45 On line application for extension of time to comply with revised Sch M on ONDLS portal 2025-Mar-24 50 KB

File No: IT/Sch M ex/ONDLS/2025/002 Government of India Directorate General of Health Services Central Drugs Standard Control Organization FDA Bhawan. Kotla Road, New Delhi-110002

Circular 4 MAR 2025

On line application for extension of time to comply with revised Sch M on ONDLS portal-regarding

It is informed that Department of Health and Family Welfare has published a notification vide G.S.R. 127(E) dated 11% February 2025 regarding seeking extension of the timeline for implementation and for that purpose shall make an application to the Central Licence Approving Authority in Form ‘A’ annexed to the notification, within a period of three months from the date of publication of this notification, along with a plan of upgradation for the small and medium manufacturers with turnover less than two hundred and fifty crores may, the timeline for implementation shall be extended till 31% day of December, 2025.

in this regard, the Central Drugs Standard Control Organization (CDSCO) has developed an online system for submitting application through the ONDLS Portal (www.statedrugs.gov.in).

The applicant/ Manufacturer seeking extension of the timeline has to register on the ONDLS portal and thereafter submit an application. No hard copy of the application for seeking extension of the timeline for implementation will be considered.

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