drugs and cosmetics act, 1940 & drugs and cosmetics rules 1945
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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
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