New bio medical waste management rules 2016

Environmentally safe Disposal of
Hospital & Health care Wastes
Bio-Medical Waste
Management Rules 2016
Dr. Gunwant Joshi
Former Chief Chemist
Madhya Pradesh Pollution Control Board
8/27/2016 1Dr. Gunwant Joshi

 The Biomedical Waste (Management
& Handling) Rules, 1998 as amended
up till March2016
2
up till March2016
 The Municipal Solid Waste
(Management & Handling) Rules,
2000, amended up till 2016

What Causes wastes from Hospital premises
HAZARDOUS ?
1. Waste Chemical-medications, Solutions, or
2. Infectious microbes,
3. Chemicals such as formaldehyde,
waste anesthetic gases, etc.,waste anesthetic gases, etc.,
4. Used disposables, Wasted equipments and
Chemotherapeutic agents,
5. Laser Smoke and aerosolized medications

Apart from Hospitals
Infectious wastes are also generated at
 Dental Chambers
 Nursing homes
 Cosmetic clinics
 Path. Laboratories
 Blood Banks
Aayush Hospitals Aayush Hospitals
 Veterinary institutions
 Bio-Medical & Biotech Research centers
 Medical check-up & Surgical camps
 Mortuaries & Autopsy centres
The work environments similar to
Hospital environment.

Recurrence of
Older infectious diseases
& Advent of Newer infections
Prompted improvements in
Medical technology and
Centralized Medicare, and
5
Centralized Medicare, and
Brought huge volumes of
Toxic & Hazardous Waste
Situation forced a serious
rethinking & necessitated
an appropriate refinement
in pre-existing Legislation

Unsafe BMW disposal : Who’s at Risk ?
• Doctors and nurses
• Other Patients
• Hospital support staff
• Waste collection and disposal staff• Waste collection and disposal staff
• General public in the vicinity and
• The Environment

•
Health care Associated infections : 5-10% of admissions in
acute care hospitals, 20 times higher in developing world
Oct. 2004, World alliance for Patient safety formed,
Identified certain challenges w/r to safety of patients.
“Clean care is Safer Care” (2005)
A formal pledge committing to address health care-
associated infection in the country was signed by
Government of India.
acute care hospitals, 20 times higher in developing world
1.4 million people worldwide suffer from HCAUI, 50% preventable.
India contributes to 25%-30% of the global injections
[3-6 Billion], nearly two-thirds (62.9%injections) unsafe
prevalence rate of blood born disease is on rise-
Hepatitis B 38/1000, Hepatitis c also on rise
HIV 7/1000

 To minimize the potential for spread of disease
from a medical settings to the general public;
 To reduce the overall amount of infectious
medical waste produced.medical waste produced.
 Infectious agents may become toys of terrorists,
as Bioweapons of Mass Destruction
a tight control over BMW management can reduce the risk & Response time

Hospital Waste is Hazardous waste:
But only a fraction of the Hospital waste is actually
hazardous and can be injurious to humans or
animals, and is deleterious to the environment.
This may be either
A. Infectious Bio-hazard
Infectious in nature
A. Infectious Bio-hazard
Infectious in nature
B. Sharps that may lead to
secondary infections
C. Toxic Bio-hazard
Cytotoxic in nature
D. Radiation Bio-hazard
Radioactive in nature8/27/2016 9Dr. Gunwant Joshi

Other Potentially Infectious Material
 Any body fluid with visible blood
 Amniotic fluid
 Cerebrospinal fluid
 Pericardial fluid
 Peritoneal fluid Peritoneal fluid
 Pleural fluid
 Saliva in dental procedures
 Semen/vaginal secretions
 Synovial fluid
 Anywhere body fluids that are indistinguishable

Blood and Fluid Borne Pathogen
Exposures may typically occur
by one of the following ways:
 Puncture from contaminated needles, broken glass,
or other sharps
 Contact between non-intact (cut, abraded, acne, or
sunburned) skin and infectious body fluids
 Direct contact between mucous membranes and
infectious body fluids
Example: A splash in the eyes, nose, or mouth

Hospital Wastes are dangerous and
require more careful attention
These are heterogeneous waste,
both solid & liquid, primarily
from Health Care Facilities
The available techno-economic
options for the disposal are
largely determined by the
Nature of activity of HCF and
volume of the various waste
components

Liquid wastes
Approx. Quantity : 4 to 250 liters / bed / day
1. Domestic Effluents and sewage
2. Sewage from isolation wards, ICU’s
toilets & urinals, Bed-bath, bathrooms
and hospital’s laundry
3. Wash waters from laboratories,OPD,
Dressing rooms & Operation theaters.

