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**Executive Summary:**
This circular from the Central Drugs Standard Control Organization (CDSCO) announces a change to the application process for registration and import of cosmetics via the SUGAM online portal. To streamline processing and ensure timely disposal of applications as per the Cosmetics Rules, 2020, the number of products per online application will be restricted. This restriction will be effective from August 16, 2024.
**Key Points / Main Content:**
* **Purpose:** To streamline the processing and disposal of cosmetic registration and import applications.
* **Restriction on Number of Products:**
* A maximum of fifty products will be allowed per single online application.
* Multiple applications can be submitted.
* **Implementation Date:** The restriction will be implemented from August 16, 2024.
* **Application Platform:** SUGAM online portal.
**Impact Analysis**
* **Cosmetics Associations/Concerned Stakeholders:**
* *Impact:* Will need to adapt to the new application limit when submitting applications for cosmetic registration and import.
* *Action Required:* Note the change and ensure that applications submitted on or after August 16, 2024, comply with the new restriction.
* **JDCIs/DDCIs of CDSCO HQ:**
* *Impact:* Will be responsible for processing applications under the new guidelines.
* *Action Required:* Implement the new restriction on the number of products per application starting August 16, 2024.
Key Entities Referenced
Central Drugs Standard Control Organization: A national regulatory body in India responsible for the regulation of pharmaceuticals and medical devices.
Cosmetics Rules, 2020: Indian regulation governing the manufacture, import, and sale of cosmetics.
SUGAM: Online portal used by the Central Drugs Standard Control Organization for application submissions related to drugs and cosmetics.
eGovernance: The application of information and communication technology (ICT) for delivering government services, exchange of information, transactions, integration of various systems and services between Government-to-Citizen (G2C), Government-to-Business (G2B), Government-to-Government (G2G) as well as back office processes and interactions within the entire government framework.
FDA Bhawan, New Delhi: Location of Central Drugs Standard Control Organization Cosmetics Division.
Dr. Rajeev Singh Raghuvanshi: Drugs Controller General of India
Directorate General of Health Services: An attached office of the Department of Health and Family Welfare.
Import of Cosmetics: Importation of cosmetics into India which is regulated by CDSCO
File No.: COS-11018(11)/18/2024-eoffice
Government of India
Directorate General of Health Services
Central Drugs Standard Control Organization
(Cosmetics Division)
FDA Bhawan, New Delhi
Dated:
9 9 AUG 2024
Circular
In pursuance to the implementation of e-Governance vide F No.
D21013/230/2016-DC dated 2" December 2016, Central Drugs Standard
Control Organization (CDSCO), receives various applications for
registration and Import of Cosmetics including post approval change
through SUGAM on-line portal.
In order to further streamline the process, it has been decided to restrict
the number of products to a maximam of fifty per single online
application and multiple applications can be made. This has been
evolved for processing and disposal of the applications within stipulated
time line as per the Cosmetics Rules, 2020.
The said restriction will be implemented w.e.f 16% August 2024. All
stakeholders are requested to note the said change for submission of
applications on SUGAM online portal.
(Dr. Rajeev Si aghuvansi)
Drugs Controfler General (India)
Copy to:
1. All Cosmetics Associations/Concerned stakeholders
2. JDC(I)s/DDC(I)s of CDSCO(HQ)