Hubei Phoenix Baiyunshan Pharmaceutical Company was reported to be suspected of selling shoddy drugs, which was produced in 2021.OneeyedjacksvideopokerA certain batch of drugs was determined to be inferior drugs by the drug administration of Hubei Province. The whistleblower said that although the company issued a notification saying that the inferior drugs did not enter the market, the sales orders, invoices and other evidence proved that part of the batch of inferior drugs did enter the market.

Beijing News reporter Li Yingqiang Editor Gan Hao Liu Qian proofread Zhang Yanjun

On May 13, in response to a report by the Beijing News that Hubei Phoenix Baiyunshan Pharmaceutical Company was suspected of selling shoddy drugs, concealing the flow of substandard drugs to the market, and privately recalling drugs that failed to report in accordance with the regulations, Huanggang Branch of Hubei Provincial Drug Administration said in response to a reporter from Beijing News that it had made a decision to refile the case for investigation against the company.

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Recently, Hubei Phoenix Baiyunshan Pharmaceutical Company was reported to be suspected of selling shoddy drugs. The whistleblower said that Tongguanteng Oral liquid (Xiaogaoping Oral liquid), which was produced by the company on March 15, 2021, was found to be inferior by the Hubei Institute of Drug Supervision and Inspection, but the company concealed the situation that it had entered the market before it was determined. And after privately initiating the recall, it somehow sold 80 boxes of substandard drugs to a pharmaceutical e-commerce company.

According to a notice released on the official website of the Hubei Provincial Drug Administration in November 2021, "Tongguanteng Oral liquid (Xiaoaiping Oral liquid) produced by Hubei Phoenix Baiyunshan Pharmaceutical Co., Ltd. on March 15, 2021, has been tested by Hubei Provincial Institute of Drug Supervision and Inspection that each containing customs vine does not meet the regulations and is an inferior drug." Afterwards, the pharmaceutical company and the Huanggang branch of the Hubei Provincial Drug Administration issued "situation notes" respectively, saying that the batch of drugs had not been released from the factory.

The product sales orders and invoices obtained by the Beijing News reporter show that the batches of substandard drugs involved have been sold to a number of pharmaceutical companies.

On May 8, 2024, the Beijing News telephoned Mr. Peng, the head of production quality of Hubei Phoenix Baiyunshan Pharmaceutical Co., Ltd., to verify whether the inferior drugs had flowed to the market and whether they had concealed the reports of leaving the factory. The reply from the Huanggang Branch of the Hubei Provincial Drug Administration is that because the company has a record of destroying the inferior drugs, it has issued a statement that "the products have not been released from the factory."

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It was found to be inferior drugs after the tender purchase application for testing.

The batch of Tongguanteng oral liquid produced by Hubei Phoenix Baiyunshan Pharmaceutical Company was found to be inferior because of a voluntary application for testing by the company.

Hubei Phoenix Baiyunshan Pharmaceutical Co., Ltd. issued a "situation statement" showing that on July 15, 2021, the company applied for the inspection of relevant batches of Tongguan Teng oral liquid because "due to the need of the company's drug bidding and procurement, using the test report of the provincial drug testing agency for the product, so took the initiative to apply for random inspection of the batch of products."

In November of the same year, the official website of the Hubei Provincial Drug Administration reported that the Tongguanteng oral liquid (Xiaoaiping oral liquid) produced by the company on March 15, 2021 was tested by the Hubei Provincial Institute of Drug Supervision and Inspection that each bottle did not comply with the regulations and was a shoddy drug.

Subsequently, Hubei Phoenix Baiyunshan Pharmaceutical Company issued a "situation statement", saying that a batch of Tongguanteng oral liquid produced by the company on March 15 of that year had hidden quality problems due to internal control, and especially emphasized that although some items in the inspection of these products did not comply with the regulations (that is, called "inferior drugs"), the product was not released from the factory and did not circulate in society.

