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Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals 1
SVKM’s Institute of Pharmacy , Dhule
F.Y. Pharm. , Branch Pharmaceutics
Mr. Saurabhasing J. Rajput
PRN No: 2254482817012
Indian Regulatory Requirements For Cosmetics
Presented by :
Dr. Babasaheb Ambedkar Technological University
Lonere-402103 Tal. - Mangaon, Dist. - Raigad (M.S.) India
(MPH204T) COSMETICS & COSMECEUTICALS
Guided by :
Dr. Aarti Belgamwar
Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals 2
Points to be discussed :
 Definition of cosmetics
 Cosmetics regulation in INDIA & Chapters
 List of Categories of Cosmetics
 Types of License for cosmetics
 Regulatory requirements for mfg. of Cosmetics
 Regulatory requirements for Labelling of Cosmetics
 New Schedules & Forms
 Reference
Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals
Cosmetic Products (as per Indian regulation)
Cosmetic is defined under section 3(aaa) of the Drugs and
Cosmetics Act, 1940 as, any article intended to be rubbed, poured,
sprinkled or sprayed on, or introduced into, or otherwise applied
to, the human body or any part thereof for cleansing, beautifying,
promoting attractiveness or altering the appearance, and includes
any article intended for use as a component of cosmetic
3
Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals
Cosmetics Regulation In INDIA
• Cosmetic Legislation is driven in INDIA through Drugs and
Cosmetics Act 1940 & rules 1945, and the legislative body is
CDSCO headed by DCGI
• Import of cosmetics is regulated under a system of registration
by CDSCO who is the main authority to regulate activities
relating to cosmetics.
• Manufacturing of cosmetics in India is regulated under a
system of inspection and licensing by the State Drug Control
Department .
4
Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals
New Cosmetics Rule , 2020
 The Ministry of Health and Family Welfare notified the
Cosmetics Rules,2020, on December 15, 2020 :-
with an aim to separately codify and update the rules
relating to import, manufacture, labelling, sale and
distribution of cosmetics in India, which were earlier set
out under the Drugs and Cosmetics Rules, 1945
 Cosmetic Rules 2020 have been modified vide notification
No. G.S,R. 763 (E) Dated 15- 12-2020 and the same have
come into force from the date of its notification i.e. 15-12-
2020.
5
Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals
New Cosmetics Rule,2020 Chapters :
Chapter 1
• Preliminary
• Definitions & Explanation
Chapter 2
• Licensing Authorities & Officers
• Functions of Central Cosmetics Laboratory
Chapter 3
• Import of Cosmetics
• Import Registration Certificate
Chapter 4
• Manufacture of Cosmetics for sale or
Distribution
Chapter 5
• Permission for Import or Manufacture of New
Cosmetics
6
Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals
Chapter 6
• Labelling , Packaging & Standards
for sale or Distribution of Cosmetics
Chapter 7
• Procedure of Sampling for Test
• Analysis, Seizure & Report
Chapter 8
• Approval of Laboratory for carrying
out Tests on Cosmetics & their Raw
Materials
Chapter 9 • Miscellaneous
Continue...
7
Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals 8
List of Categories of Cosmetics for sale in Country:
(A) Powders
(B) Skin Powder for Infants
(C) Creams, lotions, emulsions, pastes, cleansing milks, shampoos, pomade,
brilliantine, shaving-creams and hair-oils, etc.
(D) Nail Polishes and Nail Lacquers.
(E) Lipsticks and Lip-gloss.
(F) Depilatories
(G) Preparations used for Eyes
1. Eyebrows, Eyelashes, Eyeliners.
2. Kajal and Surma.
(H) Aerosol
(I) Alcoholic Fragrance solutions
( J) Hair Dyes
(K) Tooth-powders and toothpastes, etc.
1. Tooth-powder in General.
2. Tooth pastes.
3. Tooth — Powder (Black).
(L) Toilet Soaps
Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals
Central Licensing
Authority
Import of cosmetics is
regulated under a system of
registrationby the CDSCO
State Licenscing
Authority
The State Government
appoints a Licensing
Authority State Drug Control
Department ,who inspect and
provide license for
manufacturing of the
products.
IMPORT LICENSE MANUFACTURING LICENSE
Types of Cosmetics License in INDIA :
9
Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals
As per D&C Act & Rules 1945 certain cosmetics are
prohibited to Import in India:
01
02
03
04
05
06
07
COSEMETICS
CONTAINING
MERCURY
COSMETICS
CONTAINING
LEAD
COSMETICS
CONTAINING
HEXACHLOROPHENE
.
