SUGAM : An e-Governance Solution for CDSCO SUGAM : An e-Governance Solution for CDSCO cdscoonline.gov.incdscoonline.gov.in

Modules & Processes Modules & Processes

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VeterinarVeterinaryy

NOTE: Certificates/NOC for Export of Drugs functionality is disabled from SUGAM and power delegated to STATE.

Import of DrugsImport of Medical DevicesImport of CosmeticsImport of Veterinary Clinical Trials NOCBA-BE NOCTest LicensePermission to manufacture/Import

NOC

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License ApprovalsCitizen Centric Info Approved DrugsNSQ DrugsApproved Clinical trials

Inter department Communication, Data sharing with national portal, national health portal

G2BG2B

G2CG2C G2GG2G

G2EG2EPersonal Information system Budget information SystemStores Management SystemFile Tracking SystemLibrary Management System

Services DeliveredServices Delivered

SUGAM: Key Features & AchievementsSUGAM: Key Features & Achievements……Ke

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Register with SUGAM PortalRegister with SUGAM Portal

Purpose of Registration Purpose of Registration • Applicant can register with different purposes with the assigned roles and forms given

below: Purpose of Registration Roles on SUGAM Document Requirement Forms Available

Cosmetics Registration Applicant for Cosmetics ID Proof Details, Power Of Attorney, Corporate Address Proof

Form 42

Ethics Committee Registration Ethics Committee ID Proof Details, Power Of Attorney, Corporate Address Proof

Form CT-01

Formulation R&D Organization Formulation R&D Organization ID Proof Details, Power Of Attorney Form12, Form CT-10/CT-12/CT-13/CT-16

Import or Manufacture of drugs/Test License

Corporate Importer (Application in Form 8) Foreign Enterprise holding Indian Subsidiary Indian Agent

ID Proof Details, Power Of Attorney, Corporate Address Proof and Manufacturing License or Wholesale Licenses (Form 20B & Form 21B

For Importer: (Form 8, Form 12, Form CT-16) For Others:(Form 40, Form 8, Form 8A, Form12, Form CT-10/CT-12/CT-13/CT-16, Form CT-05/CT-04/CT-18/CT-21)

BA/BE Approved Sites BA/BE Approved Sites ID Proof Details, Power Of Attorney, Corporate Address Proof

Form CT-04/CT-05, Form12 , Form CT-10/CT-12/CT-13/CT-16

Sponsors (BA/BE & CT) Sponsors (BA/BE & CT) ID Proof Details, Power Of Attorney, Corporate Address Proof

Form CT-04/CT-05, Form12 , Form CT-10/CT-12/CT-13/CT-16,

User Registration – For Application Submission User Registration – For Application Submission Purposes for registration on SUGAM portal.

1. For application submission and receive permissions/licenses.

2. For uploading Manufacturing and Formulation data.

To Register for application submission

• Step 1: Open link www.cdscoonline.gov.in , Click on ‘Sign Up Here’ to register yourself on the portal .

• Step 2: In the opened window fill out Applicant’s Registration Details.

• Step 3: After filing up the details click on check box “I agree to the CDSCO terms of service and privacy policy” and submit the application.

• Step 4: Check your registered email , click on the validation link to validate to email id.

• Step 5: After clicking the verification link, registration application of the user will be sent for approval to the concerned authority (CDSCO Officials).

• Step 6: In case of approval/rejection of the application, a mail will be sent to user's registered email id.

To Login

• Step 1: Enter the login credentials in the ‘Sign In’ Box and click on ‘Login’.

• Step 2: After login, in the opened window click on ‘Menu’ on top of left hand side to view the options.

User Registration - For Data Upload User Registration - For Data Upload To Register for uploading Manufacturing and Formulation data

• Step 1: Open link www.cdscoonline.gov.in , Click on ‘Guidelines for uploading data for Manufacturing and Formulation data’ to register yourself on the portal .

• Step 2: In the opened window fill out Applicant’s Registration Details.

Each firm needs to do self-registration for each of its site with unique valid email id through the following link : https://cdscoonline.gov.in/CDSCO/UserRegistrationForm

• Step 3: After filing up the details click on check box “I agree to the CDSCO terms of service and privacy policy” and submit the application.

• Step 4: On submission of registration form, the user needs to enter OTP that will be either sent on email/ SMS. Once OTP is entered correctly, user account will be activated and user will be able to login to SUGAM for uploading the data.

