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Published bySilvester Scott Modified over 9 years ago
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Drugs and Cosmetics Act, 1940 & Drugs and Cosmetics Rules 1945
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Object To make available Standard Quality drug/ cosmetic to consumer
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Section 2 Application of other Laws not barred.
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Aim & Object An Act to regulate Import Manufacture
Distribution and sale of Drugs [and Cosmetic]
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Various Section of Act Section 1 – Short Title extent
Notification by – Central Govt. To give effect State Govt.
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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
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Section 3(aa) Ayurvedic Sidda & Unani D.T.A.B.
Drug & Cosmetic, D.T.A.B. To advise Govt. for effective implementation
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Section 3(aaa) Cosmetic
Article – rubbed poured sprinkled sprayed introduce or applied to human body For cleansing beautifying promoting attractiveness or altering appearance & include components of cosmetics
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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 capsule Devices – for external & internal use – Notified by Central Govt.
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Section 3(c) Govt. Analyst – person appointed Ayurvedic – Section 33
Drugs or Cosmetics – Section 20
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Section 3 (e) Inspector - in relation to Ayurvedic – Section 33G
Drug/Cosmetic – Section 21
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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.
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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)
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Allopathic License (25, 28, 28C)
Condition of License Premises Technical Staff Plant & Machinery Documents
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Schedule ‘M’ Premises as per Schedule ‘M’ for allopathic drug manufacturer & also for Blood Bank & Blood product Technical Staff Approved chemist for Drugs Manufacturing Approved chemist for Drugs Testing S.O.P. for each & every process of Drug manufacturing & testing.
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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 person Any other document called by Licensing Authority
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Rules 68 to Rules 106 Regarding Control of manufacturing of Drugs and also regarding procedure of getting licenses and Renewal of licenses.
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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.
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Documents Requisite Drugs Trading License
Premises/ ownership document of premises Pharmacist or Competent person. Partnership deed/Memorandum of Article etc Pharmacist appointment & acceptance letter Refrigerator purchase receipt
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Rules 59 to 67 Details condition and procedure for getting Trading license
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