Bio-Medical Waste Management Rules, 1998 & 2016: A Comparative Study

Bio-Medical Waste Management Rules, 1998 & 2016: A Comparative Study


The study here tries to throw a light on the various aspects of the Bio-Medical waste Rules that has changed/amended from Bio-Medical Waste Management Rules, 1998 to Bio Medical Waste Management Rules, 2016. The Amendments/changes that has been done by the Government in the Bio Medical Waste management rules,2016 are for the better disposal of Bio-Medical Waste, through which the society can be a better place to live in.


What are Bio Medical Wastes? - UPSC Notes

Bio-Medical Waste:

Bio-medical waste is a waste which is generated during diagnosis or treatment of people or animals. This includes all the people and institutes which generate, store, collect, transport, treat, any forms of Bio-Medical Waste. There are many types of Bio-Medical wastes out which some are easy to treat and not harmful or contagious, and the other is very harmful as it can spread highly contagious diseases to the present and the future generation as well. This kind of waste can even be threat to the environment too as it can cause air, water, and soil pollution.

Many studies have stated that health care workers have very less or no knowledge about the disposal of Bio-Medical Waste which can be harmful and may seriously affect the environment. Due to the same reason, there is an increase in the awareness about the Bio-Medical Waste segregation and disposal. In our country there is a very much need of the awareness and knowledge about the same as many reports suggest that there is a lacunae in the practices among the many Health Care Workers. The Bio-Medical Waste Management Rules has been amended several times, but there is a lack of update among Healthcare workers and institutions.

Harmful Effects of Poorly Managed Biomedical Waste:

Biomedical waste when not disposed properly can pose serious risks to society and the environment through air emissions, contamination of water and physical contact.

Improper disposal refers to open dumping, unrestrained burning, and improper handling of waste during generation, collection, storage, transport and treatment.

Improper handling involves unsafe procedures followed during handling of wastes i.e. without wearing protective equipment, poor storage (high temp, high residence), transporting manually for longer distances, uncovered or unpacked containers instead of puncture proof bags, etc. all of which effect hospital workers in different ways.

The following groups are exposed:

Inside Health Care Centers: 

staff- doctors, nurses, auxiliaries, stretcher bearers, patients, scientific and technical personnel, housekeeping staff, laundry, waste managers, maintenance, and lab technicians.


In site and off site transport personnel, waste processing personnel, public, and rag pickers. Improper management of wastewater and sludge can result in contamination of air, soil and water with pathogens and toxic chemicals which may affect all forms of life. Inadequate waste management can cause environmental pollution, unpleasant odors, growth and multiplication of insects, rodents and worms and may lead to transmission of diseases like typhoid, cholera, etc. Infectious agents such as faeces, vomit, saliva, secretions, blood can cause serious health risks on individuals by affecting organs or systems like gastrointestinal, respiratory, eye, skin and cause Anthrax, Meningitis, AIDS, Haemorrhagic Fever, Hepatitis A, B, C, Influenza etc. Research and radio-immunoassay activities may generate small quantities of radioactive gases.

Infections Associated with Different Types of Waste:

OrganismDisease CausedRelated waste

HIV, Hepatitis B, Hepatitis A, C, Arboviruses, Enteroviruses

AIDS, Infectious Hepatitis, Dengue, Japanese encephalitis, tick-borne, fevers, meningitis, etc.Infected needles, body fluids, Human excreta, soiled linen, blood

Salmonella typhi, vibrio cholera, clostridium Tetani, Pseudomonas, Streptococcus

Typhoid, Cholera, Tetanus, Wound Infections, Septicaemia, Rheumatic fever, endocarditis, skin and soft tissue infections, meningitis, bacteraemiaHuman excreta and body fluids in landfills and hospital wards, sharps such as needles, surgical blades in hospital waste 

Wucheraria Bancrofti, Plasmodium

Cutaenous leishmaniosis, Kala Azar, MalariaHuman excreta, blood and body fluids in poorly managed sewage system of hospitals


Bio-Medical Waste Management Rules:

Bio-Medical Waste Management Rules were implemented under Environment Protection Act,1986 in our country on 20th July,1998. After that the Rules have undergone many amendments in the passing years. Bio-Medical waste Rules,2016 is the latest Bio-Medical Rules after significant and many changes done to Bio-Medical Rules,1998 keeping in mind the health care of the people. Primarily this waste was divided among various categories. Further multiple categories were clubbed to disposed in four colour coded bags. This was very hard to be remembered by the housekeeping and healthworker staff which formed a very weak section in the Bio Medical Waste Management system. It was found that the Bio-Medical waste generators had their own waste disposal techniques and systems which were not very effective or required significant improvement as they posed a threat to the public as well as the environment.

