Industry Update – Application Process for Seeking Extension of Schedule M

The Central Drugs Standard Control (CDSCO) has issued a Circular on 24th March 2025, that an online portal ONDLS has been launched for submission of application for extension of the timeline to comply with Schedule M by Small and Medium Manufacturers.

Small and Medium manufacturers with turnover of less than Rs.250 crores, can submit an application within 3 months of this notification in Form A (plan of upgradation) to the Central License Approving Authority for extension of implementation till 31st December 2025.

In this regard, CDSCO has developed an online system for submiting application through ONDLS portal.

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 will be considered.

Circular of CDSCO is given below :

Source: https://statedrugs.gov.in/SFDA/ondls-login.html