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1. INTRODUCTION
The progress made by medical science during the last century and its positive impact on
society are well known. Medicinal products are an important element of the medical practice and
their beneficial effects (and side-effects) on human and veterinary health are widely
acknowledged. However, the area where we lack a global view is understanding what happens
when these medicinal products are discharged into the environment, either through consumption
or as unused or expired products. Residues of various types of medicinal products (hormones,
anti-cancer, antidepressants, antibiotics, etc.) Have been detected in various environmental
compartments, such as surface water, groundwater, soil, air, and biota. Such widespread
occurrence obviously begs the question whether a concentration of medicinal products in the
environment poses a risk for exposed biota or humans.
Recent pharmacovigilance legislation in the EU acknowledges that the pollution of
waters and soils with pharmaceutical residues is an emerging environmental issue. The European
commission was asked to deliver a report on the scale of the issue, the causes, and possible
policy options to mitigate such impacts. More recently, in the framework of the adoption of the
directive regarding priority substances in the field of water policy, the commission has been
asked to develop, instead of the report, a strategic approach to pollution of water by
pharmaceutical substances by the end of 2015.
This study, together with other relevant studies and reports, will provide the basis to develop that
strategic approach. The study covers both human and veterinary medicinal products but personal
care products are excluded.
The consumption phase is considered to be the biggest contributor to the emissions of
medicinal products into the environment, notably through excretions and incorrect disposal of
unused medicines through sinks and toilets. Between 30 and 90% of the orally administered dose
is generally excreted as active substance in the urine of animals and humans. However, the
nature and amount of medicinal residues mainly depend on the volumes and nature of the
administered substances, their modes of administration, and metabolisation rates.
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FIG : 1
However, the nature and amount of medicinal residues mainly depend on the volumes and
nature of the administered substances, their modes of administration, and metabolisation rates.
Medicinal products can also directly enter the environment through feed surplus, notably in the
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not explicitly illustrated or presented. Moreover, a recent study showed that the discharges of a
pharmaceutical manufacture could have adverse effects on the fish living downstream of a river.
FIG : 2
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Releases of medicinal products also occur through the incorrect disposal of unused
medicines through the sinks and toilets. Although contamination does not seem to reach the same
extent as pollution from excretions, it is not negligible and a large share can be avoidable.
Some substances tend to adsorb to sewage sludge, of which subsequent use for soil
amendment results in further risks of emissions into the environment. More precisely, the risk
concerns the persistent medicinal products that resist biodegradation during the aerobic or
anaerobic treatments of the sludge. The hydrophilic nature of some compounds can lead to
transfers of active molecules from soils to surface water or groundwater by the phenomenon of
mobility.
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4. ENVIRONMENTAL HAZARDS
Exposure to hazardous health-care waste can result in disease or injury. The hazardous nature
of health-care waste may be due to one or more of the following characteristics:
It contains infectious agents.
It is genotoxic;
It contains toxic or hazardous chemicals or pharmaceuticals;
It is radioactive;
It contains sharps.
FIG : 3
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The severity of the hazards for health-care workers responsible for the handling or
disposal of genotoxic waste is governed by a combination of the substance toxicity itself and the
extent and duration of exposure. Exposure to genotoxic substances in health care may also occur
during the preparation of or treatment with particular drugs or chemicals. The main pathways of
exposure are inhalation of dust or aerosols, absorption through the skin, ingestion of food
accidentally contaminated with cytotoxic drugs, chemicals, or waste, and ingestion as a result of
bad practice, Such as mouth pipetting. Exposure may also occur through contact with the bodily
uids and secretions of patients undergoing chemotherapy.
4.3 HAZARDS FROM RADIOACTIVE WASTE
The type of disease caused by radioactive waste is determined by the type and extent of
exposure. It can range from headache, dizziness, and vomiting to much more serious problems.
