Legal and Regulatory Framework for Biomedical Waste Management in India: A Critical Review

Abstract

Biomedical waste management is a complex issue that combines public health, environmental sustainability, and regulatory effectiveness, and remains one of the most critical challenges for environmental governance in India. Healthcare infrastructure is being built at an accelerated pace across urban and rural areas, which has led to a corresponding rise in the amount of biomedical waste generated, and a high risk of environmental and occupational health hazards if these wastes are not managed properly. This doctrinal review discusses the legal and regulatory structure of biomedical waste management in India, highlighting its constitutional underpinnings, legislation, institutions, and barriers to enforcement. The study, through systematic analysis of legislation (specifically Biomedical Waste Management Rules, 2016), judicial pronouncements, government reports from the Central Pollution Control Board and the Ministry of Environment, Forest and Climate Change as well as peer reviewed scholarly literature, is able to highlight the substantive strengths, and continue to point out implementation gaps. Since 1998, the regulatory framework has developed comprehensively in India, but the challenges include non-uniformity in compliance, inadequate enforcement systems, lack of infrastructure in rural areas, and lack of coordination between institutions. Overall, the paper recommends that transformation of biomedical waste governance must go beyond mere attempts at incremental change in legislation, and must include adaptation of regulation, building capacities, and technological innovation.

Keywords: Biomedical waste; Environmental law; Regulatory framework; Healthcare waste management; Institutional governance; Environmental protection.