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Bio Waste License

The proper management and disposal of biomedical waste is crucial for maintaining a healthy and safe environment. In India, following the Bio-medical Waste (Management & Handling) Rules notified by the Ministry of Environment is mandatory for all those who generate, collect, transport, treat, dispose, or handle biomedical waste. This includes hospitals, clinics, veterinary institutions, research labs, and many more. To ensure compliance with these regulations, obtaining a Bio Medical Waste License is necessary. Parinitha Business Consultancy is a reputed service provider that offers high-quality Bio Medical Waste License Processing Services that help businesses smoothly set up their operations while adhering to the laws and legal requirements of the country. In this article, we’ll delve deeper into the importance of Bio Waste License in India and how Parinitha Business Consultancy can help your business obtain one.

I. Introduction

A. Explanation of what is Bio-medical Waste

Biomedical waste refers to any waste produced as a result of healthcare services, such as diagnosis, treatment, or vaccination of human or animal patients or in research and production. It can also include waste from health camps and healthcare-related institutions. The cradle to grave approach that is followed for biomedical waste includes its characterization, quantification, segregation, storage, transportation, and treatment. Good biomedical waste management practices are based on three principles namely reduce, recycle, and reuse. The most effective biomedical waste management methods aim to avoid waste generation or recover as much of it as possible instead of disposing of it. The hazardous part of biomedical waste presents physical, chemical, and microbiological risk associated with handling, treatment, and disposal. It is, therefore, necessary to ensure proper waste management to reduce environmental pollution and make the environment cleaner. In India, the latest eco-friendly methods for biomedical waste disposal involve plasma pyrolysis or gasification treatment. [1][2]

B. Importance of proper disposal of Bio-medical Waste

Proper disposal of Bio-medical Waste is of utmost importance for healthy humans and a cleaner environment. The hazardous waste presents physical, chemical, and/or microbiological risks to the general population and health-care workers associated with handling, treatment, and disposal of waste. Effective Bio-medical Waste Management (BMWM) is mandatory and a social and legal responsibility of all people supporting and financing healthcare activities.

Here are some reasons why proper disposal of Bio-medical Waste is crucial:
– Exposure to hazardous healthcare waste can cause diseases or injuries.
– Improper disposal can lead to environmental pollution and contamination of water bodies.
– Bio-medical waste can lead to the spread of infections and diseases amongst humans and animals.
– It is the moral and legal obligation of all stakeholders to ensure the safety of others and to share the cost of proper management of BMW.

To ensure effective disposal of BMWM, a collective teamwork with committed government support in terms of finance and infrastructure development, dedicated healthcare workers and facilities, continuous monitoring of BMW practices, tough legislature, and strong regulatory bodies are required. Proper BMWM will lead to healthier humans and a cleaner environment for all. [3][4]

C. Overview of Bio-medical Waste Management Authorization

Biomedical waste management is crucial for the safety of humans and the environment. The Bio-medical Waste Management Authorization (BMWM) authorizes entities for the collection/reception/treatment/transport/storage/disposal of biomedical waste. The authorization must be obtained from the Board, which has been designated as the prescribed authority under the Rules. Biomedical waste-generating institutions need to comply with the rules, which include treating the waste using autoclaving standards or plasma pyrolysis or gasification guidelines. Emission standards and air pollution control measures also need to be followed. The Rules prescribe a schedule for waste treatment facilities, and fees for obtaining authorization are based on bed capacity, treatment facility providers, transporters, and all other biomedical waste-generating and handling agencies. The basic principle of BMWM is the segregation of waste at source and waste reduction. A lot of research and development needs to be done for the development of environmental-friendly medical devices and BMW disposal systems for a greener and cleaner environment. [5][6]

