drug production license, product inspection form and other procedures Wang Guiping provided to Qiqihar Second Pharmaceutical Co., Ltd. were all forged. These procedures were all handled by Wang Guiping to Qiqihar Second Pharmaceutical Co., Ltd. in the name of Taixing Chemical Plant of China National Geology and Mineral Corporation. In addition, the counterfeit propylene glycol products sold by Wang Guiping to Qidian No. 2 Factory also had forged certificates of conformity on the packaging. The labeled unit is still Taixing Chemical Plant of China National Geological and Mining Corporation. On the value-added tax invoices for the purchase and sale of propylene glycol and diethylene glycol, the name of the unit issued by Wang Guiping is basically the same as that of the General Chemical Plant. After identification, these invoices were authentic.
The reporter found the Taixing Chemical Plant of China National Geology and Mineral Corporation in Yinta Village, Quxia Town, Taixing City. After investigation, the factory mainly produces industrial dyes and does not have the equipment and capabilities to produce propylene glycol and diethylene glycol. However, the person in charge of the chemical plant admitted that the invoices for Wang Guiping's purchase and sale of industrial propylene glycol and diethylene glycol were indeed issued by the plant, and that Wang Guiping packaged the purchase and sale invoices from the plant.
In this regard, Wang Guiping explained, "Just rent its account and issue some VAT invoices. A formal enterprise can only do business by issuing some VAT invoices."
The reporter’s investigation found that Wang Guiping mainly purchased industrial propylene glycol and diethylene glycol from Huabang International Trading Co., Ltd. in Zhangjiagang Free Trade Zone. Zhou Dongjun, the legal representative of the company, said that they do not deal in pharmaceutical grade propylene glycol, only industrial grade propylene glycol. Wang Guiping purchased in the name of chemical companies and chemical plants.
NO.3 CCTV investigates Qiqihar
Who is to blame for counterfeit raw materials?
According to the latest investigation results released by Heilongjiang Province, in addition to the fatal pseudoephedrine injection, the industrial raw material diethylene glycol purchased by Qiqihar Second Pharmaceutical Co., Ltd. was also used to produce four other drugs, namely Pueraria lobata injection, betamethasone sodium phosphate injection, pediatric acetaminophen enema, nefilazepam hydrochloride injection. Among them, pediatric acetaminophen enema is an over-the-counter drug, mainly used to treat fever in children, and can be purchased by ordinary patients in pharmacies. After testing by the National Institute for Drug Control, these four drugs were also fake.
According to information provided by the police, the buyer of Qiqihar Second Pharmaceutical Co., Ltd. who purchased the industrial raw material diethylene glycol is named Niu Zhongren, 55 years old. He has worked in the company for decades. In his early years, he was a worker in the equipment department and later transferred to the company's drug purchaser.
Qiqihar Second Pharmaceutical Co., Ltd. passed the National Good Manufacturing Practice Certification in 2002, also known as GMP certification. According to regulations, pharmaceutical raw materials entering the factory should be inspected, but industrial-grade propylene glycol and diethylene glycol were treated as pharmaceutical-grade propylene glycol and put on the production line. They were eventually made into fake Leukocyte A injection and sold to hospitals.