Reengineering Pharmaceutical Regulatory Lifecycle Governance in India: A Critical Review of Post-Approval Change Classification, CMC Risk Assessment, and Compliance Accountability Aligned with ICH Q12 Frameworks

Post-approval chemistry, manufacturing, and controls (CMC) updates present monumental hurdles within India's current pharmaceutical regulatory climate. The traditional regulatory pathway governed by the Central Drugs Standard Control Organization (CDSCO) relies heavily on rigid, checklist-driven compliance models. These mechanisms often cause extensive delays in deploying post-approval modifications, directly hindering technical innovations and manufacturing modernizations. This comprehensive review examines the strategic integration of the International Council for Harmonisation (ICH) Q12 guideline into the Indian pharmaceutical sector. By replacing administrative oversight with structured, risk-based operational strategies, the ICH Q12 framework provides critical tools like Established Conditions (ECs), Post-Approval Change Management Protocols (PACMPs), and Product Lifecycle Management (PLM) strategies. This paper analyzes current regulatory gaps between regional CDSCO procedures and global standards while defining explicit cross-functional accountabilities linking Regulatory Affairs (RA) and Quality Assurance (QA). Through operational models and strategic implementation frameworks, this review outlines an advanced governance roadmap designed to enhance compliance velocity, mitigate structural risks, and ensure uninterrupted supplies of high-quality medicinal products globally.