Brief about The Central Drugs Standard Control Organisation (CDSCO)

Works under:  DGHS, Ministry of Health & Family Welfare. It is a National Regulatory Authority (NRA) of India.

Location: FDA Bhawan, Kotla Road, New Delhi 110002

Zonal offices: 6    Sub-zonal offices: 4 Port offices: 13 Laboratories: 7

Main Act putting the responsibilities: The Drugs & Cosmetics Act,1940 and rules 1945

  • Under the Drugs and Cosmetics Act, CDSCO is responsible for
  • Approval of New Drugs
  • Conduct of Clinical Trials
  • Laying down the standards for Drugs,
  • Control over the quality of imported Drugs in the country
  • Coordination of the activities of State Drug Control Organizations by providing expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act.
  • Along with state regulators, is jointly responsible for grant of licenses of certain specialized categories of critical Drugs such as blood and blood products, I. V. Fluids, Vaccine and Sera.

SUGAM Portal: SUGAM builds a comprehensive database of the various permissions and licenses issued by State FDAs.

This includes details of 1. Manufacturers 2. Manufacturing site 3. Drug formulations.

Manufacturer can view their consolidated data about permissions issued to them from State FDA.

Sugam compressed pic

To Sign Up – For Manufacturer for Adding Manufacturing Unit and Formulations

General Guidelines for State FDA Dashboard

General Guidelines for Manufacturer

Registration guidelines for SUGAM Portal

Points to be Noted:

  • Applicant who can register on the portal are Corporate, Indian Agent, Importer, Foreign Enterprise holding Indian Subsidiary.
  • Manufacturing Unit cannot directly register on the portal.
  • Corporate will create login credentials for the manufacturing unit and these credentials will be used by the manufacturing unit for login on the portal.

Guidelines for Form Submission (Guidelines for Export NOC)

Guidelines for Creating Sub-Logins

How to use SUGAM Portal: Video Tutorials

Frequently Asked Questions

  1. Who can register on CDSCO online portal?

Following users can register on CDSCO online portal:

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

2. How do I get my login credentials on CDSCO online portal?

To get login credentials on CDSCO online portal, go to ‘Sign up Here’ link available under ‘Sign In’ section on homepage of portal. Fill out the required details and upload the essential documents. Please note that the email id provided in this form should be an official email id. All correspondence w.r.t. CDSCO online portal would be done on this registered email id.

After successful registration, check your registered email id for further action. Once your email id gets verified, you are required to submit all the uploaded documents during registration in Hard Copy to CDSCO office for verification.

You will receive your login credentials on the registered email id after completion of verification process from CDSCO office.

Manufacturing unit(s) working under any Corporate Unit need not to register themselves on CDSCO portal. They can get their login credentials from the registered corporate user.

  1. I am not able to receive any confirmation mail from CDSCO Online Portal?

Check your Junk/Spam folder for CDSCO PORTAL mails. If you are receiving our mails in Junk/Spam then you can save “cdscoonline-noida@cdac.in” in your contacts. If you are still not able to find the mails, then kindly contact the Administrator. To report your problem to Administrator, please refer ‘Report a Problem’ section on home page of portal.

  1. I am not able to use SMS service of CDSCO Online Portal?

You will receive SMS alerts only if you have selected the option to receive SMS at the time of registration. If you still do not receive SMS then please check whether DND (Do Not Disturb) service is activated on your mobile phone. If No, then kindly contact the Administrator. To report your problem to Administrator, please refer ‘Report a Problem’ section on home page of portal.

  1. How do I submit a form to any division of CDSCO?

To submit a form to any of the division of CDSCO, follow below steps:

Login with your credentials

Go to ‘Submit Application’ link available on the dashboard.

Select division and the required form and click on the ‘Proceed’ button. Please ensure that you read the mandatory guidelines displayed on this webpage.

  1. I am not able to find my application which I have saved earlier?

All saved applications are visible in Saved Applications sub menu. Go to Menu>>Application Submission>>Click on Saved Applications. Displayed webpage contains all the Applications saved in Draft Mode. Each Application has different Actions and Status based on the stage of Application submission. For further processing, go to the action column and select the desired action. Now you can make the desired changes and submit the application.

