Over the years there have been tremendous advancements in the healthcare system. However it is ironic that the healthcare settings, which restore and maintain community health, are also threatening their well-being. Poor waste management practices pose a huge risk to the health of the public, patients, professionals and contribute to environmental degradation [1] Bio-Medical Waste is defined as any waste fabricated during the diagnosis, testing, treatment, research or production of biological materials by either animals or mankind. Such waste has the potential to be hazardous to human health if it is left unregulated. It originates from Bio-Medical Waste facilities, such as hospitals, clinics, nursing homes, laboratories, funeral homes, dentist offices, veterinarian or physician complexes, medical transporters (e.g., ambulances) and storage and treatment facilities for biological entities since they all produce Bio-Medical Waste [2,3]. It contains human body parts, tissues and organs as well as animal body parts, carcasses, excreted bodily wastes, parts containing blood and wastes generated at veterinary hospitals. Besides, microbiology and biotechnology cultivate Bio-Medical Waste in the form of laboratory cultures, live or non-live vaccines and human and animal cell cultures used during research.

Items that come into contact with biological-waste functions are also considered Bio-Medical Waste originators. Needles, syringes, blades, scalpels, blood stained material or cotton balls and dirtied plasters are a few such examples. Discarded medicines, used tubing and catheters, chemicals used for disinfection purposes and any waste that is a consequence of laboratory upkeep are all instigators of Bio-Medical Waste as well.

In the area of pollution, the management of wastes is a perennial agenda and of these wastes, the Bio-Medical Waste is a special kind of waste. The infectious nature of the Bio-Medical Waste itself reveals the danger of its mismanagement. Bio-Medical Waste (also popularly called healthcare waste or hospital waste) is a by-product of healthcare and includes sharps, non-sharps, blood, body parts, chemicals, pharmaceuticals, medical devices and radioactive materials.

Generation of Bio-Medical Waste in sizeable quantities, depending upon the number of patients and the nature of activity, is an unavoidable side effect of healthcare delivery systems which primarily and predominantly takes within its fold processes like diagnosis, treatment, surgical intervention, post-operative care, rehabilitative care, clinical research, clinical trials etc. The objectives of the study are to analyze the existing rules and regulations pertaining to the management and handling of Bio-Medical Wastes for their efficacy, especially in the context of enforcement and feasibility and to analyze the problem of Bio-Medical Waste Management in government hospitals in district Srinagar and investigate the adequacy of law and efficacy of administrative agencies in effective handling and proper disposal of Bio-Medical Wastes [6].

Research Methodology adopted for accomplishment of this work is partly doctrinal and partly empirical. The nature of study is both to review the existing literature on the subject and will also involve empirical data collection. The doctrinal part involves review of literature (Books, journals), laws, judicial pronouncements, surveys conducted, e-resources etc. It may also take into consideration all the data collected from secondary and tertiary resources. Thus, on one side it explores the present legal frame work on the topic from the perspective of writings, judicial decisions and relevant statutes and other relevant material collected from the primary and secondary sources. On the other hand, for the purpose of empirical study a questionnaire has been administered to purposive random stratified representative sample of: 

Personnel in Occupiers

At the level of the Occupier, the researcher identified certain categories and numbers of personnel associated with different healthcare settings, i.e. ten Medical Superintendents, thirty Doctors, thirty Nursing Staff and thirty Auxiliary staff (supporting staff), totaling in all 100. Having obtained the sample of healthcare settings, a questionnaire was designed to suit these categories referred to above which developed after literature survey and review. The said questionnaire was distributed to the identified personnel from amongst the sample of Occupiers, after a pilot survey [7]. 

Enforcement Authorities

The prescribed authority under the rules is the Jammu and Kashmir State Pollution Control Board and it is entrusted with a very big role in the effective monitoring of the rules. This study involved interviewing the officials of the Jammu and Kashmir State Pollution Control Board. Besides, this study identified ten officials Jammu and Kashmir State Pollution Control Board of different ranks, involved in the implementation of the BWM Rules. A questionnaire designed to suit these officials, developed on the basis of the problem of mismanagement Bio-Medical Waste was distributed. In addition, informal interviews were conducted with a few of these officials in order to deviate from the structured context of the questionnaire distributed to them [8].

