new bio medical waste management rules 2016

Environmentally safe Disposal ofHospital & Health care Wastes Bio-Medical Waste Management Rules 2016

Dr. Gunwant JoshiFormer Chief ChemistMadhya Pradesh Pollution Control Board

8/27/2016 1Dr. Gunwant Joshi

The Biomedical Waste (Management & Handling) Rules, 1998 as amended up till March2016

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up till March2016 The Municipal Solid Waste

(Management & Handling) Rules, 2000, amended up till 2016


What Causes wastes from Hospital premisesHAZARDOUS ?

1. Waste Chemical-medications, Solutions, or 2. Infectious microbes,3. Chemicals such as formaldehyde, waste anesthetic gases, etc.,waste anesthetic gases, etc.,4. Used disposables, Wasted equipments and Chemotherapeutic agents, 5. Laser Smoke and aerosolized medications


Apart from HospitalsInfectious wastes are also generated at Dental Chambers Nursing homes Cosmetic clinics Path. Laboratories Blood BanksAayush Hospitals Aayush Hospitals Veterinary institutions Bio-Medical & Biotech Research centers Medical check-up & Surgical camps Mortuaries & Autopsy centresThe work environments similar to Hospital environment.8/27/2016 4Dr. Gunwant Joshi

Recurrence ofOlder infectious diseases& Advent of Newer infectionsPrompted improvements in Medical technology and Centralized Medicare, and

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Centralized Medicare, andBrought huge volumes of Toxic & Hazardous Waste Situation forced a serious rethinking & necessitated an appropriate refinement in pre-existing Legislation


Unsafe BMW disposal : Who’s at Risk ?

• Doctors and nurses• Other Patients• Hospital support staff• Waste collection and disposal staff• Waste collection and disposal staff• General public in the vicinity and• The Environment


•Health care Associated infections : 5-10% of admissions in acute care hospitals, 20 times higher in developing world

Oct. 2004, World alliance for Patient safety formed, Identified certain challenges w/r to safety of patients. “Clean care is Safer Care” (2005)A formal pledge committing to address health care-associated infection in the country was signed by Government of India. acute care hospitals, 20 times higher in developing world1.4 million people worldwide suffer from HCAUI, 50% preventable.India contributes to 25%-30% of the global injections[3-6 Billion], nearly two-thirds (62.9%injections) unsafe

prevalence rate of blood born disease is on rise-Hepatitis B 38/1000, Hepatitis c also on riseHIV 7/10008/27/2016 7Dr. Gunwant Joshi

To minimize the potential for spread of disease from a medical settings to the general public;

To reduce the overall amount of infectious medical waste produced.medical waste produced.

Infectious agents may become toys of terrorists, as Bioweapons of Mass Destruction

a tight control over BMW management can reduce the risk & Response time


Hospital Waste is Hazardous waste:But only a fraction of the Hospital waste is actually

hazardous and can be injurious to humans or animals, and is deleterious to the environment.

This may be eitherA. Infectious Bio-hazardInfectious in natureA. Infectious Bio-hazardInfectious in natureB. Sharps that may lead tosecondary infectionsC. Toxic Bio-hazard Cytotoxic in natureD. Radiation Bio-hazard Radioactive in nature8/27/2016 9Dr. Gunwant Joshi

Other Potentially Infectious Material Any body fluid with visible blood Amniotic fluid Cerebrospinal fluid Pericardial fluid Peritoneal fluid Peritoneal fluid Pleural fluid Saliva in dental procedures Semen/vaginal secretions Synovial fluid Anywhere body fluids that are indistinguishable


Blood and Fluid Borne Pathogen Exposures may typically occurby one of the following ways: Puncture from contaminated needles, broken glass,

or other sharps Contact between non-intact (cut, abraded, acne, or

sunburned) skin and infectious body fluids Direct contact between mucous membranes and

infectious body fluidsExample: A splash in the eyes, nose, or mouth


Hospital Wastes are dangerous and require more careful attentionThese are heterogeneous waste, both solid & liquid, primarily from Health Care FacilitiesThe available techno-economic options for the disposal are largely determined by theNature of activity of HCF and volume of the various waste components


Liquid wastesApprox. Quantity : 4 to 250 liters / bed / day1. Domestic Effluents and sewage2. Sewage from isolation wards, ICU’s toilets & urinals, Bed-bath, bathrooms and hospital’s laundry3. Wash waters from laboratories,OPD,Dressing rooms & Operation theaters.8/27/2016 14Dr. Gunwant Joshi

Solid wastesApproximate Quantity : 0.3 to 3.5 kg/bed/day

1.Garbage 55%(Bulk Density :330 kg/m3,Cal.Value:1000 K.cal / kg, Moisture :40%)

2.Bio-medical waste (sensu stricto) 13%2.Bio-medical waste (sensu stricto) 13%A. Wasted body remains 05%(Blood,Cultures,Anotomicals)B. Pharmaceutical & Chemical Wastes. 02%C. Pathological wastes (may be infectious). 06%

3.Sharp Objects 20%4.Pressurized Containers & Discarded Instruments 02%5.Radioactive Wastes 0.3%


