Indian Pharma Charts Clear Path to Meet Revised Schedule M Rules

As global pressure and expectations increase with the drug quality, Indian pharma has to become intolerant to non-compliance with Good Manufacturing Practice (GMP), stressed Mahantesh Wali, Regulatory Affairs Head at Maiva Pharma. At the latest IPA Mysuru conference on Pharmaceutical Quality Assurance, Wali made a specific point of underscoring that compliance with GMP is not just a regulatory necessity but a strategic necessity for global competitiveness.

Wali underlined the need to instill ongoing improvement within every layer of operations in order to achieve manufacturing excellence, safety, and reliability. "The industry must go beyond the compliance level in order to achieve real excellence," he reiterated, highlighting the necessity of a qualified workforce, enhanced facilities, efficient processes, and open documentation.

The previous pressure on small and mid-sized pharmaceutical manufacturers forced them to shut down, as they failed to provide the required upgrade plans under the new Schedule M regulations. Discussing the adoption timelines of the new Schedule M on June 28, 2024, for big manufacturers and December 31, 2025, for MSMEs, Wali urged advance adoption of global harmonization schemes such as ICH and PIC/S. He added that regulatory inspections and audit readiness require strong quality systems and digitization.

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Technologies like AI, IoT, and blockchain, and applications like LIMS are critical in facilitating 21 CFR Part 11 compliance and improving quality management systems. Quality metrics, Wali explained, are crucial to track product life cycle, foresee shortages, and drive creativity.

Going forward, he indicated that the industry has to be concerned about flexibility, sustainability, and regulatory adaptation. "A company culture of zero tolerance for noncompliance is a must," Wali further stated, calling upon leadership and regulation units to drive this change for public health security and trust.