**Summary:**
This notice, issued by the Directorate General of Health Services, Central Drugs Standard Control Organisation (CDSCO), Government of India, on September 9, 2021, concerns the online application process for Written Confirmation Certificates (WCCs). It follows up on a previous notice dated July 7, 2021, and announces the operational status of an improved module on the SUGAM portal for online WCC applications. The improvements incorporate suggestions and comments received from stakeholders. The notice mandates that all stakeholders holding valid WCCs must submit applications for any further endorsement or additional product through the "Historical mode" of application available on the applicant portal. This submission is compulsory for the issuance of WCCs with additional product endorsements. The notice is addressed to the Bulk Drugs Manufacturing Association India (BDMAI) for dissemination to its members, and to all stakeholders via the CDSCO website. Copies have been sent to all Zonal and Sub-Zonal Offices of CDSCO and the CDAC Team. The issuing authority is Dr. V. G. Somani, Drugs Controller General of India.
Key Entities Referenced
Directorate General of Health Services: An agency of the Government of India.
Central Drugs Standard Control Organisation: National Regulatory Authority responsible for regulating drugs and cosmetics in India.
New Delhi, Delhi: Location of the office issuing the notice.
Written Confirmation Certificate: A certificate issued for regulatory purposes related to drug manufacturing and export.
SUGAM portal: Online portal for processing applications, in this case, for WCC.
Bulk Drugs Manufacturing Association India: An association of drug manufacturers in India.
CDSCO Website: The official website of the Central Drugs Standard Control Organisation.
Dr. V. G. Somani: Drugs Controller General of India
7-5/2015/Misc/034 (e-Governance)
Government of India
Directorate General of Health Services
Central Drugs Standard Control Organisation
(International Cell Division)
FDA Bhawan, Kotla Road,
New Delhi-110002
Dated .
Notice 0 9 SEP 2021
Subject: Online Application for issuance of Written Confirmation Certificate (WCC) —-
Regarding
In continuation to this office notice of even number dated 07.07.2021 on the
subject cited above; it is informed that the suggestions/comments received from stakeholders
have been incorporated to help improve the module developed for online processing of
applications for WCC on SUGAM portal. The module is functional now.
In furtherance to same, for obtaining any further endorsement or additional
product, it is hereby requested to all stakeholders holding valid WCCs to submit applications
of already issued valid WCCs through “Historical” mode of application in the Module as
available on applicant’s portal. Such applications are compulsory from IT perspective for
issue of WCC for additional/endorsement of products in existing WCC.
a
(Dr. V. G. Somani)
Drugs Controller General (India)
To,
1. Bulk Drugs Manufacturing Association India (BDMAI) with request to disseminate
the information to its members
2. All stakeholders through CDSCO Website
Copy to:
1. All Zonal and Sub-Zonal Offices of CDSCO
2. CDAC Team