Impact of Pharmaceutical Wastes on Human life and Environment:-A Review

CHAPTER 1

INTRODUCTION
1.1 General
Studies in many countries have demonstrated the presence of pharmaceutical products at
trace levels in water streams and waste waters. The pharmaceutical compounds may enter the
environment by different routes such as discharge of treated wastewater, seepage from
landfills sites, sewer lines, runoff from animal wastes etc. Even though the environmental
impact of pharmaceuticals in the environment at trace levels has not been clearly determined,
the precautionary principle calls for action in the face of uncertainty. Even though risk from
exposure to pharmaceuticals in drinking water is minimal, information about characterization
of pharmaceuticals is still lacking. (Patneedi, 2015)

1.2 Pharmaceutical in the Environment

The pharmaceutical industries in India are growing very rapidly. It is the world's third-largest
in terms of volume and stands 14th rank in terms of value. It is growing at about 8 to 9
percent annually and is estimated to be worth 4.5 billion dollar. (Benotti 2009)

Several studies have demonstrated that certain pharmaceutical chemical compounds are being
dispersed in the environment. It has also been established that the origin of such
Emissions are mainly due to consumers use and actions and not to manufacturing operations.
Large amounts of pharmaceutical products are discarded as their expiration date passes or
They become unwanted. At this time, the correct disposal method of waste product is not
clear to the general public. Consequently, waste is discharged through sewage systems or
sent to landfills in the household waste. (Gualetro 2005)

The environmental exposure routes of pharmaceuticals into the environment are

manufacturing units and hospital effluents, land applications (e.g., bio solids and water reuse)
etc. However; sewage treatment services are not always successful in removing the active
chemicals from waste-water. Consequently, pharmaceuticals find their way into the aquatic
environment, where they directly affect aquatic organisms and can be incorporated into food
chains. In a recent study, the extraordinarily high levels (mg/L) of several drugs were found
in the effluents from local wastewater treatment plant near Visakhapatnam in India

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 Impact of Pharmaceutical Wastes on Human life and Environment:-A Review

1.2.1 Sources of Entry of Pharmaceuticals into Environment

The source is Taken from Kadam .(2016)

Pharmaceutical chemicals can enter into the environment by a number of passages such as

 From low cost pharmaceutical production industries in developing countries such as

India and China

 Direct and improper disposal by patients/ humans by unused/expired medications in

to the trash and through the excretion of urine or faeces.

 Release from hospital waste/trash

 Disposal by pharmacies

 Veterinary use as medicine as well as additives to animal food; which is excreted into
soil or soil or surface waters

 Dairy waste disposal

 Household water/sewage, solid garbage mix with drug surplus

 Leaching from defective landfills

 Release from aquaculture which has medicated feed, as well as excretion from the
aquaculture

 Release from molecular farming/ pest control drugs

 Disposal of euthanized/medicated animal carcasses

 Even in many developing countries like India the physician samples which are given
by companies to medical representatives for sales promotion purpose; Many times we
read in local newspaper that such expired/unused drug products found across road
side.

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 Impact of Pharmaceutical Wastes on Human life and Environment:-A Review

Most common routes of pharmaceuticals entering the environment are shown in Figure
1. Source: Kadam.(2016)

Figure 1.1: Routes of pharmaceuticals entering the environment

1.3 Role of Environmental engineer in pharmaceutical industry

The main role of Environmental engineer in pharmaceutical industry is introducing pollution
prevention and clean manufacturing practices throughout product and process life cycle
analysis to reduce waste and minimize environmental impacts through adopting various
disposal methods and new technique.

Pharmaceutical company must establish its own health, safety and environmental policies
covering the key principles established at the corporate level and must maintain appropriate
arrangements to facilitate and monitor effective implementation on the generation of
pharmaceutical bi products which are wastes. Also provide information, instructions, training
and supervision for all staff so that they can carry out their duties in all environmentally
responsible manners. Corporate safety and environmental engineering groups should work
with manufacturing executives to improve process safety, waste management, pollution

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 Impact of Pharmaceutical Wastes on Human life and Environment:-A Review

control and environmental stewardship. Ensure that new construction projects and buildings
comply with all environmental regulations during construction and operations.