II. Guidelines for Bio-medical Waste Management Authorization

A. Rule compliance requirements

In India, proper management and disposal of biomedical waste (BMW) has become a significant health concern, as reflected in the Bio-medical Waste (Management & Handling) Rules 2016 under the Environment (Protection) Act 1986. The rules require every health care facility to obtain authorization from the concerned State Pollution Control Board or Pollution Control Committee, depending on the category of biomedical waste generated, to handle, transport, and dispose of it. Compliance with the rules is mandatory for all health care facilities, including hospitals, clinics, blood banks, veterinary institutions, and research establishments. To adhere to the regulations, it is necessary to segregate the waste at the source and reduce its quantity. The waste should be divided into ten categories and packed in five-color bags. Every occupier should apply on Form 1 for Authorization, submit an annual report to the respective authority by Jan 31, and follow specific treatment protocols for each category of BMW. The regulations also outline the roles and responsibilities of the occupiers, operators, and specified authorities in managing BMW. [7][8]

B. Details of authorized entities

Biomedical waste management rules in India mandate all healthcare facilities to obtain authorization from the State Pollution Control Board (SPCB) and the Central Pollution Control Board (CPCB) to ensure the safe handling and disposal of biomedical waste. Under the Bio-Medical Waste Management Rules 2016, the SPCB grants authorization to healthcare facilities and common biomedical waste treatment and disposal facilities (CBMWTF). As of now, TNPCB has authorized over 25426 private and government hospitals in the state under these rules. The CBMWTF includes facilities like autoclave shredders, incinerators, and secured landfill units to enable proper handling and disposal of biomedical waste. In Tamil Nadu, 10 CBMWTFs are currently operational, and three more are undergoing construction in Gummidipoondi, Hosur, and Tiruppur districts. The details of authorized entities involved in biomedical waste treatment and disposal in Tamil Nadu are given below:

1. M/s. G. J. Multiclave (India) Pvt Ltd, Thenmelpakkam, Chengalpattu Taluk, Chengalpattu District
2. M/s. Tamilnadu Waste Management Ltd., Kinnar Village, Maduranthakam Taluk, Chengalpattu District
3. M/s. Medicare Enviro Systems, Sengipatti, Thanjavur Taluk, Thanjavur District
4. M/s. Ken Bio Links Private Ltd, Kandipedu, Katpadi Taluk, Vellore District
5. M/s. Ramky Energy and Environment Ltd, Thangayur, Salem District
6. M/s. Teknotherm Industries, Orattukuppai, Coimbatore District
7. M/s. Aseptic System Bio Medical Waste Management Co., Pappankulam, Tirunelveli District
8. M/s. Ramky Energy and Environment Ltd, Undurmikidakulam, Virudhunagar District
9. Kovai Biowaste Management (P) Ltd, Coimbatore
10. Pondicherry Solid Waste Management Company Pvt Ltd, Virudhachalam Taluk, Cuddalore District.

All authorized entities ensure to comply with the BMW management rules and adhere to the guidelines for filing submissions and obtaining authorization. The SPCB constantly monitors the compliance of various provisions of rules to ensure proper handling, transportation, and disposal of biomedical waste. [9][10]

C. Autoclaving standards

Autaving is a widely accepted method of treating biomedical waste. According to the Bio-medical Waste Management Rules, 2016, autoclaving is one of the acceptable methods of treating and disposing of BMW. The autoclave method uses high-pressure steam to kill the microorganisms present in the waste. Autoclaving is an effective method for treating infectious waste and reduces the volume of waste. The efficiency of the autoclaving process can be determined by monitoring the temperature and pressure conditions. The temperature required for proper disinfection is around 121°C, and the pressure should be maintained at around 15 PSI. Proper monitoring of these parameters is necessary to ensure that the waste is effectively treated. The autoclaving process reduces the volume of waste by around 25-30%. After autoclaving, the treated waste can be safely disposed of in a landfill. However, it is important to ensure that the landfill site is authorized to accept BMW. Regular maintenance and calibration of the autoclave machine are necessary to ensure that the process is effective and efficient. [11][12]

