**Summary:**
This notice from the Central Drugs Standard Control Organization (CDSCO), dated 2018-07-04, announces the mandatory online submission of applications for the import and manufacture for marketing of Bulk Vaccines through the SUGAM portal (www.cdscoonline.gov.in). Effective immediately from the date of notice, CDSCO will no longer accept physical applications for Bulk Vaccines. This initiative is part of CDSCO's ongoing eGovernance implementation to reduce processing time and transaction costs for stakeholders. The notice is addressed to all pharmaceutical associations and relevant CDSCO officials. The Drugs Controller General India, Dr. S. Eswara Reddy, authorized the notice.
Key Entities Referenced
Dr. S. Eswara Reddy: Drugs Controller General of India (DCGI).
New Delhi: Capital of India, location of FDA Bhawan (Food and Drug Administration Bhawan).
Central Drugs Standard Control Organization: The national regulatory body for pharmaceuticals and medical devices in India. Also referred to as CDSCO.
SUGAM: An online portal launched by CDSCO for e-governance related to drug regulation.
Bulk Vaccine: Refers to vaccines in large quantities, subject to import and manufacturing regulations.
Ministry of Health Family Welfare: A ministry within the Government of India.
All Pharmaceutical Associations: Represents various pharmaceutical manufacturers and related organizations.
CDSCO / IT / 2018 - (33)
Government of India
Ministry of Health & Family Welfare
Directorate General of Health Services
Central Drugs Standard Control Organization
FDA Bhawan, New Delhi
Dated: 2¢ (ty loot 4
Notice
The Central Drugs Standard Control Organization (CDSCO) in pursuance to
implementation of e-Governance has launched an online portal 'SUGAM'
(www.cdscoonline.gov.in) on 14.11.2015. Various services rendered by CDSCO are
being rolled out in phases.
In the latest phase, module for submission of application for Import, manufacture for
marketing of Bulk Vaccine has been launched and the stakeholders are requested to
avail this facility which is intended to further reduce time and thereby the transaction
cost, with immediate effect.
It is now decided that from today onwards, no physical application for Bulk Vaccine
will be accepted and all applications should be mandatorily filed on the SUGAM portal.
Ozh.
(Dr. S. Eswara Reddy)
Drugs Controller General (India)
To
All Pharmaceutical Associations
Copy to
1. All ]DC(I), DDC(I), ADC(I) and Dis of Biological Division.
2. PPS to AS & DG, MoHFW
3. PPS to JS(R), MoHFW
4. Guard File
5. Website