The definition of inferior drugs in the Drug Administration Law: A drug whose content does not meet the national drug standards is considered inferior drugs. Drugs under any of the following circumstances shall be punished as inferior drugs:
(1) The expiration date is not indicated or changed;
(2) the production batch number is not indicated or changed;
(3) beyond the validity period;
(4) The packaging materials and containers that come into direct contact with drugs are not approved;
(5) adding colorants, preservatives, spices, correctants and auxiliary materials without authorization;
(6) others that do not meet the requirements of drug standards.
II. Relevant punishment measures and law enforcement basis for inferior drugs
(1) Law enforcement basis:
1. Whoever produces or sells inferior drugs in Article 75 of the Drug Administration Law of the People's Republic of China, the illegally produced and sold drugs and illegal income shall be confiscated, and a fine of more than one time but less than three times the value of the illegally produced and sold drugs shall be imposed; If the circumstances are serious, it shall be ordered to stop production, suspend business for rectification or revoke the certificate of drug approval, and revoke the Pharmaceutical Production License, Pharmaceutical Trading License or Pharmaceutical Preparation License of Medical Institutions; If a crime is constituted, criminal responsibility shall be investigated according to law.
2. Article 76 of the Drug Administration Law of the People's Republic of China. Enterprises or other units engaged in the production and sale of counterfeit drugs and the production and sale of inferior drugs are serious, and the directly responsible person in charge and other directly responsible personnel shall not engage in drug production and business activities within ten years.
the raw and auxiliary materials, packaging materials and production equipment specially used by producers to produce inferior drugs shall be confiscated.
13. Article 88 of the Drug Administration Law of the People's Republic of China. The administrative punishment stipulated in Articles 73 to 87 of this Law shall be decided by the pharmaceutical supervisory and administrative department at or above the county level according to the division of responsibilities stipulated by the pharmaceutical supervisory and administrative department of the State Council. Revocation of the Pharmaceutical Production License, Pharmaceutical Trading License, Pharmaceutical Preparation License of Medical Institution, Practice License of Medical Institution or revocation of the certificate of drug approval shall be decided by the original issuing and approving department.
(2) Type and extent of punishment: confiscation of illegally produced drugs; Confiscation of illegal income; And impose a fine of not less than one time but not more than three times the value of illegal production and sale of drugs; Ordered to suspend production or business for rectification; Restrict the qualifications of the directly responsible person in charge and other directly responsible personnel in drug production and business activities; Confiscation of raw and auxiliary materials, packaging materials and production equipment specially used for the production of inferior drugs.
(3) Discretionary refinement and quantification:
1. If a lighter punishment is given, the illegally produced and sold drugs and illegal income will be confiscated, and a fine of more than 1 time and less than 1.8 times the value of the inferior drugs will be imposed:
(1) The value of the goods is small, which has not caused harmful consequences or adverse effects;
(2) there is no subjective intention;
1. If general punishment is given, the illegally produced and sold drugs and illegal income shall be confiscated, and a fine of more than 1.8 times but less than 2.2 times the value of the inferior drugs sold shall be imposed.
13. If a heavier punishment is given, the illegally produced and sold drugs and illegal income shall be confiscated, and a fine of 2.2 times but not more than 3 times the value of the inferior drugs shall be imposed. If the circumstances are serious, the Drug Business License shall be revoked by the original issuing authority:
(1) If the value of the goods is huge;
(2) The inferior drugs sold belong to special drugs, first-aid drugs, injection drugs, biological products, blood products, drugs for pregnant women, drugs for infants and children;
(3) the general inferior drugs sold have caused serious social harmful consequences or adverse effects;
(4) out of subjective intention.