Lanzhou Intermediate People’s Court of Gansu Province
Criminal verdict
(2020) Gan 01 was sentenced to No.37.
The original public prosecution organ is the People’s Procuratorate of Yuzhong County, Gansu Province.
Appellate unit (defendant in the original trial) Gansu Yalan Pharmaceutical Co., Ltd., unified social credit code 91620123745890028F, domicile: No.148, Gongmao Street, heping town, Yuzhong County, and legal representative Dong Wanyou.
Litigation representative Li, male, Han nationality, born on September 5, 1969, is the general manager of Gansu Yalan Pharmaceutical Co., Ltd. and lives in Chengguan District of Lanzhou City.
Defender Xie Yanren, lawyer of Gansu Qiming Law Firm.
Appellant (defendant in the original trial) Peng Mou, male, Han nationality, born on December 28, 1968, with a university education, is from Chengguan District, Lanzhou City, Gansu Province, and is the director of the third marketing department of the sales management center of Gansu Yalan Pharmaceutical Co., Ltd., living in Chengguan District, Lanzhou City. On April 14, 2017, he was released on bail pending trial by Yuzhong County Public Security Bureau on suspicion of producing and selling counterfeit drugs. On January 2, 2018, he was released on bail pending trial by Yuzhong County People’s Procuratorate.
Defender An Aiming, lawyer of Gansu Sailai Law Firm.
The People’s Court of Yuzhong County of Gansu Province tried the case that the People’s Procuratorate of Yuzhong County of Gansu Province accused the defendant Gansu Yalan Pharmaceutical Co., Ltd. (hereinafter referred to as Yalan Pharmaceutical Co., Ltd.) and the defendant Peng Mou of committing the crime of producing and selling counterfeit drugs, and made a criminal judgment of (2019) Gan 0123 Chu No.51 on November 28, 2019. After the verdict was pronounced, both the defendant Yalan Pharmaceutical Co., Ltd. and the defendant Peng Mou in the original trial refused to accept it and filed an appeal. Our court appealed according to law. The trial is now over.

The judgment of Yuzhong County People’s Court in Gansu Province found that:
In 2009, the defendant Peng went to work in Yalan Pharmaceutical Company, engaged in the procurement and sales of Chinese herbal medicines. On March 25th, 2015, the defendant Peng was appointed by Yalan Pharmaceutical Company as the Director of Marketing Department 3 of the Sales Management Center, responsible for the raw material procurement, processing and finished product sales of Chinese herbal pieces.
In February 2014, the defendant Pengmou purchased 3.2 kg of raw materials of Rhizoma Drynariae from Lanzhou Yellow River Market, and put into production 3 kg of Chinese herbal pieces of Rhizoma Drynariae with batch number of 140201 on February 8, at the price of 28 yuan per kg. This batch of Chinese herbal pieces was sold to Gansu Longyou Pharmaceutical Logistics Co., Ltd. on April 14, 2015. On August 18th, 2015, the Food and Drug Administration of Chengguan District, Lanzhou City sampled the batch of Chinese herbal pieces of Rhizoma Drynariae from Gansu Longyou Pharmaceutical Logistics Co., Ltd., and on October 12th, 2015, it was inspected by Lanzhou Food and Drug Inspection Institute, and the conclusion was: according to the 2015 edition of China Pharmacopoeia, it was inconsistent with the control and did not meet the requirements.
In May 2016, the defendant Peng purchased 100 kilograms of raw materials of Peucedanum chinense, and on May 7, he processed and produced 97 kilograms of Chinese herbal pieces of Peucedanum chinense with the batch number of 160501, with the pre-sale price of 26 yuan per kilogram. On October 21, 2016, Lanzhou Food and Drug Administration made a random inspection of this batch of Radix Peucedani Chinese herbal pieces. On December 9, 2016, it was inspected by Lanzhou Food and Drug Inspection Institute, and the conclusion was: according to the 2015 edition of China Pharmacopoeia, it was inconsistent with the control and did not meet the requirements. On December 21, 2016, Lanzhou Food and Drug Administration seized the batch of Radix Peucedani decoction pieces according to law. On January 23, 2017, it was reinspected by Gansu Institute for Drug Inspection, and the conclusion was: According to the "Processing Standard of Traditional Chinese Medicine in Gansu Province (2009 Edition)", the result was Peucedanum, and the non-medicinal parts accounted for 19%, which did not meet the requirements.
