Fourty-four batches of drugs were found to be substandard

In order to strengthen drug quality supervision and ensure the safety of public drug use, according to the annual sampling work plan of the provincial drug regulatory bureau, the provincial bureau has carried out spot checks and inspections on the quality of drugs produced, operated and used by the units, and now announces the situation of non-compliant drugs found in spot checks as follows: First, after verification and confirmation, 12 varieties of 10 production enterprises (preparation units) a total of 14 batches of drugs, after sampling does not meet the standards.
2. The relevant drug regulatory department has taken control measures such as seizure, seizure, suspension of sales and product recall of non-compliant products, and shall, in accordance with relevant laws and regulations, seriously investigate and punish the relevant production enterprises (preparation units) and sampled units in accordance with the law, and may inquire about the website of the relevant municipal market supervision authority.
, for non-compliant products and corresponding production and operation enterprises and units, the relevant drug regulatory departments should strengthen supervision, urge them to identify the causes of the problems, formulate and implement corrective measures, and effectively eliminate hidden risks.
attached to the list of non-conforming drugs production, sale of counterfeit and inferior drugs, from strict punishment can be found that the conventional drug quality supervision work, the inspection of non-conforming drugs are concentrated in the "features" above, and to unqualified Chinese medicine tablets in the majority.
Take Shandong Province as an example, on December 8th, Shandong Province issued a drug quality sampling notice (No. 7 of 2020), 15 batches of drugs were found to be unqualified, but also concentrated on the main symptoms of non-conformity.
It can be said that the supervision of non-conforming drugs has become the focus of the regulatory authorities, for the production and sale of counterfeit drugs, the new version of the Drug Administration Law will be promulgated after the more stringent, the provinces will also be refined violations, different degrees of violations of the discretionary benchmarks.
Taking Liaoning Province as an example, recently, the Liaoning Provincial Drug Administration issued the Jilin Provincial Drug Supervision and Administration System Drug Administrative Penalty Discretionary Benchmark (Version 2020) (Draft for Comments), which provides for different degrees of violations, and the pharmacy conducts a self-examination.
, the administrative penalty discretion benchmarks include the Drug Administration Act, the Vaccine Management Act, the Drug Production Supervision and Administration Measures, etc.
it is understood that the administrative discretion benchmark shall be applied in the case of light administrative punishment set by relevant laws and regulations or other relevant provisions, as well as in the case of severe administrative punishment.
Jilin Province Drug Supervision and Administration System Drug Administrative Penalty Discretionary Benchmark (2020 edition) (draft for comments) Article 1 of the Drug Administration Law, Article 115" and the illegal production and sale of drugs (including sold and unsold drugs, the same below) the value of the fine 15 times to 30 times" shall be applied to the following discretion: ( 1 ) If the value of the drugs illegally produced or sold is more than 15 times or less than 20 times the value of the drug : ( 1 ) if no counterfeit drugs are found and the conditions and procedures for their production and operation are in accordance with the relevant provisions ; ( 2 ) the pharmaceutical production enterprise has applied for new production scope and obtained a drug registration approval , but organizes the production of drugs without approval ( except for the trial production products used for verification ) ; (3) If the risk of the drugs involved is low; (4) meeting the quality standards of the drug; (5) If the drugs involved have not yet been sold; (6) the value of the goods is less than 3000 yuan.
the case of heavy administrative punishment, a fine of 25 times or less than 30 times the value of the drug illegally produced or sold shall be imposed.
circumstances that do not comply with the provisions of the second and third paragraphs of this Article, the general administrative penalty shall be a fine of 20 times or less than 25 times the value of the drug produced or sold illegally.
Article 2 Article 116 of the Drug Administration Law " and a fine of 15 times or less than 30 times the value of the drug illegally produced or sold" shall apply the following discretion: If the following discretions are met: if the penalty is met, a fine of 15 times or less than 20 times the value of the drug illegally produced or sold shall be imposed: (1) if the risk of the drugs involved is low; (2) conforming to the quality standards of the drugs; (3) the drugs involved have not yet been sold; (4) the value of the goods is less than 3000 yuan; (5) taking the initiative to take measures such as correction, recall or compensation to mitigate the harmful consequences.
