This document provides an overview of biomedical waste management rules and regulations in India. It defines biomedical waste and outlines the key steps for managing waste, including characterization, quantification, segregation, storage, transportation, treatment, and disposal. It discusses the current scenario of biomedical waste generation and treatment in India. It also summarizes the major differences between the 1998 and 2016 biomedical waste management rules, including changes to waste categories, treatment standards, and operator duties. Formats for authorization applications, annual reports, and accident reporting are also included.

1. BIOMEDICAL
WASTE
MANAGEMENT
2016
PRESENTED BY : DR. VISHAL BATHMA
MBBS, MBA(HA), MD
ASST. PROFESSOR
COMMUNITY MEDICINE
PCMS&RC

2. CONTENT
DEFINITION
STEP TO MANAGE WASTE
NEED FOR BIOMEDICAL WASTE
MANAGEMENT
PRESENT SCENARIO
NOTIFICATIONS AND AMENDMENTS
MAJOR DIFFERENCE BETWEEN BMW RULES
1998 & 2016
CONCLUSION

3. DEFINITION
“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 these rules

4. Biomedical Waste (BMW)
is…
Healthcare Waste
85% Non-infectious
15% Infectious/
Hazardous

5. Step to manage waste
BIOMEDICAL WASTE MANAGEMENT
(CRADLE TO GRAVE)
• CHARACTERIZATION
• QUANTIFICATION
• SEGREGATION
• STORAGE
• TRANSPORTATION
• TREATMENT
• DISPOSAL

7. Shri Prakash Javadekar releasing the
new Bio-Medical Waste Management
Rules

8. PRESENT SCENARIO
According to the MoE,F&CC
• Gross generation of BMW in India is 484 TPD
from 1,68,869 healthcare facilities (HCF), out
of which 447 TPD is treated, which means that
• Almost 38 TPD of the wastes is left untreated
and not disposed finding its way in dumps or
water bodies and re-enters our system.

9. There are 198 (CBMWF) are in operation
and
28 are under construction.
21,870 HCFs have their own treatment facilities
and
1,31,837 HCFs are using the CBMWFs.

10. 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

11. • The MoE,F&CC has notified the new BMW (M)
Rules, 2016 on 28TH March, under the
Environment (Protection) Act, 1986 to replace
the earlier Rules (1998) and the amendments
thereof.
• Published in the Gazette of India, Extraordinary,
Part II, Section 3, Sub-section (i)

12. Provide uniform guidelines and
Code of practice for management and handling of
biomedical wastes generated from
 Hospitals, nursing homes, clinics, dispensaries,
veterinary institutions, animal houses,
 Pathological laboratories, blood banks,
 Ayush hospitals, clinical establishments, research or
educational institutions,
 Health camps, medical or surgical camps,
vaccination camps, blood donation camps, first aid
rooms of schools, forensic laboratories and
 Research labs.

13. This New Rules are more………….
• comprehensive in nature
• It contains important features of BMW (M & H)
Rules, 1998
• Several new provisions have been added in the
new Rules.

14. SHORT TITLE AND COMMENCEMENT
• These rules may be called the Bio-Medical
Waste Management Rules, 2016.
• They shall come into force on the date of their
publication in the official Gazette.

15. Bio-medical Waste Management Rules
2016
• SCHEDULES- 1 to 4
• FORMS- 1 to 5
• Rules – 1 to 18

16. Major Difference between BMW Rules
1998 & 2016
1998 2016
1 Occupiers with more than 1000
beds required to obtain
authorisation
Every occupier generating BMW,
Including health camp or ayush requires
to obtain authorisation
2 Operator duties absent Duties of the operator listed
3 Biomedical waste divided in ten
categories
Biomedical waste divided in 4 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 Shudule I, II, III, IV,V Change of Shudule I, II, III, IV

17. DUTIES OF THE OPERATOR
1. 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.
2. To ensure timely collection of BMW from the health
care facilities.
3. To inform the prescribed authority immediately
regarding the health care establishments/facilities,
which are not handling over the segregated BMW.
4. To provide training of all its workers.

