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 33GDrug/Cosmetic – Section 21

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.

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