SUGAM

and
National Drugs Licensing System
National Database of Manufacturer & Formulations

0-Self 3-Update
2-Update
Registration Formulations 4-Approval 5-Upload
1- Login to manufacturi 6-Apply for
of data from State production
Portal ng license GMP/COPP
manufacturi manufacture FDA details
data for site
ng Site d at each site

Generation of unique ID for

Manufacturing Site &
Formulation
Data Captured from Manufacturer
Formulation Production
User Manufacturing Formulations
Production Capacity of
Registration Site Details Details
Details Site
Drug Type
License No (BD/FDC/Single)
Quarterly quantity
Applicant Details produced
Generic Name
Form No Dosage Form
Brand Name Pack size
Manufacturing Site
Name & Address Date of Issuance Dosage Form(Capsules
etc)
Batch No
Pharmacological
Site Type (Own License validity Classification
/Loan)
Indication MRP
Issuing Authority Strength
Pack Presentation
Manufacturing
license copy License Document Ingredients
PTS
Manufacturer registration on SUGAM portal for adding
Manufacturing Unit and Formulation details
Manufacturer registration on SUGAM portal for
adding Manufacturing Unit and Formulation details
Manufacturer registration on SUGAM portal for
adding Manufacturing Unit and Formulation details
Dashboard to add Manufacturing site and product
information
Add Manufacturing site and Licence details
Add FormulationData
Add production details
Add production Capacity
National Drugs Licensing System
Scope of Work for National Drug Licensing System
• Online Licensing system application submission and grant/ renewal of licenses for
1. manufacturing and sales of pharmaceuticals- Drugs, Vaccines and Blood Products.

• Online process for amendments in the approved licenses and permissions.

2.

• Online process for application and issue of certificates and no objection certificates (NOC)
3.

• Online Processes for Pharmaceutical Product Surveying

4.

• Online process for Enforcement Activities carried by State Drug Controller Officers
5.

• Management Information System(MIS) and Analytical platform

6.

• Software Administration
7.
Work In Progress
• Online Licensing system application submission and grant/ renewal of licenses for
1. manufacturing and sales of pharmaceuticals- Drugs, Vaccines and Blood Products.

• Online process for amendments in the approved licenses and permissions.

2.

• Online process for application and issue of certificates and no objection certificates (NOC)
3.

• Online Processes for Pharmaceutical Product Surveying

4.

• Online process for Enforcement Activities carried by State Drug Controller Officers
5.

• Management Information System(MIS) and Analytical platform

6.

• Software Administration
7.
 Portal Features

Configurable ,
Registrations
Role based, Online Online Post Communicatio Report an
(Unique Id
Workflow Processes Submission Submission n Platform Issue
generation)
enabled

Location
enablement Manufacturing Manufacturing Tracking
Submission for SMS
Unit
additional For Applicants
State Admin documents
creation
Sale Review
Official Technical
e-Mail
registrations Member Staff

PAN India Surveying Query

Resource Pool of
Technical Persons Amendments For Officials
State FDA
e-Vaartalaap
Technical Staff Officials Enforcement Approvals
Tracking
 Available Roles
Super
Admin Future addition of Roles
State FDA
State
officers
Admin
(NO,RO,LA) Wholesaler /
Retailer

Blood Banks

State Drug Manufactur

Controller Stakeholders er/ Firm
Enforcement
officers

State Labs
Technical
Wholesaler
Staff(Site/L
/Retailer
ab)

Bloood
Banks
Business Rules Applicable for developed processes

Loan Site will be able to register to portal after own site user registration is approved

User Registration of Technical Staff and allocation of unique id mandatory

Manufacturer authorized person should provide valid email & mobile no and furnish

One Technical Staff can be engaged in one manufacturing site

Applicant (Owner) should provide details of its facilities before filling up application for
manufacturing license

Loaner will use facility details of owner site

On receipt of application at official end the verification of its facility details must be done

There could be only 5 chapters of query at the time of application processing

Applicant Processes

6. Post
Submission
5. Application Notifications to
Form Departments
4. Formulation Form 29/30 against
Details Application
3. License Manufacturing
Drug name License Form
Details Dosage
2. 24/24A,
License type Composition
Manufacturing 25/25A,27/28,2
1. Users Site Facility License No Indication 7A/28A,27B/28
Onboard ( Schedule M) Validity B,24A/25A,Lice
…Registratio Dosage Form nce to re-pack
Copy of License drugs 24B/25B
n Process Manf site
Manufacturer facilities
(Owner/ Lab facilities
Loaner)
Technical Staff
State Drug
Controller Staff
Department Processes

Manufacturer Application
Application Facility detail
registration e-Vartalaap allocation & Approval/Grant
receipt approval
approvals review
File Processing & Available Roles in the Department
File gets processed at various levels in hierarchy – Nodal officer, Reviewing Officer, Deputy Decision Authority,
Decision Authority, Licensing Authority
Maximum allowed officer levels in software : 5
Maximum number of chapters of query : 5
Number of items to be queried : No limit
Generally, officer Generally, officer View all applications

Reviewing Officer(RO)
Nodal Officer(NO)

designated : ADC designated : Drug received in department

Licensing Authority
Receives applications Inspector Review Documents &
from Applicant First level review of Query items
View Submitted Docs Application & Raise Query to Applicant
Documents
Assign File to Reviewing Approve/ Reject
Officer Generate Note sheet Application
Review Comments of RO Send file with his Generate Permission/
comments to NO/LA License

(LA)
Review Documents
Generate permission on Upload Permission/
Receive post submission approval by LA
requests License
Receive query response
Receive query response
Roadmap
Launch of phase -3
services

Launch of phase -2
services

Drug Surveying and

Enforcement
Sale Licenses
Launch of phase -1
services
Certificates Related
to manufacturing
CLAA Workflow
Remaining forms of
Pre Launch Manufacturing
manufacturing
License & Test
User Registrations License
license

Registration
User & Profile
Building
(Firm/Technical
members/
Officials)
 National Portal : Functionalities to be released in First Phase

User License Facility Application Application

Roles Super Admin Admin
registrations Management Details Submission Processing
• Manufactur • Super • Enable • Approve • License • Dosage • Form 30 • Allocation
er admin Locations- manufactur Details Forms • Form 24 • Review
• Technical • Local Admin States on er accounts • Drug Details • Site Details • Form 24F • Query
Person & • State portal & • Lab Details • Grant
generation Licensing • Creation of generation
of unique Authorities ( local admin of unique
technical NO, RO, accounts manufacturi
person ID DA,DDA, LA) ng unit ID
• Manufactur • Create
er/ Firm credentials
for state
• Technical
officials
Person