The Central Drugs Standard Control Organization (CDSCO) has launched an online portal to facilitate Micro, Small, and Medium Enterprises (MSMEs) in the pharmaceutical sector to apply for an extension on the implementation of the revised Schedule M.

This initiative is integrated into the Online National Drugs Licensing System (ONDLS) and follows the Health Ministry's notification granting an extension for compliance with updated Good Manufacturing Practices (GMP).

Dr. Rajeev Singh Raghuvanshi, the Drugs Controller General of India (DCGI), emphasized in an official circular that only online applications will be accepted, stating, "No hard copy of the application for seeking extension of the timeline for implementation will be considered."?

According to the Union Ministry of Health and Family Welfare's notification dated February 11, MSME pharmaceutical units with an annual turnover of less than INR 250 crore can request a one-year extension by submitting Form ‘A’ through the ONDLS portal within three months from the notification date. Applicants are required to provide a detailed section-wise gap analysis covering aspects such as plant infrastructure, equipment, HVAC systems, technical staffing, and documentation.

Additionally, they must outline a compliance plan with specific timelines to meet the revised GMP standards and submit an undertaking to commence upgradation within three months of application submission, ensuring full compliance with Schedule M by December 31, 2025. ?

While this extension offers relief to MSME manufacturers, some industry stakeholders have expressed concerns regarding the application requirements. There are objections to the condition mandating submission of extension requests to the Central Licence Approving Authority (CLAA), as manufacturing licensing traditionally falls under the jurisdiction of State Licensing Authorities.

Furthermore, some manufacturers argue that the detailed gap analysis and the commitment to complete upgradation within the stipulated timeline may be challenging to fulfill. Notably, the original deadline in the draft notification was January 1, 2026, but the final notification has revised it to December 31, 2025, thereby tightening the compliance window. ?