To undertake all these issues the new Bio-Medical Waste Management Rules were laid down by the ministry of Environment, Forest and Climate change under the Environment Protection Act, 1986 on 28th March, 2016.

Difference between Bio-Medical Waste Management Rules, 1998 and 2016:

The major changes are as follows: (1) the removal of multiple categories and to continue with only four color-codes (2) that no occupier was permitted to establish an on-site treatment and disposal facility if service of a common biomedical waste treatment facility (CBMWTF) is available within a distance of 75 km, and (3) changes in the form numbers of accident reporting, authorization, annual reporting, and appeal. The difference between Bio-Medical Waste Management Rules, 1998 and 2016 has been discussed by dividing it into various points and showing the difference between them.

Duties of the Occupier:

Duties of the occupier are delineated better as it wasn’t delineated in 1998. There is pretreatment by disinfection and sterilization on-site of infectious lab waste blood bags as per the WHO guidelines Occupier ensures liquid waste is segregated at source by pretreatment,  whereas, No pretreatment of waste on-site Chlorinated plastic bags, gloves, and blood bags were recommended. ETP is mandatory Occupier ensures to maintain BMWM register daily and on website monthly Annual report should be made available on the website within two years The occupier (30 bedded) establishes BMWM committee Records of equipment, training, health checkup, and immunization are compulsory whereas any of the above were not mandatory in the Biomedical waste management rules, 1998.

Duties of the CBMWTF:

Duties are delineated better The occupier has to establish barcoding and GPS and ensure occupational safety of all its HCWs by TT and HBV vaccination Reporting of accidents and maintenance of records of equipment, training, and health checkup, whereas, in BMWM Rules, 1998 Duties are not delineated, better Barcoding and GPS not documented and vaccinations for HCWs not documented, Records not documented.

Accident Reporting:

Major accidents are reported to authorities and in annual report whereas, No specific reporting of accidents were mandated in BMWM Rules,1998.

Deep Burial:

As per rules 2016, Deep Burial is an option for only remote and rural areas and not in towns and villages with less than 5 lakhs population.

Chemical Treatment:

Changes to chemical treatment from 1% hypochlorite to 10% hypochlorite in 2016 which was again rolled back to 1%-2% in 2018.


No demarcation of foetus was mentioned in BMWM rules 1998 but the new amendment of rules in 2016 said Foetus younger than the age of viability is to be treated as human anatomical waste.


Antibiotics and other drugs and solid chemical waste suggested for incineration Cytotoxic drugs: return back to supplier and incineration up to 1200 C whereas, the rules, 1998 mentioned that all the drugs to be discarded in the black bag for cytotoxic drugs, destruction and drugs disposal in secured landfills

Liquid-infected waste:

Effluent treatment plant is mandatory, and effluent to conform to standards mentioned whereas rules, 1998 states chemical treatment and discharge into drains to conform to effluent standards mentioned.

Microbiology and biotechnology waste:

Rules, 2016 states the Pre-treatment of infectious waste as per the WHO guidelines whereas pre-treatment was not at all mandatory in rules, 1998.

Infected plastics, sharps and glass:

The infected plastics and sharps go in the red bag and the white container, respectively, and are sent to authorized recyclers. The glass articles are discarded in a cardboard box with blue marking whereas, infected plastics, metal sharps, and glass go in the blue container with disinfectant, and local autoclaving/microwaving/incineration is recommended.


A focus on recycling of plastic, sharps, and glass to authorized recyclers whereas, no such mention in rules, 1998.

Form I:

Changed to accident reporting from application for authorization.


Changed to Authorization or renewal of Authorization from Annual Report in rules, 1998.


Changed to Authorization for opening a facility for collectin, reception, treatment, storage, transport, and disposal of BMW from Accident Reporting in BMW Rules in 1998.


Changed to Annual Report from Authorization for operating a facility for collection, reception, treatment, storage, transport, and disposal of BMW.


Changed to Application for filing appeal against order passed by the prescribed authority from Application for filing appeal against order passed by the prescribed authority in rules 1998.


Further, after publishing Bio-Medical Waste Management Rules, 2016 the Ministry of Environment, Forest and Climate change made some amendments and published Biomedical Waste Management (Amendment) Rules, 2018 on 16th March, 2018. In this amendment, typographical errors were corrected, rules regarding non-infectious wastes were updated.


Author: Arjun Rathod

Editor: Adv. Aditya Bhatt & Adv. Chandni Joshi

Laws existing in India to prevent and control water pollution

Laws existing in India to prevent and control water pollution

Environmental Rule of Law

Environmental Laws in India and Gujarat

The need for protection and conservation of environment and sustainable use of natural resources is reflected in the constitutional framework of India and also in the international commitments of India.

Constitution of India

The Constitution under Part IVA (Art 51A-Fundamental Duties) casts a duty on every citizen of India to protect and improve the natural environment including forests, lakes, rivers and wildlife, and to have compassion for living creatures.