In June 2015, the defendant Peng bought 12 kilograms of raw materials of Taxilli from Anhui Bozhou Medicinal Materials Market. On May 5, 2016, he put in 11 kilograms, produced and processed 10 kilograms of Chinese herbal pieces of Taxilli with batch number 160501, and passed the self-inspection on May 7. On October 11th, it was sold to Jilin Luwang Pharmaceutical Company with 5 kg of 13 yuan per kg; Sales to Jilin Qixingshan Pharmaceutical Co., Ltd. 3 kg, 11 yuan per kg. On May 5, 2017, Lanzhou Food and Drug Inspection Bureau made a random inspection of the Chinese herbal pieces. On May 27, 2017, it was inspected by Lanzhou Food and Drug Inspection Bureau, and the conclusion was that it was not consistent with the control and did not meet the requirements according to the 2015 edition of China Pharmacopoeia. On July 31, 2017, it was reinspected by Gansu Institute for Drug Inspection, and the conclusion was that according to China Pharmacopoeia (2015 edition), the results did not meet the requirements (with the characteristics of mistletoe).
On April 25, 2018, Lanzhou Food and Drug Administration organized relevant experts to identify the Inspection Report of the above-mentioned Chinese herbal pieces. The conclusion was: To determine the authenticity of this batch of drugs, it is necessary to check the production enterprise. If the enterprise has been registered and filed in our province in accordance with relevant laws and regulations, it has the qualification to produce and process "Big Leaf Rhizoma Drynariae", and it is not realized in our province. If there is no qualification to produce and process "Rhizoma Drynariae with big leaves", it is suggested to treat it as fake medicine. For Radix Peucedani with batch number 160501, the supervision unit should further check the registration of the drug manufacturer to see if it has the qualification to produce and process "hard Radix Peucedani". If it has the qualification, it is suggested to treat it as inferior drug, and urge the drug manufacturer to correct the name of the product and punish it according to the relevant provisions of GMP/GSP. If there is no qualification, and because "Peucedanum rigidum" belongs to the variety recorded in the standard of traditional Chinese medicine in Gansu Province, the enterprise is beyond the scope of processing and operation, it will be handled in accordance with the relevant provisions of GMP. Taxilli with batch number 160501 is suggested to be treated as fake medicine.
On October 11, 2019, Gansu Provincial Drug Administration replied to the questions involved in this case: (1) Yalan Pharmaceutical Co., Ltd. has the production qualification for the production of Chinese herbal pieces of Rhizoma Drynariae, Radix Peucedani and Herba Taxilli. Drynaria macrophylla was not included in Pharmacopoeia of China (2015 edition), Processing Standard of Traditional Chinese Medicine in Gansu Province (2009 edition) and Standard of Traditional Chinese Medicine in Gansu Province (2009 edition). (2) Gansu Institute of Drug Inspection found that the results of Chinese herbal medicine Qianhu were "hard Qianhu", which was recorded in Gansu Province Chinese Medicine Processing Standard (2009 edition) and Gansu Province Chinese Herbal Medicine Standard (2009 edition), and can be used instead of Qianhu in hospitals, pharmacies and other dispensing departments and retail pharmacies in our province. Does not belong to the current "Drug Administration Law of People’s Republic of China (PRC)" Article 48, paragraph 2, item 2, of the situation of passing off other drugs as such drugs. Gansu Provincial Institute of Drug Inspection found that Taxilli, a traditional Chinese medicine decoction piece, has the characteristics of mistletoe, which belongs to the situation that other drugs are passed off as this drug as stipulated in Item 2, Paragraph 2, Article 48 of the Drug Administration Law of People’s Republic of China (PRC). Viscum mistletoe is also recorded in China Pharmacopoeia (2015 edition), and its "function and indication" are consistent with those of Taxilli, so it is interoperable in clinical use.
The above facts were confirmed by the following evidence:
(1) Documentary evidence
1. The source of the case, the transfer of suspected criminal cases by Lanzhou Food and Drug Administration, the brief introduction of the case, and the notice of case transfer review by Lanzhou Public Security Bureau confirmed that on March 8, 2017, Lanzhou Food and Drug Administration transferred the case that Yalan Pharmaceutical Company was suspected of producing and selling fake Chinese herbal pieces of Qianhu and Rhizoma Drynariae to Yuzhong County Public Security Bureau; On November 9, 2017, Lanzhou Public Security Bureau transferred the case that Yalan Pharmaceutical Company was suspected of producing and selling fake medicine Taxilli to Yuzhong County Public Security Bureau.
