Form 42 and Form 43: Import of Cosmetic Products in India

Form 42 and Form 43: Import of Cosmetic Products in India. The cosmetic industry in India has seen significant growth over the past decade. With a large and growing consumer base, India has become a prominent market for both domestically manufactured and imported cosmetic products. However, before importing cosmetic products into India, businesses must comply with the regulations laid down under the Drugs and Cosmetics Act, 1940 and the associated Drugs and Cosmetics Rules, 1945. Two essential components in this regulatory framework are Form 42 and Form 43, which are specifically associated with the Import of Cosmetic products into India.
Definition of Cosmetic as per the Act
The term "cosmetic" is defined in Section 3(aaa) of the Drugs and Cosmetics Act, 1940. According to this section, cosmetic includes any article intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance. It also includes any substance intended for use as a component of a cosmetic product.
This broad definition covers a wide range of products, including creams, lotions, perfumes, makeup, and more. Therefore, any person or organization intending to import cosmetic products into India must obtain a registration certificate from the Central Drugs Standard Control Organization (CDSCO) using Form 42 and Form 43.
What is Form 42 and Form 43?
Form 42 is an application form used for seeking a Registration Certificate for the Import of Cosmetic products into India. It must be submitted by the importer or the authorized representative of the manufacturer to the CDSCO, along with all necessary documents and government fees.
Form 43, on the other hand, is the actual Registration Certificate issued by CDSCO after successful evaluation of the Form 42 application. This certificate allows the applicant to legally import the specified cosmetic products into India.
These two forms are essential for any entity involved in the import of cosmetic products and must be carefully completed and submitted with the required documentation.
Types of Cosmetic Registration under CDSCO in India
Cosmetic products in India can either be manufactured domestically or imported. Based on this, there are two types of cosmetic registrations:
Manufacturing License
If a company plans to manufacture cosmetic products in India, it must obtain a manufacturing license. The following forms are required under the Drugs and Cosmetics Act, 1940:

Form 31: Application for manufacturing license.

Form 32: License issued for the manufacturing of cosmetic products.

Form 31-A: Application for loan license for manufacturing.

Form 32-A: Loan license for manufacturing issued.

Form 37: License issued for testing cosmetics, drugs, or raw materials.

Importing License
For companies that wish to import cosmetic products into India without manufacturing them locally, it is mandatory to apply for an import license. This process requires submission of Form 42 to CDSCO, and on successful verification, Form 43 is issued as a Registration Certificate.
Role of CDSCO in Cosmetic Imports
CDSCO (Central Drugs Standard Control Organization) is the primary regulatory authority overseeing the import of cosmetic products into India. Its functions related to cosmetics import include:

Framing and amending rules under the Cosmetic Rules, 2020 for import and registration.

Reviewing and approving applications for Registration Certificates.

Issuing No Objection Certificates (NOCs) and clarifications.

Handling complaints from consumers, NGOs, or public forums.

Coordinating with other government bodies such as BIS.

Responding to queries from the Parliament, RTIs, legal and court cases.

Addressing public grievances and helping with hearings related to cosmetic imports.

Information Required for Form 42 and Form 43 Application
To apply for the import of cosmetic products, the following information must be submitted with Form 42:

Complete details about the manufacturer and the manufacturing site.

Proof of payment of registration fees.

Specific information related to the cosmetic product.

Product details including variants, sizes, and ingredients.

Each of these pieces of information helps CDSCO to evaluate the safety, authenticity, and quality of the cosmetic products proposed for import.
Documents Required for Cosmetic Registration
The registration process for the import of cosmetic products requires multiple documents. These include:

Covering Letter: This letter is provided by the importer stating the purpose of the application.

Form 42: After the government fee is paid, Form 42 must be submitted online. A hard copy signed and stamped by the importer is also necessary.

Challan: The challan is a receipt containing applicant details and payment confirmation for the registration fee.

Power of Attorney: Provided by the manufacturer, this document authorizes the importer and outlines the list of products, categories, and pack sizes covered.

Schedule D (III): This schedule provides technical details about the manufacturer and the manufacturing facility.

Product Labels: Original or copy of the product labels must be included.

Free Sale Certificate (FSC): Issued by the regulatory authority of the country of origin, this certificate shows that the product is freely sold there.

Product Testing Methods and Specifications: Detailed information on how the products are tested and their quality standards.

Authorization Letters and Marketing Approvals: Documents showing the product is approved for sale in other countries.

