Law Relating to Biomedical Waste Management in India

The current legislation which provides for the management and specific treatment of
biomedical waste is the Biomedical Waste Management Rules, 2016.
The rules were notified by Ministry of Environment Forests & Climate Change in
March, 2016 in suppression of earlier Biomedical Waste (Management & Handling)
Rules, 1998.
The 1998 Rules was made in exercise of power conferred by Section 6, 8, and 25
of Environment Protection Act, 1986.

Section 6 - RULES TO REGULATE ENVIRONMENTAL POLLUTION. Central

Govt can make rules in respect of all or any of the matters referred to in Section 3.
One of the matter stated in Section 3 is laying down procedures and safeguards for the
handling of hazardous substances.

Section 8 - PERSONS HANDLING HAZARDOUS SUBSTANCES TO

COMPLY WITH PROCEDURAL SAFEGUARDS

Section 25 - POWER TO MAKE RULES.

Central Govt has the power to make rules carrying out the purposes of this Act.

What is biomedical waste?

As per the definition provided by the BMWM Rules 2016, "bio-medical waste"
means any waste, which is generated during the diagnosis, treatment or
immunization of human beings or animals or research activities pertaining thereto or
in the production or testing of biological or in health camps, including the categories
mentioned in Schedule I appended to the rules.

Schedule 1 consists of 2 parts. Part I talks about different categories of biomedical

wastes & the specific way or method to treat them.
Part II states that what all to be used while segregation, collection, treatment,
disposal of biomedical waste or what quality of product is to be used.
Types of biomedical waste

Schedule 1 provides different kinds of biomedical wastes such as :

 Human Anatomical Waste
 Animal Anatomical Waste
 Soiled Waste
 Expired or Discarded Medicines
 Chemical Waste
 Discarded linen, mattresses, beddings contaminated with blood or body fluid
 Waste sharps including Metals
 Glassware

Hazards of Biomedical Waste

 Occupational Health Hazards

 Hazards to General Public
 Hazards to animals and birds

Important Definition

 Occupier
 Operator of a Common Biomedical waste Treatment Facility (CBWTF)
 Prescribed Authority

Duties of Occupier

Rule 4 - Duties to segregate, pre-treat, ensure occupational safety, conduct regular

health checkups of health care workers (at least once a year), inform to prescribed
authority if CBWTF is not collecting waste or not collecting at the given time etc.

Note - Occupier can establish on-site treatment & disposal facility BUT if a
CBWTF is available at a distance of 75 km then it cannot be allowed.
Duties of Operator of CBWTF

Rule 5 - Collection, treatment, disposal of biomedical waste; inform prescribed

authority if the occupier is not handing over segregated medical waste; train the
staffs, allow occupier to see whether treatment is carried out as per the rules;
Collection on holidays as well.

Duties of Authorities

Rule 6 - Different Authorities have different duties mentioned in Schedule III of the
Act.

Ministry of Environment, Forest (i) Making Policies concerning

and Climate Change, Government bio-medical waste Management in the
of India Country including notification of Rules
and amendments to the Rules as and
when required.
(ii) Providing financial assistance for
training and awareness programmes on
bio-medical waste management related
activities to for the State Pollution
Control Boards or Pollution Control
Committees.
(iii) Facilitating financial assistance for
setting up or up-gradation of common
bio-medical waste treatment facilities.
(iv) Undertake or support operational
research and assessment with reference to
risks to environment and health due to
bio-medical waste and previously
unknown disposables and wastes from
new types of equipment.
Central or State Ministry of Health and (i) Grant of license to health care
Family Welfare, Central Ministry for facilities or nursing homes or veterinary
Animal Husbandry and Veterinary or establishments with a condition to obtain
State Department of Animal Husbandry authorisation from the prescribed
and Veterinary. authority for bio-medical waste
management.
(ii) Monitoring, Refusal or Cancellation
of license for health care facilities or
nursing homes or veterinary
establishments for violations of
conditions of authorisation or provisions
under these Rules.
(iii) Publication of list of registered health
care facilities with regard to bio-medical
waste generation, treatment and disposal.
(iv) Undertake or support operational
research and assessment with reference to
risks to environment and health due to
bio-medical waste and previously
unknown disposables and wastes from
new types of equipment.
(v) Coordinate with State Pollution
Control Boards for organizing training
programmes to staff of health care
facilities and municipal workers on
bio-medical waste.
Ministry of Defence (i) Grant and renewal of authorisation to
Armed Forces health care facilities or
common bio-medical waste treatment
facilities
(ii) Conduct training courses for
authorities dealing with management of
bio-medical wastes in Armed Forces