2. The business license, organization code certificate, drug production license, trademark registration certificate, tax registration certificate, license for purchasing Chinese herbal medicines exclusively, customs declaration registration certificate of consignor and consignor of import and export goods, and drug GMP certificate of Yalan Pharmaceutical Company confirm that Yalan Pharmaceutical Company is a legally registered company with the organization code of 74589002-8, which is a member of China Commodity Bar Code System, engaged in purchasing Chinese herbal medicines, and allowed to produce Chinese herbal medicines and medicines with Chinese herbal medicines.
3. The notice of appointment of Yalan Pharmaceutical Company confirmed that Peng was appointed as the marketing director of the sales management center of Yalan Pharmaceutical Company on March 25th, 2015.
4. The production record, sales list, acceptance receipt of Gansu Longyou Pharmaceutical Logistics Co., Ltd. and sampling flow of traditional Chinese medicine decoction pieces of Yalan Pharmaceutical Company confirmed that on February 8, 2014, Yalan Pharmaceutical Company produced 3 kg of cannon bone fragments with batch number of 140201. On April 14th, 2015, Yalan Pharmaceutical Co., Ltd. produced 3 kilograms of Rhizoma Drynariae with batch number of 140201 and sold it to Gansu Longyou Pharmaceutical Logistics Co., Ltd. at the price of 28 yuan per kilogram. On May 7, 2016, Yalan Pharmaceutical Co., Ltd. produced 97 kg of Radix Peucedani with batch number 160501. On May 5, 2016, Yalan Pharmaceutical Company produced 10 kilograms of Taxilli with batch number 160501, which was sold to Jilin Luwang Pharmaceutical Co., Ltd. on October 11, 2016 with 5 kilograms of 13 yuan per kilogram, and on November 15, 2016, it was sold to Jilin Qixingshan Pharmaceutical Co., Ltd. with 3 kilograms of 11 yuan per kilogram.
5. The inspection report of Yalan Pharmaceutical Co., Ltd. confirmed that on February 18th, 2014, the company made a self-inspection of the production batch No.140201, and the results met the requirements according to the China Pharmacopoeia 2010. On May 7, 2016, the company conducted a self-inspection on the Peucedanum chinense with the batch number of 160501, and the results met the requirements. On May 5, 2016, the company carried out a self-inspection of Taxilli parasitica with the production batch number of 160501. The results showed that this product was tested according to the China Pharmacopoeia (2015 edition), and the results met the requirements.
6. Receipt confirmation: On January 10th, 2014, Yalan Pharmaceutical Company purchased 3.2kg of Rhizoma Drynariae from Ma, and the unit price was 20 yuan. On June 6th, 2015, Yalan Pharmaceutical Company purchased 12kg of Taxilli at a certain place in Cheng, and the unit price was 10 yuan.
7. The written decision of administrative punishment and the receipt of fines and confiscations from Lanzhou Chengguan Food and Drug Administration confirmed that on July 18th, 2016, Lanzhou Chengguan Food and Drug Administration purchased the inferior medicine of bone fracture and tonic from Yalan Pharmaceutical Company for Gansu Longyou Pharmaceutical Logistics Co., Ltd. for sale. An administrative penalty of 362.7 yuan was imposed, and the company has paid the fine.
