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Special Article

Biomedical Waste Management Guidelines 2016: What’s done

and what needs to be done
Lipika Singhal, Arpandeep Kaur Tuli, Vikas Gautam1
Department of Microbiology, Government Medical College and Hospital, 1Department of Medical Microbiology, Postgraduate Institute of Medical Education and
Research, Chandigarh, India

Abstract
The latest biomedical waste (BMW) management guidelines which have been introduced in 2016 are simplified and made easier so that they
can be easily followed by various health agencies. The categories of BMW have been reduced from ten (in 1998) to four in the latest (2016)
guidelines. Many changes have been made in these latest guidelines, which have been summarised in the article below. The segregation of
hospital waste plays a very important role, so the waste has to be sorted out at the source of generation according to the category to which
it belongs as given in the newer guidelines. Newer waste treatment facilities such as plasma pyrolysis, encapsulation, inertisation have been
introduced, and we have to do away with older facilities such as incineration as toxic fumes (dioxins and furans) are produced which are
harmful to both health and environment. We can even think of using these wastewater treatment plants to remove the antimicrobial resistance
genes during the processing of the waste, which is being generated from the hospitals.

Keywords: 2016 guidelines, biomedical waste, categories, differences, duties, schedules

Let the waste of the ‘sick’not contaminate the lives of ‘the healthy’.
Introduction
‘Biomedical waste’ (BMW) means any waste, which is generated
during the diagnosis, treatment or immunisation 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.[1]
Infectious waste includes all those medical wastes, which have
the potential to transmit viral, bacterial, fungal or parasitic
diseases. It includes both human and animal infectious waste
and the waste generated in any laboratory and during veterinary
practice. Any waste with a potential to pose a threat to human
health and life is called hazardous waste. Infectious waste is
hazardous in nature, and if the infectious component mixes up
with the general non‑infectious waste in the black bag, the entire
bulk of that black bag waste becomes potentially infectious and
to be treated as infectious waste. Therefore, the hospital waste, in
addition to the risk for patients and workforce who handle these
wastes, poses a serious threat to public health and environment.[2,3]
Taking cognizance of inappropriate BMW management, Ministry
of Environment and Forests notified the ‘BMW (management and
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handling) Rules, 1998’ in July 1998. BMW Management Rules
have thereafter undergone timely revisions to meet the prevailing
needs. Till date, four amendments have been made in 2000, 2003
and 2011 with these latest guidelines coming into force from
28th March 2016. This article discusses comprehensively about the
major changes to be implemented by a health facility in lieu of the
new BMW rules 2016. These new rules are more comprehensive
in nature and contain important features of BMW (M and H)
rules, 1998 with several new provisions added to these new rules.
BMW (M) rules 2016 contains 4 schedules, 5 forms and 18 rules.
Following are the major changes in the new rules as compared to
the previous version of the rules [Tables 1-4].[1,4,5]
Schedules
Let’s have a look in details, the changes in the schedules’
contents, and as there is no change in the Schedule IV,
therefore, it has not been discussed.
Address for correspondence: Dr. Vikas Gautam,
Postgraduate Institute of Medical Education and Research,
Chandigarh, India.
E‑mail: r_vg@yahoo.co.uk
This is an open access article distributed under the terms of the Creative Commons
Attribution-NonCommercial-ShareAlike 3.0 License, which allows others to remix, tweak,
and build upon the work non-commercially, as long as the author is credited and the
new creations are licensed under the identical terms.
For reprints contact: reprints@medknow.com

DOI: How to cite this article: Singhal L, Tuli AK, Gautam V. Biomedical waste
10.4103/ijmm.IJMM_17_105 management guidelines 2016: What’s done and what needs to be done.
Indian J Med Microbiol 2017;35:194-8.

194 © 2017 Indian Journal of Medical Microbiology | Published by Wolters Kluwer ‑ Medknow