D. Plasma Pyrolysis or Gasification guidelines

Plasma pyrolysis or gasification is a technology that is gaining prominence in treating biomedical waste in India, especially in the post-COVID-19 era. The technology involves heating waste to high temperatures that convert it into a gaseous state, followed by cooling to form a non-toxic, stable, and easy-to-store residue. The technology has numerous benefits, such as reducing the volume of waste by up to 95%, minimizing the formation of hazardous waste such as dioxins and furans, and recovering energy from the waste in the form of heat and electricity. The technology has been extensively reviewed by various research articles and implemented in some major cities such as Mumbai, Hyderabad, and Kochi. To ensure compliance with plasma pyrolysis or gasification guidelines, the biomedical waste management authorization specifies the standards for operation, maintenance, and monitoring of the technology, including emission standards and air pollution control measures. Proper adherence to these guidelines is crucial to ensure the efficacy of plasma pyrolysis or gasification technology in treating biomedical waste effectively and to minimize environmental and health risks [13][14]

E. Emission standards and Air Pollution Control Measures

When it comes to Bio-medical waste management, Emission standards and Air Pollution Control Measures play a significant role. BMW treatment and disposal facilities have to comply with the emission standards set by the Central Pollution Control Board (CPCB), which limits the discharge of pollutants into air and water. These standards help in controlling pollution and ensuring a safe environment for all.

Apart from the CPCB guidelines, BMW facilities also have to follow the Air (Prevention and Control of Pollution) Act and the Water (Prevention and Control of Pollution) Act. These acts provide a framework for ensuring the proper management of biomedical waste and reducing environmental pollution.

To ensure compliance with these regulations, BMW facilities have to undertake regular monitoring and testing of their emissions to ensure they do not exceed prescribed limits. The discharge of pollutants above permissible limits can attract penalties and even lead to the closure of the facility.

By following these emission standards and air pollution control measures, we can create a safe, sustainable, and healthier environment for all. [15][16]

III. Hospitals and Healthcare Establishments with less than 51 beds

A. Authorization and Consent procedures under BMW Rules

In to collect, store, transport, treat, and dispose of bio-medical waste in India, it is necessary to obtain an authorization from the regulatory boards. The Bio-medical Waste (Management and Handling) Rules of 1998 mandates that all hospitals, nursing homes, and health care facilities obtain authorization to handle bio-medical waste. The fees for authorization vary depending on the bed capacity of the hospital. The Bio-medical Waste Management Cell is responsible for approving applications for authorization and consent under the BMW rules. Common Bio-medical Waste Treatment Facilities (CBWTFS) are available in Delhi. Two operators of CBWTFs are currently available, and two specialized agencies have been identified to collect mercury from hospitals and health care establishments. The fee structure for obtaining authorization and consent under BMW rules as amended to date is INR 100 per annum for health care units run by the government or government bodies. It is essential for all health care facilities to follow the guidelines for Bio-medical Waste Management Authorization to ensure proper disposal of bio-medical waste. [17][18]

B. Guidelines for file submission

Under Bio-medical Waste Management Authorization, file submission guidelines have been established for obtaining authorization to handle biomedical waste. The authorized entities need to submit their application in Form II to the prescribed authority, which is APPCB. The application must include details such as the name of the applicant, the name of the health care facility/CBMWTF, activity for which authorization is sought, and the type of authorization application (fresh or renewal). The application should also include the previous authorization number (in case of renewal), address and GPS coordinates of the HCF or CBMWTF, and details of the facilities (number of patients treated per month, treatment capacity, quantity of waste treated/biowaste generated, etc.). Additionally, the form requires information on the mode of transportation of biomedical waste, details of treatment equipment, and contingency plans of CBMWTF. The applicant must also provide any further information requested by the prescribed authority. [19][20]

C. Fee structure for obtaining Authorization

Bio-medical waste management requires proper authorization from regulatory bodies to ensure compliance with established guidelines. The Karnataka State Board for the Prevention and Control of Water Pollution has introduced a consent fee structure for industries and organizations seeking consent to establish or operate under Bio-medical Waste Management rules. The consent fee ranges between Rs. 400 to Rs. 1,250,000 per annum, depending on the capital investment made on land, buildings, machinery, and other assets by new or existing industries. Private healthcare units are required to pay a fee of Rs. 100 per annum for authorization under Bio-Medical Waste Management Rules 2016. The consent fee for obtaining authorization and consent to establish, operate, or renew under Air and Water Act for healthcare establishments is Rs. 100 per annum. The validity of authorization and consent under these rules and acts is for a period of five years. All fees can be paid online through payment gateways or NEFT/RTGS. Compliance with these guidelines ensures ethical and safe disposal of bio-medical waste and ensures a healthier environment for all. [21][22]

