BIO MEDICAL WASTE

MANAGEMENT IN THE
HOSPITALS(Law &
Reality)

Wg Cdr Dr Yogesh Chandra

MBA(HA) Ist Semester
Reg No.19P0119023
 A GLOBAL PERSPECTIVE
• Hospital/Bio-medical Waste Management: A global perspective
The proper management of Hospital/Healthcare/Biomedical
waste has become a topic of enormous concern having global
implications and attention. It is of course well known and
documented that Hospital waste is a potential health hazard to
the health care workers, public, flora and fauna of the area. A
1990 report by the U.S. Agency for Toxic Substances and
Disease Registry concluded that biomedical waste from health
care settings may pose an injury and exposure risks via
occupational contact with medical waste for doctors, nurses, and
janitorial, laundry and refuse workers. Hence, Biomedical waste
must be properly managed and disposed off to protect the
environment, general public and workers, especially healthcare
and sanitation workers who are at risk of exposure to biomedical
waste as an occupational hazard. Steps in the management of
biomedical waste include generation, accumulation, handling,
storage, treatment, transport and disposal.
 BMW MANAGEMENT UNDER THE
AMBIT OF ENVIRONMENT
PROTECTION ACT 1986
• The international impetus came in the form of the Stockholm
conference in 1972, to discuss Humans and their role in the
Environment.The process received a major push when the Bhopal Gas
Tragedy happened in 1984.

• In this background the Parliament passed the Environment Protection Act, 1986
and the Environment Protection Rules, 1986. Under  Indian Constitution’s Article
48(A) and Article 51(A)g. The Act is a part of Article 253 of the Indian
Constitution.

• The Act came into force on Nov. 19, 1986 and extends to the whole of India. The
Act contains 26 sections divided into 4 chapters.

• The Act was passed  to provide for the protection and improvement of environment
and for matters connected there with.

• The Act gives certain powers to the Central Government to take measures for the
purpose of protecting and improving the quality of the environment and to prevent
environmental pollution.
 ENVIRONMENT PROTECTION
ACT 1986 –AN UMBRELLA
LEGISLATION
• The Act is an “umbrella” legislation designed to provide a
framework for Central Government coordination of the
activities of various central and state authorities established
under previous laws, such as the Water Act(1974) and the Air
Act(1981).
• Environment Protection Rules, 1986
• Hazardous Waste Rules, 1989 (Now 2016)
• Bio Medical Waste Rules, 1998
• Municipal Solid Waste Rules, 2000
• Noise Pollution Rules, 2000
• Ozone Depleting Substances Rules, 2000
• Battery Waste Rules, 2001
• Plastic Waste Rules, 2011
• Electronic waste Rules, 2011
 EPA-1986 FEATURES
• The Act covers all forms of pollution; air, water, soil
and noise.
• It provides the safe standards for the presence of
various pollutants in the environment.
• It prohibits the use of hazardous material unless
prior permission is taken from the Central
Government.
• It allows the central government to assign authorities
in various jurisdictions to carry out the laws of this
Act.
 EPA-1986 FEATURES Cont’d
• To co-ordinate the activities of the various regulatory
agencies already in existence
• To appoint environment officers to check environmental
pollution
• To improve the quality of life by protection of environment
• Establishing environmental laboratories
• To protect the forests and wildlife in the country
• Planning and execution of a nation-wide program for the
prevention, control and abatement of environmental
pollution
• Laying down standards for emission or discharge of
environmental pollutants from various sources whatsoever
and etc.
 DEFINITIONS OF EPA TERMS
(a) ‘Environment' includes water, air and land and the inter-relation-
ship which exists among and between water, air and land, and human
beings, other living creatures, plants, micro-organism and property.

(b) ‘Environmental pollutant' means any solid, liquid or gaseous

substances present in such concentration as may be, or tend to be,
injurious to environment.

(c) ‘Environmental pollution' means the presence in the environment of

any environmental pollutant.