Because radioactive waste, like certain pharmaceutical waste, is genotoxic, it may also affect
genetic material. Handling of highly active sources, e.g. Certain sealed sources from diagnostic
instruments, may cause much more severe injuries (such as destruction of tissue, necessitating
amputation of body parts) and should therefore be undertaken with the utmost care. The hazards
of low-activity waste may arise from contamination of external surfaces of containers or
improper mode or duration of waste storage. Health-care workers or waste-handling or cleaning
personnel exposed to this radioactivity are at risk.
FIG:4
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FIG : 5
Depending on the different use rates of organic fertilisers such as manure or sewage
sludge and of treated surface water as drinking water, the potential exposure of humans to
medicinal products may vary among eu countries. Organic fertilisers transport medicinal
products to food, and medicinal products in surface waters may end up in fish and drinking
water.
Furthermore, the indirect environmental exposure of antibiotics and medicinal products
having anti-bacterial, anti-viral or disinfectant properties may create antimicrobial or anti-viral
resistance in human gut flora leading to less effective antibiotics or anti-viral medicinal products
in the future. The biggest issue is the transport and spread of resistance around the globe from
human to human. If a person from europe is exposed to an antibiotic compound in a third
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country, this person will take back the resistance genes in infected bacteria to europe and be able
to spread the bacteria (resistant genes) to other individuals here. Today it may take humans more
than 1 year to lose resistance gut bacteria again. Therefore, the possibility to spread them to
vulnerable individuals during this period is high. It is important to realise that incorrect
application of antibiotics or anti-viral pharmaceuticals is a global problem that can affect
vulnerable individuals many thousands of miles away. A minor exposure pathway might result
from recreational activities (e.g. Open water swimming, or children eating contaminated soil).
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water produced from surface sources. Higher levels of concentrations in surface water does not
necessarily result in a higher level of human exposure to medicinal products in countries using
predominantly surface water, since the actual exposure will mostly depend on the quality of
drinking water treatment. The environmental occurrence of medicinal products in surface water
have been evaluated and generally found to be low if the waste water is treated before release to
the environment, as a large proportion of the contaminants may be removed during filtration
processes in drinking water treatment plants.for example, sanderson (2011) collected data
showing trace amounts of medicinal products in surface waters in the nano- to microgram per
litre range, but only in the nanogram per litre range and in drinking water. No difference between
surface and groundwater sources were reported in terms of human health risks.
The human health risks of trace amounts of medicinal products in drinking water have
been evaluated in a report edited by the world health organisation (who, 2011)46 as well as in a
few countries such as in the uk and the netherlands (boxall et al., 2011; boxall, 2012b; schricks,
2010; versteegh, 2007). All reports conclude that, based on available evaluations, the majority of
compounds a substantial margin of safety exists between the maximum concentration in drinking
water and the concentrations likely to trigger adverse effects, and then that adverse health effects
from targeted medicinal products occurring in european water are not expected to individually
pose any appreciable risks to human health. However, although preliminary screening level
assessments suggest the exposure to be low, they are often based on the use of proxy indicators
such as the lowest therapeutic doses as points of departure for the risk assessment (e.g. In boxall
et al., 2011), which does not reflect the specificities of pharmaceutical exposures through
drinking water. Therefore, uncertainties remain, in particular with regards to the particularly
active nature of the molecule, concerning mixture effects, chronic long-term effects at low doses
and sensitive sub-populations. These aspects should be investigated further to verify whether the
current exposure leads to a significant risk.
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for fish). Humans can then be exposed to the contaminants through the consumption of meat,
dairy and fishery products.
Fao, who, the international office of epizootics (oie) and a number of national
governments have lately raised the issue of irresponsible use of antibiotics in all production
sectors, including fish industries, with particular concern for the potential risks to public health.