Key to proper Bio - Medical Waste Management is the segregationas individual categories of waste are to be treated & disposed off in different specific ways


1. Out rightly send Domestic Effluents to ETP or..the municipal sewers2. Isolate & Collect the possibly infectious liquid wastes (from Path Labs,OTs,Laundry ,etc.),Disinfect completely and then send to ETP, municipal sewers or as per terms of Consentmunicipal sewers or as per terms of Consent3. Send the pre segregated Solid Waste that ispacked according to prescribed mode and


May be

Where,The BMW shall be treated using prescribed Standard methods such as prescribed Standard methods such as Incineration, Autoclaving, Micro- waving, and Chemical & Mechanical techniquesand the treated waste residue shall be finally disposed off in a secured Landfill8/27/2016 18Dr. Gunwant Joshi

Under Environment Protection Act,1998BIO-MEDICAL WASTE (Management & handling) RULES 19981st Amendment Rules vide S.O.201(E) Dated 06/03/20002ndAmendment Rules vide S.O.1069(E) Dated 17/09/2003BIO – MEDICAL WASTE MANAGEMENT RULES, 2016

The Authorization is required forGeneration/Collection/Reception/StorageGeneration/Collection/Reception/StorageTransportation/Treatment/Disposalor any other form of handling of BMWExclussions: Municipal Solid Waste, Lead acid batteries wastes,hazardous wastes, e-Waste, Radioactive wastes,Hazardous micro organisms, GEMS & cellsand Haz Chem [MSIHC Rules’89]8/27/2016 19Dr. Gunwant Joshi

Never mix Infectious Bio waste in to Municipal wastes.[The entire waste lot shall become infectious]

Basic Concepts of Hospital waste management

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Segregation and safe containment (packing) of waste at Generator level.[Health care facility] Processing & storage for the final or terminal disposal.8/27/2016 Dr. Gunwant Joshi

Genesis of the Rules 2016 (Draft Rules3rd June,2015 )The Bio Medical Waste Management Rules, 2016

CONTAINS 18 RULES, 4 SCHEDULES & 5 FORMS. BMW categories, Segregation, Colour coding, Collection ,Treatment & Disposal - Schedule I Standards for Treatment & Disposal - Schedule II Prescribed Authorities & Responsibilities - Schedule IIILabels for BMW containers & Bags - Schedule IV Labels for BMW containers & Bags - Schedule IV Accident Reporting - Form - I Application & Authorization Document - Form II & III Annual Reporting - Form IV APPEAL - Form V

The Bio Medical Waste Management Rules, 20161. Date of enforcement : Date of publication: 28/03/20162. Application & Exclussions, 3. Definition (a to p), 4. Duties of the occupier [Generator] - (a to t), 5. Duties of the occupier [Operator of CTDF] - (a to q),6. Duties of the Authorities[Operator of CTDF] - (a to q),7. Treatment & Disposal - (1 to 11),8. Segregation, packaging, Transportation & storage - (1 to 8),9. Prescribed authority (1 to 7),9. Prescribed authority (1 to 7),10. Procedure for Authorization (1 to 4), 11. Advisory committee (1 to 4),12. Monitoring & Implementation (1 to 6),13. Annual report, (1 to 4), 14. Maintenance of records (1 to 2), 15. Accident Reporting (1 to 2),16. Appeal (1 to 4),17. Site for CBMWTDF (1 to 2),18. Liability of the Occupier[Generator/Operator] (1 to 2)

Classification & Management as per BMW rules,2016Schedule-I . Category-1: YELLOW, 2:RED

Category 1YELLOW

(a) Human Anatomical Waste:(b)Animal Anatomical Waste :(c) Soiled Waste: (d) Expired or Discarded Medicines:(e) Chemical Waste:(f) Chemical Liquid Waste :(g) Discarded linen, (h) Microbiology, Bio-technology & Clinical Laboratory Waste:

Treatment & Disposal OptionsIncineration/Plasma Pyrolysis/ deep burial*In absence of above autoclaving/ micro-waving/ hydroclaving followed by shredding/mutilation or combination of sterilization and shredding. Treated waste to be sent for energy recovery. & Clinical Laboratory Waste: recovery.

Category 2RED

Contaminated Waste (Recyclable)(a) Wastes generated from disposable items such as tubing, bottles, intravenous tubes andsets, catheters, urine bags, syringes (withoutneedles and fixed needle syringes) vaccutainers with their needles cut)/ gloves

Autoclaving or micro-waving/ hydroclaving followed byshredding /mutilation or combination of sterilization & shredding. Treated waste to be sent to registered or authorized recyclers or for energy recovery or plastics to diesel or fuel oil or for road making, whichever is possible.Plastic waste should not be sent to landfill sites.


Category 3Trans-luscent

Waste sharps including Metals:Needles, syringes with fixed needles, needles from needle tip cutter or burner, scalpels, blades, or any other contaminated sharp object that may cause puncture and cuts.This includes both used, discarded and contaminated metal Sharps .

