Food and Drugs Administration, (FDA) Haryana, India. |
Email ID: dahiya19@yahoo.com
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Last Updated on July 31, 2025 by The Health Master
WHO-GMP
The Online National Drugs Licensing System (ONDLS) is a unified online platform designed for processing various applications related to manufacturing and sales licenses for drugs, including those for Blood Centers, WHO-GMP certificates, CoPPs, and other certificates.
The portal can be accessed at www.statedrugs.gov.in.
Here’s a step-by-step procedure for applying for WHO-GMP certificate and Certificate of Pharmaceutical Products (CoPPs) on the ONDLS portal:
Login/Registration:
Access the ONDLS homepage.
Click on “Login/Register“.
You can log in by entering your registered mobile number to receive an OTP, or by using your username and password.
Submitting Existing License (for WHO-GMP & CoPP):
For WHO-GMP and CoPP applications, first submit your existing license through the “Old License Management” tile.
Ensure your existing license is approved by the respective State FDA.
If you wish to retain an old license, submit its data through the “Old License Management” tile for FDA verification.
After FDA verification of old license data, you can file for retention/renewal or endorsement or post-approval.
No details can be changed or updated after successful submission of the application or old license data.
Initiating a Fresh Application:
From the Manufacturer Dashboard, click on “Application Processing“.
Then, click on “Fresh Application Submission“.
Selecting Application Type and Form Name:
On the “Application Draft Initial Page,” select “Issue of Certificate” as the Application Type.
Under “Form Name,” select “Certificate of Pharmaceutical Product (COPP)”.
Firm Detail Confirmation:
Confirm the applicant firm details, including Firm Name, Firm Constitution, Firm Address, Site Type, and Site ID.
Select the “Authorized Person” and click “Save Details“.
Proceeding with CoPP Application:
Select whether you are applying for “New Products For Which Inspection is Required” or “Old Products For Which Inspection is Not Required“.
“New Products For Which Inspection is Required” refers to products where inspection was not conducted during the WHO-GMP inspection.
“Old Products For Which Inspection is Not Required” refers to products inspected during the WHO-GMP inspection but for which CoPP was not previously applied.
Adding Product Details for CoPP:
Select the relevant “Licence” from the active licenses available.
Select the “Product” from the list available for the chosen license.
Select the “Brand.”
If the brand is not registered, you can register it by clicking “Add Brand“.
Select the “Country” (you can choose multiple countries, and a separate CoPP certificate will be generated for each product-country combination).
Fill in the Brand Name and Brand Details, then click “Save Brand Detail“.
After adding the brand, the brand name will appear for the selected product.
Generating and Uploading Form 51:
Select your brand and click “Generate Form 51“.
Download Form 51, get it signed and sealed, and then upload it.
Click to upload the signed Form 51 and then click “Submit“.
Confirm and Proceed:
After saving the product data, it will be displayed in a table.
You can also delete any drafted products.
Click “Confirm and Proceed“.
Checklist Document Validation and Upload:
Upload all required checklist documents.
For each document, click to upload the related document, add remarks, and submit.
After uploading all required documents, click “Proceed“.
Payment Details:
Upload the challan details for payment.
Click on “Save & Proceed“.
Application Preview and Final Submission:
Review the application preview.
Click “Final Submission“.
After final submission, you will receive an application number.
Tracking Submitted Application:
You can track the status of your submitted application by going to the “Application Processing” tile and then “Submitted Application“.
You can also take further steps by clicking on the “Action Button“.
Compiled by:
Rakesh Dahiya, Asstt. State Drugs Controller, FDA Haryana