Product Inserts: Information that comes inside the product packaging.

Digital Data: Soft copies of all product and brand details.

Documents Required for Re-Registration of Cosmetics
Cosmetic products already registered but nearing expiry need to be re-registered. For this, the following documents must be submitted:

Original Power of Attorney.

Requisite government fee.

Completed and signed Form 42 with a renewed product list.

Valid FSC or marketing authorization letter.

Copies of previously issued Registration Certificates and endorsements.

A self-declaration affirming that product details remain unchanged.

These documents help CDSCO validate that the products and manufacturers continue to meet Indian standards and are safe for public use.
Who Can Apply for Form 42 and Form 43?
The following individuals or organizations are permitted to apply for the Import of Cosmetic products using Form 42 and receive the certificate in Form 43:

The manufacturer with a registered office in India.

The manufacturer’s authorized agent or representative.

A subsidiary or affiliate of the manufacturer.

Any authorized importer based in India.

These applications must be submitted to the Drugs Controller General (India), CDSCO, New Delhi, along with supporting documents and fees. One single application using Form 42 can cover multiple brands from one manufacturer even if they are produced at different sites.
Registration Validity and Processing Time
Once a complete application is submitted under Form 42, the Registration Certificate in Form 43 is usually issued within 90 days, depending on the completeness and accuracy of the application.
As per Rule 129C of the Drugs and Cosmetics Rules, 1945, the Registration Certificate must be issued within six months of receiving the application. In exceptional cases, the authority may take longer, but only after providing written justification.
Once issued, the Registration Certificate under Form 43 is valid for three years from the date of issuance. After three years, the certificate must be renewed using the re-registration process.
Conclusion
Import of Cosmetic products into India is a regulated process under the Drugs and Cosmetics Act, 1940. The Central Drugs Standard Control Organization (CDSCO) acts as the regulatory authority responsible for overseeing the import and registration process. Form 42 is the application form, and Form 43 is the Registration Certificate required for legally importing cosmetic products into the Indian market.
Obtaining Form 43 via a properly submitted Form 42 is essential for ensuring that imported cosmetics meet Indian safety and quality standards. Whether you are a manufacturer or an importer, understanding and following the correct procedures and documentation requirements is key to successful and smooth entry into the Indian cosmetic market.
By maintaining a strong compliance framework, India ensures that cosmetic products used by its citizens are safe, effective, and manufactured following proper international standards.
If you need any help with CDSCO Registration, then you can book a consultation with Compliance Calendar LLP experts through email at info@ccoffice.in or Call/Whatsapp at +91 9988424211.
FAQs
Q1. What is the purpose of Form 42 in the cosmetic import process?
Ans. Form 42 is the application form submitted to the CDSCO by an importer or manufacturer’s authorized agent to obtain a Registration Certificate for importing cosmetic products into India. This form must be filled with detailed product and manufacturer information, along with the required documents and fee.
Q2. What does Form 43 signify in the registration process?
 Ans. Form 43 is the Registration Certificate issued by CDSCO after reviewing and approving the Form 42 application. It allows legal import and marketing of the cosmetic products mentioned in the certificate within India for a validity period of three years.
Q3. Who can apply for Form 42 and Form 43?
 Ans. The manufacturer with a registered office in India, their authorized representative, any subsidiary or affiliate of the manufacturer, or any authorized Indian importer can apply for Form 42 and receive Form 43 from CDSCO.
Q4. What is the validity period of Form 43?
 Ans. Once issued, Form 43 is valid for a period of three years from the date of issuance. Importers must apply for re-registration before the certificate expires to continue lawful import of the products.
Q5. Can one Form 42 application include multiple cosmetic products or brands?
 Ans. Yes, one Form 42 application can cover multiple brands and products from the same manufacturer, even if manufactured at different facilities. This makes the process more streamlined and cost-effective.
Q6. What documents are required for the import of cosmetic products?
 Ans. Some of the key documents include a covering letter, signed Form 42, challan receipt of fee payment, power of attorney, Schedule D(III), product labels, Free Sale Certificate, testing methods, marketing approvals, and product inserts.
Q7. What is the typical timeline for receiving Form 43 after submitting Form 42?
 Ans. Generally, Form 43 is issued within 90 days of submitting a complete and valid Form 42 application. However, as per Rule 129C, it can take up to six months in certain cases where additional review is needed.
Q8. What happens if the Registration Certificate is not renewed on time?
 Ans. If the Form 43 certificate is not renewed before its expiry, the importer may face restrictions or penalties, and the import of the specified cosmetic products will no longer be legally permitted until a new certificate is obtained.

