Notification/Circular No. – CIDSCO IT-13011(12)/7/2025 dated August 7, 2025
Applicable Act/Rule: Drugs and Cosmetics Act, 1940
The Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, has reiterated that all applications for WHO-GMP (Certificate of Pharmaceutical Product – COPP) must be submitted exclusively through the ONDLS portal, effective August 15, 2025. This requirement was originally mandated via Circular No. IT/COPP/ONDLS/2025/001 dated June 25, 2025, with physical submissions discontinued from July 15, 2025. However, considering stakeholder representations, the deadline for discontinuing physical submissions was extended until August 15, 2025, as per Circular No. CDSCO T-13011(12)/7/2025 dated July 15, 2025.
CDSCO has conducted multiple awareness and training sessions—both physical and hybrid—at Zonal and Sub-Zonal levels from July 21, 2025, in collaboration with CDAC officials, to ensure smooth adoption of the online system. These sessions addressed queries from State Licensing Authorities (SLAs) and pharmaceutical stakeholders.
No extension beyond August 15, 2025, will be granted for physical submissions. Manufacturing units are required to submit applications for WHO-GMP (COPP) approval through the ONDLS portal from August 15, 2025.
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