Volume : 13, Issue : 09, September – 2026

Title:

COMPARATIVE STUDY OF INDIA’S SCHEDULE M VERSUS WHO-GMP GUIDELINES FOR PHARMACEUTICAL MANUFACTURING

Authors :

Ishwarya Gitta*, P. Srikanth

Abstract :

The pharmaceutical industry operates under stringent regulatory frameworks to ensure drug quality, safety, and efficacy. In India, Schedule M of the Drugs and Cosmetics Act provides mandatory requirements for pharmaceutical manufacturing, covering areas such as facilities, equipment, personnel, documentation, and quality control. Globally, the World Health Organization’s Good Manufacturing Practices (WHO-GMP) guidelines offer comprehensive standards emphasizing risk-based approaches, process validation, data integrity, and continuous quality improvement. This study presents a comparative analysis of India’s Schedule M and WHO-GMP guidelines, identifying similarities, differences, and areas of convergence in facility design, production processes, quality assurance, documentation, and personnel training. The analysis highlights regulatory gaps, challenges faced by Indian manufacturers in achieving international compliance, and opportunities for harmonization to facilitate global market access. The findings underscore the importance of aligning domestic regulations with international standards to enhance product quality, ensure patient safety, and strengthen India’s position in the global pharmaceutical industry.
Keywords: Schedule M, WHO-GMP, pharmaceutical manufacturing, quality assurance, regulatory compliance, process validation, data integrity, international harmonization

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