1.3.1 Plans and programs to prevent pollution

The Source is Obtained from Rajkumar(2012)

To achieve pollution prevention goals the following points can be considered –

 Developing integrated EHS programs.

 Adopting pollution prevention and clean manufacturing practices.

 Eliminating hazardous emissions and wastes.

 Recycling and reusing materials.

 Conserving energy, water and other natural resources.

 Lowering the concentration of hazardous chemicals from the pharmaceutical effluent.

 Adopting proper treatment methods before discharging

 Implement environmental guidelines on how to properly dispose unwanted

pharmaceuticals, especially when it comes to the general public.

Pharmaceutical organizations must provide effective occupational health and hygiene

programs, develop and maintain appropriate emergency response procedures and
contingency plans by educating management, employees, stakeholders, customers,
suppliers and communities.

 New Product Environmental Requirements Tracking (NPERT)

Identify all regulatory and environmental quality requirements in the selection of chemicals
and raw materials, manufacturing scale-up processes and in working directly with R&D and
production facilities to select waste management and pollution prevention strategies.

 Materials Reduction and Recycling (Waste Management)

 Energy and Water Conservation

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 Impact of Pharmaceutical Wastes on Human life and Environment:-A Review

1.4 Objectives
Reducing the environmental impact of manufacturing. Sustainable manufacturing practices
aim to reduce waste, energy, and water use across the value chain. Green manufacturing
reducing energy, water, and waste in direct operations are important elements of a green
manufacturing program.
Currently there is no Bureau of Indian Standards (BIS)/ regulations limiting the levels of
pharmaceuticals in wastewater or drinking water. However, the United States Environmental
Protection Agency has added four pharmaceutical compounds, which extensively used by
human, to the most recent contaminant (Patneedi 2015).

Currently, pharmaceutical compounds are being merged into the environment in extremely
large quantities regularly and present system of regulations of their release is not able to
control the untreated or partially treated pharma effluents. The impacts of drugs are entering
into and occurring on ecosystems, biota and humans. The side effects on human, aquatic and
animal health need to be investigated through thorough safety and toxicological studies.
Sincere efforts are required to reduce the problem along with some adequate regulations to
monitor or to control them. Water quality guidelines enforced in India needs to include
analysis of most commonly used pharmaceutical compounds in drinking water sources.
Moreover, the latest remedial measures need to be adopted at large in effluent treatment
plants of pharmaceutical industrial units to check long term environmental and health
hazards.

The following are the some of important aspects which should take under
consideration-

1.4.1 Pollution prevention measures

 First: Minimization/reduction

 Second: Reuse

 Third: Recycling

 Last: Proper disposition (incineration – waste to energy facilities)

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 Impact of Pharmaceutical Wastes on Human life and Environment:-A Review

1.4.2 Minimization and Reduction

 Healthy life style:

 Public awareness

 Patient compliance and education

 Health care practitioner’s education

 Reuse & Recycling

 Proper Disposal

 Pharmaceutical Product Take Back Programs

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 Impact of Pharmaceutical Wastes on Human life and Environment:-A Review

CHAPTER 2
PROPERTIES OF PHARMACEUTICAL EFFLUENTS
2.1 Pharmaceuticals as pollutants

During the last three decades, the impact of chemical pollution has focused almost
exclusively on the conventional “priority” pollutants (e.g. pesticides), however this is just one
piece of the larger puzzle (Daughton 1999). The occurrence of pharmaceutical products in the
environment has gained increasingly attention since the 1980s; however its occurrence has
become more widely evident since the 1990s because the continual improvement in chemical
analysis methodologies (Daughton 2003).

