90 Grant of manufacturing licences for Large Volume Parenterals (Form 28D/Form 28DA) and endorsement of additional products in the licence through ONDLS portal 2025-Jan-07 138 KB

To File No. X-11050/Misc/LVPI01/2025-D Government of India Directorate General of Health Services Central Drugs Standard Control Organization (LVP Division) All State/UTs Drugs Controller cum Licensing Authorities. Sir/Madam, FDA Bhawan, Kotla Road, New Delhi-110002.

Subject: Grant of manufacturing licences for Large Volume Parenterals (Form

28D/Form 28DA) and endorsement of additional products in the licence through ONDLS portal-Regarding. Dated: As you are aware that the Online National Drugs Licensing System (ONDLS) portal has been developed by CDAC in coordination with States for processing of application and online licensing of Sale/Manufacturing license Recently. CDAC has also developed online portal for submission and processing of the applications for grant of manufacturing licence for Large Volume Parenterals (LVPs) & endorsement of additional products of LVPs in licence and other CLAA items on the ONDLS Portal. 97 JAN 2025 In this regard, you are requested to direct all the Large Volume Parenterals manufacturers under your jurisdiction to submit application for grant of manufacturing licences for Large Volume Parenterals (Form 28D/Form 28DA) and endorsement of additional products in the licence through ONDLS portal only. Further, it may be noted that physical files will not be entertained for approval of grant/ endorsement of additional products from 01.02.2025. Copy for information to In case of any difficulties, CDAC may be contacted at uttamkumar@cdac. in or ondlssupport-noida@cdac.in for any assistance regarding processing/submission of applications on ONDLS portal. This is for your information and necessary compliance. 2. Joint Secretary, Drugs Regulation, MoHFW. Yours faithfully (Dr. Rajeev Sing-Raghuvanshi) Drug Controller General (India) 1 All ZonaVSub Zonal offices of CDSCO for necessary compliance and coordination with respective State/UTs Licensing Authorities in the matter. 3. Director CDAC Noida with request to assist the States for onboarding on the ONDLS Portal.