Professional Documents
Culture Documents
National Drugs Licensing System India
National Drugs Licensing System India
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
• Online process for application and issue of certificates and no objection certificates (NOC)
3.
• Online process for Enforcement Activities carried by State Drug Controller Officers
5.
• 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 application and issue of certificates and no objection certificates (NOC)
3.
• Online process for Enforcement Activities carried by State Drug Controller Officers
5.
• 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
Blood Banks
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
Manufacturer authorized person should provide valid email & mobile no and furnish
Applicant (Owner) should provide details of its facilities before filling up application for
manufacturing license
On receipt of application at official end the verification of its facility details must be done
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)
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
Registration
User & Profile
Building
(Firm/Technical
members/
Officials)
National Portal : Functionalities to be released in First Phase