CDSCO Launches Online Portal for MSMEs to Seek Extension on Revised Schedule M Implementation

The new system, integrated into the Online National Drugs Licensing System (ONDLS), follows the Health Ministry’s notification granting an extension for compliance with revised Good Manufacturing Practices (GMP).

The Central Drugs Standard Control Organization (CDSCO) has introduced an online system for small and medium pharmaceutical enterprises (MSMEs) to submit applications for an extension of the Revised Schedule M implementation deadline.

The new system, integrated into the Online National Drugs Licensing System (ONDLS), follows the Health Ministry’s notification granting an extension for compliance with revised Good Manufacturing Practices (GMP).

Drugs Controller General of India (DCGI) Dr Rajeev Singh Raghuvanshi, in an official circular, stated, "No hard copy of the application for seeking extension of the timeline for implementation will be considered."

Application Process & Key Requirements

The Union Ministry of Health and Family Welfare issued a final notification on February 11, extending the implementation deadline by one year for MSME pharma units that apply within three months from the notification date.

The amendment to the Drugs Rules, 1945, specifies that MSMEs with an annual turnover of less than INR 250 Cr can request an extension by submitting an application in Form ‘A’ through the ONDLS portal.

As per the notification, applicants must:

• Register on the ONDLS portal and submit Form ‘A’ within three months.

• Provide a detailed section-wise gap analysis on aspects such as plant infrastructure, equipment, HVAC systems, technical staffing, and documentation.

• Outline a compliance plan with timelines to meet revised GMP standards.

• Submit an undertaking to commence upgradation within three months of application submission and comply with Schedule M by December 31, 2025.

Industry Concerns Over Compliance Challenges

While the extension relieves MSME manufacturers, some industry stakeholders have expressed concerns over the application requirements. A section of the industry has raised objections to the condition mandating submission of extension requests to the Central Licence Approving Authority (CLAA), given that manufacturing licensing traditionally falls under the jurisdiction of State Licensing Authorities.

Additionally, some manufacturers argue that the detailed gap analysis and undertaking to complete upgradation within the stipulated timeline may be difficult to meet. The original deadline in the draft notification was January 1, 2026, but the final notification revised it to December 31, 2025, further tightening the compliance window.