IV. Hospitals and Healthcare Establishments with more than 50 beds

A. Authorization and Consent procedures under BMW Rules

The authorization and consent procedures under BMW Rules are a crucial component of proper bio-medical waste management. According to the rules, all institutions generating bio-medical waste need to obtain authorization for its collection, reception, treatment, transport, storage, and disposal. The authorization can be obtained from the Board, which has been declared as a prescribed authority under the Rules. The fee structure for obtaining authorization varies depending on the bed capacity of the institution and the type of activity involved. The fees can be paid in the form of a demand draft on any nationalized bank. Consent to establish and operate under BMW Rules is also required for healthcare establishments having a bed strength of more than 50. The applications for authorization and consent are decided by committees appointed by the Biomedical Waste Management Cell. The validity of both authorization and consent is for a period of five years. It is essential to follow the guidelines for authorization and consent to ensure proper management of bio-medical waste to maintain a safe and healthy environment. [23][24]

B. Guidelines for file submission

To Bio-medical Waste Management Authorization in India, it is important to follow the guidelines for file submission. The occupier or operator handling the waste must make an application in Form II to the prescribed authority, which is the Andhra Pradesh Pollution Control Board in this case. The application can be for fresh authorization or renewal of authorization. The form asks the applicant for details of the healthcare facility or common bio-medical waste treatment facility, such as the number of patients treated per month, the installed treatment and disposal capacity, and the quantity of biomedical waste handled, treated or disposed. It also requires a brief description of arrangements for handling biomedical waste and details of treatment equipment. Additionally, a contingency plan for the common bio-medical waste treatment facility must be provided along with any directions, notices, or legal actions taken during the previous authorization period. The file submission should be accompanied by a map with GPS locations of the facility and area of coverage.

C. Fee structure for obtaining Authorization

The structure for obtaining Authorization under Bio-Medical Management Rules 2016 has been defined by DPCC. The fee is charged annually and differs based on whether the healthcare unit is run by the government or private bodies. Private establishments need to pay a consolidated fee of Rs. 100 per annum for Authorization under Bio-Medical Management Rules 2016. For government healthcare units, the fee remains the same, Rs. 100 per annum, for both consent to establish/operate/renewal under Air and Water Act and Authorization under Bio-Medical Management Rules 2016. It should be noted that the validity of both consent and authorization is for five years. In case any healthcare establishment completes the validity period earlier, they are required to apply for both consent and authorization again. Additionally, the consent fee for industries and organizations other than coffee pulping covered under I(b) and projects covered under I(c), I(d) and I(e) in Karnataka varies based on capital investment. The fee ranges from Rs. 400 per annum to Rs. 1,250,000 per annum.

Frequently asked questions

What are Section 12A and Section 12AA?

These are the sections under the Income Tax Act that provide for the registration of a trust or society seeking tax exemption. Section 12A is for registration, while Section 12AA is for online registration of the trust.

What are the benefits of Section 80G registration?

Section 80G provides tax benefits to the donor of an NGO. It also helps the organization to get an exemption from income tax.

How can I apply for 80G registration?

The process involves drafting an application for a Section 80G exemption certificate, approval from the Income tax commissioner, and end-to-end follow-up with tax authorities. You can also seek assistance from a CA/CS/CMA registered with the government.

Who is eligible for 80G registration?

Only NGOs and charitable organizations can apply for 80G registration.

What is the validity of 80G registration?

Once you receive the 80G registration certificate, it is valid for the next five years.

What happens after five years?

After five years, the NGO needs to provide evidence of activities undertaken during this period to renew its registration.

Are there any deadlines for 12A/12AB registration?

If your NGO is already registered under Section 12A or 12AA, you must apply for migration to Section 12AB by April 2021, i.e., up to 3 years from the introduction of Section 12AB.

Maintain complete records of your donors, as donation benefits provided under Section 80G are available to donors for exempt NGOs on a stable basis. Keep yourself updated with the latest legal updates in India to make informed decisions.

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