Sharps Non Sharps
Regulatory Framework: India
Environmental Protection Rules, 1986 - This regulations were drawn up by the government under the powers
conferred on it in terms of the Environment Protection Act, 1986.
1. The Municipal Solid Wastes (Management and Handling) Rules 1999
2. The Hazardous Waste (Management and Handling) Rules, 1989
3. The Plastics (Manufacture, Usage and Waste Management Rules), 2009
4. The E-Waste (Management and Handling Rules), 2010
5. National Rural Health Mission (NRHM) under Ministry of Health and Family Welfare, in 2007 developed and
adopted an Infection Management Environment Plan (IMEP) which outlines a comprehensive framework for
implementation of infection control measures and effective healthcare waste management generated by
6. The issue of Bio-Medical Waste Management (BMWM) in India has attracted the attention of the highest judicial
body at the level of Supreme Court of India.
7. It has issued instructions regarding management of Bio-Medical Waste and Government of India was one of the
first countries to frame and implement Bio-Medical Waste Management and Handling Rules, 1998 (later
amended in 2000 and 2003) in the exercise of power conferred by Sections 6, 8, and 25 of the Environment
(Protection) Act, 1986.
Bio-Medical Waste Management and Handling Rules
• Definition of biomedical waste - Any waste that is generated during the diagnosis, treatment, or immunization of human beings or animals, or in research activities
pertaining to or in the production or testing of biologicals.
• Application of the Biomedical Waste Rules - The rules apply to all persons who generate, collect, receive, store, transport, treat, dispose, or handle BMW’s in any form.
• Duty of occupier (operator) - of a healthcare facility (hospital, nursing home, clinic, dispensary, veterinary institution, animal house, pathological laboratory, blood bank
etc) to ensure that BMWs are handled without any adverse effect to human health and the environment, and according to the prescribed treatment and disposal
requirements as per the Biomedical Waste Rules.
• Prescribed authority - State Pollution Control Boards (SPCBs) in States and Pollution Control Committees in territories are responsible for permitting and enforcing the
requirements of the Biomedical Waste Rules.
• Permit - Each occupier (operator) handling BMW’s and providing services to 1,000 or more patients per month is required to obtain a permit from the prescribed
• Recordkeeping - Each occupier (operator) is required to maintain records on the generation, collection, reception, storage, transportation, treatment, and disposal of
BMWs. All records are subject to inspection and verification by the prescribed authority at any time.
• Accident reporting - Each occupier (operator) is required to report any accident related to the management of BMW’s.
• Annual reporting - Each occupier is required to submit an annual report to the prescribed authority to provide information about categories and amounts of wastes
generated and treated, and modes of treatment used.
• Common disposal/ Incineration sites - Local public entities are required to provide common disposal / incineration sites, and the occupiers (operators) of such sites are
required to comply with the Biomedical Waste Rules.
• Segregation, Packaging, Transportation, and Storage - BMWs are not to be mixed with other waste. According to the Rules, BMWs are to be segregated into labelled
bags/containers. Transportation of BMWs is to be conducted in authorized vehicles. No untreated waste is to be stored more than 48 hours, unless special permission is
obtained from the regulatory authorities.
• Standards - Technology and discharge standards for incineration, autoclaving, microwaving, liquid waste discharges, and deep burial are prescribed in the Biomedical
Categories and Segregation of Bio-Medical Waste
S. No. Bio-Medical Waste Categories Container Colour Treatment and Disposal
1. Human anatomical waste Yellow Incineration / Deep Burial
2. Animal Waste Yellow Incineration / Deep Burial
3. Microbiology and biotechnology waste (infectious
wastes from laboratory)
Yellow / Red Incineration / Autoclaving / Microwaving
4. Waste sharps (for example, needles, syringe,
Blue / White /
Disinfection / Mutilation / Autoclaving / Microwaving
5. Discarded medicines and cytotoxic drugs Black Incineration/Destruction and Secure Landfilling
6. Soiled waste (items contaminated with blood or
body fluids such as cotton dressings, beddings)
Yellow / Red Incineration / Autoclaving / Microwaving
7. Solid waste (for example, tubing, catheters,
Blue / White /
Translucent / Red
Disinfection by chemical treatment / Autoclaving / Microwaving
8. Liquid waste (from laboratory, washing, cleaning,
- Disinfection by chemical treatment and discharge into drains
9. Incineration ash Black Municipal Landfilling
10. Chemical wastes Black Chemical treatment and discharge into drains for liquids, and
secured landfills for solids.
