Biomedical Waste Management

Rules, 2016

By:
Youthika
Senior Environmental Engineer
Waste Management Division 1
 Background

u Bio-medical Waste (Management & Handling)

Rules, 1998 was notified by Ministry of
Environment Forests & Climate Change in July,
1998

u Bio-medical Waste Management Rules, 2016

notified by Ministry of Environment Forests &
Climate Change and came into effect from
28.03.2016.
 Comparison of Bio-Medical Waste Rules 1998 with 2016

S. No. 1998 2016

1 Occupier with more than Every occupier generating BMW,
1000 beds required to including health camp and ayush
obtain authorization require to obtain authorization

2 Operator duties absent Duties of the operator listed

3 Bio-medical waste Bio-medical waste divided in 4

divided in 10 category category

4 Rules restricted to Treatment and disposal of bio-

HCE’s with more than medical waste mandatory for all
1000 bed. HCE’s.

5 No format for Annual A format for annual report

Report appended with rules

6 Schedule I,II,III,IV & V Change schedule I,II, III &IV

 Biomedical Waste Management Scenario
in India
(based on Annual Report data for the year 2018)

u No. of HCFs : 2,70,416

u No. of bedded HCFs : 97,382
u No. of non-bedded HCFs : 1,73,831
u No. of beds : 22,06,362
u No. of CBWTFs : 200* + 28**
u No. of HCFs granted authorization : 1,10,356
u No. of HCFs having Captive Treatment Facilities :12,326
u No. of Captive Incinerators Operated by HCFs :120
u Quantity of bio-medical waste generated in Tonnes/day : 614
u Quantity of bio-medical waste treated in Tonnes/day : 534
u No. of HCFs violated BMW Rules : 27,301
u No. of Show-cause notices/Directions issued to defaulter HCFs : 16,956
Legal Framework for Biomedical Waste Management in India

u Government of India has notified Biomedical Waste Management

Rules under Environment (Protection) Act, 1986 which are in
effect since 1998

u These Rules are revised in 2016 with better vision for safe and
effective disposal of biomedical waste
 OBJECTIVE
To improve the collection, segregation, processing, treatment and
disposal of bio-medical wastes in an environmentally sound
management.

BIO MEDICAL WASTE ?

It is defined as “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
BMWM Rules 2016.
 Important Definitions
"authorization" means permission granted by the prescribed
authority for the generation, collection, reception, storage,
transportation, treatment, processing, disposal or any other form
of handling of bio-medical waste in accordance with these rules
and guidelines issued by the Central Government or Central
Pollution Control Board (CPCB).

"bio-medical waste treatment and disposal facility" means any

facility wherein treatment, disposal of bio-medical waste or
processes incidental to such treatment and disposal is carried out,
and includes Common Bio-medical Waste Treatment Facilities
(CBMWTF);
 IMPORTANT Definitions –
contd…

u "occupier" means a person having administrative control

over the institution and the premises generating bio-medical
waste, which includes a hospital, nursing home, clinic,
dispensary, veterinary institution, animal house, pathological
laboratory, blood bank, health care facility and clinical
establishment, irrespective of their system of medicine and by
whatever name they are called

u “prescribed authority” means the State Pollution Control

Board in respect of a State and Pollution Control Committees
in respect of an Union Territory; DGAFMS in respect of Armed
Force Health Care Establishments.
 Provisions under
Bio-medical Waste Management Rules, 2016

Provisions

Ø Application
Ø Definitions ( from a to p)
Ø Duties of the Occupier / Facility Operator and Authorities
Ø Procedures for Segregation, Packing, Transportation, Storage, Treatment
and Disposal
Ø Procedure for Authorization
Ø Advisory Committee and Monitoring Committee
Ø Reporting Requirements
Ø Maintenance of Records
Ø Accident Reporting
Ø Appeal
Ø Procedure for setting up CBWTDF
Ø Liability of the occupier, operator of a facility
 Application
These Rules shall apply to all persons who generate, collect, receive, store, transport, treat, dispose
or handle bio-medical waste in any form including:
q Hospitals,
q Nursing homes,
q Clinics,
q Dispensaries,
q Veterinary institutions,
q Animal houses,
q Pathological laboratories,
q Blood banks,
q Ayush hospitals,
q Clinical establishments,
q Research or educational institutions,
q Health camps,
q Medical or surgical camps,
q Vaccination camps,
q Blood donation camps,
q First aid rooms of schools,
q Forensic laboratories and research labs
Bio-medical Waste Management Rules, 2016

Schedules
u Schedule I – Bio-medical Wastes categories and their segregation,
collection, treatment, processing and disposal
u Schedule II – Standards for treatment and disposal of bio-medical
wastes
u Schedule III – List of Prescribed Authorities and Corresponding duties
u Schedule IV – Label for Bio-medical Waste Containers or Bags

