How to Get Cosmetic Registration in India?

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. 

Definition of Cosmetics

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.

Types of Cosmetics Registration in India

There are two types of cosmetic registration in India, i.e. manufacturing license and importing license.

Manufacturing 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. 

Importing license

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:

• A manufacturer having a registered office in India
• An authorised agent of the manufacturer
• A subsidiary of the manufacturer
• Any other importer

Regulations Relating to Cosmetic Registration

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:

• Pharmacy Diploma approved by the Pharmacy Council of India under the Pharmacy Act, 1948
• Registered under the Pharmacy Act, 1948
• Passed intermediate examination with Chemistry as one of the subjects or any other equivalent examination recognised by the licensing authority.

Rules concerning the labelling of products

The manufacturers must comply with the following labelling requirements:

• The product’s name, manufacturer’s name, and the manufacturing premises’ complete address should be clearly mentioned on the inner and outer labels. However, if the container is not big in size, then the principal place of manufacture and pin code can be mentioned instead of the manufacturing premises’ address.
• The outer label must provide the details of the ingredients used in the product’s manufacturing.
• The inner label should provide the direction of use, existing hazards and necessary warnings to ensure safety.
• A separate batch number preceded by the letter ‘B’ and a manufacturing license number with ‘M’ must be mentioned on the label.
• The labelling requirements as provided by the Bureau of Indian Standards (BIS) must also be complied with.

Cosmetic Registration Process

The manufacturers of cosmetics or cosmetic importers can apply for the manufacturing license or registration certificate for import by following the below process:

• Visit the SUGAM portal.
• Click on the ‘Login/Sign Up’ button and click on the ‘Sign Up Here’ option. 
• Select the registration purpose as ‘For Cosmetic Registration’ and click on the ‘Submit’ button.
• Enter the details, upload the documents (ID proof of the authorised signatory, undertaking and company address proof) and click on the ‘Submit’ button.
• A verification link will be sent to the registered email ID. Upon clicking on the verification link, the application will be sent for approval to the concerned authority, i.e. CDSCO officials.
• The authority will send the approval of registration to the email ID.
• After receiving the approval, log in to the portal by entering the user and password.
• Select the department and type of form in the form submission section.
• Select the type of application to be submitted. 
• After submission of the application, click on the ‘continue’ button. 
• Preview the page and click on the ‘Save and Continue’ button. 
• The ‘Checklist’ page will open. On this page, click on each point to upload documents and click on the ‘Submit’ button.
• The payments page will open. Fill out the form and click on the ‘Submit’ button.
• The preview page will open. Click on the ‘PDF’ button to generate the PDF of the filled application form, and click on the ‘Submit’ button. 
• On the next page, upload the application form downloaded as a PDF and click on the ‘Submit’ button.
• The online application form will be forwarded to the respective designated officer for issuing the license.

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.

Documents Required for Cosmetic Registration

The documents required to apply for a manufacturing licence are:

• Declaration form
• Blueprint of key and site plan 
• Proof of ownership of the manufacturing premises
• Proof of registration/constitution of the firm 
• Affidavit of non-conviction of partners, proprietor or directors under the Act
• Certified copy of registration certificate of Pharmacy Council of India, experience certificate of the registered pharmacist or competent person and their qualification certificates
• Bio-data form
• Affidavit of a registered pharmacist or competent person regarding full time working with the firm duly attested by a Notary public
• Appointment letter of the registered pharmacist or competent person in charge
• Downloaded PDF of the filled application form (Form 31, 31-A or 36)

The documents required to apply for importing licence are:

• Covering letter by the importer
• Original copy of power of attorney showing the connection between the importer and manufacturer
• Certificate of free sale, manufacturing licence or marketing authorisation letter
• Copy of the label of the product
• Downloaded PDF filled form 42 
• Schedule D III signed by the manufacturer or authorised agent
• Product specification and testing protocols
• NOC from the pollution control board
• Layout plan of the premises
• Rental agreement, in case of rented premises
• List of laboratory equipment
• List of machines installed for manufacturing, if any

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