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On December 15, 2020, India released and implemented the Cosmetics Rules 2020. To streamline the import registration process of cosmetics and facilitate enterprises’ businesses, the Central Drugs Standard Control Organization (CDSCO) published a collection of frequently asked questions (FAQs) and a guidance document for cosmetic import registration under the new regime on January 19, 2021. 1
The details of the documents are as follows:
Import Cosmetic Categories
Any articles falling within the definition of cosmetics specified in the Drugs and Cosmetics Act 1940 and Cosmetics Rules 2020 shall be registered with the CDSCO along with pack size, variants (e.g., different colors, shades, flavors), and manufacturing premises before import into India.
The cosmetic categories permitted for import mainly include 80 classes, such as face care products excluding face masks, face masks, eye contour products, lip care products, hand care products, foot care products, body care products, external intimate care products, soap products, etc.
Application Procedures
The application for cosmetic import registration shall be submitted online in Form Cos-1 on the SUGAM Portal of CDSCO either by the manufacturer himself or his authorized agent or the importer in India or the India's subsidiary authorized by the manufacturer, with requisite fee and documents. Once approved, an import registration certificate in Form Cos-2 will be granted by the Central Licensing Authority.
In case of a new cosmetic, the applicant shall obtain prior permission in Form COS- 3.
Forms | Purposes |
Cos-1 | Application for grant of a Registration Certificate for Import of cosmetics into India |
Cos-2 | An Import Registration Certificate to be issued for import of cosmetics into India |
Cos-3 | Permission to import or manufacture new cosmetics in India |
Necessary Application Documents
No. | Documents |
1 | Covering Letter |
2 | Authorization from Manufacturer |
3 | Filled in Part-I of the Second Schedule of the Cosmetics Rules 2020 |
4 | List of Ingredients along with its Percentage Contents |
5 | Labels of Proposed Products |
6 | Specification and Testing Methods |
7 | Pack Insert (If any) |
8 | Manufacturing Licenses/An undertaking for no provision of manufacturing license in the country. |
9 | Free Sale Certificate* |
10 | Non-Animal Testing Declaration |
11 | Declaration for Heavy Metal and Hexachlorophene Content |
12 | Other Documents (If any) |
13 | Application in Form Cos-1 of the Cosmetics Rules 2020 |
14 | Fee: (Original Bharatkosh e-receipt for the fee paid) |
Note: When applying for the import of bulk finished formulation ready to fill, the following additional documents shall also be provided:
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* It is worth noting that the Free Sale Certificate shall be submitted for all variants of the cosmetic products to be imported. In addition to the Free Sale Certificate issued by the actual manufacturer from the country of origin, the following types of documents can also be accepted.
Free Sale Certificate issued by national regulatory authority from the country of the principal manufacturer;
Free Sale Certificate issued by other competent associations or organizations duly authenticated from the Indian Embassy of the country of origin;
Free Sale Certificate issued by other competent associations or organizations authenticated from the chamber of commerce/notary public and apostilled.
Import Registration Fees
Administrative Items | Fee Payable |
Fee for grant or retention of registration certificate for each category of cosmetics | $1,000 |
Fee for grant or retention of registration certificate for additional category of cosmetic | $1000 |
Fee for registration of each manufacturing site | $500 |
Fee for each variant of cosmetics | $50 |
The fees can be paid through Bharatkosh only, via Bharatkosh gateway under Head of Account “0210041040000-00-1” Import and Registration in dollars or its equivalent in Indian Rupees. The acknowledgement receipt shall be submitted along with the application for registration.
Registration Time
As per the CDSCO’s circular issued on 30 May 2014, the registration certificate for import of cosmetics shall be issued within 90 days from the date of submission of the application form and other required documents as listed above.
Validity
The registration certificate for import of cosmetics shall remain valid in perpetuity, subject to payment of the certificate retention fee.
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