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CDSCO Cosmetic Import Registration in India

CDSCO_Cosmetic_Import_Registration_in_India_-_Corpseed.png

Introduction: CDSCO Cosmetic Import

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.

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.

Any article falling within the definition of cosmetic (Section 3aaa of D&C Act, 1940) is required to be registered along with pack size and manufacturing premises before import into the country.

An application for issue of a Registration Certificate for cosmetics intended to be imported into India shall be made online in COS I Form on SUGAM Portal of CDSCO either by the manufacturer himself or by his authorized Consultants or importer in India or by the subsidiary in India authorized by the manufacturer to the Licensing Authority under the Act i.e. Drugs Controller General (I), CDSCO (HQ).

Role of CDSCO Cosmetic

  • Amendment of the Cosmetic Rules, 2020 with respect to registration and import of Cosmetic products.
  • Examining applications for registration of cosmetic items for import into the nation in accordance with the requirements of the Drugs and Cosmetics Act 1940 and its Rules. 
  • Scrutiny of various applications for NOC /Clarification relating to the import of cosmetic products.
  • Preparation of draft replies to RTI, court cases, VIP references and Parliament Question related to cosmetics.
  • Replying to Government correspondences/ BIS as and when required.
  • Handling of PMOPGs/public inquiries/hearings related to the cosmetic import registration process and providing guidance thereto.
  • Handling of public/NGOs/Consumer forums complaints/grievances regarding standards of cosmetic products

Scope of Applicant for CDSCO Cosmetic Import

As per the Drug and Cosmetic act, 1945, the Central Drugs Standard Control Organization (CDSCO) has listed the applicants who are eligible to apply for CDSCO Cosmetic import license in India.

  • Manufacturer: The manufacturer himself can apply for the grant of CDSCO cosmetic import license.
  • Authorized Consultant: In case the manufacturer has authorized an importing Consultanton his behalf to import cosmetics. In the said scenario, the authorized importer needs to apply for the license.
  • Subsidiary of manufacturer: For any foreign manufacturer of cosmetic. The Indian subsidiary firm can apply on behalf of the manufacturer for the import of cosmetic license with CDSCO.
  • Any other Importer: Any Indian importer willing to import cosmetic to India from foreign manufacturer can apply for the CDSCO Cosmetic import license.

Documents Required For CDSCO Cosmetic Import

Guidance Documents for Submission of Application for Grant of Registration Certificate in Cos I form to Import Cosmetics

Documents Required For CDSCO Cosmetic Import - Corpseed

  • Covering Letter: Corpseed will provide the necessary filled format after details are received from the client.
  • Power of Attorney: 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. Power of Attorney including product list duly apostilled and authenticated from the country of origin. All the pages of Power of Attorney including product list should be signed by both authorized Indian Consultants and the manufacturer before authentication. (Customer will provide)
  • Second Schedule Part I: Corpseed will provide the necessary filled format after details are received from the client.
  • List of Ingredients: Corpseed will provide the necessary filled format after details are received from the client.
  • Labels of proposed products: Corpseed will provide sample label and labeling instructions as per the CDSCO guidelines.
  • Specifications and testing methods: The specific document is required from the manufacturer end. Test Protocol for testing of cosmetics and specification as per the standards specified in the Cosmetics Rules, 2020 for the applied product.
  • Pack insert, if any
  • Manufacturing Licenses: Authenticated copy of manufacturing licenses/registration/marketing authorization in respect of applied products issued by Regulatory Authority from country of origin. or undertaking.
  • Free Sale Certificate: Original Free Sale Certificate issued by National Regulatory Authority of Country of origin for the applied products or from the Indian Embassy of the country of origin. Product list of free sale certificate should be signed and stamped by issuing authority. Free sale certificate should contain the statement that in which country the applied products are freely sold.
  • Non-Animal Testing Declaration: The Manufacturer either legal or actual /brand owner of the products/ Indian subsidiaries can submit a one-time self-declaration that the applied products have not been tested on animals on and after 12.11.2014 along with import registration dossiers to CDSCO. The acknowledgement copies for submission of this undertaking as received by the applicants from CDSCO can be produced at port offices in future for clearing their future consignments. The necessary draft template will be provided by Corpseed.
  • Declaration for Heavy Metal and Hexachlorophene content:  Corpseed will provide the necessary filled format after details are received from the client.
  • Other documents (If any).
  • Application (Cos I Form): The application COS I Form is generated post submission of application online
  • Fee: TR-6 Challan (In Original) 

**If the documents are not in English language, English version of the documents will be provided by the customer, translated from qualified translator.

Procedure for CDSCO Cosmetic Import Registration

Determine the cosmetic category as per cosmetic rules 2020.

The CDSCO authority has provided a list of 88 cosmetic categories that need to compulsorily obtain registration under the Drugs and Cosmetics Act 2020. The applicant firm needs to identify the cosmetic category under which its final product and its variants falls. Once the category is finalized the, the applicant further needs to identify all the variants as well.

The identification of categories and variants is necessary as the same will define the fees structure of the application.

