In a significant development for India’s pharmaceutical manufacturing sector, the Drugs Technical Advisory Board (DTAB) has officially ratified the Union Ministry of Health and Family Welfare’s February 2025 notification, which grants an extension to micro, small, and medium enterprises (MSMEs) for complying with the revised Schedule M Good Manufacturing Practices (GMP) standards.

Extension Timeline and Eligibility

Under the newly approved provisions, MSME pharmaceutical units with an annual turnover of less than ₹250 crore can now avail an extension to implement the revised GMP norms until December 31, 2025. To benefit from the extension, eligible units must apply to the Central Licence Approving Authority (CLAA) within three months from the date of the final notification. Applications are to be submitted using Form A.

Conditions for Application

To qualify for the extension, applicants must provide:

• A section-wise gap analysis of their current GMP status against the revised standards

• A detailed upgradation plan with timelines

• A clear justification for requiring the extended deadline

• A management undertaking committing to commence necessary upgrades within three months of submitting the application

Background on Revised Schedule M

The revised Schedule M was originally notified in December 2023 as part of India’s efforts to align its GMP framework with global quality standards. While larger units with a turnover exceeding ₹250 crore were given a six-month window to comply, MSMEs were initially granted a 12-month period.

However, several stakeholders in the MSME sector raised concerns about the feasibility of meeting the new standards within the prescribed timeframe, citing financial constraints, resource limitations, and administrative confusion over jurisdiction, particularly the involvement of the CLAA over State Licensing Authorities.

Industry Representation and Regulatory Response

The final rule, as ratified by DTAB, reflects extensive industry input. The Ministry emphasized that it had carefully considered public objections before finalizing the amendment. The extension aims to strike a balance between regulatory stringency and operational feasibility for smaller manufacturers.

Key Updates in Revised Schedule M

The 2023 revision of Schedule M introduced several enhancements, including:

• Implementation of a Pharmaceutical Quality System (PQS)

• Quality Risk Management (QRM) procedures

• Regular Product Quality Reviews (PQR)

• Comprehensive qualification and validation protocols

• Efficient recall systems

• Mandatory quality and supplier audits

• Stability studies to ensure product efficacy over time

Inspection and Enforcement

To monitor compliance with the revised norms, the Central Drugs Standard Control Organization (CDSCO) has already conducted inspections at more than 800 manufacturing units and 252 public testing laboratories nationwide.

Conclusion

The DTAB’s ratification of the extension provides critical relief to MSMEs, allowing them more time to align with globally benchmarked GMP standards without compromising on product quality and patient safety. While the new compliance framework is demanding, it represents a pivotal step toward elevating India’s pharmaceutical manufacturing ecosystem.