Cosmetic License To Import And Manufacture Cosmetic Products In India

The use of cosmetics has become essential in our daily lives, particularly in a time when beauty norms are constantly changing. With the younger generation increasingly interested in cosmetics and beauty products, there is a profitable opportunity in the market for those looking to start their businesses. Nevertheless, it is crucial to grasp and comply with the regulatory framework that controls the cosmetics industry before fully engaging in it.

The Drugs and Cosmetics Act of 1940, in conjunction with the Cosmetics Rules of 2020, regulates the import, manufacturing, distribution, and sale of cosmetics in India. These rules guarantee the safety, quality, and effectiveness of cosmetic products available for purchase.

What is a Cosmetics Import Registration Certificate?

The Central Drugs Standard Control Organisation (CDSCO) regulates the import of cosmetics items into India through an online registration system (portal) to assure the safety and quality of products on the market.

According to the Drugs and Cosmetics Act and Rules, cosmetics in India are defined as products intended to be massaged, poured, streaked or sprayed on, or applied to the human body for purifying, enhancing beauty, enhancing attractiveness, or altering appearance, and includes any product intended for use as a cosmetic ingredient.

Once a cosmetic product has been successfully registered through the online portal (the "SUGAM" site), the Central Licencing Authority will issue an Import Registration Certificate under Rule 13 of the Cosmetics Rules 2020, allowing the product to be imported and used in India.

Who can apply for a Cosmetic Import Licence?

• The manufacturer himself has a registered office in India.
• An Authorised Agent for the Manufacturer 
• Manufacturer's subsidiary 
• Any other importers

There are two types of cosmetics registration in India e.g. manufacturing license and imposing license are mentioned below with an explanation:

In India, registration can be done through three main avenues: manufacturing license, loan license, and import license

• Production of cosmetics within India requires a Manufacturing license issued by the State Licensing Authorities.
• A loan License is a permit issued by State Licensing Authorities that permits a company to produce drugs and cosmetics at a facility owned by a licensed manufacturer.
• License for Importation Required by the Central Drugs Standard Control Organization (CDSCO), this license is necessary for imported cosmetics products in the country.

The application should be filed with a fee of USD 250 or equal to Indian rupees for each cosmetics brand. The registration of the certificate (Form 43) is valid for three years from the issuing date. Below following can make the applications for obtaining a certificate of registration for the import of cosmetics products:

• A manufacturer has a registered in India office.
• An authorized agent of the manufacturer
• A subsidiary of the manufacturer
• Any other importer

• The Manufacturer has a registered office in India.
• The Manufacturer's Authorised Agent
• The Manufacturer's branch
• Any individual or company claiming to import cosmetic products who is not the manufacturer is considered as any other Importer.

• Legal Compliance: Ensures that your cosmetic items meet Indian rules, encouraging safety and quality. 
• Consumer Trust: Increases consumer confidence by demonstrating that your items fulfil recognized criteria.
• Market Access: Allows you to legally manufacture and sell cosmetics in India, increasing your market share. 
• Business Credibility: Increases your brand's credibility and repute in the competitive cosmetics sector. 
• Regulatory Support: Provides access to regulatory guidelines and assistance from authorities as needed. 
• Quality Assurance: demonstrates your commitment to creating safe and effective cosmetic products.

How to Apply for a Cosmetic Registration Certificate (COS-2) in India?

• Registration of importer on SUGAM and drafting. Document compilation for application filing.
• Submit Upload important documents online. 
• Pay government fees and upload the challan. 
• Signed-Form generate COS-1 and upload signed Form COS-1.

Step 1: Involves identifying the classification of a product as a cosmetic according to Section 3(aaa) of the Drugs and Cosmetics Act, 1940, which refers to any item meant to be applied to the human body for cleansing, beautifying, enhancing attractiveness, or changing appearance, including those used as cosmetic components. It is important to remember that only products mentioned in the Drugs and Cosmetics Rules, 1945, along with the Cosmetic Rules, 2020, are required to be registered, not all products. Identify the specific cosmetics category that your product belongs to.

Step 2: Submitting the Application.: The process starts with Form COS-5 for manufacturers planning to produce cosmetics for selling or distribution. Submitting this form begins the process of acquiring a manufacturing license.

Likewise, importers who want to bring cosmetics into India must fill out Form COS-1. This application is being submitted to obtain a registration certificate for the importation of cosmetics.