Pharmaceuticals do not usually persist in the environment but continuous input into the
environment keep concentrations relatively constant. As it will be described later, many drugs
have been detected in various water streams through out several countries. However, their
concentrations are usually below the therapeutic level (e.g. ng/l, µg/l). The risks and effects
of these substances in these concentrations in the environment have not been determined yet.
However, this issue continues to be viewed with concern due to some of the properties that
many pharmaceuticals have: biological activity, lipophilic nature and resistance to
biodegradation (Valagaleti, 2002).
Table 2.1 Pharmacology and Eco pharmacology: Source Kummerer (2014)

Pharmacology(in Humans) Eco Pharmacology

Number of compounds
administered
Desirable physiochemical
properties
Administration
Wanted effects/side effects
Metabolism/biotransformation One type of organism
affected organisms
One or only a few compound An unknown cocktail of
at the same time different compounds
stable Readily (bio) degradable
Targeted on demand Diffuse i.e.,s emissions from
controlled medical care units and
community
Active wanted effects side "Wanted effects" i target
effects organism are often the most
important "side effects" in
the environment
Various types of organism of
different tropic levels

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 Impact of Pharmaceutical Wastes on Human life and Environment:-A Review

2.1.1 Toxicity due to Some Pharmaceutical Compounds

Studies on antibiotics have shown that up to 95% of antibiotic compounds can be released
unaltered into the sewage system. Moreover, higher concentrations of antibiotics can lead to
change in microbial community structure and ultimately affect food chains. Non-steroidal
anti-inflammatory drugs (NSAIDs), like ibuprofen, naproxen and diclofenac are widely being
used and consequently are frequently detected in sewage, surface water and may be found in
ground water system. Ibuprofen, ketoprofen, naproxen, indomethacin, diclofenac, acetyl
salicylic acid and phenazone have been found in surface water system. However, diclofenac,
ibuprofen and propyphenazone are the most commonly found drugs in the water bodies after
clofibric acid. Moreover, diclofenac has been proven to be highly toxic for vultures and
cattle’s. NSAIDs like ibuprofen, naproxen and aspirin are the most commonly used drugs,
which are usually found in effective quantities in municipal effluents.

2.1.2 Properties of Pharmaceutical Effluents

Many pharmaceutical industries are responsible to generate toxic effluent as a consequence of

their operation. The waste water generated from these industries possess solids,
biodegradable and non degradable organic compounds etc. Pharmaceutical effluents offer
basic information about the reliability of the aquatic habitat in rivers and streams, into which
they are discharged. The physico-chemical analysis of the effluents should indicate that most
of these industries obey the standard guidelines of Federal Environmental Protection Agency
(FEPA). An important pollution index of industrial wastewaters is the oxygen content in
chemical oxygen demand (COD) and biological oxygen demand (BOD), where the nutrients
status are measured in terms of amount of nitrogen and phosphorus in waste water. Besides
this, other significant water quality parameters include pH, temperature and total suspended
solids (TSS). However; pharmaceutical effluents are also categorized by their unusual
turbidity, conductivity, COD, TSS and total hardness. (Patneedi C.B, Prasadu K.D 2015)

2.1.3 Sources of Hazardous in Pharma

The Source is Obtained from Rajpurohit S(2013)

 Manufacturing and formulation installations.

 Handling and storage of hazardous chemicals including ware houses, godowns, tank
forms in ports/fuel depots/docks.

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 Impact of Pharmaceutical Wastes on Human life and Environment:-A Review

 Transportation (road, rail, air, water, pipelines).

 Emission of pollutants –the air pollutants include carbon monoxide (CO),

 Nitrogen dioxide (NO2), particulate matter of 10 microns or less (PM10),

 Total suspended particulate matter (SPM), sulphur dioxide (SO2), and

 Volatile organic compounds (VOCs). The most common VOCs include methanol,
dichloromethane, toluene, ethylene glycol, N,Ndimethylformamide ,and acetonitrile.

