What are Counterfeit Drugs?

All products that meet the requirements of Article 48 of the Drug Administration Law of the People's Republic of China are counterfeit medicines. According to Article 31 of China's Drug Administration Law, the production of new drugs or drugs that have national standards has been approved by the State Council s drug regulatory department (National The Food and Drug Administration has approved the national medicine standard for medicines (except for traditional Chinese medicinal materials and Chinese medicine decoction pieces that are not subject to approval number management). Only the use of such approval number is a regular medicine. In addition, a certain health medicine on the market Zhunzi (the expiration date has expired), this product name is also a counterfeit medicine, and other batches such as Jingwei Food Certificate, Guoshi Jianzi or Weishi Jianzi belong to the category of health food and are not allowed as medicines. For sale. Products such as Xiaoxiao and Xiaoxiao in the market are disinfection products, and not drugs.

All products that meet the requirements of Article 48 of the Drug Administration Law of the People's Republic of China are counterfeit medicines. According to Article 31 of China's Drug Administration Law, the production of new drugs or drugs that have national standards has been approved by the State Council s drug regulatory department (National The Food and Drug Administration has approved the national medicine standard for medicines (except for traditional Chinese medicinal materials and Chinese medicine decoction pieces that are not subject to approval number management). Only the use of such approval number is a regular medicine. In addition, a certain health medicine on the market Zhunzi (the expiration date has expired), this product name is also a counterfeit medicine, and other batches such as Jingwei Food Certificate, Guoshi Jianzi or Wei Shijian belong to the category of health food and are not allowed as medicine For sale. Products such as Xiaoxiao and Xiaoxiao in the market are disinfection products, and not drugs.

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2019-11-30 16:11 A number of laws and regulations will be implemented in December 2019-11-30 16:11

Starting from December 1, the new edition of the Drug Administration Law will re-define the scope of counterfeit and inferior drugs: drugs imported without approval will no longer be treated as "counterfeit drugs". For a small number of drugs that have been legally marketed abroad without the approval of import, the punishment may be reduced. In addition, with regard to the emerging problem of online sales of prescription drugs in recent years, the newly revised drug management law clearly states that the drug sales network must be interconnected with the information system of medical institutions, and information can be shared to ensure that the source of prescriptions is authentic and to ensure the safety of patients' medications. It must meet the requirements of the quality standards for drug operation. ... more

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Content from

Chinese name

Fake medicine

Foreign name

Bogus Drug

Pinyin

jiayao

evaluation standard

National Medicine Standard and its valid food and health certificate

Related legislation

Drug Administration Law of the People's Republic of China

Regulatory Authority

State Food and Drug Administration

Introduction to counterfeit medicine

Bogus Drug: According to the Drug Administration Law of the People's Republic of China, any of the following conditions is a fake drug:

(1) The ingredients contained in the medicine do not conform to the ingredients stipulated in the national pharmaceutical standards;

(2) Impersonating a drug as a non-medicine or as another drug.

Drugs in any of the following situations shall be treated as counterfeit drugs:

(1) those prohibited by the State Council's drug regulatory authority;

(2) those that must be approved in accordance with this Law without being approved for production or import, or must be inspected in accordance with this Law and sold without inspection;

(3) Metamorphic;

(4) Contaminated;

(5) Manufactured using APIs that must obtain an approval number in accordance with this law but have not obtained an approval number;

(6) The indicated indications or functional indications exceed the prescribed range.

Fake medicine supplement

Star celebrity drugs that are known to be counterfeit drugs will be prosecuted. Xiong Xuanguo, vice president of the Supreme People's Court, pointed out at a press conference held by the State Council Information Office that celebrity endorsement drugs that are known to be counterfeit drugs will be investigated for criminal responsibility.

Xiong Xuanguo mentioned the act of celebrity endorsement, and from the perspective of judicial interpretation, it was first to provide the positioning of such behavior. According to the "Criminal Law", the production and sale of counterfeit drugs and inferior drugs are intentional crimes, which constitute the accomplice on the premise that they know or should know that others have produced or sold counterfeit drugs and inferior drugs. Therefore, if the celebrity's endorsement behavior is that he knows that someone else produces and sells counterfeit medicines and inferior medicines, and meets the provisions of the Criminal Law, it is possible to deal with them as an accomplice, but this premise is very important.

