Drugs and Cosmetics Act, 1940 & Drugs and Cosmetics Rules 1945
اسلاید 1: www.tabaye.ir
اسلاید 2: Drugs and Cosmetics Act, 1940 & Drugs and Cosmetics Rules 1945
اسلاید 3: Object To make available Standard Quality drug/ cosmetic to consumer
اسلاید 4: Section 2 Application of other Laws not barred.
اسلاید 5: Aim & ObjectAn Act to regulate ImportManufacture Distribution and sale of Drugs [and Cosmetic]
اسلاید 6: Various Section of ActSection 1 – Short Title extent Notification by – Central Govt. To give effect State Govt.
اسلاید 7: Definitions -Section 3 – Ayurvedic Sidda or Unnani drugs all medicines – for internal/ external use manufactured as per formula given in authoritive books listed in 1st schedule
اسلاید 8: Section 3(aa) Ayurvedic Sidda & Unani D.T.A.B. Drug & Cosmetic, D.T.A.B. To advise Govt. for effective implementation
اسلاید 9: Section 3(aaa) CosmeticArticle – rubbed poured sprinkled sprayed introduce or applied to human body For cleansing beautifying promoting attractiveness or altering appearance & include components of cosmetics
اسلاید 10: Section 3(b) – Drug All medicine for internal & external use – in diagnosis treatment mitigation, prevention of disease or dis-order preparation applied on body include repelling insect like mosquitoes Such substances- notified by Central Govt. Component of Drugs & include empty gelatin capsuleDevices – for external & internal use – Notified by Central Govt.
اسلاید 11: Section 3(c)Govt. Analyst – person appointed Ayurvedic – Section 33 Drugs or Cosmetics – Section 20
اسلاید 12: Section 3 (e) Inspector - in relation to Ayurvedic – Section 33GDrug/Cosmetic – Section 21
اسلاید 13: Section 3(f) Manufacture – include process/ or part of process – Making ornamenting, altering, finishing packing labelling breaking – in view to sale- but not include packing for Retail sale.
اسلاید 14: Drugs Manufacturing License Own License (Form)Drugs (25 & 28)Cosmetics (32)Homeopathic (25C)Ayurvedic (25D)Blood Bank (28C)Loan License (Form) Drugs (25A & 28A)Cosmetics (32A)Ayurvedic (25E)
اسلاید 15: Allopathic License (25, 28, 28C)Condition of License Premises Technical Staff Plant & Machinery Documents
اسلاید 16: Schedule ‘M’Premises as per Schedule ‘M’ for allopathic drug manufacturer & also for Blood Bank & Blood productTechnical Staff Approved chemist for Drugs Manufacturing Approved chemist for Drugs Testing S.O.P. for each & every process of Drug manufacturing & testing.
اسلاید 17: Documents Approved plan of premises NOC of MIDC, Pollution Control Board, Local Self Govt. etc. Document of legal possession of premises (certificates)Qualification & experience of Technical person Constitution document of Company Appointment & Acceptance letter of Technical personAny other document called by Licensing Authority
اسلاید 18: Rules 68 to Rules 106Regarding Control of manufacturing of Drugs and also regarding procedure of getting licenses and Renewal of licenses.
اسلاید 19: Trading License Allopathic Retailer – Form 20, 21 & 20C (Homeopathic)Wholesaler – Form 20B, 21B & 20D (Homo.)Note – No trading license for sale of Ayurvedic Drugs as per Drugs & Cosmetics Act.No trading license required for sale of cosmetics.
اسلاید 20: Documents Requisite Drugs Trading License Premises/ ownership document of premises Pharmacist or Competent person. Partnership deed/Memorandum of Article etcPharmacist appointment & acceptance letterRefrigerator purchase receipt
اسلاید 21: Rules 59 to 67Details condition and procedure for getting Trading license
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