Section 16
submission Of Letter Of Guarantee To Department
A drug manufacturer him/herself or his/her authorized agent or exporter or importer shall submit to the Department a certified copy of the document issued by the manufacturer guaranteeing that the drug registered pursuant to Section 8A is safe for public consumption, efficacious and of quality standard.
Drugs Act, 2035, (1978
Chapter - 4
Section 7: Recommendation Letter To Be Obtained To Establish Drug IndustrySection 8: Product License To Be ObtainedSection 8A: registration Of DrugSection 9: Recommendation Letter To Be Obtained For Exportation Or Importationof DrugSection 10: Registration Of Name For Sale And Distribution Of DrugSection 10A: Sale And Distribution Of Registered Drugs OnlySection 11: validity Period And Renewal Of Product License, Recommendation Letterand Certificate
Chapter - 5
Section 12: Drugs To Be Safe For Public Consumption, Efficacious And Of Quality StandardSection 13: Prohibition On Manufacture, Sale, Distribution, Export, Import, Storage Or Consumption Of Drug Not Conforming To Prescribed StandardSection 14: Return Of Drug Which Is Not Safe For Public Consumption, Efficacious And Of Quality StandardSection 15: Provision Of CompensationSection 16: submission Of Letter Of Guarantee To DepartmentSection 17: Categorization Of DrugsSection 18: Prohibition On Misuse Or Abuse Of DrugsSection 19: Prohibition On False Or Misleading Advertisement Of Drugs
Chapter - 7
Section 25: powers Of Government Of Nepal To Prohibit Manufacture, Sale,distribution, Storage, Transportation, Export, Import Or Consumption OfdrugsSection 26: Powers To Fix Price Of DrugSection 27: Provisions Relating To PrescriptionSection 28: Prohibition On Manufacture, Sale, Distribution, Dispensing Or Storagewithout Making Arrangement Of Required Human Resource♦ ♦ Orresource SSection 29: Prohibition On Adulteration In Drugs And Sale Of Adulterated DrugsSection 30: Prohibition On Sale Or Distribution Of Date Expired DrugsSection 31: License To Be Obtained From Department For Clinical Trial Of New DrugSection 32: Disclosure Of System Of Drug And Other Particulars While Manufacturing DrugSection 33: Narcotic And Poisonous Drug To Be Kept SafelySection 34: PenaltiesSection 35: Ceiling Of Fine And Imprisonment In Lieu Of FineSection 36: Right To Register Patent Of DrugSection 37: Delegation Of AuthoritySection 38: Government To Be The PlaintiffSection 39: Investigation And Filing Of CaseSection 40: Power To Frame Rules