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. 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)

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