a brief introduction to various section of drug and cosmetics act 1940 and rules 1945

1. Drugs and Cosmetics Act, 1940
&
Drugs and Cosmetics Rules
1945
“A brief introduction to
different sections”
BINDU KSHTRIYA

2. Object
To make available Standard Quality drug/
cosmetic to consumer
Regulation of import
Regulation of manufacturing, distribution, and sale
of drugs and cosmetics.

3. Definitions -
Section 3 –
a) Ayurvedic Siddha or Unani drugs
all medicines – for internal/ external use
manufactured as per formula given in
authoritative books listed in 1st schedule

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

5. 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

6. 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.

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

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

9. 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.

10. Drugs Manufacturing
License
Own License (Form)
Drugs (25 & 28)
Cosmetics (32)
Homeopathic (25C)
Ayurvedic (25D)
Blood Bank (28C)

11. • Loan License (Form)
Drugs (25A & 28A)
Cosmetics (32A)
Ayurvedic (25E)

12. Allopathic License (25, 28,
28C)
Condition of License
Premises
Technical Staff
Plant & Machinery
Documents

13. 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.

14. 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

15. Rules 68 to Rules 106
Regarding Control of manufacturing of Drugs and
also regarding procedure of getting licenses and
Renewal of licenses.

16. 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.

17. 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

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

19. –BINDU KSHTRIYA
“Thank you”