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Industry specific-Medical Central Ministry of Health & Family Welfare Drugs (Control) Act, 1950

Online Application for Extension of Time to Comply with Revised Schedule M

24-Mar-2025 | File No: IT/Sch M ex/ONDLS/2025/002

Central Drugs Standard Control Organization has issued a notification regarding the extension of the timeline for compliance with the revised Schedule M. As per the notification G.S.R. 127(E) dated 11th February 2025, small and medium manufacturers with a turnover of less than 250 crores can apply for an extension until 31st December 2025. The application must be made to the Central Licence Approving Authority in Form 'A' within three months of the publication date, along with an upgradation plan.

By virtue of the notification, the Central Drugs Standard Control Organization (CDSCO) has developed an online system on the ONDLS Portal (www.statedrugs.gov.in) for submitting applications. Manufacturers seeking an extension must register on the portal and submit their application online. Hard copies of applications will not be accepted.

Please refer the attached documents for more information.

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