Forms
u Form I – Accident Reporting
u Form II – Application for Authorisation or Renewal of Authorisation
u Form III – Authorisation
u Form IV – Annual Report
u Form V – Application for filing appeal against order passed by the
Prescribed Authority
Salient features of Bio-Medical Waste Rules 2016

u The ambit of the rules -include vaccination camps, blood

donation camps, surgical camps or any other healthcare
activity;
u Phase-out the use of chlorinated plastic bags excluding blood
bags and gloves by 27.03.2019;
u Pre-treatment of the laboratory waste, microbiological waste,
blood samples and blood bags through disinfection or
sterilization on-site
u Provide training to all its health care workers and immunize all
health workers regularly;
u Establish a Bar-Code System for bags or containers containing
bio-medical waste for disposal by 27.03.2019.;
u Report major accidents;
u Existing incinerators to achieve the standards for retention
time in secondary chamber and Dioxin and Furans within two
years;
Salient features of Bio-Medical Waste Rules 2016

u Bio-medical waste classified in to 4 categories instead 10 to

improve the segregation of waste at source;

u Automatic authorization for bedded hospitals. The validity of

authorization synchronized with validity of consent orders for
Bedded HCFs. One time Authorization for Non-bedded HCFs;

u State Government to provide land for setting up common bio-

medical waste treatment and disposal facility;
u No occupier shall establish on-site treatment and disposal
facility, if a service of common bio-medical waste treatment
facility is available at a distance of seventy-five kilometer.

u Operator of a common bio-medical waste treatment and

disposal facility to ensure the timely collection of bio-medical
waste from the HCFs and assist the HCFs in conduct of training.
Steps for Implementation of
BMWM Rules, 2016
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 Duties of Occupier
u Segregation of Waste: at source as per Schedule I.;
u Storage of Waste : Safe and secured location;
u Pre-treatment of waste: laboratory waste, microbiological waste,
blood bags and blood samples through disinfection or sterilization;
u Phase out use of chlorinated plastic bags and gloves (Chlorinated
plastic bags” shall not include urine bags, effluent bags, abdominal
bags, blood bags and chest drainage bags);
u Trainings : to all its HCWs-at the time of induction & thereafter
atleast once in a year and maintain such records.
u Immunize all healthcare workers : Hepatitis & Tetanus;
u Bar Code: Establish a Bar-Code System for bags or containers within
one year from 27.03.2019;
u Pre-treatment of Liquid Chemical Waste: Source segregation and pre-
treatment or neutralization prior to mixing with other effluent.;
u Treatment of liquid waste: Ensure treatment & disposal of liquid
waste accordance with Water Act, 1974.
u Occupational safety: Ensure Occupational Safety of HCWs by
providing PPEs;
 Duties of Occupier
u Accident Reporting: Major accidents reporting in Form I to
SPCB/PCC;
u Record Maintenance: Maintain register/records on day-to-day basis
& display monthly record on website as per Schedule-I.
u Website: All bedded HCFs should have own website within 2 years
and make available the AR on web-site;
u Waste not collected by CBMWTF: Inform SPCB/PCC immediately.;
u Record Keeping: Maintain all records for operation of Captive
Treatment Equipment for a period of five years;
u Review and monitor the BMW activities: through existing Committee
or by a new Committee.
v Committee: meet once in every six months and submit record
of minutes of the meeting along with AR to SPCB/PCC.
v HCF having < 30 no. of beds: designate a qualified person to
review and monitor
Duties of Municipalities or Corporation, ULBs
and Gram Panchayats

u Provide or allocate suitable land for development

of common bio-medical waste treatment facilities
in their respective jurisdictions as per the
guidelines of Central Pollution Control Board.
u 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.
u Any other function stipulated under these Rules.
SEGREGATION, PACKAGING, TRANSPORTATION AND
STORAGE
u No untreated bio-medical waste shall be mixed with other wastes.
u BMW shall be segregated into containers or bags at the point of
generation in accordance with Schedule I prior to its storage,
transportation, treatment and disposal.
u Containers or bags shall be labeled as specified in Schedule IV.
u Bar code and global positioning system shall be added by the Occupier
and common bio-medical waste treatment facility.
u CBMWTF shall transport the BMW from the premises of an occupier to
any off-site BMWTF only in the vehicles having label as provided in
part ‘A’ of the Schedule IV along with necessary information as
specified in part ‘B’ of the Schedule IV.
u Vehicles used for transportation should be: as per authorization of
SPCB/PCC and register under Motor Vehicle Act, 1988.
u Untreated human anatomical waste, animal anatomical waste, soiled
waste and, biotechnology waste shall not be stored beyond a period
of 48 hours.
 SEGREGATION OF BIO-MEDICAL WASTE