The cosmetic industry in India has seen significant growth over the past decade. With a large and growing consumer base, India has become a prominent market for both domestically manufactured and imported cosmetic products. However, before importing cosmetic products into India, businesses must comply with the regulations laid down under the Drugs and Cosmetics Act, 1940 and the associated Drugs and Cosmetics Rules, 1945. Two essential components in this regulatory framework are Form 42 and Form 43, which are specifically associated with the Import of Cosmetic products into India.

Definition of Cosmetic as per the Act

The term "cosmetic" is defined in Section 3(aaa) of the Drugs and Cosmetics Act, 1940. According to this section, cosmetic includes any article intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance. It also includes any substance intended for use as a component of a cosmetic product.

This broad definition covers a wide range of products, including creams, lotions, perfumes, makeup, and more. Therefore, any person or organization intending to import cosmetic products into India must obtain a registration certificate from the Central Drugs Standard Control Organization (CDSCO) using Form 42 and Form 43.

What is Form 42 and Form 43?

Form 42 is an application form used for seeking a Registration Certificate for the Import of Cosmetic products into India. It must be submitted by the importer or the authorized representative of the manufacturer to the CDSCO, along with all necessary documents and government fees.

Form 43, on the other hand, is the actual Registration Certificate issued by CDSCO after successful evaluation of the Form 42 application. This certificate allows the applicant to legally import the specified cosmetic products into India.

These two forms are essential for any entity involved in the import of cosmetic products and must be carefully completed and submitted with the required documentation.

Types of Cosmetic Registration under CDSCO in India

Cosmetic products in India can either be manufactured domestically or imported. Based on this, there are two types of cosmetic registrations:

Manufacturing License

If a company plans to manufacture cosmetic products in India, it must obtain a manufacturing license. The following forms are required under the Drugs and Cosmetics Act, 1940:

Form 31: Application for manufacturing license.
Form 32: License issued for the manufacturing of cosmetic products.
Form 31-A: Application for loan license for manufacturing.
Form 32-A: Loan license for manufacturing issued.
Form 37: License issued for testing cosmetics, drugs, or raw materials.

Importing License

For companies that wish to import cosmetic products into India without manufacturing them locally, it is mandatory to apply for an import license. This process requires submission of Form 42 to CDSCO, and on successful verification, Form 43 is issued as a Registration Certificate.

Role of CDSCO in Cosmetic Imports

CDSCO (Central Drugs Standard Control Organization) is the primary regulatory authority overseeing the import of cosmetic products into India. Its functions related to cosmetics import include:

Framing and amending rules under the Cosmetic Rules, 2020 for import and registration.
Reviewing and approving applications for Registration Certificates.
Issuing No Objection Certificates (NOCs) and clarifications.
Handling complaints from consumers, NGOs, or public forums.
Coordinating with other government bodies such as BIS.
Responding to queries from the Parliament, RTIs, legal and court cases.
Addressing public grievances and helping with hearings related to cosmetic imports.

Information Required for Form 42 and Form 43 Application

To apply for the import of cosmetic products, the following information must be submitted with Form 42:

Complete details about the manufacturer and the manufacturing site.
Proof of payment of registration fees.
Specific information related to the cosmetic product.
Product details including variants, sizes, and ingredients.

Each of these pieces of information helps CDSCO to evaluate the safety, authenticity, and quality of the cosmetic products proposed for import.

Documents Required for Cosmetic Registration

The registration process for the import of cosmetic products requires multiple documents. These include:

Covering Letter: This letter is provided by the importer stating the purpose of the application.
Form 42: After the government fee is paid, Form 42 must be submitted online. A hard copy signed and stamped by the importer is also necessary.
Challan: The challan is a receipt containing applicant details and payment confirmation for the registration fee.
Power of Attorney: Provided by the manufacturer, this document authorizes the importer and outlines the list of products, categories, and pack sizes covered.
Schedule D (III): This schedule provides technical details about the manufacturer and the manufacturing facility.
Product Labels: Original or copy of the product labels must be included.
Free Sale Certificate (FSC): Issued by the regulatory authority of the country of origin, this certificate shows that the product is freely sold there.
Product Testing Methods and Specifications: Detailed information on how the products are tested and their quality standards.
Authorization Letters and Marketing Approvals: Documents showing the product is approved for sale in other countries.
Product Inserts: Information that comes inside the product packaging.
Digital Data: Soft copies of all product and brand details.

