
Extension of GMP Compliance Deadline for Pharma MSMEs to December 2025
In a significant move aimed at supporting the pharmaceutical Micro, Small, and Medium Enterprises (MSMEs) sector, the Government of India has announced an extension of the deadline for mandatory Good Manufacturing Practices (GMP) compliance until December 2025. This decision comes as a relief to thousands of MSMEs operating in the pharmaceutical industry, offering them additional time to align with the revised Schedule M standards of the Drugs and Cosmetics Act. Schedule M outlines the minimum requirements for premises, plant, and equipment for pharmaceutical manufacturing to ensure product quality and safety.
Earlier, the compliance deadline posed a significant concern for small and medium pharma enterprises, which constitute a crucial part of India's healthcare supply chain. The cost implications associated with upgrading facilities to meet GMP standards were seen as a major obstacle, especially for enterprises still recovering from the economic disruptions caused by the COVID-19 pandemic.
The extension till December 2025 provides these enterprises with breathing space to gradually implement the required changes without causing operational disruptions. It also allows MSMEs to explore financial assistance schemes and incentives introduced by both central and state governments.
The government has also urged MSMEs to utilize the extended timeline effectively, emphasizing that there will be no further extensions beyond December 2025. MSMEs are encouraged to prioritize infrastructure upgrades, invest in skilled manpower, and adopt modern manufacturing technologies to meet global regulatory standards.