**Summary:**
Effective August 16, 2017, the Central Drugs Standard Control Organization (CDSCO) will exclusively accept online applications for fresh import registration, endorsement, and re-registration of cosmetics via the SUGAM portal (www.cdscoonline.gov.in). This decision follows the successful implementation of e-governance initiatives and a significant increase in online applications since the service's launch on June 6, 2016. As of July 6, 2017, over 449 approvals have been granted through the SUGAM portal. While the transition to online applications is implemented for the aforementioned processes, applications for post-approval changes and amendments will continue to be accepted offline until the SUGAM portal is updated by CDAC to accommodate these submissions. This notice, issued by the Drugs Controller General of India on July 6, 2017, is addressed to all cosmetics associations, concerned stakeholders, and relevant CDSCO officials (JDCIs and DDCIs of CDSCO HQ).
Key Entities Referenced
Central Drugs Standard Control Organization: The national regulatory body for pharmaceuticals and medical devices in India.
CDSCO: Abbreviation for Central Drugs Standard Control Organization.
Import registration of Cosmetics: The regulatory process for registering imported cosmetic products.
SUGAM portal: Online portal used for filing applications, specifically for import registration of cosmetics.
Digital India: A Government of India initiative to transform India into a digitally empowered society and knowledge economy.
CDAC: Centre for Development of Advanced Computing, an organization providing technological solutions.
Dr. . Singh: Drugs Controller General of India
New Delhi, Delhi: Location of FDA Bhawan
FDA Bhawan, New Delhi
Date:
k 6 JUL 2017
Notice
The Central Drugs Standard Control Organization (CDSCO), in pursuance of
implementation of e-Governance has rolled out online service for filing applications for the
Import registration of Cosmetics on the SUGAM portal (www.cdscoonline.gov.in) w.e.f.
06.06.2016. In this regard, a notice dated 30.05.2016 has been published & uploaded on the
CDSCO website.
Overall review of the online service for filling applications for import registration of
Cosmetics have been carried out and it has been observed that in recent months there is a
continuous rise in the percentage of online applications vis-a-vis offline mode. The increasing
trend towards filing online applications by the applicants are very encouraging since more than
449 approvals have been granted through SUGAM portal. This trend commensurates with the
Government’s vision of Digital India. In view of these trends, it has been decided that the
cosmetics import registration application for fresh registration, endorsement and re-registration
shall be received through online mode only on the SUGAM portal of CDSCO from 16" August
2017 onwards and applications for post approval changes and amendments shall be accepted
through offline mode until provision for such applications in the SUGAM portal is provided by
CDAC.
(Dr. . Singh)
Drugs Controller Genéral (India)
To:
1. All Cosmetics Associations/ Concerned stakeholders
2. JDC(1)s/ DDC(1)s of CDSCO (HQ)