BMW Categories Draft - 2011 Amendments
BMWM RULES - 2011 BMWM RULES - 1998
Every occupier generating BMW, irrespective of the quantum of wastes
comes under the BMW Rules and requires to obtain authorization.
Occupiers with more than 1000 beds required to obtain authorization.
Duties of the Operator are clearly listed Duties of Operator were absent
Categories of Biomedical Waste reduced to Eight. Category No. 8
(containing liquid waste generated from laboratory, cleaning, washing,
and disinfection activities) and Category No. 9 (containing incineration
ash) have been discarded.
Biomedical waste was divided in ten categories
Treatment and disposal of BMW made mandatory for all the Healthcare
Treatment and disposal of BMW made mandatory for all the Healthcare
Establishments with more than 1000 beds.
A format for annual report is appended with the Rules. Accident reporting
has been made mandatory.
There was no format for Annual Report
Form VI i.e. the report of the operator on HCEs not handing over the BMW
added to the Rules. It empowers the operator of CBMWTF to report
against the HCEs who are not carrying out proper segregation of their
Form VI absent
Healthcare Waste and Examples
Types of Healthcare Wastes Examples
Communal or General healthcare waste (solid
wastes that are not infectious, chemical, or
Infectious waste (wastes suspected of
Heavy metal waste
Cardboard boxes, paper, food waste, plastic and glass bottles
Cultures, tissues, dressings, swabs, and other blood-soaked items; waste from isolation wards
Recognizable body parts, amputated organs, placenta, aborted foetuses
Needles, scalpels, knives, blades, broken glass
Expired or no longer needed medicines or pharmaceuticals
Wastes containing genotoxic drugs and chemicals (used in cancer therapy)
Laboratory reagents, film developer, solvents, expired or no longer needed disinfectants, and
organic chemical wastes (for example, formaldehyde, phenol-based cleaning solutions)
Batteries, broken thermometers, blood pressure gauges
Aerosol cans, gas cylinders (that is, anaesthetic gases such as nitrous oxide, halothane, enflurane,
and ethylene oxide; oxygen, compressed air)
Unused liquids from radiotherapy; waste materials from patients treated or tested with unsealed
Problems With Healthcare Wastes
• According to the Ministry of Environment and Forests (MoEF) gross generation of bio-medical wastes in India is
4,05,702 kg/day of which only 2,91983 kg/day is disposed, which means that almost 28 percent of the bio-
medical and hospital waste is left untreated and not disposed off.
• Extrapolating from past figures of number of beds and average quantity of waste generation at the rate of 1 to
1.5 kg per bed per day, it is estimated that about 0.33 million tonnes of hospital waste is being generated per
year which is far less than waste generated by other developed countries.
• Almost 53.25 percent of healthcare establishments are in operations without the adequate authorization from
State Pollution Control Board (SPCB), and the waste generated from such facilities goes unaccounted / untreated
and is dumped without any treatment illegally.
• The waste generated by healthcare establishments by the process of rendering healthcare services, can be
hazardous, toxic, and even lethal due to the presence of pathogens in sufficient concentration or quantity that
could result in rapid proliferation, transmission, and spreading of infectious, dangerous and fatal communicable
diseases such as Hepatitis, HIV/AIDS, Cancer, and other blood borne diseases.
• During incineration, in most cases there is no proper filtering of emitted flue gases which pollutes the air causing
illnesses to the nearby populations. Therefore institutionalizing effective healthcare waste management systems
in all healthcare facilities is a key prerequisite to improving efficiency and effectiveness of healthcare of people.
Genotoxic waste is highly hazardous and may have mutagenic, teratogenic, or carcinogenic properties.
It raises serious safety problems, both inside hospitals and after disposal, and should be given special attention.
Genotoxic waste may include certain cytostatic drugs (see below), vomit, urine, or faeces from patients treated
with cytostatic drugs, chemicals, and radioactive material.
Cytotoxic (or antineoplastic) drugs, the principal substances in this category, have the ability to kill or stop the
growth of certain living cells and are used in chemotherapy of cancer. They play an important role in the therapy
of various neo-plastic conditions but are also finding wider application as immunosuppressive agents in organ
transplantation and in treating various diseases with an immunological basis.
Cytotoxic drugs are most often used in specialized departments such as oncology and radiotherapy units, whose
main role is cancer treatment; however, their use in other hospital departments is increasing and they may also
be used outside the hospital setting.