If it meets the situation of heavy administrative punishment, a fine of 25 times or less than 30 times the value of the drug illegally produced or sold shall be imposed: if it does not meet the provisions of the second and third paragraphs of this Article, the general administrative penalty shall be imposed, and a fine of 20 times or less than 25 times the value of the drug illegally produced or sold shall be imposed.
article 3 Article 117 (1) of the Drug Administration Law "and a fine of ten times or less than 20 times the value of a drug illegally produced or sold" shall apply the following discretion: "If one of the following conditions is met, a fine of 10 times or less than 13 times the value of the drug illegally produced or sold shall be imposed from a light administrative penalty: (1) The non-conforming items listed are individual and belong to the status, visible foreign body, moisture, related substances, pH, color of the solution and other items, and the non-conforming items have not been found to cause harm to the safety of human drug use; (2) only in violation of Article 98 (3), (4), (5), (6) of the Drug Administration Law and no harm has been found; (3) The content of the pharmaceutical content is calculated to be higher or lower than 20% of the indicated quantity; (4) The content of the pharmaceutical content is only stipulated by the low limit, which is less than 20% of the standard; (5) If the drugs involved have not yet been sold; (6) the value of the goods is less than 3000 yuan.
If it meets the situation of heavy administrative punishment, a fine of 17 times or less than 20 times the value of the drug produced or sold illegally does not meet the provisions of the second and third paragraphs of this Article, and the general administrative penalty shall be imposed: a fine of 13 times the value of the drug produced or sold illegally and not more than 17 times the value.
Article 4 Article 117 (2) of the Drug Administration Law , "a fine of between 100,000 yuan and 500,000 yuan" shall apply the following discretion: If it complies with the second paragraph of Article 3 of these Measures, a fine of between 100,000 yuan and 230,000 yuan shall be imposed.
in accordance with The third paragraph of Article 3 of these Measures, a fine of between 370,000 yuan and 500,000 yuan shall be imposed from a heavy administrative penalty.
circumstances that do not comply with the provisions of the second and third paragraphs of this Article, the general administrative penalty shall be a fine of between 230,000 yuan and 370,000 yuan.
Article 5 Of the Drug Administration Law, Article 118 ,"Production, sale of counterfeit drugs, or production or sale of inferior drugs and serious circumstances", "and the fine of not more than 30 percent of the income received by the office shall be subject to the following discretion": If it meets one of the following circumstances, a fine of not less than 30% of the income received by the department shall be proved to have fully fulfilled its statutory and internal rules and regulations; (2) In accordance with The second paragraph of Article 2 of these Measures.
the case of heavy administrative punishment, the department shall receive a fine of 2.1 times or less than 3 times the income.
circumstances that do not comply with the provisions of the second and third paragraphs of this Article, the general administrative penalty shall be a fine of 1.2 to 2.1 times the income received by the Office.
Article 6 Of the Drug Administration Law, Article 120, "and a fine of between one and five times the illegal income", shall apply the following discretions: If no counterfeit drugs are found to be involved and meet one of the following conditions, a fine of 1 times or less than 2.3 times the illegal income shall be imposed: (1) the initial provision of storage, transportation and other convenient conditions; (2) If the illegal income is less than 20,000 yuan and the harmful consequences are minor; (3) taking the initiative to take measures such as correction, recall or compensation to eliminate the harmful consequences; (4) actively cooperating with the administrative organs in investigating or investigating the illegal acts.
the case of heavy administrative punishment, a fine of 3.7 times or less than 5 times the illegal income shall be imposed.
circumstances that do not comply with the provisions of the second and third paragraphs of this Article, the general administrative penalty shall be a fine of 2.3 times or 3.7 times the illegal income.
Article 7 Of the Drug Administration Law, Article 122 , "And a fine of more than twice or less than five times the illegal income" shall apply the following discretions: If one of the following conditions is met, a fine of 1 times or less than 2.3 times the illegal income shall be imposed: (1) if the illegal drug is not involved;
the case of heavy administrative punishment, a fine of 3.7 times or less than 5 times the illegal income shall be imposed.
circumstances that do not comply with the provisions of the second and third paragraphs of this Article, the general administrative penalty shall be a fine of 2.3 times or 3.7 times the illegal income.
Article 8 Article 123 of the Drug Administration Law, "and a fine of between 500,000 yuan and 5 million yuan" shall apply the following discretion: If one of the following conditions is met, a fine of between 500,000 yuan and 2 million yuan shall be imposed: (1) a fine of 500,000 yuan or less shall not yet be produced, operated or used; (2) If no counterfeit or inferior drugs are found and their production, operating conditions and processes comply with the relevant provisions; (3) if the drugs involved are of low risk; and (4) if they meet the quality standards of the drugs.
the case of heavy administrative punishment, a fine of 3.5 million yuan to 5 million yuan or less shall be imposed.
circumstances that do not comply with the provisions of the second and third paragraphs of this Article, the general administrative penalty shall be a fine of between 2 million yuan and 3.5 million yuan.
