Bio-Medical Waste (Management and Handling) Rules, 1998

Published on 19/06/2013

Bio-Medical Waste (Management and Handling) Rules, 1998

Revised 19 June 2013

The Ministry of Environment & Forest, Govt. of India has prescribed rules for Bio Medical Waste Management under the Environment (Protection) Act, 1986. These rules control the indiscriminate disposal of hospital waste/bio medical waste and apply to all persons who generate, collect, receive, store, transport, treat, dispose, or handle bio medical waste in any form.

Rule 3 Of the notification defines Biomedical Waste, to mean any waste, 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 biologicals, and including categories mentioned in Schedule I.- An occupier has been defined as a person who has control over that institution and/or its premises.

Rule 4  Of the notification prescribes that it shall be the duty of every occupier of an institution generating bio-medical waste which includes a hospital, nursing home, clinic, dispensary, veterinary institution, animal house, pathological laboratory, blood bank by whatever name called to take all steps to ensure that such waste is handled without any adverse effect to human health and the environment.

Rule 5 Classifies Biomedical Waste and lays down procedures (schedule 1) and standards (schedules -5) for disposal and also prescribes the need to set up in a time bound manner (as in Schedule VI.), The requisite bio-medical waste treatment facilities like incinerator, autoclave, microwave system for the treatment of waste, or, ensure requisite treatment of waste at a common waste treatment facility or any other waste treatment facility.

Rule 6 describes Segregation, Packaging, Transportation and Storage of Bio-Medical Wastes and prescribes that Bio-medical Waste shall not be mixed with other wastes, but be segregated at the point of generation in accordance with Schedule II and containers labeled according to Schedule III. In case the container is transported to any waste treatment facility outside the premises where it is generated, the container shall also carry information prescribed in Schedule IV.

Vehicles transporting Bio-medical Wastes have also to be authorized for the purpose by the competent authority as specified by the Government.

No untreated Bio-medical waste shall be kept stored beyond a period of 48 hours, however if for any reason it becomes necessary to store the waste beyond such period, permission of the prescribed authority must be taken done with steps to ensure that the waste does not adversely affect human health and the environment.

Rule 7 The State Pollution Control Board have been designated as the prescribed authority for grant and renewed of applications under this rule.An authorization is granted for a period of three years, including an initial trial period of one year from the date of issue and has to be renewed thereafter for period of three years.

Failure to comply may lead to cancellation after giving proper opportunity of hearing.

Rule 8 This rule prescribes that every occupier of an institution generating, collecting, receiving, storing, transporting, treating, disposing and/or handling bio-medical waste in any other manner, except such occupier of clinics, dispensaries, pathological laboratories, blood banks providing treatment/service to less than 1000 (one thousand) patients per month, shall make an application in Form 1 to the prescribed authority for grant of authorization. Every operator of a bio-medical waste facility shall make an application in Form 1 to the prescribed authority for grant of authorisation.

Rule 12 Provides that if an accident occurs in premises, where bio-medical waste is handled or during transportation of such waste, the authorised person shall report the accident in Form Ill to the prescribed authority.

Rule 13 Any person aggrieved by an order made by the prescribed authority under these rules may, within thirty days from the date on which the order is communicated to him, prefer an appeal to such authority as the Government of State/Union Territory may think fit to constitute:

Provided that the authority may entertain the appeal after the expiry of the said period of thirty days if it is satisfied that the appellant was prevented by sufficient cause from filing the appeal in time.

The Rules are appended with a series of schedules-

Schedule -1        Describes 10 Categories of wastes and prescribes the treatment and disposal options for each as follows-

  1. Human Anatomical Waste by incineration and deep burial.
  2. Animal waste by incineration and deep burial.
  3. Microbiology and Biotechnology wastes by local autoclaving/microwaving/incineration.
  4. Waste sharps by disinfection, chemical treatment, autoclaving, microwaving and conciliation/shredding.
  5. Discarded Medicines and Cytotoxic Drugs by incineration/distraction and drugs disposal in segued landfills.
  6. Solid wastes like cotton, plasters, other contaminated things like bedding etc by incineration/autoclaving and microwaving
  7. Solid Wastes like tubing’s, catheters etc by disinfection, chemical treatment, autoclaving, microwaving and mutilation/shredding.
  8. Liquid Wastes by disinfection, chemical treatment and discharge into drains.
  9. Incineration Ask by disposal in municipal land fill.
  10. Chemical Waste by chemical treatment and discharge into drains for liquids and seemed landfill for solids.

The rules also prescribed that Chlorinated Plastics should not be incinerated and there will be no pretreatment before incineration Deep burial shall be an option only in towns with a population of less than 5 lakhs.

Schedule -2        provides a color coding for segregation, collection and treatment options for different wastes (10 Categories) as classified above.

Schedule -3        prescribes for Labels to be put on Bio-Medical Waste Container bags.

Schedule -4        for Labels for transport of Bio-Medical Waste Container Bags.

Schedule -5        is of particular importance as it prescribes standards for treatment and disposal of Bio-Medical Wastes including operational and emission Standards for incinerators, standards for autoclaving, standards for liquid waste, standards for microwaving and deep burial.

Being prescribed under the Environment Protection Act 1986, non compliance is covered as provided under section 5, 15 and 19 of the aforesaid act which includes closure, fine and imprisonment on conviction.

While the National Green Tribunal Act of 2010 provides for redressal of grievances occurring out of orders passed by Appellate bodies constituted under the Water and Air Acts, and section 5 of the E.P. Act 1956 it is not clear whether it can consider an application for relief on an order passed under Rule 13 of the Biomedical Waste Handling Rules. This needs clarification.


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