Further to what we reported earlier (please refer to the e-mail in trail), the CDSCO has developed a new system for online submission of applications through the ONDLS Portal. The applicant/manufacturer, seeking extension of the timeline for implementation and adherence with the updated regulations under the revised Schedule M, are required to register on the ONDLS Portal and thereafter submit an application.
Moreover, it has been notified that any hard copy of the application will not be considered for seeking extension of timeline.
Background:
The Ministry of Health had revised Schedule M, granting small and medium scale manufacturers the opportunity to extend their compliance timeline till 31st December, 2025. This extension was with a view to provide eligible manufacturers (with annual turnover of Rs. 250 crores or less) with sufficient time to implement the necessary upgrades and ensure adherence to the updated regulations. In order to avail this extension, eligible manufacturers are to required to submit an application to the Central Licence Approving Authority in Form ‘A’ by 11th May 2025, accompanied by a detailed plan outlining the necessary upgrades.
Source: Ministry of Health and Family Welfare