Further, the Constitution of India under Part IV (Art 48A-Directive Principles of State Policies) stipulates that the State shall endeavor to protect and improve the environment and to safeguard the forests and wildlife of the country.

Some of the important legislation for environment protection are as follows:

  • The National Green Tribunal Act, 2010
  • The Air (Prevention and Control of Pollution) Act, 1981
  • The Water (Prevention and Control of Pollution) Act, 1974
  • The Environment Protection Act, 1986
  • The Hazardous Waste Management Regulations, etc.

The National Green Tribunal Act, 2010

The National Green Tribunal Act, 2010 (No. 19 of 2010) (NGT Act) has been enacted with the objectives to provide for establishment of a National Green Tribunal (NGT) for the effective and expeditious disposal of cases relating to environment protection and conservation of forests and other natural resources including enforcement of any legal right relating to environment and giving relief and compensation for damages to persons and property and for matters connected therewith or incidental thereto.

Water Prevention and Control of Pollution Act, 1974

The prime object of this Act is to provide for the prevention of water pollution and cater to the maintenance of the water bodies and carry out activities to promote restoration of water. With the objective of giving practical implementation to this Act, the Central Pollution Control Board and the State Pollution Control Board have been established by the central and state authorities. The Central Pollution Control Board is to promote the cleanliness of streams and wells in different areas of the state. The Central Pollution Control Board has the power to advise the central government on various matters, which are concerned with the prevention and control of pollution of water. Under the Act mentioned above, the board has the power to encourage and conduct research and investigation with a view of promoting, the prevention of contamination of water in a significant manner.

The Water Prevention and Control of Pollution Cess Act, 2003

Industrial waste is one of the causes of the of water pollution. Often the waste from the industries is being disposed of into the rivers which pollute the river to a significant extent. According to Section 2 of this Act, industries include any operation or process or sewage or disposal treatment or any industrial effluent. Section 3 of this Act provides an exemption to industries from levying cess on those industries, which consume water below the specified limit. Water gets polluted through the toxic or non-biodegradable substances when the processing of these materials is being done in any industry, and such industries are required to pay cess under this law.

Relevance of Section 24 of this Act

To promote the proper implementation of the Act, Section 24 of the Act imposes a duty upon a person to refrain from allowing any poisonous or noxious matter, as determined by the standards laid down by the Central Pollution Control Board, into any stream or sewer or on the land. Another duty imposed by this Act upon the person is that no person shall, knowingly enter into any stream in a manner so as to impede the flow of water or in any other way causes pollution of water. According to this Section, any person who violates or contravenes with the provision of this Section shall be made liable to be punished with imprisonment of one year and six months which may extend up to six years.

Drawbacks of this Act

  • One of the chief drawbacks of this Act is that the Act is silent about the Groundwater Management policies.
  • Another drawback with which this Act suffers from is the fact that it does not deal with the indiscriminate tapping of ground water, rain water harvesting, etc.

The Indian Penal Code and Pollution

  • Under the Indian criminal law, provisions have been explicitly laid down to punish the person who commits an offence in contravention to the Code. Section 277 of the Code provides for the punishment to be given to the person who commits an offence of fouling of a public reservoir or a public spring voluntarily shall be liable to be punished with imprisonment of three months or with a fine of 500 Rupees or with both. The explanation of this situation can be given through an illustration. A, a resident of Chandigarh, goes near a reservoir and voluntarily puts a toxic substance with an intention to cause harm to the environment and in consideration pollutes the water. The reservoir was fit for public use before, but after the Act of A, the reservoir became unfit for the utilization of the public. Therefore, A was being held liable for the offence under Section 277 of the IPC, and he was punished with imprisonment of up to three months and a fine of Rupees 500.

The River Boards Act, 1956

  • This act aimed at the establishment of rivers and the regulation of interstate water disputes. The interest of the public is considered to be the prime concern of this Act. The Act gives the power to the State Government to establish Boards by issuing a special notification. The object of this Act is to resolve and regulate the inter-state water disputes. Article 262 of the Constitution of India gives the power to the Union to establish and adjudicate the inter-state water disputes prevailing in the country. Through this Act, awards and tribunals were being formulated to regulate the interstate dispute prevailing in a particular country.

Public Liability Insurance Act, 1991

The Public Liability Insurance Act, 1991 was enacted with the objectives to provide for damages to victims of an accident which occurs as a result of handling any hazardous substance. The Act applies to all owners associated with the production or handling of any hazardous chemicals.)

Coastal Regulation Zone Notification

The Ministry of Environment and Forests had issued the Coastal Regulation Zone Notification vide Notification no. S O. 19(E), dated January 06, 2011 with an objective to ensure livelihood security to the fishing communities and other local communities living in the coastal areas, to conserve and protect coastal stretches and to promote development in a sustainable manner based on scientific principles, taking into account the dangers of natural hazards in the coastal areas and sea level rise due to global warming.


