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@article{205432,
        author = {Praksh Sharma},
        title = {A Comprehensive Analysis of Regulatory Transformation from Prohibition-Based to Systems-Based Quality Assurance (1940-2023)},
        journal = {International Journal of Innovative Research in Technology},
        year = {2026},
        volume = {13},
        number = {1},
        pages = {6788-6799},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=205432},
        abstract = {The evolution of pharmaceutical regulation in India from 1940 to 2023 represents a fundamental transformation in legal philosophy, regulatory approach, and quality assurance methodology. This paper traces the historical development of pharmaceutical regulation through four distinct phases: the Foundational Period (1940-1988) characterized by prohibition-based regulatory frameworks; the Good Manufacturing Practice (GMP) Adoption Period (1988-2005) marked by the introduction of systems-based thinking; the International Alignment Period (2005-2023) reflecting gradual harmonization with international standards; and the Contemporary Period (2023-onwards) defined by comprehensive systems-based quality assurance. Through doctrinal analysis of statutory provisions, regulatory instruments, and judicial interpretation, this paper demonstrates that Schedule M 2023 represents a watershed moment consolidating eight decades of regulatory evolution. The analysis reveals that the transformation reflects not merely administrative modernization but fundamental shifts in regulatory philosophy, burden of proof allocation, and legal conception of manufacturer responsibility. This paper contributes to understanding how regulatory frameworks evolve in response to global standards, technological advancement, public health imperatives, and international trade requirements, with implications for pharmaceutical governance in developing economies.},
        keywords = {Pharmaceutical Regulation, Schedule M, Quality Assurance, GMP, Regulatory Evolution, India, Doctrinal Analysis, Quality Systems, Harmonization},
        month = {June},
        }