(2) Testimony of witnesses
1. The testimony of Chang (the marketing staff of Yalan Pharmaceutical Company) and Dong (the sales department of Yalan Pharmaceutical Company) confirmed that Peng was mainly responsible for the procurement and production of raw materials for marketing three Chinese herbal medicines and the sales of finished Chinese herbal pieces. The main work of the sales department is the processing and sales of Chinese herbal pieces. Our department is fully responsible for the procurement, production and sales of Chinese herbal medicines, and the quality of finished Chinese herbal medicines is inspected by the company’s quality assurance department. Sales department 3 produces and sells according to the order. After receiving the order, raw materials are purchased first, and the raw materials are processed after passing the quality inspection. On October 21, 2016, Lanzhou Food and Drug Administration randomly sampled one kilogram of finished Peucedanum praeruptorum, which was found to be inconsistent with the provisions of the National Pharmacopoeia and was suspected of producing counterfeit drugs. Later, it was sent to Gansu Provincial Institute for Drug Control, and this batch of Chinese medicinal materials of Peucedanum praeruptorum did not meet the processing specifications of Chinese medicinal materials in Gansu, and was characterized as hard Peucedanum praeruptorum. Traditional Chinese medicine for Rhizoma Drynariae was found by Lanzhou Food and Drug Administration from Gansu Longyou Pharmaceutical Logistics Co., Ltd. to be non-compliant, and was later tested by Lanzhou Food and Drug Inspection Institute, which did not meet the requirements of China Pharmacopoeia. These two batches of drugs all passed the self-inspection.
2、杨某(甘肃陇邮医药物流股份有限公司采购总监)的证言证实:2015年4月16日,甘肃陇邮医药物流股份有限公司从亚兰药业公司采购了一批次的骨碎补中药材,批号是140201,总共3公斤,采购价是84元,这批中药材是经亚兰药业检验合格才采购的,最后分发给公司下属的药店销售。兰州市城关区食药局2015年6月26日抽检了该批中药材,检验报告是不符合规定,2016年7月14日对甘肃陇邮医药物流股份有限公司作出行政处罚。2015年10月接到检验报告后甘肃陇邮医药物流股份有限公司对该批药品召回处理。
3. The testimony of Zhang (the person in charge of quality assurance department of Yalan Pharmaceutical Company) confirmed that Yalan Pharmaceutical Company started the inspection according to the standard of China Pharmacopoeia from the purchase of raw materials, and then entered the next production link after passing the inspection. After being processed into Chinese herbal pieces, the finished products were inspected, and the batches of drugs were sampled according to the standard for inspection, which was divided into factory inspection and factory inspection. The peucedanum and hard peucedanum sampled by Yalan Pharmaceutical Company are sold only after passing the self-inspection by their own quality inspection department.
4. The testimony of Li (general manager of Yalan Pharmaceutical Co., Ltd.) confirmed that Peng’s third marketing department took office on March 25, 2015. Mainly responsible for the procurement, production and product sales of raw materials. He is solely responsible for the procurement, production and sales of Chinese herbal medicines, and is responsible for all the affairs of Chinese herbal medicines in the company according to the needs of production. If there are any problems with the procurement, processing and sales of Chinese herbal medicines, he is entirely responsible for them, and the quality of finished Chinese herbal medicines is inspected by the quality assurance department of the company. The raw materials of parasitic loranthus that failed the sampling inspection were purchased by the department in charge of Peng, and all the medicines passed the self-inspection.
(3) Appraisal opinions
1. The drug inspection report of Lanzhou Food and Drug Inspection Institute confirmed: On October 12, 2015, the Rhizoma Drynariae (Canned Rhizoma Drynariae) with batch number of 140201 produced by Yalan Pharmaceutical Company was inspected, and there were two large vascular bundles in the center of about 62% of the section, which were crescent-shaped, which did not meet the requirements; The thin-layer chromatography is inconsistent with the control and does not conform to the regulations. Conclusion: This product was tested according to China Pharmacopoeia (2010 edition), and the results did not meet the requirements.
On December 9, 2016, the Peucedanum Peucedanum with batch number 160501 produced by Yalan Pharmaceutical Company was tested, and the conclusion was that this product was tested according to China Pharmacopoeia 2015, which was inconsistent with the control, and the result did not meet the requirements. On May 5, 2017, the batch number of Taxilli parasitica produced by Yalan Pharmaceutical Company was 160501, and the conclusion was that this product was tested according to China Pharmacopoeia 2015, which was inconsistent with the control and the result did not meet the requirements.
2. The inspection report of Gansu Institute of Drug Inspection confirmed that on January 23, 2017, the Peucedanum praeruptorum with batch number of 160501 produced by Yalan Pharmaceutical Company was reinspected, and the conclusion was that this product was tested according to the Standard for Processing Traditional Chinese Medicine in Gansu Province (2009 edition), and the conclusion was that Peucedanum praeruptorum was hard, with non-medicinal parts accounting for 19%, which did not meet the requirements. On July 31st, 2017, the batch number of Taxilli produced by Yalan Pharmaceutical Company was 160501, and the conclusion was: according to China Pharmacopoeia 2015, the results did not meet the requirements (with the characteristics of mistletoe).
