This document provides an overview of cosmetics regulations in India. It discusses the regulatory bodies that oversee cosmetics, including the Central Drugs Standard Control Organization and state licensing authorities. Import requirements for cosmetics are also summarized, such as the ports cosmetics can be imported through and standards they must meet. Labelling standards are outlined as well as what constitutes a misbranded or spurious cosmetic.

1. COSMETICS
REGULATORY
PRESENTED BY
ARUN PANDIYAN.E
1ST YR M.PHARMACY
DEPT. OF PHARMACEUTICS,
SRIHER (DU), PORUR.

2. CONTENTS
COSMETICS REGULATORY2 SRIHER
1. INTRODUCTION
2. REGULATORY BODIES FOR COSMETICS (INDIA)
3. REGULATORY PROVISIONS RELATED TO IMPORT OF COSMETICS
4. REGULATORY REQUIREMENT FOR LABELLING OF COSMETICS
5. MISBRANDED COSMETIC
6. SPURIOUS COSMETIC
7. REFERENCES

3. 1. INTRODUCTION
COSMETICS REGULATORY3 SRIHER
• DEFINITION (As per Indian Regulation ) :
According to Section 3(aaa) of Drugs and
Cosmetics Act, 1940 “Cosmetic” means “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.”

4. SRIHERCOSMETICS REGULATORY4
2.REGULATORY BODIES (COSMETICS) - INDIA
CDSCO (Central Drugs Standard Control Organization)
State Licensing Authorities The Drugs Controller General (India)
The manufacture of cosmetics is regulated
under a system of inspection and licensing by
the State Licensing Authorities appointed by the
respective State Governments.
Functions as the Licensing Authority who
grants the registration certificate and regulates
the import of cosmetics in India vide Gazette
notification G.S.R 426(E) under the provisions
of Drugs and Cosmetics Act, 1940.

5. 3.REGULATORY PROVISIONS RELATED TO IMPORT OF
COSMETICS
COSMETICS REGULATORY5 SRIHER
Chapter III of Drug and Cosmetic Act deals with import of Drug and Cosmetic. Now
import of certain cosmetic is prohibited under section 10 of the Act and rules 134A, 135, 135A
of Drug and Cosmetic Rules 1945 they are:
• Any cosmetic this is not of Standard Quality.
• Any cosmetic this is misbranded or spurious.
• A cosmetic containing ingredient which render it injurious or harmful or unsafe to use.
• A cosmetic whose import is prohibited by rule.
• Any cosmetic containing hexachlorophene.
• Any cosmetic in which lead or arsenic compound used for coloring purpose.
• Any cosmetic which contains mercury compounds.

6. Contd…
COSMETICS REGULATORY6 SRIHER
• The Government of India In Feb 2007, the Ministry of Health and Family Welfare has
bring amendment in Drug and Cosmetic Rule, 1945 according to which a cosmetic to
be imported into the India has to be get registered under Rule 129D by licensing
authority appointed by Central Government under Rule 21.
• Usually Drug controller General of India is the Licensing Authority. There should be a
single Application made for one or more cosmetic which are manufactured by same
manufacturer. And the registration Certificate which is provided is valid for 3 years if it
is not cancelled.
• The application for the registration should be made either by manufacturer or his agent
or importer in India.

7. Contd…
COSMETICS REGULATORY7 SRIHER
• Cosmetic can be imported in India only through following ports as per the
rule 43A.
1. Firozpur Cantonment and Amritsar Railway Stations.
2. Chennai, Kolkata, Mumbai, Cochin, Nhava Sheva and Kandla by Sea route.
3. Ahmedabad, Chennai, Delhi, Hyderabad, Kolkata, and Mumbai by Air.
4. Raxaul by Road/Railway lines connecting in India.

8. COSMETICS REGULATORY8 SRIHER
• Now there are 28 Cosmetic which are Placed under Schedule S to the rule which are
imported in India only after compliance with the Indian standards. They are:
1. Skin Powder.
2. Skin Powder for infants.
3. Tooth powders.
4. Toothpastes.
5. Skin Creams.
6. Hair oils.
7. Shampoos soap based.
8. Shampoos synthetic detergent based.
9. Hair creams.
10. Oxidation hair dyes, liquid.

