34 Grant of WHO-GMP COPP through ONDLS portal 2025-Jun-25 80 KB

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----- Start of picture text -----<br> GREE " File No: IT/COPP/ONDLS/2025/001<br>“Se Government of India<br>7PAYAL Directorate General of Health Services<br>Feé: EN. ~ Central Drugs Standard Control Organization<br>a FDA Bhawan. Kotla Road,<br>soma Sra New Delhi-110002<br>----- End of picture text -----<br>

Dated 29 JUN 2025

To

All State/UTs Drugs Controllers

Sub: Grant of WHO-GMP COPP through ONDLS portal-reg.

Sir/Madam,

As you are aware that the ONDLS portal has been developed by CDAC in coordination with States for processing of application and online licensing of Sale/Manufacturing license, Blood Centre license and Grant of manufacturing License and Large Volume Parenterals. Recently, CDAC has also developed online portal for submission and processing of the application for grant of WHO-GMP (COPP) on the ONDLS Portal. Step wise procedure for registration with the ONDLS portal is annexed.

In view of the above, you are requested to direct the Manufacturing units under your jurisdiction to submit application for the approval of WHO GMP (COPP) through ONDLS portal from 15.07.2025. It may be noted that physical files will not be entertained for approval of grant of manufacturing License and WHO-GMP (COPP) from 15.07.2025. Further, CDAC may be contacted at uttamkumar@cdac.in or ondlssupport-noida@cdac.in & CDSCOC(it-cell@cdsco.nic.in) for any assistance regarding ONDLS portal.

This is for your information and necessary compliance.

Yours faithfully (Dr. Raje€v Si Raghuvanshi) ontroller General (India)

Copy to: 1. All Zonal and Sub Zonal office with direction not to accept the application in hard copy after the deadline mentioned above.

Annexure

Procedure for application of WHO/COPP Certificate

Before applying for grant ofWHO GMP/COPP Certificate to state authorities, the license and product details must be approved on ONDLS portal. The following steps are required for approval of product before filing COPP application by the applicant:

• 1. Manufacturing site registration
• 2. After registration ofmanufacturing site, details ofthe technical staffwhich are currently on license should be registered.
• 3. Add all license product through old license management data
• 4. Add license basic data through old license management data
• 5. Submit license data to the concern state drug regulatory
• 6. state drug regulatory approved the license data, New number will be generated against old license
  • number.
• 7. You can file the application once the data is approved.