Form 42 and Form 43 for the Import of Cosmetics in India

• As Per Section 3(aaa) of the Drugs and Cosmetics Act, 1940

Cosmetic means any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to, the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and includes any article intended for use as a component of cosmetic.

• As per Rule 129 of Drugs and Cosmetic Rules, 1945

No cosmetic shall be imported into India unless the product is registered under the rules by the licensing authority appointed by the Central Government under rule 21 or by any person to whom such powers may be delegated under Rule 22.

Any article falling within the definition of cosmetic (Section 3aaa of D&C Act, 1940) is required to be registered along with pack size and manufacturing premises before import into the country.

An application for issue of a Registration Certificate for cosmetics intended to be imported into India shall be made online in Form 42 on SUGAM Portal of CDSCO either by the manufacturer himself or by his authorized agent or importer in India or by the subsidiary in India authorized by the manufacturer to the Licensing Authority under the Act i.e. Drugs Controller General (I), CDSCO (HQ).

Guidance Documents for Submission of Application for Grant of Registration Certificate in Form 43 to Import Cosmetics

• Covering Letter

Power of Attorney [Executed & authenticated either in India before a First-class Magistrate or in the country of origin before such an equivalent Authority or attested by the Indian Embassy of the said country or Apostilled from Hague convention member countries. Power of Attorney including product list duly apostilled and authenticated from the country of origin. All the pages of Power of Attorney including the product list should be signed by both the authorized Indian agent and manufacturer before authentication.

• Schedule D (III) 
• List of Ingredients 
• Labels of proposed products
• Specifications and testing methods 
• Pack insert, if any

Manufacturing Licenses (Authenticated copy of manufacturing licenses/registration/marketing authorization in respect of applied products issued by Regulatory Authority from the country of origin. or undertaking) 

Free Sale Certificate (Original Free Sale Certificate issued by the National Regulatory Authority of the Country of origin for the applied products or from the Indian Embassy of the country of origin. The product list of free sale certificates should be signed and stamped by issuing authority. Free sale certificate should contain the statement in which country the applied products are freely sold.)

Non-Animal Testing Declaration (The Manufacturer either legal or actual /brand owner of the products/ Indian subsidiaries can submit a one-time self-declaration that the applied products have not been tested on animals on and after 12.11.2014 along with import registration dossiers to CDSCO. The acknowledgment copies for submission of this undertaking as received by the applicants from CDSCO can be produced at port offices in the future for clearing their future consignments.)

• Declaration for Heavy Metal and Hexachlorophene content
• Other documents (If any).
• Application (Form-42) 
• Fee: TR-6 Challan (In Original)
• If the documents are not in English language, an English version of the documents will be provided by the customer, and translated by a qualified translator.

Timelines for Grant of License

• Normal - 6 months.
• Exceptional - 3 months.
• Target - 90 days.

From the date of application is submitted.

Validity - Three years from the date of issuance.

• Fees to be Submitted for Form 42 and Form 43 for the Import of Cosmetics in India
• Government charges - $2000 + $50 for each variant. (Equivalent to INR)

Renewal of Form 42 and Form 43 for the Import of Cosmetics in India

• 'No change declaration' to be given if no change is made.
• If change is made, then whole filing procedure will be followed.