The information collected through the questionnaire and interview from the respondents has been processed and analyzed for testing the hypothesis. The collected data is analyzed below.

The quantity of waste generated in ten major hospitals of Srinagar per day is 5760.25 kilograms, which has drastically increased over the years. Despite of such large quantities of biomedical waste only Sher-I-Kashmir Institute of Medical Sciences is having the incineration facility and the other hospitals if having facility is non-functional.

In a majority of the areas of this study, the scene is dismal and calls for serious and immediate amelioration. It was found by the researcher that knowledge and awareness of biomedical waste (M&H) Rules among the respondents is negligible, 90% of respondents failed to answer the name of rules applicable to hospital waste, it means that the Government has not done enough to sensitize the personnel who are employed in healthcare establishments that generate Bio-Medical Wastes. Less than half (48%) of the respondents reported that their healthcare settings followed a waste management plan that too small a percentage in an area of risk-prone environment. It was found that a good number of respondents were not aware of the job responsibilities associated with BMW which is again a major concern.

It was found by the researcher that vast majority (70%) of the respondents were not even aware that authorization given by the Jammu and Kashmir State Pollution Control Board which reflects the starting point of the disconnection in the system between the prescribed authority under the rules and the Occupiers.

It was found by the researcher that only two hospitals are having their own official websites in contravention of Rule 4 (P) of Biomedical wastes Management Rules which provides that all health care facilities shall have their own website within 2 years from the date of notification of these rules, for the purpose of uploading Annual Bio-Medical waste report. It was also found that no hospital has uploaded the annual report of BMW on their official website as envisaged by Rule 13 (4) of BMW rules. It was again observed that vast majorities (90% of Occupiers have not submitted the annual report to the SPCB and even greater majorities do not maintain any records and hence there is very little information related to the generation, collection, reception, storage, transportation, treatment, disposal and/or any form of handling of Bio-Medical Waste . Further, no accidents have been reported until today in prescribed format to the prescribed authority. In respect of mandatory annual reporting, meant to be furnished to the prescribed authority by 30 June annually, only one hospital had submitted such reports since last two years. The Jammu and Kashmir State Pollution Control Board has not undertaken any measures due to non-receipt of such reports even though CPCB has to be compulsorily intimated on or before 31 July of every year, which shall have further send this information to Ministry of Environment, forest and climate change on, or before 31 August every year [4,5].

The methods of treatment and disposal of Bio-Medical Wastes are the main aspects of these Rules. Schedule I has laid down the categories of wastes and their methods of treatment while the scientific standards for operating technical instruments like incinerators, autoclaves and microwaves are prescribed in Schedule II. For abiding by Schedule I, which prescribes the various ways by which treatment of Bio-Medical Wastes must be undertaken, the Occupier must possess certain specified facilities like autoclaves or microwaves. However, majority of the Occupiers did not even possess autoclaves. As for the other mandatory facilities required to treat Bio-Medical Wastes as per the rules, it was found by the researcher only one hospital is having incineration facility to dispose of the BMW and rest of the hospital transports the waste to Common Biomedical Waste Treatment Facility which are also only two in Kashmir Division, which implies failure of government and authorities to establish waste disposal plants taking into the consideration the quantum of waste generated by health care establishments.

Segregation, packaging, transportation and storage are equally important in the management and handling of Bio-Medical Waste. Segregation is the first step and it is clearly prescribed that Bio-Medical Waste should not be mixed with other wastes. In the rules laid down for segregation, Schedule I prescribes a certain type of container with a particular color coding to be adopted and Schedule IV prescribes the symbols to be used on such containers However, alarming amounts (80%) of Occupiers were not able to match the waste type with its color which clearly indicates failure of occupiers in segregating the waste. Though the respondents were aware of the fact that segregation is important but when seen practically hardly any segregation was done according to the Rules. Not only sanitation staff and nurses but also doctors were also unable to match the codes. It was found that in some health care establishments the BMW is collected through authorized waste collection. However, it was also observed by the researcher many occupiers burn the BMW in open and it was found that unsegregated waste remains scattered in the open, which is easily accessible to rag pickers and animals.