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Singhal, et al.: BMW guidelines 2016
Table 1: Major differences between biomedical waste rules 1998 and 2016
1998
Occupiers with more than 1000 beds required to obtain authorisation
Operator duties are not listed
BMW was divided into ten categories (reduced to eight categories in 2011
guidelines)
No format for annual report (format for annual report included in 2011
guidelines)
Schedule present were I, II, III, IV, V, VI
Forms I, II, III, IV, V (VI form was included in 2011 guidelines)
Chemical pre‑treatment was with 1% sodium hypochlorite
The minimum limit for the release of carcinogenic dioxins and furans have
not been specified
Outsourcing of BMW was not mandatory
The methods of disposal are incineration/autoclaving/microwaving/
mutilation/shredding
Cytotoxic drugs to be discarded in black colour bag
Chemical solid waste to be discarded in black bag
Waste sharp/metal sharp are to be discarded in blue/white bag
Metallic body implants are to be discarded in blue/white bag
Majority of the BMW rules were for discarding the waste
BMW: Biomedical waste
Table 2: Changes in the schedules
1998
Schedule I: Categorisation of waste or type of waste (ten categories)
Schedule II: Colour code, type of container, waste category and treatment
options
Schedule III: Label for BMW container/bags
Schedule IV: Label for transportation of BMW
Schedule V: Standard for treatment and disposal of BMW
Schedule VI: Schedule for waste treatment facilities such as incinerator etc
BMW: Biomedical waste
Schedule I
In Schedule I of BMW rules 1998, BMW has been categorised
into ten categories according to the type of waste, and in
new rules 2016, categorisation of BMW has been done
according to colour code and type of waste with treatment/
disposal options, which are described below. Major change
is in the number of categories in these new rules to avoid
confusion with the large number of categories, and the
number of containers with new coloured container (white)
added for the sharps. The key steps for safe and scientific
management of BMW in any establishment include handling,
segregation, disinfection, storage and proper disposal.[4] The
most appropriate way of identifying the categories of BMW
is that the waste is sorted out into colour‑coded plastic bags
or containers after identifying the category to which the
BMW belongs [Table 4].[5] BMW needs to be segregated
into containers/bags at the point of generation of waste only
Indian Journal of Medical Microbiology  ¦  Volume 35  ¦  Issue 2  ¦  April‑June 2017
2016
It is now mandatory for all the healthcare facilities generating BMW
including health camp or AYUSH to obtain authorisation
Duties of the operator have been listed
BMW is divided into four categories
A format for annual report has been appended with the rules
Change of Schedule to I, II, III, IV [Table 2]
Forms I, II, III, IV, V [Table 3]
Chemical pre‑treatment with 10% sodium hypochlorite
The minimum limit of carcinogenic dioxins and furans released from
incinerator has been clearly specified
Outsourcing is strongly recommended (if treatment facility is located within
75 km of radius from hospital)
The newer methods introduced apart from those of 1998 are plasma
pyrolysis/hydrolysis/encapsulation/inertisation
Cytotoxic drugs to be discarded in yellow bag
Chemical solid waste to be discarded in yellow bag
Waste sharp/metal sharp are to be discarded in transparent puncture proof
box
Metallic body implants are to be discarded in transparent puncture proof box
Majority of the waste disposal rules are directed for recycling the waste
2016
Schedule I: Categorisation according to colour code and type of waste
with treatment/disposal option (four categories)
Schedule II: Standard for treatment and disposal of BMW (including
plasma pyrolysis and inertisation)
Schedule III: Includes list of prescribed authorities and their corresponding
duties
Schedule IV: Part A label for BMW container/bags
Part B label for transporting
This schedule has been moved to Schedule II
This schedule has been moved to Schedule III
and no bag/container to be opened once the waste has been
put into it.[5]
Schedule II
In Schedule II of BMW rules 1998, BMW has been categorised
according to colour code, type of container, waste category and
treatment options. The Schedule II of BMW rules 2016 enlists
the standards for treatment and disposal of BMW (including
plasma pyrolysis and dry heat sterilisation).
Standards for treatment and disposal of biomedical
waste (2016)
Every healthcare facility dealing with BMW shall set up
required waste treatment facilities such as autoclave and
microwave system or make sure that the requisite treatment of
waste occurs at a common BMW treatment facility (CBMWTF)
or any other BMW treatment facility. The major change in the
new rules is that if CBMWTF service is available within
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Singhal, et al.: BMW guidelines 2016