 Effluents, especially those that are not easily biodegradable and toxic in nature. The
effluent releases could go directly to streams, rivers, lakes, oceans, or other bodies of
water.

 The releases due to runoff, including storm water runoff, could also be a potential
hazard.

The toxic releases from the pharmaceuticals industry includes on-site discharge of a toxic
chemical to the environment. This includes emissions to the air, discharges to bodies of
water, releases at the facility to land, as well as contained disposal into underground injection
wells.

2.1.4 Various types of pharmaceutical waste –chemical waste

The Source is Obtained from Rajpurohit (2013)

 Organic chemical residues from manufacturing processes

 Heavy metals

 Dust during formulation

 Gaseous Vapours / emissions during API /Bulk drugs

 Chemical Spills

 Leakages –water , oils, solvents chemicals.

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 Impact of Pharmaceutical Wastes on Human life and Environment:-A Review

2.1.5 Most common environment hazards by pharma firm

The source is obtained from Rajpurohit (2013)

The hazards from the pharmaceuticals could be categorized as:

 Ecotoxic -damage is caused to the environment.

 Carcinogenic -contribute to the causation of cancer.

 Persistent -remain dangerous for a long time.

 Bio-accumulative –accumulates as it makes its way up the food chain.

 Disastrous due to a catastrophe, mishap, calamity or grave occurrence in any area.

 Water Pollution –because of spillage, drains and generation of effluent water,

sewage water for uncontrolled pH, and treating it ineffectively. Most dangerous for
aquatic living organisms or their livelihood.

 Air Pollution –releases of gaseous, fumes, dust, particulates to atmosphere, poor air
quality.

 Land /Soil Pollution –Spillage, chemicals, oils, lubricants leakages to land /soil –
seepage causation of non fertility to soil /lands, dumping or disposal of incinerated
sludge unauthorized.

 Noise Pollution –persistent vibration in operating machines equipments, use of non

acoustic power generators, air compressors .

 Odour :-spillage of blood, bio medical waste and culture burning in autoclave etc -
poor effect on ambient air quality, -leading to mass air pollution and hazards to
neighbourhood –plants, trees, human, animals etc .

 Global warming –CO2 Emission , CO , suspended particulates in atmosphere , NOx ,

-very sensitive issue globally now posing great threat of GLACIAL melting

 Heat Stress :-Uncontrolled work environment , high temp , exothermic reactions , use
of solvents , -very dangerous occupational hazard and also affecting environment.

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 Impact of Pharmaceutical Wastes on Human life and Environment:-A Review

2.2 Analysis of pharmaceutical wastes in drinking water

The mystery of pharmaceutical occurrence in drinking water has particularly concerned the
public health. While unpleasant human health results from the existing levels of drugs and
pharmaceuticals in drinking water are highly unlikely, the resulting impacts to aquatic
ecosystems are more dangerous. Moreover, pharmaceuticals have been detected in waters for
more than four decades. In the past decade, the number of papers on the analysis of drugs or
pharmaceuticals in drinking water sources has increased considerably.

In a monitoring study, out of fourteen pharmaceutical drugs analyzed, some pharmaceuticals

like acetaminophen (detection frequency 0.32%), codeine (0.16%), p-xanthine (0.08%),
sulfamethoxazole (0.41%), caffeine (0.24%), carbamazepine (1.5%) and trimethoprim
(0.08%) have been detected at concentrations more than or equal to detection limits of
selected methods. Besides, detection frequencies of pesticides (33%) and trihalomethanes
(28%) in the same sources were reported considerably higher. The pharmaceuticals have been
identified in water cycle at trace levels by advanced analytical techniques and
instrumentation. Several reports have confirmed the presence of pharmaceuticals in effluents
of pharma industries and in municipal wastewaters and these have been recognized as a major
source of drugs and pharmaceuticals in drinking water. Most of the research work has been
performed on the analysis and detection of pharmaceutical in drinking water samples in
developed countries including India USA, Japan, the Republic of Korea and some countries
in Europe. (Patneedi 2015)