Labelling must be done for Bio-Medical Waste containers or bags in accordance with Schedule IV of the BWM Rules. The symbols for depicting biohazard and cytotoxic wastes are provided in the BWM Rules. However, it was found that 49% of respondents were not aware of the labelling of infectious waste with Biohazard symbols. 

It was found as per the data collected from the respondents that less than 48% of occupiers maintain a register for biomedical waste As far as the findings drawn on Employee Education and Suitability are concerned, of the three aspects, viz. whether the respondent has undergone any training programme on hospital waste management; whether the hospital provides annual education on waste management for an employee and whether the concerned respondent would like to attend a programme on hospital waste management, the first two aspects again show a poor level of employee education since a very large segment (80%) of respondents have not undergone any training on waste management and an equally large number (80%) reported that their healthcare setting does not have any annual education programme on waste management. There is however, some consolation in observing that a majority of them was interested in attending a programme on Bio-Medical Waste Management and it shows their willingness to contribute to a hygienic environment in their healthcare establishments.

It was found that only 74% of respondents were provided protective equipment’s and the rest were without any protective gears, which again is violation of Rule 4(l) of BMW rules 2018. It was also found annual checkup of respondents was also limited to a specific percentage. The main stakeholders that is the sanitary staff who handles and carries BMW before it is transported to Common Biomedical Waste Treatment Facility are not checked annually for the probable effects of BMW, which violates rule 4(m) of the BMW rules 2018.

Bio-Medical Waste Regulation and Management: A Critical Overview

Having completed a detailed evaluation of Bio-Medical Waste Management in the District Srinagar of the State of Jammu and Kashmir in the light of the BWM Rules, the findings of which are detailed above, a critical evaluation of the BWM rules themselves is also necessary in the context of the hypothesis postulated in this study. For this purpose, the content of the relevant rules have been examined and the need for having such rules in their existing form, has been ascertained, giving reasons for the same.

According to BMW Rules 2018 waste is categorized in four categories however, such classification is not comprehensive as for example there is no special attention on pharmaceutical waste being a form of biomedical waste. On the contrary, in developed countries such as U.S. there are special guidelines on pharmaceutical waste management wherein detailed classification of pharmaceutical waste is mentioned along with disposal methods.

According to BMW Rules 2018 Biomedical waste means any waste which is generated during the diagnosis, treatment or immunization of human being or animals or research activities pertaining there to or in production or testing of biological or in health camps including categories mentioned in schedule I. However, it does not necessarily comprise certain wastes such as those produced during manufacture of pharmaceuticals, processing of drug products or excipients. The disposal method stated for outdated, contaminated and discarded medicines as per current guidelines for biomedical waste includes incineration, destruction and drugs disposal in secured landfills, this seems satisfactory at hospital level however there is no rule-specifying disposal of expired or discarded medicines at household level.

The methods provided for the disposal of BMW in the Rules of 2018 like incineration, autoclaving though no doubt are efficient methods for the disposal of BMW but in a hospital environment, technologies like those of incineration fail because untrained staff runs them. The incinerator should be used at its optimum level otherwise; the waste may not be treated properly. In most of the surveys carried out, incinerators run at temperatures lower than those specified in the rules and due to this poor operation and maintenance, these incinerators do not destroy the waste, need a lot of fuel to run and are often out of order. When every hospital uses an incinerator, it is underutilized since the amount of infectious waste of a single hospital is not sufficient for the optimum use of the machine, thereby leading improper treatment of Bio-Medical Waste. Therefore, overall, it is not feasible for every hospital to use an incinerator and it is preferable to have centralized incinerators instead.

BMW Rules 2018 provides that it shall be the duty of occupier not to give treated biomedical waste with municipal solid waste however; there are no means to distinguish with an absolute precision between the two types of wastes. A small carelessness of throwing a syringe or a needle contaminated by infectious waste will pose great danger as the waste, which is assumed non-biomedical solid waste could in fact be infectious waste as a result. Therefore, this Rule is not at all feasible as utmost care is required while segregating and findings reveal that the required standard of care is not present. Hence this Rule requires reconsideration to ensure the objectives of segregation since, as of now, segregation of the Bio-Medical Waste into specific categories of Bio-Medical Waste and storage in different color-coded containers is not being implemented to an appreciable extent. 

