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Cosmetic Registration in India

Cosmetic License in India is required for all forms of businesses that carry out manufacturing and exporting of cosmetics. Cosmetic license is also required for international companies that set up manufacturing hubs in India. It is important to secure this form of license if you are entering into the business of dealing with cosmetics.

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How to Get Cosmetic Registration in India?

Cosmetic Market in India is expanding its arms everywhere from starting their first look in the television advertisement to making money from a social media platform nowadays. Hundreds and thousands of people are advertising and filing their pocket with the cosmetic market as the market has the magic of never going into recession.

People from all over the world use the cosmetic whether they fall into male section or female section. Yes, you heard me right the male section also, these days the male society has been witnessed rubbing their hands with the lotion or whitening cream. The cosmetic industry does not discriminate between male or female.

But as we all know power comes with responsibility, hence the cosmetic industry also become the star of eyes of government due to its popularity and amount of fraud that can be eventually occur in this market. Currently, the Drugs & Cosmetics Act, 1940 governs the cosmetic registration in India which exclusively defines the word “Cosmetic” as an “article that intends to be, poured, sprinkled rubbed or sprayed on or introduced into or otherwise applied to any human body or any part thereof for cleansing, beautifying, promoting attractiveness or altering the appearance and also includes an article intended to use as a component of cosmetic”.

Types of Cosmetic Registration in India

Types of Cosmetic Registration in India

The manufacturing license for cosmetics is required when you intend to manufacture the cosmetics. Hence, Following is the license that is required for cosmetic product manufacturing and market in India according to D & C Act, 1940-

  • License in Form no 32 that is issued for manufacturing cosmetics for sale or for distribution and the supplication is filed in Form no 31.
  • License in Form 32-A that is issued for loan license for manufacturing cosmetics for sale for distribution and the application is filed in form no 31-A
  • The license on Form 37 is issued for grant or renewal of approval for carrying out tests on drugs or cosmetic or raw material used in the manufacturing thereof on behalf of license for manufacture for sale of drugs and cosmetics.

The Importer License for cosmetic is required when we do not manufacture the cosmetic but import and resale it in India and for that we need an importer cosmetic registration in India.

Benefits of Cosmetic Registration in India

By registering your entity or industry with the cosmetic authority in India you would receive the following benefits:

Benefits of Cosmetic Registration in India

Reputation-

Any industry or manufacturer having this form of license would be more reputed in the eyes of the public. Increased use age of cosmetics would occur through this process. This would not only increase the reputation of the company, but also increase the amount of sales and turnover.

Government Compliance-

By registering with the competent authority for cosmetics, your business would be compliant with the laws laid down in India. Plus you would have to any form of penalty for non-compliance.

Increase in Protection-

By registering under Cosmetic registration in India your business would increase the amount of protection for products. For example, your products would not have any form of infringement. Plus another added benefit for this form of registration, is your business would not have any intellectual property suits. If another business tries to imitate the products of your business then an intellectual property infringement can be brought against the business.

 

Regulatory Authority/ Body for Cosmetic Registration in India

The primary regulatory authority or body for Cosmetic Registration in India is the Central Drug Standard Control Organisation (CDSCO). All cosmetic license and drugs are regulated by this body.  All the requirements related to registration are required to be liaised and regulated by this authority. The law which regulates cosmetic businesses in India is the Drug and Cosmetic Act 1940 & Rules 1945(Such rules have been amended in the year 2016).

Apart from this body the BIS (Bureau of Indian Standards) brings out various standards for cosmetic registration in India. The ingredients which have to be present in cosmetics are regulated by these bodies.

Guidelines for Manufacturing or Importer of Cosmetics in India

An Undertaking specifying that the product is not tested in animals

It is clearly stated that any manufacturer or importer of cosmetic products before registering their cosmetic registration should give an undertaking detailing that the products have not been tested on the animals and along with that the details of import registration and received acknowledgment copy by CDSCO to the applicants which can be used for future consignments.

Letter of Authorization in case of third party manufacturing outside India

In case when the brand owner of the product is outside India then the manufacturer needs to sign a letter of authorization to brand owner and authorize him to do an act on behalf of the owner which authorize the importer to do an act in the behalf of the manufacturer sitting outside India and this letter is considered as Power of Attorney.

Import Bulk Cosmetics

The applicant can also obtain a certificate of free sale and bulk importer for sale of the same products and can obtain customs clearance approval after the testing of Cosmetic business license.

