"Comparing Current and Revised Schedule M: Evolving GMP Standards in India's Pharmaceutical Sector"

In India, both the existing Schedule M and the updated Schedule M of the Drug Act are pivotal in regulating Good Manufacturing Practices (GMP) for pharmaceutical products. However, significant disparities exist between the two:

Spotlight:

The current Schedule M primarily centres on the physical facets of manufacturing, such as infrastructure, equipment, and raw materials.

Conversely, the revised Schedule M adopts a broader perspective, advocating for a more comprehensive quality control approach. It introduces innovative concepts like:

• Pharmaceutical Quality System (PQS): A robust framework ensuring consistent product quality throughout its lifecycle.
• Quality Risk Management (QRM): Proactively identifying, assessing, and mitigating potential quality risks.
• Product Quality Review (PQR): Periodically evaluating product quality data to detect and rectify any issues.

Demand:

The current Schedule M offers less detailed and more prescriptive requirements, allowing for interpretation.

In contrast, the updated Schedule M presents more specific and risk-based requirements, aligning closely with international GMP standards. This includes:

• Equipment qualification and validation: Ensuring the reliability and consistency of equipment performance.
• Computerized storage system: Enhancing data integrity and traceability.
• Supplier audits: Placing greater emphasis on assessing and auditing supplier quality systems.
• ALCOA principles: Ensuring data accuracy, legibility, contemporaneity, originality, and accountability.

Time Line:

• Compliance timelines under the current Schedule M were relatively flexible, especially for smaller manufacturers.
• However, the revised Schedule M imposes stricter compliance deadlines, with specific timelines set for different categories of manufacturers: Small and medium-sized manufacturers (turnover < Rs. 250 crore) are granted a 12-month compliance window. Large manufacturers (turnover > Rs. 250 crore) are given a 6-month compliance period.

In summary, the revised Schedule M signifies a significant advancement in GMP standards within India's pharmaceutical sector. By aligning with global best practices, it aims to elevate the quality and safety standards of pharmaceutical products. #GMP #cGMP #ScheduleM #DrugAct #Pharmaceuticals

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