9th July, 2025

🔍 Introduction

In a significant move toward the digitization of drug regulatory processes in India, the Central Drugs Standard Control Organization (CDSCO), in collaboration with the Centre for Development of Advanced Computing (CDAC), has introduced a major update for pharmaceutical manufacturers and exporters by integrated a new feature into the Online Drug Licensing System (ONDLS) portal.

This update now facilitates seamless submission and processing of WHO-GMP (COPP) applications by eliminating paperwork and manual intervention.

This strategic shift is designed to enhance transparency, operational efficiency, and ensure timely processing of regulatory submissions across the pharmaceutical manufacturing and export sectors.

 📅 Mandatory Timeline: 15 July 2025

According to the official CDSCO circular, dated 15.07.2025,

physical submissions of COPP applications will not be accepted by CDSCO or State Drug Licensing Authorities after 15.07.2025.

All manufacturers are therefore instructed to:

  • Complete portal registration
  • Update relevant license data
  • Transition to online submission before the cutoff date.

🧾How to Submit WHO-GMP COPP Application via ONDLS Portal

To file smoothly, manufacturers need to complete these steps in the ONDLS portal before submitting a COPP application:

  1. Register the manufacturing site
  2. Register technical staff currently listed on the valid manufacturing license
  3. Add all licensed products using the existing license management data
  4. Update basic license details
  5. Submit updated data to the relevant State Drug Regulatory Authority
  6. Once approved, a new license number will be generated
  7. Only then can the COPP application be filed online

🤝 How Vaayath Can Help You Navigate the ONDLS Transition

At Vaayath, we understand that regulatory transitions can be challenging—Our team of compliance experts and technical consultants provides end-to-end assistance to ensure your organization transitions to the ONDLS portal with No disruption and full compliance.

âś… Our ONDLS Support Services Include:

  • Online registration of manufacturing units and technical staff
  • Validation and formatting of license data for digital upload
  • COPP application drafting and portal-based submission
  • Compliance checks and document readiness review
  • Real-time tracking, updates, and escalation management

Whether you’re a manufacturer or a global exporter relying on WHO-GMP certification, Vaayath ensures you’re ready, compliant, and ahead of deadlines.

đź“© Need help? Contact us at info@vaayath.com

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