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Manufacturers urged to apply online for extension of timeline for revised Schedule M
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Shardul Nautiyal, Mumbai
April 03 , 2025
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In a crucial development for small and medium-scale pharmaceutical manufacturers, the Pharmaceuticals Export Promotion Council of India (Pharmexcil) Director General (DG) K Raja Bhanu has directed the companies to apply online for an extension of the timeline to comply with the revised Schedule M on the Online National Drug Licensing System (ONDLS) portal.
This directive follows the Central Drugs Standard Control Organization (CDSCO) circular dated March 24, 2025, which outlines that small and medium-scale manufacturers (with annual turnovers under Rs. 250 crore) seeking an extension to implement the revised Schedule M must submit their applications to the Central License Approving Authority in Form ‘A.’ The application should be filed within three months of the notification, which was issued on March 24, 2025.
Addressing the industry, Bhanu emphasized the importance of adhering to the updated regulations and submitting applications online through the ONDLS portal. He stated, "We urge all eligible small and medium-scale manufacturers to register on the ONDLS portal and submit their applications for an extension. This will ensure a smooth transition and allow sufficient time for manufacturers to comply with the revised Schedule M requirements."
According to the circular, the Department of Health and Family Welfare issued a notification (G.S.R. 127(E) dated February 11, 2025) regarding the extension of the implementation timeline. Manufacturers who qualify for this extension will be allowed additional time until December 31, 2025, provided they submit a detailed upgradation plan along with their application.
DG Pharmexcil further clarified, “The application process is entirely online. No hard copy submissions will be considered. We encourage all relevant companies to make use of this digital platform to submit their requests in a timely manner. Manufacturers are required to visit the ONDLS portal at www.statedrugs.gov.in to register and file their applications. The system has been designed to streamline the process and ensure that all requests are handled efficiently.”
“This initiative is expected to give much-needed relief to smaller pharmaceutical manufacturers, allowing them to upgrade their facilities and meet the necessary compliance standards in line with the revised regulations. For further details, manufacturers can visit www.statedrugs.gov.in or refer to the CDSCO’s official notification,” DG Pharmexcil informed.
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