COSMETICS CONTAINING
HARMFUL INGREDIENT
MISBRANDED COSMETICS
SPURIOUS & ADULTRATED
COSMETICS
NOT OF STANDARD QUALITY
10
Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals
Regulatory requirements to Import of Cosmetics
• The import of cosmetics is regulated
under a system of registration by
central licensing authority appointed
by central Government
• Require compulsory
registration certificate for
importing from DCGI (CDSCO)
• Cos 1 Application of a product to be
imported made through online
portal on SUGAM Portal by
Importer
11
Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals
Regulatory requirements for manufacturing of
Cosmetics :
Loan License :
A person(applicant) who does not have his own
arrangements(factory) for manufacture but who wish to avail the
manufacturing facilities owned by another licensee. Such licenses
are called Loan licenses.
Labelling Conditions For Loan License :
 Manufactured By
 Marketed By
12
Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals
Application for grant of loan license & Manufacturing
License to manufacture cosmetics for sale or for
distribution :
13
Any person who
intends to mfg.
cosmetics .
• For Distribution
• Loan license
Online
Application on
SUGAM Portal
• Form COS– 5&6
• Fee 3 rd. Schedule
• 45 Days
State Licensing
Authority
• Site inspection by
officer
• License granted in
form COS 8 & 9
who Issue
How
Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals
Conditions of license :
Manufacturing of Cosmetics :
Manufacture of cosmetics shall be conducted under the direction and personal supervision of at least one person who
is a whole-time employee and who possesses any one of the following qualifications.
(i) Holds a Diploma in Pharmacy approved by the Pharmacy Council of India under the
Pharmacy Act, 1948 (8 of 1948), or
(ii) Must beregistered under the Pharmacy Act, 1948 (8 of 1948), or
(iii) Has passed the Intermediate Examination with Chemistry as one of the subjects or an
examination recognized by the Licensing Authority as equivalent to it.
(iv) Holds a bachelor degree in Cosmetic Technology from recognized university.
Factory Premises :
comply with the requirements and conditions specified in the 7 th Schedule.
The manufacturer shall either :
(i) Provide and maintain adequate staff.
(ii) Laboratory equipment approved by the Central Licensing Authority
(i) Documents in respect of the ownership or occupation on rental or other basis of the
(ii) constitution of the firm.
The applicant shall maintain documentary evidence of :
14
Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals
Grant & Validity of license :
1) If the Licensing Authority, is satisfied then shall grant a license
in Form COS-8 or Form COS-9 .
2) If the Licensing Authority is not so satisfied, he shall reject the
application with Reason.
3) within a period of 6 months from the rejection of an application
for a license is granted if rejected requirements are fulfilled
4) A license or loan license issued in Form COS- 8 or Form COS- 9
shall remain valid from 5 years from the date of its issue, unless, it
is suspended or cancelled by the State Licensing Authority.
15
Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals
Requirements of plant and equipment :
Creams, lotions, emulsions, pastes, cleansing milks, shampoos, pomade,
brilliantine, shaving-creams and hair-oils, etc.-
 Equipment’s:
(a) Mixing and storage tanks of suitable materials.
(b) Heating kettle — steam, gas or electrically heated.
(c) Suitable agitator.
(d) Colloidal mill or homogenizer (wherever necessary).
(e) Triple roller mill (wherever necessary).
(f) Filling and sealing equipment.
(g) Weighing and measuring devices.
 An area of 25 square metres is recommended.
16
Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals
Regulatory Requirements for Labelling of
Cosmetics :
 Generic or common name of the commodity packed. (Brand Name)
 Name and address of the importer if imported .
 Net quantity in terms of standard unit of weights and measures. (gm/ml)
 Month and year of packing & Expiry Date
 Maximum retail sales price (MRP) in INR
 Adequate direction for safe use
 Full ingredients listing .
 Any warning, caution or special direction required to be observed by the consumer
 A statement of the names and quantities of the ingredients that are hazardous or poisonous
 Batch number starting with “ B ”
 Manufacturing license number starting with suffix “ M ”
 Import Registration No. (in case of Imports)
 QR Code & Bar Code .
 Name of the manufacturer with complete address of the premises of the manufacturing place
17
Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals
New Schedules Introduced in Cosmetics Rules 2020 :
18
Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals
New Schedules Introduced in Cosmetics Rules 2020 :
19
Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals
Forms comes under New Cosmetics Rules 2020 :
20
Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals
Forms comes under New Cosmetics Rules 2020 :
21
Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals
Forms comes under New Cosmetics Rules 2020 :
22
Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals
SUGAM Portal :
23
Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals
CDSCO Official Website :
24
Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals
References :
• https://cdsco.gov.in/opencms/opencms/en/Cosmetics/cosmetics/
• https://cdscoonline.gov.in/CDSCO/UserRegistration
• MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health
and Family Welfare) NOTIFICATION New Delhi, the 15th December,
2020 , Cosmetics Rules, 2020.