Article 9 Of the Drug Administration Law, Article 124 , "and a fine of 15 times or less than 30 times the value of the illegally produced, imported or sold drugs" shall apply the following discretions: If one of the following conditions is met, a fine of 15 times or less than 20 times the value of the drugs illegally produced, imported or sold shall be imposed: (1) the raw materials approved for use meet the raw material standards; (2) The quality of the drugs conforms to the standards; (3) the drugs involved have not yet been sold; (4) the value of the goods is less than 5000 yuan.
the case of heavy administrative punishment, a fine of 25 times or less than 30 times the value of the drug produced, imported or sold illegally shall be imposed.
circumstances that do not comply with the provisions of the second and third paragraphs of this Article, the general administrative penalty shall be a fine of 20 times or less than 25 times the value of the drug produced, imported or sold illegally.
Article 10 Of the Drug Administration Law, Article 125 , "and a fine of between 500,000 yuan and 5 million yuan" shall apply the following discretions: If one of the following forms is met, a fine of between 500,000 yuan and 2 million yuan shall be imposed: (1) if the subject has not yet used the drug without approval; (2) The purchase channel for the sale of packaging materials or containers produced without direct contact with drugs without review shall be lawful; (3) the revision of drug labels and instructions shall not involve specifications or usage.
shall be fined between 3.5 million yuan and 5 million yuan if they meet the conditions of heavy administrative punishment.
circumstances that do not comply with the provisions of the second and third paragraphs of this Article, the general administrative penalty shall be a fine of between 2 million yuan and 3.5 million yuan for illegal income.
article 11 of the Drug Administration Law, Article 126 "If it fails to be corrected in time, a fine of between 100,000 yuan and 500,000 yuan or less" and "serious circumstances" shall be subject to the following discretion: if it meets one of the following circumstances, a fine of between 100,000 yuan and 230,000 yuan shall be imposed: (1) if the products involved have not yet been sold; (2) If the product involved is of low risk; (3) takes the initiative to take corrective, recall or compensation measures to mitigate the harmful consequences; (4) if the value of the products sold is less than 30,000 yuan, the harmful consequences are minor; (5) there are general defects but no problems with the quality of the drugs.
the situation of heavy administrative punishment, he shall be fined between 370,000 yuan and 500,000 yuan.
meets one of the following conditions, severe punishment shall be imposed according to the circumstances: (1) the person in charge of drug quality management and supervision of the implementation of quality management norms shall not be equipped with a special quality person in charge; (2) The drug market license holder is not equipped with a special quality licensee to fulfill the responsibility of drug market release; (3) the pharmaceutical production enterprise is not equipped with a special quality licensee to fulfill the responsibility of drug release from the factory; (4) the quality management system is not up to normal operation, the records and data of drug production process control and quality control are not true; (5) the identified risks are not taken in a timely manner effective risk control measures, can not guarantee product quality; (6) other serious violations of drug production quality management norms;
circumstances that do not comply with the provisions of the second, third and fourth paragraphs of this Article, the general administrative penalty shall be a fine of between 230,000 yuan and 370,000 yuan.
article 12 of the Drug Administration Law, "a fine of between 100,000 yuan and 500,000 yuan" shall apply the following discretions: If one of the following conditions is met, a fine of between 100,000 yuan and 230,000 yuan shall be imposed: (1) the products involved have not yet been sold; (2) the products involved in the case are of low risk; (3) take the initiative to correct, recall or pay compensation and other measures to mitigate the harmful consequences.
to meet the situation of heavy administrative punishment, a fine of 370,000 yuan to 500,000 yuan or less shall be imposed.
circumstances that do not comply with the provisions of the second and third paragraphs of this Article, the general administrative penalty shall be a fine of between 230,000 yuan and 370,000 yuan.
Article 13 of the Drug Administration Law, "and a fine of two times or less than ten times the value of the illegal purchase of drugs", shall apply the following discretions: If one of the following conditions is met, a fine of 2 times the value of the illegal purchase of drugs and less than 4.7 times the value of the illegal purchase shall be imposed: (1) the seller sells the drugs involved by forgery, change, lease, sale license, batch or other supporting materials; (2) If the drugs in the case have not yet been sold; (3) the quality of the drugs meets the standards; (4) the value of the drugs is less than 3000 yuan; (5) the measures of correction, recall or compensation are taken to mitigate the harmful consequences.
the case of heavy administrative punishment, a fine of 7.3 times or less than 10 times the value of the illegal purchase of drugs shall be imposed.
circumstances that do not comply with the provisions of the second and third paragraphs of this Article, the general administrative penalty shall be a fine of 4.7 times or less than 7.3 times the value of the illegal purchase of drugs.
article 14 of the Drug Administration Law, Article 131 , "and a fine of between 200,000 yuan and 2 million yuan" shall apply the following discretions: If one of the following conditions is met, a fine of between 200,000 yuan and 800,000 yuan shall be imposed: (1) if the operator enters the platform for business through forgery, change, leasing, sale of licenses, approvals or other supporting materials;