Updated on: Apr 29th, 2022
10 min read
People in India, including people residing in rural areas, use cosmetics for occasions or even daily. Thus, the cosmetic market is expanding its reach in India as this market has the magic of never going into recession. However, to conduct a cosmetic business in India, a manufacturer or importer must comply with the legal requirements.
The cosmetic manufacturers or importers need to obtain a cosmetic registration or import registration before establishing a cosmetic business in India. The Drugs and Cosmetics Act, 1940 (‘Act’) and the Drugs and Cosmetic Rules, 1945 (‘Rules’) regulate the cosmetic registration in India.
The Act defines cosmetics as an article used on the human skin. Section 3(aaa) of the Act defines cosmetics as an article intended to be poured, rubbed, sprayed, sprinkled, introduced or applied to the human body for promoting attractiveness, beautifying, cleansing or altering the appearance. It also includes an article intended for use as a component of a cosmetic.
The state licensing authorities appointed by the respective state governments are the regulating authority or the licensing authority for the manufacture of cosmetics. The central licensing authority appointed by the Central Government is the regulating authority for the import of cosmetic products. The Drugs Controller General (India) acts as the Central Licensing Authority that issues the import registration certificate.
There are two types of cosmetic registration in India, i.e. manufacturing license and importing license.
When an entity intends to manufacture cosmetics, a manufacturing license for cosmetics is required. The manufacturing license of cosmetics is valid for five years from the grant date. The entity can apply for any of the following manufacturing licenses for cosmetic product manufacturing and market in India:
License for manufacturing cosmetics for sale or distribution
The Rules provide that a manufacturer can obtain a license to manufacture cosmetics for sale or distribution (Form 32) by applying Form 31 (application for grant of license to manufacture cosmetics for sale or distribution) with the licensing authority appointed by the state government.
A manufacturer can apply for the grant of license to manufacture cosmetics for up to ten items of each category of cosmetics mentioned in Schedule MII of the Rules. The application should be filed along with a license fee of Rs.2,500 and an inspection fee of Rs.1,000 for each inspection.
Loan license for manufacturing cosmetics for sale or distribution
The Rules provide that a manufacturer can obtain a loan license for manufacturing cosmetics for sale or distribution (Form 32-A) by applying Form 31-A (application for grant of loan license to manufacture cosmetics for sale or distribution) with the licensing authority appointed by the state government.
A manufacturer can apply for the grant of loan license to manufacture cosmetics for sale for up to ten items of each category of cosmetics mentioned in Schedule MII of the Rules. The application should be filed along with a license fee of Rs.2,500 and an inspection fee of Rs.1,000 for each inspection.
License for grant of approval for carrying out tests on cosmetics
The Rules provide that a manufacturer can obtain approval for carrying out tests on cosmetics and raw materials used in their manufacture on behalf of licensees for manufacturing for the sale of cosmetics (Form 37).
The manufacturer should apply Form 36 (application for grant of approval for carrying out tests on cosmetics used in the manufacture on behalf of licensees for manufacture for sale of cosmetics) with the state licensing authority. The application should be filed along with an inspection fee of Rs.1,500 for the testing of cosmetics.
The license for a cosmetic importer is required when an entity does not manufacture the cosmetic but imports and resales them in India. The importers must apply Form 42 (application for the issue of registration certificate for import of cosmetics into India with the central licensing authority to obtain the license for import of cosmetics). The Rules provide that a registration certificate for importing cosmetics into India from other nations is issued in Form 43.
The application should be filed along with a fee of USD 250 or its equivalent to Indian rupees for each cosmetic brand. The registration certificate (Form 43) is valid for three years from the issue date. The following persons can make the application for obtaining a certificate of registration for the import of cosmetics:
Before granting the license for the manufacture of cosmetics or certification of registration for import of cosmetics, the licensing authority will conduct an in-depth inspection of the entire premises. The inspection officer will submit a comprehensive report to the licensing authority, which will decide whether to issue the license or not. The manufacturers or importers must comply with the below regulations as provided in the Rules.
Qualification criteria for working staff in a cosmetic manufacturing unit
The manufacturers need to ensure that the production of cosmetics is done in the presence of a qualified and competent technical staff, and at least one staff person should possess the below educational requirement:
Rules concerning the labelling of products
The manufacturers must comply with the following labelling requirements:
The manufacturers of cosmetics or cosmetic importers can apply for the manufacturing license or registration certificate for import by following the below process:
After the license application form is sent to the designated officer, the designated officer will review and verify the form and documents. If the application form is found to be satisfactory, it will be forwarded for approval of the licensing authority. Once the licensing authority approves the form, the approval letter will be available in the applicants’ SUGAM dashboard.
When the application form is not found to be unsatisfactory, then the designated officer informs of the discrepancies in the application to the applicant on the SUGAM portal. Once the applicant complies with the discrepancies, it will be processed for approval.
The documents required to apply for a manufacturing licence are:
The documents required to apply for importing licence are:
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