2.2.1 Occurrence of Pharmaceuticals in Water

The Source is taken from WHO/HSE/WSH/11.05

Pharmaceuticals are synthetic or natural chemicals that can be found in prescription

medicines, over-the-counter therapeutic drugs and veterinary drugs. Pharmaceuticals contain
active ingredients that have been designed to have pharmacological effects and confer
significant benefits to society. The occurrence of pharmaceuticals in the environment and the
water cycle at trace levels (in the range of nanograms to low micrograms per litre) has been
widely discussed and published in literature in the past decade. The increase in detection is
largely attributable to the advances in analytical techniques and instrumentation. Many
surveys and studies have confirmed the presence of pharmaceuticals in municipal wastewater

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 Impact of Pharmaceutical Wastes on Human life and Environment:-A Review

and effluents, and these have been identified as a major source of pharmaceuticals in
drinking-water.

Routine monitoring programmes to test drinking-water for pharmaceuticals have not been
implemented, as is the case for regulated chemical and microbial parameters. Generally, data
on the occurrence of pharmaceuticals in drinking-water have resulted from ad hoc surveys or
targeted research projects and investigations. Available studies have reported that
concentrations of pharmaceuticals in surface waters, groundwater and partially treated water
are typically less than 0.1 µg/l (or 100 ng/l), and concentrations in treated water are generally
below 0.05 µg/l (or 50 ng/l).

The below figure explains the transport of pharmaceuticals/Entry of of pharmaceuticals from

different aids in to the Environment

Figure 2.1: Fate and transport of pharmaceuticals in the environment (Ternes, 1998)

2.2.2 Human health risk assessment for pharmaceuticals in drinking-water

Analysis of the results indicated that appreciable adverse health impacts to humans
are very unlikely from exposure to the trace concentrations of pharmaceuticals that could
potentially be found in drinking-water. Concentrations of pharmaceuticals in drinking-water

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 Impact of Pharmaceutical Wastes on Human life and Environment:-A Review

are generally more than 1000-fold below the MTD, which is the lowest clinically active
dosage. The findings from these three case-studies are in line with the evidence published
over the past decade, which suggests that appreciable risks to health arising from exposure to
trace levels of pharmaceuticals in drinking

Figure 2.2 Treatment technologies for removal of pharmaceuticals from drinking water
(Source Internet)

Conventional wastewater treatment facilities generally have activated sludge processes or

other forms of biological treatment such as bio filtration. These processes have demonstrated
varying removal rates for pharmaceuticals, ranging from less than 20% to greater than 90%.
The efficiency of these processes for the removal of pharmaceuticals varies within and
between studies and is dependent on operational configuration of the wastewater treatment
facility. Factors influencing removal include sludge age, activated sludge tank temperature
and hydraulic retention time. Comparatively, advanced wastewater treatment processes, such
as reverse osmosis, ozonation and advanced oxidation technologies, can achieve higher
removal rates for pharmaceuticals.

Studies on conventional drinking-water treatment processes have shown that coagulation is

largely ineffective in removing pharmaceuticals. Free chlorine is able to remove up to

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 Impact of Pharmaceutical Wastes on Human life and Environment:-A Review

approximately 50% of the pharmaceuticals investigated, whereas chloramines have lower

removal efficiency. Compounds that showed high removal by free chlorine but low removal
by chloramines include antibiotics, such as sulfamethoxazole, trimethroprim and
erythromycin.

Advanced water treatment processes, such as ozonation, advanced oxidation, activated

carbon and membranes (e.g. nanofiltration, reverse osmosis), are able to achieve higher
removal rates (above 99%) for targeted pharmaceutical compounds in various studies in the
published literature.

2.2.3 Preventing pharmaceuticals in drinking-water

As outlined in the WHO Guidelines for Drinking-water Quality, the water safety plan
approach is “the most effective means of consistently ensuring the safety of a drinking-water
supply through the use of a comprehensive risk assessment and risk management approach
that encompasses all steps in the water supply from catchment to consumer”. Water safety
plans highlight the importance of considering risk assessment and risk management
comprehensively from source to tap and adopting preventive measures to address the source
of risks.

