Home India Ministry of Health and Family Welfare Additonal varant circular on 12.02.2025...
Date: 2025-02-12 Category: Not Applicable State: Union Government Country: India

Additonal varant circular on 12.02.2025

Issued by Ministry of Health and Family Welfare · Central Drugs Standard Control Organization

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Executive Summary & Key Takeaways

What it means

  • The Central Drugs Standard Control Organization (CDSCO) has issued a circular regarding the online application process for additional variants of already approved cosmetic products.
  • This circular announces the implementation of an online module on the SUGAM portal for submitting applications and obtaining permissions for additional variants of approved cosmetics.

Key Changes

  • A new online provision for application and issuance of permission for additional variants of approved cosmetics products has been developed on the SUGAM portal.
  • The module will be implemented 10 days after the date of the circular (17th May 2024).
  • Stakeholders are now required to submit applications for additional variants through the SUGAM online portal.

Impact Analysis

Cosmetic Manufacturers/Importers

  • Action Item: Ensure that all required documentation is available in a digital format suitable for online submission.

CDSCO

  • Action Item: Monitor the implementation of the new module and address any issues or concerns raised by stakeholders.

Cosmetics Associations

  • Action Item: Act as a liaison between their members and the CDSCO to address any questions or concerns.

Key Entities Referenced

CDSCO: Central Drugs Standard Control Organization, responsible for regulating drugs and cosmetics in India. SUGAM Portal: Online portal used by CDSCO for various application processes, including registration and import of cosmetics. Directorate General of Health Services: Government of India organization under which CDSCO operates.
Official Source Record View Original Source →
See Full Document Text
F.No. COS-1 1 018(11l,1 1 512024+otlice Government of lndia Directorate of General of Health Services Central Drugs Standard Control Organization (Cosmetics Division) FDA Bhawan, New Delhi Dated: ,lFttszoz5 C ircu la r ln pursuance to the implementation of e-governance vide F. No. D.210131230120'16 dated 02.12.2016, Central Drugs Standard Control Organization (CDSCO), receives various applications for registration and import of cosmetics including post approval change through SUGAM online portal. ln order to streamline the process, online provision for application and issuance of permission of additional variant (for already approved cosmetics products) is developed on SUGAM portal. The said module for additional variant will be implemented after 10 days from the date of this circular. All stakeholders are requested to note the said provision for submission of applications on SUGAM online portal. Raghuvanshi) Drugs Con ller General (lndia) Copy to: 1. All Cosmetics Associations/Concerned stakeholders through CDSCO website 2. JDC(l)s/DDC(l)s of CDSCo(HQ) 3. CDAC Team

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