75 km, on‑site treatment and disposal facility shall not be and the bags should comply with the Bureau of Indian
established by any occupier. Before the commencement of its Standards (BIS). The bags used for storing and transporting
operation, every operator of CBMWTF shall set up requisite BMW shall be in compliance with the BIS. Till the standards
BMW treatment equipment such as incinerator, autoclave or are published, the carry bags need to be treated as per the
microwave and effluent treatment plant. Plastic Waste Management Rules, 2011.
Another concern raised in these new rules is the use of Rationale: This is to make the installation and operation of
chlorinated plastic bags. Within 2 years from the date of common treatment facility a viable one.
notification of these rules, the use of chlorinated plastic bags,
gloves and blood bags is to be phased out. The operator of a Segregation, packaging, transportation and storage
CBMWTF should not dispose of such plastics by incineration There are two major changes in this schedule. First, as stated
in previous guidelines, untreated waste not to be stored beyond
a period of 48 h. If it is necessary to store such waste beyond
Table 3: Changes in the forms such a period, the occupier shall take appropriate measures to
1998 2016 ensure that the waste does not harm the human health and the
Form 1: Application for Form 1: Accident reporting environment. The prescribed authority should be informed
authorisation along with the reasons for doing so. Second, microbiological
Form 2: Annual report Form 2: Application for and other clinical laboratory waste is to be pretreated by
authorisation or renewal of sterilisation to Log 6 or disinfection to Log 4, as per the
authorisation
World Health Organization (WHO) or National AIDS Control
Form 3: Accident reporting Form 3: Authorisation (for operating
facility) for BMW management Organization (NACO) guidelines before packing and sending
Form 4: Authorisation (for Form 4: Annual report it to the CBMWTF.
operating facility)
Rationale: This will improve the segregation of waste at source
Form 5: Application for filing Form 5: Application for filing
appeal against the order passed appeal against the order passed by and channelise proper treatment and disposal. It will eliminate
by the prescribed authority the prescribed authority obtaining permission within 48 h, which is not practically
BMW: Biomedical waste feasible.

Table 4: Types of biomedical waste (rule 2016) in Schedule I

Category Type of bag/container used Type of waste Treatment/disposal options
Yellow Non‑chlorinated plastic bags Human anatomical waste Incineration/plasma pyrolysis/deep burial
Animal anatomical waste
Soiled waste
Expired or discarded medicines
Chemical waste
Chemical liquid waste
Discarded linen, mattresses, beddings contaminated
with blood or body fluids
microbiology, biotechnology and other clinical
laboratory waste
Red Non‑chlorinated plastic bags or Contaminated waste (recyclable) tubing, bottles, Autoclaving/microwaving/hydroclaving and
containers intravenous tubes and sets, catheters, urine bags, then sent for recycling. Not to be sent to landfill
syringes (without needles and fixed needle syringes)
and gloves

White Puncture, leak, tamper proof
containers (Translucent)
Waste sharps including Metals: Needles, syringes Autoclaving or dry heat sterilisation followed
with fixed needles, needles from needle tip cutter or by shredding or mutilation or encapsulation
burner, scalpels, blades or any other contaminated
sharp object that may cause puncture and cuts. This
includes both used, discarded and contaminated
metal sharps

Blue Cardboard boxes with blue Glassware: Broken or discarded and contaminated Disinfection or autoclaving/microwaving/
coloured marking glass including medicine vials and ampoules except hydroclaving and then sent for recycling
those containing cytotoxic wastes
Metallic body implants

