Overview of Bio Medical Waste Authorisation

"Bio-Medical Waste" or BMW includes any waste generated during the diagnosis, treatment or immunisation of human beings, animals, or research activities. The BMW Rules of 2016 brought down the number of categories of Biomedical Waste to 4 from earlier 8 in the previous rules that applied to BMW. The changes have eased the segregation process at the source of generation and helped organise the transportation and disposal of Bio-medical waste. BMW is now categorised into four colour-coded categories, i.e. yellow, red, white and blue. This segregation mechanism has helped prevent potential exposure to workers handling contagious biological waste in bio medical waste recycling plants. The authorisation criteria aided in collection storage and disposal afterwards by specifying the Standard Operating Procedure (SOP). About 10%–25% of BMW is hazardous and presents physical, chemical, and microbiological risks to the general population and healthcare workers. Bio Medical Waste Recycling plants needs to adhere to specialised collection, transportation and disposal protocols that are very different from the handling of solid waste under the SWM rules. BMW waste disposal must be done through scientific disposal techniques that require the handler to have pre-installed infrastructure and basic knowledge about the constituents of biomedical waste. The SPCB/PCC assess the capacity and capabilities of the CBMWTF and HCFs before granting the authorisation.

Need for Bio medical Waste Authorisation

The MoEF&CC has come up as the nodal monitoring authority for post-authorisation compliances which was missing in the earlier version of the rules. MoEF&CC reviews the compliance of Health Care Facilities (HCF) once a year through state health secretaries, the SPCB and the CPCB. A District Level Monitoring Committee for districts are also being set up in every state or UT after the implementation of the 2016 Rules. They submit their monitoring report once every six months to the State Advisory Committee and the concerned SPCB/PCC. Any establishment involved in the generation, collection, reception, storage, transportation, treatment, processing, disposal or any other form of handling of bio-medical waste needs prior authorisation from the concerned State Pollution Control Board (SPCB)/ Pollution Control Committee.

Responsibilities post Biomedical Waste Authorisation

Responsibilities of HCFs: Through Bio-medical Waste Authorisation, CPCB has focussed on the responsibilities of HCFs. The responsibilities of bio-medical waste generators or HCFs include

• Adhering to the segregation, packaging and transport rules as they are the source of generation and therefore aware of the potential hazard of the waste.
• HCFs have been made responsible for the prior treatment of laboratory and microbiological waste, blood samples and blood bags through disinfection or sterilisation (on-site) in the manner prescribed by the World Health Organization or National Aids Control Organisation before discarding it as waste. This protocol must be followed regardless of whether final treatment and disposal happen on-site or at a common biomedical waste treatment facility.

Responsibilities of CBMWTF: The 2016 rules also mention a few guidelines for CBMWTF and require SPCBs to monitor the post compliance by these facilities. These responsibilities of CBMWTF include

• CBWTF intending to use new technologies to treat bio medical waste other than those listed in Schedule I will need prior permission from the Central Government to lay down the standards or operating parameters.
• The operator of CBWTF shall set up requisite biomedical waste treatment equipments like incinerator, autoclave or microwave, shredder and effluent treatment plant as a part of treatment before commencement of its operation and maintain their standard as laid down by the board from time to time.
• The operator of a CBMWTF must maintain a record of recyclable wastes sold to other dealers along with the records of waste collected and disposed by it.
• Timely authorisation and Renewal of registration and post-compliance are the foremost legal requirements to run any Health Care Facilities and Common Biomedical Waste Treatment Facilities in the country. Covering all legal fronts and licencing needs can require expert guidance and timely assistance because of the increased vigilance by these inspection authorities in the current pandemic.

 Authorisation Requirements of Common Biomedical Waste Treatment Facilities (CBMWTF)

The Role of CBMWTF has increased after the BMW Amendment Rules, 2016. The amount of biomedical waste from HCFs that needs scientific disposal is very high. Also, recyclable components like glass and plastic need prior disinfection before being sent for recycling. The total biomedical waste generated in the country is approximately 484 Tonnes Per Day (TPD) from around 1,68,869 registered HCFs. Only 447 TPD of this BMW is being treated before disposal. The law requires only authorised units to transport, treat and dispose of this waste. A CBMWTF must register with the concerned SPCB/PCC prior to the collection, transportation, tracking, and handling of biomedical waste. There are certain post-compliance and safety protocols that need to be followed as per the SPCB/PCC.

Documents Required by BMW Generator/ HCF for Authorisation

• Copy of Aadhar Card
• Copy of Pan card
• Filled in Form- II with the quantity of Four categories of BMW
• Self-declaration in case Bio-medical waste is not generated by the HCF.
• Copy of Registration from the State Medical Council
• Copy of Agreement with Operator of a Bio-Medical Waste Facility.
• Copy of Authorisation in case of Renewal
• Copy of Noise Monitoring Report, if applicable
• Undertaking in prescribed format duly signed by the applicant.

Registration Process for Health Care Facilities

Documentation and Application Fee The Occupier, who generates Bio-Medical Waste, shall apply for the first time in prescribed Form –II. A one-time registration fee has to be paid by non-bedded HCFs

Document Scrutiny   The applications are verified and examined at the field level to examine the compliance status & to decide the issue authorisation for the generation of Bio-Medical Waste to HCFs.

Issuance of authorisation The authorisation is usually issued for three years in case of bedded HCFs and one time for non-bedded facilities. HCFs with bed facilities have to apply for Renewal of the Authorisation 60 days before the expiry of their authorisation.

Documents required by a CBWTF for Authorisation

• Application in Form-II of Biomedical Waste Management Rules, 2016
• Letter of Requisition
• Treatment, storage and disposal facility agreement copy
• Site Plan of the facility
• Affidavit Self Declaration for Ownership
• Affidavit/Self Declaration for Liquid Waste Treatment
• Copy of Consent to Establish Certificate
• Copy of consent to operate order issued by SPCB
• Map with GPS locations of CBMWTF and area of coverage.
• Contingency plan of CBMWTF.
• Copy of the manifests of the lifting of waste 

Registration Process for CBMWTF

Documentation and Application Fee Every operator handling bio-medical waste must apply in Form II to the concerned SPCB/ PCC along with the required fee facility, and the operator of a common facility shall be synchronised with the validity of the consents.

Documentation and site inspection by Authorities Documents will be scrutinised by the SPCB/PCC to assess the capacity and capabilities of the CBMWTF. A site inspection is carried out  and an inspection report is prepared on its behalf.

Issuance of Authorisation The SPCB/ PCC will grant the authorisation in Form III after successful inspection and redressal of all issues. The authorisation is issued within 90 days of submission of a completed application.

How will Enterclimate Assist You? 

Meet all your Legal requirements in one place. Enterclimate provides one-stop support for HCFs and BMW treatment facilities to fulfil all legal obligations and licencing requirements for authorisation under BMW Rules, 2016

Assistance from Experts in the field The Enterclimate experts have years of experience in streamlining the process of authorisation for Healthcare facilities and BMW treatment facilities. Approach us for a swift and hassle-free experience.

Individual specific solutions for all your queries We have dedicated customer support with an excellent understanding of authorisation protocols so that our customers get precise advice every time.