Treatment & Disposal OptionsAutoclaving or Dry Heat Sterilization followed by shredding/mutilation or encapsulation in the metal container or cement concrete;Combination of shredding cum autoclaving.sent for final disposal to iron foundries (having consent to operate from PCB)or sanitary landfill or designated concrete

Classification & Management as per BMW rules,2016Schedule-I . 3:WHITE and 4: BLUE

discarded and contaminated metal Sharps . or sanitary landfill or designated concrete waste sharp pit.

Category 4BLUE

(a) Glassware:Broken /discarded &contaminated glass including medicine vials and ampoules

except those contaminated with cytotoxic wastes.(b) Metallic Body Implants

Disinfection (by soaking the washed glass waste after cleaning with detergent & Sodium Hypochlorite treatment)or through autoclaving or microwaving or hydroclaving and then sent for recycling.Disinfection followed by recycling


B M Waste categories segregation, collection, treatment, processing & disposal optionsB M Waste categories Container andPre Treatment Treatment & Disposal(a) Human Anatomical Waste: Human tissues, organs,body parts and fetus below the viability period (as per MTPAct’71, amended up to date). Yellow coloured non-chlorinated plastic bags

Incineration or Plasma Pyrolysis or deep burial*(b)Animal Anatomical Waste : Experimental animal carcasses, body parts, organs, tissues, including the waste generated from animals used in experiments or testing in veterinary hospitals or colleges or animal houses.(c) Soiled Waste: Items contaminated with blood, body fluids like dressings, plaster casts, cotton swabs and bags containing residual or

Incineration/Plasma Pyrolysis/deep burial*In absence of above autoclaving/ micro-waving/ hydroclaving followed cotton swabs and bags containing residual or discarded blood and blood components. micro-waving/ hydroclaving followed by shredding/mutilation or combination of sterilization and shredding. Treated waste to be sent for energy recovery. (d) Expired or Discarded Medicines:Pharmaceutical waste like antibiotics, cytotoxic drugs including all items contaminated with cytotoxic drugs along with glass or plastic ampoules,vials etc.

Yellow coloured non-chlorinated plastic bags or containers

Expired `cytotoxic drugs & items contaminated with themto be sent back to Manufacturer/supplier for incineration at >1200 C, or to CBMWTF or HWTSDF for incineration at >1200C, Or Encapsulation or Plasma Pyrolysis at >1200C. All other discarded medicines shall be either sent back to manufacturer or disposed by incineration.8/27/2016 26Dr. Gunwant Joshi

B M Waste categories segregation, collection, treatment, processing & disposal optionsB M Waste categories Container andPre Treatment Treatment & Disposal(e) Chemical Waste:Chemicals used in production of biological and used or discarded disinfectants.

(f) Chemical Liquid Waste :Liquid waste generated due to use of chemicals in production of biological and used ordiscardeddisinfectants, Silver X-ray film developing liquid, discarded Formalin, infected secretions,aspiratedbody fluids, liquid from laboratories and floor washings, cleaning, house-keeping and disinfecting

Separate collection system leading to effluent treatment system.After resource recovery, the chemical liquid waste shall be pre-treated before mixing with other wastewater. The combined discharge shall conform to the discharge norms given in Schedule-III.washings, cleaning, house-keeping and disinfecting activities etc.norms given in Schedule-III.

(g) Discarded linen, mattresses, beddings contaminated with blood or body fluid.Non-chlorinated yellow plastic bags or suitable packing material

Non- chlorinated chemical disinfection followed by incineration or PlazmaPyrolysis or for energy recovery.In absence of above shredding/mutilation or combination of sterilization and shredding. Treatedwaste to be sent for energy recovery or incineration or Plazma Pyrolysis.(h) Microbiology, Biotechnology and Clinical Laboratory Waste:Blood bags, Laboratory cultures, stocks or specimens of microorganisms, live or attenuated vaccines, human & animal cell cultures used in research, industriallaboratories, production of biological, residual toxins, dishes and devices used for cultures.

Yellow colouredcontainers ornon-chlorinated safeplastic bags Autoclave /Pre-treat to sterilize with nonchlorinatedchemicals on-site as per NACO or WHO guidelinesthereafter for Incineration.


B M Waste categories segregation, collection, treatment, processing & disposal optionsB M Waste categories Container andPre Treatment Treatment & Disposal

Contaminated Waste(Recyclable)(a) Wastes generated from disposable items such as tubing, bottles, intravenous tubes and sets, catheters, urine bags, syringes (without needles and fixed needle syringes) and vaccutainers with their needles cut) and gloves.