25
Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals 26

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Cosmetics regulations in India.pptx

  • 1. Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals 1 SVKM’s Institute of Pharmacy , Dhule F.Y. Pharm. , Branch Pharmaceutics Mr. Saurabhasing J. Rajput PRN No: 2254482817012 Indian Regulatory Requirements For Cosmetics Presented by : Dr. Babasaheb Ambedkar Technological University Lonere-402103 Tal. - Mangaon, Dist. - Raigad (M.S.) India (MPH204T) COSMETICS & COSMECEUTICALS Guided by : Dr. Aarti Belgamwar
  • 2. Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals 2 Points to be discussed :  Definition of cosmetics  Cosmetics regulation in INDIA & Chapters  List of Categories of Cosmetics  Types of License for cosmetics  Regulatory requirements for mfg. of Cosmetics  Regulatory requirements for Labelling of Cosmetics  New Schedules & Forms  Reference
  • 3. Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals Cosmetic Products (as per Indian regulation) Cosmetic is defined under section 3(aaa) of the Drugs and Cosmetics Act, 1940 as, any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to, the human body or any part thereof for cleansing, beautifying, promoting attractiveness or altering the appearance, and includes any article intended for use as a component of cosmetic 3
  • 4. Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals Cosmetics Regulation In INDIA • Cosmetic Legislation is driven in INDIA through Drugs and Cosmetics Act 1940 & rules 1945, and the legislative body is CDSCO headed by DCGI • Import of cosmetics is regulated under a system of registration by CDSCO who is the main authority to regulate activities relating to cosmetics. • Manufacturing of cosmetics in India is regulated under a system of inspection and licensing by the State Drug Control Department . 4
  • 5. Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals New Cosmetics Rule , 2020  The Ministry of Health and Family Welfare notified the Cosmetics Rules,2020, on December 15, 2020 :- with an aim to separately codify and update the rules relating to import, manufacture, labelling, sale and distribution of cosmetics in India, which were earlier set out under the Drugs and Cosmetics Rules, 1945  Cosmetic Rules 2020 have been modified vide notification No. G.S,R. 763 (E) Dated 15- 12-2020 and the same have come into force from the date of its notification i.e. 15-12- 2020. 5
  • 6. Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals New Cosmetics Rule,2020 Chapters : Chapter 1 • Preliminary • Definitions & Explanation Chapter 2 • Licensing Authorities & Officers • Functions of Central Cosmetics Laboratory Chapter 3 • Import of Cosmetics • Import Registration Certificate Chapter 4 • Manufacture of Cosmetics for sale or Distribution Chapter 5 • Permission for Import or Manufacture of New Cosmetics 6
  • 7. Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals Chapter 6 • Labelling , Packaging & Standards for sale or Distribution of Cosmetics Chapter 7 • Procedure of Sampling for Test • Analysis, Seizure & Report Chapter 8 • Approval of Laboratory for carrying out Tests on Cosmetics & their Raw Materials Chapter 9 • Miscellaneous Continue... 7
  • 8. Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals 8 List of Categories of Cosmetics for sale in Country: (A) Powders (B) Skin Powder for Infants (C) Creams, lotions, emulsions, pastes, cleansing milks, shampoos, pomade, brilliantine, shaving-creams and hair-oils, etc. (D) Nail Polishes and Nail Lacquers. (E) Lipsticks and Lip-gloss. (F) Depilatories (G) Preparations used for Eyes 1. Eyebrows, Eyelashes, Eyeliners. 2. Kajal and Surma. (H) Aerosol (I) Alcoholic Fragrance solutions ( J) Hair Dyes (K) Tooth-powders and toothpastes, etc. 1. Tooth-powder in General. 2. Tooth pastes. 3. Tooth — Powder (Black). (L) Toilet Soaps
  • 9. Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals Central Licensing Authority Import of cosmetics is regulated under a system of registrationby the CDSCO State Licenscing Authority The State Government appoints a Licensing Authority State Drug Control Department ,who inspect and provide license for manufacturing of the products. IMPORT LICENSE MANUFACTURING LICENSE Types of Cosmetics License in INDIA : 9
  • 10. Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals As per D&C Act & Rules 1945 certain cosmetics are prohibited to Import in India: 01 02 03 04 05 06 07 COSEMETICS CONTAINING MERCURY COSMETICS CONTAINING LEAD COSMETICS CONTAINING HEXACHLOROPHENE . COSMETICS CONTAINING HARMFUL INGREDIENT MISBRANDED COSMETICS SPURIOUS & ADULTRATED COSMETICS NOT OF STANDARD QUALITY 10
  • 11. Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals Regulatory requirements to Import of Cosmetics • The import of cosmetics is regulated under a system of registration by central licensing authority appointed by central Government • Require compulsory registration certificate for importing from DCGI (CDSCO) • Cos 1 Application of a product to be imported made through online portal on SUGAM Portal by Importer 11