Solid wastes
Approximate Quantity : 0.3 to 3.5 kg/bed/day
1.Garbage 55%
(Bulk Density :330 kg/m3,Cal.Value:1000 K.cal / kg, Moisture :40%)
2.Bio-medical waste (sensu stricto) 13%2.Bio-medical waste (sensu stricto) 13%
A. Wasted body remains 05%
(Blood,Cultures,Anotomicals)
B. Pharmaceutical & Chemical Wastes. 02%
C. Pathological wastes (may be infectious). 06%
3.Sharp Objects 20%
4.Pressurized Containers & Discarded Instruments 02%
5.Radioactive Wastes 0.3%

Key to proper Bio - Medical Waste
Management is the segregation
as individual categories of waste
are to be treated & disposed off
in different specific ways

1. Out rightly send Domestic Effluents
to ETP or..the municipal sewers
2. Isolate & Collect the possibly infectious
liquid wastes (from Path Labs,OTs,Laundry ,etc.),
Disinfect completely and then send to ETP,
municipal sewers or as per terms of Consentmunicipal sewers or as per terms of Consent
3. Send the pre segregated Solid Waste that is
packed according to prescribed mode and

May be
Where,
The BMW shall be treated using
prescribed Standard methods such asprescribed Standard methods such as
Incineration, Autoclaving, Micro- waving,
and Chemical & Mechanical techniques
and the treated waste residue shall be
finally disposed off in a secured Landfill

Under Environment Protection Act,1998
BIO-MEDICAL WASTE (Management & handling) RULES 1998
1st Amendment Rules vide S.O.201(E) Dated 06/03/2000
2ndAmendment Rules vide S.O.1069(E) Dated 17/09/2003
BIO – MEDICAL WASTE MANAGEMENT RULES, 2016
The Authorization is required for
Generation/Collection/Reception/StorageGeneration/Collection/Reception/Storage
Transportation/Treatment/Disposal
or any other form of handling of BMW
Exclussions:
Municipal Solid Waste, Lead acid batteries wastes,
hazardous wastes, e-Waste, Radioactive wastes,
Hazardous micro organisms, GEMS & cells
and Haz Chem [MSIHC Rules’89]

 Never mix Infectious Bio waste in to
Municipal wastes.
[The entire waste lot shall become infectious]
Basic Concepts of
Hospital waste management
20
 Segregation and safe containment
(packing) of waste at Generator level.
[Health care facility]
 Processing & storage for the final or
terminal disposal.
8/27/2016 Dr. Gunwant Joshi

Genesis of the Rules 2016
(Draft Rules3rd June,2015 )
The Bio Medical Waste Management Rules, 2016
CONTAINS 18 RULES, 4 SCHEDULES & 5 FORMS.
 BMW categories, Segregation, Colour coding,
Collection ,Treatment & Disposal - Schedule I
 Standards for Treatment & Disposal - Schedule II
 Prescribed Authorities & Responsibilities - Schedule III
Labels for BMW containers & Bags - Schedule IV Labels for BMW containers & Bags - Schedule IV
 Accident Reporting - Form - I
 Application & Authorization Document - Form II & III
 Annual Reporting - Form IV
 APPEAL - Form V

The Bio Medical Waste Management Rules, 2016
1. Date of enforcement : Date of publication: 28/03/2016
2. Application & Exclussions,
3. Definition (a to p),
4. Duties of the occupier [Generator] - (a to t),
5. Duties of the occupier [Operator of CTDF] - (a to q),
6. Duties of the Authorities[Operator of CTDF] - (a to q),
7. Treatment & Disposal - (1 to 11),
8. Segregation, packaging, Transportation & storage - (1 to 8),
9. Prescribed authority (1 to 7),9. Prescribed authority (1 to 7),
10. Procedure for Authorization (1 to 4),
11. Advisory committee (1 to 4),
12. Monitoring & Implementation (1 to 6),
13. Annual report, (1 to 4),
14. Maintenance of records (1 to 2),
15. Accident Reporting (1 to 2),
16. Appeal (1 to 4),
17. Site for CBMWTDF (1 to 2),
18. Liability of the Occupier[Generator/Operator] (1 to 2)

Classification & Management as per BMW rules,2016
Schedule-I . Category-1: YELLOW, 2:RED
Category
1
YELLOW
(a) Human Anatomical Waste:
(b)Animal Anatomical Waste :
(c) Soiled Waste:
(d) Expired or Discarded
Medicines:
(e) Chemical Waste:
(f) Chemical Liquid Waste :
(g) Discarded linen,
(h) Microbiology, Bio-technology
& Clinical Laboratory Waste:
Treatment & Disposal Options
Incineration/Plasma Pyrolysis/
deep burial*
In absence of above autoclaving/
micro-waving/ hydroclaving followed by
shredding/mutilation
or combination of sterilization and
shredding.
Treated waste to be sent for energy
recovery.
& Clinical Laboratory Waste:
recovery.
Category
2
RED
Contaminated Waste
(Recyclable)
(a) Wastes generated from
disposable items such as tubing,
bottles, intravenous tubes and
sets, catheters, urine bags,
syringes (withoutneedles and
fixed needle syringes)
vaccutainers with their needles
cut)/ gloves
Autoclaving or micro-waving/
hydroclaving followed by
shredding /mutilation or
combination of sterilization & shredding.
Treated waste to be sent to registered or
authorized recyclers
or for energy recovery or plastics to diesel
or fuel oil or for road making, whichever is
possible.
Plastic waste should not be sent to landfill
sites.

