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Bio Medical Waste Authorisation

Biomedical waste Authorisation is required by hospitals, clinics (dental clinics, physicians clinic etc), medical research laboratories, pathology laboratories etc. and generally includes management of waste produced by hospitals, clinics (dental clinics,

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What is Bio-Medical Waste?

Biomedical waste also known as hospital waste implies any waste which contains infectious or potentially infectious material(s).This kind of waste generally includes waste produced by hospitals, clinics (dental clinics, physicians clinic etc), medical research laboratories as well as pathology laboratories.  

Bio-medical Waste (Management & Handling) Rules, 1998 have defined Bio-Medical as a type of bio-waste because of the possibility that it might contain hold bodily fluids like blood or other contaminants prescribed thereunder. These rules were prescribed by the Ministry of Environment & Forests (MoEF) which was formed under the Environment (Protection) Act, 1986.

Examples of Bio-Medical Waste are:

1. Discarded blood

2. Waste Sharps include potentially contaminated (used or unused) needles, scalpels, lancets and other devices capable of penetrating skin etc

3. Unwanted microbiological cultures and stocks

4. Identifiable body parts 

5. Other human or animal tissue

6. Used bandages and dressings

7. Discarded gloves

8. Other medical supplies that may have been in contact with blood and bodily fluids

9. Laboratory waste which has any of the characteristics described above.

What is BioMedical Waste Authorisation?

Bio-medical Waste Authorisation is an authorisation issued under the provisions of Bio-medical Wastes Management Rules, 2016 for the generation or collection or reception or storage or transportation or treatment or disposal or any other manner of handling of biomedical wastes listed in Schedule 1 of the Bio-medical Wastes Management Rules, 2016.

Medical wastes, which is generated during the diagnosis, treatment or immunization of human beings or animals or in research activities pertaining thereto or in the production or testing of biological, and including categories mentioned in Schedule I, of the BMW rules, 2016 is called as Bio-Medical Waste. Clinics, hospitals, labs and other medical establishments which generate, collects, stores, transport, dispose of, this bio-medical waste needs to set-up the requisite mechanism for the efficient disposal of generated waste either directly or through a common biomedical waste treatment and disposal facility (ies).

The Bio-Medical Waste Management Rules, 2016 have hence been notified to efficiently manage the generated bio-waste in the country. Every occupier or operating handling bio-medical waste, irrespective of quantity, is required to obtain authorization under section 10 of bio-medical waste management rule 2016.

Untreated disposal of medical waste will cause environmental pollution, unpleasant smell, and growth and leads to develop insects, rodents and worms and may lead to the transmission of diseases like typhoid, cholera, hepatitis and AIDS through contaminated syringes and needles with an infected human.

Diseases, which spread through water, sweat, blood, body fluids and contaminated organs, which are communicable in nature are important to be prevented. Diseases like plague and rabies are also spread through this medical waste which is around the hospitals invites flies, insects, rodents, cats and. Rag pickers in the hospital, sorting out the garbage are at risk of getting tetanus and HIV infections. One of the primary responsibilities of Health administrators is to manage hospital waste in the most safe and eco-friendly manner

Documents Required

➲ ID and Address proof of authorized person of the medical establishment.

➲ PAN card copy of the authorized person of the medical establishment.

➲ Address proof of establishment like a rent agreement, electricity bill etc

➲ MCD license

➲ Waste collection agreement

➲ Company’s PAN, MOA, COI if the establishment is in of company form.

➲ Board declaration for authorized signatory. (if the establishment is in of company form)

Who needs Biomedical Waste Authorisation?

In accordance with the provisions of the Bio-medical Waste Management Rules, 2016, every occupier/operator handling or collecting bio-medical waste is required to obtain BIomedical Waste Authorisation, irrespective of quantity:

➲ prior to establishment,

➲ before undertaking any expansion or change in activity or infrastructure, and

➲ at the time of change in name or ownership.

Following is a list of some institutions which mandatorily need to obtain Biomedical Waste Authorisation

➲ Govt. hospitals/private hospitals/nursing homes/ dispensaries and Clinics.

➲ Primary health centres.

➲ Medical colleges and research centres/ paramedic services.

➲ Veterinary colleges and animal research centres.

➲ Blood banks/mortuaries/autopsy centres.

➲ Biotechnology institutions.

➲ Production units.

Categories of Biomedical Waste Authorisation

Chemical treatment with a solution of at least 1% hypochlorite or an equivalent chemical reagent. Chemical treatment must be ensured to be free from disinfection.

* Mutilation/shredding must be done in such a way that unauthorised reuse is prevented..

** Before incineration, there will be no chemical pre-treatment. Incineration of chlorinated plastics is prohibited.

*** Only towns with populations under five lakhs and rural areas will have the option of a deep burial.

 

Option

Treatment & Disposal  

Waste Category

Cat. No. 1

Incineration ** /deep burial ***

Anatomical Waste from Humans (human tissues, organs, body parts)

Cat. No. 2

Incineration ** /deep burial

Animal waste includes animal tissues, organs, carcasses, bleeding parts, fluid, blood, and experimental animals used in research, as well as garbage generated by veterinary hospitals and colleges, discharge from hospitals, and animal houses.

