This article is written by Harshit Bhimrajka currently pursuing B.A.LLB (Hons) from the Rajiv Gandhi National University of Law, Patiala. This is an exhaustive article which talks about the objective, features, critical appraisal, and suggestions regarding the Biomedical Waste Management Rules, 2016.


Hospitals and various other laboratories engender a wide range and a significant quantity of wastes (including biomedical or infectious waste) that has the ability to give rise to various health problems and environmental hazards. Generally in India, 1-2 kg waste per bed per day in a hospital and 600 gm waste per day per bed in a clinic is generated, out of which more than 15% is hazardous or infectious and this hazardous waste is mixed with remaining waste which results into the contamination of the entire waste. This is why proper, effective, and efficient rules and regulations are needed for segregation and disposal of waste. The sustainable management of these wastes is the social and legal responsibility of the government as well as the public at large. So these wastes have to be properly collected, transported, and disposed of in order to safeguard the environment, and to streamline these activities various guidelines and rules were published by the Government of India in 1998 known as the Biomedical Waste (Management and Handling) Rules, 1998. 

These rules are continuously monitored, altered, and updated from time to time as effective management is necessary for a cleaner and greener environment. In 2016, the Government of India decided to publish a new set of rules, Biomedical Waste Management Rules, 2016, supervening the old one with various changes and additions in order to improve the collection, segregation, treatment, and disposal facilities of these biomedical waste produced by the hospitals and laboratories to mitigate the environmental pollution. The treatment technologies identified include incineration, microwaving, autoclaving, and chemical treatment. This article includes the objective, salient features, and suggestions regarding the new rules i.e. Biomedical Waste Management Rules, 2016.

Biomedical waste 

Biomedical waste (hereinafter BMW) is defined under the rules as any waste produced during the diagnosis, treatment, or immunization of human or animal research activities pertaining thereto or in the production or testing of biological or in health camps.

In simple words, these wastes include animal anatomical waste, human waste, medical apparatus like syringes, needles, and other materials used in hospitals and other laboratories(research center, nursing homes, blood bank, pathological laboratories, etc) in the process of research and treatment.

Biomedical wastes are divided into four color category:

  1. Yellow: In this category, eight types of waste are categorized- Human anatomical waste, animal anatomical waste, soiled waste, expired or discarded waste, chemical waste, chemical liquid waste(separate collection system leading to effluent treatment system), discarded linen, mattresses, beddings contaminated with blood or body fluid, and microbiology, biotechnology, and other clinical laboratory waste.
  2. Red: It includes contaminated waste that is recyclable like waste generated from disposable items such as tubing, bottles, intravenous tubes and sets, urine bags, syringes, and gloves.
  3. White(Translucent): It includes waste sharps including metals (includes used, contaminated and discarded metal sharps)
  4. Blue: It includes broken or contaminated or discarded glass and metallic body implants.
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The main objective of these rules is based on the concept of 3Rs, namely, reduce, recycle, and reuse. It aims to delimit the waste, recover or reuse it as much as possible, and avoid disposing of it. The waste should be tackled at the origin or at source rather than the “end of pipe approach”.

These guidelines mainly focus on the application and implementation of rules and regulations for the betterment of the environment as well as the people. In these rules, it was explicitly mentioned that these guidelines don’t apply to hazardous chemicals, municipal solid waste, radioactive waste, lead-acid batteries, e-waste, genetically engineered organisms, and cells, and hazardous microorganisms which are governed under other rules. The important elements of the rules are training to workers, health checkups, immunization, and occupation safety of the workers.

As per the Indian government data, the total biomedical waste generated is 484 tonnes per day from 1,68,869 health care facilities in the country but only 447 tonnes per day is treated. There are only 198 common biomedical waste treatment facilities in operation. The number of healthcare facilities using common biomedical waste treatment facilities is 1,31,837 and approximately 21870 health care facilities have their own treatment facilities on-site. To overcome this problem, these stringent rules have been notified by the government and to ensure no pilferage of recyclables items occurs. 

Main provisions

These rules have been modified completely to ensure the management of regulation of biomedical waste in the country. The term ‘handling’ is also being removed from the name which gives more clarity about the management and implications of the rules. Some of the updated and salient features of the rules are as follows:

  1. Now the wastes from vaccination camps, blood donation camps, and surgical camps are also included, thus expanding the scope of the rules.
  2. Duties of both occupiers (one who has administrative control over the health care facilities that is generating biomedical wastes) and operators (one who controls the facilities of collection, reception, transportation, treatment, and disposal of biomedical wastes) are unambiguously specified under these rules.
  3. Setting up of a barcode system for biomedical waste that is to be sent for treatment or disposal.
  4. Maintenance of biomedical waste register daily and monthly updates on the website either by the operator or occupier and also the maintenance of all the records for operation of hydroclaving/incineration/autoclaving for a period of 5 years.
  5. The method i.e. segregation, packaging, transportation, and storage of biomedical wastes has been improved and the waste has been classified into four categories instead of ten for efficacious management.
  6. There should be a distance of seventy-five kilometers of common biomedical waste treatment facility and onsite treatment or disposal facility. State governments should also provide the land for the establishment of a common biomedical waste treatment facility and disposal facility.
  7. The use of chlorinated plastic gloves, bags, blood bags, etc. should be gradually stopped.
  8. Compulsory pretreatment of the laboratory, microbiological waste, and blood bags on-site before disposal either at Common biomedical waste treatment facility or on-site. The method of sterilization/disinfection should be in accordance with the World Health Organisation or the National AIDS Control Organization (NACO).
  9. Standards for emission from incinerators have been modified to be more environmentally friendly. Residence time in the secondary chamber of the incinerator – two seconds; standard for dioxin and furans – 0.1 ng TEQ/Nm^3 are the permissible limit for SPM-50 mg/nm^3.
  10. The Ministry of Environment, Forest, and Climate change will monitor the implementation of rules yearly. The responsibility of each state to check for compliance will be done by setting up a district-level committee under the chairpersonship of District Collector or District Magistrate or Additional District Magistrate. In addition, every 6 months, this committee shall submit its report to the State Pollution Control Board.


