In this presentation I have mentioned whatever the possible relevant content required for the title. Citation Is done at the end of slide. Content is up to date & true to my belief. Thanks & Best Regards. Anurag Pandey B.Pharm (FACULTY OF PHARMACY, INVERTIS UNIVERSITY) M.Pharm (INSTITUTE OF PHARMACY, NIRMA UNIVERSITY) Email :- anurag.dmk05@gmail.com

1. COMPARISON of Cosmetics
REGULATION BETWEEN
USFDA VS CDSCO
PRESENTED BY :- ANURAG PANDEY
M.PHARM (PHARMACEUTICS)
COSMETICS
INSTITUTE OF PHARMACY, NIRMA
UNIVERSITY UNDER THE GUIDANCE OF:- DR. MOHIT SHA
ASST. PROFESSOR
INSTITUTE OF PHARMACY, NIRMA UNIVERSI

2. DEFINITION OF COSMETICS AS PER
CDSCO & USFDA
• India: As per Drugs and Cosmetics Act 1940 and Rules 1945,
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.
• United States: Defines cosmetics as “articles intended to be
rubbed, poured, sprinkled, or sprayed on, introduced into, or
otherwise applied to the human body or any part thereof for
cleansing, beautifying, promoting attractiveness, or altering the
appearance, and articles intended for use as a component of any
such articles; except that such term shall not include soap”.

3. DOSSIER SECTION FOR COSMETICS
LIFE CYCLE MANAGEMENT
PRODUCT
INFORMATION
FILE/ DOSSIER
SPECIFICATION
&
COA’s
LABELLING
&
PACKAGING
STABILITY
&
SHELF LIFE
SAFETY
PROTOCOL
& REPORT
SURVILLANCE
/MARKET
ANALYSIS
ADMINISTRATION
/NOTIFICATION

4. MAIN
FEATURES
USFDA CDSCO (INDIA)
{IN GENERAL}
Manufacturer has full responsibility for
safety of products
Required Required
In-market control by authorities Required Required
Freedom to use and distribution channel Required Required
{PRE-MARKET REQUIREMENTS}
Notification of products Voluntary Mandatory
Initial notification for producer premises. Voluntary Compulsory
COMPARISON OF KEY FEATURES
OF
COSMETIC REGULATION IN MAJOR MARKETS

5. MAIN
FEATURES
USFDA CDSCO (INDIA)
{CONTROL OVER INGREDIENT}
POSITIVE LIST;
Coloring agents, UV filter,
preservatives
Required Required
NEGATIVE LIST;
Prohibited & Restricted
substance
Required Required
Scientific
Advisory
committee’s
Voluntary committee if experts
organized by industry advices on safety
of ingredients
CDSCO, Drug
consultative
committee, Drug
technical advisory
board & bureau of
Indian standard
Notification of ingredients to
poison centers
Not Required Not Required
CONT….

6. MAIN
FEATURES
USFDA CDSCO (INDIA)
LABELING REQUIREMENTS
INCI labeling of ingredients Required Not Required
Quantity labeling Mandatory
(Metric & Non-metric labeling)
Not Required
Identity of producer/Importer on
label
Required Required
Expiry date Not mentioned Indicated as
“Use before date”
CONT….

7. MAIN
FEATURES
USFDA CDSCO (INDIA)
TESTING & SAFETY
Data on product
safety & efficacy
No equivalent PIF. If the manufacturer does
not have any data to prove safety of his
product, The compulsory warning, ‘The safety
of this product has not been determined’ must
appear on packaging
No equivalent product
information file.
Manufacturer must be able
to prove safety upon request
from authorities.
Testing requirements No specific test required
(As per Industry Guidelines)
No specific test required
Animal testing ban Animal testing allowed Animal testing allowed
GMP Voluntary
(As per Industry Guidelines)
Reference in
Drug & Cosmetics Act
Product Categories Drug, Cosmetics & OTC drug Drug, Cosmetics & OTC
drug
CONT….

8. SUMMARY OF BORDERLINE PRODUCTS
WITH SOME EXAMPLES
Product
Category
COUNTRY
USFDA CDSCO (INDIA)
Sunscreen &
Anti-Perspirant
OTC drug Cosmetics
Antidandruff Drug and cosmetics Cosmetics
Anti-bacterial
skin washes
Drug (If Antibacterial
claim are made)
OTC on Cosmetics
Anti-acne lotion OTC drug Cosmetics
Mouth wash Drug and cosmetics Cosmetics
Tooth pastes
(Fluoride)
Drug and cosmetics Cosmetics

9. SUMMARY OF COSMETICS REGULATIONS
CONTENTS USA INDIA
AUTHORITY FDA CDSCO
RULES AND
REGULATIONS
FOOD,DRUG AND
COSMETIC Act
DRUGS AND COSMETICS
Act
PRE-MARKET
APPROVAL
Not required Required under state government
licensing
LABELLING Should comply with the FD&C
and FP&L
Should comply with part XV of
D&C rules 1945
EXPIRY DATE No date required Indicated as “Use before date”
POST MARKETING
REPORTING SYSTEM
Yes. (Voluntary Cosmetic
Registration Program)
N/A

10. CONT…..
CONTENTS USA INDIA
Color additive safety
requirement
21 CFR 73, 74, 81, 82 Applicable
Labeling declarations FDA 21 CFR 701 & 740 BIS and PCRO
Safety warning On Principal Display Panel On inner label only
Label language English English
Safety Responsibility of manufacturer. Manufacturer must maintain records.
Nomenclature of colors Henna is listed in hair color only Henna is not listed in hair color only

11. REFERENCES
• REVIEW ARTICLE
• A comparative view on cosmetic regulations: USA, EU and INDIA
Srikanth.T1, Syed sajjad Hussen1, Anand Abha 1, Vasantharaju SG1 &
Sandeep Gummudavelly2
• Regulatory Requirements for Cosmetics in Relation with Regulatory
Authorities in India against US, Europe, Australia and Asean Countries
Rahul Kumar Raj *, Kaushal K Chandrul Department of Pharmacy, Shri Venkateshwara
University, Rajabpur, Gajraula, Amroha, Uttar Pradesh 244236, India.
• Cosmetics: Regulatory Scenario in USA, EU and India DHULL K1, SWAGAT
TRIPATHY2 AND HARISH DUREJA1* 1Department of Pharmaceutical Sciences,
Maharshi Dayanand University, Rohtak India, 2IPCA Laboratories Limited, Kandivli
(West) Mumbai, Maharashtra India.

12. THANK
YOU