Category
3
Trans-
luscent
Waste sharps including Metals:
Needles, syringes with fixed
needles, needles from needle
tip cutter or burner, scalpels,
blades, or any other
contaminated sharp object that
may cause puncture and cuts.
This includes both used,
discarded and contaminated
metal Sharps .
Treatment & Disposal Options
Autoclaving or Dry Heat Sterilization
followed by shredding/mutilation or
encapsulation in the metal container or
cement concrete;
Combination of shredding cum autoclaving.
sent for final disposal to iron foundries
(having consent to operate from PCB)
or sanitary landfill or designated concrete
Classification & Management as per BMW rules,2016
Schedule-I . 3:WHITE and 4: BLUE
metal Sharps .
or sanitary landfill or designated concrete
waste sharp pit.
Category
4
BLUE
(a) Glassware:
Broken /discarded &
contaminated glass including
medicine vials and ampoules
except those contaminated
with cytotoxic wastes.
(b) Metallic Body
Implants
Disinfection
(by soaking the washed glass waste after
cleaning with detergent & Sodium
Hypochlorite treatment)
or through autoclaving or microwaving or
hydroclaving and then sent for recycling.
Disinfection followed by recycling

B M Waste categories segregation, collection, treatment, processing & disposal options
B M Waste categories Container and
Pre Treatment
Treatment
& Disposal
(a) Human Anatomical Waste: Human tissues,
organs,body parts and fetus below the viability
period (as per MTPAct’71, amended up to date).
Yellow coloured
non-chlorinated
plastic bags
Incineration or Plasma
Pyrolysis or deep burial*
(b)Animal Anatomical Waste : Experimental
animal carcasses, body parts, organs, tissues, including
the waste generated from animals used in experiments or
testing in veterinary hospitals or colleges or animal houses.
(c) Soiled Waste: Items contaminated with
blood, body fluids like dressings, plaster casts,
cotton swabs and bags containing residual or
Incineration/Plasma
Pyrolysis/deep burial*
In absence of above autoclaving/
micro-waving/ hydroclaving followedcotton swabs and bags containing residual or
discarded blood and blood components.
micro-waving/ hydroclaving followed
by shredding/mutilation or
combination of sterilization and
shredding. Treated waste to be sent
for energy recovery.
(d) Expired or Discarded Medicines:
Pharmaceutical waste like
antibiotics, cytotoxic drugs
including all items contaminated
with cytotoxic drugs along with
glass or plastic ampoules,
vials etc.
Yellow coloured
non-chlorinated
plastic bags or
containers
Expired `cytotoxic drugs &
items contaminated with them
to be sent back to
Manufacturer/supplier
for incineration at >1200 C, or
to CBMWTF or HWTSDF for
incineration at >1200C, Or
Encapsulation or Plasma
Pyrolysis at >1200C. All other
discarded medicines shall be
either sent back to manufacturer
or disposed by incineration.

Pre Treatment
Treatment
& Disposal
(e) Chemical Waste:
Chemicals used in production of biological and
used or discarded disinfectants.
(f) Chemical Liquid Waste :
Liquid waste generated due to use of chemicals in
production of biological and used ordiscarded
disinfectants, Silver X-ray film developing liquid,
discarded Formalin, infected secretions,aspirated
body fluids, liquid from laboratories and floor
washings, cleaning, house-keeping and disinfecting
Separate collection
system leading to effluent
treatment system.
After resource recovery, the
chemical liquid waste shall
be pre-treated before mixing
with other wastewater. The
combined discharge shall
conform to the discharge
norms given in Schedule-III.washings, cleaning, house-keeping and disinfecting
activities etc.
norms given in Schedule-III.
(g) Discarded linen, mattresses, beddings
contaminated with blood or body fluid.
Non-chlorinated yellow
plastic bags or suitable
packing material
Non- chlorinated chemical disinfection
followed by incineration or Plazma
Pyrolysis or for energy recovery.
In absence of above
shredding/mutilation or combination
of sterilization and shredding. Treated
waste to be sent for energy recovery
or incineration or Plazma Pyrolysis.
(h) Microbiology, Biotechnology and
Clinical Laboratory Waste:
Blood bags, Laboratory cultures, stocks or
specimens of microorganisms, live or
attenuated vaccines, human & animal cell
cultures used in research, industrial
laboratories, production of biological, residual
toxins, dishes and devices used for cultures.
Yellow coloured
containers or
non-chlorinated safe
plastic bags
Autoclave /Pre-treat to
sterilize with nonchlorinated
chemicals on-site as per
NACO or WHO guidelines
thereafter for Incineration.