Red, non-chlorinated plasticbagsor containers

Autoclaving / micro-waving/ hydroclaving followed by shredding / mutilation or combination of sterilization & shredding. Treated waste be sent to registered or authorized recyclers or for energy recovery or plastics to diesel or fuel oil or for road making, whichever is possible.Plastic waste should not be sent to landfill sites.Waste sharps including Metals White Autoclaving or Dry Heat Sterilization Waste sharps including Metals: Needles, syringes with fixed needles, needles from needle tip cutter or burner, scalpels, blades, or any other contaminated sharp object that may cause puncture and cuts. This includes both used, discarded and contaminated metal sharps

White(Translucent)PunctureProofLeak proof, tamper proof containers

Autoclaving or Dry Heat Sterilization followed by shredding/mutilation or encapsulation in metal container or cement concrete; combination of shredding cum autoclaving; and sent for final disposal to iron foundries (having consent to operate from PCB or sanitary landfill or designated concrete waste sharp pit.(a) Glassware: Broken/discarded & contaminated glass including medicine vials & ampoules except those contaminated with cytotoxics(b) Metallic Body Implants

Cardboard boxes withblue colourmarkingDisinfection (by soaking the washed glass waste after cleaning with detergent and Sodium Hypochlorite treatment) or through autoclaving or microwaving or hydroclaving and then sent for recycling.8/27/2016 28Dr. Gunwant Joshi

Category YellowMANAGEMENT OF HOSPITAL WASTE(a) Human Anatomical Waste: Human tissues, organs, body parts and fetus below the viability period (as per MTPAct’71, amended up to date)(b)Animal Anatomical Waste : Experimental animal carcasses, body parts, organs, tissues, including the waste generated from animals used in experiments or testing in veterinary hospitals or colleges or animal houses.colleges or animal houses.(c) Soiled Waste: Items contaminated with blood, body fluids like dressings, plaster casts, cotton swabs and bags containing residual or discarded blood and blood components.(d) Expired or Discarded Medicines:Pharmaceutical waste like antibiotics, cytotoxicdrugs including all items contaminated with cytotoxic drugs along with glass or plastic ampoules, vials etc.8/27/2016 29Dr. Gunwant Joshi

Category YellowMANAGEMENT OF HOSPITAL WASTE

(e) Chemical Waste: Chemicals used in production of biological and used or discarded disinfectants.(f) Chemical Liquid Waste : Liquid waste generated due to use of chemicals in production of biological, used or discarded disinfectants, Silver X-ray film developing liquid, discarded Formalin, infected secretions, aspirated body fluids, liquids from theLaboratory floor washings, cleaning, house-keeping Laboratory floor washings, cleaning, house-keeping and disinfecting activities etc.(g) Discarded linen: Clothing, Mattresses, beddings contaminated with blood or body fluid.(h) Microbiology, Biotechnology & Clinical Lab Waste: Blood bags, Lab. cultures, Stocks or specimens of microorganisms, live or attenuated vaccines, human & animal cell cultures used inResearch, Industrial labs production of biologicals, Residual toxins, dishes & devices used for cultures.8/27/2016 30Dr. Gunwant Joshi

Category RedContaminated Waste (Recyclable)Wastes generated from disposable items such as tubing, bottles, intravenous tubes and sets, catheters,

MANAGEMENT OF HOSPITAL WASTE

tubes and sets, catheters, urine bags, syringes (without needles and fixed needle syringes) and vaccutainerswith their needles cut and the gloves.8/27/2016 31Dr. Gunwant Joshi

Waste sharps including Metals: Needles, syringes with fixed needles, needles from needle tip cutter or burner, scalpels, blades,

White Dustbin with Puncture/ Leak/Temper proof ContainerMANAGEMENT OF HOSPITAL WASTE

Category WHITE

cutter or burner, scalpels, blades, or any other contaminated sharp object that may cause puncture and cuts. This includes both used, discarded and contaminated metal sharps8/27/2016 32Dr. Gunwant Joshi

Blue Dustbins or Cardboard boxes with blue colour marking

MANAGEMENT OF HOSPITAL WASTE

(a) Glassware:

Category BLUE

(a) Glassware:Broken /discarded & contaminated glass including medicine vials and ampoules except those contaminated with cytotoxicwastes.(b) Metallic Body Implants


Colour-Coded Bins & well ventilated storage space for Segregated BMW


Schedule-IIOperational standards, Emission standards and Testing & Recording protocole for Treatment Technology Options Incinerstor [Stack height/emission std] Plasma Pyrolysis/Gasification system Autoclaving Microwaving


Microwaving Deep Burrial Sterilization Chemical disinfection Liquid wasteRoutine test and validation by spore strip/Vials or Chemical vials

Schedule-IIIPrescribed Authorities & DutiesMOEF & CC [Policy making/Training/Assistance/Monitoring Hearing Appeals/specify Stds. & op. Parameters]MOHFWF [Liscenceing/Listing/Coordinating PCB/ Monitoring/ Operational Research/Training & Awareness ]MOD [Authorization/Treatment & disposal/ Training/Reiew/ Advisory committee/ submission of reports to CPCB]CPCB[Guide lines/Coordination with SPCB & MOD/Training/ Lay standards/Random inspections & Monitoring/ Research]CPCB[Guide lines/Coordination with SPCB & MOD/Training/ Lay standards/Random inspections & Monitoring/ Research]State MOHFF & Administration [Insure implementation/ allocation of Funds/procurement of equipments/ constitute State & District Advisory Committee/Advise SPCB ]PCB[Inventorisation of Occupiers/ Authorization & Consent/ Training / Monitoring and Action for violation/ Compilation & Reporting to CPCB/ Implementation of Advisory committee Issues/Publish List of registered Occupiers]Municipal bodies[provide suitable land/Collect & ManageMSW]8/27/2016 36Dr. Gunwant Joshi

