1. The document discusses India's Bio-medical Waste Management and Handling Rules. It outlines the need for proper management of biomedical waste to prevent disease transmission and protect public health. 2. The rules categorize biomedical waste into 8 categories and specify treatment and disposal requirements for each category, such as incineration, autoclaving, or disposal in secured landfills. 3. The duties of waste generators and operators are defined to ensure safe and responsible handling of biomedical waste from the point of generation through treatment and disposal. Proper segregation, packaging, transportation, and record-keeping are mandated.

1. Bio-medical Waste Management
And Handling Rules
Presented byDR ANWAR AHMAD
Community Medicine &
Public health Department
KGMU U.P LUCKNOW

2. NEED OF BIOMEDICAL WASTE
MANAGEMENT AND HANDLING
 Biomedical wastes, if not handled in a proper way, is a
potent source of diseases, like AIDS, Tuberculosis,
Hepatitis and other bacterial diseases.
 Nosocomial infections in patients from poor infection
control practices and poor waste management.
 Drugs & Syringes which have been disposed of, being
repacked and sold off to unsuspecting buyers.
Owing to the discussed potential threats this waste
needs prime attention for its safe and proper disposal.

3. MAGNITUDE OF THE PROBLEM
Developed countries generate 1 to 5 kg/bed/day BMW
INDIA:- No national level study
Local/regional level study showshospitals generate roughly 1-2 kg/bed/day
According to WHO total BMW consist of: 85% non infectious/non hazardous waste
: 10% infective waste
: 5% non-infectious but hazardous.

4. BIO-MEDICAL WASTE MANAGEMENT & HANDLING RULES
NOTIFICATIONS AND AMENDMENTS
On 20th July 1998 Ministry of Environment and Forests
(MoEF), Govt. of India, Framed a rule known as ‘Bio-
medical Waste (Management and Handling) Rules,
1st Amendment Dated 06/03/2000
2nd Amendment Dated 17/09/2003
The MoEF has notified the new Draft “Bio-Medical Waste
(Management & Handling) Rules 2011” on 24TH August,
2011 under the Environment Protection Act, 1986 to
replace the earlier Rules. Provide uniform guidelines and
code of practice for management and handling of
biomedical wastes generated from Hospitals, clinics & other
institutions generating Biomedical Waste.

5. Major Difference between BMW Rules 1998 & 2011
1998
2011
1
Occupiers with more than 1000 beds
required to obtain authorisation
Every occupier generating BMW,
requires to obtain authorisation
2
Operator duties absent
Duties of the operator listed
3
Biomedical waste divided in ten
categories
Biomedical waste divided in 8 categories
4
Rules restricted to HCEs with more
than 1000 beds
Treatment and disposal of BMW made
mandatory for all the HCEs
5
No format for annual report
A format for annual report appended
with the rules
6
Form VI is absent
Form VI i.e. the report of the operator on
HCEs not handing over the BMW added
to the Rules

6. Bio-medical Waste Management And Handling
Rules 2011
 RULES- 1 to 17
 SCHEDULES- I to VI
 FORMS- I to VI

7. 1. SHORT TITLE AND COMMENCEMENT:
 (1) These rules may be called the Bio-Medical Waste
(Management and Handling) Rules, 2011.
 (2) They shall come into force on the date of their
publication in the official Gazette.

8. 2. APPLICATION:
 These rules apply to all persons who generate, collect, receive,
store, transport, treat, dispose, or handle bio medical waste in
any form & shall not apply to-
a)
b)
c)
d)
e)
Radioactive waste as covered under the “Atomic energy Act
1962”
Hazardous chemicals covered under the “Manufacture, storage
& import of hazardous chemicals Rules 1989”
Wastes covered under the Municipal solid wastes Rules 2000
The lead acid batteries covered under the “Batteries Rules
2001”
Hazardous wastes covered under the “Hazardous waste Rules
2008”

9. 3. DEFINITIONS:
(1) "Act" means the Environment (Protection) Act,
1986 (29 of 1986);
(2) "Animal House" means a place where animals are
reared/kept for experiments or testing purposes;
(3) "Authorisation" means permission granted by the
prescribed authority for the generation, collection,
reception, storage, transportation, treatment, disposal
of bio-medical waste.
(4) "Authorised person" means an occupier or operator
authorised by the prescribed authority to generate,
collect, receive, store, transport, treat, dispose and/or
handle bio-medical.