(d) ‘Handling’ is defined, in relation to any substance, as meaning the

manufacture, processing, treatment, package, storage,
transportation, use, collection, destruction, conversion, offering for
sale, transfer or the like, of such substance
DEFINITIONS OF EPA TERMS Cont’d

(e) ’Hazardous substance’ is that the substance or

preparation to be liable to cause harm to human
beings, other living creatures, plants, micro-organism,
properties or the environment.
(f)’Occupier’, in relation to any factory or premises, as
meaning "a person who has control over the affairs of
the factory or the premises" and further provides
that in relation to any substance, it "includes the
person in possession of the substance“
(g)’Prescribed’, as meaning prescribed by rules made
under the Act.
 PENALTY FOR CONTRAVENTION
• Penalty for contravention of the provisions of the Act and the rules,
orders and directions (sec. 15)
• (1) Whoever fails to comply with or contravenes any of the
• provisions of this Act, or the rules made or orders or directions
issued there under, shall, in respect of each such failure or
contravention, be punishable with imprisonment for a term which may
extend to 5 years 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 or contravention.

• (2) If the failure or contravention referred to in sub-section 1

• continues beyond a period of one year after the date of conviction,
the offender shall be punishable with imprisonment for a term which
may extend to seven years
HOSPITAL-A SOURCE OF
INFECTION
 WHAT IS 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 1 of the Biomedical Waste Handling Rules
2016.”
• The Bio-medical Waste Management rules are
applicable to all persons who generate, collect, receive,
store, transport, treat, dispose, or handle bio medical
waste in any form.
 WASTE NOT UNDER BMW
Bio-Medical Waste rules 2016 doesn’t apply to the
following types of wastes as they are covered
under different acts enumerated below:
• Radioactive wastes(Atomic Energy Act,1962)
• Hazardous chemicals(Manufacture,Storage &
import (1989)
• Lead acid batteries(2001)
• Hazardous wastes(2016)
• E-Waste(2016)
• Municipal Solid Wastes(2016)
• Hazardous microorganisms,genetically engineered
microorganisms and cells(1989)
 HOSPITAL WASTE-TYPES
• According to WHO,
• Nearly 85% of all waste generated by hospital is
general waste.
• About 15% waste is Bio-medical Waste, which includes

Infectious waste - 10% Non-infectious waste such as radioactive

and chemical wastes -5%
• Remember all Bio-medical-waste is hazardous in nature
But when hazardous waste is not segregated at the
source of generation and mixed with nonhazardous
waste, then 100% waste becomes hazardous.
 NEED OF BIOMEDICAL WASTE MANAGEMENT

The need or rationale for spending so many resources in

terms of money, manpower, material and machine for
management of hospital waste are due to following risks:
1. Injuries from sharps leading to infection to all
categories of hospital personnel and waste handlers.

2. Nosocomial infections in patients from poor infection

control practices and poor waste management.

• 3. Risk of infection outside hospital for waste handlers

and scavengers and at times, general public living in the
vicinity of the hospitals.
NEED OF BIOMEDICAL WASTE
MANAGEMENT Cont’d
4. Risk associated with hazardous chemicals and drugs
to persons handling wastes at all levels.

5. Risk of recycling of “Disposables” which are being

repacked and sold by unscrupulous elements.

6. Risk of spurious drugs due to repacking of disposed

off drugs to unsuspecting buyers.