Pre Treatment
Treatment & Disposal
Contaminated Waste(Recyclable)
(a) Wastes generated from
disposable items such as tubing,
bottles, intravenous tubes and sets,
catheters, urine bags, syringes
(without needles and fixed needle
syringes) and vaccutainers with their
needles cut) and gloves.
Red, non-
chlorinated
plasticbags
or
containers
Autoclaving / micro-waving/
hydroclaving followed by shredding
/ mutilation or combination of
sterilization & shredding.
Treated waste be sent to registered
or authorized recyclers or for
energy recovery or plastics to diesel
or fuel oil or for road making,
whichever is possible.
Plastic waste should not be sent to
landfill sites.
Waste sharps including Metals White Autoclaving or Dry Heat SterilizationWaste sharps including Metals:
Needles, syringes with fixed needles,
needles from needle tip cutter or
burner, scalpels, blades, or any other
contaminated sharp object that may
cause puncture and cuts. This
includes both used, discarded and
contaminated metal sharps
White
(Translucent)
PunctureProof
Leak proof,
tamper proof
containers
Autoclaving or Dry Heat Sterilization
followed by shredding/mutilation or
encapsulation in metal container or
cement concrete; combination of
shredding cum autoclaving; and
sent for final disposal to iron
foundries (having consent to
operate from PCB or sanitary
landfill or designated concrete
waste sharp pit.
(a) Glassware: Broken/discarded
& contaminated glass including
medicine vials & ampoules except
those contaminated with cytotoxics
(b) Metallic Body Implants
Cardboard
boxes with
blue colour
marking
Disinfection (by soaking the washed
glass waste after cleaning with
detergent and Sodium Hypochlorite
treatment) or through autoclaving
or microwaving or hydroclaving and
then sent for recycling.

Category
Yellow
MANAGEMENT OF HOSPITAL WASTE
(a) Human Anatomical Waste: Human tissues,
organs, body parts and fetus below the viability
period (as per MTPAct’71, amended up to date)
(b)Animal Anatomical Waste : Experimental
animal carcasses, body parts, organs, tissues,
including the waste generated from animals used
in experiments or testing in veterinary hospitals or
colleges or animal houses.colleges or animal houses.
(c) Soiled Waste: Items contaminated with
blood, body fluids like dressings, plaster casts,
cotton swabs and bags containing residual or
discarded blood and blood components.
(d) Expired or Discarded Medicines:
Pharmaceutical waste like antibiotics, cytotoxic
drugs including all items contaminated with
cytotoxic drugs along with glass or plastic
ampoules, vials etc.8/27/2016 29Dr. Gunwant Joshi

Category
Yellow
(e) Chemical Waste: Chemicals used in production of
biological and used or discarded disinfectants.
(f) Chemical Liquid Waste : Liquid waste generated
due to use of chemicals in production of biological,
used or discarded disinfectants, Silver X-ray film
developing liquid, discarded Formalin, infected
secretions, aspirated body fluids, liquids from the
Laboratory floor washings, cleaning, house-keepingLaboratory floor washings, cleaning, house-keeping
and disinfecting activities etc.
(g) Discarded linen: Clothing, Mattresses, beddings
contaminated with blood or body fluid.
(h) Microbiology, Biotechnology & Clinical Lab
Waste: Blood bags, Lab. cultures, Stocks or
specimens of microorganisms, live or attenuated
vaccines, human & animal cell cultures used in
Research, Industrial labs production of biologicals,
Residual toxins, dishes & devices used for cultures.8/27/2016 30Dr. Gunwant Joshi

Category RedContaminated Waste (Recyclable)
Wastes generated from
disposable items such as
tubing, bottles, intravenous
tubes and sets, catheters,
tubes and sets, catheters,
urine bags, syringes (without
needles and fixed needle
syringes) and vaccutainers
with their needles cut and
the gloves.8/27/2016 31Dr. Gunwant Joshi

Waste sharps including Metals:
Needles, syringes with fixed
needles, needles from needle tip
cutter or burner, scalpels, blades,
White Dustbin with Puncture/
Leak/Temper proof Container
Category WHITE
cutter or burner, scalpels, blades,
or any other contaminated sharp
object that may cause puncture
and cuts.
This includes both used,
metal sharps

Blue Dustbins or Cardboard
boxes with blue colour marking
(a) Glassware:
Category BLUE
(a) Glassware:
Broken /discarded & contaminated glass
including medicine vials and ampoules
except those contaminated with cytotoxic
wastes.
(b) Metallic Body Implants

Colour-Coded Bins & well ventilated
storage space for Segregated BMW

Schedule-II
Operational standards, Emission standards and
Testing & Recording protocole for Treatment
Technology Options
 Incinerstor [Stack height/emission std]
 Plasma Pyrolysis/Gasification system
 Autoclaving
 Microwaving
 Microwaving
 Deep Burrial
 Sterilization
 Chemical disinfection
 Liquid waste
Routine test and validation by spore strip/Vials or Chemical vials

Schedule-III
Prescribed Authorities & Duties
MOEF & CC [Policy making/Training/Assistance/Monitoring
Hearing Appeals/specify Stds. & op. Parameters]
MOHFWF [Liscenceing/Listing/Coordinating PCB/ Monitoring/
Operational Research/Training & Awareness ]
MOD [Authorization/Treatment & disposal/ Training/Reiew/
Advisory committee/ submission of reports to CPCB]
CPCB[Guide lines/Coordination with SPCB & MOD/Training/
Lay standards/Random inspections & Monitoring/ Research]
CPCB[Guide lines/Coordination with SPCB & MOD/Training/
Lay standards/Random inspections & Monitoring/ Research]
State MOHFF & Administration [Insure implementation/
allocation of Funds/procurement of equipments/ constitute
State & District Advisory Committee/Advise SPCB ]
PCB[Inventorisation of Occupiers/ Authorization & Consent/
Training / Monitoring and Action for violation/ Compilation &
Reporting to CPCB/ Implementation of Advisory committee
Issues/Publish List of registered Occupiers]
Municipal bodies[provide suitable land/Collect & ManageMSW]8/27/2016 36Dr. Gunwant Joshi

