You are viewing the translated version of औषधि व्यवस्था विभाग.
Section 5
Drug Administration Department
(1) In order to implement the objectives of this Act, the Government of Nepal shall establish the Drug Administration Department.
(2) The department established in accordance with sub-section (1) shall conduct all activities related to drug control in accordance with this Act and the rules made under this Act.
Drugs Act, 2035, (1978
Preamble - 0
Chapter - 4
Section 7: Need to get a letter of recommendation to establish a pharmaceutical industrySection 8: required to obtain production licenseSection 8A: Medicines to be registeredSection 9: A prescription should be obtained to import the drugSection 9A: Emergency Use of Medicines and VaccinesSection 10: Name to be registered to sell-distribute medicineSection 10A: Only registered medicines should be sold and distributedSection 11: Duration and Renewal of Product Licenses, Recommendations and Certificates
Chapter - 5
Section 12: Medicines should be public safe, effective and efficientSection 13: Prohibition of production, sale-distribution, export-importation, or consumption of drugs that do not have the prescribed levelSection 14: Returning medicines that are not safe, effective or efficient for the publicSection 15: Compensation to be paidSection 16: Document of assurance to be submitted to the departmentSection 17: Medicines can be divided into groupsSection 18: No improper use or abuse of medicineSection 19: No false or misleading advertising of medicines
Chapter - 6
Section 20: which the inspector may examine and inspectSection 20A: can be investigated and inspected by inspectors appointed by the state governmentSection 21: who can appeal on the order of the administratorSection 22: Procedures to be adopted during inspection or investigationSection 23: Qualifications for inspectors and analystsSection 24: Sending drug samples for testing
Chapter - 7
Section 25: The Government of Nepal may prohibit the production, sale, distribution, storage, transportation, export, import or consumption of drugsSection 26: TheSection 27: Arrangements related to giving prescriptionsSection 28: Production, sale-distribution, dispensing or storage of medicine should not be done without gathering the necessary manpower and equipmentSection 29: Adulteration of drugs and adulterated drugs not to be soldSection 30: Expired medicines should not be soldSection 31: License required for clinical trials:Section 32: Drug system and other things to be disclosedSection 33: to preserve applicable and poisonous drugsSection 34: Penalty PunishmentSection 35: Upper limit of fine and imprisonment for fineSection 36: The right to register a drug patentSection 37: Delegation of authoritySection 38: GovernmentalistSection 39: Case study and scopeSection 40: Power to make rules