7. Risk of air, water and soil pollution directly due to

waste, or due to defective incineration, emissions and
ash.
 STEPS IN BMW MANAGEMENT

a. Generation
b. Segregation
c. Collection
d. Storage
e. Treatment
f. Transport
g. Disposal
Thus, the Bio-medical Waste Management rules are applicable to
all persons who generate, segregate, collect, receive, store,
treat, transport dispose, or handle bio medical waste in any form.
 BMW MANAGEMENT-LEGAL
• Bio-medical Waste Management: A Legal Requirement:
• The Environment Protection Act 1986, the Bio Medical Waste
(Management and Handling) Rules in July 1998, subsequently
revised in 2011and now the “Bio-medical Waste Management
Rules, 2016” are an attestation to the commitment of the Govt
of India. The law works on a simple “the polluter pays principle”
• The responsibility of hospital administrator as regards to proper
handling and disposal of Biomedical waste had become a
statutory requirement with the promulgation of Government of
India (Min of Environment, Forests& climate change) gazette
notification no. 460 dated 27 Jul 1998 & notification of the Bio-
medical Waste (Management and Handling) Rules in July 1998 &
subsequently revised in 2011.“Bio-medical Waste Management
Rules, 2016” came into force in supersession of the 1998 rules
with gazette notification no. G.S.R. 343(E) dated 28thMarch
2016.
 BMW MANAGEMENT-LEGAL
Cont’d
• The Central Pollution Control Board and the State Pollution Control Committees have
the authority to cancel the Consent to Operate and the Authorization of Healthcare
Institutions and under the Bio-medical Waste Management Rules 2016 for non-
compliant Hospitals. Indeed there have been such instances in India It is therefore
essential that all officials concerned with the administration of hospitals and other
health care echelons take all steps to adhere to the laid down directives to ensure
that waste generated is handled without any adverse effect to human health and
environment. It is equally important that all medical, dental, nursing officers, other
paramedical staff and waste handlers such as safai karmacharis, Hospital attendants
& Sanitation attendants be well oriented to the basic requirements of handling and
management of biomedical waste.

• From the ethical perspective, needle stick injury endured by a Healthcare workers
due to incorrect Bio medical waste management practices are liable for legal suits
besides being ethically incorrect. Failure to comply with the provisions of the Rules,
will attract penal action as per the provisions of the Environment (Protection) Act,
1986, which includes imprisonment for a period of 5 years or a fine of Rs.1 lakh or
both.
 AUTHORIZATION
• 1. One time Authorization for Non-bedded HCFs.

• 2. The validity of authorisation for bedded health

care facility and operator of a common facility shall
be synchronised with the validity of the consents
SCHEDULES of BMW MANAGEMENT
• There are 4 schedules (or parts) in the Bio-Medical Waste rules,
2016:
• Schedule I (Part-1 & 2): Categorization and Management of
BMW.
• Schedule II: Standards for treatment and disposal of BMW.
• Schedule III: Prescribed Authorities and corresponding
duties.
• Schedule IV: Label of containers or bags (Part A) and label
for transportation of Bio-Medical waste bags or containers
(Part B)
SCHEDULE- BMW MANAGEMENT
SCHEDULE- BMW MANAGEMENT
Cont’d
 SCHEDULE- BMW MANAGEMENT
Cont’d
• 1. Chemical treatment should be done using at least 10% sodium
hypochlorite having 30% residual chlorine for twenty minutes. But
as per BMW (amendment) rules, 2018, 1% to 2% sodium
hypochlorite should be used.(obsolete),no use of solution
• 2. There is no need of chemical pre-treatment before incineration,
except for microbiological, lab and highly infectious waste.
• 3. Needles should not be cut and only stored in tamper proof, leak
proof and puncture proof containers.
• Schedule II: Standards for treatment and disposal of BMW- It
does not pertain to occupier but is relevant for operator of
CBMWTF.
• Schedule III: Prescribed Authorities and corresponding duties
 SCHEDULE- BMW MANAGEMENT
Cont’d
• Schedule IV:
• Part A: LABEL FOR BIO-MEDICAL WASTE CONTAINERS
OR BAGS
 SCHEDULE- BMW MANAGEMENT
Cont’d
• Schedule IV:
• Part B: LABEL FOR TRANSPORTING BIO-MEDICAL
WASTE BAGS OR CONTAINERS
 BMW Management-FEATURES