9. Contd…
COSMETICS REGULATORY9 SRIHER
11. Cologne.
12. Nail Polish.
13. Aftershave Lotion.
14. Pomades and Brilliantine’s.
15. Depilatories.
16. Shaving Creams
17. Cosmetic Pencils.
18. Lipstick.
19. Toilet soap.
20. Liquid Toilet soap.
21. Baby Toilet soap.
22. Transparent toilet soap
23. Shaving soap.
24. Lipsalve.
25. Powder Hair dye.
26. Bindi.
27. Kumkum Powder.
28. Henna Powder.

10. Contd…
COSMETICS REGULATORY10 SRIHER
• As per Rule 129 of Drugs and Cosmetic Rules, 1945
No cosmetic shall be imported into India unless the product
is registered under the rules by the licensing authority appointed by the
Central Government under rule 21 or by any person to whom such powers
may be delegated under rule 22.
• An application for issue of a Registration Certificate for cosmetics
intended to be imported into India shall be made online in Form 42 on
SUGAM Portal of CDSCO by the manufacturer.

11. Guidance Document for Submission of application for grant of
Registration
Certificate in Form 43 to import cosmetics
COSMETICS REGULATORY11 SRIHER
1. Covering Letter
2. Power Of Attorney
3. Schedule D II
4. List of Ingredients
5. Labels of proposed product
6. Specification
7. Pack insert (If any)
8. Manufacturing License
9. Free Sale Certificate
10.Non Animal Testing Declaration
11.Declaration for Heavy Metal and Hexachlorophene content.

12. 1.Covering Letter
COSMETICS REGULATORY12 SRIHER
• Purpose (Fresh or Endorsement of Products/Pack Size/Additional
Sourcing Location or ReRegistration) should be clearly mentioned
along with the details of earlier issued Registration certificate (If any)
and product/ product category (whether already registered or not).
• Note: Mention the Section no. of checklist where the correlation
charts between Serial number of products in Form-42 with Free Sale
Certificate/ Power of Attorney is uploaded.

13. SRIHERCOSMETICS REGULATORY13
2. Power Of Attorney
• Executed & authenticated either in India before a First class Magistrate or in the country of
origin.
• Name and full address of the manufacturer & its manufacturing premises as per Form-42.
• Name and full address of the authorized Indian Agent as per Form-42.
• Name of the Cosmetic product.
• In case the Brand Owner is located in India and gets its products manufactured from sites
located outside India, a Letter of Authorization (LOA) of the Brand Owner and acceptance by
the overseas manufacturer is required. LOA should be executed & authenticated either in
India before a First class Magistrate or in the country of origin before such an equivalent
Authority or attested by the Indian Embassy of the said country or Apostilled from Hague
convention member countries.

14. SRIHERCOSMETICS REGULATORY14
3. Schedule D III
Duly filled and signed Schedule D III by manufacturer or authorized Indian
agent.
• It consists of :
1. Particulars of the manufacturer and manufacturing premises.
2. Particulars of the cosmetics to be registered under registration certificate.
3. Chemical information of cosmetics.
4. Declaration.

15. SRIHERCOSMETICS REGULATORY15
4.List of Ingredients
• Name of the cosmetic and name of Ingredients in the
nomenclature of standard reference along with
percentage contained in the cosmetic duly signed by
competent authorized person with stamp from the
manufacturer.

16. SRIHERCOSMETICS REGULATORY16
5.Labels of proposed products
As per Drugs and Cosmetics Rules, 1945 which includes following:-
• Name of Cosmetic
• Name and address of the manufacturer and name of the country where
the product has been manufactured. Direction for safe use/Caution.
• Batch no.
• Manufacturing License no.( If any)
• Registration Certificate Number and R.C holders name and address.
• Information (if any) as per Part XV of Drugs and Cosmetics Rules,
1945.

17. SRIHERCOSMETICS REGULATORY17
6. Specification :
• Specification and testing method for testing of cosmetics
7. Pack insert :
• If any
8. Manufacturing Licenses :
• Authenticated copy of manufacturing licenses/registration/marketing
authorization in respect of applied products issued by Regulatory
Authority from country of origin.