10. (5) "Bio-medical waste" means any waste, which is generated during the
diagnosis, treatment or immunisation of human beings or animals or in
research activities & including categories mentioned in Schedule I of these
rules;
(6) "Biologicals" means any preparation made from organisms or microorganisms or product of metabolism and biochemical reactions intended for
use in the diagnosis, immunisation or the treatment of human beings or
animals or in research activities;
(7) "Bio-medical waste treatment and disposal facility" means any facility
wherein treatment, disposal of bio-medical waste is carried out;
(8) "Occupier" means a person having administrative control over the
institution and the premises generating biomedical waste;
(9) "Operator of a bio-medical waste treatment facility" means a person who
controls or operates a facility handling the bio-medical waste;
(10) "Schedule" means schedule appended to these rules;
(11) “Form” means form appended to these rules;

11. 4. DUTIES OF THE OCCUPIER:
It shall be the duty of every occupier1. To take all steps to ensure that BMW is handled without
any adverse effect to human health & environment.
2. To provide training for all its health care workers.
3. To immunize all its health care workers.
4. To ensure segregation of BMW at the point of generation.
5. To ensure occupational safety of all its heath care workers
by providing personal protective equipments.
6. To conduct health care check-up annually for all its
workers & maintain the records for the same.
7. To install necessary equipments & regular supply of
materials required for handling BMW.

12. 4. DUTIES OF THE OCCUPIER: cont..
8. To maintain & update everyday BMW management
register according to quantity, categories & final mode of
disposal as specified in SCHEDULE-1.
9. To develop a system of reporting of unintended accidents
like sharp injuries, mercury spills, fire hazards which are
likely to occur during BMW handling. Such records shall be
maintained and reported in Form III along with annual
report and should indicate even the nil report.
10. To inform the prescribed authority immediately in case
the operator of a facility does not collect the BMW within the
intended time.
11. To establish a BMW management cell or unit if the facility
has more than 30 beds. Such unit or cell shall meet once in
six months & the records of minutes of such meetings shall be
submitted along with the annual report to the prescribed
authority.

13. 5. DUTIES OF THE OPERATOR:
1.
2.
3.
4.
5.
6.
7.
8.
To take all necessary steps to ensure that the BMW collected from
the occupier is transported, handled, stored, treated & disposed of
without any adverse effect to human health & environment.
To ensure timely collection of BMW from the health care facilities.
To inform the prescribed authority immediately regarding the
health care establishments/facilities, which are not handling over
the segregated BMW.
To provide training of all its workers.
To undertake appropriate pre-placement & periodic medical
examination and immunize all its workers and records for the same.
To ensure occupational safety by providing protective equipments.
To develop system of reporting of unintended accidents in Form III
with annual report even the nil reporting.
To maintain a log book of treatment equipment according to weight
of batch; categories of waste treated; time; date; duration of
treatment cycle & total hours of operation.

14. 6.RESPOSIBILITIES OF AUTHORITIES:
 The authority specified in
column 2 of the ScheduleVI shall perform the
duties as specified in
column 3 of the said
Schedule as per the
provisions of these Rules.

15. 7. TREATMENT AND DISPOSAL:
 (1) Bio-medical waste shall be treated and disposed of in
accordance with Schedule I, and in compliance with the
standards prescribed in Schedule V.
 (2) Any person including an occupier/operator of a BMW
treatment facility intends to promote new technologies for
treatment of BMW shall approach the Central
Government/Central Pollution Control board for prior
approval.
 (3) Every occupier shall either set up his own BMW
treatment equipment, prior to commencement of its
operation or ensure treatment of BMW through an
authorised common BMW treatment facility.
 (4) Every operator of a common BMW treatment facility
shall set up BMW treatment equipments, prior to
commencement of its operation.

16. 7. TREATMENT AND DISPOSAL: cont.
 (5) Use of chlorinated plastic bags for handling of BMW
shall be prohibited & the occupier/operator of a common
BMW facility shall not dispose of such plastics by
incineration.
 (6) The occupier/operator of a BMW treatment facility shall
dispose of the recyclable BMW such as plastics & glass etc.
through authorised recyclers. The occupier shall maintain a
record of such recyclable wastes auctioned or sold.
 (7) In the event of breakage of mercury containing medical
instruments, necessary precautions shall be taken by the
occupier to segregate such waste as per guideline.