According to the "product recall notice" within the drug company provided by the whistleblower in 2021, the batch of substandard drugs involved was the Tongguan Teng oral liquid product with batch number 210301 produced on March 15 of that year.

On May 10, 2024, a staff member surnamed Wang of the Huanggang Branch of the Hubei Provincial Drug Administration told the Beijing News that he remembered the test report of the Hubei Provincial Institute of Drug Supervision and Inspection received on August 25, 2021, and determined that the relevant batches of Tongguanteng oral liquid were inferior drugs.

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Drug companies deny that inferior drugs enter the market

Hubei Phoenix Baiyunshan Pharmaceutical Co., Ltd. has issued two consecutive instructions, saying that the batch of drugs was not released from the factory, and that the market circulation link was not sampled.

Whistleblower Wang Hui (pseudonym) said that the relevant sales records, invoices, etc., can prove that the batch of inferior drugs entered the market.

According to the sales record of Hubei Phoenix Baiyunshan Pharmaceutical Company issued by Wang Hui, from April to July 2021, the price of Tongguanteng oral liquid in the involved batches ranged from 12 yuan to 111 yuan per box. sold to pharmaceutical companies and large pharmacies in Jilin, Guangxi, Henan, Anhui and other nine provinces. According to statistics, 6544 boxes of drugs were sold, with a total amount of 99370 yuan.

The two invoices for the purchase of Tongguan Teng oral liquid by a pharmaceutical company in Henan are completely consistent with the sales records and registration information of Hubei Phoenix Baiyunshan Pharmaceutical Company. A reporter from the Beijing News checked that according to the name of the buyer and seller of the invoice and the identification number of the taxpayer, the contents of the heavenly inspection are correct, and the invoice is also true and valid.

On April 26, a reporter from the Beijing News asked a pharmaceutical company in North China about the purchase of Tongguanteng oral liquid. The product sales (along with the goods) of Hubei Phoenix Baiyunshan Pharmaceutical Company showed that it had purchased Tongguanteng oral liquid produced on March 15, 2021, and the production batch number was 210301. In addition, the invoice is the same as the quantity purchased on the sales list.

The sales list of the pharmaceutical company concerned produced by a pharmaceutical company in ▲ proves that the batch number 210301 Tongguan Teng oral liquid produced on March 15, 2021 has entered the market. Photo taken by Beijing News reporter Li Yingqiang

The person in charge of the pharmaceutical company recalled, "I can't remember the details of the drug purchase at that time. I have the same order and invoice shipped by the manufacturer. I must have bought this medicine."

On May 8, 2024, a reporter from the Beijing News telephoned Peng Fayang, head of production quality of Hubei Phoenix Baiyunshan Pharmaceutical Company, to verify how much Tongguan Teng oral liquid produced on March 15, 2021 went to the market. The other party said he "didn't know" and hung up.

In addition, in May 2022, the Huanggang Branch of the Hubei Drug Administration also issued a "situation note", saying that "after investigation, the products were not released from the factory, nor did they adversely affect the public." A staff member of the bureau said that because the company had a record of destroying inferior drugs in Tongguanteng oral liquid, it issued a statement that "the products were not released from the factory."

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Internal recall of the problem drug and not reported

Wang Hui said that the drug involved was submitted for inspection on July 15, 2021. On the seventh day after the drug was submitted for inspection, the company began to recall the Tongguan Teng oral liquid with batch number 210301, and the company also drafted a "product recall notice." The report he showed to the boss by the employees of the company showed that the recall notice was not given to commercial customers, but was used by the sales department to communicate the recall with customers.

The content of the "Product recall notice" states that the Tongguanteng oral liquid (batch number 210301) sent to your company was disturbed by adverse factors during the storage period due to the flood situation in Hubei Province. In order to ensure the safety and effectiveness of clinical medication, after the quality risk assessment of our quality management department, we decided to stop using the products of this batch number. Upon receipt of the notice, your company shall immediately organize the relevant departments to withdraw all the Tongguan Teng oral liquid (batch number 210301) that has been sold to the downstream business units, seal the unsold drugs on the spot, and recall the above-mentioned products.

