The Central Drugs Standard Control Organization (CDSCO) has mandated that all applications for the WHO- GMP Certificate of Pharmaceutical Product (COPP) be submitted exclusively through the Online Drugs Licensing System (ONDLS) portal. This directive was issued on June 25, 2025 and will be effective from July 15, 2025.
The new directive marks a significant step in the digitization of regulatory services for the pharmaceutical industry. Effective immediately, all zonal and sub-zonal offices of CDSCO will only accept COPP applications made through the ONDLS portal. Manual submissions or applications through other means will no longer be considered valid.
This initiative is part of a broader strategy by the Ministry of Health and Family Welfare to modernize pharmaceutical regulation and improve transparency, efficiency, and traceability in the issuance of critical export documentation. The COPP is a vital certificate required for the export of pharmaceutical products to several countries and serves as evidence that a pharmaceutical product is authorized for sale in the exporting country.
CDSCO has urged all stakeholders to familiarize themselves with the ONDLS system to ensure seamless compliance with the updated procedure. The ONDLS portal offers features such as real-time tracking of application status, document management, and automated alerts, which are expected to reduce processing times and improve communication between applicants and regulatory authorities.