17. 8. SEGREGATION, PACKAGING,
TRANSPORTATION AND STORAGE:
(1) Untreated BMW shall not be mixed with other wastes.
(2) Bio-medical waste shall be segregated into containers/bags at the point of
generation in accordance with Schedule II.
(3) The containers shall be labelled according to Schedule III.
(4) The transporter shall transport the BMW from the premises of an occupier to
any off-site BMW treatment facility only with label as prescribed in schedule III
along with the necessary information prescribed in Schedule IV.
(5) Untreated BMW shall be transported only in specific vehicle authorised by the
competent authority.
(6) No untreated BMW of categories 1,2,3&6 shall be kept stored beyond a period
of 48 hours. If for any reason it becomes necessary to store the waste beyond such
period, the authorised person must take permission of the prescribed authority .
(7) The municipal body of the area shall continue to pickup & transport
segregated non BM solid waste as well as dully treated BMW for disposal at
municipal dump site.

18. 9. PRESCRIBED AUTHORITY:
The prescribed authority shall be the State Pollution
Control Boards in respect of State & Pollution control
Committees in respect of Union Territories.
2) The prescribed authority in respect of all health care
establishments of the Armed Forces shall be the
Director General, Armed Forces Medical Services.
3) The prescribed authority shall function under the
supervision & control of the respective Government of
the state.
4) The prescribed authorities shall comply with the
responsibilities as stipulated in Schedule VI of the
Rules.
1)

19. 10. PROCEDURE FOR AUTHORISATION:
1)
2)
3)
4)
5)
6)
7)
Every occupier/operator of BMW treatment facility shall make an application
in Form-1 to the prescribed authority for grant of authorization.
The prescribed authority shall on receipt of Form-1 make such enquiry as it
deems fit & if it is satisfied may grant /renew an authorization.
A provisional authorization in Form-IV shall be granted for trial run for a
period of one year. On satisfactory performance during trial period , the
authorization shall be renewed for a further period of five year.
The prescribed authority, after giving reasonable opportunity to the applicant,
may refuse to grant/renew authorization & to be recorded in writing.
Every application for authorization shall be disposed of by the prescribed
authority within ninety days.
The prescribed authority may cancelled/suspend an authorization.
Every occupier/operator shall intimate the prescribed authority about any
change/variation in the activity relating to BMW management & shall submit a
fresh application in Form-I.

20. 11. ADVISORY COMMITTEE:
The government of every state shall constitute an Advisory
Committee under the chairmanship of State Health
secretary. The committee shall include representatives from
state department of health, environment, urban
development, animal husbandry & veterinary sciences, State
Pollution Control Board, local bodies/urban/municipal
corporation, representative from Indian Medical
Association, common BMW treatment facility & non
government organization. The advisory committee shall
meet once in six months & review all the matters related to
implementation of Rules.
2) Ministry of defence shall constitute an advisory committee
under chairmanship of Additional Director General of
Armed Forces Medical Services.
3) The Government of every State shall constitute District
Level Monitoring Committee in the districts under the
chairmanship of District Medical Officer.
1)

21. 12. ANNUAL REPORT:
1) Every occupier/operator shall submit an annual report to
the prescribed authority in Form-II by 31st January every
year, to include information about the categories and
quantities of BMW handled during the preceding year.
2) The prescribed authority shall send this information in a
compiled form to the Central Pollution Control Board by
31 March of every year.
3) The Central Pollution Control Board shall send this
information in a compiled Form to the Ministry of
Environment and Forest by 30th June of every year

22. 13. MAINTENANCE OF RECORDS:
1) Every authorised person shall maintain records
related to the generation, collection, reception,
storage, transportation, treatment, disposal and/or
any form of handling of bio-medical waste.
2) All records shall be subject to inspection and
verification by the prescribed authority at any time.

23. 14. ACCIDENT REPORTING:
When any accident occurs
at any institution or facility
or any other site where biomedical waste is handled
or during transportation of
such waste, the authorised
person shall report the
accident in Form-III to the
prescribed authority
forthwith.

