What is Cosmetic?
As per the provisions of Section 3(aaa) of the Drugs and Cosmetics Act, 1940, the term cosmetic denotes any item designed for application to the human body, including by means of rubbing, pouring, sprinkling, spraying, introducing, or by any other method onto the human body or its parts, with the purpose of cleansing, beautifying, enhancing attractiveness, or modifying appearance.
Cosmetic Import in India
All cosmetic products intended for commercial import into India are required to be registered with the relevant licensing authority for Cosmetic import license, as stipulated under Rule 21 of the Drugs and Cosmetics Rules, 1945. The Cosmetic Import License application must be submitted in Form 42, along with the prescribed documentation, to the Drugs Controller General (India) at Central Drugs Standard Control Organisation (CDSCO), located at FDA Bhavan, Kotla Road, New Delhi – 110002.
Eligible applicants for Cosmetic Import License
The following entities are authorized to apply for cosmetic import registration in India:
- The manufacturer with a registered office within India
- An authorized representative of the manufacturer
- A subsidiary company of the manufacturer
- Any other designated importer
Checklist / Documents required for Cosmetic Import License
Applicants are required to submit the following documents when applying for a cosmetic import license:
- A covering letter from the applicant
- Duly filled Form 42
- Treasury challan evidencing fee payment
- A valid Power of Attorney
- Schedule D(III) document
- Original or duplicate of the product label
- Free Sale Certificate (FSC), Marketing Authorization, or Manufacturing License (if applicable)
- Detailed product specifications and testing protocols
- List of countries where market authorization/import approval/registration has been granted
- Product insert or leaflet (if available)
- Digital copies containing information about brands, products, and the manufacturer
As per Section 3(aaa) of the Drugs and Cosmetics Act, 1940 and Rules, 1945, cosmetics are any item designed for application to the human body, including by means of rubbing, pouring, sprinkling, spraying, introducing, or by any other method onto the human body or its parts, with the purpose of cleansing, beautifying, enhancing attractiveness, or modifying appearance.
Regulation ensures the safety and quality of imported cosmetics, safeguarding consumer health and welfare.
Yes. Imported cosmetics are governed by the Drugs & Cosmetics Act, 1940 and the associated Rules of 1945.
No. The CDSCO does not issue manufacturing licenses for cosmetics within India.
The regulatory oversight is provided by the Drugs Controller General (India) under the Central Drugs Standard Control Organization (CDSCO), operating under the Ministry of Health and Family Welfare, Government of India.
Yes. All imported products that meet the definition of cosmetics under the Drugs and Cosmetics Act are subject to regulation.
Applicants must submit Form 42 with required documents to CDSCO for obtaining a Registration Certificate in Form 43.
The Cosmetics Division of CDSCO Headquarters is responsible for handling registrations related to the importation of cosmetics.
Eligibility includes manufacturers, their authorized agents, subsidiaries, or other designated importers.
These licenses are issued by the respective State Licensing Authorities appointed by individual State Governments.