Medical Laws

New Compliances in relation to Bio-Medical Waste Handling

The economic and environmental consequences of bio – medical waste have come to be a paramount issue of concern in developing countries. Safe handling of bio-medical waste has always been the biggest concern for health authorities in India for, if waste is not managed in an appropriate fashion, it can unleash a major threat to human health and the environment.

Waste generated from medical activities involving usage of needles and syringes for laboratory samples, cultures, handling of live vaccines and bodily fluids, treatment using cottons and bandages smeared with blood, radioactive wastes etc., are considered as toxic and in some cases may be lethal. Usually generated in medical establishments, such bio-medical wastes must not be allowed to be mixed with other municipal waste. Hence, the necessity for regulating the generation, collection and disposal of bio-medical waste.

In India, bio-medical waste was regulated through the the Bio-Medical Waste (Handling and Management) Rules, 1998 as amended in 2000 by the Ministry of Environment and Forests. Inorder to implement these rules more effectively and to improve the collection, segregation, processing, treatment and disposal of these bio-medical wastes in an environmentally sound management thereby, reducing bio-medical waste generation and its impact on the environment, the Central Government reviewed the existing rules.

Recently, Ministry of Environment, Forest and Climate Change exercised their power under section 6, 8 and 25 of the Environment (Protection) Act, 1986 and on 28th March, 2016 notified the new Bio – Medical Waste Management Rules, 2016 (“Bio – Medical Rules”).

Applicability of the Bio Medical Rules

The Bio-Medical Rules apply to entities or persons who generate, collect, receive, store, transport, treat, dispose, or handle bio-medical waste in any form including hospitals, nursing homes, clinics, dispensaries, veterinary institutions, animal houses, pathological laboratories, blood banks, ayush hospitals, clinical establishments, research or educational institutions, health camps, medical or surgical camps, vaccination camps, blood donation camps, first aid rooms of schools, forensic laboratories and research labs.

The Bio – Medical Rules shall not be applicable to the wastes released by entities covered under the provisions of:

  1. Atomic Energy Act, 1962 and rules;
  2. Manufacture, Storage and Import of Hazardous Chemicals Rules, 1989;
  • Muncipal Solid Waste (Management and Handling) Rules, 2000;
  1. Batteries (Management and Handling) Rules, 2001;
  2. Hazardous wastes (Management, Handling and Transboundary Movement) Rules, 2008;
  3. e- waste (Management and Handling) Rules, 2011; and
  • hazardous microorganisms, genetically engineered microorganisms and cells covered under the manufacture, use, import, export and storage of hazardous microorganisms, genetically engineered microorganisms or Cells Rules, 1989.

Waste Segregation

The Bio – Medical Rules have stipulated a disposal mechanism by instructing the entities dealing with bio medical waste to segregate biomedical waste at the individual level into bags coloured yellow, red, blue/white and black according to the category of the biomedical waste. The number of categories of bio-medical waste having decreased as compared with the previous bio – medical rules is hoped to ensure easy segregation of all bio – medical waste.

Storage Norms

The entities dealing in bio – medical waste can store the bio – medical waste for up to 48 (forty eight) hours. After the expiry of the above mentioned period the health care entities shall take proper measure to ensure that the waste doesn’t affect the environment or human health and shall inform the appropriate authority with reasoning.

The Bio – Medical Rules have also established a bar code system for bags/containers containing biomedical waste. The bags shall also have the global positioning system attached to it, so that the bio – medical waste are tracked.

Waste Treatment

The bio – medical waste shall be treated by the common biomedical waste treatment facility according to the colour of the bags. The different colours of the bag indicate the distinct methods of treatment of the waste namely incineration, deep burial, autoclaving, shredding, chemical treatment, disposal in a landfill, etc.

Health care entities are anyway responsible for pre-treatment of laboratory and microbiological waste, blood samples and blood bags through disinfection/sterilisation on-site in the manner prescribed by the World Health Organization (WHO) or National Aids Control Organisation (NACO), irrespective of the fact whether final treatment and disposal happens on-site or at a common biomedical waste treatment facility.

Further, no occupier of an health care facility shall establish an on-site treatment and disposal facility if a common bio – medical waste treatment facility is available at a distance of 75 km from the establishment of that particular health care entity.

Use of Plastic

Plastic bags, gloves and blood bags emit dioxins and furans on being burnt therefore the use of these materials is to be phased out by the health care entities within a period of 2 (two) years from the date of notification of the Bio – Medical Rules, to eliminate the emission of such toxins.

Safety of Health-workers

The Bio – Medical Rules also provides for the immunisation of health workers dealing with bio – medical waste, complete health check-up at the time of their induction and the same needs to be done on yearly basis.

Authorisation of regulated entities

Every occupier or operator handling bio-medical waste, irrespective of the quantity shall make an application in Form II to the prescribed authority i.e. State Pollution Control Board and Pollution Control Committee, as the case may be, for grant of authorisation and the prescribed authority shall grant the provisional authorisation in Form III and the validity of such authorisation for bedded health care facility and operator of a common facility shall be synchronised with the validity of the consents. The authorisation shall be one time for non-bedded occupiers and the authorisation in such cases shall be deemed to have been granted, if not objected by the prescribed authority within a period of ninety days from the date of receipt of duly completed application along with such necessary documents.

Review

The Ministry of Environment, Forest and Climate Change shall review the iimplementation of the Bio – Medical Rules Health Care Facilities once a year through state health secretaries, the SPCB and the CPCB. The SPCB, in its turn, will oversee implementation through district level monitoring committees that will report to the State Advisory Committee or the SPCB. Moreover, according to the new rules, the advisory committee on biomedical waste management is now mandated to meet every six months.

In Sum

Developing countries are in dire need of more stringent rules and regulations. The new Bio – Medical Rules have to some effect tried to comprehensively encompass all the entities dealing in bio – medical waste.  It would be considered as a progressive step if the Bio – Medical Rules are properly implemented.

All health care facilities including clinics are now under an obligation to ensure that proper identification, segregation at the source of generation, collection in prescribed colored containers, safe transportation, appropriate treatment and environmentally sound disposal of bio medical waste is implemented. Further, the authorities dealing with the bio – medical waste should be provided appropriate health education and training in managing and handling of bio-medical waste.

The salient features and the process of handling the waste can be accessed on here and here.

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