Schedule-IV: Container’s Colour/Markings/Label
Colour tells other staff what is in the container
 Tells the contractor what to do with the waste
 Can apply to both sacks and rigid containers

Schedule -V
a - STANDARD FOR LIQUID WASTE
pH 6.5 to 9.0
Suspended Solids 100 mg/l.
Oil & grease 10 mg/l.
BOD 30 mg/l.
COD 250 mg/l.COD 250 mg/l.
Bio assay 90 % Survival of fish after
96 hours in 100% effluent
Send Domestic Effluents to municipal sewers
Disinfect the infectious liquid waste and then
send it to municipal sewers

Bio Medical Liquid Wastes Disinfection
by Sodium Hypochlorite

Bio Medical Liquid Wastes Treatment
by an Effluent Treatment Plant

Garbage Wastes Collection &Transport

Sharp Management
Always
Remember
Not to recap
the Needle
and cut it
Immediately
after the useafter the use
80 %
Reduction in
Secondary
Infection in a
SuperSpeciality
Hospital
Sharp Sign

Sharps Issues
 Must be collected at the point of generation, in a
leak-proof and puncture-resistant container
 Containers must bear the international biohazard
symbol and appropriate wording
 Containers should never be completely filled, nor
filled above the full line indicated on box.
Unauthorised
Use/Reuse
Unsafe collection Unsafe disposal

Sharp Encapsulation : Sharp Pit
• MUTILATE & DISTROY
•DISINFECT:-
Chemically/Autoclave/Microwave
•DISPOSE IN SHARP PIT
•SEAL PIT WHEN 2/3 FULL•SEAL PIT WHEN 2/3 FULL
•START DISPOSAL IN NEW PIT.
•Alternatively, after Destruction/
Mutilation and Disinfection the
Stored Sharps can be sold as
Scrap

Waste Sharp & Syringe Destruction
 The Shredded Needles,
Sharps and Plastics may
be kept in the secured
containers and
could be sent to
Plastic / Metal
Recycling Plants

Bio Medical Wastes:
Segregate and
Pack it right at the
point of Generationpoint of Generation
only to 75%
capacity

Bio Medical Wastes Collection, Labelling &Transport

Bio Medical Wastes Collection &Transport

BMW
CTDF
at Bhopal
Bio Medical Wastes
Collection &Transport
by
Common
Treatment
& Disposal Facility
Govindpura Industrial Area8/27/2016 49Dr. Gunwant Joshi

Inspection & Re-Segregation issues
It requires to segregate again to ensure the final
disposal of BMW as per BMW Rules 1998 (M & H)

Autoclave
Validation test :
Spot testing by
Bacillus stearo-
thermophilus spores
on a spores strip
with at leastwith at least
1 x 104 Spores/ml.
Routine test :
Chemical indicator
strip/tape

Sharp Storage & Disposal

Bio Medical Plastic Wastes Disinfection
by Sodium Hypochlorite

Bio Medical Wastes Destruction by
Double Chambered Incinerator

Details of Double Chambered Incinerator

New Double Chambered Incinerator

Incinerator Ash Disposal

Schedule -V
DEEP BURIAL PIT for BMW

Schedule -V
D - STANDARD FOR DEEP BURIAL
Entry of scavengers to the burial site be
prevented may be by using covers of
galvanized iron/wire mash.
After every burial in the same secured
pit a layer of 10 cm. soil be added .
Burial must be performed under close and dedicated supervision.Burial must be performed under close and dedicated supervision.
Deep burial site should be relatively impermeable and
distant from habitat.
There should be no well, lake, river etc. close to the site to
avoid contamination of surface water or ground water.
Location of the deep burial site to be authorized by the
Prescribed Authority.
The occupier shall maintain record for all the pits8/27/2016 59Dr. Gunwant Joshi

Land Disposal Facility for Rural & Remote
areas with population less than 5 lacs

Other Bio Medical Wastes Treatment Options

Microwaveing8/27/2016 62Dr. Gunwant Joshi

Plasma Pyrolysis

Duties of the Occupier
"occupier" means a person having administrative
control over the institution and the premises
generating biomedical waste, which includes a
hospital, nursing home, clinic, dispensary,
veterinary institution, animal house, pathology
laboratory, blood bank, health care facility and
clinical establishment, irrespective of their
system of medicine and by whatever name they
clinical establishment, irrespective of their
system of medicine and by whatever name they
are called
Occupier / institution generating, collecting, receiving,
storing, transporting, treating, disposing and/or
handling Bio-medical waste to ensure that bio-medical
waste is handled without any adverse effect to human
health & the environment and in accordance with rules;