• Step 5: Further, user needs to update its site address (One time updating), license details and subsequently needs to update its product details against each of the license

• Step 6:  Step by step guidance for  uploading of data is provided at the following link: https://cdscoonline.gov.in/CDSCO/resources/app_srv/cdsco/global/helpfiles/Manufacturer_sign_up.pdf

Sub-LoginsSub-LoginsSUGAM allows corporate user accounts to create Sub-Login accounts for the following:-

• Branch Office

• CRO

• Manufacturing Site

• R&D Site

Note: To create sub login credentials users has to first add the details of the other offices under user Profile section in the ‘Add Manufacturing License details’ / ‘Add R&D Sites’ / ‘Add Branch Offices’. Once you add these details, the list of offices will be available for you to create sub-login accounts under create Sub-logins section.

How To Submit an Application form?How To Submit an Application form?

Departments & Forms availableDepartments & Forms availableS. No. Modules CDSCO Departments / Stakeholders Processes Forms Available

1 CDSCO HQ Import & Registration Fresh Registration certificate(RC), Endorsement & re-registration,Post submission & Post Approval Changes (PAC)

Form 40 / 41Form 8 / 10Form 8A, 17 Cases of PAC

Veterinary Fresh Registration certificate(RC), Endorsement & re-registration,Post submission

Form 40 / 41Form 8 / 10

Medical Devices & Diagnostics Post Approval Changes 17 Cases of PAC

Cosmetics Registration Fresh RC, Endorsement, Re-registration Form 42 / 434 Cases of PAC

Ethics Committee Registration Ethics committee registration & re-registration Form CT-01/CT-02

Global Clinical Trials Permission to conduct Clinical Trials Import license for Test & Analysis

Form CT-04 / CT-06Form CT-16/CT-1711 Cases of PAC

BA/BE Permission to conduct BA/BE studies, Import license for Test & Analysis Form CT-05/CT-07Form CT-16/CT-17

Biological – New Drugs-Vaccines Permission to Market / Import / Conduct Clinical trials Form CT-04/CT-18/CT-21Form CT-06/CT-19/20/CT-22/23

New Drugs/ SND/ FDC/IND Permission to Market / Import / Conduct Clinical trials Form CT-04/CT-18/CT-21Form CT-06/CT-19/20/CT-22/23

4. CDSCO Port Offices

Port Offices ( 7 Locations) Permission to Import Drugs in small quantity for personal use Form 12A/ 12B

5. CDSCO Zone Zonal / Sub Zonal Offices Import License for Test & Analysis, for Drugs more than 4 years (Old Drugs)

Form 12 / 11Form CT-10/CT-11, CT-12/CT-14, CT-13/CT-15, CT-16/CT-17

Forms as per the New Drugs and Clinical Trials Forms as per the New Drugs and Clinical Trials Rules, 2019 Rules, 2019 S. No.

Type of Form Division Application

Permission/ License

1 Registration/Renewal of Ethics Committee Relating Clinical Trial or Bioavailability and Bioequivalence Study or Biomedical Health Research

Ethics Committee CT-01 CT-02

2 Registration of Ethics Committee Relating To Biomedical Health Research Ethics Committee CT-01 CT-03

3 Permission to Conduct Clinical Trial of New Drug or Investigational New Drug GCT, Biologicals, FDC, NDD, SND, IND

CT-04 CT-06

4 Information to Initiate Clinical Trial of New Drug or Investigational New Drug as Part of Discovery, Research and Manufacture in India

GCT, Biologicals, FDC, NDD, SND, IND

CT-04A

5 Permission to Conduct Bioavailability or Bioequivalence Study BA/BE CT-05 CT-07

6 Registration/Renewal of Bioavailability or Bioequivalence Study Centre International Cell CT-08 CT-09

7 Permission to Manufacture New Drug or Investigational New Drug for Clinical Trial or Bioavailability or Bioequivalence Study or For Examination, Test and Analysis

Biologicals, FDC, NDD, SND, IND, Zonal office

CT-10 CT-11

8 Permission to Manufacture Formulation of Unapproved Active Pharmaceutical Ingredient for Test or Analysis or Clinical Trial Or Bioavailability Or Bioequivalence Study

Biologicals, FDC, NDD, SND, IND, Zonal office

CT-12 CT-14

9 Permission to Manufacture Unapproved ActivePharmaceutical Ingredient for Development of Formulation for Test or Analysis or Clinical Trial or Bioavailability or Bioequivalence Study

Biologicals, FDC, NDD, SND, IND, Zonal office

CT-13 CT-15

Forms as per the New Drugs and Clinical Trials Forms as per the New Drugs and Clinical Trials Rules, 2019 Rules, 2019

