The nature of the illegal act is bad.
Judging from the investigation results and evidence of illegal acts of Changchun Changsheng Company, the violations of drug management laws and regulations implemented by the company mainly include:
Firstly, different batches of stock solutions are blended and prepared, and then the production batch number is re-fabricated; The second is to change the production batch number or actual production date of some batches of products involved; The third is to use expired stock solution to produce some products involved; Fourth, the titer of the finished preparation was not determined according to the prescribed method; Fifth, the changes of centrifuges used in drug production were not filed as required; Sixth, destroy the original production records and fabricate false batch production records; Seventh, submitting false information to defraud biological products to issue certificates; Eight is to destroy hard disks and other evidence to cover up illegal facts.
Li Jiang said that the illegal production of rabies vaccine by Changchun Changsheng Company is an organized, persistent and harmful illegal act, which is shocking and an extremely rare illegal case in the field of drug safety.
Deception and evasion of supervision
Changchun Changsheng Company's production of rabies vaccine in violation of drug administration regulations is an illegal act carried out by the company's management and personnel in different positions according to different division of labor and mutual cooperation. This kind of illegal behavior is purposeful, premeditated and organized.
Li Jiang said that the illegal activities of Changchun Changsheng Company are obviously subjective and intentional, and its illegal means are hidden, so it is not easy to be found because it has evaded supervision for a long time.
In addition to the judicial authorities filing a case for investigation and investigating criminal responsibility, the drug regulatory authorities conducted a serious investigation on this case in line with the principle of implementing the "four strictest" and administration according to law, ascertained the facts of the case, obtained and mastered sufficient and conclusive evidence, and made a decision on the top administrative punishment according to law.
Li Jiang said that according to the Drug Administration Law of People's Republic of China (PRC) and its implementing regulations, and the Administrative Punishment Law of the People's Republic of China, the drug regulatory authorities have made corresponding punishments for different illegal acts. Not only did Changchun Changsheng Company make a decision to confiscate the illegal income and impose a fine for producing rabies vaccine in violation of the drug administration regulations, but it also made behavioral penalties and qualification penalties according to the need to control and restrict the behavioral capacity of the offenders.
Punish severely according to law
In this administrative punishment, the drug supervision department imposed a top penalty on Changchun Changsheng Company's illegal production of rabies vaccine according to law: confiscation of its illegally produced products, confiscation of illegal income of 65.438+0.89 billion yuan, and a fine of 72/kloc-0.00 billion yuan, which is three times the value of illegally produced and sold goods, totaling 965.438+0 billion yuan; Revoke its "Drug Production License" and its rabies vaccine drug approval certificate; The directly responsible person in charge and other directly responsible personnel involved in Gao Gao 14 were punished for not engaging in pharmaceutical production and business activities according to law.
Li Jiang believes that this punishment decision is the highest punishment made by comprehensively considering the illegal acts of Changchun Changsheng Company. Seriously investigating this case not only plays a warning role in the field of drug safety, but also shows the determination of the regulatory authorities to crack down on drug violations and protect public health.