Cosmetic Regulations in India for Cosmetic license

Under the Drugs and Cosmetic Rules, 1945, Schedule M-II classifies cosmetics into 11 broad products categories-

  • Powders
  • Creams, lotions, cleansing, milk, shampoos, pomade, shaving creams, hair oils etc.
  • Nail polishes and Nail lacquers
  • Lipsticks and Lipgloss
  • Depilatories
  • Preparations used for eyes
  • Aerosol
  • Alcoholic Fragrance Solutions
  • Hair Dyes
  • Tooth powder and toothpaste
  • Toilet soaps

To manufacture any item from the above-discussed list, a license is required that has been obtained from a licensing authority appointed by the State Government. The application has to be submitted in Form 31 along with a license fee of Rs. 2500 and with an inspection fee of Rs 1000. Furthermore, the manufacturer needs to keep a check that the production is done in the presence of a skilled and competent technical staff and at least one of the staff people should possess the following educational requirements-

  • Holds a diploma in pharmacy by the Pharmacy Council of India under the Pharmacy Act, 1948 or
  • Is registered under the Pharmacy Act, 1948 or
  • Has passed the intermediate examination with the chemistry as one of the subjects or any education as the Licensing Authority may deem fit

Now before granting or refusing the license, the Licensing Authority is required to inspect the whole premises where the operation is to be carried out and also the inspector is to appointed according to the act. The Inspection officer needs to submit the complete report to the Licensing Authority which will decide whether to grant the license or not.

Regulation for Manufacturer pertaining to labeling of the products

Following are the labeling requirements as laid down under the Drugs and Cosmetic Rules, 1945:

  • The name of the product should be clearly mentioned on both the inner and the outer labels and in case the container is small in size then the principal place and the pin code are fine.
  • The outer label should clearly display the ingredients that are used in the manufacturer of the products.
  • The inner label must contain the direction for use along with the warning or cautions that may be necessary
  • A separate batch number preceded by letter “B” and manufacturing batch with “M” must be stated on the label.

The Bureau of Indian Standards (BIS) checks the quality of the product for time to time and also revised the Indian standard.

Documents Required for Cosmetic Registration in India

  • Original copy of Power of Attorney in case of Importer
  • Certificate of free sale, marketing authorization letter
  • Form 42 duly signed and filed and the list of products to be renewed
  • Fees as mentioned
  • A self-declaration that there are no changes in earlier shred information
  • NOC from Pollution Control Board
  • Plan the layout of the premises
  • Rent agreement in case of rented premises
  • list of laboratory equipment
  • Affidavit of Applicant
  • list of machines installed for manufacturing

The Importer needs to apply for cosmetic registration products by

  • An authorized agent of the manufacturer
  • A Subsidiary of the manufacturer
  • A manufacturer having registered premises in India
  • Any other importer

Each and every product that is manufactured or import should conform with the Drugs and Cosmetics Rules, 1945and the registration is valid for the period of three years.

The penalty imposed for not complying with Drugs and Cosmetic Act, 1940

The Drugs and Cosmetics Act, 1940 is a penalty act in which it is clearly stated that if any provision or rules under the Act with respect to Cosmetics is not complied with, imprisonment up to one year or more and fine up to Rs 1000 or both can be imposed on first conviction and in the subsequent conviction imprisonment can be extended to two years and fine to Rs 2000.

Why Enterslice?

Enterslice has been proved to be the finest legal firm in complying and providing the Importer registration and the Cosmetic registration in India with a very pocket-friendly price as compared to another marketer. Kindly contact us at info@enterslice.com for any query or to place your order. We will get back to you very soon.

How to reach Enterslice for Cosmetic Registration in India

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Frequently Asked Questions

Yes it is mandatory for all businesses that deal with cosmetics to secure the above license. Without the license a business cannot operate properly.

Yes cosmetic registration ins India is required for the import of cosmetic products in India. Till 2011, there was no form of regulation in India for the import of cosmetics in India. Now any form of foreign cosmetic products would require registering with the appropriate bodies for getting cosmetics in India.

The Central Drug General of India is an executive body above the CDSCO. This body executes all the functions related to compliance of cosmetics and drugs in India.

The following cosmetic regulations apply in India:

• The CDSCO is the main regulatory authority for drugs and cosmetics in India.

• The Drugs and Cosmetics Act and the Related Drug and Cosmetics Rules would be applicable for all manufacturing and licensing of drugs in India.

• Compliance has to be maintained as per the requirements of part 15 (XV) of the Drugs and Cosmetics Act and the Drugs and Cosmetics Rules.

Yes pre-marketing approval would be required from the respective state government for specific cosmetic registration in India.

As per the regulations of the CDSCO, any manufacture of cosmetic or import of cosmetics must be in compliance with the requirements of the act. Apart from this, any cosmetics which are imported in India after 2014 have to make a declaration that cosmetic products are not used on animal testing.

Form 43 should be utilised by the applicant for cosmetic registration in India. After the documents are submitted to the authority, the same will be vetted by the CDSCO. After this process is complete the CDSCO will report back to the Indian agent with the first query letter. If there are no other forms of compliance requirements, the CDSCO will get back to the Indian agent with the registration certificate or the certificate of registration.

Yes cosmetics which are brought into India through imports have to comply with the requirements of labelling. All the instructions on the cosmetic use must be appropriately put on the products. Along with this information, other information related to the expiry of the cosmetics must also be included.

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