Duties of the Occupier[Generator]
 to ensure that there shall be no secondary handling,
pilferage of recyclables or inadvertent scattering or
spillage by animals and bio-medical waste from such
place or premises shall be directly transported in the
manner as prescribed in these rules to CBMWTF or for
appropriate treatment & disposal, in manner prescribed
in Schedule I;in Schedule I;
 Phase out use of chlorinated plastic bags, gloves and
blood bags within 2 yrs from the date of notification
that is 28th March’ 2018.
 Provide within the premises a safe, ventilated & secured
location for storage of Segregated biomedical waste in
colored bags or containers in the manner as specified in
Schedule I,

 Pre-treat the laboratory waste, microbiological waste, blood
samples and blood bags through disinfection or sterilisation
on-site in the manner as prescribed by (WHO)/(NACO)
guidelines & then sent CBMWTF for final disposal
 Dispose of solid waste other than bio-medical waste in
accordance with the provisions of respective waste
management rules made under the relevant laws andmanagement rules made under the relevant laws and
amended from time to time;
 Provide training to all its health care workers & others,
involved in handling of BMW at the time of induction and
thereafter at least once every year and the details of training
programmes conducted, number of personnel trained and
number of personnel not undergone any training shall be
provided in the Annual Report;

 Not to give treated BM waste or mix with MS waste;
 Immunise all its health care workers & others, involved in
handling of bio-medical waste for protection against diseases
including Hepatitis B and Tetanus that are likely to be
transmitted by handling of BMW, in the manner as
prescribed in the National Immunisation Policy or the
guidelines of the Ministry of Health and Family Welfareguidelines of the Ministry of Health and Family Welfare
issued from time to time;
 Establish a Bar- Code System for bags or containers
containing bio-medical waste to be sent out of the premises
or place for any purpose within one year from the date of
the notification of these rules;

 Ensure segregation of liquid chemical waste at
source and ensure pre-treatment/neutralisation prior
to mixing with other effluent generated from health
care facilities;
 Ensure treatment and disposal of liquid waste in
accordance with the Water (Prevention and Controlaccordance with the Water (Prevention and Control
of Pollution) Act, 1974 ( 6 of 1974);
 Ensure occupational safety of all its health care
workers and others involved in handling of bio-
medical waste by providing appropriate and adequate
personal protective equipments;

 Conduct health check up at the time of induction
and at least once in a year for all its health care
workers and others involved in handling of bio-
medical waste and maintain the records for the same;
 maintain and update, on day to day basis, the BMW
management register and display the monthly record
on its website according to the bio-medical waste
management register and display the monthly record
on its website according to the bio-medical waste
generated in terms of category and colour coding as
specified in Schedule I;
 report major accidents including accidents caused by
fire hazards, blasts during handling of BMW, the
remedial action taken & the records relevant thereto,
(including nil report) in Form I to the prescribed
authority and also along with the annual report;


 make available the annual report on its web-site and
all the health care facilities shall make own website
within two years from the date of notification of
these rules;
 inform the prescribed authority immediately in case
the operator of a facility does not collect the bio-
medical waste within the intended time or as per themedical waste within the intended time or as per the
agreed time;
 Establish a system to review and monitor activities
related to BMW management, either through an
existing committee or by forming a new committee
to meet once in every six months
 record of the minutes of the meetings of this
committee shall be submitted along with the annual
report to the prescribed authority8/27/2016 70Dr. Gunwant Joshi

 healthcare establishments with less than 30 beds
shall designate a qualified person to review and
monitor the activities relating to bio-medical waste
management within that establishment and submit
the annual report;
 maintain all record for operation of incineration,
hydro or autoclaving etc., for a period of 05 years;hydro or autoclaving etc., for a period of 05 years;
 existing incinerators to achieve the standards for
treatment and disposal of bio-medical waste as
specified inSchedule II for retention time in
secondary chamber and Dioxin and Furans within
two years from the date of this notification

Duties of the Operator[CBMWTDF]
(a)take all necessary steps to ensure that the bio-medical waste
collected from the occupier is transported, handled, stored,
treated and disposed of, without any adverse effect to the
human health and the environment, in accordance with
these rules and guidelines issued by the Central Government
or, as the case may be, CPCB/SPCB from time to time;
(b)ensure timely collection of bio-medical waste from the
occupier as prescribed under these rules;
(c)establish bar coding and global positioning system for
handling of bio- medical waste within one year;
(d)inform the prescribed authority immediately regarding
the occupiers which are not handing over the segregated
bio-medical waste in accordance with these rules;

 (e) provide training for all its workers involved in handling of
Bio-medical waste at the time of induction and at least once
a year thereafter;
 (f) assist the occupier in training conducted by them for
Bio-medical waste management;Bio-medical waste management;
 (g) undertake appropriate medical examination at the time of
induction and at least once in a year and immunise all its
workers involved in handling of bio-medical waste for
protection against diseases, including Hepatitis B and
Tetanus, that are likely to be transmitted while handling
Bio-medical waste & maintain the records for the same;8/27/2016 73Dr. Gunwant Joshi