Human & animal

anatomical waste, Glassware &
Contaminated Waste sharps
Soiled waste, Metallic body
Plastic Waste including
expired implants
(Recyclable) Metals
medicines,
chemical waste,
discarded linen,
microbiology
laboratory waste

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Labeling
 BMW categories and storage
BMW Treatment Options
Category

Yellow Incineration
Plasma Pyrolysis
In bags / Expired cytotoxic drugs to be returned back to manufacturer
containers Chemical liquid waste shall be pretreated and then conform to
Schedule III
Non-chlorinated chemical disinfection followed by incineration
or plasma pyrolysis or for energy recovery
Pre-treat to sterilize with non-chlorinated chemicals on-site
thereafter for incineration
Red Autoclaving or microwaving/ hydroclaving followed by shredding
In bags or mutilation or combination of sterilization and shredding
Treated waste to be sent to recyclers for energy recovery
Plastic waste should not be sent to landfill
 BMW categories and storage – contd….

BMW Category Treatment Options

White Autoclaving
In container / Dry Heat Sterilization followed by shredding or
bags mutilation or encapsulation in metal container or
cement concrete
Combination of shredding cum autoclaving and sent for
final disposal to iron foundries or sanitary landfill

Blue Disinfection -
Boxes by soaking the washed glass waste after cleaning with
detergent and Sodium Hypochlorite treatment/
Autoclaving/microwaving/hydroclaving and then sent
for recycling
 Treatment & disposal
u BMW shall be treated & disposed of in accordance with Schedule I & II
u Occupier shall handover the segregated BMW to CBWTF including pre-treated
lab and highly infectious waste for further treatment. Efficacy: Log4 for
Disinfection and Log 6 for Sterilization.
u No Occupier shall establish captive treatment facility if CBWTF is located at 75
Km. If services of CBWTF not available, occupier shall setup captive treatment
facility as per authorization from SPCB.
u Every occupier shall phase out use of chlorinated plastic bags within two
years.
u The bags used for handling of BMW should be as per BIS Specifications (to be
formulated) till such time as per PWM Rules, 2016 (i.e., = or > 50 µ thick)
u After treatment, the recyclable BMW shall be given to recyclers authorized /
registration from Prescribed Authority
u Handling and disposal of mercury waste and lead waste shall be in
accordance with the respective rules / guidelines
TREATMENT AND DISPOSAL AT CBMWTF
 Infrastructure for Biomedical Waste
Management
o Desired Infrastructure (CBMWTFs)

§ Developing Common Facilities

In States Arunachal Pradesh, Goa,

Mizoram, Nagaland & Sikkim A & N
Islands and Lakshadweep

§ Upgrading all existing incinerators

for complying with Dioxin norms ( 2
years)

§ Online emission monitoring

§ Vehicles for transportation of BMW

§ Bar code systems ( 1 year)

 Typical Common Biomedical Waste Treatment Facility

Sharp encapsulation pits for sharps disposal

BMW collection vehicle
 Non-burn Technologies

Combination of
sterilization & shredding
Incinerator
Burning of waste inside incinerator chamber
Conveyor belt for feeding of waste in
incinerator
Segregation of treated plastic waste
Segregation of treated glass waste
Segregation of treated glass waste
Shredder
Autoclave
Autoclave
Procedure for Authorization

Every HCF/CBWTF shall make an application

in Form II

SPCB/PCC shall grant provisional authorization

for bedded HCFs & CBWTF in Form III
Validity will be synchronized with validity of
Consents

One time authorization for non-bedded

HCFs within 90 days

In case of refusal or cancellation of

authorization reasons shall be record in
writing
 Advisory committee
u Advisory Committee shall be Department Health, Environment,
constituted by every State Urban Development, Animal
Husbandry and Veterinary
Government or Union Territory Sciences
Administration under
chairmanship of Health Secretary

State Pollution Control

Boards/Pollution Control
Committees

Urban Local Bodies/Local

Bodies/Municipal Corporation,
representatives from Indian
Medical association, CBWTF and
non-governmental organization
 Advisory committee
Ministry of Defence shall also Ministry of Defence
constitute Advisory Committee
(Defence)-Chairmanship of Director
General Health Services of Armed
Force Ministry of Environment
Forest & Climate Change

Advisory Committee shall meet at least Central Pollution control

once in six month Board

Ministry of Health & Family

Welfare

Armed Force Medical College

or Command Hospital
 Monitoring of implementation of Rules

u MoEF & CC : review implementation of Rules once in year

u CPCB : shall monitor the AFHCEs with prior intimation

u Every State Government or Union Territory Administration :

