The top ten typical fines for pharmaceutical companies in 2019 are 83.17 million

Release date: 2019-12-27 Views: 0

Source: Dandelion

In 2019, oh, in a blink of an eye, it will be over again.

In 2019, the four most stringent, tax inspections, environmental protection inspections, medical insurance negotiations, medical bribery, evaluation of consistency of western medicines, prescriptions for Chinese patent medicines, pharmacopoeia standards disputes of Chinese medicine tablets, etc., were not smooth throughout the year.

In 2019, institutional reforms, the promulgation of a new drug law, and a new version of the Pharmacopoeia 2020 are coming again; various regulations are updated, endless, and inaccessible; one year of understanding new institutions, one year of learning.

In 2019, it's not easy for pharmaceutical companies , it's really not easy; how much sleepless nights do medicines make, how can outsiders understand and understand!

2020 is coming! Everyone stands by!

There are many things going on in autumn; at the end of the year and at the end of the year, some things are worth taking inventory; warn yourself and remind yourself.

Today we will take a look at the typical tickets of this year. (Note: Not selected according to the standard of fines, but selected according to the typical case.)

Single ticket: Keywords: antitrust ticket 12.43 million yuan

See also the monopoly of bulk drugs. Two companies in Henan and one of Hunan's flummin API manufacturers were fined 12.43 million yuan for alleged monopoly.

Ticket 2: Keyword: Tax verification ticket 83.17 million

The tax inspection of 77 pharmaceutical companies has revealed a lot of results; fines range from hundreds of thousands, millions to tens of millions.

Choose one to represent: A pharmaceutical company in Henan Province obtained 4,501 input invoices for value-added tax due to illegal gains, amounting to 44,165,700, taxes amounting to 7,508,21 thousand, and other tax-related violations, involving taxes of RMB 80,972; The tax has been repaid by 67,205,500 yuan. Note: As of the date of the announcement, it is not known yet) and was transferred to the judicial organ according to law.

Tickets3. Keywords environmental protection ticket 1 million yuan

A pharmaceutical company reported that the wastewater was pumped to the sewer due to mass reports. After investigation and verification, the pharmaceutical company was suspected to evade supervision by entrusting the company that did not have the disposal capacity to dispose of the wastewater that needed to enter the sewage treatment facility.

This act violates Article 39 of the "Water Pollution Prevention Law of the People's Republic of China" and stipulates that "the artificial recharge of groundwater shall not deteriorate the quality of groundwater." A fine of 1 million was imposed.

Four tickets, keywords 930,000 ticket without license

A pharmaceutical retail company purchased illegally a total of about 200 varieties of Chinese medicine decoction pieces and a total of 1536 batches. The behavior of the parties exceeding the scope of business approved by the Pharmaceutical Business Permit and engaging in the retail operation of Chinese medicine decoction without authorization violates Article 17, paragraph 2, of the Measures for the Supervision and Administration of Drug Circulation. "Permitted business scope for pharmaceuticals."

In view of the parties' refusal to cooperate with the investigation after the crime, inciting others to provide perjury, and secretly continuing to engage in illegal business practices, the Market Supervision Bureau confiscated the Chinese medicine detained by the parties; about 180,000 yuan of illegal income was confiscated, and a fine of 740,000 yuan was imposed. The total fine was RMB 930,000.

Fifth, 51,000 keyword ticket ticket

A pharmaceutical company in the name of its own company provides convenient conditions such as qualification certification documents for others to sell drugs. It leases the "drug business license" and collects "administrative fees". The rental period lasts more than 6 months, and the number of drugs involved is relatively large. Good value.

According to the regulations, the drug supervision and administration department has adopted a "heavy punishment" against the pharmaceutical company, and confiscated the illegal income, and imposed a fine of 388,280.46 yuan, a total fine of 517,707.28 yuan.

Sixth, ticket 700 thousand yuan for illegal advertising

A pharmaceutical company conducts a webcast through a live broadcast platform. In the live broadcast, by inviting male doctors, internet celebrities anchors, TV hosts, etc. as guests, the introduction of on-site props, interaction between guests and the host, introduced the efficacy, use methods, and efficiency of the prescription Viagra. Publicity, and "teasing men, uniforms and temptations" appeared in verbal interaction.

At the same time, during the live broadcast, the parties carried out a discount sale of prescription drugs "Viaike". According to statistics, more than 150,000 people watched the live event online.

The Market Supervision Bureau pointed out that the parties used the live broadcast of the media to promote, publicize and sell the prescription drug "Viaike", which did not meet the definition of Article 2 of the Advertising Law. The advertisement not only severely violates the prescription drug advertising regulations, but also contains other illegal content in violation of social good practice in live broadcast activities.

In addition, Viagra (common name Sildenafil Citrate Tablets) is a prescription medicine for treating male erectile dysfunction, which requires a physician's prescription to purchase and use. Paragraph 2 of Article 15 of the Advertising Law stipulates that prescription drugs can only be advertised in medical and pharmaceutical professional publications jointly designated by the health administrative department of the State Council and the drug regulatory department of the State Council. In other words, even if the drug is to be published, it cannot be promoted on the Internet, nor can it be promoted through live broadcast.

According to this, the market supervision bureau ordered the publisher to stop publishing illegal advertisements and imposed an administrative fine of 700,000 yuan.