3. Lanzhou Food and Drug Administration’s reply to the Application for Identification of Chinese Herbal Pieces such as Rhubarb confirmed that on April 25, 2018, the bureau set up a "Drug Identification Expert Database" and organized relevant experts to identify the Inspection Report of Chinese Herbal Pieces such as Rhubarb. The conclusion is that the batch number of Rhizoma Drynariae is 140201, and the manufacturer needs to be verified to determine the authenticity of this batch of drugs. If the enterprise has been registered and put on record in our province in accordance with relevant laws and regulations, has the qualification to produce and process "Daye Rhizoma Drynariae", and has been produced, processed and transshipped in our province, but it has not been corrected, it will be handled in accordance with the relevant provisions of GMP/GSP. If there is no qualification to produce and process "Rhizoma Drynariae with big leaves", it is suggested to treat it as fake medicine. For Radix Peucedani with batch number 160501, the supervision unit should further check the registration of the drug manufacturer to see if it has the qualification to produce and process "hard Radix Peucedani". If it has the qualification, it is suggested to treat it as inferior drug, and urge the drug manufacturer to correct the name of the product and punish it according to the relevant provisions of GMP/GSP. If there is no qualification, and because "Peucedanum rigidum" belongs to the variety recorded in the standard of traditional Chinese medicine in Gansu Province, the enterprise is beyond the scope of processing and operation, it will be handled in accordance with the relevant provisions of GMP. Taxilli with batch number 160501 is suggested to be treated as fake medicine.
4. The reply from Gansu Provincial Drug Administration confirmed that: (1) Yalan Pharmaceutical Company has the production qualification to produce Chinese herbal pieces of Rhizoma Drynariae, Radix Peucedani and Herba Taxilli. Drynaria macrophylla was not included in Pharmacopoeia of China (2015 edition), Processing Standard of Traditional Chinese Medicine in Gansu Province (2009 edition) and Standard of Traditional Chinese Medicine in Gansu Province (2009 edition). (2) Gansu Institute of Drug Inspection found that the results of Chinese herbal medicine Qianhu were "hard Qianhu", which was recorded in Gansu Province Chinese Medicine Processing Standard (2009 edition) and Gansu Province Chinese Herbal Medicine Standard (2009 edition), and can be used instead of Qianhu in hospitals, pharmacies and other dispensing departments and retail pharmacies in our province. Does not belong to the current "Drug Administration Law of People’s Republic of China (PRC)" Article 48, paragraph 2, item 2, of the situation of passing off other drugs as such drugs. Gansu Provincial Institute of Drug Inspection found that Taxilli, a traditional Chinese medicine decoction piece, has the characteristics of mistletoe, which belongs to the situation that other drugs are passed off as this drug as stipulated in Item 2, Paragraph 2, Article 48 of the Drug Administration Law of People’s Republic of China (PRC). Viscum mistletoe is also recorded in China Pharmacopoeia (2015 edition), and its function and indications are consistent with those of Taxilli, so it is interoperable in clinical use.
(4) transcripts of on-site inquests and inspections
Records of on-site inspection and photos, and records of seizure and detention confirmed that Lanzhou Food and Drug Administration inspected the drugs produced by Gansu Yalan Company, and seized and detained Rhizoma Drynariae, Radix Peucedani and Herba Taxilli.
