Development of innovative standards for the registration of drugs in India based on International norms

Abstract

This research endeavors to pioneer a paradigm shift in drug registration protocols within the Indian pharmaceutical sector, aligning them with internationally recognized norms. The study delves into the imperative need for harmonizing regulatory standards to ensure the safety, efficacy, and quality of pharmaceutical products entering the Indian market. By integrating key benchmarks from global authorities, this initiative aims to foster a robust and transparent registration process, ultimately bolstering consumer trust and industry competitiveness. The research methodology encompasses a comprehensive review of international regulatory frameworks, comparative analysis, stakeholder consultations, and case studies to propose a refined set of standards tailored to the Indian context. Additionally, this study addresses potential challenges and proposes strategies for effective implementation. Through this innovative approach, the research aspires to lay the foundation for a more dynamic and globally integrated pharmaceutical landscape in India, poised for sustained growth and excellence.