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CDSCO Urges MSME Pharma Firms to Apply Online for Schedule M Extension

In a circular dated March 20, the CDSCO emphasized the necessity for companies to register on the ONDLS platform, which serves as a single-window system for processing various regulatory requests. These include applications for manufacturing and sales licenses, certificates for Good Manufacturing Practices (GMP), market standing certificates, and approvals for post-licensing changes.

• By Newsdesk
• New Delhi
• Mar 24, 2025

News

The Central Drugs Standard Control Organisation (CDSCO) has directed small and medium-sized pharmaceutical enterprises (MSMEs) to submit their applications exclusively through the Online National Drugs Licensing System (ONDLS) portal for seeking an extension to comply with the revised Schedule M norms.

In a circular dated March 20, the CDSCO emphasized the necessity for companies to register on the ONDLS platform, which serves as a single-window system for processing various regulatory requests. These include applications for manufacturing and sales licenses, certificates for Good Manufacturing Practices (GMP), market standing certificates, and approvals for post-licensing changes.

Extension Following Industry Appeals

This development follows the Union Health Ministry’s decision on February 11 to extend the deadline for Schedule M compliance by one year for MSME pharma firms with an annual turnover below Rs 250 crore. The ministry’s decision was influenced by multiple industry representations highlighting the difficulties faced by smaller companies in upgrading their facilities to meet the revised standards.

However, the extension is contingent upon eligible companies submitting a formal application, known as Form A, to the central licensing authority. Along with the application, companies are required to provide a detailed upgrade plan within three months from the notification’s publication date.

Comprehensive Gap Analysis Mandatory

Form A mandates pharmaceutical companies to conduct a comprehensive gap analysis across critical operational areas. This includes assessments of plant infrastructure, laboratory equipment, heating, ventilation, and air conditioning (HVAC) systems, as well as utilities and other essential processes. Additionally, companies must present an itemized strategy for achieving compliance with the revised GMP standards, with implementation slated to begin no later than March 31.

Stringent Oversight and Compliance Measures

To ensure accountability, the health ministry has announced plans to conduct audits of MSME pharma units following the three-month application window. Non-compliance or inadequate progress in implementing the proposed upgrades may invite regulatory action.

The revised Schedule M, which was notified in December 2023 and came into effect on January 1, 2025, aims to enhance pharmaceutical manufacturing quality and safety standards in India. Despite the initial compliance deadline, the ministry acknowledged the challenges faced by smaller enterprises and subsequently extended the timeline to December 31, 2025.

Significant Impact on MSME Pharma Sector

India's pharmaceutical landscape is significantly driven by MSMEs, with approximately 10,500 pharmaceutical units, out of which around 8,500 belong to the MSME sector. Among them, only about 2,000 units currently possess a WHO-GMP certification, reflecting the gap in compliance readiness.

By facilitating an online application system and providing a structured compliance pathway, the government aims to support MSMEs in aligning with global quality benchmarks while ensuring continued access to safe and effective medicines for consumers.

Pharma companies are urged to promptly register on the ONDLS portal and submit their applications to avail themselves of the extended compliance timeline. Failure to comply with the necessary requirements may lead to stricter regulatory scrutiny and operational consequences.

The CDSCO's move highlights a balanced approach to regulatory enforcement, fostering industry growth while maintaining stringent quality control standards in the pharmaceutical sector.