There is a specific direction in the Rules that the maximum permissible period of storage of untreated Bio-Medical Waste is 48 hours. The question here is as to how the authorities ensure compliance with this rule when there is no technology to test this period of 48 hours in respect of such wastes. The authorities also do not have any designated officials to undertake surprise inspections in this regard. Apparently, the only way left for the authorities is to rely on the statement of the hospital staff, which speaks of the weakness of this Rule. 

The Rules mention that the Central or the relevant State or Union territory Pollution Control Boards as the prescribed authority. However, these Boards are already over-stressed because of lack of infrastructure, labor and technical power to implement the existing legislative requirements. New responsibilities of this kind have certainly put added pressure on Boards and in turn have resulted in poor implementation. An analysis of the Rules vis-à-vis their implementation portrays the total lack of preparedness on the part of the State of Jammu and Kashmir, in terms of both infrastructure and skill.

The law relating to Bio-Medical Waste Management should play an important role in curbing the menace of mismanagement and the bio-medical Rules have to face to such challenges in order to strengthen regulation [9-12]. The fear of punishment for contravention of the Rules seems illusory and meaningless as much enforcement of penal provisions under the Environment (Protection) Act, 1986 has not been done. In view of this, regulation of bio- medical waste presents significant challenges. The scenario of Bio-Medical Waste demands better management. The present rules appear ineffective to manage the volumes of Bio-Medical Waste. Law has stumbled in performing its duty, much of attribute from the lack of proper implementation mechanism. Time has come to act seriously and implement the rules effectively. Greater commitment is required on the part of the Government looking into the magnitude of the problem. The regulatory body should be strengthened. There is certainly a need to re-look at the rules. Taking into consideration the above findings and shortcomings of the BMW Management Rules 2018, it is submitted that both the hypothesis stands proved i.e. [13].

Government hospitals in Srinagar function in gross violation of the existing Bio-Medical Waste (Management and Handling) Rules, thereby posing dangers to in-patients, visitors and the public at large.

The Bio-Medical Waste Management Rules, suffer from certain basic shortcomings due to which they have become ineffective in protecting the environment generally and health of the people in particular.

To sum up, the solution of environmental pollution on Bio-Medical Waste Management solicits concerted multi-disciplinary endeavors. Therefore, proper environmental health requires the co-operation and service of public health and medical professionalism apart from educating people about the menace. As far as policy and legal framework, the relevant provisions should provide for the respective standards, formalities and procedures to be complied by all people concerned. However, it is crucial to understand that despite enunciation of law dealing with pertinent standards, formalities and procedures as detailed above, unless appropriate efforts are made to translate the same into action, law will remain more on paper; an act of futility, when it comes to achieving the contemplated objective in practice. This is the precise reason why, appropriately structured and customized strategies need to be identified for the purpose of meaningful implementation of the Law. 

One such strategy is the effective dissemination of provisions of law among those who are either directly or indirectly obligated under the Act for its proper implementation. Inclusion of Bio-Medical Waste Management component in the curriculum of medical, dental and nursing courses will contribute towards improvement. The environmental issue is slowly gaining ground in the Indian society. This is because environmental problems affect each individual thus resulting in substantial awareness at all levels. The younger generation must be entrusted with this task since they are the future of the country. The Bio-Medical Waste Management is certainly an environmental issue and therefore, proper training must be given to the people, who will be directly responsible for its management. Therefore, it is important to include Bio-Medical Waste Management in the curriculum of courses above referred. This is because doctors, dental surgeons and nurses are directly responsible for the supervision and handling of the Bio-Medical Waste and they are directly handling such waste in their routine jobs [14,15]. 

Educating the public about the potential hazards about Bio-Medical Waste is also very important. The cooperation of the people is necessary to ensure proper treatment of Bio-Medical Waste. The education of the public should begin in the hospitals, where nurses, who regularly come in contact with the patients, can educate them about Bio-Medical Waste especially diabetic patients, who regularly use insulin injections and then simply throw the infected injections in the dustbin. However, the most important category that must receive education is the private clinics, medical testing centers and small hospitals, which individually generate wastes in smaller quantities but cumulatively, the waste generation is substantial and significant. 