Step 3: Preparation and filing of documents for submission.

For Manufacturing or Loan License

• Letter of application
• Power of Attorney with specific instructions
• Building site plan and layout
• Deed of Sale/Lease Agreement, Tax Receipt
• Approval from the State Pollution Control Board is required to begin operations
• Register of Company Directors, Partners including Registry of Companies Copy
• Collection of Skilled Technical Employees
• Letter confirming the appointment of skilled technical staff for the manufacturing section.
• Letter confirming the appointment of qualified technical staff in the Testing Section.
• List of plant and equipment categorized by section.
• Department of Industrial Safety & Health's NOC.
• Information about how the product is made, a Diagram showing the steps in the Manufacturing process
• App
• Site Master file and so on.

For Import

• Letter of application
• Manufacturer's authorization (Original POA) is required.
• Committing to serve as Authorising Agent
• First section of the Second Schedule
• Inventory of Components and their respective proportions
• Application form (COS 1)
• Names of suggested items of merchandise
• Method for testing cosmetics (BIS) specification and testing.
• Product information leaflet (if provided)
• Production permissions obtained from the nation of origin
• Certificate of free sale.
• Declaration against testing on animals
• Announcement regarding the presence of Heavy Metal and Hexachlorophene levels
• Additional paperwork (if applicable)
• Cost: (Payment through Bharatkosh Online)
• Assortment of product samples

Step 4: involves thoroughly examining and submitting the necessary documents. After the documents are submitted, the licensing authority carefully examines them

Step 5: Selection of Authorized Representative (For Importers) An Authorised Agent in India is a person or entity that has been permitted by the manufacturer. The appointed representative will oversee the manufacturer’s operations in India, ensuring adherence to all aspects of the Drug and Cosmetics Act

Step 6: Authorization and Consent: After applying for a manufacturing license, it usually takes around 45 days to get approved. It usually requires 3 to 6 months to obtain an import license

After submitting the application form and all relevant documentation, the registration certificate for cosmetic importation will be issued within 6 months of submission. Registration certificates for cosmetic importation are valid for five years from the date of issue. Each additional item in the cosmetic category incurs a price of RS. 500. The cosmetic manufacturing license (COS 8/COS 9) is valid for five years.

Registration under the Rules of Legal Metrology for Packaged Commodities of 2011

Under the LEGAL METROLOGY (PACKAGED COMMODITIES) RULES, 2011, it is compulsory to register the importer, packer, or manufacturer of pre-packaged commodities.

According to Section 2(l) of the Legal Metrology Act, 2009, a "pre-packaged commodity" is a product placed in a package, sealed or unsealed, with a pre-determined quality, without the buyer being present.

According to Rule 27 of the Legal Metrology (Packaged Commodities) Rules, 2011, manufacturers, packers, brand owners, and importers of pre-packaged commodities must register.

What are the Exemptions on Cosmetic licenses to import and manufacture cosmetic products?

• Imported cosmetic labels will carry the brand's certificate number, as well as the certificate holder's name and address.
• Label snickering that includes the brand's registration certificate number, as well as the manufacturer's name and address, may be authorized following an import at an appropriate declared place approved by the Licencing Authority on an application made to the Licencing Authority.
• The product's producer and the country in which it is manufactured should also be identified on the label. If the product was not created in the producer's plant, the label should include the name and address of the real manufacturer, such as "Made in……… (Name of country)".

Additional Requirement

In addition to completing the application, certain criteria must be fulfilled. When obtaining a manufacturing license, it is important to make sure that the factory is situated in a clean environment, far from housing developments. Additionally, it is necessary to employ at least one full-time technical staff member who holds a Bachelor's in Pharmacy or a Pharmacy Diploma. These criteria are crucial for the authorization process of the manufacturing permit.

Labelling Regulations

Following labelling regulations is a crucial part of cosmetic manufacturing. Manufacturers need to make sure that product names, manufacturer information, and full addresses are visible on both the inner and outer labels. Additionally, it is important to communicate ingredient lists, usage directions, and safety warnings to consumers. It is essential to adhere to the labeling regulations set by regulatory bodies like the Bureau of Indian Standards (BIS).

CORPSEED is a team of expert corporate strategists, compliance, regulatory, and management consultants, along with advisory experts, operating throughout India. We assist clients in meeting regulatory obligations and implementing changes to enhance the efficiency of their operations and create stronger businesses.