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 License in India
The very first question that arises here is what kind of License you need for your business because the license purely depends upon the nature of your business. Hence, the following are two kinds of cosmetic license in India–
- For manufacturer
- For importers
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.
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-
- Creams, lotions, cleansing, milk, shampoos, pomade, shaving creams, hair oils etc.
- Nail polishes and Nail lacquers
- Lipsticks and Lipgloss
- Preparations used for eyes
- 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 agreementin 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.