Adapting the water safety plan approach to the context of pharmaceuticals in drinking-water
means that preventing pharmaceuticals from entering the water supply cycle during their
production, consumption (i.e. excretion) and disposal is a pragmatic and effective means of
risk management. Preventive measures need to be applied as close as possible to the source of
the risk and hazard. Inappropriate disposal practices, such as flushing unwanted or excess
drugs down toilets and sinks and discarding them into household waste, are common and may
be the main contributors to pharmaceuticals in wastewater and other environmental
media, such as surface waters and landfill leachate.

Preventive measures, such as policies promoting or regulations governing disposal practices

at concentrated point sources (e.g. health-care and veterinary facilities), can reduce the
amount of pharmaceutical waste entering water bodies. In addition, take back programmes,
guidance and enhanced consumer education will support efforts for the proper disposal of
medicines and reduce the impact of pharmaceuticals entering our water sources.

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2.3 Health hazardous and risk

The long term exposure of lower concentration of complex pharmaceutical mixtures on

stream biota may result in acute and chronic damages, behavioural changes, accumulation in
tissues, reproductive damage and inhibition of cell proliferation .Several studies have
demonstrated that fish exposed to wastewater effluents can exhibit reproductive
abnormalities. Moreover, fish exposed to trace levels of birth control pharmaceuticals in the
range of concentrations found in the environment show dramatic decreases in reproductive
success, suggesting population level impacts are possible.

2.3.1 Need for hazard management

 Major Accidents do happen in many ways and places

 Damage caused to plant, environment and people

 Exposure can/does go beyond the plant area

 Prevention is not an absolute guarantee

 Awareness must therefore be raised

 Response capability must be before an accident

 Emergency plans must be devised and tested

Figure 2.3 Steps in Risk Assessment Process

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 Impact of Pharmaceutical Wastes on Human life and Environment:-A Review

2.3.2 Occupational disease caused by pharmaceutical industry

 Diseases caused by Chemical Agents

 Diseases caused by Physical Agents

 Diseases caused by Biological Agents

 Occupational Respiratory Diseases

 Occupational Skin Diseases

 Occupational cancer

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 Impact of Pharmaceutical Wastes on Human life and Environment:-A Review

CHAPTER 3
LIFE CYCLE ASSESSMENT
3.1 Life cycle assessment
The life cycle of a pharmaceutical drug product is described in Figure 5 (adapted from
Valagaleti, 2002). It can be seen that there may be releases to the environment during the
following stages: API synthesis, extraction and purification; commercial scale manufacture;
human clinical studies and use/disposal of unwanted pharmaceuticals. Gualtero(2005)

The Flow diagram is taken from Gualetro.S (2005) it shows life cycle of pharmaceutical
waste

Figure 3.1. Life cycle of a pharmaceutical product. Adapted from (Valagaleti, 2002).

3.2 Occurrence and fate

In the last few years, there have been a number of attempts to try to determine the
occurrence of pharmaceuticals in the environment. A major study was conducted by the US
Geological Survey in 2002. This survey used five newly developed analytical methods to

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measure concentrations of 95 OWC (organic waste water contaminants) in water samples

from a network of 29 streams across the US during 1999 and 2000. The selection of sampling
sites was biased towards streams susceptible to contamination (i.e downstream of intense
urbanization and livestock production). In 80% of the samples analyzed, one or more of the
pharmaceuticals were detected. The high overall frequency of detection for the OWC was
likely influenced by the design of this study which placed focus on stream sites that were
generally considered susceptible to contamination. Gualetro (2005)
There have been a number of other studies that have identified pharmaceuticals in water
streams in India. In general, medical substances have been detected in the effluent from
medical care units, sewage and the effluent of sewage treatment plants, in surface water,
ground water, and in drinking water. Pharmaceuticals have also been detected in the effluent
from landfill sites. However it has not been possible to determine how much of these
substances were due to human and animal excretion and how much to the disposal of
unwanted pharmaceuticals.

