The Bio-Medical Waste Management Rules, 2016 represent an important development in India’s approach to the safe handling, treatment and disposal of waste generated by healthcare facilities. Bio-medical waste includes waste generated during diagnosis, treatment or immunisation of human beings or animals, research activities, production or testing of biological products, and health camps. Improper management of such waste can expose healthcare workers, patients, waste handlers and the general public to infections, injuries, toxic substances and environmental pollution. The evolution of the 2016 Rules therefore reflects a gradual shift from basic disposal-oriented practices towards systematic segregation, treatment, environmental protection and occupational safety. Before 2016, bio-medical waste management was primarily governed by the Bio-Medical Waste (Management and Handling) Rules, 1998, notified under the Environment (Protection) Act, 1986. These Rules were introduced because increasing healthcare activities were generating substantial quantities of infectious and potentially hazardous waste. The 1998 Rules established responsibilities for healthcare establishments and prescribed procedures for collection, handling, treatment and disposal. They also introduced the concept of segregation of bio-medical waste and required healthcare establishments to obtain authorisation from the relevant pollution control authorities. The 1998 Rules were an important beginning, but their implementation revealed several limitations. Healthcare facilities differed considerably in their capacity to segregate and treat waste. There were problems relating to inadequate infrastructure, poor compliance, insufficient training, improper disposal and limited monitoring. The rules also required amendments as healthcare technology, treatment practices and environmental standards changed. Consequently, the Bio-Medical Waste (Management and Handling) Rules, 1998 were amended in 2000, 2003 and subsequently through other regulatory measures to strengthen their implementation. The major transformation came with the notification of the Bio-Medical Waste Management Rules, 2016 by the Ministry of Environment, Forest and Climate Change. These Rules replaced the earlier 1998 framework and were designed to simplify classification, improve segregation, strengthen accountability and promote environmentally sound treatment. They applied to all persons who generate, collect, receive, store, transport, treat, dispose of or otherwise handle bio-medical waste, irrespective of