It is time that hospitals and other medical institutions realized the importance of managing and treating Bio-Medical Waste in a safe and non-hazardous manner that can prevent the spread of pathogens and microbial infections into our environment and society. The State of Jammu and Kashmir needs to wake up to this problem as quickly as possible and confront it with courage and determination. This requires greater investment in the healthcare technology to improve the quality of its management systems. However, what it first needs is awareness about the magnitude of this problem. Awareness can be brought about by NGOs who are aware and have the capability to educate others. The Government of Jammu and Kashmir in this regard can offer financial help to these NGOs to carry out the necessary awareness and training operations required by the hospitals. The corporate sector too can contribute a great deal by developing innovative technologies and manufacturing environment friendly products [16]. 

It is the ethical and social responsibility of healthcare professionals to control the process of disposal of dangerous wastes of hospital. It is the duty of the State, Legislators, Healthcare establishments and the public to make sure that environmentally acceptable Bio-Medical Waste disposal is introduced and implemented effectively. Though it is the moral duty of medical professionals to see that hazardous wastes are systematically processed and disposed, it is the duty of the Union Territory of the Jammu and Kashmir to introduce effective legal machinery for the purpose. 

It can therefore be stated that social regulation can be achieved through the establishment of norms of conduct and the creation of required legal machinery along with accompanying empowerment on the authority. Law serves as one of the key instruments of such social regulation.

Therefore, it is essential for developing a legal frame work on the management of Bio-Medical Waste and implementation of the same thought an effective medium for sustainable development. This needs an integrative character highlighting consensus planning, policy and procedure which are not considered inimical to the social norms. Therefore, a judicious balance between environment protection and Bio-Medical Waste Management is the need of the hour.

1. Ludwig, K. and E. Orlando, Principles of Environmental Law. Edward Elgar Publishing, 2018, pp. 63.

2. Kulkarni and A.M. Afonso. “Dioxins sources and current remediation technologies-a review.” Environment International, vol. 34, 2007, pp. 139–153.

3. Dar, M.A. “Mismanagement and mishandling of bio-medical waste in paradise: An appeal for life and legal overhaul.” Kashmir University Law Review, vol. 9, 2002, pp. 130.

4. Geoffrey, M.L. Packaging in the Environment. 2nd Edn., Springer, 2012, pp. 98.

5. Murugan, M. International Regime of Environmental Law. Regal Publications, 2016, pp. 68.

6. Jain, M.P. Indian Constitutional Law. 7th Edn., LexisNexis, 2014.

7. Mara, D. and D. Trouba. “Sanitation and Health.” PLoS Medicine, vol. 7, no. 11, 2010.

8. Yadav, M. “Hospital Waste-A Major Problem.” JK-Practitioner, vol. 8, 2001, pp. 275.

9. Nadagoudar and M. Kiran. “The law relating to management of bio-medical waste: A critical analysis.” All India Reporter, vol. 90, 2003, p. 325.

10. Nandimath, O.V. and S. Rao. Enforcers Training Manual in Hazardous Waste and Management Law. 1st Edn., CEERA, 2005, pp. 58.

11. Jaswal, P.S. and Nishtha Jaswal. Environmental Law. 3rd ed., Law Publishers, 2012.

12. Raffensperger, C. and J. Tickner. Protecting Public Health and the Environment: Implementing the Precautionary Principle. Island Press, 1999.

13. Aljabre, S. “Hospital generated waste: A plan for its proper management.” Journal of Family and Community Medicine, vol. 9, 2002, p. 61.

14. Rao, S.V.J. Bio-Medical Waste and the Law: A Referral Guide. 1st Eds., Legalaxy, 2004, pp. 196.

15. Shastri, S.C. “The polluter pays principle and the supreme court of India.” Journal of the Indian Law Institute, vol. 42, 2000, p. 108.

16. Mishra, S.N. Indian Penal Code. 17th Edn., Central Law Publications, 2010, pp. 384.