Abstract
This article provides a comprehensive analysis of the regulatory landscape for generic drugs in India, emphasizing the assessment of quality, safety, and efficacy standards. The article synthesizes existing literature, policy documents, and empirical studies to construct a detailed overview of the current regulatory framework overseen by the Central Drugs Standard Control Organization. It highlights the evolution of India’s drug regulations, focusing on amendments and policies specifically impacting generic drugs. The review critically examines the procedures and standards set for the approval of generics, including comparative analysis with international norms. Special attention is given to the challenges in implementing rigorous quality control, ensuring safety, and verifying efficacy in the Indian context, where large-scale production of generics plays a pivotal role in both domestic and global markets. The article also discusses the influence of global regulatory trends on India’s policies and practices. Concluding with insights and recommendations, it aims to inform policy makers, health care professionals, and stakeholders in the pharmaceutical industry, aiming to enhance the quality, safety, and efficacy of generic drugs in India.
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