Department of Health and Family Welfare has published a notification vide G.S.R. 127(E) dated 11th February 2025 regarding seeking extension of the timeline for implementation and for doing so manufacturer shall make an application to the Central Licence Approving Authority in Form ‘A’ annexed to that 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 and after Form ‘A’ submission, the timeline for implementation shall be extended till 31st day of December, 2025.
Further, for submission of Form ‘A’, Central Drugs Standard Control Organization (CDSCO) has
developed an online system for submitting application through the ONDLS Portal (www.statedrugs.gov.in). Hence, the applicant/ Manufacturer seeking extension of the timeline has to register on the ONDLS portal and thereafter submit an application in Form ‘A’.
Also, CDSCO has made it clear that no hard copy of the application for seeking extension of the timeline for implementation will be considered by the CDSCO.
Application Form ‘A’ can be submitted by the manufacturers at www.statedrugs.gov.in
Link to submit Application Form ‘A’ : https://www.statedrugs.gov.in/SFDA/ondls-login.html
Circular issued by DCG(I) dated 24.03.2025 regarding online application for extension of time to comply with revised Sch M on ONDLS portal :
Online user manual for submission of online application for extension of time to comply with revised Sch M on ONDLS portal can be accessed at following address :
https://www.statedrugs.gov.in/SFDA/resources/app_srv/SFDA/startup/user-mannual/who.pdf