India: WHO-GMP COPP Now Mandatory via ONDLS Portal (effective from 15 August 2025)

In its ongoing efforts to streamline pharmaceutical regulatory procedures and embrace digital transformation, the Central Drugs Standard Control Organization (CDSCO) has made it mandatory for all applications for the grant of the WHO-GMP Certificate of Pharmaceutical Product (COPP) to be submitted exclusively through the ONDLS portal.

Initially announced via Circular File No IT/COPP/ONDLS/2025/001 dated 25 June 2025, the directive emphasized that from 15 July onwards, physical files would no longer be accepted for the grant of WHO-GMP COPP or manufacturing licenses. All such applications were to be submitted online via the Online Drug Licensing System (ONDLS) portal.

This initiative is part of India’s broader regulatory modernization efforts, aimed at enhancing transparency, traceability, and operational efficiency in the pharmaceutical licensing process. The ONDLS portal already supports the processing and online licensing of sale and manufacturing licenses, Blood Centre licenses, and large volume parenteral.

Extension Granted: New Deadline – 15 August 2025

Following feedback from manufacturers and industry associations regarding onboarding challenges and technical preparedness, CDSCO issued a follow-up circular, CDSCO IT–13011 (12)/7/2025 dated 15 July 2025, officially extending the deadline to 15 August 2025.

The extension aims to support the industry in adapting to the new digital submission requirements without disrupting operational continuity.  Stakeholders have highlighted ongoing efforts to register and upload the necessary documents, with many requesting additional time.

To aid in this transition, CDSCO is organizing multiple knowledge sessions at Zonal and Sub-Zonal levels, providing stakeholders with guidance on portal navigation, documentation uploads, and procedural clarifications.

What This Means for Manufacturers

From 15 August 2025, the submission of physical files for WHO-GMP (COPP) applications and Grant of Manufacturing Licenses will be discontinued. All manufacturers are required to:

• Register on the ONDLS portal

• Submit applications and supporting documents via the portal only

• Avoid physical file submissions, which will no longer be accepted by any Zonal or Sub-Zonal offices

  
  

The Road Ahead

This digital shift reflects India’s continued commitment to regulatory best practices aligned with global standards. By enabling end-to-end online application processing, the ONDLS portal is expected to reduce delays, improve accountability, and foster a more efficient pharmaceutical compliance environment.

Manufacturers are encouraged to leverage this extension period to complete registrations, familiarize themselves with the system, and participate in CDSCO-led training sessions to ensure seamless adoption.

Source: Central Drug Standard Control Organization (CDSCO)