CDSCO Registration for Cosmetic Manufacturing - Procedure, Checklist & Benefits

Section 3(aaa) of Drugs & Cosmetics Act, 1940 defines cosmetics as any product or article that is intended to be applied on human body or any part of the body by rubbing, pouring, sprinkling or spraying for cleansing, beautifying, promoting attractiveness, or altering the appearance.

State licensing Authorities (SLA) appointed by the respective state governments issues license for the manufacture of cosmetics, whereas the central licensing authority appointed by the Central Government is the regulatory authority for import of cosmetic products. CDSCO Registration for cosmetic manufacturing ensures that Cosmetic Products are free of heavy metals and other toxins; no animals are harmed or tested during the production process, and the product is safe to be consumed by the masses.

Cosmetics Manufacturing License

Organizations intending to manufacture cosmetics need to obtain a manufacturing license. Manufacturing licenses for cosmetics is valid for 5 years from the date of issuance. Entities can apply for any of the following manufacturing licenses to manufacture and market cosmetic products in India:

1. License for manufacturing cosmetics for sale or distribution : A license to manufacture cosmetics for sale or distribution (COS-8) can be secured by applying through COS-5 with the licensing authority appointed by the respective state government.
2. Loan License for manufacturing cosmetics for sale or distribution : A loan license for the manufacturing of cosmetics for sale or distribution (COS-9) can be obtained through the submission of COS-6 (Application for grant of loan license to manufacture cosmetics for sale or distribution) with the designated licensing authority of the state government.
3. License for grant of approval for carrying out tests on cosmetics : Approval for conducting tests on cosmetic s and raw materials used in their manufacture on behalf of licensees for manufacturing for the sale of cosmetics (COS-14) can be obtained. Approval for conducting tests on cosmetics and raw materials used in their manufacture on behalf of licensees for manufacturing for the sale of cosmetics (COS-14) can be obtained. An application must be filed under COS-13 (application form for grant of approval for conducting tests on cosmetics used in the manufacture of cosmetics on behalf of licensees for the manufacture and sale of cosmetics with the state licensing authority.

Cosmetic Import License

1. Cosmetic Import License is required when an organization is not producing but importing and re-selling cosmetics in India. Importers must apply for COS-1 (Application for issuance of registration certificate for import of cosmetics in India with the central licensing authority) to obtain the cosmetic import license. The Rules provide that a registration certificate for importing cosmetics into India from other nations is issued in COS-2. It is valid for 5 years from the date of issuance.

Table of Classification :

Manufacturers seeking a cosmetic manufacturing license must comply with the prescribed eligibility conditions, infrastructure standards, and regulatory requirements laid down by the licensing authority.

• The applicant must be a legal registered entity (Proprietorship, Partnership, or Limited Company)
• The manufacturing facility must meet Good Manufacturing Practices (GMP), including proper sanitary conditions and adequate space
• Pharmacy Diploma approved by the Pharmacy Council of India
• Registered under the Pharmacy Act, 1948
• Passed the Intermediate Examination with Chemistry as one subject

Understanding the product classification helps businesses ensure proper regulatory compliance and licensing:

• Creams, lotions, cleansing, milk, shampoos, pomade, shaving creams, hair oils, etc.
• Powders
• Nail polishes and Nail lacquers
• Lipsticks and Lip-gloss
• Depilatories
• Alcoholic Fragrance Solutions such as DEO, perfume, body mist and so on.
• Preparations used for eyes
• Aerosol
• Hair Dyes
• Tooth powder and toothpaste
• Toilet soaps and liquid

While the COS-8 license remains perpetually valid, license holders are required to pay the retention fee once every 5 years as per the Third Schedule of Cosmetics Rules 2020 to maintain its validity, any delay attracts a late fee of 2% of the retention fee for each month of default.

Packaging and labeling are not just marketing essentials but are also mandatory under the Cosmetics Rules, 2020. CDSCO implements stringent labeling policies to protect consumers from any hazards while ensuring full visibility and accountability of cosmetic products across the Indian market. Proper labelling protects consumers, enhances credibility, and helps prevent legal complications. Failure to meet the labelling requirements of CDSCO may result in the seizure of goods, cancellation of the license, and the imposition of fines.

Post licensing compliance for cosmetic manufacturing license requires adherence to CDSCO regulatory framework, ensure product quality, consumer safety, and uninterrupted operations. Once the license is granted, manufacturers must fulfill the following ongoing responsibilities:

• Maintain Manufacturing and Quality Records : All production, testing, and quality control records must be preserved for a minimum period of 3 years and made available for inspection upon request.
• Retain Qualified Technical Staff On-Site: A competent technical team, including qualified chemists and quality control personnel, must always be present at the manufacturing facility during operations.
• Notify SLA of Any Changes: Any modifications relating to product formulation, manufacturing premises, equipment, or ownership structure must be promptly reported to the State Licensing Authority.
• Cooperate with SLA Inspections: Manufacturers must be prepared for both scheduled and unannounced inspections conducted by SLA officials to verify compliance with Good Manufacturing Practices (GMP).
• Adhere to BIS Standards Updates: Stay updated with the latest Bureau of Indian Standards (BIS) specifications and ensure that all cosmetic products meet revised quality benchmarks.

As per CDSCO guidelines, the following details must be clearly and legibly printed on both the inner and outer packaging of every cosmetic product:

• Product Name : The trade name or brand name of the cosmetic product.
• Net Quantity : The exact weight, volume, or number of units in the package.
• Manufacturer's Name and Address : Complete details of the manufacturing entity.
• COS-8 License Number : The valid manufacturing license number issued by the State Licensing Authority.
• Batch Number : Prefixed with "B" for batch number and "M" for manufacturing number, ensuring product traceability.
• Manufacturing Date and Expiry Date : Clearly mentioned to indicate product shelf life.
• INCI Ingredient List : A complete list of ingredients in descending order of concentration, following International Nomenclature of Cosmetic Ingredients (INCI) standards.
• Directions for Use : Clear usage instructions, along with any precautions or warnings.
• Country of Origin : The country where the product is manufactured.

Securing CDSCO Registration for cosmetic manufacturing is an important aspect that must be fulfilled by organizations intending to manufacture and sell cosmetic products in India. Registration of cosmetic products assists in ensuring that the quality of the product, its safety, and conformity with the standards are properly maintained.

Professional guidance can simplify the registration procedure, minimise delays, and help manufacturers complete the approval process efficiently. Seeking expert assistance from Professional Utilities ensures proper application filing, regulatory coordination, and end-to-end support for obtaining CDSCO Registration for cosmetic manufacturing in India.