Hazardous Wastes Management Regulations

Hazardous waste means any waste which, by reason of any of its physical, chemical, reactive, toxic, flammable, explosive or corrosive characteristics, causes danger or is likely to cause danger to health or environment, whether alone or when in contact with other wastes or substances.

There are several legislations that directly or indirectly deal with hazardous waste management. The relevant legislation are the Factories Act, 1948, the Public Liability Insurance Act, 1991, the National Environment Tribunal Act, 1995 and rules and notifications under the Environmental Act. Some of the rules dealing with hazardous waste management are discussed below:

  • Hazardous Wastes (Management, Handling and Trans Boundary) Rules, 2008, brought out a guide for manufacture, storage and import of hazardous chemicals and for management of hazardous wastes.
  • Biomedical Waste (Management and Handling) Rules, 1998, were formulated along parallel lines, for proper disposal, segregation, transport, etc, of infectious wastes.
  • Municipal Solid Wastes (Management and Handling) Rules, 2000, aim at enabling municipalities to dispose municipal solid waste in a scientific manner
  • E – Waste (Management and Handling) Rules, 2011 have been notified on May 1, 2011 and came into effect from May 1, 2012, with primary objective to reduce the use of hazardous substances in electrical and electronic equipment by specifying threshold for use of hazardous material and to channelize the e-waste generated in the country for environmentally sound recycling. The Rules apply to every producer, consumer or bulk consumer, collection Center, Dismantler and recycler of e-waste involved in the manufacture, sale, purchase and processing of electrical and electronic equipment or components as detailed in the Rules.
  • Batteries (Management & Handling) Rules, 2001 deal with the proper and effective management and handling of lead acid batteries waste. The Act requires all manufacturers, assemblers, re-conditioners, importers, dealers, auctioneers, bulk consumers, consumers, involved in manufacture, processing, sale, purchase and use of batteries or components thereof, to comply with the provisions of Batteries (Management & Handling) Rules, 2001.

Other states acts for water pollution control:

  1. The Shore Nuisance Bombay and Kolaba Act – The objective, with which this act was being brought into force, was with the purpose of facilitating the removal of nuisances below the high water mark in the islands Bombay and Kolaba. This act aimed at safe navigation of the harbour in Bombay along with the objective of giving importance to the interest of the public. The Act empowered the land revenue collector of Bombay to issue a notice to remove the nuisances or obstructions which exist below the high water mark.
  2. Orissa River Pollution Act, 1953 – This Act was formulated with the view of regulating the disposal of waste and effluents into the river by the factories and enable maintenance of the streams and water bodies. With the intention of giving this Act a practical implementation, the state of Orissa had established a board to govern the provisions of the Act above. This Act gives the board the competency to represent the inhabitants of a particular locality.

Damodar Valley Corporation Prevention of Water Pollution Act, 1948

  • The Damodar Valley has been among the most flourished river basins which the country has witnessed since time immemorial. With the view of keeping a check on the functioning of this valley, Damodar Valley Corporation was established. During the monsoon season, 80 percent of the waste comprising of waste from mines and industries is discharged into this river. With the coming up of this Cooperation, the agricultural sector had undergone a change. The agricultural area decreased from[6]59 percent in 1925 to just 10 percent in 1984. The mining industry had become the need of the hour during that period. The discharge of effluents from these mines was made into this river. This results in the pollution of water.

Right To Clean Water: a Fundamental Right

  • The Indian Judiciary has initiated a positive step, with the view of controlling pollution of water. Under the Indian Constitution, the judiciary has given a liberal interpretation to Article 21 of the Constitution of India and included the right to clean water and environment under the ambit of Article 21, Article 48, Article51(g) of the Constitution of India. Various judicial decisions throughout the history of Fundamental Rights have paved a way to the broad concept of Right to Life. The judiciary had propounded that the Right to Clean water comes under the ambit of the right to life and hence the scope of Article 21, Article 48 and Article 51(g) can include the right to clean water. In the case of Narmada Bachao Andolan Vs. The Union of India, the Supreme Court, held that the right to clean water is a fundamental right under Article 21 of the Indian Constitution. The court had observed that right to clean water is a part of the basic necessity of the human’s right to life.The state is duty bound to prevent the water from getting polluted.In the leading case of MC Mehta vs. The Union of India, the court held that the preventing the water of river Ganga from being polluted is the need of the hour.
  • Though many acts have been passed by the Parliament to control the pollution of water still, there is an urgent need for preventing our streams, reservoirs ,rivers, lakes from being polluted. The government should keep a check on the functioning of reservoirs, streams, lakes and a body should be established to monitor the working of the government.