**Summary:**
The Central Drugs Standard Control Organization (CDSCO), under the Directorate General of Health Services, has issued a notice on April 3, 2017, regarding the creation of databases for drug manufacturing facilities and approved drug formulations on the SUGAM portal. As part of its eGovernance program, CDSCO has developed modules within the SUGAM portal (https://cdscoonline.gov.in) to facilitate the creation of these databases, along with a database of retail and wholesale licenses.
All pharmaceutical drug manufacturers not yet registered on SUGAM are required to register their firms via the "Register Data with State FDA" section on the SUGAM homepage. Upon online submission of the registration form, the respective State Drugs Controller will verify the details and activate the account. Once activated, manufacturers can submit the required data. A user manual is available to guide the data submission process.
Firms with manufacturing facilities in multiple states need only register once on SUGAM; data for each facility can be submitted from a single account. Existing SUGAM users can access the data submission form through their user profile.
Inquiries can be directed to the respective State Drugs Controller or via email to ithelpdeskcdsco.nic.in or to Sh. R Chandrasekhar, DDCI, eGovernance Cell at ranga.cscdsco.nic.in.
Key Entities Referenced
Sh. R Chandrasekhar: DDCI, eGovernance Cell. Contact person for queries regarding SUGAM portal.
Central Drugs Standard Control Organization: A national regulatory body in India responsible for the regulation of pharmaceuticals and medical devices.
Drugs Controller General India: The head of the Central Drugs Standard Control Organization (CDSCO) in India.
SUGAM: An online portal developed by CDSCO for filing, tracking, and processing applications related to various services rendered by CDSCO.
State Drugs Controller: The drug regulatory authority for each state in India, responsible for authentication of data uploaded by manufacturers on the SUGAM portal.
FDA Bhawan, Kotla Road New Delhi: Address of Central Drugs Standard Control Organization office.
Directorate General of Health Services: An attached office of the Department of Health and Family Welfare.
All Drug Manufacturers Associations: Associations representing pharmaceutical manufacturers in India.
CDSCO/IT/2017- (7)
Directorate General of Health Services
Central Drugs Standard Control Organization
0/o Drugs Controller General (India)
FDA Bhawan, Kotla Road
New Delhi:110002
Dated: 03.04.2017
NOTICE
Sub: Creation of databases of drug manufacturing facilities and approved drug formulations on
SUGAM portal-regarding
CDSCO as part of its comprehensive e-Governance program has launched the online portal
“SUGAM” for filing, tracking and processing of applications for the various services rendered by CDSCO.
The portal is being developed in phases.
In the latest phase, modules for the creation of databases of drug manufacturing facilities,
approved drug formulations and retail and wholesale licenses in the country have been developed under
the portal SUGAM. In regard to the database of the drug manufacturing facilities and approved drug
formulations the data is to be uploaded by the respective manufacturer and subsequently authenticated
by the Concerned State Drugs Controller.
All pharma drug manufacturers, not yet registered in SUGAM, are hereby requested to register
their firm under SUGAM portal at https://cdscoonline.gov.in. The registration page can be accessed
from the “Register Data with State FDA” section of the homepage of SUGAM. This section is available as
you scroll down the home page. Once the web form is filled up and submitted online, the details will be
verified by the respective State Drugs Controller and your account will be activated by him. After the
account is activated you have to submit the data as per the procedure provided. A user manual with
detailed steps is provided for ease of operation. Please note that the firm has to be registered only once
on SUGAM even if a firm is holding manufacturing facilities in more than one State. No separate
registration is required on SUGAM for each additional site. However, the data regarding the facilities
located in various States can be submitted from single account.
The existing users of SUGAM can fill their manufacturing facility details from their user profile.
For any queries in this regard please contact your State Drugs Controller or you may write to us
at it-helpdesk@cdsco.nic.in or to Sh. R Chandrasekhar, DDC(I), e-Governance Cell at
ranga.cs@cdsco.nic.in
Yours faithfully,
(Dr/G. N Singh)
Drugs Controller General (India)
To;
All Drug Manufacturers/Associations
Copy to:
1. All State Drugs Controllers
2. PPS to JS(R)