(5) confessions of the defendant
The confession of the defendant Peng confirmed: I am responsible for the acquisition, processing and sales of Chinese herbal medicines in Yalan Pharmaceutical Company, and now I am the sales manager of the company. At the end of 2016, Lanzhou Food and Drug Administration randomly sampled the Chinese herbal medicines Rhizoma Drynariae and Radix Peucedani produced by our unit. The Radix Peucedani was tested by Lanzhou Food and Drug Inspection Institute according to China Pharmacopoeia (the first part of 2015 edition), and the conclusion was inconsistent with the control and did not meet the requirements. After the re-inspection by Gansu Institute for Drug Inspection, according to the Standard for Processing Traditional Chinese Medicine in Gansu Province (2009 edition), it was determined that the Chinese herbal medicine produced by our company was Peucedanum rigidum, and the non-medicinal part accounted for 19%, which did not meet the requirements. Peucedanum praeruptorum is a standard term collected in China Pharmacopoeia. Peucedanum praeruptorum is produced in Gansu Province, mainly because of its different characters, but Peucedanum praeruptorum conforms to the standard of Gansu Province’s Processing Standard of Traditional Chinese Medicine (2009 edition). Peucedanum praeruptorum used in this batch of products of our company conforms to the standard of Gansu Province, and 19% of it refers to the stem of Peucedanum praeruptorum. I know that the stem of Peucedanum Peucedanum is a non-medicinal part, which is considered as an impurity in the standard of processing decoction pieces, but we control it within the allowable range. In March 2016, I bought the raw materials of Peucedanum in Hebei Anguo Medicinal Materials Market, with a total of 100 kilograms per kilogram of 20 yuan. On May 7th, 2016, it was produced and processed into 97kg of Chinese medicinal materials of Radix Peucedani. This batch of medicine was produced according to the company’s production plan. The batch number of this batch of medicine was 160501, and the cost price was 26 yuan per kilogram. Now it is not sold, and it was detained by Lanzhou Food and Drug Administration in the company’s warehouse.Our company’s Rhizoma Drynariae was tested according to the standard of China Pharmacopoeia (2015 edition), and the results did not meet the requirements. Drynaria fortunei was put into production by our company on February 8, 2014. The original medicinal materials were purchased from the Yellow River Market in Lanzhou. At that time, 3.2 kilograms of the original medicinal materials were purchased, and 3 kilograms of the finished Chinese medicinal materials were processed and produced. The batch number was 140201. These 3 kilograms of Chinese medicinal materials were wholesale to Gansu Longyou Pharmaceutical Logistics Co., Ltd., with a total of 84 yuan per kilogram of 28 yuan. The raw materials of Taxilli parasitica produced and sold by our company were purchased in June 2015 in Haozhou, Anhui Province, with a total purchase of 12kg at the unit price of 10 yuan. On May 5th, 2016, 11kg of raw materials were put in, and processed into 10kg of Chinese herbal pieces. On May 7th, the quality inspection department of our unit passed the self-inspection and released for sale. On October 11th, it sold 5kg of 13 yuan to Jilin Luwang Pharmaceutical Co., Ltd., and on November 15th, it sold 3kg of 11 yuan to Jilin Qixingshan Pharmaceutical Co., Ltd. This year, the Food and Drug Administration sampled 1kg, and now there is 1kg left in stock. The batch number of this batch of Herba Taxilli Chinese herbal pieces is 160501. Inspection by Lanzhou Food and Drug Inspection Institute and re-inspection by Gansu Institute of Drug Inspection showed that the batch number of Chinese traditional medicine decoction pieces of Herba Taxilli produced by our unit was 160501, and the re-inspection results showed that it had the characteristics of mistletoe. I can’t tell the difference between mistletoe and mistletoe, both of which are used medicinal materials. They were originally called mistletoe, and their functions and effects are the same. They are harmless to human body and cannot be distinguished by naked eyes.I am responsible for purchasing all the raw materials for the production of traditional Chinese medicine, and our company has inspected them before releasing them after passing the self-inspection.
The court of first instance held that the defendant, Yalan Pharmaceutical Company, had violated the national drug administration laws and regulations by producing and selling counterfeit drugs, which had violated the criminal law and constituted the crime of producing and selling counterfeit drugs, and should be punished according to law. The accusation by the public prosecution agency that the batch number 140201 of Rhizoma Drynariae and the batch number 160501 of Herba Taxilli produced and sold by Yalan Pharmaceutical Company are counterfeit drugs, the facts are clear, the evidence is true and sufficient, and the charges are established, which should be supported. The accusation of the public prosecution agency that the batch number of Qianhu Chinese medicine decoction pieces produced by Yalan Pharmaceutical Company is 160501 is counterfeit is not supported because of insufficient evidence. Defendant Peng, as the head of the third marketing department of Yalan Pharmaceutical Company, is the person directly responsible for purchasing, processing and selling the raw materials of the two batches of Chinese herbal medicines, namely Rhizoma Drynariae and Herba Taxilli, and should be convicted and punished for the crime of producing and selling counterfeit drugs. In view of the fact that the number of fake medicines produced by the defendant unit is small, the description of fake medicine Taxilli is consistent with that of mistletoe, and there is interoperability in clinical use, so the circumstances of the crime are minor, and the defendant unit Yalan Pharmaceutical Company and the defendant Peng Mou can be given a lighter punishment according to law. According to the provisions of Articles 141, 150, 30, 31, 52, 53, 72, 1 and 3, and 73, 1 and 3 of the Criminal Law of People’s Republic of China (PRC), the defendant Gansu Yalan Pharmaceutical Co., Ltd. was convicted of producing and selling counterfeit drugs and fined 10,000 yuan; The defendant Peng was convicted of producing and selling counterfeit drugs and sentenced to six months in criminal detention.Suspended for ten months and fined 5000 yuan.