18. 5. To undertake appropriate pre-placement &
periodic medical examination and immunize all
its workers and records for the same.
6. To ensure occupational safety by providing
protective equipments.
7. To develop system of reporting of unintended
accidents in Form III with annual report even
the nil reporting.
8. 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.

19. TYPES OF BIOMEDICAL WASTES
RULE 1998SCHEDULE-I
WASTE CATEGORY TYPE OF WASTE
Category No. 1 Human Anatomical Waste
Category No. 2 Animal Waste
Category No. 3 Microbiology & Biotechnology Waste
Category No. 4 Waste Sharps
Category No. 5
Discarded Medicine and Cytotoxic
drugs
Category No. 6 Soiled Waste
Category No. 7 Solid Waste
Category No. 8 Liquid Waste
Category No. 9 Incineration Ash
Category No.10 Chemical Waste

20. TYPES OF BIOMEDICAL
WASTES RULE 2016
SCHEDULE-I

21. Cat. Type of Bag/
Container used
TYPE OF WASTE Treatment /Disposal
options
Yellow non-chlorinated
plastic bags
Separate collection
system leading to
effluent
treatment system
a) Human Anatomical Waste
b) Animal Anatomical Waste
c) Soiled Waste
d) Expired or Discarded Medicines
e) Chemical Waste
f) Micro, Bio-t and other clinical
lab waste
g) Chemical Liquid Waste
Incineration or Plasma
Pyrolysis or deep burial*
Red non-chlorinated
plastic bags or
containers
Contaminated Waste (Recyclable)
tubing, bottles, intravenous tubes
and
sets, catheters, urine bags, syringes
(without needles) and gloves.
Auto/ Micro/Hydro and
then sent for recycling. not
be sent to landfill
White (Translucent)
Puncture, Leak,
tamper proof
containers
Waste sharps including Metals Auto or Dry Heat
Sterilization
followed by shredding or
mutilation or
encapsulation
Blue Cardboard boxes
with blue
colored marking
Glassware Disinfection or auto/
Micro/hydro and then
sent for recycling.

22. COLOR
CODE
TYPE OF CONTAINER WASTE
CATEGORY
TREATMENT
OPTIONS
Yellow Plastic bags 1, 2, 3 and 6 Incineration/deep
burial
Red Disinfected
container/plastic bag
3, 6 & 7 Autoclaving/Micro
Waving/Chemical
treatment
Blue/white
transparent
Plastic bags/puncture
proof container
4 & 7 Autoclaving/Micro
waving/chemical
treatment,
Destruction &
shredding
Black Plastic bag 5, & 9,
AND
10 (SOLID)
Disposal in
secured land fills
SCHEDULE-II RULE 1998

23. SCHEDULE II
[See rule 4(t), 7(1) and 7(6)]
STANDARDS FOR TREATMENT AND DISPOSAL OF
BIO-MEDICALWASTES (2016)
• STANDARDS FOR INCINERATION
A. Operating Standards
B. Emission Standards
C. Stack Height
• Operating and Emission Standards for Disposal by
Plasma Pyrolysis or Gasification
A. Operating Standards
B. Air Emission Standards and Air Pollution Control
Measures
C. Disposal of Ash Vitrified Material

24. • STANDARDS FOR AUTOCLAVING OF BIO-MEDICAL
WASTE
• STANDARDS FOR MICROWAVING
• STANDARDS FOR DEEP BURIAL
• STANDARDS FOR EFFICACY OF CHEMICAL
DISINFECTION
• STANDARDS FOR DRY HEAT STERILIZATION
• STANDARDS FOR LIQUID WASTE

25. SCHEDULE-III (1998)
LABEL FOR BIO-MEDICAL WASTE
CONTAINERS/BAGS
Note : Label shall be non-washable and prominently visible.
HANDLE WITH CARE
BIOHAZARD CYTOTOXIC
BIOHAZARD SYMBOL CYTOTOXIC HAZARD SYMBOL

26. Schedule III
[See rule 6 and 9(3)] (2016)
• List of Prescribed Authorities and the
Corresponding Duties

27. SCHEDULE-IV (1998)
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.

28. SCHEDULE-IV (2016)
LABEL FOR BIO-MEDICAL WASTE
CONTAINERS/BAGS (PART ‘A’)
Note : Label shall be non-washable and prominently visible.
HANDLE WITH CARE
BIOHAZARD CYTOTOXIC
BIOHAZARD SYMBOL CYTOTOXIC HAZARD SYMBOL