S. No.

Type of Form Division Application

Permission/ License

10 Licence to Import New Drug or Investigational New Drug For Clinical Trial or Bioavailability or Bioequivalence Study or For Examination, Test and Analysis

BA/BE, GCT, Biologicals, FDC, NDD, SND, IND, Zonal Office

CT-16 CT-17

11 Permission to Import New Drug for Sale or for Distribution Biologicals, FDC, NDD, SND, IND

CT-18

12 For New Active Pharmaceutical Ingredient Biologicals, FDC, NDD, SND, IND

CT-19

13 For Pharmaceutical Formulations of New Drug Biologicals, FDC, NDD, SND, IND

CT-20

14 Permission to Manufacture New Drug Formulation for Sale or For Distribution Biologicals, FDC, NDD, SND, IND

CT-21

15 For New Active Pharmaceutical Ingredient Biologicals, FDC, NDD, SND, IND

CT-22

16 For Pharmaceutical Formulations of New Drug Biologicals, FDC, NDD, SND, IND

CT-23

17 Licence to Import of Unapproved New Drug for Treatment of Patients Of Life Threatening Disease in a Government Hospital or Government Medical Institution

Biologicals, NDD CT-24 CT-25

18 Permission to Manufacture Unapproved New Drug But Under Clinical Trial for Treatment of Patients of Life Threatening Disease in a Government Hospital or Medical Institution

Biologicals, NDD CT-26 CT-27

Forms as per the New Drugs and Clinical Trials Forms as per the New Drugs and Clinical Trials Rules, 2019 Rules, 2019 # Main Forms Sub-Category Input (Applicant) Output (Permission)

1 CRO Registration   CT-08 CT-09

2 Ethics Committee   CT-01 (CDSCO-CT /DHR-BHR) CT-02 (CDSCO), CT-03 (DHR)

3 Marketing Authorization   CT-18, CT-21 CT-19, CT-20, CT-22, CT-23

4 BA/BE Studies

Manufacturing-CT-10, CT-11, API-CT-12, CT-14, Formulation-CT-13, CT-15 CT-05, CT-16 CT-07, CT-17Import-CT-16, CT-17

5 Clinical Trials   CT-04, CT-4A, CT-10, CT-12, CT-13, CT-16

CT-06, CT-11, CT-14, CT-15, CT-17

6 Import for Test and Analysis   CT-16 CT-17

7 Manufacturer for Test and Analysis Active Pharmaceutical Ingredient (API) CT-10, CT-12 (FF), CT-13 (API) CT-11, CT-14, CT-15

8 Manufacture of Unapproved new drug for patient treatment   CT-26 CT-27

9 Import of Unapproved new drug for patient treatment   CT-24 CT-25

Forms as per the New Drugs and Clinical Trials Forms as per the New Drugs and Clinical Trials Rules, 2019 Rules, 2019 Division Form CT-10 Form CT-12 Form CT-13 Form CT-16

Biologicals Simultaneously applied along with Form CT-04

Simultaneously applied along with Form CT-04

Simultaneously applied along with Form CT-04

New Drugs Simultaneously applied along with Form CT-04

Simultaneously applied along with Form CT-04

Simultaneously applied along with Form CT-04

SND Simultaneously applied along with Form CT-04

Simultaneously applied along with Form CT-04

Simultaneously applied along with Form CT-04

IND Simultaneously applied along with Form CT-04

Simultaneously applied along with Form CT-04

Simultaneously applied along with Form CT-04

FDC Simultaneously applied along with Form CT-04

Simultaneously applied along with Form CT-04

Simultaneously applied along with Form CT-04

GCT Simultaneously applied along with Form CT-04

BA/BE Simultaneously applied along with Form CT-05

An applicant can simultaneously apply for CT-16 along with application in Form CT-04 under GCT Division.An applicant can simultaneously apply for CT-16 along with application in Form CT-05 under BA/BE Division.An applicant can simultaneously apply for CT-10 or CT-12 or CT-13 along with application in Form CT-04 under Biologicals, New Drugs, SND, IND & FDC Divisions.

Users Role in Application SubmissionUsers Role in Application Submission

JDCI (Signing Authority)

Activity· Receive : Acception/ Rejection

Request· Respond : Accept/ Reject Request

Nodal Officer (ADC)

Activity· Allocate Application to DI· Receive Query/ Acceptation / Reject

Request· Raise Query or Send permission /

Rejection Letter

Drug Inspector

Activity· Receive Application· Evaluate and generate Query/

Acceptation/ Rejection Report

DCGI

Activity· View Reports· View Submitted Applications

Applicant

Activity· Submit Application· Receive Query/ Acceptation/

Rejection Report

CDSCO Admin

· Activity

Approve Registration Form· View Master Forms

Application Submission (1/2) Application Submission (1/2) Step 1: Click on Menu on the top of left hand side.

