Cosmetic Registration in India

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You will require Cosmetics registration

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The cosmetics and personal care industry is one of the fastest growing consumer products sector in India. The personal care and cosmetics sector in India have shown continuous strong growth, with increasing shelf space in retail stores and boutiques in India, stocking cosmetics from around the world. But this is not all, cosmetic industry too requires government registration. The cosmetic registration in India is an intricate process and requires detailed planning and review of the ingredients and labelling. Currently, the Drugs & Cosmetics Act, 1940 governs the cosmetic registration in India. The Drug and Cosmetic Act 1940 and Rules 1945 were passed by the Indian Parliament to regulate the import, manufacture, distribution and sale of drugs and cosmetics.

Types of Cosmetic Registration in India

The type of license depends upon the nature of business conducted. The two types are:

  • For Manufactures
  • For Importers

[1] For Manufacturers-
Manufacturing license is required when cosmetics are manufactured. The below mentioned licenses are required for cosmetic product manufacturing & marketing in India according to Drugs & Cosmetics Act, 1940.

  • License in Form 32 is issued for manufacturing cosmetics for sale or for distribution, the application here is filed in Form 31;
  • License in Form 32-A is issued for loan license for manufacturing cosmetics for sale or for distribution, application here is filed in Form 31-A;
  • License in Form 37 is issued for grant or renewal of approval for carrying out tests on drugs/cosmetics or raw material used in the manufacture thereof on behalf of licenses for manufacture for sale of drugs/cosmetics, application here is filed in Form 36.

[2] For Importers-
All cosmetic products imported for sale in India are required to be registered with the Central Drugs Standard Control Organization (CDSCO) which is the Indian licensing authority within the office of the Drug Controller General of India in the Ministry of Health & Family Welfare, Government of India (GOI).

Process of Cosmetic Registration (for Importers) in India

[1] Determining whether your product requires registration-
All cosmetic products imported for sale in India need to be registered with CDSCO as defined under Rule 21 of Drugs & Cosmetics Act, 1940.

[2] Appointment of Authorised Indian Agent-
Foreign manufacturers are required to appoint an authorised agent in India who will act as a point of contact for registration process, assist in product approvals, post compliances.

[3] Submission of Application in Form-42 with requisite documents-
The application for registration in Form-42 with required documents, are submitted to Drugs Controller General, CDSCO, New Delhi. This application is submitted with the fee specified along with information and undertaking in Schedule D-III. A single application is made in Form 42 for any number of brands manufactured at one or more locations by a single manufacturer.

[4] Self-Declaration that products are not tested on animals-
A one-time self-declaration that the products applied for registration has not been tested on animals along with import registration dossiers should be submitted to the CDSCO. At the time of clearance of consignment, the acknowledgement copy received by the applicant from CDSCO shall be submitted at the port offices.

[5] Obtain Registration Certificate in Form 43-
After the submission of documents, the CDSCO will approach the Authorised agent for first query letter. Upon satisfaction the CDSCO will either issue subsequent query letter or grant license. The Registration in Form 43 will be obtained in approximately three months.

[6] Amendment in Cosmetic Registration Certificate-
[a] Fresh Registration in case of change of following-

  • Any change with respect to manufacturer like change in name, change in constitution, change in address, etc. Any change with respect to importer/ Authorised Indian Agent like change in name, change in constitution, etc.
  • The manufacturer or his authorized agent in India should inform the licensing authority as soon as possible if any change in the constitution of the firm and/or address of the registered office/factory premises functioning under this Registration Certificate. In such cases, the current Registration Certificate shall be valid for a maximum period of three months from the date on which the change has taken place from the date on which the change has taken place unless, in the meantime, a new Registration Certificate has been given by the licensing authority in the name of the entity with the changed constitution of entity and/or changed address of registered office or factory premises.
  • In case of acquisition/merger of one company by another company, the Indian agent/ Importer has to inform the licensing authority immediately in writing and has to submit a fresh application as per Rules, as acquisition/merger of one company is considered as change in constitution of the company.

[b] Changes not requiring Fresh Registration Certificate:
Following changes do not require a fresh registration and only amendment may be obtained:

  • Change in the method of testing;
  • Change in composition;
  • Updating in packaging and labels;
  • Minor changes in the manufacturing process that will not affect the final product specifications.

The timeline for response to a change is about 90 working days. If applicant has applied for Registration Certificate and still not issued but in between a change has happened in constitution of either Indian Agent or the Manufacturer or, address of manufacturer a fresh application has to be submitted including the fees.

Who can be an Importer of Cosmetic products?

