How To Handle Post-Approval Changes In CDSCO Cosmetic Registration

In the last 10 years, India has had an increasing demand in the consumer cosmetics market and has continued to experience growth, mostly fueled by the demand for high-quality international cosmetics. The Central Drugs Standard Control Organization (CDSCO) is the governing authority for all cosmetics sales within India, including local and imported cosmetics, and about safety, quality, and compliance. Registering cosmetics for sale in India is a slow process, and for those cosmetics that are imported, they must first register and receive CDSCO approval.

The process extends once the approval and registration have been granted to the manufacturer for a cosmetic. Manufacturers can change and modify their registered cosmetics. In India, registration is not a one-time approval, but is a recertification process. Once CSDO approved and registered, a manufacturer can change the cosmetics formulation, packaging, the label, and even the site of production. Any regulatory change to a cosmetic must be formally submitted for acknowledgment and/ or approval under Indian law if a regulatory approval change is warranted.

This article outlines each step to handle post-approval changes in CDSCO cosmetic registration, configuration of alterations, compliance obligations, post-approval change process, documentation, and best practices.

Understanding Post-Approval Changes In CDSCO Cosmetic Registration

Changes that occur after approval refer to changes in a cosmetic product or any registration information related to a cosmetic product made after obtaining a Registration Certificate (Form COS-2) from the Central Licensing Authority. Changes may be administrative, technical, or commercial. Depending on the nature of the change, this may require new registration, an amendment, or simply a notification to CDSCO.

3 Types Of Post-Approval Changes And Their Requirements

To manage perceived risk to product registration, CDSCO has a risk-based classification scheme for post-approval changes, which is linked to changes to the original product registration. It is important for businesses to understand the categories so they can assess whether they need to re-register the product, amend it, or notify the authority.

1. Changes Requiring Fresh Registration

Some changes are substantial and result in the original product registration becoming invalid. In such cases, companies must submit a new application for cosmetic registration in Form COS-1.

Examples of changes that require fresh registration include:

• Change in the manufacturer’s name or address
• Change in the legal constitution of the manufacturer or Indian agent
• Change in the ownership or transfer of product rights
• New manufacturing site or addition of an unapproved site
• Major change in product formulation affecting safety or efficacy

Such changes require a new application along with all supporting documentation, including a power of attorney, GMP certificate, detailed formulation, and label artwork.

2. Amendments Not Requiring Fresh Registration

Some post-approval changes do not affect the safety or quality of the product significantly. In these cases, companies can submit an amendment request through the SUGAM portal to update the registration.

Examples of amendable changes include:

• Updates in packaging materials or pack sizes
• Minor changes in product labeling or artwork
• Change in the testing method or specifications (without impacting safety)
• Extension of shelf life supported by stability data
• Inclusion of additional variants with similar base formulations

These changes require justification, supporting documents, and sometimes test reports. Approval is granted by CDSCO after review, and the registration certificate remains valid.

3. Changes Requiring Notification or Intimation Only

Minor changes that do not impact the registered product’s specifications or regulatory status can be simply notified to the CDSCO. In most cases, such notifications must be submitted within 15 to 60 days of implementing the change.

Typical examples include:

• Change in the Indian agent’s contact details
• Change in the address of the registration holder (within the same legal entity)
• Withdrawal of certain SKUs or variants
• Change in artwork without altering product claims

These changes must be communicated to CDSCO along with a declaration that there is no change in the product’s quality, efficacy, or intended use.

How To Submit Post-Approval Changes In CDSCO Cosmetic Registration Via Sugam Portal?

To submit post-approval changes via the CDSCO’s SUGAM portal, follow these steps:

1. Log in to the SUGAM Portal: Go to the official CDSCO website home page and log in with your user information.
2. Locate and click on “Post Approval Changes.” Once you are logged into the SUGAM portal, you will see a specific section or menu item titled Post Approval Changes.
3. Click on the Appropriate Category: After monitoring a specific scenario (e.g., changes to a drug approval, an import license, etc.), identify the appropriate post approval change you are requesting.
4. Complete the Application: The online application process should describe the procedure for recording the fields of interest, including your relevant CDSCO file number and your previous application’s PKR. 
5. Uploading Required Documentation: Before you commence this process, make sure you have the appropriate cover letter and documentation required to support your request and have it saved in the specified format and with the required labels for uploading. Follow the guidelines in the SUGAM online application.
6. Pay Application Fee (if applicable): If you are applying for a change that previously required a fee for your original application, pay online.
7. Submit Your Application: After completing the SUGAM sections as indicated above using the online external application form, submit your application.
8. Track the Status: You may track the status of your application using the same login info you used to apply.

Documentation Required for Post-Approval Changes

The documents needed for post-approval changes in CDSCO cosmetic registration vary as on the type of change. Here is the list of documents for the most common changes:

For Fresh Registration:

• Application Form COS-1
• Cover letter and justification
• Certificate of Incorporation and IEC (Import Export Code)
• Authorized Indian agent details
• GMP certificate of the new manufacturer
• Power of Attorney
• Complete formulation details
• Product testing methods
• Packaging and labeling information

For Amendments:

• Cover letter describing the change
• Copy of existing Registration Certificate (Form COS-2)
• Revised artwork or product labels
• Justification and supporting documents
• Shelf life or stability data (if applicable)
• Updated testing reports or technical documentation

For Notifications:

• Cover letter and self-declaration
• Existing registration certificate
• Proof of change (e.g., updated address or contact)
• Undertaking for compliance with Indian regulatory standards

Timeline For Post-Approval Changes In CDSCO Cosmetic Registration

The CDSCO generally processes post-approval amendments within 30 to 60 working days. However, timelines may vary based on the complexity of the change and the completeness of the submission. Simple notifications may not take more than two to three weeks.

Fees for amendments are generally lower than for fresh registrations. The fee structure is available on the CDSCO portal or can be confirmed through the latest CDSCO guidance document.

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