The Future of Pharmaceutical Regulatory Science in India

Author

Shraddha Vijay Jagtap, Prajakta S. Gadakh, Shubham N. Kanawade

Abstract

 Pharmaceutical regulatory science in India is undergoing a monumental paradigm shift, transitioning from a reactive administrative review mechanism to a highly proactive, scientifically driven framework. This critical review examines the strategic modernization of India's regulatory pathways, focusing on key focus areas including regulatory exclusivity, artificial intelligence (AI)-driven compliance, clinical research ecosystem overhauls, comprehensive lifecycle governance, and advanced predictive quality surveillance. By analyzing the structural alignment with global standards such as ICH and WHO guidelines, this paper highlights how the Central Drugs Standard Control Organization (CDSCO) is addressing legacy bottlenecks like post-approval variations, complex impurity profiles, and supply chain vulnerabilities. Through extensive contextual data, detailed compliance matrices, and systematic risk management overviews, we demonstrate how India is positioning itself not just as a global manufacturing hub, but as an international leader in regulatory excellence and clinical data integrity.

Keywords

Regulatory Science, CDSCO, India Pharmaceuticals, Data Integrity, Digital Intelligence, Clinical Research, Regulatory Exclusivity, Impurity Risk Management, Global Convergence, Post-Approval Changes.

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References

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