صفحه 1:
صفحه 2:
Drugs and دك Act, 1940
Drugs and Cosmetics Rules 1945
صفحه 3:
1 Object
* To make available Standard Quality
drug/ cosmetic to consumer
صفحه 4:
1 Section 2
EEE
سا __
* Application of other Laws not
barred.
صفحه 5:
Aim & Object
* An Act to regulate
1 Import
2 Manufacture
3. Distribution and sale of Drugs [and
Cosmetic]
صفحه 6:
| Section of Act
* Section 1 - Short Title extent
* Notification by -
» Central Govt.
To give effect
> State Govt.
صفحه 7:
1 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 1*
schedule
صفحه 8:
1 Section 3(aa)
__ سا
* Ayurvedic Sidda & Unani D.T.A.B.
* Drug & Cosmetic, D.T.A.B.
* To advise Govt. for effective
implementation
صفحه 9:
‘Section 3(aaa) Cosmetic
EEE
سا __
* Article - rubbed poured sprinkled
sprayed introduce or applied to
human body
* For cleansing beautifying promoting
attractiveness or altering appearance
& include components of cosmetics
صفحه 10:
1 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.
صفحه 11:
section 310) Section 3(c)
__ سا
* Govt. Analyst - person appointed
» Ayurvedic - Section 33
» Drugs or Cosmetics - Section 20
صفحه 12:
| ۳ Section 3 (e)
2.
* Inspector - in relation to
» Ayurvedic - Section 33G
» Drug/Cosmetic - Section 21
صفحه 13:
Section 300 Section 3(f)
__ سا
* 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.
صفحه 14:
[=e Drugs Manufacturing
License
* Own License * Loan License 75
(Form) (Form)
= Drugs (25 & 28)
= Cosmetics (32)
= Homeopathic (25C)
" Ayurvedic (25D)
* Blood Bank (28C)
= Drugs (25A & 28A)
= Cosmetics (32A)
= Ayurvedic (25E)
صفحه 15:
Allopathic License (25, 28,
wu 28C)
* Condition of License
= Premises
= Technical Staff
= Plant & Machinery
= Documents
صفحه 16:
1 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.0.P. for each & every process of Drug
manufacturing & testing.
صفحه 17:
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
۰
صفحه 18:
"Rules 68 to Rules 106
* Regarding Control of manufacturing
of Drugs and also regarding
procedure of getting licenses and
Renewal of licenses.
صفحه 19:
Trading License
EEE
سا __
* 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.
صفحه 20:
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
صفحه 21:
1 Rules 59 to 67
__ سا
* Details condition and procedure for
getting Trading license