COSMETICS

REGULATORY SERVICES

NKG team has designed regular and value added services for importers and overseas brands looking to place their products in the Indian Markets. These services have been designed in a way to cover the exhaustive spectrum of regulatory needs that may be required from time to time for Import of Cosmetics.

DEFINITION OF

COSMETICS

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.

Drugs & Cosmetics Act 1940

NKG Experts help our clients navigate through the tough, complex and often changing regulatory requirements regulating Cosmetics in India. Having been behind thousands of registrations over years, Team NKG assists its clients in overcoming various challenges by systematically following a transparent , predictable and efficient regulatory strategy.

Cosmetics and beauty products are regulated in two broad ways in India.

CosmeticsImporterManufacturer_1
COS-2

Application for request of Registration Certificate for import of cosmetics in India is submitted under COS-1.

COMPLIANCE OF INGREDIENTS AND SPECIFICATION

For a cosmetic product to be approved in India, whether manufactured in India or Imported in India, it has to follow standards , limits, acceptable limits laid in Drugs & Cosmetics Act, & Bureau of Indian Standards.

LABELLING

Various aspects of India specific labelling & mandatory declarations need to be followed on the product labels before the products are placed on the Indian Markets. Cosmetic Products have to follow the mandatory declarations on label requirements as per both the Drugs & Cosmetics Act as well as the Legal Metrology (PACKAGED COMMODITIES) Rules 2011.

REGISTRATION UNDER THE LEGAL METROLOGY (PACKAGED COMMODITIES) RULES 2011

Cosmetic products are Packaged Commodities, therefore they are also regulated under the Legal Metrology (PACKAGED COMMODITIES) Rules 2011. Cosmetic products will also need certification by the Director or Controller Legal Metrology New Delhi

Cosmetics Manufactured in India are regulated by State Licensing Authorities (SLA) across all States/UT of India respectively.

Under the Drugs & Cosmetics Act 1940, Licenses and registrations regarding manufacturing of Cosmetics, Renewal of manufacturing licenses of cosmetic products have been granted by the Respective SLAs since decades.

Licenses issued by SLA under the Drugs & Cosmetics Act 1940 to manufacture cosmetics are

COS-8:

License to manufacture/sell/distribute cosmetics.

(COS-5)

COS-8 A:

License for loan license for manufacture/ sale distribution of cosmetics.

(COS-5-A)

 

Cosmetics Imported into India are regulated by CDSCO, New Delhi, India under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India. CDSCO is the National Regulatory Authority (NRA) of India.

COS-2:

Application for request of Registration Certificate for import of cosmetics in India is submitted under COS-1. Gazette Notification G.S.R 426(E) issued by Government of India has made registration of imported cosmetics with CDSCO mandatory.

2013

YEAR

1 April 2013, all imported Cosmetics shall be Subject to Registration with the CDSCO, Ministry of Health and Family welfare, India.

80+

CATEGORIES

Under the Column 3 of the “Guidelines to Registration of Imported Cosmetics” issued by CDSCO. Imported cosmetics are classified under roughly 80 categories.

1

COS

Under Rule 21 of Drugs and Cosmetics Act, Application for Registration of Imported Cosmetics can be filed in COS-1.

 

India is an important market for cosmetic and beauty brands. With the rise in disposable income and internet penetration across India, including tier 2 & 3 cities , the coming decade promises to be an action packed decade for the beauty industry in India. Various estimates by credible agencies forecast the increase in the size of the industry in billions of dollars for the coming 5 to 10 years.

 

We understand how important it is to succeed timely in the India Market  for the entrants. Our  team is one of the oldest, time tested regulatory partners for the beauty industry in India.Our experts hand hold clients and overseas partners in preparing the regulatory dossier in a time tested step by step process. We understand our job is to assist in complete compliance of the products of our clients.

 

Our team has been behind thousands of brand registrations in India. Our teams have seamlessly worked with major e-commerce giants, 5 of the 10 biggest beauty groups in the world, start- ups,  wholesaler of beauty products, importers, manufacturers or practically any other active and respectable stakeholder.

 

The Government mandated that from 1 April 2013, imported Cosmetics shall be Subject to Registration with the CDSCO Office, FDA Bhawan, Ministry of Health and Family welfare, India. Under the RULE 21 of Drugs & Cosmetics Rules 1945,  All cosmetic products that are imported for sale in India need to be registered with the licensing authority

 

Before going deep into the application process, the documentation and the requisite government fee, it is important to know the framework of the rules which have been laid out for the industry to follow.

These rules mandates that all cosmetics must be Registered by CDSCO under Rule 21 or any other person to whom such powers maybe delegated under rule 22 from 1st April 2013

Applicable Rules for Imported Cosmetics As per Drugs and Cosmetics Act 1940 are:

Cosmetics Imported into India are regulated by CDSCO New Delhi, India under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India. CDSCO is the National Regulatory Authority (NRA) of India.

CATEGORY LIST: PRODUCT FAMILY CLASSIFICATION

Under the Column 3 of the list enclosed in the “Guidelines to Registration of Imported Cosmetics” issued by CDSCO. (Attach Link) Imported cosmetics are classified under roughly 80 product families.

The categories available for registration under Rule 21.

The Government fees is USD 2000 per Category and USD 50 per Variant of a product.