Schedule-IV: Container’s Colour/Markings/Label Colour tells other staff what is in the container Tells the contractor what to do with the waste Can apply to both sacks and rigid containers


Schedule -Va - STANDARD FOR LIQUID WASTE

pH 6.5 to 9.0Suspended Solids 100 mg/l.Oil & grease 10 mg/l.BOD 30 mg/l.COD 250 mg/l.COD 250 mg/l.Bio assay 90 % Survival of fish after 96 hours in 100% effluent

Send Domestic Effluents to municipal sewersDisinfect the infectious liquid waste and then send it to municipal sewers


Bio Medical Liquid Wastes Disinfectionby Sodium Hypochlorite


Bio Medical Liquid Wastes Treatmentby an Effluent Treatment Plant


Garbage Wastes Collection &Transport


Sharp ManagementAlwaysRememberNot to recap the Needle and cut it Immediatelyafter the useafter the use

80 % Reduction inSecondaryInfection in a SuperSpeciality HospitalSharp Sign8/27/2016 42Dr. Gunwant Joshi

Sharps Issues Must be collected at the point of generation, in a leak-proof and puncture-resistant container Containers must bear the international biohazard symbol and appropriate wording Containers should never be completely filled, nor filled above the full line indicated on box.Unauthorised Use/Reuse

Unsafe collection Unsafe disposal


Sharp Encapsulation : Sharp Pit• MUTILATE & DISTROY•DISINFECT:-Chemically/Autoclave/Microwave•DISPOSE IN SHARP PIT•SEAL PIT WHEN 2/3 FULL•SEAL PIT WHEN 2/3 FULL•START DISPOSAL IN NEW PIT.•Alternatively, after Destruction/ Mutilation and Disinfection the Stored Sharps can be sold as Scrap


Waste Sharp & Syringe DestructionThe Shredded Needles,

Sharps and Plastics may be kept in the secured containers and could be sent to Plastic / MetalRecycling Plants


Bio Medical Wastes:Segregate and

Pack it right at thepoint of Generation point of Generation

only to 75%capacity


Bio Medical Wastes Collection, Labelling &Transport


Bio Medical Wastes Collection &Transport


BMW CTDF

at BhopalBio Medical Wastes Collection &Transportby Common Treatment & Disposal Facility

Govindpura Industrial Area8/27/2016 49Dr. Gunwant Joshi

Inspection & Re-Segregation issues

It requires to segregate again to ensure the final disposal of BMW as per BMW Rules 1998 (M & H)8/27/2016 50Dr. Gunwant Joshi

AutoclaveValidation test :Spot testing by Bacillus stearo-thermophilus spores on a spores strip with at least with at least 1 x 104 Spores/ml.Routine test :Chemical indicator strip/tape


Sharp Storage & Disposal


Bio Medical Plastic Wastes Disinfectionby Sodium Hypochlorite


Bio Medical Wastes Destruction byDouble Chambered Incinerator


Details of Double Chambered Incinerator


New Double Chambered Incinerator


Incinerator Ash Disposal


Schedule -VDEEP BURIAL PIT for BMW


Schedule -VD - STANDARD FOR DEEP BURIAL

Entry of scavengers to the burial site be prevented may be by using covers of galvanized iron/wire mash. After every burial in the same secured pit a layer of 10 cm. soil be added .

Burial must be performed under close and dedicated supervision.Burial must be performed under close and dedicated supervision.Deep burial site should be relatively impermeable and distant from habitat.There should be no well, lake, river etc. close to the site to avoid contamination of surface water or ground water. Location of the deep burial site to be authorized by the Prescribed Authority. The occupier shall maintain record for all the pits8/27/2016 59Dr. Gunwant Joshi

Land Disposal Facility for Rural & Remote areas with population less than 5 lacs


Other Bio Medical Wastes Treatment Options


Other Bio Medical Wastes Treatment Options

Microwaveing8/27/2016 62Dr. Gunwant Joshi

Other Bio Medical Wastes Treatment OptionsPlasma Pyrolysis


Duties of the Occupier"occupier" means a person having administrative control over the institution and the premises generating biomedical waste, which includes a hospital, nursing home, clinic, dispensary, veterinary institution, animal house, pathology laboratory, blood bank, health care facility and clinical establishment, irrespective of their system of medicine and by whatever name they clinical establishment, irrespective of their system of medicine and by whatever name they are called

Occupier / institution generating, collecting, receiving, storing, transporting, treating, disposing and/or handling Bio-medical waste to ensure that bio-medical waste is handled without any adverse effect to human health & the environment and in accordance with rules;8/27/2016 64Dr. Gunwant Joshi

Duties of the Occupier[Generator] to ensure that there shall be no secondary handling, pilferage of recyclables or inadvertent scattering or spillage by animals and bio-medical waste from such place or premises shall be directly transported in the manner as prescribed in these rules to CBMWTF or for appropriate treatment & disposal, in manner prescribed in Schedule I;in Schedule I; Phase out use of chlorinated plastic bags, gloves and blood bags within 2 yrs from the date of notification that is 28th March’ 2018. Provide within the premises a safe, ventilated & secured location for storage of Segregated biomedical waste in colored bags or containers in the manner as specified in Schedule I,