It is understood that on May 13, 2009, the Supreme People's Court and the Supreme People's Procuratorate signed the Interpretation on Several Issues Concerning the Specific Application of Laws in Handling Criminal Cases of Production and Sale of Counterfeit and Inferior Drugs, which will come into effect on May 27, 2009. . The "Explanation" clarified some difficult issues in the application of the law in handling criminal cases involving the production and sale of counterfeit and inferior drugs. (According to the Chinese website text) ^[1]

Fake medicine example

Xinhua News, Shenyang, December 22, 2003. From January 1, 2004, medicines produced according to local standards such as "Liaowei" medicine will be classified as counterfeit medicines. It is understood that the same drug has different production standards in different places, which was an important reason for the low quality and low-level repeated production of drugs in China. Beginning in June 2003, the Ministry of State Drug Administration began to unify the national drug approval documents. With the end of the work, the problem that the quality of this medicine cannot be guaranteed will be solved fundamentally.

By the end of 2003, the medicines sold by major pharmaceutical companies in Shenyang had basically been produced in accordance with the unified national standards. Only a small number of small pharmaceutical companies produced drugs still in local standards, such as those marked with "Liao Wei Zhunzi". Words, etc. From January 1, 2004, all such medicines produced according to local standards will be listed as counterfeit medicines . The public is reminded to check the approval number of the drug when purchasing.

On April 15, 2012, the CCTV "Weekly Quality Report" program "Secrets in Capsules" exposed some enterprises in Hebei, processed leather waste with quicklime, boiled them into industrial gelatin, and sold them to some companies in Xinchang, Shaoxing to make medicines. With the capsule, it will eventually flow into the pharmaceutical company and enter the patient's abdomen. Because leather is used in industrial processing, chrome-containing tanning preparations are used, so capsules made in this way often have heavy metal chromium exceeding the standard. After testing, 13 batches of medicines from 9 pharmaceutical factories, including the pharmaceutical industry, were corrected, and the chromium content of the heavy metal in the capsules used exceeded the standard. ^[2]

How to check fake drugs

The State Food and Drug Administration is a direct agency of the State Council for comprehensive supervision of food, health products, cosmetics safety management and drug supervision. It is responsible for administrative and technical supervision of research, production, distribution, and use of drugs; Comprehensive supervision of cosmetics safety management, organization and coordination, and organization of investigation and punishment of major accidents according to law; responsible for the approval of health products.

On the homepage of the website, there is a "data quick search" query entrance, which can be divided into "domestic drugs", "imported drugs" and "pharmaceutical manufacturers". If you enter the content you want to query, you can display relevant information. If the query in the database is "No record" may be a counterfeit drug and should be purchased with caution and reported to the local drug regulatory department. ^[3]

Exposure of fake drug fake chain

According to the Voice of China "News Evening Peak" report, the Ministry of Public Security recently instructed the national public security organs to launch a campaign against the production and sale of counterfeit drugs. The large-scale counterfeit drug case worth 2 billion yuan was successfully closed. The origin of this huge case A batch of pill boxes seized in a taxi in Jinhua police. After an in-depth investigation, the police found that the lowest level in the entire chain of interests in the production and sale of fake drugs turned out to be hospital cleaners.

After investigation by the police, the suspect Li has bought medicine boxes and empty bottles in Zhejiang and other places for many years, and gradually formed a family medicine packaging recycling gang with him at the core. Li and his family are in charge of each In the hospital, an informant was installed in each hospital. This informant is the hospital's cleaners and cleaners. Jiang Yiqun, deputy branch leader of the Economic Investigation Brigade of the Jinhua Public Security Bureau, told reporters that they had searched for cleaning staff in the top three hospitals and purchased various prescription drug packaging boxes from them. Jiang Yiqun said: "The main thing they bought was anti-tumor drug packaging boxes. Some imported drugs have relatively high prices, some granules, and various forms of drugs." Jiang Yiqun said that the acquisition of packaging boxes is very profitable. Like a set of Herceptin's box, including an empty bottle, instruction manual, and cut-out anti-counterfeiting logo, it can sell for 1,500 yuan a set; "Mirova" also costs about 1,200 yuan a set. Hospital cleaners can also earn at least 300 yuan from receiving such a box.

With the deepening of the investigation, the police found that the gang in Beijing, who was operating in Beijing, produced fake medicines by changing the batch number, changing the packaging, filling low-grade APIs, and blending brine. After counterfeit drugs were made, counterfeit drug dealers began to post sales information online. The prescription drugs "Melohua", "Herceptin", and "Terrokai" made of these fake drugs for treating tumors can be sold on the market for tens of thousands or even tens of thousands of yuan.

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