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
1. Import 2. Manufacture 3. Distribution and sale of Drugs [and Cosmetic]

Various Section of Act

Section 1 Short Title extent Notification by
Central Govt. To give effect State Govt.

Definitions Section 3
a) Ayurvedic Sidda or Unnani drugs all medicines for internal/ external use manufactured as per formula given in authoritive books listed in 1st schedule

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

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

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.

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

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

Section 3(f)
Manufacture include process/ or part of process
Making ornamenting, altering, finishing packing labelling breaking in view to salebut not include packing for Retail sale.

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)

Allopathic License (25, 28, 28C)

Condition of License
Premises Technical Staff Plant & Machinery Documents

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.

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

Rules 68 to Rules 106

Regarding Control of manufacturing of Drugs and also regarding procedure of getting licenses and Renewal of licenses.

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.

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

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