24. 15. APPEAL:
1) Any person aggrieved by an order made by the
prescribed authority under these rules, may prefer
appeal within 30 days in Form-V to the Secretary
(Environment) of State Government.
2) Any person aggrieved by an order of the Director
General Armed Forces Medical Services under
these rules, may prefer an appeal within 30 days in
Form-V to the Ministry of Environment and Forest.

25. 16. COMMON DISPOSAL /INCINERATION SITES:
The Municipal Corporation, Municipal Boards, Urban
or Local Bodies, shall be responsible for providing
suitable common disposal/incineration sites for the
biomedical wastes generated in the area under their
jurisdiction.

26. 17. LIABILITY OF THE OCCUPIER, OPERATOR OF A
FACILITY
1)
The occupier/operator of a BMW treatment facility shall be
liable for all the damage caused to the environment or the
public due to improper handling of BMW.
2) The occupier/operator of BMW treatment facility shall be liable
for action under section 5 and 15 of Environment Protection
Act 1986. This is punishable with imprisonment for a term
which may extend to five years or with fine which may extend
to one lakh rupees, or with both, and in case the failure or
contravention continues, with additional fine which may extend
to five thousand rupees for every day during which such failure
or contravention continues after the conviction for the first
such failure.

27. SCHEDULE I
CATEGORIES OF BIO-MEDICAL WASTE
Category
Waste category
(type)
Treatment & disposal option
Category No. 1
Human Anatomical
Waste
Incineration
Category No. 2
Animal waste
Incineration
Category No. 3
Microbiology &
Biotechnology Waste &
their laboratory waste
Disinfection at source by chemical
treatment/autoclaving/microwaving
followed by mutilation/shredding then
final disposal in secured landfill or disposal
of recyclable waste through authorised
recyclers
Category No. 4
Waste Sharps
Disinfection by chemical
treatment/autoclaving/microwaving or
destruction by needle tip cutter followed by
mutilation/shredding & final disposal
through authorised CBWTF or in secured
landfill or designated concrete waste sharp

28. SCHEDULE I
CATEGORIES OF BIO-MEDICAL WASTE cont.
Category
Waste category
(type)
Treatment & disposal option
Category No. 5
Discarded Medicine &
Cytotoxic drugs
Disposal in secured land fill/Incineration
Category No. 6
Solid Waste ( item
contaminated with
blood & body fluids)
Incineration
Category No. 7
Infectious solid waste
(such as catheters, hand
gloves, tubings, saline
bottles etc.)
Disinfection by chemical
treatment/autoclaving/microwaving
followed by mutilation/shredding then
disposal through authorised recyclers
Category No. 8
Chemical Waste
(disinfection,
insecticides etc.)
Chemical treatment & discharge into
drains meeting the norms & solid disposal
in secured landfill
 Chemical treatment using at least 1% hypochlorite solution or any other equivalent
chemical reagent.
 Mutilation/shredding must be such that so as to prevent unauthorised reuse.
 There may be no chemical treatment before incineration.

29. SCHEDULE-II
COLOUR CODING & TYPE OF CONTAINER FOR DISPOSAL OF
BIO-MEDICAL WASTES
COLOR
CODE
TYPE OF CONTAINER
WASTE
CATEGORY
TREATMENT OPTIONS
Yellow
Non chlorinated plastic bags
1, 2, 5 and 6
Incineration
Red
Non chlorinated plastic
bags/puncture proof
container for sharps
3, 4 & 7
As per Schedule-I
Blue
Non chlorinated plastic bags
containers
8
As per schedule -I
Black
Non chlorinated plastic bags
Municipal
Waste
Disposal in municipal dump
sites
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Biomedical Waste (BMW) Management
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30. 2/10/2014
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31. SCHEDULE-III
LABEL FOR BIO-MEDICAL WASTE
CONTAINERS/BAGS
BIOHAZARD SYMBOL
CYTOTOXIC HAZARD SYMBOL
CYTOTOXIC
BIOHAZARD
HANDLE WITH CARE
Note : Label shall be non-washable and prominently visible.