Most Common Genotoxic Wastes
Classified as carcinogenic
Cytotoxic and other drugs: azathioprine, chlorambucil, chlornaphazine, ciclosporin, cyclophosphamide, melphalan,
semustine, tamoxifen, thiotepa, treosulfan
Radioactive substances: (radioactive substances are treated as a separate category in this handbook)
Classified as possibly or probably carcinogenic
Cytotoxic and other drugs: azacitidine, bleomycin, carmustine, chloramphenicol, chlorozotocin, cisplatin, dacarbazine,
daunorubicin, dihydroxymethylfuratrizine (e.g. Panfuran S—no longer in use), doxorubicin, lomustine, methylthiouracil,
metronidazole, mitomycin, nafenopin, niridazole, oxazepam, phenacetin, phenobarbital, phenytoin, procarbazine
hydrochloride, progesterone, sarcolysin, streptozocin, trichlormethine a
Classified by working groups of the International Agency for Research on Cancer (IARC).
Categories of Harmful Cytotoxic Drugs
• Alkylating agents: cause alkylation of DNA nucleotides, which leads to cross-linking and miscoding of the genetic stock;
• Antimetabolites: inhibit the biosynthesis of nucleic acids in the cell;
• Mitotic inhibitors: prevent cell replication. Cytotoxic wastes are generated from several sources and can include the
• Contaminated materials from drug preparation and administration, such as syringes, needles, gauges, vials, packaging;
• Outdated drugs, excess (leftover) solutions, drugs returned from the wards;
• Urine, faeces, and vomit from patients, which may contain potentially hazardous amounts of the administered
cytostatic drugs or of their metabolites and which should be considered genotoxic for at least 48 hours and sometimes
up to 1 week after drug administration. In specialized oncological hospitals, genotoxic waste (containing cytostatic or
radioactive substances) may constitute as much as 1% of the total healthcare wastes.
• Formaldehyde is a significant source of chemical waste in hospitals. It is used to clean and disinfect equipment (e.g.
haemodialysis or surgical equipment), to preserve specimens, to disinfect liquid infectious waste, and in pathology,
autopsy, dialysis, embalming, and nursing units.
• Photographic chemicals Photographic fixing and developing solutions are used in X-ray departments. The fixer usually
contains 5–10% hydroquinone, 1–5% potassium hydroxide, and less than 1% silver. The developer contains
approximately 45% glutaraldehyde. Acetic acid is used in both stop baths and fixer solutions.
• Solvents Wastes containing solvents are generated in various departments of a hospital, including pathology and
histology laboratories, and engineering departments. Solvents used in hospitals include halogenated compounds, such
as methylene chloride, chloroform, trichloroethylene, and refrigerants, and non-halogenated compounds such as
xylene, methanol, acetone, isopropanol, toluene, ethyl acetate, and acetonitrile.
• Organic chemicals Waste generated in health-care facilities include: • disinfecting and cleaning solutions such as
phenol-based chemicals used for scrubbing floors, perchlorethylene used in workshops and laundries; • oils such as
vacuum-pump oils, used engine oil from vehicles (particularly if there is a vehicle service station on the hospital
premises); • insecticides, rodenticides.
• Inorganic chemicals Waste inorganic chemicals consist mainly of acids and alkalis (e.g. sulfuric, hydrochloric, nitric, and
chromic acids, sodium hydroxide and ammonia solutions). They also include oxidants, such as potassium permanganate
(KMnO4) and potassium dichromate (K2Cr2O7), and reducing agents, such as sodium bisulfite (NaHSO3) and sodium
Wastes with High Content of Heavy Metals
• Wastes with a high heavy-metal content represent a subcategory of hazardous chemical waste, and are usually
• Mercury wastes are typically generated by spillage from broken clinical equipment but their volume is
decreasing with the substitution of solid-state electronic sensing instruments (thermometers, blood-pressure
• Whenever possible, spilled drops of mercury should be recovered. Residues from dentistry have a high mercury
• Cadmium waste comes mainly from discarded batteries. Certain “reinforced wood panels” containing lead are
still used in radiation proofing of X-ray and diagnostic departments.
• A number of drugs contain arsenic, but these are treated here as pharmaceutical waste.
• Anaesthetic Gases: nitrous oxide, volatile halogenated hydrocarbons (such as halothane, isoflurane, and
enflurane), which have largely replaced ether and chloroform. Applications in hospital operating theatres, during
childbirth in maternity hospitals, in ambulances, in general hospital wards during painful procedures, in
dentistry, for sedation, etc.
• Ethylene oxide: Applications for sterilization of surgical equipment and medical devices, in central supply areas,
and, at times, in operating rooms.
• Oxygen stored in bulk tank or cylinders, in gaseous or liquid form, or supplied by central piping. Application
inhalation supply for patients.
• Compressed Air: Applications in laboratory work, inhalation therapy equipment, maintenance equipment, and
environmental control systems.