Documents Required for Re-Registration of Cosmetics

Cosmetic products already registered but nearing expiry need to be re-registered. For this, the following documents must be submitted:

Original Power of Attorney.
Requisite government fee.
Completed and signed Form 42 with a renewed product list.
Valid FSC or marketing authorization letter.
Copies of previously issued Registration Certificates and endorsements.
A self-declaration affirming that product details remain unchanged.

These documents help CDSCO validate that the products and manufacturers continue to meet Indian standards and are safe for public use.

Who Can Apply for Form 42 and Form 43?

The following individuals or organizations are permitted to apply for the Import of Cosmetic products using Form 42 and receive the certificate in Form 43:

The manufacturer with a registered office in India.
The manufacturer’s authorized agent or representative.
A subsidiary or affiliate of the manufacturer.
Any authorized importer based in India.

Registration Validity and Processing Time

Once a complete application is submitted under Form 42, the Registration Certificate in Form 43 is usually issued within 90 days, depending on the completeness and accuracy of the application.

As per Rule 129C of the Drugs and Cosmetics Rules, 1945, the Registration Certificate must be issued within six months of receiving the application. In exceptional cases, the authority may take longer, but only after providing written justification.

Once issued, the Registration Certificate under Form 43 is valid for three years from the date of issuance. After three years, the certificate must be renewed using the re-registration process.

Conclusion

Import of Cosmetic products into India is a regulated process under the Drugs and Cosmetics Act, 1940. The Central Drugs Standard Control Organization (CDSCO) acts as the regulatory authority responsible for overseeing the import and registration process. Form 42 is the application form, and Form 43 is the Registration Certificate required for legally importing cosmetic products into the Indian market.

Obtaining Form 43 via a properly submitted Form 42 is essential for ensuring that imported cosmetics meet Indian safety and quality standards. Whether you are a manufacturer or an importer, understanding and following the correct procedures and documentation requirements is key to successful and smooth entry into the Indian cosmetic market.

By maintaining a strong compliance framework, India ensures that cosmetic products used by its citizens are safe, effective, and manufactured following proper international standards.

If you need any help with CDSCO Registration, then you can book a consultation with Compliance Calendar LLP experts through email at info@ccoffice.in or Call/Whatsapp at +91 9988424211.

FAQs

Q1. What is the purpose of Form 42 in the cosmetic import process?

Ans. Form 42 is the application form submitted to the CDSCO by an importer or manufacturer’s authorized agent to obtain a Registration Certificate for importing cosmetic products into India. This form must be filled with detailed product and manufacturer information, along with the required documents and fee.

Q2. What does Form 43 signify in the registration process?

Ans. Form 43 is the Registration Certificate issued by CDSCO after reviewing and approving the Form 42 application. It allows legal import and marketing of the cosmetic products mentioned in the certificate within India for a validity period of three years.

Q3. Who can apply for Form 42 and Form 43?

Ans. The manufacturer with a registered office in India, their authorized representative, any subsidiary or affiliate of the manufacturer, or any authorized Indian importer can apply for Form 42 and receive Form 43 from CDSCO.

Q4. What is the validity period of Form 43?

Ans. Once issued, Form 43 is valid for a period of three years from the date of issuance. Importers must apply for re-registration before the certificate expires to continue lawful import of the products.

Q5. Can one Form 42 application include multiple cosmetic products or brands?

Ans. Yes, one Form 42 application can cover multiple brands and products from the same manufacturer, even if manufactured at different facilities. This makes the process more streamlined and cost-effective.

Q6. What documents are required for the import of cosmetic products?

Ans. Some of the key documents include a covering letter, signed Form 42, challan receipt of fee payment, power of attorney, Schedule D(III), product labels, Free Sale Certificate, testing methods, marketing approvals, and product inserts.

Q7. What is the typical timeline for receiving Form 43 after submitting Form 42?

Ans. Generally, Form 43 is issued within 90 days of submitting a complete and valid Form 42 application. However, as per Rule 129C, it can take up to six months in certain cases where additional review is needed.

Q8. What happens if the Registration Certificate is not renewed on time?

Ans. If the Form 43 certificate is not renewed before its expiry, the importer may face restrictions or penalties, and the import of the specified cosmetic products will no longer be legally permitted until a new certificate is obtained.