Central Pollution Control Board
State Government of Health or
Union Territory Government or
Administration
health care facilities or treatment facilities
in association with State Pollution
Control Boards or Pollution Control
Committees or Central Pollution Control
Board or Ministry of Environment, Forest
and Climate Change.
(i) Prepare Guidelines on bio-medical
waste Management and submit to the
Ministry of Environment, Forest and
Climate Change.
(ii) Co-ordination of activities of State
Pollution Control Boards or Pollution
Control Committees on biomedical
waste.
(i) To ensure implementation of the rule
in all health care facilities or occupiers.
(ii) Allocation of adequate funds to
Government health care facilities for
bio-medical waste management.
(iii) Procurement and allocation of
treatment equipments and make provision
for consumables for bio-medical waste
management in Government health care
facilities.
(iv) Constitute State or District Level
Advisory Committees under the District
Magistrate or Additional District
Magistrate to oversee the biomedical
waste management in the Districts.
(v) Advise State Pollution Control Boards
or Pollution Control Committees on
implementation of these Rules.
(vi) Implementation of recommendations
 of the Advisory Committee in all the
health care facilities.
State Pollution Control Boards or (i) Inventorisation of Occupiers and data
Pollution Control Committees on bio-medical waste generation,
treatment & disposal.
(ii) Compilation of data and submission
of the same in annual report to Central
Pollution Control Board within the
stipulated time period.
(iii) Grant and renewal, suspension or
refusal cancellation or of authorisation
under these rules
(iv) Monitoring of compliance of various
provisions and conditions of
authorisation.
(v) Action against health care facilities or
common biomedical waste treatment
facilities for violation of these rules
(vi) Organizing training programmes to
staff of health care facilities and common
bio-medical waste treatment facilities and
State Pollution Control Boards or
Pollution Control Committees Staff on
segregation, collection, storage,
transportation, treatment and disposal of
bio-medical wastes.
(vii) Undertake or support research or
operational research regarding
bio-medical waste management.
Municipalities or Corporations, (i) Provide or allocate suitable land for
Urban Local Bodies and Gram development of common bio-medical
Panchayats waste treatment facilities in their
respective jurisdictions as per the
 guidelines of Central Pollution Control
Board.
(ii) Collect other solid waste (other than
the biomedical waste) from the health
care facilities as per the Municipal Solid
Waste ( Management and handling)
Rules, 2000 or as amended time to time.
(iii) Any other function stipulated under
these Rules.

In short, the most important obligation of the authorities is to monitor the

implementation of the given Rules at different level.

Annual Report is to be submitted as well. Occupier & Operator to SPCB or PCC (on
or before 30th June of every year). SPCB or PCC to CPCB (on or before 31st July of
every year). CPCB to Ministry of Environment, Forest & Climate Change (on or
before 31st July of every year).

Liability under section 5 & 15 of Environment Protection Act, 1986 for non
compliance of the Rules.

Biomedical Waste During Covid - 19

Wastes such as infected masks, gloves, syringes, samples, and other protective
equipment, drain bags, urine bags, body fluid or blood-soaked tissues/cotton,
empty ampules etc. generated due to the diagnosis and treatment of Covid-19
patients would fall under the definition of BMW as per the BMWM Rules.
On an estimate, medical waste generation has increased six-fold compared to
pre-COVID-19 times in India. Therefore there is an urgent need for the safe disposal
of biomedical waste.

In addition to the existing Rules regarding disposal of biomedical wastes, the CPCB,
has released guidelines for handling, treatment and safe disposal of biomedical waste
generated during treatment, diagnosis and quarantine of patients confirmed or
suspected to have the novel coronavirus disease. The CPCB guidelines provide a
series of steps for safe disposal of waste generated in isolation wards with
COVID-19 patients, sample Collection Centres and Laboratories for COVID-19
suspected patients and quarantine camps/home-care facilities. The guidelines also
outline the duties of CBWTFs, SPCBs and Urban Local Bodies(ULBs).

The key actions mandated for various stakeholders include:

 Double-layered bags (using two bags) for collection of waste from COVID-19
isolation wards to ensure zero-leaks.
 Dedicated/marked collection bin and temporary storage area of biomedical waste
prior to handing over the same to authorized staff at CBWTF for priority
treatment and immediate disposal.
 Maintaining separate record of waste generated from COVID-19 isolation wards.
 Disinfection of inner and outer surface of containers/bins/trolleys used for storage
of COVID-19 waste with 1 per cent sodium hypochlorite solution daily.
 Reporting operation of COVID-19 ward and COVID ICU ward to SPCBs and
respective CBWTF located in the area.
 Dedicated sanitation workers for biomedical waste so that COVID-19 waste can
be collected and transferred timely to temporary waste storage area.
 General solid waste generated from quarantine centers to be handed over to waste
collector identified by ULBs.
 Biomedical waste, if any, generated from quarantine centers/camps to be
collected separately in yellow coloured bags (suitable for biomedical waste
collection) provided by ULBs.
 COVID-19 waste to be disposed-off immediately upon receipt by the CBWTF.
The CBWTF may employ any of the permitted methods under the Bio-medical
Waste Management Rules, 2016. These methods include incineration, Plasma
 Pyrolysis, Autoclaving/Hydroclaving, microwaving, chemical disinfection,
among others.
 At the quarantine facilities and during home care for suspected COVID-19
patients, the guidelines noted that even though a low quantity of biomedical waste
is expected to be generated, they still need to follow strict steps to ensure safe
handling and disposal of waste.
 In case of home-care for suspected patients, biomedical waste should be collected
separately in yellow bags (yellow coloured, non-chlorinated plastic bags) and
handed over to authorised waste collectors engaged by local bodies. ULBs should
engage the CBWTFs to pick up such waste either directly from such quarantined
houses or from identified collection points.

CPCB recommended that COVID-19 waste should be disposed of immediately upon

receipt at facilities and emphasised that they should not allow “any worker showing
symptoms of illness to work at the facility.”

It also specified that these guidelines are based on current knowledge of

COVID-19 and existing practices in the management of infectious waste
generated in hospitals while treating viral and other contagious diseases and will
be updated if needed.

With regard to the general public, they need to dispose their used napkins, tissues,
empty sanitizer bottles in a separate bag, to ensure the safety of municipal workers
and ragpickers. It will also ensure that the cycle of garbage collection and plastic
recycling don’t get affected. The government should also provide safety kits to
municipal workers urgently and educate them on how to handle household waste
during the outbreak, to help in halting the chain of transmission.

Meanwhile, as far as the state pollution control boards are concerned, the
guidelines said they shall maintain separate records of COVID-19 treatment
wards, quarantine centers, quarantined homes in respective states.