Definition of Cosmetics

The Act has defined cosmetics as an article used on the human skin. Section 3 (aaa) defines cosmetic 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 comprises an article intended for use as a component of a cosmetic.

The State Licensing Authorities appointed by the respective State Governments are the licensing authority or the regulating authority for the manufacture of Cosmetics. The competent authority for the import of cosmetic products is the central licensing authority appointed by the Central Government. The Drugs Controller General (India) acts as the Central Licensing Authority that issues the import registration certificate. 

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How to Get Cosmetic Registration in India?

The cosmetic market of India is expanding its arms everywhere right from their first look on the television advertisement to make money from social media platforms nowadays. Hundreds and thousands of people are advertising and filling their pockets with the cosmetic market as the market has the magic of never going into recession.

People from all parts of the world use the cosmetic, be it from the male section or the female section. Yes, you heard me right, the male section also. These days, male society has been witnessed rubbing their hands with lotion or whitening cream. Cosmetic industries do not discriminate between males and females.

Now, as we all know, with power comes great responsibility, so because of the popularity of the cosmetic industry and the amount of fraud that can finally occur in this market, it also becomes a star in the eyes of the government. The prevailing Act in force is the Drugs & Cosmetics Act, of 1940, 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".

Regulations Relating to Cosmetic Registration

Before granting a license for the manufacture of cosmetics or a cosmetics registration certificate for the import, the licensing authority shall inspect the entire premises. The inspecting officer shall submit a detailed report to the licensing authority, which will decide whether the license shall be granted or not. Manufacturers or importers shall comply with the following 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 requirements:

• Diploma in Pharmacy 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 recognized by the licensing authority.

Rules regarding the labeling of products

The manufacturers should adhere to the following labeling requirements:

• The inner and outer labels shall indicate the name of the product, the name of the manufacturer, and the complete address of the manufacturing premises. However, if the container is not large, then the principal place of manufacture and pin code can be indicated instead of the complete address of the manufacturing premises.
• The outer label shall indicate the details of the ingredients used in the manufacture of the product.
• It should also specify 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 Bureau of Indian Standards has provided certain labeling requirements and they must also be complied with.

Cosmetic Registration Process

Manufacturers of cosmetics or cosmetic importers may apply for the manufacturing license or the registration certificate for import by following the process below:

• Visit the SUGAM portal.
• Click on the 'Login/Sign Up' button and then click the 'Sign Up Here' option. 
• Select 'For Cosmetic Registration' as the purpose of registration and click 'Submit'.
• Enter the details, upload the documents (ID proof of the authorized signatory, undertaking, and company address proof), and click the 'Submit' button.
• The form shall be forwarded to the concerned authority, that is, CDSCO officials, for approval of the application by clicking the verification link.
• The acceptance of registration shall be sent by the authority to the email ID.
• After getting the approval log in to the portal using the provided user and password.
• Under the form submission section, select department and form type.
• Select the type of application to be submitted. 
• After applying click on the 'continue' button. 
• Preview the page and then click on the 'Save and Continue' button.
• The 'Checklist' page will open. On this page, against each point, click 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.
• Upload the application form downloaded as a PDF on the next page and click the 'Submit' button.
• The online application form shall be forwarded to the respective licensed Designated Officer for issuing the license.

The application form for license along with the form and documents shall be scrutinized and verified by the officer designated. On satisfaction, the application form shall be forwarded to the licensing authority for approval. On approval by the licensing authority, the approval letter shall be available in the applicant's SUGAM dashboard.

When the application form is found unsatisfactory, the irregularities in the application are informed to the applicant on the SUGAM portal by the designated officer. In compliance with the discrepancies by the applicant, it will be processed for approval.

Documents Requirements for Cosmetics Registration

• Covering letter by the applicant
• Form 42
• Treasury Challan
• Power of Attorney
• Schedule D IIII
• 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 in Which Import Permission or Registration for Market Authorization was Granted
• Pack insert, if any
• Soft copies of the information about the brands, products, and manufacturers.

Every application shall be accompanied by a fee of USD 250 or its equivalent Indian rupees for every Brand viz. every category of cosmetic as mentioned in Column 3 of the list enclosed at Annexure.

Penalty for failure to comply with the Drugs and Cosmetic Act of 1940

The Drugs and Cosmetics Act, of 1940 is a penalty act in which clearly it has been stated that in case of failure to comply with any provision or rules under the Act concerning Cosmetics, there is a provision for imprisonment up to one year or more and a fine up to Rs 1000 or both on first conviction and in the subsequent conviction, the imprisonment can be extended to two years and fine to Rs 2000.