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CDSCO Checklist For Cosmetic Registration in India

This document provides a checklist for pre-screening applications for granting registration certificates for cosmetics in India. It lists 14 required administrative, legal, and technical documents including a covering letter, application form, fees payment details, power of attorney, product labels, ingredient lists, manufacturing licenses from the country of origin, chemical testing reports, and samples. Applicants must submit all required documents for review, and applications found to be incomplete will not be accepted.

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vinay1988
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625 views3 pages

CDSCO Checklist For Cosmetic Registration in India

This document provides a checklist for pre-screening applications for granting registration certificates for cosmetics in India. It lists 14 required administrative, legal, and technical documents including a covering letter, application form, fees payment details, power of attorney, product labels, ingredient lists, manufacturing licenses from the country of origin, chemical testing reports, and samples. Applicants must submit all required documents for review, and applications found to be incomplete will not be accepted.

Uploaded by

vinay1988
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Central Drugs Standard Control Organization

Directorate General of Health Services


Office of Drugs Controller General (India)
Cosmetic Division

Checklist for Pre Screening of Applications for Grant of Registration Certificate in Form 43 under the
provisions of Drugs and Cosmetics Rules.

Name of the Firm---------------------------------------------------Date:---------------------

S. No. Administrative/Legal/Technical Documents. Status

Please Pg. No. Annexure


Tick(√ )

1 Covering Letter-Purpose should be clearly mentioned with page


number and Index.
2 Application ( Form-42)
2.1 Duly filled, signed & stamped original application by the Indian
Agent/ importer/Manufacturer.
2.2 Name of the Cosmetic product, variants (if any) alongwith actual
manufacturer of the productto be registered. The categorization of
the product should be as per Column 3 of guidelines of cosmetics.

2.3 Name & full address of Authorized Agent/ importer in India.


2.4 Name & full address of Manufacturer & its Factory Premises.
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 Colum 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 Realisation Stamp,
Note:- The categories of applied products and manufacturer’s name
shall be mentioned in TR-6 Challan.
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) alongwith 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.
4.7 Time period for which POA is valid must be mentioned in power
of attorney.
5 Duly filled, signed and sealedSchedule 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 no
 Manufacturing License no.
 Registration Number and Importer name and address
 Other Information(if any)
7 List of Ingredients with details of concentration of each ingredient
used in the product composition duly signed by competent QC
person from the manufacturer.

8 Regulatory Certificates:-
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.
9 Chemical Information of cosmetics:-
9.1 Test protocol for testing of cosmetics
9.2 Specification
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.
12 One sample pack of product shall be submitted after its first
import.
13 List of countries where market authorisation or import permission
or registration was granted.
14 Other documents (if any)
Mailing Address of the applicant :
Stamp & Signature of the
Authorised Signatory of the applicant

Mobile No. :……..…………………………….

E-mail:…………………………………………

Office Use Only:


------------------------------------------------------------------------------------------------
Accepted for review/Not accepted due to incomplete information in respect of point no. (s)
………………………………………….mentioned above.

Signature: …………………………..

Name of the Reviewer:….……………………….

Date:…………….…………….

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