Tickets 7. Keyword Inferior Drugs Tickets 9.99 million

A batch of drugs "Somatostat for Injection" produced by a pharmaceutical company was announced in the announcement issued by the State Drug Administration, and its "content determination" item did not meet the requirements of the Chinese Pharmacopoeia.

The pharmacopoeia standard stipulates that its content should be "90.0-110.0% of the labeled amount", but the content of the batch of products was detected to exceed the upper limit (the highest is 111.8% and the lowest is 110.6%), which violates the "People's Republic of China Drug Administration" According to the relevant provisions of the Law, 1040 sticks of somatostatin for injection were recalled and confiscated; the sales income was confiscated at RMB 4,960,094.21; a fine of RMB 5,037,770.4 was doubled for the value of the goods. These two items totaled 9,997,864.61 yuan.

8. Tickets: 3.1 million yuan for inferior drugs

Niuhuang Jiedu Tablets from a pharmaceutical company has been inspected by the Food and Drug Inspection Institute. The unqualified items are [content determination]. The inspection is based on the 2015 edition of the Chinese Pharmacopoeia and the State Food and Drug Administration ’s supplementary inspection methods and inspection items. Pieces 2008009 and 2008013.

At the same time, in the process of producing and recalling the above batch of bezoar detoxification tablets, there were also improper storage of intermediate intermediate tablets, improper handling, etc., which violated the "Good Manufacturing Practice" and failed to promptly stop sales and use as required. Recalling bezoar detoxification Film behavior.

The following administrative penalties were given: 1. Warning; 2. The confiscation of 4,601 bottles of 170601 batches of bezoar detoxification tablets (a value of 76253.4 yuan); 3. the confiscation of illegal income of 723983.67 yuan; 4. a fine of RMB2436218.48.4.

Nine tickets, keyword 730,000 yuan for inferior drugs

A Chinese herbal medicine manufacturer producing Bupleurum for sale with a pharmaceutical company, after inspection, the results did not meet the relevant requirements of the 2015 edition of the Chinese Pharmacopoeia. After receiving the unqualified inspection report, the Chinese medicine decoction piece manufacturer collaborating with the pharmaceutical company jointly forged a set of production, inspection and sales records of the batch of Chinese medicine decoction piece Bupleurum. The production and sales quantity was compiled from the original 949.88 kilograms to 49.88 kilograms. Law enforcement officers discovered when conducting a peripheral inspection. In response to the above illegal facts, the FDA has dealt with the following:

1. The traditional Chinese medicine decoction piece manufacturer will confiscate 2.35 kg of inferior medicine traditional Chinese medicine piece Chaihu which is recalled in accordance with the law and sell the inferior medicine traditional medicine decoction piece Chaihu illegally obtained 83,600 yuan, and punish the illegal production of inferior medicine Chinese medicine piece Chaihu worth 3 times the value The fine was 251,500 yuan, and the fines totaled 351,500 yuan.

2. The pharmacy company confiscated 99,100 yuan in illegal income from the sale of inferior Chinese medicine decoction pieces of Chaihu, and imposed a fine of 298,200 yuan on the illegal sales of inferior medicine Chinese decoction pieces of Chaihu, which amounted to three times the value of the fines, and the total fine was 397,400.

Ten fines, up to 16 fines, 66,000 fines

A batch of Chinese herbal medicines produced by a Chinese herbal medicine manufacturer and 2 batches of Scutellaria baicalensis and 1 batch of Scutellaria baicalensis. After inspection, the results did not meet the requirements, and they were treated as inferior medicines. Conduct full inspections and other acts.

According to the relevant provisions of the Drug Administration Law of the People's Republic of China, the Regulations for the Implementation of the Drug Administration Law of the People's Republic of China, and the Disciplinary Measures for Administrative Penalties for Drugs of a Provincial Food and Drug Administration, the Provincial Market Supervision Administration issued it on March 29, 2019. The decision on punishment confiscated 11,1361.3 yuan for the recall of inferior drugs and the sale of inferior drugs, and imposed a fine of 5,4785.9 yuan, with a total fine of 66147.2 yuan; and ordered the production and business to be suspended for 2 months. According to inquiries, the company was punished 16 times. (Note: The company has a small amount of fines, but many times; of course, among peers, it is definitely not the most punished for unqualified, just choose a representative)

Non-editing tickets: keywords court does not support 40 million tickets

A medical equipment company, without obtaining a sterilizer registration certificate (Note: the old certificate has expired), produced 25 sterilizers and sold them to relevant agencies without authorization; the value of the goods was 21,115,200 yuan, and the illegal gain was 4,120 yuan. Among them, the equipment company provided a medical device registration certificate when it sold a sterilizer to a hospital, which proved to be counterfeit. It shall be punished by 1, confiscation of 4,120 yuan of illegal income; 2. a fine of 20,615,200 yuan; 3. an additional fine of 20,615,200. The fines and confiscated funds totaled 41,234,520 yuan.

However, the punishment decision of the case was rejected by the local court, demanding lighter. There is a bit of representativeness, although it happened in 2018, I have only recently paid attention to it, and put it here.

At the end of 2018, several cases also occurred, and a brief review:

A foreign capital was fined 3 billion for bribes to non-state staff;

A vaccine company was fined 9.1 billion yuan; it was gone.

The three companies of Mozambique APIs fined 12.83 million.

Because the information comes from the network, if the key information is inaccurate, please timely feedback and correction.


Editor-in-Chief: Luer

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