Regarding manufacturers requesting an extension to adopt the updated Schedule M, the Central Drugs Standard Control Organization (CDSCO) has developed an online application process via the Online National Drugs Licensing System (ONDLS) (www.statedrugs.gov.in).
Manufacturers seeking an extension to adopt the updated Schedule M can apply online through the Online National Drugs Licensing System (ONDLS).
However, the notice stated, “The applicant manufacturer seeking an extension of the timeline has to register on the ONDLS portal and thereafter submit an application.”
This came as the Department of Health and Family Welfare, which has published a notification vide G.S.R. 127(E) dated 11th February 2025, stating that the small and medium manufacturers with turnover less than two hundred and fifty crores may seek an 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 this notification, within a period of three months from the date of publication of this notification, along with a plan of upgradation and for such manufacturers, the timeline for implementation shall be extended till the 31st day of December, 2025.
Earlier, the Medical Dialogues Team reported that the Health Ministry informed drug manufacturers that those seeking an extension for implementing the revised Schedule M must conduct a gap analysis and submit an application to the drug regulator, detailing their compliance strategy.
Also Read:Relief for Drugmakers: Health Ministry Extends Schedule M Deadline, Sets Compliance Terms Under the new rules, manufacturers must conduct a thorough gap analysis of key areas, such as plant, equipment, HVAC systems, utilities, technical staff, and documentation. The analysis will serve as the foundation for a compliance strategy, which must be submitted to the Central Licence Approving Authority (CLAA) in Form A. This form requires manufacturers to justify the time needed for compliance and present a detailed plan for upgrading, starting by March 2025. In this regard, the Central Drugs Standard Control Organization (CDSCO) has developed an online system for submitting applications through the ONDLS Portal (www.statedrugs.gov.in).
In addition to the above, the CDSCO further mentioned that the applicant manufacturer seeking an 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,” the notice added.
