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Drugs and Cosmetics Act, 1940 & Drugs and Cosmetics Rules 1945

Drugs and Cosmetics Act, 1940 & Drugs and Cosmetics Rules 1945. Object . To make available Standard Quality drug/ cosmetic to consumer . Section 2. Application of other Laws not barred. . Aim & Object. An Act to regulate Import Manufacture Distribution and sale of Drugs [and Cosmetic].

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Drugs and Cosmetics Act, 1940 & Drugs and Cosmetics Rules 1945

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  1. Drugs and Cosmetics Act, 1940 & Drugs and Cosmetics Rules 1945

  2. Object • To make available Standard Quality drug/ cosmetic to consumer

  3. Section 2 • Application of other Laws not barred.

  4. Aim & Object • An Act to regulate • Import • Manufacture • Distribution and sale of Drugs [and Cosmetic]

  5. Various Section of Act • Section 1 – Short Title extent • Notification by – • Central Govt. To give effect • State Govt.

  6. 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

  7. Section 3(aa) • Ayurvedic Sidda & Unani D.T.A.B. • Drug & Cosmetic, D.T.A.B. • To advise Govt. for effective implementation

  8. 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

  9. 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.

  10. Section 3(c) • Govt. Analyst – person appointed • Ayurvedic – Section 33 • Drugs or Cosmetics – Section 20

  11. Section 3 (e) • Inspector - in relation to • Ayurvedic – Section 33G • Drug/Cosmetic – Section 21

  12. 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.

  13. 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) Drugs Manufacturing License

  14. Allopathic License (25, 28, 28C) • Condition of License • Premises • Technical Staff • Plant & Machinery • Documents

  15. 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.

  16. 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

  17. Rules 68 to Rules 106 • Regarding Control of manufacturing of Drugs and also regarding procedure of getting licenses and Renewal of licenses.

  18. 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.

  19. 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

  20. Rules 59 to 67 • Details condition and procedure for getting Trading license

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