**Summary:**
The Central Drugs Standard Control Organization (CDSCO), under the Directorate General of Health Services, Government of India, announces the extension of its e-governance initiative, implemented through the SUGAM online portal (www.cdacoonline.gov.in), to include online submission of applications for Blood Products Registration Certificates and Import Licenses. Effective immediately, applicants seeking these registrations are required to register on the SUGAM portal and upload their historical data. A meeting of all stakeholders (firms involved in filing applications for registration and import licenses of blood products) will be held on September 6, 2018, at 11:00 am at CDSCO HQ, FDA Bhawan, Kotla Road, New Delhi. The purpose of the meeting is to discuss the online submission process and gather input/suggestions from stakeholders. Dr. V.G. Somani, Joint Drugs Controller India, issued the notice (F.No:X11026052018BP).
Key Entities Referenced
Central Drugs Standard Control Organization: A national regulatory body in India responsible for the approval of pharmaceuticals, medical devices, and cosmetics.
CDSCO HQ, FDA Bhawan, Kotla Road, New Delhi: Headquarters of the Central Drugs Standard Control Organization, located in New Delhi, Delhi.
SUGAM: An online portal launched by the Central Drugs Standard Control Organization (CDSCO) for e-governance in the pharmaceutical sector.
Registration Certificate: A certificate required for the registration of blood products with the CDSCO.
Import Licenses: Licenses required for importing blood products into India, regulated by the CDSCO.
Blood Products: Products derived from human blood, subject to regulation by the CDSCO.
Dr.V.G.Somani: Joint Drugs Controller India
E-Governance: Implementation of electronic governance to deliver services online.
F.No:X-11026/05/2018-BP
Government of India
Directorate General of Health Services
Central Drugs Standard Control Organization
(Biological Division)
FDA Bhawan, New Delhi
Dated: ,
Notice
The Central Drugs Standard Control Organization (CDSCO) in pursuance to
implementation of E-Governance has launched an_ online portal “SUGAM”
(www.cdacoonline.gov.in)
on 14.11.2015. Various services rendered by CDSCO are
being rolled out in phases.
Now the service is being extended to online submission of blood products
Registration Certificate and Import Licenses and it has been decided that applicants
desiring to apply for grant of said registration shall register in the portal for uploading
their historical data.
In this regard, it is decided to convene a meeting of all stake holders i.e. firms
involved in filing of application of registrations and import licenses of blood products on
06.09.2018 at 11:00am in CDSCO (HQ), FDA Bhawan, Kotla Road, New Delhi. It is
also proposed to give inputs/suggestions by the stakeholders on the same during the
meeting.
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—
(Dr.V.G.Somani)
Joint Drugs Controller (India)
To
All Stake Holders Concerned