• The major salient features of BMW Management

Rules, 2016 include the following:
• (a) The scope of the rules has been expanded to
include vaccination camps, blood donation camps,
surgical camps or any other healthcare activity;

(b) Phase-out the use of chlorinated plastic bags,

gloves and blood bags within two years
 BMW Management-FEATURES
Cont’d
• (c) Pre-treatment of the laboratory waste, microbiological
waste, blood samples and blood bags through disinfection
sterilization on-site in the manner as prescribed by WHO or
NACO

(d) Provide training to all its health care workers and immunize
all health workers regularly
 BMW Management-FEATURES
Cont’d
• (e) Establish a Bar-Code System for bags or
containers containing bio-medical waste for disposal;

(f) Report major accidents;

(g) Existing incinerators to achieve the standards for retention
time in secondary chamber and Dioxin and Furans within two
years.
 BMW CATEGORY
• (h) Bio-medical waste has been classified into 4 categories
instead of 10categories as per Biomedical Waste (Management &
Handling) Rules,1998 to improve the segregation of waste at
source.
 BMW Management-FEATURES
Cont’d
• (i) Procedure to get authorization simplified. The validity of authorization
synchronized with validity of consent orders for Bedded HCFs.

• (j) The new rules prescribe more stringent standards for incinerator to
reduce the emission of pollutants in environment;

• (k) Inclusion of emissions limits for Dioxin and furans;

• (l) No occupier shall establish on-site treatment and disposal facility, if a

service of `common bio-medical waste treatment facility is available at
seventy-five kilometers.

• (n) Operator of a common bio-medical waste treatment and disposal facility

to ensure the timely collection of bio-medical waste from the Health Care
Facility and assist the Health Care Facility in conduct of training.
 DUTIES OF OCCUPIER (HOSPITAL/
HEALTHCARE FACILITY)
1.To provide a safe, ventilated and secured location for
storage of segregated BMW within premises.
2. As per the Bio-Medical Waste Management
(Amendment) Rules, 2018, use of chlorinated plastic
bags (excluding blood bags) and gloves has to be
phased out by the 27th March, 2019.
3. Provide training to all its health care workers and
others involved in handling of bio medical waste at
the time of induction and once a year thereafter and
maintain records for the same.
4. Immunization against Hepatitis B and tetanus for
workers.
 DUTIES OF OCCUPIER (HOSPITAL/
HEALTHCARE FACILITY)Cont’d
5. Establish a Bar-Code System for bags or containers
containing biomedical waste to be sent out of the
premises by 27th march, 2019 as per the Bio-Medical
Waste Management (Amendment) Rules, 2018.
6. Maintain and update the bio-medical waste
management register daily and display the monthly
and annual record on website.
7. Report major accidents like needle stick injuries,
broken mercury thermometer, accidents caused by
fire, blasts during handling of biomedical waste and
the remedial action taken and record the same in
Form no. 1
 DUTIES OF OCCUPIER (HOSPITAL/
HEALTHCARE FACILITY)Cont’d
FORM No. 1

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 accident 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........................
 DUTIES OF OPERATOR OF
COMMONBIO-MEDICAL WASTE
TREATMENT FACILITY
• 1. Report major accidents including accidents caused by fire,
blasts during handling of bio-medical waste and the remedial
action taken and record the same in Form I to State Pollution
Control Board.
• 2. Ensure timely collection of BMW from healthcare facilities
• 3. Handing over of recyclable waste after treatment by
autoclaving and incineration.
• 4. Establish bar coding and global positioning system for
handling by 27th March, 2019 as per the Bio-Medical Waste
Management(Amendment) Rules, 2018.
• 5. Assist health care facilities in training of workers.
• 6. Up gradation of existing incinerators and achievement of
standards for secondary chamber.
 RECORD MAINTENANCE
• MAINTENANCE OF RECORDS:
• 1. Maintain and update the bio-medical waste
management register daily and display the monthly
and annual record on website
• 2. Records in relation to generation, collection,
reception, storage, transportation, treatment and
disposal shall be maintained for 5 years as per rules.
• ACCIDENT REPORTING:
• 1. In case of major accident, the authorised person
shall intimate immediately and submit a report within
24 hours regarding the remedial steps taken.(Form I)
 RECORD MAINTENANCE
Cont’d
1. Every occupier or operator of CBMWTF shall submit an
annual report to the prescribed authority by 30th of
June every year.(Form IV)

