The Union Health Ministry’s draft notification to extend the deadline for the implementation of revised Schedule M norms for micro, small, and medium enterprises (MSMEs) with turnovers below Rs 250 crore has provided interim relief for these businesses. However, industry leaders argue that the move is insufficient to address the significant challenges they face in meeting the updated manufacturing standards.
According to media reports, the Ministry issued the draft notification on 4 January 2025, allowing public comments for seven days before finalising the notification. The extension requires eligible MSMEs to register with the Central Drugs Standard Control Organisation (CDSCO) within three months and submit a comprehensive upgrade plan. These units will receive a 12-month extension, moving the compliance deadline to 31 December 2025, provided they adhere to the outlined requirements.
After the three-month registration period, the Ministry plans to conduct audits to evaluate the progress of the submitted upgrade plans. Units failing to meet the commitments may face regulatory action.
The draft notification mandates that MSMEs perform a section-wise gap analysis, covering areas such as plant and equipment, HVAC systems, utilities, technical staff, documentation, and more. Companies must justify the time required to comply and ensure that any extension does not go beyond 1 January 2026.
As per media, the Ministry acknowledged that the extension responds to concerns raised by industry associations about financial constraints and the time needed to implement necessary changes. To date, CDSCO has inspected over 800 manufacturing units and 252 public testing laboratories, with data showing significant awareness and progress in adopting Good Manufacturing Practices (GMP) among MSMEs.
The revised Schedule M, notified in December 2023, aims to align India’s GMP standards with international benchmarks, particularly WHO standards, to ensure the production of high-quality, globally acceptable drugs. The initial compliance deadline for large manufacturers (turnover above Rs 250 crore) was set for 1 July 2023, while MSMEs were given until 1 January 2025.
In preparation, CDSCO conducted 15 awareness sessions in key manufacturing hubs, attended by over 36,000 stakeholders in hybrid mode. Despite these efforts, the industry continues to highlight the need for additional time and government support to achieve compliance without risking the survival of smaller firms.
As the Ministry reviews industry feedback, the final notification will determine whether the concerns of MSMEs are adequately addressed to ensure a smooth transition to the revised standards.
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