When Is Re-Registration Required For Cosmetics In India?

Understanding the scenarios in which re-registration required for cosmetics in India can help businesses ensure compliance with the rules and regulations. Whether you’re an Indian manufacturer or you have an international cosmetic brand, being aware of the procedure and when to re-register is vital for ensuring compliance with legislation.

In India, the Central Drugs Standard Control Organization regulates cosmetic products. However, there may be situations in which companies need to re-register their products. The following circumstances can be changed in ingredients, change in formulation, changes in packaging, or changes in the location at which the product was manufactured.

This article will review all the situations when a re-registration is required for cosmetics, so companies can identify how to go through the re-registration process. For easier understanding, this guide includes a listing of required documents and process steps.

What Is Cosmetic Re-Registration?

Cosmetic re-registration is used in a situation when a new cosmetic registration certificate can be issued because of a change in product or registration particulars that is not considered a normal renewal. Cosmetic re-registration differs from the usual CDSCO cosmetic license renewal, which is done before the expiry date of a current certificate. Re-registration becomes necessary when:

• There’s a change in the manufacturer’s details,
• The brand name is altered,
• There’s a shift in the manufacturing location,
• Or any critical technical specifications are updated.

When Is Re-Registration Of Cosmetics Required?

Below are key scenarios where re-registration required for cosmetics under CDSCO norms:

1. Change In Manufacturer’s Name Or Ownership

If there is any change to the name of the manufacturing company in a legal manner, or the company is merged or acquired, or the ownership changes, even if a new registration has been issued in the future, a new registration certificate must be issued. CDSCO will consider this a different entity, even if the product is otherwise unchanged.

2. Change In Manufacturing Site

If your cosmetics are manufactured in a different location or factory, you will need to apply for new registration. Each manufacturing location must be inspected and approved by CDSCO, and the certificate is for the location described in the original registration.

3. Brand Name Change

A change in the brand or product name automatically invalidates the existing registration. Even if the formulation and packaging remain identical, a new cosmetic registration certificate must be obtained for the updated branding.

4. Change In Product Composition Or Formulation

If the product experiences any changes to the ingredients, formulation, or specifications, however minor, the CDSCO requires a new registration. This is because the revised product is considered a new product, and they want to make sure that the product satisfies safety requirements and labelling requirements as specified by Indian cosmetic regulations.

5. Addition Of New Product Variants

When introducing new shades, fragrances, or variations under an existing cosmetic brand, re-registration required for cosmetics, depending on whether the variant is covered under the same category and formulation.

6. Lapsed Registration Not Renewed On Time

If a registration certificate expires and the renewal was not initiated within the allowed time (minimum six months before expiry), the applicant must apply for a fresh registration. There is no provision for late renewal.

Why Is Re-Registration Necessary?

The CDSCO places high importance on consumer safety. Any change that could affect the safety, efficacy, or quality of a cosmetic product requires a fresh evaluation. Re-registration helps:

• Maintain accurate records in the CDSCO database
• Ensure product compliance with the latest regulatory norms
• Prevent legal or import issues at Indian ports
• Build consumer trust through regulatory transparency

Cosmetic Re-Registration Vs Cosmetic Renewal

Here’s the difference between re-registration required for cosmetics and cosmetic renewal:

Parameter	Cosmetic Re-Registration	Cosmetic Renewal
Purpose	Required due to major changes in registration details	Required when the certificate is nearing expiration
Trigger	Change in manufacturer, formulation, location, etc.	Time-based, usually before the 5-year validity ends
Timeline	Any time during the validity, based on the change	Must be filed at least 6 months before expiry
Process	New application, treated like a fresh registration	Similar to initial registration, but with continuity
CDSCO Form	Form 42 and Form 43	Form 42 and Form 43 (renewal with updated documents)

Documents Required For Re-Registration

Here is the list of documents for re-registration required for cosmetics:

• Power of Attorney (in original and legalized)
• Product labels as per Indian norms
• Product specification and testing reports
• Details of the manufacturer and the manufacturing site
• Safety and stability data
• List of ingredients with composition
• Declaration of changes made

Always consult with a professional regulatory consultant or licensing agent to ensure complete documentation.

Step-by-Step Re-Registration Process

Here is a list of steps for the re-registration required for cosmetics certificate process:

1. Assess the Change: Identify the nature of change (manufacturer, site, formula, etc.) and verify whether it qualifies for re-registration or just an amendment.
2. Prepare Documentation: Compile all documents related to the new manufacturer, site, product formulation, or branding.
3. File Online Application: Submit the re-registration application via the SUGAM Portal of CDSCO using Form 42, along with the applicable government fees.
4. CDSCO Review: CDSCO will review the documents, seek clarifications if required, and may inspect the site or product if deemed necessary.
5. Issuance of New Registration: If approved, a new Form 43 certificate will be issued, valid for five years from the date of issue.

How ELT Corporate Pvt. Ltd. Can Help?

Re-registration of a cosmetic product with the Central Drugs Standard Control Organization (CDSCO) is often necessary when:

A product registration certificate (Form COS-2) has expired (CDSCO’s 2023 Annual Report confirmed that they will not review your renewal application without a historical record of previous registration).

There are changes to the formulation, labeling, and packaging, or changes in ownership of the brand;

The regulatory requirements or guidance from the CDSCO have changed.

ELT Corporate Pvt. Ltd. provides expert and compliant end-to-end guidance on the cosmetic product’s re-registration process in accordance with the Drugs and Cosmetics Rules, 1945, in India.

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