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Singhal, et al.: BMW guidelines 2016
Schedule III
Schedule III of BMW rules 1998 contains the label for BMW
container/bags. The Schedule III of BMW rules 2016 enlists
the prescribed authorities and the corresponding duties, which
are as follows.
List of prescribed authorities and the corresponding
duties
Duties of the operator:
• To ensure that the BMW collected from the occupier is
handled, stored, transported and disposed off properly
after treatment without any harm to human health and
environment
• To ensure timely collection of BMW from the healthcare
facilities
• The prescribed authorities should be informed immediately
about the healthcare establishments/facilities, which are
not handling the segregated BMW
• To provide training of all its workers
• To undertake appropriate pre‑placement and periodic
medical examination and immunise all its workers and
records for the same
• To ensure occupational safety by providing protective
equipment
• To develop system of reporting of unintended accidents
in Form III with annual report even the nil reporting
• A log book of treatment equipment according to
categories of waste treated; weight of batch should be
maintained. Time, date, duration of treatment cycle and
total hours of operation of the equipment to be noted in
the log book.
Duties of healthcare facilities:
• Initially, in 1998 guidelines, every occupier of an
institution generating BMW was to take all the steps to
ensure that the waste is handled without any adverse effect
to human health and the environment.
Additions made in biomedical waste rules 2016
• The laboratory waste, microbiological waste, blood
samples and blood bags are to be pretreated through
disinfection or sterilisation on‑site in the same manner as
prescribed by WHO or NACO guidelines, which should
then be sent to the CBMWTF for final disposal
• Within 2 years from the date of notification of these rules,
the use of chlorinated plastic bags, gloves and blood bags
are to be phased out
• The healthcare workers and others involved in handling
of BMW need to be trained at the time of induction, and
at least once every year, thereafter
• Immunise all its healthcare workers and others involved
in handling of BMW for protection against diseases
including hepatitis B and tetanus
• Major accidents caused by fire hazards, blasts occurring
while handling BMW and the remedial action accordingly
taken need to be reported to State Pollution Control
Board.
Indian Journal of Medical Microbiology  ¦  Volume 35  ¦  Issue 2  ¦  April‑June 2017
Concluding Remarks
Newer guidelines have been simplified, and the rules have
been made easier to be followed by various health agencies.
However, there is always a scope of improvement. Antibiotic
resistance is a burning issue today, and it is often conferred by
specific genes called as antibiotic resistance genes.[6] The major
cause of the accumulation of these genes in the environment
is human activity including the waste generated from various
health agencies,[7] and the failure of wastewater treatment
plants to remove these genes during processing. As observed
in various Indian water matrices, a very high hazard quotient
represents a potential environmental concern, especially in
pharmaceutical industrial wastewater.[8] This is something
which we need to focus on priority in future lest our country
faces dire consequences in terms of environmental, agricultural
and medical fields. Hospitals are the main source of antibiotics
which are released into environment and to reduce these
residues, research to improve knowledge of the dynamics of
antibiotic release from hospitals is essential.[9]
Furthermore, newer technologies need to be adapted fast in our
country. Most medical waste is being incinerated, a practice
that is short lived because of environmental considerations.
The burning of solid and regulated medical waste generated
by healthcare system creates many problems such as emitting
toxic air pollutants and toxic ash residues, which are the major
source of dioxins in the environment. Public concerns about
incinerator emissions and its toxic emissions, as well as the
creation of strict regulations for medical waste incinerators, are
causing many healthcare facilities to reconsider their choices
in medical waste treatment. The newer non‑incineration
treatment technologies can be adapted to create a toxin‑free
environment.[10]
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
References
1. Ministry of Environment and Forests, Notification  N. S.O.630  (E).
Biomedical Waste (Management and Handling) Rules, 1998. The
Gazette of India, Extraordinary, Part II, Section 3(ii), Dated 27th July,
1998. p. 10‑20, 460.
2. Singh IB, Sarma RK. Hospital waste disposal system & technology.
J Acad Hosp Adm 1996‑1997;8‑9:33‑9.
3. Chitnis V, Vaidya K, Chitnis DS. Biomedical waste in laboratory
medicine: Audit and management. Indian J Med Microbiol 2005;23:6‑13.
4. Acharya DB, Meeta S. The Book of Hospital Waste Management.
New Delhi: Minerva Press; 2000. p. 15, 47.
5. Ministry of Environment, Forest and Climate Change, Notification. The
Gazette of India, Extraordinary, Part II, Section 3(i). Available from:
http://www.iwma.in/BMW%20Rules,%202016.pdf. [Last accessed on
2016 Mar 28].
6. Zhu YG, Zhao Y, Li B, Huang CL, Zhang SY, Yu S, et al. Continental‑scale
pollution of estuaries with antibiotic resistance genes. Nat Microbiol
2017;2:16270.
7. Chandran SP, Diwan V, Tamhankar AJ, Joseph BV, Rosales‑Klintz S,
Mundayoor S, et al. Detection of carbapenem resistance genes and
197
[Downloaded free from http://www.ijmm.org on Sunday, May 13, 2018, IP: 182.77.118.195]

Singhal, et al.: BMW guidelines 2016

cephalosporin, and quinolone resistance genes along with oqxAB gene
in Escherichia coli in hospital wastewater: A matter of concern. J Appl
Microbiol 2014;117:984‑95.
8. Mutiyar PK, Mittal AK. Risk assessment of antibiotic residues in
different water matrices in India: Key issues and challenges. Environ
Sci Pollut Res Int 2014;21:7723‑36.
9. Diwan V, Stålsby Lundborg C, Tamhankar AJ. Seasonal and temporal
variation in release of antibiotics in hospital wastewater: Estimation
using continuous and grab sampling. PLoS One 2013;8:e68715.
10. Gautam V, Thapar R, Sharma M. Biomedical waste management:
Incineration vs. environmental safety. Indian J Med Microbiol
2010;28:191‑2.

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