Procedure for Authorization Process for Handling Bio-Medical Waste

Shreya Jain

Shreya Jain

Published on: Nov 3, 2025

Deepti Mudgal

Updated on: Nov 3, 2025

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Introduction

Bio-medical waste refers to any waste generated during the diagnosis, treatment or immunization of humans or animals or during related research activities. Such waste often contains infectious materials and poses serious health and environmental risks if not managed properly.

To address this, the Government of India introduced the Bio-Medical Waste Management Rules, 2016, requiring all Healthcare Facilities and waste handlers to obtain Bio-Medical Waste Authorisation. This authorisation ensures the proper collection, storage, transport, treatment, and disposal of biomedical waste in a safe and eco-friendly manner, preventing the spread of diseases and protecting public health.

Applicability Provisions

1. Section 6, 8 and 25 of the Environment (Protection) Act, 1986.
2. Rule 10 of Bio-Medical Waste Management Rules, 2016

Mandatory Requirement

1. All Health care facilities (HCFs) and Common bio-medical waste treatment facilities (CBMWTFs) shall obtain authorization from the relevant State Pollution Control Board (SPCB)
2. Submit Form II as prescribed under the Bio-Medical Waste Rules, 2016.

Procedure:

1. Submission Requirements- The following documents shall accompany the application:
   • Duly filled Form II indicating quantity of waste under four categories.
   • Copy of agreement with a CBMWTF for final disposal of waste.
   • Consent to Establish Certificate (from SPCB/PCC).
   • Consent to Operate Certificate (if applicable).
2. Application Review Process
   • Application is first scrutinised by a Section Officer for completeness and initial verification.
   • A field-level inspection is conducted to assess compliance and waste handling practices.
   • The Supervising Officer reviews the inspection and makes recommendations.
   • Final authorisation or renewal is granted in Form III by the Member Secretary based on the recommendations.
3. Time Period
4. The SPCB/PCC shall dispose of the application within 90 days of receiving a completed application with all necessary documents.
5. Deemed approval: If not disposed within 90 days, authorisation is deemed to be granted.
6. Conditions for Refusal, Cancellation or Suspension
   • The SPCB/PCC may refuse, cancel or suspend authorisation with written justification.
   • Before any such action, the applicant shall be given an opportunity to be heard.
7. Change in Activity- If there is any change in the bio-medical waste generation, handling, treatment, or disposal, the Occupier shall:
   • Inform the prescribed authority.
   • Submit a fresh application in Form II to modify the conditions of authorisation.
8. Validity
• Bedded HCFs: Initial authorisation is granted for three years.
• Non-bedded HCFs: Authorisation is one-time and deemed granted if not objected within 90 days.
9. Process of Renewal
   • Occupier shall apply for renewal at least 60 days prior to expiry.