  1. I am not able to find my submitted applications?

All submitted proposals are visible in Submitted Applications sub menu. Go to Menu>>Application Submission>>Click on Submitted Applications. Displayed webpage contains all the Applications which are submitted to CDSCO. To view the submitted form and checklist documents: – Go to action column in the displayed webpage and select the desired action.

  1. How do I get Endorsement/Re-registration on the RC issued to me earlier by CDSCO office?

If fresh/Re-registered RC is issued in the year 2012 or later, then you need to fill its details online. Follow below steps to fill your details:

Login with your credentials

Click on ‘Menu’ link available on left hand side on the top line displayed on dashboard webpage.

Go to Permissions Owned>>Add RC details link.

Enter RC details in the displayed webpage.

  1. How do I get Endorsement/Renew on the Import License issued to me earlier by CDSCO office?

If fresh/Renewed Import License is issued in the year 2012 or later, then you need to fill its details online. Follow below steps to fill your details:

Login with your credentials

Click on ‘Menu’ link available on left hand side on the top line displayed on dashboard webpage.

Go to Permissions Owned>>Add Import License Details link.

Enter Import License details in the displayed webpage.

  1. How do I view the details of historical data I have submitted online in CDSCO portal?

Follow below steps to view your online submitted historical data on CDSCO portal:

Login with your credentials

Click on ‘Menu’ link available on left hand side on the top line displayed on dashboard webpage.

Go to Permissions Owned>>View Permissions Owned.

Displayed webpage displays files with following status:

‘Saved as Draft’, if file is in draft mode.

‘Submitted to CDSCO’, if file is submitted to CDSCO.

‘Verified by CDSCO’, if details are verified and approved by CDSCO officials.

‘Rejected by CDSCO’, if details are rejected by CDSCO officials.

  1. I have submitted my historical data, but I am not able to apply for Endorsement/ Re-registration against it?

If you have already filled the details of the permissions you owe and still you are not able to apply for Endorsement/Re-registration against it, and then check status of your submitted application. You would be able to apply only if your submitted details get approve by CDSCO i.e. its status is ‘Verified by CDSCO’.

To view status of your submitted applications in section ‘Permissions owned’, follow below steps:

Login with your credentials

Click on ‘Menu’ link available on left hand side on the top line displayed on dashboard webpage.

Go to Permissions Owned>>View Permissions Owned.

Displayed webpage displays files with following status:

‘Saved as Draft’, if file is in draft mode.

‘Submitted to CDSCO’, if file is submitted to CDSCO.

‘Verified by CDSCO’, if details are verified and approved by CDSCO officials.

‘Rejected by CDSCO’, if details are rejected by CDSCO officials.

  1. How do I answer a raised query?

You can view and answer to the raised queries online. View submitted applications, if file status is ‘Query Raised’. Go to action column -> click ‘View/Modify checklist’ link. You will be able to upload the revised document against the checklist item for which query has been raised by CDSCO officials.

  1. I am not able to find my submitted applications?

All submitted proposals are visible in Submitted Applications sub menu. Go to Menu>>Application Submission>>Click on Submitted Applications. Displayed webpage contains all the Applications which are submitted to CDSCO. To view the submitted form and checklist documents: – Go to action column in the displayed webpage and select the desired action.

  1. How do I track the status on my submitted application?

You can view status of your submitted applications online. View submitted applications, in the displayed webpage check the ‘Status’ column to view status of submitted application.

Source: https://cdscoonline.gov.in/CDSCO/FAQ as accessed on 23 July 2018.

Import of Small Quantity of Drugs for Personal Use: Form 12A, Application status tracking can be done from here.

SUGAM AT A GLANCE : This part will give updated statistics over: Application count of total Applications received, Import & Registration Division, Medical Device & Diagnosis, Cosmetic Division, BA/BE Division, GCT Division, Ethics Division, Test Licence, Personal Licence, Biologicals Division, Export NOC Division, Subsequent New Drug Division, FDC Division.

Industry Information: This section contains following information

Guidelines & Approvals by CSDCO

List of state FDA approved manufacturing sites

Foreign Manufacturer & their sites

List of New Drugs Approved by CDSCO

Online System for Medical Devices

Disclaimer: The Information has been compiled from the SUGAM portal – An e-Governance solution for CDSCO as accessed on 23 July 2018. The site keeps on updating the information time to time, so readers are advised to visit the official website of SUGAM portal for latest updates. We do not take the guarantee of accuracy or any information & data pertaining to this publication.

 

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