Form 42 and Form 43 are essential for ensuring standards of cosmetic products by maintaining the quality, and safety of cosmetic products as per regulatory guidelines. The demand for beauty products in the Indian market is expanding every year which presents significant opportunities to the importer or any businessman to import cosmetic products from other countries into the Indian market.
What Form Form 42 & Form 43 Signify?
- Form 42 – The application for grant of Import license is applied by Form 42.
- Form 43 – The certificate for Import is granted by Form 43.
What Is The Need To Obtain Form 43 and Form 43?
As per Rule 129 of Drug and Cosmetic Rule,1945 any product falling under section 3 (aaa) must be registered by the Central Licensing Authority before the import of cosmetics into India. Cosmetic products must obtain an import license because without a license you are not allowed to import goods in India.
Who Grants the License For Cosmetics Regulatory?
Central Drug Standard Control Organization (CDSCO) is the regulatory body of India responsible for the manufacturing, approval, and import of cosmetic products in India. It is governed by the Director General of Health Service for cosmetics regulatory in India. Any product that is imported to India must meet the regulatory requirements set by the CDSCO under section 3 (aaa) of the Drug and Cosmetic Act, of 1945.
What Is CDSCO Section 3 (AAA) For Cosmetics?
Section 3 (aaa) States that without an import license certificate importer is not allowed to import cosmetic products. So, for the grant of an import registration certificate Form 42 is filled and under Form 43, an import registration certificate is issued as per the Drug and Cosmetic Rule, of 1945.
Types of Cosmetic Registration in India
The various types of Cosmetic Registration As per Drug and Cosmetic Rule 1945 and Cosmetic Rule, 2020 are mentioned below:
Who can Apply for Cosmetics Import Form-42?
- Manufacturers have a manufacturing license in India and want to import cosmetics from other countries to India.
- Any authorized person appointed by the Manufacturer or Importer can apply for the license on their behalf.
- Subsidiary Agent of the Manufacturer.
Documents Required for Import License Registration of Cosmetic Products
The various essential documents submitted for the seamless process of Import License registration by applying form 42 are discussed below:
- The first document needed is a cover letter including all the details of the applicant or importer.
- Form 42 must be submitted along with a stamped copy of the same to the government after paying the fees applicable as per the application.
- Payment proof details in the form of challan must be submitted.
- Power of Attorney is the document submitted by both the manufacturer and importer representing mutual contract arrangement for imported goods and services.
- Manufacturing site information included in Schedule D must be submitted.
- A free sale certificate must be attached, representing the imported goods can be sold without restriction in the country or nation of its origin.
- Specifications of product and testing methods must be submitted.
- Non-Animal Testing Declaration that declares the cosmetic products to be imported have not been tested on animals.
- Declaration for the presence of Hexachlorophene and other heavy metals in cosmetics products must comply with the guidelines of the Bureau of Indian Standards.
- Packaging information and documents presenting manufacturer or brand name.
Procedure of Import License Registration by Form 42
The various essential steps to be followed for Import License Registration by applying Form 42 are given below:
- Applicants must visit the SUGAM portal and complete the login credentials.
- Login to the portal and select the application and department section.
- Review the application and submit which will redirect to the document uploading page.
- Upload all the required documents electronically along with the challan and Form 42 which was generated already.
- After the successful filling and submission of the application, the Licensing authority will review and analyze the application, if found according to the regulatory requirements the import license will be granted to the importer within 180 days.
- If not found as per the standard then they will be notified to the applicant about the discrepancies and once it will be rectified by the applicant, it will be submitted again for approval.
Information Required for Application of Cosmetic Registration – Form 42 and Form 43
The various information required for seamless Application of Cosmetic Registration Form 42 and Form 43 are as listed below:
- Cover Letter
- Application Form 42
- Power of Attorney Certificate
- Free Sale Certificate
- Manufacturing License Number
- Market Authorisation certificate from the origin country
- Product Information File ( Product name, composition, etc)
- Good Manufacturing Practice CertificateÂ
- Safety Data
- Â Specification Test Report
- Â Non-Animal Testing Report
- Â Cosmetics Labelling Details
- Â Manufacturer Details
- Fees Payment Proof
After Review and verification of all the documents Form 42 and Form 43 is issued as Import License Certificates by Central Licensing Authority. No additional document is required for Form 43.
CDSCO’s Function in Cosmetic Imports
The Central Drug Standard Control Organization is the Indian Regulatory body under the Directorate General of Health Services for making rules and regulatory compliance for New Drug Approval, Import, Manufacturing, sale, or distribution. Any person who wants to manufacture, Import, sell, or Distribute Cosmetic Products in India must obtain a CDSCO Registration Certificate.
Charges of Form-42 Import License Registration
A Fee of 1000 US dollars or its equivalent in Indian rupees for a grant of import registration certificate per category. An additional 50 USD for each variant and for each additional category 1000 USD.
Validity
The validity of Form 43 Import License Certificate issued by applying Form 42 is Up to five years from the date of issue.
Conclusion – Form 42 and Form 43
The cosmetic market is expanding greatly worldwide with a high demand for beauty products among the young generation. Therefore, cosmetic products must be safe and of high quality for human use. To facilitate the safety and quality of cosmetic products imported from other countries in India, the products must meet the standard and compliance set by the regulatory body of India CDSCO under the Ministry of Health and Family Welfare who issue the import registration certificate after analyzing and reviewing all the documents submitted by the importer in Form 42 and Form 43 in favour of importing and registering cosmetic products in India.
FAQs
Who Approves Cosmetics In India?
The Central Drug Standard Control Organisation is the main Regulatory authority that grants permission for the Import, Manufacturing, Sale or Distribution of Products.
What Is The Purpose Of Form 43?
 It includes the grant of import registration certificates.
How Much Time Does It Take For Review and Approval Of Form-42?
 A Time period of 180 days or 6 months is taken by the Regulatory authority for verification and approval of the Import License.