  • The Manufacturer himself having registered office in India.
  • The Authorised Agent of the Manufacturer
  • The Subsidiary of the Manufacturer
  • Any other importer

Classification of Cosmetics

Brands of Cosmetic Products
Skin products 1. Skin care 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
2. Skin cleansing products 1. Soap products
2. Bath / shower products
3. Make-up remover products
4. External Intimate hygiene products
5. Other skin cleansing products
3. Body hair removal products 1. Chemical depilatories
2. Physical epilation products
3. Other body hair removal products
4. Bleach for body hair products 1. Bleach for body hair
5. Correction of body odour and/or perspiration 1. Products with antiperspirant activity
2. Products without antiperspirant activity
6. Shaving and pre- / after- shaving products 1. Shaving products
2. Pre- / after-shaving products
3. Other shaving and pre- / after- shaving products
7. Make-up products 1. Foundation
2. Concealer
3. Other face make-up products
4. Mascara
5. Eye shadow
6. Eye pencil
7. Eye liner
8. Other eye make-up products
9. Lip stick
10. Lipstick sealer
11. Other lip make-up products
12. Body or face paint, including “carnival make-up”
13. Other make-up products
8. Perfumes 1. Hydroalcoholic perfumes
2. Non hydroalcoholic perfumes
9. Sun and self-tanning products 1. Before and after sun products Sun protection products
2. Self-tanning products
3. Other sun and self-tanning products
10. Other skin products 1. Other skin products
2. Hair and scalp products 11. Hair and scalp care and cleansing products 1. Hair conditioner
2. Scalp and hair roots care products
3. Antihairloss products
4. Other hair and scalp care and cleansing products
5. Antidandruff products
12. Hair colouring products 1. Oxidative hair colour products
2. Non-oxidative hair colour products
3. Hair bleaching and dye remover products
4. Other hair colouring products
13. Hair styling products 1. Products for temporary hair
2. Styling Permanent wave products
3. Hair relaxer / straightener products
4. Other hair styling products
14. Other hair and scalp products 1. Hair sun protection products
2. Other hair and scalp products
3. Nail and cuticle products 15. Nail varnish and remover 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
16. Nail care / nail hardener products 1. Nail care products
2. Nail hardener
3. Other nail care / nail hardener products
17. Nail glue remover products 1. Nail glue remover
18. Other nail and cuticle products 1. Cuticle remover / softener
2. Nail sculpting products
3. Other nail and cuticle products
4. Oral hygiene products 19. Tooth care products 1. Toothpaste
2. Tooth cleansing powder / salt
3. Other tooth care products
20. Mouth wash / breath spray 1. Mouth wash
2. Breath spray
3. Other mouth wash / breath spray products
21. Tooth whiteners 1. Tooth whiteners
22. Other oral hygiene products 1. Other oral hygiene products

Validity and Re-registration of Cosmetic Registration Certificate
Cosmetic license is valid for 3 years unless it is suspended or cancelled sooner. It has to be renewed after the validity period gets over.

Labelling Guidelines

  • The inner and the outer labels should contain the Name of the product along with its manufacturing address. Principal place of manufacturing and the pin code is enough if the container is small in size as per the cosmetic labelling instruction required.
  • List of ingredients used in the manufacture of the product should be clearly specified on the outer label.
  • ‘Directions for use’ along with any warning or caution should be mentioned on the inner label. Names and quantities of ingredients which are hazardous in nature should also be mentioned.
  • A distinctive batch number, Manufacturing Date, Best Before along with manufacturing license number (if any) must be mentioned on the label as per the cosmetic labelling instruction laid down under the Drugs and Cosmetics Rules.
  • Maximum retail sales price (MRP) to be mentioned on the cosmetic product. The MRP includes all taxes, total transport charges, commission payable to dealers, and all charges towards advertising, delivery and packing.

Penalty for non-compliance of Drugs & Cosmetics Act, 1940
If any of the provisions under the Act and the Rules are not complied with, imprisonment upto 1 year or Rs.1000 or both can be imposed upon first conviction. On subsequent convictions, imprisonment can be extended to 2 years and fine to Rs.2000.

Documents required for Cosmetic Registration
  • Covering letter by the applicant
  • Form 42 for Importers/ Form 31 for manufacturers
  • Treasury Challan
  • Power of Attorney
  • Schedule D III
  • Original or a copy of the Label
  • Free Sale Certificate (FSC)/Marketing Authorization letter/Manufacturing License, (if any)
  • Product specification and testing protocol
  • List of countries where Market Authorization or import permission or registration was granted
  • Pack insert, (if any)
  • Soft copies of the information about the brands, products and manufacturer
Documents required for Cosmetic Re-registration
  • Power of attorney in original
  • Necessary fees
  • Duly filled and signed Form 42 along with the list of products to be renewed
  • Certificate of free sale or manufacturing license or marketing authorization letter if any
  • Copies of original RC and endorsement certificates that were granted earlier; and
  • Undertaking/ self-declaration stating that there are no changes in information that was shared earlier as regards product details (like composition, test methods, specifications, label etc., constitution of the firm and location / site of the products)

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This information is in summary form and is therefore intended for general guidance only. It is not intended to be a substitute for detailed research or the exercise of professional judgment. Mind Sync does not accept any responsibility for loss occasioned to any person acting or refraining from action as a result of any information provided herein. On any specific matter, reference should be made to the appropriate advisor.