The appellate unit Yalan Pharmaceutical Company and its defenders put forward that the court of first instance decided that Rhizoma Drynariae was a counterfeit drug on the basis of the inspection report issued by Lanzhou Food and Drug Inspection Institute, and the inspection method adopted in this appraisal opinion was wrong, which led to the wrong appraisal conclusion; "Mistletoe" and "Taxilli" are difficult to distinguish in reality, which leads to the company’s inability to distinguish from the purchase to the identification. The company did not intentionally produce counterfeit drugs, and the social harm was not great, so it could not be recognized as counterfeit drugs. It requested to revoke the first-instance judgment and change the verdict to innocence.
Appellant Peng proposed that the conclusion of the appraisal opinion of the cannon bone fragments identified by the court of first instance was wrong, and the inspection method on which the appraisal opinion was based was wrong, so the cannon bone fragments involved should not be identified as counterfeit drugs; Because it is difficult to distinguish mistletoe from mistletoe in reality, there is a wrong understanding, and there is no intention to produce and sell counterfeit drugs subjectively; In this case, it is only responsible for purchasing, and the main responsibility should be borne by the quality assurance department; In the whole case, the circumstances are obviously minor, and the harm is not great. As the person in charge of drug procurement, processing and sales, he should not be considered as other directly responsible personnel, and requested to revoke the judgment of first instance and change his sentence to innocence.
Defender of Appellant Peng proposed: The basis for the first instance to determine that the batch number of the Chinese herbal pieces of Cannabis Rhizoma Drynariae with batch number of 140201 belongs to counterfeit drugs, that is, there are contradictory appraisal opinions, which is a fact finding error; The appellant did not have the subjective intention to produce and sell "Taxilli" as "Mistletoe", which did not constitute the crime of producing and selling counterfeit drugs; It is doubtful whether this case meets the prosecution standard of the crime of producing and selling counterfeit drugs.
The court found that the original judgment found that the appellant Yalan Pharmaceutical Company and the appellant Peng had committed the crime of producing and selling counterfeit drugs, and the evidence was true and sufficient. The listed evidence had been publicly presented, cross-examined and certified in the court of first instance. The court confirmed the facts and evidence found in the first instance according to law, and no new evidence was submitted by the appellant, appellant and defender in the second instance.
The appraisal opinions of the appellate unit, the appellant and the defender that the court of first instance identified counterfeit drugs are the reasons for appeal and defense opinions that the inspection method is wrong and cannot be used as the basis for finalizing the case. After investigation, Lanzhou Food and Drug Inspection Institute is a specialized inspection institution with drug inspection qualification. The LZ2015Y2363 inspection report issued by it shows that the inspection result of Rhizoma Drynariae with the batch number of 140201 is not in conformity with the regulations. In view of this inspection report, the appellant did not apply for re-inspection within the effective period, so the inspection result should be considered valid. Lanzhou Food and Drug Administration’s reply to the Application for Identification of Chinese Herbal Pieces such as Rhubarb indicated that the manufacturer of Rhizoma Drynariae (batch No.140201) needs to be verified in order to judge the authenticity of this batch of drugs. If the company has been registered in our province in accordance with relevant laws and regulations, it has the qualification to produce and process Rhizoma Drynariae with big leaves, but it has not been corrected in our province, it will be in accordance with GMP/GSP. If there is no qualification to produce and process "Rhizoma Drynariae with big leaves", it is suggested to treat it as fake medicine. According to the reply of Gansu Drug Administration on this case, Gansu Yalan Pharmaceutical Co., Ltd., the appellant, has the production qualification to produce pieces of Rhizoma Drynariae, and "Rhizoma Drynariae with big leaves" has not been included in China Pharmacopoeia, Gansu Province Chinese Medicine Processing Standard and Gansu Province Chinese Medicine Standard. According to the second paragraph of Article 141 of the Criminal Law, whether it is a counterfeit drug shall be subject to the Drug Administration Law of People’s Republic of China (PRC), and according to the relevant provisions of this law,Chinese herbal pieces must be produced in accordance with the national drug standards and the production technology approved by the drug supervision and administration department of the State Council. If there are no provisions in the national drug standards, they must be processed in accordance with the processing standards formulated by the drug supervision and administration departments of the people’s governments of provinces, autonomous regions and municipalities directly under the Central Government. Drynaria macrophylla is not included in China Pharmacopoeia, Gansu Chinese Medicine Processing Standard and Gansu Chinese Medicine Standard. Therefore, Drynaria macrophylla is not a drug prescribed by the state, and the production and sale of Drynaria macrophylla is a fake drug, which is a non-drug or another drug. Therefore, the appeal reason and the defense opinion put forward by the appellant and the appellant cannot be established.