32. SCHEDULE-IV
LABEL FOR TRANSPORT OF BIO-MEDICAL WASTE
CONTAINERS/BAGS
Label shall be non-washable & prominently visible
Day………………. Month…………….day
Year………………
Date of generation……………………
Waste Category No………………
Waste quantity…………………….
Sender’s Name and Address
Receiver’s Name and Address
Phone No………
Phone No………………
Telex No………..
Telex No………………..
Fax No…………..
Fax No……………………
Contact Person……….
Contact Person……..
In case of emergency please contact
Name and Address:
Phone No.
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33. SCHEDULE-V
STANDARDS FOR TREATMENT AND DISPOSAL OF
BIO-MEDICAL WASTES
 STANDARDS FOR INCINERATORS
 STANDARDS FOR WASTE AUTOCLAVING
 STANDARDS FOR LIQUID WASTE
 STANDARDS FOR MICROWAVING
 STANDARDS FOR DEEP BURIAL

34. SCHEDULE-VI
List of authorities and the corresponding duties
1) Ministry of Environment & forests
2) Central/State Ministry of Health Family Welfare,
Veterinary and Animal Husbandry
3) Ministry of Defence
4) Central Pollution Control Board
5) State Gov./Union Territory Gov./Administration
6) State Pollution Control Boards/Committees
7) Local bodies such as Gram Panchayat,
Municipalities

35. Bio-Medical Waste (Management and Handling) Rules, 2011
FORM I
APPLICATION FOR AUTHORISATION
(To be submitted in duplicate.)
To
The Prescribed Authority
(Name of the State Govt/UT Administration) Address.
1. Particulars of Applicant
(i) Name of the Applicant
(In block letters & in full)
(ii) Name of the Institution:
Address:
Tele No., Fax No. Telex No.
2. Activity for which authorisation is sought:
(i) Generation (ii) Collection (iii) Reception (iv) Storage (v) Transportation (vi) Treatment (vii) Disposal (viii) Any
other form of handling
3. Please state whether applying for fresh authorisation or for renewal:
(In case of renewal previous authorisation-number and date)
4. (i) Address of the institution handling bio-medical wastes:
(ii) Address of the place of the treatment facility:
(iii) Address of the place of disposal of the waste:
5. (i) Mode of transportation (in any) of bio-medical waste:
(ii) Mode(s) of treatment:
6. Brief description of method of treatment and disposal (attach details):
7. (i) Category (see Schedule 1) of waste to be handled
(ii) Quantity of waste (category-wise) to be handled per month
8. Declaration; I do hereby declare that the statements made and information given above are true to the best of
my knowledge and belief and that I have not concealed any information. I do also hereby undertake to provide any
further information sought by the prescribed authority in relation to these rules and to fulfil any conditions
stipulated by the prescribed authority.
Date :
Signature of
the Applicant
Place :
Designation of
the Applicant

36. Bio-Medical Waste (Management and Handling) Rules, 2011
FORM II
ANNUALREPORT
(To be submitted to the prescribed authority by 31 January every year)
1 . Particulars of the Occupier:
(i) Name of the authorised person (occupier/operator):
(ii) Name of the institution:
Address
Tel. No
2. Type of health care facility:
3. Categories of Bio-medical waste generated:
4. Category-wise quantity of waste treated:
5. Additional details:
6. Any other relevant information:
7. Certified that the above report is for the period from………
Date ...............................
Place..............................
Name and Signature
of the Head of the Institution

37. Bio-Medical Waste (Management and Handling) Rules, 2011
FORM III
ACCIDENT REPORTING
1. Date and time of accident:
2. Sequence of events leading to accident:
3. The waste involved in accident :
4. Assessment of the effects of the accidents on human health and the
environment:
5. Emergency measures taken:
6. Steps taken to alleviate the effects of accidents:
7. Steps taken to prevent the recurrence of such an accident:
Date ...............................
Place..............................
Signature .........................
Designation......................

38. OTHER FORMS
FORM-IV: Authorization for operating a facility for
collection, reception, treatment, storage,
transport and disposal of BMW
FORM-V: Application for filing appeal against order
passed by the prescribed authority
FORM-VI: Report of the Operator of the Common
BMW treatment & disposal facility/
Establishment not handing over BMW

39. LET THE WASTE OF THE “SICK”
NOT CONTAMINATE THE LIVES OF
“THE HEALTHY”
THANK YOU
2/10/2014
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