**Summary:**
The Central Drugs Standard Control Organisation (CDSCO), under the Directorate General of Health Services, Government of India, has launched an online module for processing applications for Written Confirmation Certificates (WCC). This initiative, developed in collaboration with CDAC, is in accordance with Article 46b(2)(b) of Directive 2001/83/EC, addressing EU requirements for the import of active substances used in medicinal products for human use. The module is accessible through the SUGAM portal at https://cdscoonline.gov.in. Stakeholders are encouraged to utilize the online facility and provide feedback for improvement. Physical applications for WCC issuance will no longer be accepted after July 23, 2021. Inquiries and suggestions can be directed to the Drugs Controller General of India, Dr. V. G. Somani. This notice is addressed to the Bulk Drug Manufacturers Association India (BDMAI) and all stakeholders via the CDSCO website. Copies have been distributed to all Zonal and Sub-Zonal Offices of CDSCO and the CDAC Team.
Key Entities Referenced
Directorate General of Health Services: An organization under the Government of India, related to health services.
Central Drugs Standard Control Organisation: A national regulatory body for pharmaceuticals and medical devices in India.
New Delhi, Delhi: The location of the Central Drugs Standard Control Organisation (CDSCO) office.
SUGAM portal: An online portal used by CDSCO for providing eGovernance services.
CDAC: Centre for Development of Advanced Computing, collaborated with CDSCO to develop the online module.
Written Confirmation Certificate: A certificate required for import of active substances into the European Union.
European Union: The destination for import of active substances requiring Written Confirmation Certificate.
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 7/7 [ 2<-|
Notice
Subject: Module for online processing of applications for issuance of Written
Confirmation Certificate (WCC) — Regarding
CDSCO in pursuance to implementation of the e-Governance mechanism has
launched various online services through the “SUGAM” portal on 14.11.2015. In
continuation to same, CDAC in collaboration with CDSCO has developed a module for
online processing of applications for issuance of Written Confirmation Certificate as per
requirement of EU for import of active substances into the European Union (EU) for
medicinal products for human use, in accordance with Article 46b(2)(b) of Directive
2001/83/EC.
The module is finalized and has been made functional, which can be accessed
through https://cdscoonline.gov.in. All concerned stakeholders are requested to avail
this facility and any comments/suggestions to help improve the module shall be
welcomed and addressed properly.
Thereafter, the WC application processing will be online and physical
application for issuance of WCC may not be accepted after 23.07.2021 in this regard.
ue
(Dr. V. G. Somani)
Drugs Controller General (India)
To,
1. Bulk Drug Manufacturers Association India (BDMAI)
2. All Stakeholders through CDSCO Website
Copy to:
1. All Zonal and Sub-Zonal Offices of CDSCO
2. CDAC Team