As for the appeal unit, the appellant and the defender, it is difficult to distinguish mistletoe and Taxilli because of reality, and there is no subjective and intentional appeal reason and defense opinion for producing and selling counterfeit drugs. After investigation, the drug inspection report of Lanzhou Food and Drug Inspection Institute and the inspection report of Gansu Drug Inspection Institute confirmed that the "Taxilli" with batch number of 160501 did not meet the requirements, and it had the characteristics of "mistletoe", which belonged to the situation that other drugs passed off as this drug. According to the People’s Republic of China (PRC) Pharmacopoeia, there was a certain difference between "mistletoe" and "Taxilli", indicating that there was an objective possibility to distinguish them. In this case, the Appellant and the Appellant, as professional organizations and personnel with professional knowledge, should have the ability to distinguish between mistletoe and Taxilli, and their inability to distinguish between mistletoe and Taxilli as the subjective and intentional appeal reason and defender for not producing and selling counterfeit drugs cannot be established.
Appeal reasons and defense opinions of the appellant and the defender that the case does not meet the prosecution standard for the crime of producing and selling counterfeit drugs, and that the circumstances of the crime are obviously minor and the harm is not great, so it is not suitable for criminal treatment. After investigation, after the implementation of the Criminal Law Amendment (VIII) of People’s Republic of China (PRC), the constitutive elements of the crime of producing and selling counterfeit drugs are no longer required to be "harmful to human body". As a professional, there have been many irregular purchases and sales, and their actions have endangered public health. The actions of the appellant and the appellant have constituted the crime of producing and selling counterfeit drugs and should be punished according to the Criminal Law. The court of first instance combined the criminal motives, subjective intention, objective behavior and social harmfulness of the two appellants, and made a judgment, which was given a lighter sentence within the statutory penalty range, which was an appropriate sentence. Therefore, the appeal reason and the defender’s defense opinion could not be established.
As the person in charge of drug procurement, processing and sales mentioned by the appellant Peng and his defenders, it should not be regarded as the appeal grounds and defense opinions of other directly responsible personnel. After investigation, according to the documents of Gansu Yalan Pharmaceutical Co., Ltd., witness testimony and Peng’s confession, Peng, as the director of the marketing department of the sales management center, is responsible for the procurement, processing and sales of raw materials of the department, and is responsible for the supervision and management of the drugs produced and sold. As the directly responsible person in charge, Peng should bear corresponding criminal responsibilities. The grounds for appeal cannot be established.
We believe that the facts of the original judgment that the appellant Gansu Yalan Pharmaceutical Co., Ltd. and the appellant Peng Mou committed the crime of producing and selling counterfeit drugs are clear, the evidence is indeed sufficient, the applicable law is correct, the sentencing is appropriate, and the trial procedure is legal. In accordance with the provisions of Article 236, Paragraph 1 (1) and Article 244 of the Criminal Procedure Law of People’s Republic of China (PRC), the ruling is as follows:
Reject the appeal and uphold the original judgment.
This ruling is final.
Presiding judge Zhao Jinrong
Judge An Hairong
Judge Song Ximin
February 25, 2020
Judge? Assistant Zhu Yiming
Clerk Ren Zixuan
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