Cat. No. 3

Local autoclaving/ micro waving/ incineration **

Waste from microbiology and biotechnology (wastes from laboratory cultures, stocks or specimens of micro-organisms live or attenuated vaccines, human and animal cell culture used in research and infectious agents from research and industrial laboratories, wastes from production of biological, toxins, dishes and devices used for transfer of cultures)

Cat. No. 4

Disinfections (chemical treatment  /autoclaving/micro waving and mutilation shredding *

Sharps (needles, syringes, scalpels, blades, glass, etc.) that could cause puncture and cuts should be thrown away. This includes sharps that have been used as well as those that have not been used.)

Cat. No. 5

Incineration ** / destruction & drugs disposal in secured landfills  

Medicines that have been thrown away and cytotoxic drugs (wastes comprising of outdated, contaminated and discarded medicines)

Cat. No. 6

Incineration **, autoclaving/micro waving

Disposal of Solid Waste (Items contaminated with blood and body fluids including cotton, dressings, soiled plaster casts, line beddings, other material contaminated with blood)

Cat. No. 7

Disinfections by chemical treatment  autoclaving/micro waving & mutilation shredding. *

Disposal of Solid Waste (waste generated from disposable items other than the waste sharps such as tubing, catheters, intravenous sets etc.)

Cat. No. 8

Disinfections by chemical treatment  and discharge into drain

Waste in Liquid Form (waste generated from laboratory & washing, cleaning , house-keeping and disinfecting activities)

Cat. No. 9

Disposal in municipal landfill

Ash from incinerators (ash from incineration of any bio-medical waste)

Cat. No. 10

Chemical treatment  & discharge into drain for liquid & secured landfill for solids 

Waste Chemicals (chemicals used in production of biological, chemicals, used in disinfect ion, as insecticides, etc)

 

The separation of bio-medical waste is the most important aspect of hospital waste management. Segregation of trash should take place on the premises of the hospital or nursing home. The colour coding, container type, and suggested treatment solutions for each waste category are listed below.

Color Coding and Container Type For Disposal Of Bio-Medical Waste

Colour Coding

Type of   Containers

Waste Category

Treatment Options as per Schedule 1

Yellow

Plastic bag

1,2,3,6

Incineration/deep burial

Red

Disinfected Container/ Plastic bag

3,6,7

Autoclaving/Micro waving/ Chemical Treatment

Blue/ White translucent

Plastic bag/puncture proof container

4,7

Autoclaving/Micro waving/ chemical treatment and destruction/shredding

Black

Plastic bag

5,9,10 (Solid)

Disposal in secured landfill

 

Notes:

1. Color coding of waste categories with numerous treatment choices as established in Schedule 1 will be determined based on the treatment option selected, which must be as stipulated in Schedule 1.

2. Chlorinated plastics shall not be used in the garbage collecting bags for waste kinds that require incineration.

3. Containers/bags are not required for categories 8 and 10 (liquid).

4. If disinfected locally, Category 3 does not need to be placed in containers or bags.

Labels for Bio-Medical Waste

For identification and safe management of bio-medical waste, different labels for containers and bags will be required. These labels for biomedical waste storage and transportation are as follows: 

1. LABEL FOR BIO-MEDICAL WASTE CONTAINERS/BAGS

 

2. LABEL FOR TRANSPORT OF BIO-MEDICAL WASTE CONTAINERS/BAGS:

 

FAQs

Q. What is biomedical waste?

A. Means any waste created during the diagnosis, treatment, or immunization of humans or animals or related research activities, or in the manufacture or testing of biological or health camps, including the categories referred to in Schedule I annexed to those laws.


Q. To whom this authorization is applicable?

A. These rules shall apply to all persons who, including hospitals, nursing homes, clinics, pharmacies, veterinary institutions, animal households, pathological laboratories, blood banks, Ayush hospitals, clinical establishments, research or educational institutions, health camps, medical or surgical centers, etc. produce, process, collect, store, transport, treat, disposal or handle bio-medical waste in any type,


Q. What are the categories of Biomedical Waste?

1. YELLOW CATEGORY   

a. Human Anatomical Waste:

b. Animal Anatomical Waste

c. Soiled Waste

d. Expired and discarded medicines

e. Chemical solid waste

f. Chemical liquid waste

g. Discarded linen, mattresses, bedding contaminated with blood or body fluid

h. Microbiology, Biotechnology, and other clinical laboratory waste

2. RED CATEGORY

Contaminated Waste (Recyclable)

3. WHITECATEGORY

Waste sharps including Metals

4. BLUE CATEGORY

Glassware, Metallic Body Implants


Q. What are the documents required for filing an Online application for Bio-Medical Waste Management Authorisation?

Documents required for Online application of Bio-Medical Waste Authorisation are as follows:

a. Company/Partnership/LLP PAN card copy

b. Address proof of unit

c. Authorized person aadhar card and PAN card copy

d. Agreement with waste treatment facilitator

e. Other additional documents depending on state authority


Q. Whether the Consent of Air and Water is required before applying for Bio Medical Authorization?

A. Yes, a Consent from the respective Pollution Control Board is necessary before applying for Bio-Medical Authorisation Online. 


 

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