29. Part B
LABEL FOR TRANSPORTING BIO-MEDICAL WASTE BAGS OR CONTAINERS
Day ............Month ..............
Year ...........
Date of generation ...................
Waste category Number ........
Waste quantity…………
Sender's Name and Address Receiver's Name and Address:
Phone Number ........ Phone Number ...............
Fax Number............... Fax Number .................
Contact Person ........ Contact Person .........
In case of emergency please contact :
Name and Address :
Phone No.
Note :Label shall be non-washable and prominently visible.

30. SCHEDULE-V (2016)
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

31. 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
SCHEDULE-VI (2016)

32. SCHEDULES
1998
• Sch1. cat. of waste or type of waste
(10 cat.)
• Sch2. color code, type of container,
wast cat. & tretment options
• Sch3. Label for BMW container / bags
• Sch4. Label for transportation of BMW
• Sch5. Standard for treatment &
disposal of BMW
• Sch6. List of authorities and
corresponding duties
2016
• Sch1. cat. According to color code &
type of waste with tretment/disposal
option
• Sch2. Standard for treatment &disposal
of BMW (including plasma pyrolisis &dry
heat sterilization)
• Sch3. List of prescribed authorities and
the corresponding duties.
• Sch4. Part A label for BMW
container/bags
Part B label for transporting

33. To
The Prescribed Authority
(Name of the State Govt/UT Administration) Address.
1. Particulars of Applicant
(i) Name of the Applicant (ii) Name of the Institution:
(In block letters & in full) 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
Bio-Medical Waste (Management and Handling) Rules 1998, 2011
FORM I
APPLICATION FOR AUTHORISATION
(To be submitted in duplicate.)

34. FORM – I
[ (See rule 4(o), 5(i) and 15 (2)]
ACCIDENT REPORTING
1. Date and time of accident :
2. Type of Accident :
3. Sequence of events leading to accident :
4. Has the Authority been informed immediately :
5. The type of waste involved in accident :
6. Assessment of the effects of the
accidents on human health and the environment:
7. Emergency measures taken :
8. Steps taken to alleviate the effects of accidents :
9. Steps taken to prevent the recurrence of such an accident :
10. Does you facility has an Emergency Control policy? If yes give details:
Date : …………………… Signature …………………….
Place: …………………… Designation …………………..

35. 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

36. Bio-Medical Waste (Management and Handling) Rules 1998, 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 ............................... Name and Signature
Place.............................. of the Head of the Institution

37. ACCIDENT REPORTING
When any accident occurs
at any institution or
facility or any other site
where bio-medical waste
is handled or during
transportation of such
waste, the authorised
person shall report the
accident in Form-III to the
prescribed authority along
with the remedial action.

38. Bio-Medical Waste (Management and Handling) Rules, 1998, 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 ............................... Signature .........................
Place.............................. Designation......................

39. OTHER FORMS (1998, 2011 Draft)
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:It empowers the operator of CBMWTF to
report against the HCEs who are not
carrying out proper segregation of their
wastes.

40. FORMs
1998
• F1. Application for
authorization
• F2. Annual report
• F3. Accident reporting
• F4. Authorization (for operating
facility)
• F5. Application for filling
‘appeal’
• F6. Empower the operator of
CBMWTF to report against the
HCFs how are not carrying out
proper segregation their waste
2016
• F1. Accident reporting
• F2. Application for
“authorization or renewal of
authorization” (submitted by
occupier of HCFs or CBMWTFs)
• F3. Authorization (for operating
facility) For generation,
collection, reception,
treatment, storage, transport,
disposal
• F4. Annual report
• F5. Application for filling
‘appeal’ against order pass by
the prescribe authority

41. CONCLUSION
• The new Rules on BMW are elaborate, stringent and
several new provisions have been added in it.
• The new Rules have definitely cleared certain
ambiguities of the previous one but still lacks on
many fronts.