SKIN PRODUCTS

1. Face Care products other than Face mask

2. Face mask

3. Eye contour products

4. Lip care products

5. Hand care products

6. Foot care products

7. Body care products

8. External intimate care products

9. Chemical exfoliation products

10. Mechanical exfoliation products

11. Skin lightening products

12. Other skin care products

13. Soap products

14. Bath / shower products

15. Make-up remover products

16. External Intimate hygiene products

17. Other skin cleansing products

18. Chemical depilatories

19. Physical epilation products

20. Other body hair removal products

21. Bleach for body hair

22. Products with antiperspirant activity

23. Products without antiperspirant activity

24. Shaving products

25. Pre- / after-shaving products

26. Other shaving and pre- / after- shaving products

27. Foundation

28. Concealer

29. Other face make-up products

30. Mascara

31. Eye shadow

32. Eye pencil

33. Eye liner

34. Other eye make-up products

35. Lip stick

36. Lipstick sealer

37. Other lip make-up products

38. Body or face paint , including “carnival make-up”

39. Other make-up products

40. Hydroalcoholic perfumes

41. Non hydroalcoholic perfumes

42. Before and after sun products Sun protection products

43. Self-tanning products

44. Other sun and self-tanning products

45. Other skin products

HAIR & SCALP PRODUCTS

1. Hair conditioner

2. Scalp and hair roots care products

3. Anti Hair Loss products

4. Other hair and scalp care and cleansing products

5. Anti Dandruff products

6. Oxidative hair colour products

7. Non-oxidative hair colour products

8. Hair bleaching and dye remover products

9. Other hair colouring products

10. Products for temporary hair

11. Styling Permanent wave products

12. Hair relaxer / straightener products

13. Other hair styling products

14. Hair sun protection products

15. Other hair and scalp products

NAIL AND CUTICLE PRODUCTS

1. Nail varnish / Nail make-up

2. Nail varnish remover

3. Nail varnish thinner

4. Nail bleach

5. Other nail varnish and remover products

6. Nail care products

7. Nail hardener

8. Other nail care / nail hardener products

9. Nail glue remover

10. Cuticle remover / softener

11. Nail sculpting products

12. Other nail and cuticle products

ORAL HYGIENE PRODUCTS

1. Toothpaste

2. Tooth cleansing powder / salt

3. Other tooth care products

4. Mouth wash

5. Breath spray

6. Other mouthwash / breath spray products

7. Tooth whiteners

8. Other oral hygiene products

As per the “Guidelines to Registration of Imported Cosmetics” document issued by CDSCO, An application for Issuance of Registration certificate in COS-2 must be applied on SUGAM Portal of CDSCO in a Prescribed COS-1 by anyone of the following types of Indian Entities:

Clinicounsel team brings method in this madness. We try to identify the variables and keep working with our clients and helping formulate the best regulatory strategy as changes keep happening.

In the  last decade, through thousands of cosmetics  regulatory submissions and approvals, , working with global regulatory teams and offices and hand holding the biggest , the best the most respectable and the most glamourous brands in the beauty business, our team has established a tried and tested , yet simple way of preparing the cosmetic regulatory dossier for product registration in India.

 

Cosmetic regulations in India are new and evolving from time to time. Various factors such as advances in science and global manufacturing practises, new technologies, formulations, newer raw materials, further accurate testing, effect on wildlife as well as climate keep pushing for evolving regulatory norms around the world.  When such changes happen globally as well as in India, it leads to changes in regulatory expectations. Something which was right till yesterday could be not so right today.

At the same time, you are looking to launch your brand in India.You are hiring PR agencies, personel, Marketing initiatives, retail spaces, trainers etc. Basically you are going all out to grab your rightful share in the Indian market. In the midst of all this entrepreneurial rush,  Such evolving regulatory changes or expectations can disrupt business plans greatly.

Our team has designed regular and value added services for importers and overseas brands looking to place their products in the Indian Markets. These services have been designed in a way to cover the exhaustive spectrum of regulatory needs that may be required from time to time.

Primary Information To Draft Power Of Attorney

 

Processing Of Apostille Documents

 

Preparation Of Secondary Documents

 

SUGAM Account

 

Payment Of Government Fees

 

System Generated COS-1

 

Submission

 

Processing By CDSCO

 

Clarification Raised

 

AS IMPORTER OR MANUFACTURER

REGISTRATION UNDER THE PCR RULES 2011

As per THE LEGAL METROLOGY (PACKAGED COMMODITIES) RULES 2011,Registration of  Importer, Packer or Manufacturer is mandatory under the Packaged commodity Rule 2011 With Legal Metrology wing under Ministry of Consumer affairs

Pre-packaged or pre-packed is a commodity which without the purchaser being present is placed in a package of whatever nature, whether sealed or not so that the product contained therein

A application has to be made for approval under Packaged commodity rules 2011 for Registration of Importer, Packer or Manufacturer as per Chapter VI of the Packaged commodity rule (PCR) 27 of legal metrology act 2009:

Every individual, firm, Hindu undivided family, society, company or corporation who or which pre-packs or imports any commodity for sale, distribution or delivery shall make an application, accompanied by a fee of rupees five hundred, to the Director or the Controller for the registration of his or its name and complete address

Cosmetics Importer