Reforms and suggestionsmedical 

Biomedical waste Management Rules, 2016 was also altered and updated to improve compliance and strengthen the implementation for a better environment. In 2018, the Government of India published the Bio-Medical Waste Management (Amendment) Rules, 2018. Some of the major reforms in 2018 rules are:

  1. Complete phasing out of chlorinated plastic items such as bags and gloves from the bio-medical waste generators including hospitals, dispensaries, animal houses, clinics, nursing homes, blood banks, etc.
  2. Within two years of the publication of these rules, all institutions have to publish an annual report on its site.
  3. In accordance with the guidelines issued by the Central Pollution Control Board, all the operators of common bio-medical waste treatment and disposal facilities have to establish a global positioning system and as well as a barcoding system for handling of bio-medical waste.
  4. The State Pollution Control Board has to compile, review and analyze the information received by the operators and also have to send these reports to the Central Pollution Control Board, which keeps detailed information regarding district-wise waste generation. 

One of the major challenges that will be faced by the healthcare facilities and hospitals in implementing these rules and guidelines is Lack of funds- as to phase out chlorinated plastic bags and to establish a global positioning and a barcode system for biomedical waste, a huge cost will be incurred and the time span for the same is very short i.e. two years.

Another major challenge is the use of incinerators and the hazards it causes.  After implementing the first rules in 1998, India saw a boom in the installation of incinerators. It is the system that is based on the high temperature that kills the pathogen and in the process, it also destroys the material in which the microbes reside. But the limitation of this system is that it produces a number of toxins during the process such as products of incomplete combustion and dioxins. These products of incomplete combustion are the particles that are formed during incineration and dissociation of waste components. By this method, metals are not destroyed but dispersed into the environment causing serious health problems. These toxins have a tendency to accumulate in fatty acids and travel up the food chain. This damages the immune and endocrine system of humans. In foreign countries like the Philippines and Denmark, the construction and use of incinerators are banned, similar steps should be taken by the Government of India to mitigate these toxins from the environment.

The major technology used for disposal of biomedical waste is incineration, microwaving, autoclaving, and chemical treatment, but apart from these some new technologies have also been developed or are still under research such as thermal processes, biological processes, irradiative processes, and chemical processes. In the thermal processes mostly waste including cultures, soft waste (gauze, bandages, and gowns), human waste, laboratory waste, and sharp medical instruments are sterilized. These thermal processes are divided into three groups- low heat technologies (operating between 93 C and 177 C) which include microwaves and autoclaves, medium heat technologies(operating between 177 C and 540 C) which include reverse polymerization and thermal depolymerization, and high heat technologies (operating between 540C and 8300C) which include plasma, induction, lase oxidation based pyrolysis. In biological processes, bio converter and biodegradable plastic systems are used for the disposal of biomedical waste.


Article 21 of the Indian Constitution gives us the right to live in a clean and safe environment. To protect this right, efficient and effective biomedical waste management should be done not only by the government but also by the people themselves. The Biomedical Waste Management Rules, 2016 are improved in terms of the facilities like segregation, collection, transportation, and disposal methods to mitigate environmental pollution and safeguard human health. These rules serve as the checklist to accomplish the goal of biomedical waste management for the operator occupier, the regulatory authority, and other authorities. The pillar of these rules is the segregation of waste and the concept of 3Rs on which it is based, namely, reduce, recycle, and reuse. Eco-friendly systems, development of newer novel technologies for disposal of biomedical wastes should be encouraged rather than using the methods which harm the environment such as the incineration process. All representatives involved in the process of biomedical waste management should take a pledge to guarantee a cleaner and greener environment.

“Reduce, Recycle, Reuse, and Repeat.”


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  3. Tiwari, Anurag & Kadu, Prashant. (2014). Biomedical Waste Management Practices in India-A Review. 
  4. Pandey, A., Ahuja, S., Madan, M., & Asthana, A. K. (2016). Bio-Medical Waste Management in a Tertiary Care Hospital: An Overview. Journal of clinical and diagnostic research: JCDR, 10(11), DC01–DC03.
  5. Datta, P., Mohi, G. K., & Chander, J. (2018). Biomedical waste management in India: Critical appraisal. Journal of laboratory physicians, 10(1), 6–14.
  6. Kharat, Dr. D.S.. (2016). Biomedical Waste Management Rules, 2016: A review. International of advanced Research and Development. 1. 48-51. 
  7. Sarangi Dhirendra & Pal Puspalata, Assessment of Biomedical Waste in Govt. Hospitals of Cuttack City, ISJRR. 

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