2. The prescribed authority shall compile, review, analyze

and report to the CPCB on or before 31st July every year.

3. The CPCB shall submit a report on the same to the

Ministry of Environment, Forest & climate change by 31st
August every year.

4. The Annual reports shall be available on the websites of

the occupier, SPCB and the CPCB
 VARIOUS FORMS BMWM-2016
S.No Form No. Purpose
.
1. Form-I Reporting of incidents
2. Form-II For Authorisation or renewal of Authorisation
application on under BMW rules and consent
under Air act & Water act (To be submitted by
occupier of health care facility or common bio-
medical waste treatment facility)
3. Form-III For Authorisation
4. Form-IV To be submitted to the prescribed authority on
or before 30th June every year for the period
from January to December of the preceding
year, by the occupier of health care facility
(HCF) or common bio-medical waste treatment
facility (CBWTF)]
 BMWM-CURRENT SITUATION
IN INDIA
• 1.Lack of funds- To phase out chlorinated plastic bags, gloves,
blood bags and to establish a bar code system for bags/containers
the cost will be high and time span for doing this
• two year is to short.
• 2.Lack of CBMWTF- Currently, in India, there are 198 CBMWTF
in operation and 28 are under construction. There is a great need
for rapid development of many more CBMWTF to fulfill the need
of treatment and disposal of all BMW generated in India.
Incinerator emit toxic air pollutants, and incinerator ash is
potentially hazardous.
• 3.Technology still under research- The various new technologies
for BMW disposal are categorized into four groups – thermal,
chemical processes, irradiative processes, and biological processes.
Most of these are still under research.
 BMWM-CURRENT SITUATION
IN INDIA Cont’d
• 4. Laxity at the end of HCFs-Most of the healthcare
establishments handover their mixed waste to CBMWTF after 48
hours. Safe and effective management of waste is not only a “legal
necessity but also a social responsibility ”
• 5.Non compliance by HCFs & CBMWTFs-Fact is that in most of
the hospitals enforcement and monitoring of BMW Rules 2016 and its
amendments in 2018 are in lax. Defaulters (HCFs, CBWTFs) are mostly,
either suspended or their contracts are cancelled through District
Magistrate (DM) but, are never levied heavily for their non-compliance.
• 6.Lack of awareness-Managing healthcare waste requires effective
knowledge not only among those who produce the healthcare waste but
also among those who handles it. So, to achieve this, HCFs and
regulatory authorities have to take stringent measures in order to
ensure safe disposal of BMW in the country. To state a few,
inventorisation of the total number of HCFs and the quantity of their
waste generation needs to be addressed; training and awareness
programme for healthcare personnel needs to be conducted.
 CONCLUSION
• BMWM should be a shared teamwork with committed
government backing, good BMW practices followed by both
health-care workers and HCFs, continuous monitoring of BMW
practices, and strong legislature. It is our fundamental right to
live in clean and safe environment. The pillar of BMWM is
segregation of waste at source and WR. The current BMWM
2016 rules are an improvement over earlier rules in terms of
improved segregation, transportation, and disposal methods, to
decrease environmental pollution and ensure the safety of the
staff, patients, and public. Moreover, more use of non-PVC
medical devices and development of newer novel, eco-friendly
systems for disposal of BMW should be encouraged. All
participants in BMWM should pledge to guarantee a cleaner and
greener environment.