Duties of the Occupier[Generator] Pre-treat the laboratory waste, microbiological waste, blood samples and blood bags through disinfection or sterilisation on-site in the manner as prescribed by (WHO)/(NACO) guidelines & then sent CBMWTF for final disposal Dispose of solid waste other than bio-medical waste in accordance with the provisions of respective waste management rules made under the relevant laws and management rules made under the relevant laws and amended from time to time; Provide training to all its health care workers & others, involved in handling of BMW at the time of induction and thereafter at least once every year and the details of training programmes conducted, number of personnel trained and number of personnel not undergone any training shall be provided in the Annual Report;


Duties of the Occupier[Generator] Not to give treated BM waste or mix with MS waste; Immunise all its health care workers & others, involved in handling of bio-medical waste for protection against diseases including Hepatitis B and Tetanus that are likely to be transmitted by handling of BMW, in the manner as prescribed in the National Immunisation Policy or the guidelines of the Ministry of Health and Family Welfare guidelines of the Ministry of Health and Family Welfare issued from time to time; Establish a Bar- Code System for bags or containers containing bio-medical waste to be sent out of the premises or place for any purpose within one year from the date of the notification of these rules;


Duties of the Occupier[Generator] Ensure segregation of liquid chemical waste at source and ensure pre-treatment/neutralisation prior to mixing with other effluent generated from health care facilities; Ensure treatment and disposal of liquid waste in accordance with the Water (Prevention and Control accordance with the Water (Prevention and Control of Pollution) Act, 1974 ( 6 of 1974); Ensure occupational safety of all its health care workers and others involved in handling of bio-medical waste by providing appropriate and adequate personal protective equipments;


Duties of the Occupier[Generator] Conduct health check up at the time of induction and at least once in a year for all its health care workers and others involved in handling of bio-medical waste and maintain the records for the same; maintain and update, on day to day basis, the BMW management register and display the monthly record on its website according to the bio-medical waste management register and display the monthly record on its website according to the bio-medical waste generated in terms of category and colour coding as specified in Schedule I; report major accidents including accidents caused by fire hazards, blasts during handling of BMW, the remedial action taken & the records relevant thereto, (including nil report) in Form I to the prescribed authority and also along with the annual report;


Duties of the Occupier[Generator] make available the annual report on its web-site and all the health care facilities shall make own website within two years from the date of notification of these rules; inform the prescribed authority immediately in case the operator of a facility does not collect the bio-medical waste within the intended time or as per the medical waste within the intended time or as per the agreed time; Establish a system to review and monitor activities related to BMW management, either through an existing committee or by forming a new committee to meet once in every six months record of the minutes of the meetings of this committee shall be submitted along with the annual report to the prescribed authority 8/27/2016 70Dr. Gunwant Joshi

Duties of the Occupier[Generator] healthcare establishments with less than 30 beds shall designate a qualified person to review and monitor the activities relating to bio-medical waste management within that establishment and submit the annual report; maintain all record for operation of incineration, hydro or autoclaving etc., for a period of 05 years;hydro or autoclaving etc., for a period of 05 years; existing incinerators to achieve the standards for treatment and disposal of bio-medical waste as specified inSchedule II for retention time in secondary chamber and Dioxin and Furans within two years from the date of this notification


Duties of the Operator[CBMWTDF](a)take all necessary steps to ensure that the bio-medical wastecollected from the occupier is transported, handled, stored, treated and disposed of, without any adverse effect to thehuman health and the environment, in accordance withthese rules and guidelines issued by the Central Governmentor, as the case may be, CPCB/SPCB from time to time; (b)ensure timely collection of bio-medical waste from the occupier as prescribed under these rules; (c)establish bar coding and global positioning system forhandling of bio- medical waste within one year; (d)inform the prescribed authority immediately regardingthe occupiers which are not handing over the segregatedbio-medical waste in accordance with these rules;


Duties of the Operator[CBMWTDF] (e) provide training for all its workers involved in handling of Bio-medical waste at the time of induction and at least once a year thereafter; (f) assist the occupier in training conducted by them forBio-medical waste management; Bio-medical waste management; (g) undertake appropriate medical examination at the time of induction and at least once in a year and immunise all its workers involved in handling of bio-medical waste for protection against diseases, including Hepatitis B and Tetanus, that are likely to be transmitted while handlingBio-medical waste & maintain the records for the same; 8/27/2016 73Dr. Gunwant Joshi

Duties of the Operator[CBMWTDF] (h) ensure occupational safety of all its workers involved in handling of Bio-medical waste by providing appropriate and adequate personal protective equipment; (i) report major accidents including accidents caused by fire hazards, blasts during handling of Bio-medical waste and the remedial action taken & records relevant thereto, and the remedial action taken & records relevant thereto, (including nil report) in Form- I to the prescribed authority and also along with the annual report; (j) maintain a log book for each of its treatment equipment according to weight of batch; categories of waste treated; time, date and duration of treatment cycle & total hours of operation;


