• Mohd Imran Uzair
• Abdul Mannan
• M Suresh Babu
• Mohammed Luqhmaan
• Mohammed Sohail

The global pharmaceutical industry faces significant challenges due to the proliferation of adulterated, spurious, and misbranded drugs, which pose serious threats to public health and safety. This article aims to provide a comprehensive overview of the definitions, classifications, regulatory frameworks, and implications of these substandard pharmaceutical products, with a particular focus on the Indian context. The article discusses the historical evolution of the counterfeit drug crisis, its economic and health impacts, and the legal mechanisms in place to combat it. It elaborates on the distinctions between adulterated, spurious, and misbranded drugs under the Drugs and Cosmetics Act, 1940, and examines the recent amendments introduced through the Jan Vishwas (Amendment of Provisions) Act, 2023. These amendments aim to decriminalize minor violations, rationalize penalties, and promote ease of doing business while maintaining regulatory compliance. The article further explores the types and sources of adulterants, categories of spurious drugs, and common misbranding practices, alongside measures taken by regulatory authorities such as the Central Drugs Standard Control Organization (CDSCO) to enhance surveillance and quality control. It also highlights India’s dual role as a major exporter of affordable generics and a country grappling with domestic and international allegations regarding substandard drug exports. By analyzing existing legal provisions, enforcement mechanisms, and recent policy reforms, this review seeks to contribute to the ongoing discourse on strengthening drug regulation, improving traceability, and safeguarding global public health.

Adulterated, Spurious, Misbranded, Jan Vishwas Act 2023.

"Regulations of Adulterated, Spurious, and Misbranded Drugs: A Comprehensive Overview", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.12, Issue 7, page no.e444-e450, July-2025, Available :http://www.jetir.org/papers/JETIR2507461.pdf

"Regulations of Adulterated, Spurious, and Misbranded Drugs: A Comprehensive Overview", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.12, Issue 7, page no. ppe444-e450, July-2025, Available at : http://www.jetir.org/papers/JETIR2507461.pdf