COSMETIC REGULATION -
INDIA
- Dr. Ashwini Kumar
CEO
CliniExperts Services (P) Ltd.
akumar@cliniexperts.com

Cosmetic- Definition
 Drugs & Cosmetic Act, 1940 defines “cosmetic” 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”

History of Indian Drug & Cosmetic
Legislation
 The Drug and Cosmetic Act 1940 and Rules 1945 were passed by the India’s
parliament to regulate the import, manufacture, distribution and sale of drugs and
cosmetics.
 In India the cosmetics are regulated by the Central Drugs Standard Control
Organization (CDSCO)
 The Drug Controller General (India) (DCGI) was established
 DCGI is the head of Central Drug Standard Control Organization, who regulates
Cosmetics, Devices & Drugs in India

Evolution of Indian Drug & Cosmetic
Legislation

Evolution of Indian Drug & Cosmetic
Legislation
May 19, 2010
First Notification for IMPORT
AND REGISTRATION OF
COSMETICS
March 30, 2011
Extension for
implementation till Oct. 1,
2011
April 1, 2013
Implementation of IMPORT
AND REGISTRATION OF
COSMETICS

Evolution of Indian Drug & Cosmetic
Legislation
 Notification, dated May 19, 2010 by Department of Health under Ministry of Health
and Family Welfare, in exercise of the powers conferred by sections 12 and 33 of
the said Act, the Central Government made the following rules further to amend
the Drugs and Cosmetics Rules, 1945
1 (a) Rules may be called the Drugs and Cosmetics (Amendment) Rules, 2010
1 (b) They shall come into force with effect from 1st day of April 2011
2. In the Drugs and Cosmetics Rules, 1945, (hereinafter referred to as the said rules),
in Part XIII, for the heading "IMPORT OF COSMETICS", the heading "IMPORT AND
REGISTRATION OF COSMETICS" shall be substituted

Evolution of Indian Drug & Cosmetic
Legislation
3. In the said rules, for rule 129, the following rules shall be substituted, namely:-
 129- Registration of cosmetic products imported into the country
 129A- Form and manner of application for Registration Certificate
 129 B- Registration Certificate for the import of cosmetics manufactured by
one manufacturer
 129 C- Grant of Registration Certificate
 129D- Duration of Registration Certificate- shall be valid for a period of three
years from the date of its issue

Evolution of Indian Drug & Cosmetic
Legislation
 129E- Suspension and cancellation of Registration Certificate
 129F- Prohibition of import of certain cosmetic
 129G- Standard for imported cosmetics
 129H- Labeling and Packing of Cosmetics

Implementation of Registration
 Prior to March 31, 2013- No registration of the cosmetic product was required to
import them in India
 Registration became mandatory from April 1, 2013 for all the cosmetics imported in
the country
 As defined under Rule 21 of Drugs & Cosmetics Rules, 1945, after amendment, all
cosmetic products that are imported for sale in India need to be registered with the
licensing authority

Organogram- Cosmetic Division
Ministry of Health and Family Welfare
CDSCO
Drug Controller General India [DCGI]
Joint Drugs Controller (India)
Deputy Drugs Controller (India)
Cosmetic Division
Drugs Inspectors/ Technical Inspectors
Technical Data
Associates
Assistant Drugs
InspectorsAssistant Drugs Controller (India)

Who can apply for Registration of Import of
Cosmetics?
1. The Manufacturer himself having registered office in India
2. The Authorized Agent of the Manufacturer
3. The Subsidiary of the Manufacturer
4. Any other importer

Guidelines on Registration of Import of
Cosmetics

Definitions
 “a Manufacturer is the ‘Brand/trade name owner’’ and not the ‘actual manufacturer
 A ‘Brand’ is a category/class of products as opposed to being just the trade name /brand. For
example, the ‘Brand’ will include all brands of lipsticks imported by the applicant and not just a
particular ‘brand name’ of Lipstick. For example, shampoo and conditioner belong to different
classes even though these may have a common ‘brand name’. A single application may be made
for registration of more than one brand of cosmetics (including its different variants and pack sizes)
by the same manufacturer
 An "Authorized Agent” means a person or entity in India authorized by the manufacturer. The
authorized agent will be responsible for the business activities of the manufacturer in India
including compliance to the provisions of the Act in all respects
 “Subsidiary" means an entity in India owned by the manufacturer
 "Any other importer" means any person or entity purporting to import cosmetic products other
than the manufacturer, its authorized agent and its subsidiary

