What is Bio-Medical waste?

Waste which are generated during the diagnosis, treatment, and immunization of human beings, animals or generated through research activities, or during the production or testing of biological camps are termed as biomedical waste. For example, a patient's blood, infected parts, biological liquids like medicines and the chemicals used in the medical field, etc. It also includes waste generated from the Health Care Facility, which if not disposed of properly, will adversely affect the environment and the people as well.

What is Authorization?

"Authorization" means permission granted by the prescribed authority for the generation, collection, reception, storage, transportation, treatment, processing, disposal or any other form of handling of bio-medical waste according to the guidelines given by the Central Pollution Control Board (CPCB).

Laws related to Bio-Medical Waste Authorization

Bio-Medical Waste Management Rules, 2016

• Bio-Medical Waste Authorization is necessary for the generation, collection, reception, storage, transportation, treatment, disposal or any other manner of handling of biomedical wastes listed in Schedule 1 of the Bio-medical Wastes Management Rules, 2016.
• As per these rules, every hospital, nursing home, clinic, dispensary, labs, blood banks, animal hospitals, and clinical establishment irrespective of their system of medicine, they are required to obtain an authorization.
• For bedded health care facilities, the authorization is valid according to the validity of the consents.
• The Armed Forces healthcare establishment has to obtain the biomedical waste management authorization from the Director General Armed Forces Medical Service.
• These rules stipulate the liabilities of the occupier/operator of the Bio-Medical waste Treatment facility as well as identified authorities. According to these rules, one needs to have an authorization from the prescribed authority as the case may be.

These rules categorize the bio-medical waste generated from the health care facility into four major groups on the basis of segregation pathway and a color code. Many types of biomedical waste come under each of these categories. Following is the segregated category-

• Yellow Category
• Red Category
• White category
• Blue Category

Who needs Bio-Medical Waste Management Authorization?

The Bio-medical Waste Management Rules, 2016, under section 10 states that every occupier/operator is required to have an authorization if they are dealing with bio-medical waste, irrespective of the quantity.

Additionally, the occupiers and operators are required to obtain a consent to operate from the Board. The occupier and operators are required to obtain a consent to establish prior to establishment, before undertaking any expansion/ change in activity or infrastructure and finally at the time of change in name or ownership.

Application Procedure for Bio-Medical Waste Authorization

The health care facility needs to apply to the SPCB in respect for fresh or renewal of the authorization.

• Applications can be filed online in a prescribed format as per Form II under the Bio-Medical Waste Management Rules, 2016.
• After submission of application online, submit hardcopy to the concerned office with challan showing payment of fees along with forwarding letter
• Both the forwarding letter and form needs to be signed by the occupier.
• After the proper verification and ensuring that the Health care facility is having all the requisite facilities, the authorization is granted by the SPCB in a prescribed form with a unique number of authorization and the issue date.

Documents Required for Bio-Medical Waste (BMW) Authorization for Health Care Units/Combined Bio-Medical Waste Treatment Facility

• An application form, in the prescribed format
• Particulars of Applicant
• Duly attested undertaking in a prescribed format
• Activity for which authorization is sought like generation, collection, storage, processing or recycling, etc.
• Application for fresh or renewal of authorization
• Address of the health care facility (HCF) or common bio-medical waste treatment facility (CBWTF)
• GPS coordinates of HCF or CBWTF
• Details of HCF or CBWTF for example month and year of establishment, number of beds, installed treatment and disposal capacity of the CBWTF, the quantity of the bio-medical waste handled, treated or disposed of, description of arrangements for handling BMW, etc.

The validity of the Bio-Medical Waste Authorization

For bedded healthcare facilities

The validity is synchronized with the validity of the consent under the Air and Water Prevention and Control of Pollution Acts.

For non-bedded healthcare facilities

A one-time authorization is needed from the SPCB. If there is any change in relation to the activities of the Health care facilities, they need to apply for a fresh authorization to amend the earlier authorization.

The authorization will be deemed to be granted if not objected by the prescribed authority within 90 days from the date of receipt of duly completed applications with the required documents.

Biomedical Waste Management Authorization with LawyerINC

• Connect with our team of experts
• Submit required documents
• Our Expert will consult you and complete the procedure
• Filing of Application with the Concerned Authorities
• Our Team will Follow-up with the authorities.

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