Duties of the Operator[CBMWTDF] (k) allow occupier , who are giving waste for treatment to the

operator, to see whether the treatment is carried out as per the rules;

(l) shall display details of authorisation, treatment, annual report etc on its web-site;

(m) after ensuring treatment by autoclaving or microwaving (m) after ensuring treatment by autoclaving or microwaving followed by mutilation or shredding, whichever is applicable, the recyclables from the treated bio-medical wastes such as plastics and glass, shall be given to recyclers having valid consent or authorisation or registration from the respective State Pollution Control Board or Pollution Control Committee; 8/27/2016 75Dr. Gunwant Joshi

Duties of the Operator[CBMWTDF] (n) supply non-chlorinated plastic coloured bags to the

occupier on chargeable basis, if required; (o) common bio-medical waste treatment facility shall

ensure collection of biomedical waste on holidays also; (p) maintain all record for operation of incineration, hydroor

autoclaving for a period of five years; and autoclaving for a period of five years; and (q) upgrade existing incinerators to achieve the standards

for retention time in secondary chamber and Dioxin and Furans within two years from the date of this notification.


BMW Treatment & Disposal (1) Bio-medical waste shall be treated and disposed of in accordance with Schedule I, and in compliance with the standards provided in Schedule-II by the health care facilities and common bio-medical waste treatment facility. (2) Occupier shall hand over segregated waste as per the Schedule-I to common bio-medical waste treatment facility for treatment, processing and final disposal: Provided that the lab and highly infectious bio-medical Provided that the lab and highly infectious bio-medical waste generated shall be pre-treated by equipment like autoclave or microwave. (3) No occupier shall establish on-site treatment and disposal facility, if a service of common bio-medical waste treatment facility is available at a distance of seventy-five kilometer.


BMW Treatment & Disposal (4) In cases where service of the common bio-medical waste treatment facility is not available, the Occupiers shall set up requisite biomedical waste treatment equipment like incinerator, autoclave or microwave, shredder prior to commencement of its operation, as per the authorisation given by the prescribed authority. (5) Any person including an occupier or operator of a common bio medical waste treatment facility, intending to common bio medical waste treatment facility, intending to use new technologies for treatment of bio medical waste other than those listed in Schedule I shall request the Central Government for laying down the standards or operating parameters. (6) On receipt of a request referred to in sub-rule (5), the Central Government may determine the standards and operating parameters for new technology which may be published in Gazette by the Central Government.


BMW Treatment & Disposal (7) Every operator of common bio-medical waste treatment facility shall set up requisite biomedical waste treatment equipments like incinerator, autoclave or microwave, shredder and effluent treatment plant as a part of treatment, prior to commencement of its operation. (8) Every occupier shall phase out use of non-chlorinated plastic bags within two years from the date of publication of these rules and after two years from such publication of these rules and after two years from such publication of these rules, the chlorinated plastic bags shall not be used for storing and transporting of bio-medical waste and the occupier or operator of a common bio-medical waste treatment facility shall not dispose of such plastics by incineration and the bags used for storing and transporting biomedical waste shall be in compliance with the Bureau of Indian Standards. Till the Standards are published, the carry bags shall be as per the Plastic Waste Management Rules, 2011.


BMW Treatment & Disposal (9) After ensuring treatment by autoclaving or microwaving followed by mutilation or shredding, whichever is applicable, the recyclables from the treated bio-medical wastes such as plastics and glass shall be given to such recyclers having valid authorisation or registration from the respective prescribed authority. (10) The Occupier or Operator of a common bio-medical waste treatment facility shall maintain a record of recyclable waste treatment facility shall maintain a record of recyclable wastes referred to in sub-rule (9) which are auctioned or sold and the same shall be submitted to the prescribed authority as part of its annual report. The record shall be open for inspection by the prescribed authorities. (11) The handling and disposal of all the mercury waste and lead waste shall be in accordance with the respective rules and regulations.


Segregation, packaging, transportation & storage(1) No untreated BM waste shall be mixed with other wastes. (2) BMW shall be segregated into containers or bags at the point of generation in accordance with Schedule I prior to its storage, transportation, treatment and disposal. (3) These containers / bags to be labelled as per Schedule IV. (3) These containers / bags to be labelled as per Schedule IV. (4) Bar code & global positioning system (GPS)to be installed by the Occupier & CBMWTF in 01 yrs time.(up till 28March 2017)(5) The operator of CBMWTF to transport BMW from occupier’s premises to any off-site CBMWTF only in specified vehicles labelled as per part ‘A’ of the Schedule IV along with necessary information as specified in part ‘B’ of the Schedule IV.


Segregation, packaging, transportation & storage(6) The vehicles used for transportation of BMW to comply with conditions specified by the MPPCB in addition to requirement of the Motor Vehicles Act, 1988 (59 of 1988), if any or the rules made there under for transportation of such infectious waste. (7) Untreated human anatomical waste, animal anatomical waste, soiled waste & biotechnology waste not be stored beyond a period of forty –eight hours: in case the condition can not be period of forty –eight hours: in case the condition can not be met, the occupier shall take appropriate measures to ensure that the waste does not adversely affect human health and the environment and inform the prescribed authority along with the reasons for doing so.


