The Central Drugs Standard Control Organization (CDSCO) has announced the launch of an online system for pharmaceutical manufacturers to apply for an extension of the timeline to comply with the revised Schedule M of the Drugs Rules, 1945. This circular was issued on March 24, 2025.
This initiative follows a notification issued by the Department of Health and Family Welfare on February 11, 2025, which allows small and medium manufacturers to seek an extension.
The Department of Health and Family Welfare, through the February notification, provided an opportunity for small and medium-sized manufacturers (with a turnover of less than ₹250 crore) to apply for an extension of the implementation timeline for the revised Schedule M. The notification stated that the timeline could be extended until December 31, 2025, provided the manufacturers submit an application along with an upgradation plan (Form A) within three months from the date of the notification’s publication, i.e. May 11, 2025.
To streamline the application process, the CDSCO has developed an online system accessible through the ONDLS Portal. This online platform will be the exclusive method for submitting applications for the extension of the implementation timeline.
Instructions for Applicants
- Manufacturers seeking an extension must first register on the ONDLS portal.
- Following registration, applicants can submit their extension application through the online system.
- The CDSCO has clearly stated that no hard copy applications for the extension will be considered. All submissions must be made through the designated online portal.
This online application system aims to:
- Provide a convenient and efficient way for manufacturers to apply for the extension.
- Create a transparent and auditable process for handling extension requests.
- Eliminate the need for physical submissions, promoting a more streamlined and environmentally friendly approach.
Pharmaceutical manufacturers who meet the criteria for seeking an extension of the revised Schedule M implementation timeline are encouraged to utilize the online application portal on the ONDLS website by May 11, 2025. This online platform is the only accepted method for submitting such applications.