 (h) ensure occupational safety of all its workers involved in
handling of Bio-medical waste by providing appropriate
and adequate personal protective equipment;
 (i) report major accidents including accidents caused by
fire hazards, blasts during handling of Bio-medical waste
and the remedial action taken & records relevant thereto,and the remedial action taken & records relevant thereto,
(including nil report) in Form- I to the prescribed
authority and also along with the annual report;
 (j) maintain a log book for each of its treatment equipment
according to weight of batch; categories of waste treated;
time, date and duration of treatment cycle & total hours
of operation;

 (k) allow occupier , who are giving waste for treatment to the
operator, to see whether the treatment is carried out as per
the rules;
 (l) shall display details of authorisation, treatment, annual
report etc on its web-site;
 (m) after ensuring treatment by autoclaving or microwaving (m) after ensuring treatment by autoclaving or microwaving
followed by mutilation or shredding, whichever is applicable,
the recyclables from the treated bio-medical wastes such as
plastics and glass, shall be given to recyclers having valid
consent or authorisation or registration from the respective
State Pollution Control Board or Pollution Control
Committee;

 (n) supply non-chlorinated plastic coloured bags to the
occupier on chargeable basis, if required;
 (o) common bio-medical waste treatment facility shall
ensure collection of biomedical waste on holidays also;
 (p) maintain all record for operation of incineration, hydroor
autoclaving for a period of five years; andautoclaving for a period of five years; and
 (q) upgrade existing incinerators to achieve the standards
for retention time in secondary chamber and Dioxin and
Furans within two years from the date of this notification.

BMW Treatment & Disposal
 (1) Bio-medical waste shall be treated and disposed of in
accordance with Schedule I, and in compliance with the
standards provided in Schedule-II by the health care facilities
and common bio-medical waste treatment facility.
 (2) Occupier shall hand over segregated waste as per the
Schedule-I to common bio-medical waste treatment facility
for treatment, processing and final disposal:
 Provided that the lab and highly infectious bio-medical Provided that the lab and highly infectious bio-medical
waste generated shall be pre-treated by equipment like
autoclave or microwave.
 (3) 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.

 (4) In cases where service of the common bio-medical waste
treatment facility is not available, the Occupiers shall set up
requisite biomedical waste treatment equipment like
incinerator, autoclave or microwave, shredder prior to
commencement of its operation, as per the authorisation
given by the prescribed authority.
 (5) Any person including an occupier or operator of a
common bio medical waste treatment facility, intending tocommon bio medical waste treatment facility, intending to
use new technologies for treatment of bio medical waste
other than those listed in Schedule I shall request the Central
Government for laying down the standards or operating
parameters.
 (6) On receipt of a request referred to in sub-rule (5), the
Central Government may determine the standards and
operating parameters for new technology which may be
published in Gazette by the Central Government.

 (7) Every operator of common bio-medical waste treatment
facility shall set up requisite biomedical waste treatment
equipments like incinerator, autoclave or microwave,
shredder and effluent treatment plant as a part of treatment,
prior to commencement of its operation.
 (8) Every occupier shall phase out use of non-chlorinated
plastic bags within two years from the date of publication of
these rules and after two years from such publication ofthese rules and after two years from such publication of
these rules, the chlorinated plastic bags shall not be used for
storing and transporting of bio-medical waste and the
occupier or operator of a common bio-medical waste
treatment facility shall not dispose of such plastics by
incineration and the bags used for storing and transporting
biomedical waste shall be in compliance with the Bureau of
Indian Standards. Till the Standards are published, the carry
bags shall be as per the Plastic Waste Management Rules,
2011.

 (9) After ensuring treatment by autoclaving or microwaving
followed by mutilation or shredding, whichever is applicable,
the recyclables from the treated bio-medical wastes such as
plastics and glass shall be given to such recyclers having valid
authorisation or registration from the respective prescribed
authority.
 (10) The Occupier or Operator of a common bio-medical
waste treatment facility shall maintain a record of recyclablewaste treatment facility shall maintain a record of recyclable
wastes referred to in sub-rule (9) which are auctioned or sold
and the same shall be submitted to the prescribed authority
as part of its annual report. The record shall be open for
inspection by the prescribed authorities.
 (11) The handling and disposal of all the mercury waste and
lead waste shall be in accordance with the respective rules
and regulations.

Segregation, packaging, transportation & storage
(1) No untreated BM waste shall be mixed with other wastes.
(2) 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.
(3) These containers / bags to be labelled as per Schedule IV.(3) These containers / bags to be labelled as per Schedule IV.
(4) Bar code & global positioning system (GPS)to be installed by
the Occupier & CBMWTF in 01 yrs time.(up till 28March 2017)
(5) The operator of CBMWTF to transport BMW from occupier’s
premises to any off-site CBMWTF only in specified vehicles
labelled as per part ‘A’ of the Schedule IV along with necessary
information as specified in part ‘B’ of the Schedule IV.