Different Formats & ApplicabilityApplication for Grant /Renewal of Authorization in form –II to MPPCB, the Prescribed Authority.Grant of Authorization in form –III by MPPCB to Occupier(BMW Generator/CBMWTDF.Submission of Annual Report by Occcupier in Submission of Annual Report by Occcupier in form –IV by 31st June Every year about the categories & quantities of BMW handling during the preceding yearApplication for Appeal against Refusal in Form-VAccident Reporting by the Occupier in Form-I


Duties of the Occupier[Generator](1)Bio-medical waste not to be mixed with MSW.(BMW shall be segregated into containers or bags at the point of generation in accordance with Schedule I prior to its storage, transportation, treatment and disposal.(3) The containers or bags be labelled as per Schedule IV.(4) Bar code & GPS be added by the Occupier & CBMTDF in 01 year time.(5) The operator of CBMTDF shall transport the bio-medical waste from the premises of an occupier to any BMWTDF only in the vehicles having label as per part ‘A’ of the Schedule IV along with necessary information as specified in part ‘B’ of the Schedule-IV.


Duties of the Occupier[Generator](6) The vehicles used for transportation of BMW to comply with the conditions if any stipulated by SPCB in addition to the requirement contained in the Motor Vehicles Act, 1988 (59 of 1988), if any or the rules made there under for transportation of such infectious waste.(7) Untreated human/animal anatomical waste, soiled waste (7) Untreated human/animal anatomical waste, soiled waste and, biotechnology waste shall not be stored beyond a period of 48 hours: Provided that in case for any reason it becomes necessary to store such waste beyond such a period, the occupier shall take appropriate measures to ensure that the waste does not adversely affect human health and the environment and inform the prescribed authority along with the reasons for doing so.


Please Remember!The Primary responsibility of responsibility of the disposal of the Bio-Medical Waste lies with the Generator


Every Occupier to ensure thatBio-medical waste shall not be mixed with other Wastes such as Municipal WasteBio-medical Waste shall be segregated, treated & disposed off in accordance with the Schedule -I disposed off in accordance with the Schedule -I and in compliance with the standards prescribed in Schedule –V.Preferably at a Common Bio Medical Waste Treatment

Facility or, if one is not within 75 kilometers, to do it on his own8/27/2016 87Dr. Gunwant Joshi

And also do not forget that Biomedical waste that are to be transported, must be securely packed, and Labeled as per (schedule-IV). Transportation of BM Waste is allowed only in vehicles authorized by the prescribed Authority A day -to -day record of the Quantity under different categories of the Bio – Medical Waste generated in premises must be maintained


And also do not forget that No untreated Bio-medical Waste shall be kept

stored beyond 48 Hrs. if for any reason, the Bio-Medical Waste is

required to be stored beyond this time limit, the Authorized person must seek a permission from Prescribed Authority and take adequate measures to ensure that waste does not affect the human life & environment adversely.


The contravention of the Act , Rules, Orders & directions may lead to legal actionThe punishment may lead to the imprisonment up to 5 years with fine up to Rs. 1 lakh.up to Rs. 1 lakh.For failure or continued contravention a fine @ Rs.5000 /Day may be charged.If the failure or the contravention continues beyond one year, the imprisonment may be extended up to 7 years.


–Segregation of waste not taken seriously at generator level –Non compliance with color coding–Monitoring segregation at source – low budgets allocated –costs are not always known/nor worked out properly

Biomedical Waste Management - Issues

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costs are not always known/nor worked out properly–Cost of color coding, staff, transport and disposal is a major deterrent but must be met–Quantification of waste generated is not done accurately


–Protection of healthcare workers not given adequate thought–Clinical waste dumped with non infectious waste -Risk for healthcare workers and public

Biomedical Waste Management – Issues contd…

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Risk for healthcare workers and public–Residual Waste disposal not effective, often dumped in open landfills


The disposal of solid wastes that are not infectious medical waste, is often done as if they were infectiousIt is the most commonly cited violation

Biomedical Waste Management – Issues contd…

It is the most commonly cited violation It increases the financial burden on patients and

taxpayers in the form of increased disposal costs for health care facilities


Biomedical Waste Management – Issues contd…When infectious waste and regular MSW mixes together, it can not be permitted to separate them Once combined, the entire contents are considered infectious waste!

Increased Volumes of medical waste generation increases the risk of costly accidents and spills due to increased handlling & Transportation required to haul the waste8/27/2016 94Dr. Gunwant Joshi

ChallengesEstablishing robust waste management policies within the Health Care Facility/organization Organization wide awareness about the health hazards Sufficient financial & Trained human resources needed

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Sufficient financial & Trained human resources needed Monitoring and control of waste disposal Clear responsibility and tracebility for appropriate handling and disposal of waste.


Hospital Waste Managementis a real issuetogether we can address itSuccessfully

new bio medical waste management rules 2016

Healthcare