Step 2: Click On Application Submission Tab.

Step 3: Under Application Submission Tab ,Click On Form Submission.

Step 4: In Form Submission, Select Department and Select Form.

Step 5: In Select Department, select Import & Registration.

Step 6: In Select Form, select Form 8.

Step 7: Tick on “I agree that I will provide accurate information and I will be solely responsible for any false or inaccurate information provided to the division”.

Step 8: Click on Proceed.

Step 9: Select the category for which you want to apply , choose one option between two of them

1. Apply as Corporate

2. Apply on behalf of Manufacturing Unit

Application Submission (2/2) Application Submission (2/2) Step 10: Click on Proceed.

Step 11: Submission of any form involves 6 steps

1. Fill Form (Fill all the required details)

2. Preview (Preview of the filled form)

3. Checklist (Upload all the essential documents)

4. Payment (Enter payment details)

5. Full Preview (Click on Generate Pdf Button to take the print of the form)

6. Upload Form (Upload Form 8 whose print was taken in Full Preview Step)

Post Submission Changes (1/2)Post Submission Changes (1/2)• Amendments refer to the

post submission changes to the already submitted or approved applications.

Post Submission Changes (2/2)Post Submission Changes (2/2)

Online Payment – Payment LinkOnline Payment – Payment Link

Online Payment – Challan DetailsOnline Payment – Challan Details

Online Payment – BharatKosh Payment GatewayOnline Payment – BharatKosh Payment Gateway

Online Payment – Payment StatusOnline Payment – Payment Status

Raise Query & Reply to Queries RaisedRaise Query & Reply to Queries Raised• Based on Reviewing Office (RO) evaluation, each checklist item would be marked with a

status i.e. ‘• Document Found OK’ or ‘Raise Query’

• If status is set as ‘Raise Query’ then RO is required to type the content of Query in the checklist webpage.

• Reply of the raised query will come to the dashboard of nodal officer for further scrutiny and he will forward request to the concerned official. However, all senior level officials who have initially reviewed the application will also be able to view the reply of raised query.

• After each complete cycle of review of application, the next chapter of Note sheet will start. Therefore, when RO and other senior levels will again scrutinize the application, their comments will go into the new chapter of Note sheet.

Submitting a Post Approval Application Submitting a Post Approval Application

Post Approval (1/2)Post Approval (1/2)• User can apply for any changes or amendments in the permission issued to them as per below table.

S.No. Division Case

1 Cosmetics •Change in address of Indian Agent in RC (without change in constitution, legal & actual manufacturer and any other technical documents)•Change of name of Legal Manufacturer in RC(Without Constitution Change)•Change of address of legal manufacturer in RC(Location Change)•Change of address of legal manufacturer in RC(No Location Change)

2 Import & Registration

•Change of shelf life in RC (Extension)•Change of shelf life in RC (Reduction)•Deletion of Site involved in Manufacturing of Drug•Change in address of Registered manufacturer in RC(No Location Change)•Change of Name of Manufacturer in RC without constitution change•Change of pharmacopoeial specification in RC•Addition of site involved in manufacturing of drug•Change In manufacturing process, or in packaging, or in labeling or in testing, or in documentation of any of the drug pertaining to Registration Certificate •Change in foreign manufacturer address in RC(No Location Change)•Change of pharmacopoeial specification of drug ingredient in finished formulation in RC

3. DCGI Division •Change in name of firm(Indian Agent, Importer, Corporate)

Post Approval (2/2)Post Approval (2/2)S.No. Division Case

4 Medical Devices & Diagnostic

•Change of shelf life in RC (Extension)•Change of shelf life in RC (Reduction)•Change of (Legal) address of manufacturer in RC(No Location Change)•Change of (Actual) address of manufacturer in RC(No Location Change)•Change of (Legal) address of manufacturer in RC(Location Change)•Change of (Actual) address of manufacturer in RC(Location Change)•Change in Address of Indian Agent•Change of Name of Actual Manufacturer in RC without constitution change•Change of Indian Agent in RC (With Constitution change)•Updation of Package Insert•Change of Name of Legal Manufacturer in RC without constitution change•Change of Name of Legal Manufacturer in RC (with constitution change)• Change of Name of Actual Manufacturer in RC (with constitution change)•Change In manufacturing process, or in packaging, or in labeling or in testing, or in documentation of any of the device pertaining to Registration Certificate •Line Extension of Additional Model Nos or Model Names•Extension of Indication