Ø Constitute District Level Monitoring Committee (DLMC) in the

District under the Chairman of District Collector or District
Magistrate or Dy. Commissioner or Add. District Magistrate.
Ø The DLMC shall submit its report once in six months to the State
Advisory Committee and a copy to SPCB/PCC for taking further
necessary action.
Ø The DLMC shall comprise of District Medical Officer (as Member
Secretary), Representatives from SPCB/PCC, Public Health
Engineering Dept., Local bodies or municipal corporation, Indian
Medical Association (IMA), CBWTF and registered NGOs
 Annual Report
(Form IV)

Every Occupier and Operator shall submit annual

report to SPCB/PCC by 30th June of every year

SPCB/PCC shall submit the compiled annual report

to CPCB by 31st July of every year

CPCB shall compile the annual report and submit to

MoEF & CC by 31st August of every year

Annual Report shall available online on website of

Occupiers, Operators, SPCBs/PCCs and CPCB
 MAINTENANCE OF RECORDS

u Every authorized person shall maintain records

related to the generation, collection, reception,
storage, transportation, treatment, disposal or
any other form of handling of BMW, for a period of
five years, in accordance with these rules and
guidelines issued by the Central Government or
the CPCB or the prescribed authority as the case
may be.

u All records shall be subject to inspection and

verification by the prescribed authority or the
MoEFCC at any time.
 ACCIDENT REPORTING
(Form I)

u In case of any major accident at any institution or

facility or any other site while handling BMW, the
authorized person shall intimate immediately to the
prescribed authority about such accident and forward a
report within twenty-four hours in writing regarding
the remedial steps taken in Form I.

u Information regarding all other accidents and remedial

steps taken shall be provided in the annual report in
accordance with rule by the occupier.
 Appeal
(Form V)

(1) Any person aggrieved by an order

of PCB/PCC:

Ø File an appeal in Form V Form-V, BMWM Rules, 2016.docx within

30 days from the date of the order to The Secretary
(Environment) of the State or UT.

(2) Any person aggrieved by an order of

the DGAFMS

Ø File an appeal in Form V within 30 days from the date of the

order to The Secretary, MoEF & CC.
(3) The authority, may entertain the appeal:

Ø after expiry of the said period of thirty days and the appeal shall
be disposed of within 90 days from the date of its filing.
 Liability of the occupier, Operator of a facility

u The occupier or operator of a CBWTF shall be

liable for all the damages caused to the
environment or the public due to improper
handling of BMW or disposal of bio-medical
waste.

u The occupier or operator of a CBWTF shall be

liable for action under Sections 5 and Section 15
of the E (P) Act, 1986 in case of any violation.
 Status on usage of CPCB’s COVID19BWM App
u As of now, COVID 19 waste generation is around 136 tons/day .

u 4,737 nos. of waste generators are registered in COVID19BWM App.

u 141 CBWTFs are reporting data on COVID19BWM App.

u All SPCBs/PCCs accept Lakshadweep, Nagaland and Sikkim, have

started reporting daily data.
Challenges in Implementation of BWMW
Rules, 2016 in COVID Pandemic
Healthcare Facilities

u Segregation of Biomedical Waste in Healthcare Facilities

u Segregation of solid waste and biomedical waste

u Record Maintenance

u Pre-treatment of infectious waste

u Awareness among hospital workers

Treatment & Disposal Facilities

u Compliance to Standards

u Daily collection of biomedical waste from HCFs

u Reporting of data

Local Bodies & Authorities

u Collection of COVID waste from Home Quarantines / Home Care
u Provide adequate PPEs to workers

u Setting up of collection centers

 Responsibilities of States / UTs and SPCBs/PCCs

u Ensure proper segregation of solid waste and biomedical waste;

u Ensure daily lifting of solid waste from hospitals treating COVID-19

patients;

u Ensure adequate capacity at common facilities to handle BMW;

u Submit report daily records through CPCB’s COVID-19 BM Waste Tracking

App and ensure use of COVID19BWM App by all CBWTFs and HCFs in their
State/UT;

u Monitor and ensure scientific management of deep burial pits;

u Compliance to CPCB Guidelines;

u Provision of PPEs to waste handlers;

u Provide awareness and training to waste handlers on safety aspects and

use of PPEs;
COVID-19 Waste Management - Requirement
u Strict implementation of existing Biomedical Waste Management
Rules, 2016, as amended
u State should develop a model plan to be implemented at
Panchayat / District level
u Safety of workers should be taken care of by providing adequate
PPEs
u Adequate Common Treatment Facilities in States
u Encourage utilization of industrial incinerators/hazardous waste
incinerators etc. in case capacity of existing biomedical waste
incinerators are exhausted
u Regular monitoring by Prescribed Authorities, identify the gaps,
preparation of action plans etc.
THANK YOU

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