Many governments around the world have introduced, changed or tightened national regulations
related to the use of veterinary medicines, and in particular of antibiotics. In order to protect the
health of consumer of foodstuff of animal origin, the eu legislation now foresees that foodstuff
obtained from animals treated with veterinary products must not contain residues of the medicine
or its metabolite which might constitute a hazard health for the consumer, and maximum residue
levels (mrls) were set in this respect. In europe, there is therefore a comprehensive control of
residues of veterinary pharmaceuticals in products issued from farming and aquaculture, and
most production is considered of high quality, not containing antibacterial agents, which are the
most used in animals, over the mrl levels. While the level of antibiotic residue is low in most
cases, this kind of low and constant exposure can lead to antibiotic resistance in both the animals
fed the antibiotics and the humans who consume the food. Eu) highlighted that consuming foods
containing antibiotics could have a direct effect on an individuals own intestinal bacteria and
could contribute directly to the bacteria in the bowel becoming resistant to later antibiotic
treatment. The risk for resistance and gi-tract disturbances are among the parameters considered
when setting mrls for antibacterial substances.
However, environmental exposure to medicinal contaminants (human or veterinary) of
animals is not considered within the mrl regulation. This pathway of exposure is currently poorly
characterised. Additional research into deriving methods for assessing these pathways and better
quantifying mrl for all medical products as well is suggested to be initiated.
FIG : 6
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A developing country like India has seen healthcare sector slowly unfold into an industry
and an unavoidable side effect of such a situation is the generation of huge quantities of bio-
medical wastes. There has been an increase in the volume of services rendered in healthcare
sector and consequently increased volumes of such waste,273 which is the subject of this study.
A large section of the healthcare sector has not given importance to the proper management and
handling of bio-medical wastes.
The state of goa, being an international tourist destination and a hotspot for medical
tourism, has got an exceptional number of patient turnovers and has therefore faced the brunt of
the ill-effects of improper bio-medical waste management to a large extent.274 hence, this study
was undertaken with several objectives, ranging from analysing the problem of bio-medical
waste mismanagement in the state of goa to, examining the nature of legal control for its overall
efficacy in the context of the existing situation. As a result, the researcher has collected
voluminous data and arrived at relevant findings, evaluated the problem and offered suggestions
and recommendations, including a proposal for a specific legislation for the state of goa, which
are the contents of this chapter.
The researcher has put forth two hypotheses; viz. Firstly, that the healthcare institutions function
in gross violation of the existing rules, thereby posing danger to in-patients, visitors and the
public at large and secondly, that these rules themselves suffer from certain basic shortcomings
and as a result, the existing rules have become ineffective in protecting the environment
generally and health of the people in particular. After having traced the growth of the legal
mechanisms, both international and domestic, as seen in the second and third chapters
respectively, the researcher perused the latest rules governing the subject of bio-medical waste
management, namely, the bio-medical waste (management and handling) rules, 1998, which
have been notified by the government of india in the exercise of power conferred by sections 6, 8
and 25 of the environment (protection) act, 1986.
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Primarily, the prevalent rules on the subject of bio-medical waste management owe their
existence to the environment (protection) act, 1986 - the parent act. Therefore these rules are in
the nature of delegated legislation and do not amount to supreme legislation. Consequently,
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the force of legislation is not present in these rules independent of the force of the parent act.
Consequently, in the event of amendment of areas of the parent legislation, the rules will be also
faced with the same treatment. In the given circumstances, the researcher feels that considering
the healthcare scenario of the state of goa and the bio-medical waste management practices, there
is a need for the legislature of the state of goa to enact legislation for the purpose of
independently managing and handling such wastes in an effective manner. The researcher has
therefore examined the legal basis by which such a law can be enacted in the light of the
constitution of india and suggested a comprehensive law for the purpose of bio-medical waste
management in the state of goa.
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8. CONCLUSION
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9. REFERENCES
1. Study on the environmental risks of medicinal products, Executive Agency for Health and
Consumers.
2. Basic Principles of Risk Management for Medical Device Design, Ganeshkumar
Palanichamy
3. http://www.health24.com
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