5 Global Clinical Trial •Site addition (GCT)•Site Closure or Deletion (GCT)•Major Protocol Amendment (GCT)•Other amendments (Minor PA or IB or ICF or IMPD or CRF)•Change in Central Laboratory (GCT)•Notification for Clinical Study Report (CSR)•Update Developmental Safety Update Report (DSUR)•Update Interim Analysis Report (IAR)•Premature study withdrawal or study closure (GCT)•Notification for Annual Status Report (ASR)•Notification for (PSUR)

Application Processing By OfficialsApplication Processing By Officials

Application Workflow for Approval by CDSCO Application Workflow for Approval by CDSCO OfficialsOfficials

The process flow of an application through various officials of a division is as follows:

Step 1: Receiving of file by the Nodal officer of concerned division.

Step 2: Application scrutiny by Reviewing Officer (RO), Subsequent level and Licensing Authority (LA).

Step 3: Application scrutiny by Licensing Authority (LA).

Step 1 : Application Processing by Nodal Officer Step 1 : Application Processing by Nodal Officer (NO)(NO)

• Application received by the Nodal Officer• Allocate application to concerned Reviewing officer (RO) for scrutiny• Transfer the application to some other Reviewing officer with proper

justification(if the previous RO is not available)• View Form : View the submitted form• View Checklist: View/Review all uploaded documents against each checklist item

with proper comments and following decision.• Document Found OK• Query OK• Change Query

• Generate Note Sheet• Send File

Step 2 : Application Processing by Licensing Step 2 : Application Processing by Licensing Authority (LA) and Subsequent level Authority (LA) and Subsequent level

• View Form : View the submitted form• View/Modify Checklist: View/Review all uploaded documents against each checklist

item with proper comments and following decision.• Document Found OK• Query OK• Change Query

• Generate Note Sheet• Send File• After Approval from LA, RO has the following option

• Generate Cover Letter• Generate Permission

Step 3 : Application Processing by Deputy Decision Step 3 : Application Processing by Deputy Decision Authority (DDA) and Decision Authority (DA)Authority (DDA) and Decision Authority (DA)• View Form : View the submitted form• View Checklist: View/Review all uploaded documents against each checklist

item with proper comments and following decision.• Document Found OK• Query OK• Change Query

• Generate Note Sheet• Send File• Raise Query

Step 4: ApplicantStep 4: Applicant Dashboard (if query is raised on Dashboard (if query is raised on the application)the application)• View Form : View the submitted form• View/Response Query: View all uploaded documents against each checklist item and

reply against the query raised document with proper comments and supportive documents.

• Edit Form• View checklist• Withdraw Application

Step 5:- Application Processing by Licensing Step 5:- Application Processing by Licensing AuthorityAuthority

• View Form

• View Checklist• View all uploaded documents against each

checklist item.• View base query generated by RO• Change final query if required

• Generate Note Sheet

• Send File - Send this application back to any of the lower levels who have worked on this application for further clarification/amendments.

• Approve - Approve the application if there are no raised queries.

• Reject - Reject the application with justification to be given in note sheet.

• Query - Send Query to applicant

Uploading Manufacturing Sites & Uploading Manufacturing Sites & Formulations DataFormulations Data

Data upload of Manufacturing sites & Data upload of Manufacturing sites & FormulationsFormulations

Generation of unique ID for Generation of unique ID for Manufacturing Site & Manufacturing Site &

FormulationFormulation

Data Captured from ManufacturerData Captured from Manufacturer

Manufacturer registration on SUGAM portal for adding Manufacturer registration on SUGAM portal for adding Manufacturing Unit and Formulation detailsManufacturing Unit and Formulation details

Manufacturer registration on SUGAM portal for Manufacturer registration on SUGAM portal for adding Manufacturing Unit and Formulation detailsadding Manufacturing Unit and Formulation details

Manufacturer registration on SUGAM portal for Manufacturer registration on SUGAM portal for adding Manufacturing Unit and Formulation detailsadding Manufacturing Unit and Formulation details

Dashboard to add Manufacturing site and product Dashboard to add Manufacturing site and product informationinformation

Add Manufacturing site and License detailsAdd Manufacturing site and License details

Add Formulation DataAdd Formulation Data

Add Production detailsAdd Production details

Add Production CapacityAdd Production Capacity

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