18. SRIHERCOSMETICS REGULATORY18
Contd…
9. Free Sale Certificate :
• Original Free Sale Certificate issued by National Regulatory Authority of Country of origin for
the applied products. Product list of free sale certificate should be signed and stamped by
issuing authority.
10.Non Animal Testing Declaration:
• Undertaking that the applied cosmetic products to be imported in to the country have not
been tested on animals (GSR No.718 (E) 13.10.2014).
11. Declaration for Heavy Metal and Hexachlorophene content :
• Test reports of Pb, As, Hg & other heavy metals, microbiological test reports &
Hexachlorophene content in product should be standard with D&G Act 1940.

19. SRIHERCOSMETICS REGULATORY19
4.REGULATORY REQUIREMENTS FOR LABELING OF
COSMETICS
Part15 – labelling
• LABELLING DECLARATION :
i) Name and address of the importer
ii) Generic or common name of the commodity packed
iii) Net quantity in terms of standard unit of weights and
measures
iv) Month and year of packing in which the commodity is
manufactured or packed or imported; and
v) Maximum retail sales price (MRP) at which the commodity in
packaged form may be sold to the end consumer.

20. SRIHERCOSMETICS REGULATORY20
Contd…
• On both the inner & outer labels :
a) Name of the cosmetic
b) Name of the manufacturer and Complete
address of the premises of the manufacturer
where the cosmetic has been manufactured.

21. SRIHERCOSMETICS REGULATORY21
On the outer label
• A declaration of the net contents expressed in terms of weight
for solids/ semi solids, fluid measure for liquids. (Note: In the
case of package of perfume, toilet water or the net content
which does not exceed 60 ml or any package of solid or semi
solid cosmetic where the net content doesn’t exceed 30 gms,
the statement of net content need not appear).
• The names of ingredients in the order of percentage of
content.

22. SRIHERCOSMETICS REGULATORY22
On the inner label
• Where a hazard exists, adequate directions for safe use,
warning, caution or special direction required to be observed
by the consumer, statement of the names and quantities of the
ingredients that are hazardous or poisonous.
• The names of ingredients in the order of percentage of content.
1.Batch number preceded by the letter “B”
2.Manufacturing license number preceded by the letter “M”.

23. SRIHERCOSMETICS REGULATORY23
5. Misbranded Cosmetic
• A cosmetic is deemed to be misbranded if:
1.If it contains a color which is not prescribed.
2.If it is not labeled in the prescribed manner.
3.If the label or container bears any statement which is false
or misleading in any particular.

24. SRIHERCOSMETICS REGULATORY24
6. Spurious cosmetic
A cosmetic is deemed to be spurious if:
• If it is imported under a name which belong to another cosmetic.
• if the label or containers bears the made of an individual or a
company purporting to be the manufacturer of the cosmetic
which individual or company is fictitious or does not exist.
• if it the product of a manufacturer of whom it is not truly a
product.

25. SRIHERCOSMETICS REGULATORY25
• Rule 134A also prescribes that no cosmetic shall be imported
which contains a coal tar color other than one prescribed in
schedule Q and Indian standards (IS: 4707 Part I) to the above
rules and coal tar color used in cosmetic should not contain
more than :
1. 2 ppm of arsenic as arsenic trioxide.
2. 20 ppm of Lead.
3. 100 ppm of heavy metals other than lead calculated as total of
the respective metals.

26. 7.REFERENCES
COSMETICS REGULATORY26 SRIHER
1.CENTRAL DRUGS STANDARD CONTROL ORGANIZATION (Cosmetics Division) - Guidance Document
2. THE DRUGS AND COSMETICS ACT, 1940.
3. https://cdsco.gov.in/opencms/opencms/en/Cosmetics/cosmetics/
4. https://testing-lab.com/2014/06/labeling-requirements-for-imported-cosmetic-goods-in-india/
5. REVIEW: REGULATORY PROVISIONS REGARDING COSMETICS IN INDIA - Abhijeet Welankiwar, Govt.
college of Pharmacy.

27. THANK YOU!
COSMETICS REGULATORY27 SRIHER