Segregation, packaging, transportation & storage
(6) The vehicles used for transportation of BMW to comply with
conditions specified by the MPPCB in addition to requirement
of the Motor Vehicles Act, 1988 (59 of 1988), if any or the rules
made there under for transportation of such infectious waste.
(7) Untreated human anatomical waste, animal anatomical waste,
soiled waste & biotechnology waste not be stored beyond a
period of forty –eight hours: in case the condition can not beperiod of forty –eight hours: in case the condition can not be
met, the occupier shall take appropriate measures to ensure
that the waste does not adversely affect human health and the
environment and inform the prescribed authority along with the
reasons for doing so.

Different Formats & Applicability
Application for Grant /Renewal of Authorization
in form –II to MPPCB, the Prescribed Authority.
Grant of Authorization in form –III by MPPCB to
Occupier(BMW Generator/CBMWTDF.
Submission of Annual Report by Occcupier inSubmission of Annual Report by Occcupier in
form –IV by 31st June Every year about the
categories & quantities of BMW handling
during the preceding year
Application for Appeal against Refusal in Form-V
Accident Reporting by the Occupier in Form-I

(1)Bio-medical waste not to be mixed with MSW.
(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.
(3) The containers or bags be labelled as per Schedule IV.
(4) Bar code & GPS be added by the Occupier & CBMTDF in
01 year time.
(5) The operator of CBMTDF shall transport the bio-medical
waste from the premises of an occupier to any
BMWTDF only in the vehicles having label as per part
‘A’ of the Schedule IV along with necessary information
as specified in part ‘B’ of the Schedule-IV.

(6) The vehicles used for transportation of BMW to comply
with the conditions if any stipulated by SPCB in addition
to the requirement contained in the Motor Vehicles Act,
1988 (59 of 1988), if any or the rules made there under
for transportation of such infectious waste.
(7) Untreated human/animal anatomical waste, soiled waste(7) Untreated human/animal anatomical waste, soiled waste
and, biotechnology waste shall not be stored beyond a
period of 48 hours: Provided that in case for any reason
it becomes necessary to store such waste beyond such
a period, the occupier shall take appropriate measures
to ensure that the waste does not adversely affect
human health and the environment and inform the
prescribed authority along with the reasons for doing so.

Please Remember!
The Primary
responsibility ofresponsibility of
the disposal of the
Bio-Medical Waste
lies with the
Generator

Every Occupier to ensure that
Bio-medical waste shall not be mixed with other
Wastes such as Municipal Waste
Bio-medical Waste shall be segregated, treated &
disposed off in accordance with the Schedule -Idisposed off in accordance with the Schedule -I
and in compliance with the standards prescribed in
Schedule –V.
Preferably at a Common Bio Medical Waste Treatment
Facility or, if one is not within 75 kilometers, to do it on
his own

And also do not forget that
 Biomedical waste that are to be transported,
must be securely packed, and Labeled as per
(schedule-IV).
 Transportation of BM Waste is allowed only in
vehicles authorized by the prescribed Authority
 A day -to -day record of the Quantity under
different categories of the Bio – Medical Waste
generated in premises must be maintained

And also do not forget that
 No untreated Bio-medical Waste shall be kept
stored beyond 48 Hrs.
 if for any reason, the Bio-Medical Waste is
required to be stored beyond this time limit, the
Authorized person must seek a permission from
Prescribed Authority and take adequate measures
to ensure that waste does not affect the human
life & environment adversely.

The contravention of the Act ,
Rules, Orders & directions
may lead to legal action
The punishment may lead to the
imprisonment up to 5 years with fine
up to Rs. 1 lakh.up to Rs. 1 lakh.
For failure or continued contravention a
fine @ Rs.5000 /Day may be charged.
If the failure or the contravention
continues beyond one year, the
imprisonment may be extended up
to 7 years.

–Segregation of waste not taken seriously at generator level
–Non compliance with color coding
–Monitoring segregation at source – low budgets allocated –
costs are not always known/nor worked out properly
Biomedical Waste Management - Issues
91
costs are not always known/nor worked out properly
–Cost of color coding, staff, transport and disposal is a major
deterrent but must be met
–Quantification of waste generated is not done accurately

–Protection of healthcare workers not given
adequate thought
–Clinical waste dumped with non infectious waste -
Risk for healthcare workers and public
Biomedical Waste Management – Issues contd…
92
Risk for healthcare workers and public
–Residual Waste disposal not effective, often
dumped in open landfills

 The disposal of solid wastes that are not infectious
medical waste, is often done as if they were
infectious
It is the most commonly cited violation
 It is the most commonly cited violation
 It increases the financial burden on patients and
taxpayers in the form of increased disposal costs
for health care facilities

When infectious waste and regular
MSW mixes together, it can not be
permitted to separate them
 Once combined, the entire contents
are considered infectious waste!
 Increased Volumes of medical waste
generation increases the risk of costly
accidents and spills due to increased
handlling & Transportation required to
haul the waste

Challenges
Establishing robust waste management policies within
the Health Care Facility/organization
 Organization wide awareness about the health hazards
 Sufficient financial & Trained human resources needed
95
 Sufficient financial & Trained human resources needed
 Monitoring and control of waste disposal
 Clear responsibility and tracebility for appropriate
handling and disposal of waste.

Hospital Waste Management
is a real issue
together we can address it
Successfully

New bio medical waste management rules 2016

New bio medical waste management rules 2016

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