Registration Guidelines
 As defined under Rule 21 of Drugs & Cosmetics Rules, 1945, all cosmetic products
imported for sale in India need to be registered with licensing authority
 Application for registration (Form-42) with required documents, are submitted to Drugs
Controller General (I), CDSCO, FDA Bhavan, Kotla Road, New Delhi
 This application will be accompanied by the fee specified along with information and
undertaking in Schedule D-III
 Single application in Form 42 for any number of brands manufactured at one or more
locations by a single manufacturer (legal)
 Single registration certificate in Form 43 issued to a particular applicant in respect of
import of any number of brands manufactured at one or more locations by a single
manufacturer

Application Fundamentals
• Nth products (or brand) per cosmetic category as per column 3 of
Annexure in guidelines
• Same legal manufacturer, same or different manufacturing facilities
• USD 250 fees
One
Application
• Two different categories of two products (or brands) as per column 3 of
Annexure in guidelines
• Two legal manufacturers, different manufacturing facilities
• USD 250 + USD 250 fees
Two
Applications
• Addition of product (or brand) in same category as per column 3 of
Annexure in guidelines
• Called Additional Product Permission
• No fees
Different
Application
Brand owner to file applications

Registration Guidelines: Power of Attorney
 Authorization by a manufacturer to his authorized agent in India will be
documented by a Power of Attorney
 The power of attorney shall be-
(a) executed and authenticated either in India before First Class Magistrate, or in the
country of origin of the manufacturer before such an equivalent authority OR
(b) attested by the Indian Embassy of the said Country OR
(c) Apostille from Hague convention member countries is also acceptable
 Original of the same to be furnished with application (Form 42)

Registration Guidelines: Power of Attorney
 Points to keep in mind while submitting the Power of Attorney:
- It should be co-jointly signed and stamped by the manufacturer as well as the
Authorized agent indicating the name & designation of the authorized signatories
- It should clearly list the names of all cosmetic products along with their trade names,
Brand as per Column 2 of the Annexure and variants (e.g. colour, shades, pack sizes,
etc). Further, the name of the cosmetics should correlate with those mentioned in the
Form 42
- The names and addresses of the manufacturer as well as the Authorized agent
stated in the Power of Attorney should correlate with the Form 42
- It should be valid for the period of said Registration Certificate (3 years)

Registration Guidelines: Case of Variation
After grant of Registration Certificate
Any change in product specification, ingredients, variant, etc.
Applicant to inform about these changes to the Licensing Authority
Submit revised Schedule D III
At least 30 days before the date of import

Registration Guidelines: Label
Imported Cosmetics Label- to bear RC number of brand and name and address of
the RC holder
Sticker of label with RC No. of brand and name and address of the RC holder, can be removed
after import, at a suitable declared place on an application made to the Licensing Authority and
that is approved by them
Label should also bear name and address of the manufacturer, name of the country
where product was manufactured
If product was not manufactured in a factory owned by the manufacturer, name and address of
actual manufacturer or name of country where it has actually been manufactured as “Made in
(country name)" should be there on label

Registration Guidelines: General
Applicant to provide
the English version
of any document
which is in any other
foreign language
from qualified
translator In case where there is
no provision for license
to manufacture
cosmetics in the country
of origin, the importer to
provide a declaration on
affidavit to that effect

Registration Guidelines: Registration Not
Required
Cosmetic products
imported to India as
bulk for repackaging
for 100% export to
other countries will not
require registration
certificate
For Import of cosmetics for
R&D purposes like packaging
trials, consumer studies, shelf
life studies and transport
studies, registration
certificate is not required
In such cases, importer has to obtain permission from Port in the form of
written undertaking that these products are not released for domestic sale

Registration: Time Line & Validity
•Approx. 3
Months
Time
Line
•3 yearsValidity

Prescreening Checklist

Contents
1. Covering Letter
2. Application ( Form-42)
3. Fee: TR-6 Challan (in Original)
4. Power Of Attorney (in Original)
5. Schedule D III
6. Labels
7. List of Ingredients/ Composition
8. Regulatory Certificates
9. Chemical Information of cosmetics
10.Pack insert
11.Soft Copies
12.Sample pack of product
13.List of countries granted market
authorization/ import permission
14.Undertaking

