The CDSCO has introduced an online system for small and medium pharma units to apply for an extension on the implementation of revised Schedule M standards. This follows a Ministry of Health notification extending the deadline by one year. Applicants must submit a gap analysis, upgradation plans, and provide a commitment to comply by December 31, 2025.
The Central Drugs Standard Control Organisation (CDSCO) has launched an online system to allow small and medium pharmaceutical units to submit applications for an extension on the revised Schedule M standards. This move follows the Union Ministry of Health and Family Welfare’s February 2025 notification extending the deadline for implementing the new manufacturing standards until December 31, 2025, for eligible micro, small, and medium-sized enterprises (MSMEs). These units, with a turnover under 250 crores, must apply within three months of the notification. The application requires a detailed gap analysis across various sections like plant, equipment, and technical staff, along with a plan for compliance with the revised Good Manufacturing Practices (GMP). Applicants must also submit an undertaking to begin upgradation within three months of applying.