27 Reminder of COPP Circular for Grant of WHO GMP COPP through ONDLS Portal 2025-Aug-07 551 KB

To All StateUTs Drugs Controllers Sir Madam, CIDSCO IT-13011(12)/7/2025 Governmcnt of India Dircctoratc General of Hcalth Services Central IDrugs Standard Control Organization PDA Bhawan. Kotla Road, Subjcet: Grant of WHO GMP COPP through ONDLS Portal reg. New Delhi-|10002 Datcd This is to inform all concerned that, as per Circular No. IT/COPP/ONDLS/2025/001 dated 25.06.2025, it was mandated that all applications for WHO-GMP (COPP) must be submitted exclusively through the ONDLS portal starting from 15.07.2025. Accordingly, physical submissions were to be discontinucd from that date. Copy to: 07 AUG 2025 However, considering various representations received from stakeholders and in support of industry intercsts, the dcadline was extended up to 15.08.2025, as communicated vide Circular No. CDSCO T-!3011(12)/7/2025 dated 15.07.2025. It is now re-cmnphasizcd that no physical applications/files will be accepted after 15.08.2025 for the grant of WHO-GMP (COPP). To facilitate a smooth transition, CDSCO has already conducted multiple physical and hybrid awareness and training sessions at Zonal and Sub-Zonal levels from 21.07.2025 onwards, in collaboration wih CDAC officials. Thesc scssions were attended by state authorities and Pharma stakcholders to address querics and ensure scamless adoption of the online system. It is requested that the SI.As cnsure proper mapping of the concerned officials along with their respective jurisdictions who arc handling these files, and that they may be instructed to approve the list of products after due verification. In view of the above, as the final deadline is approaching, it is rciteratcd that no extension beyond 15.08.2025 will be granted for the physical submission of applications for WHO-GMP (COPP) approval. Hence, you are rcquested to dircct the Manufacturing units under your jurisdiction to submit application for the approval of WIIO GMP (COPP) through (0NDLS portal from 15.08.2025. 2. All Pharmaceutical association Further, CDAC may be contacted at uttamkumar@cdac.in or ondlssupport-noida @cdac.in & CDSCO (it-cell@cdsco.nic.in) for any assistance regarding ONDLS portal. This is for your information and nccessary compliancc. Yours faithtully r Rajecer Singh Raghuvanshi) Drugs ControllerGeneral (India) 1. AlI Zonal and sub zonal officc of CDSCO with direction not to accept the application in hardcopy after the deadline mentioned above (15.08.2025).