SNO

Category Name

SNO

Category Name

SNO

Category Name

1

Body hair removal products

31

Other oral hygiene products

60

Soap products

2

Bleach for body hair products

32

Other shaving and pre- / after- shaving products

61

styling Permanent wave products

3

Correction of body odour and/or perspiration

33

Other skin care products

62

Tooth cleansing powder / salt

4

Shaving and pre- / after- shaving products

34

Other skin cleansing products

63

Tooth whiteners

5

Make-up products

35

Other skin products

64

Toothpaste

6

Perfumes

36

Other sun and self-tanning products

65

Lipstick sealer

7

Sun and self-tanning products

37

Other tooth care products

66

Make-up remover products

8

Other skin products

38

Oxidative hair colour products

67

Mascara

9

Hair and scalp care and cleansing products

39

Bleach for body hair

68

Mechanical exfoliation products

10

Hair coloring products

40

Body care products

69

Mouth wash

11

Hair styling products

41

Body or face paint , including carnival make-up

70

Nail bleach

12

Other hair and scalp products

42

Breath spray

71

Nail care products

13

Nail varnish and remover products

43

Chemical depilatories

72

Nail glue remover

14

Nail care / nail hardener products

44

Chemical exfoliation products

73

Nail hardener

15

Nail glue remover products

45

Concealer

74

Nail sculpting products

16

Other nail and cuticle products

46

Cuticle remover / softener

75

Nail varnish / Nail make-up

17

Tooth care products

47

External intimate care products

76

Nail varnish remover

18

Mouth wash / breath spray

48

External Intimate hygiene products

77

Nail varnish thinner

19

Other face make-up products

49

Eye contour products

78

Non hydro alcoholic perfumes

20

Other hair and scalp care and cleansing products

50

Eye liner

79

Non-oxidative hair colour products

21

Other hair and scalp products

51

Eye pencil

80

Other body hair removal products

22

Other hair coloring products

52

Eye shadow

81

Other eye make-up products

23

Other hair styling products

53

Face care products other than face mask

82

Physical epilation products

24

Other lip make-up products

54

Face mask

83

Pre- / after-shaving products

25

Other make-up products

55

Foot care product

84

Products for temporary hair

26

Other mouth wash / breath spray products

56

Foundation

85

Products with antiperspirant activity

27

Other nail and cuticle products

57

Bleach for body hair

86

Products without antiperspirant activity

28

Other nail care / nail hardener products

58

Self-tanning products

87

Scalp and hair roots care products

29

Other nail varnish and remover products

59

Shaving products

88

Lip stick

30

Other face make-up products

60

Skin lightening products

 

 

 

Appoint an Authorized representative (in case of Foreign Entity)

For a foreign business manufacturer entity, it shall be necessary to appoint an authorized business entity in India, who shall be the contact person for the inspection authorities during the process, assist in cosmetic approvals, and registrations process, and vigilance adverse event reporting.

Fill out the application form for Cosmetic Import Registration

In the next step, the manufacturer/importer for cosmetic shall be required to submit the registration form of a regulatory dossier, along with all the prescribed documents along with the prescribed fee on the CDSCO portal to the DGCI (Drugs Controller General of India) by logging on to the online CDSCO   portal and signing into the portal.

Obtain Certificate of Registration in Prescribed form 

Once the application is submitted on the CDSCO portal, the DGCI registration authority may send a query through an inquiry letter to the manufacturer or from the authorized representative of the importer, along with the timeline within which the query should be answered and sometimes, may also ask for a technical presentation On satisfaction the authority may issue a license in such form as provided in the above list. 

Applicable Fees of CDSCO Cosmetic Import

SNO

Subject

Applicable Fees

1

Fee for the grant or retention of registration certificate for each category of cosmetic

$1000

2

Fee for the grant or retention of registration certificate for each category of cosmetic

$1000

3

Fee for each variant of cosmetic for the grant or retention of registration certificate

$50

4

Fee for each manufacturing site for the grant or retention of registration certificate

$500

5

Fee for grant of permission for new cosmetics

$500

6

Fee for issue of duplicate copy of the registration certificate, if the original is defaced, damaged or lost

$200

7

Fee for inspection of each overseas manufacturing site of cosmetics

$5000

Drug License

To do business in pharma industry including Ayurvedic & Unani drugs, one must get a Drug license to operate legally. As per Drugs Act, 1940, License is mandatory throughout India. A particular license is required based on business requirement.

CDSCO Online Registration

Team Corpseed will help you to get CDSCO online registration / DCGI approval for your products as per CDSCO guidelines. Under the Drugs and Cosmetics Act, CDSCO has many responsibilities which includes approval of Drugs.

Medical Devices Registration

Also, CDSCO regulates the manufacturing and import of medical devices in India. As per Drug and Cosmetic act, the medical devices are categorized under the category of drugs.

This portion of the site is for informational purposes only. The content is not legal advice. The statements and opinions are the expression of author, not corpseed, and have not been evaluated by corpseed for accuracy, completeness, or changes in the law.

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Author
Sagar Sharma
I have over 8 years of experience working in product regulatory compliance. Currently, I work as the operations head at Corpseed Ites Pvt Ltd, where my Job role is providing best in class consulting in the field of product compliance.

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