A total of 468 boxes of drugs were recalled according to the sales records of Hubei Phoenix Baiyunshan Pharmaceutical Co., Ltd. But the company still sold 80 boxes of batches of drugs to an e-commerce pharmaceutical company on July 29, 2021, according to the company's sales records.

A reporter from the Beijing News sent a text message to the head of production quality of Hubei Phoenix Baiyunshan Pharmaceutical Company to ask whether the recalled drugs were reported to the drug supervision and administration department in accordance with the regulations, but as of press time, the other party did not respond.

In accordance with the provisions of the measures for the Administration of Drug recalls of the State Drug Administration, if drug manufacturing enterprises find that there may be quality problems or other hidden safety problems in the drugs produced or sold, they shall suspend production, release and sale when necessary, and report to the local drug supervision and administration department.

The measures for the Administration of Drug recall stipulate that recalled drugs that need to be destroyed shall be destroyed under the supervision of the drug supervision and administration department of the government at or above the county level or the notarization agency.

On May 10, a staff member of the Huanggang Branch of the Hubei Provincial Drug Administration, surnamed Wang, said that they did not know about the recall of unqualified Tongguan Teng oral liquid by Hubei Phoenix Baiyunshan Pharmaceutical Company, and the company did not report to the bureau. The staff member said that after receiving the test report that was identified as inferior drugs, the bureau launched an investigation and processing of Hubei Phoenix Baiyunshan Pharmaceutical Company, which explained that the drugs involved had not been released from the factory, and had taken the initiative to destroy batches of inferior drugs, so it was impossible to send personnel to carry out on-site supervision and destruction.

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Should pharmaceutical companies be held responsible for suspected concealment of the report?

The Drug Administration Law of the people's Republic of China stipulates that whoever produces or sells inferior drugs shall confiscate the drugs and illegal income illegally produced and sold, and impose a fine of not less than 10 times and not more than 20 times the value of the drugs illegally produced or sold; if the circumstances are serious, the unit shall be ordered to suspend production and business for rectification or even revoke the drug production license. The legal representative and principal responsible person shall be prohibited from engaging in drug production and marketing activities for life, and may be detained by the public security organ for not less than five days and not more than fifteen days.

The "situation statement" of Hubei Phoenix Baiyunshan Pharmaceutical Company shows that according to the regulations on drug sampling management, the sample is the purchase system, so it is only subject to administrative punishment, and the confiscated amount is 195 yuan for the sample fee submitted for inspection, and there is no other penalty.

Wang Hui believes that the company is suspected of concealing the true situation of selling Tongguan rattan oral liquid, resulting in being treated lightly.

Xu Hao, a lawyer in Beijing, believes that the Drug Administration Law stipulates that inferior drugs mean that the content of drug ingredients does not meet national drug standards. As inferior drugs are generally less harmful than fake drugs, the production and sale of inferior drugs that cause serious harm to human health constitute a crime.

The interpretation of several issues concerning the specific Application of laws in Criminal cases of production and Sale of counterfeit drugs and inferior drugs by the Supreme Law and Supreme Procuratorate stipulates that it causes serious harm to human health, which refers to the use of inferior drugs produced and sold, causing more than minor injury, or mild or moderate disability, as well as organ and tissue damage leading to general or serious dysfunction.

Xu Hao said: if an enterprise clearly knows that it is inferior drugs and carries out production and sales, and has been identified as causing serious harm to human health, the suspect is involved in the crime of producing and selling inferior drugs. That is, whoever causes serious harm to human health shall be sentenced to fixed-term imprisonment of not less than three years and not more than ten years and concurrently be sentenced to a fine; if the consequences are especially serious, the offender shall be sentenced to fixed-term imprisonment of not less than ten years or life imprisonment, and concurrently be sentenced to a fine of not less than 50% and not more than 200% of the sales amount or confiscation of property.