  • 12. Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals Regulatory requirements for manufacturing of Cosmetics : Loan License : A person(applicant) who does not have his own arrangements(factory) for manufacture but who wish to avail the manufacturing facilities owned by another licensee. Such licenses are called Loan licenses. Labelling Conditions For Loan License :  Manufactured By  Marketed By 12
  • 13. Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals Application for grant of loan license & Manufacturing License to manufacture cosmetics for sale or for distribution : 13 Any person who intends to mfg. cosmetics . • For Distribution • Loan license Online Application on SUGAM Portal • Form COS– 5&6 • Fee 3 rd. Schedule • 45 Days State Licensing Authority • Site inspection by officer • License granted in form COS 8 & 9 who Issue How
  • 14. Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals Conditions of license : Manufacturing of Cosmetics : Manufacture of cosmetics shall be conducted under the direction and personal supervision of at least one person who is a whole-time employee and who possesses any one of the following qualifications. (i) Holds a Diploma in Pharmacy approved by the Pharmacy Council of India under the Pharmacy Act, 1948 (8 of 1948), or (ii) Must beregistered under the Pharmacy Act, 1948 (8 of 1948), or (iii) Has passed the Intermediate Examination with Chemistry as one of the subjects or an examination recognized by the Licensing Authority as equivalent to it. (iv) Holds a bachelor degree in Cosmetic Technology from recognized university. Factory Premises : comply with the requirements and conditions specified in the 7 th Schedule. The manufacturer shall either : (i) Provide and maintain adequate staff. (ii) Laboratory equipment approved by the Central Licensing Authority (i) Documents in respect of the ownership or occupation on rental or other basis of the (ii) constitution of the firm. The applicant shall maintain documentary evidence of : 14
  • 15. Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals Grant & Validity of license : 1) If the Licensing Authority, is satisfied then shall grant a license in Form COS-8 or Form COS-9 . 2) If the Licensing Authority is not so satisfied, he shall reject the application with Reason. 3) within a period of 6 months from the rejection of an application for a license is granted if rejected requirements are fulfilled 4) A license or loan license issued in Form COS- 8 or Form COS- 9 shall remain valid from 5 years from the date of its issue, unless, it is suspended or cancelled by the State Licensing Authority. 15
  • 16. Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals Requirements of plant and equipment : Creams, lotions, emulsions, pastes, cleansing milks, shampoos, pomade, brilliantine, shaving-creams and hair-oils, etc.-  Equipment’s: (a) Mixing and storage tanks of suitable materials. (b) Heating kettle — steam, gas or electrically heated. (c) Suitable agitator. (d) Colloidal mill or homogenizer (wherever necessary). (e) Triple roller mill (wherever necessary). (f) Filling and sealing equipment. (g) Weighing and measuring devices.  An area of 25 square metres is recommended. 16
  • 17. Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals Regulatory Requirements for Labelling of Cosmetics :  Generic or common name of the commodity packed. (Brand Name)  Name and address of the importer if imported .  Net quantity in terms of standard unit of weights and measures. (gm/ml)  Month and year of packing & Expiry Date  Maximum retail sales price (MRP) in INR  Adequate direction for safe use  Full ingredients listing .  Any warning, caution or special direction required to be observed by the consumer  A statement of the names and quantities of the ingredients that are hazardous or poisonous  Batch number starting with “ B ”  Manufacturing license number starting with suffix “ M ”  Import Registration No. (in case of Imports)  QR Code & Bar Code .  Name of the manufacturer with complete address of the premises of the manufacturing place 17
  • 18. Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals New Schedules Introduced in Cosmetics Rules 2020 : 18
  • 19. Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals New Schedules Introduced in Cosmetics Rules 2020 : 19
  • 20. Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals Forms comes under New Cosmetics Rules 2020 : 20
  • 21. Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals Forms comes under New Cosmetics Rules 2020 : 21
  • 22. Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals Forms comes under New Cosmetics Rules 2020 : 22
  • 23. Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals SUGAM Portal : 23
  • 24. Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals CDSCO Official Website : 24
  • 25. Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals References : • https://cdsco.gov.in/opencms/opencms/en/Cosmetics/cosmetics/ • https://cdscoonline.gov.in/CDSCO/UserRegistration • MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATION New Delhi, the 15th December, 2020 , Cosmetics Rules, 2020. 25
  • 26. Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals 26