• Radioactive waste includes solid, liquid, and gaseous materials contaminated with radionuclides. It is produced
as a result of procedures such as in-vitro analysis of body tissue and fluid, in-vivo organ imaging and tumour
localization, and various investigative and therapeutic practices.
• Radionuclides used in healthcare have unsealed sources that are usually liquids that are applied directly and not
encapsulated during use; sealed sources are radioactive substances contained in parts of equipment or
apparatus or encapsulated in unbreakable or impervious objects such as “seeds” or needles.
• The waste produced by health-care and research activities involving radionuclides, and related activities such as
equipment maintenance, storage, etc., can be classified as follows: • sealed sources; • spent radionuclide
generators; • low-level solid waste, e.g. absorbent paper, swabs, glassware, syringes, vials; • residues from
shipments of radioactive material and unwanted solutions of radionuclides intended for diagnostic or
therapeutic use; • liquid immiscible with water, such as liquid scintillation-counting residues used in
radioimmunoassay, and contaminated pump oil; • waste from spills and from decontamination of radioactive
spills; • excreta from patients treated or tested with unsealed radionuclides; • low-level liquid waste, e.g. from
washing apparatus; • gases and exhausts from stores and fume cupboards.
• Indian healthcare establishments have pitiable operational strategies, absence of documented
waste management and disposal policy, very poor budgetary support in the government run
hospitals, private hospitals ignore the rules for monetary consideration, untrained ward attendants,
and other supporting staff.
• There are no waste management committees at present in Indian hospitals which should essentially
be consist of the head of the establishment, all the departmental heads, hospital superintendents,
nursing superintendents, hospital engineers with a waste management officer along with an
environmental control advisor and an infection control advisor.
• Insufficient support and guidance from regulatory agencies further complicates the problem of
waste management. Regulations in the form of waste reduction and recycling targets, carbon credit
earnings, development of minimum energy efficiency standards for equipments are necessary for
prevention of pollution and reduction of environmental load on sustained basis.
• Adequate and requisite number of sanitary landfills is lacking in India.
• Resistance to change is often a barrier to implementation of new waste management programmes.
Waste Exposure Risk
• Until recent times, healthcare waste in India was not segregated before disposal to the dump site or incinerator.
• Infectious wastes containing potentially harmful micro-organisms can also infect hospital patients, healthcare
employees, and visitors to patients and rag pickers mostly women and children from the lowest socio-economic
strata, awareness of health risks in general is poor. .
• As a result many of them contract diseases from used needles, syringes, and other sharps present risks of injury
and infection (for example, hepatitis B and C, and HIV), other infected bio-medical waste.
• WHO predicts that India is on the verge of having an HIV epidemic. Tuberculosis (TB) and HIV combined together
is taking great toll on the human health and life. Hepatitis B and C infections are on the rise. Mortality due to
Hepatitis C has gone up significantly.
• Management of healthcare waste is very important for controlling diseases.
Conclusions: Waste Related
• Waste hierarchy as well as rules are not framed for all kinds categories of waste and Waste management efforts
in India are not directed by a clear-cut policy.
• Medical wastes should be classified according to their source, typology, and risk factors associated with its
handling, storage, and ultimate disposal.
• The segregation of waste at source is the key step. Reduction, reuse, and recycling should be considered in
• MoEF / Pollution Control Boards / States do not have a complete data about all the various kinds of waste being
generated in India, risks associated to health /environment, and instances of the polluter being held responsible
for unsafe disposal were very few.
• Absence of adequate funds and trained manpower for waste management and handling activities, weak
compliance to laws, ineffective monitoring, and absence of a single body taking ownership of waste issues in
India is burgeoning challenge.
• The challenge before us is to scientifically manage growing quantities of bio-medical waste that is untreated, if
we really want to protect our environment and provide better health for community.
The toxicity of anticancer chemotherapy has been well known since its initial clinical use. Indeed, it has often
been these drugs' toxic side effects that have limited their therapeutic value. The risk-benefit equation for a
cancer patient often determines these drugs' appropriate use despite acknowledged side effects. Although
these drugs present the same potential toxicities to exposed healthcare workers, that risk-benefit ratio is
A balance must be achieved to continue the use of these beneficial drugs in patients, while assuring the health
of personnel administering them.
A body of guidance now exists on how to achieve this goal. Much of the new guidance revisits the long standing
elements of a comprehensive safe handling program and reminds us that the risk remains and our vigilance is
required, but that a harmonized safe handling approach has been adopted that assures minimal risk to workers
who provide lifesaving therapies to their patients.