Prescreening Checklist: Cover Letter
 For Pre Screening of Applications for Grant of Registration Certificate in Form 43
under the provisions of Drugs and Cosmetics Rules
 Contains 14 headers
1. Covering Letter
Purpose should be clearly mentioned with page number and Index

Prescreening Checklist: Form 42
2.Application
(Form-42)
2.1 Duly filled, signed & stamped original application by the
Indian Agent/ importer
2.2 Name of the Cosmetic product, variants (if any) along with
actual manufacturer of the product to be registered. The
categorization of the product should be as per Column 3 in
Annexure of Guidelines on Registration
2.3 Name & full address of Authorized Agent/ importer in India
2.4 Name & full address of Manufacturer & its Factory Premises

Prescreening Checklist: TR-6 Challan
3. Fee: TR-6
Challan (in
Original)
3.1 Fees paid (250 USD equivalent Indian rupees for each Brand
proposed viz. each category of cosmetics as mentioned in Column 3 of
the guidelines of cosmetics
3.2 Head of Account “0210-Medical and Public Health, 04-Public Health,
104-Fees and Fines) adjustable to PAO, DGHS, New Delhi
3.3 Total categories of cosmetics … TR6 No ... USD … INR …
3.4 TR6 Challan Number, date of challan and Realization Stamp
Note:- The categories of applied products and
manufacturer’s name shall be mentioned in TR-6 Challan

Prescreening Checklist: Power of Attorney
4. Power Of Attorney (in Original)
• 4.1 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 as per proforma attached
• 4.2 Name and full address of the manufacturer & its manufacturing site as per Form-42
• 4.3 Name and full address of the Indian Agent
• 4.4 Name of the Cosmetic product, variants (if any) along with actual manufacturer of the product to be
registered. The categorization of the product should be as per Column 3 of guidelines of cosmetics
• 4.5 Duly conjointly signed, stamped, and dated with name & designation of the signatory by both Indian
agent & the manufacturer
• Note:-All the pages of power of attorney including product list duly apostilled/notarized and
authenticated from the country of origin or It should be tamper proof seal
• 4.6 Time period for which POA is valid must be mentioned in power of attorney

Prescreening Checklist: Schedule D III &
Label
5. Duly filled, signed and sealed Schedule D III by manufacturer or Indian agent along with undertaking
6. Labels of proposed products:
6.1 Legible label of the products circulated in the country of origin
6.2 Legible Original label for proposed products along with their variants (if any) as per Drugs and Cosmetics Rules, 1945 which includes
following:-
 Name of Cosmetics
 Name of Manufacturer and Complete address of premises where the cosmetic is manufactured.
 Use Before
 Direction for safe use/Caution
 Batch number
 Manufacturing License number
 Registration Number and Importer name and address
 Other Information (if any)
 List of ingredients

Prescreening Checklist: Ingredient List &
Regulatory Certificates
• With details of concentration of each ingredient used in the product
composition duly signed by competent QC person from the
manufacturer
7. List of Ingredients
• 8.1 Authenticated copy of manufacturing
licenses/registration/marketing authorization in respect of applied
products issued by regulatory Authority from country of origin
• 8.2 Original Free Sale Certificate issued by National Regulatory
Authority of Country of origin for the applied products
• 8.3 In case if it is not issued by National Regulatory Authority from
the country of origin then from other competent Associations/
organizations duly authenticated from the Indian embassy of
country of origin need to be submitted
8. Regulatory
Certificates

Prescreening Checklist: Chemical Info,
Pack Insert, Soft Copies
9. Chemical Information of cosmetics
• 9.1 Test protocol for testing of cosmetics
• 9.2 Specification (BIS 14648:2011)
• 9.3 Test report including result of Pb, As, Hg and microbiological test. (Wherever applicable)
• Note:-Testing protocol, Specification and Test Report duly signed by competent QC
person from the manufacturer
10. Pack insert, (if any)
11. Soft copies of the information (MS Word & MS Excel) about product
name along with category, pack size and actual manufacturing site

Prescreening Checklist: Sample Pack, List
of countries, Undertaking
12. One sample pack of product shall be
submitted after its first import
• 13. List of countries where market authorization or
import permission or registration was granted
14. Other documents (if any) – Undertaking
that the product is not tested on animals

Queries ?