Studies have been revealed that the presence of pharmaceuticals and personal care products
have increased their number in the streams and water bodies in the countries like USA
Canada China and India

3.3 Impacts and Effects

There is very limited documentation regarding the effects of pharmaceuticals in the
environment. Recent studies have focused primarily on antibiotics and strogenics steroids
(hormones). some studies have suggested that compounds like synthetic steroid 17α-
ethinyloestradiol, (EE2) used in contraceptives, could affect certain species of fish. However
other studies have shown inconclusive results .
Other types of pharmaceuticals are also a concern among the scientific community, such as
selective serotonin reuptake inhibitors (SSRIs), which are a form of antidepressants, and
antiepileptic drugs. However, again, non-conclusive information is available regarding the
effects of these substances on the environment. Gualetro (2005).
The Figure shows the accumulation of waste in the water a cake formation.Source
Bruni.(2016)

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 Impact of Pharmaceutical Wastes on Human life and Environment:-A Review

Close-up of effluent by the Hetero plant in Gaddapotharam

Figure 3.2 Accumulation of Waste in water a cake formation (Pietro Bruni-2016)

There are several elements to consider when assessing the pharmaceutical sector's
environmental footprint. One is the energy used during production and processing. Another is
the generation of waste-solid, liquid or airborne – from the manufacturing process. While
pharmaceutical contamination of water has only recently permeated the public consciousness,
it has been on the scientific community's radar for decades. There is now a compelling body
of research on the negative effects resulting from the accumulation of pharmaceuticals in the
environment, which range from the near elimination of entire species to the feminisation of
fish and the spread of antimicrobial resistance (AMR).

3.4 Disposal of unwanted pharmaceuticals

3.4.1 Impact of Improper Disposal
Improper disposal may be hazardous if it leads to contamination of water supplies or local
sources used by nearby communities or wildlife. Expired drugs may come into the hands of
scavengers and children if a landfill is insecure. Pilfering from a stockpile of waste drugs or
during sorting may result in expired drugs being diverted into the market for resale and
misuse. Most of the expired pharmaceuticals are less efficacious and very few of them may
develop a different adverse drug reaction profile. Pharmaceuticals and Personal Care
Products (PPCP) have been found as pollutant in water and the environment. This poses a
serious issue of ecological imbalance due to indiscriminate disposal of expired
pharmaceutical products. Kadam et al., (2016)

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3.4.2 Disposal Methods and Remedial Measures

Habits of medicine disposal depend on socioeconomic culture as well as regulatory
guidelines, norms that prevail in the country. Most commonly used methods are throwing
medicines in sinking, toilet and dustbins, which are environmentally unfriendly. Despite vari-
ous complex variables that combine to cause pollution the most effective best management
practices (BMPs) would address source reduction, namely, reducing the amount of medicine
that goes unused.
Current FDA guidelines for the proper disposal of prescription drug recommend that
unused/leftover/ expired medicines should not be flushed down the toilet or drain. Solid
medications should be mixed with unappealing substances such as kitty litter or coffee
grounds, put into a disposable container, and placed in the trash or disposed via community
drug take-back programs. Liquid medicines should be mixed with salt, flour, charcoal, or
nontoxic powdered spice, such as turmeric or mustard, to give the mixture an unappealing
smell and texture. Medicines in blister packs should be wrapped in multiple layers of opaque
tape, and then placed inside an opaque container for sealing. The lid of the medication bottle
should be sealed with duct tape or packing tape, the medication bottle(s) should be placed
inside a container that is not see-through and disposed off in the trash after sealing. Kadam
et al., (2016)

 Take unused, unneeded, or expired prescription drugs out of their original containers
and throw them in the trash.

 Mix the prescription drugs with an undesirable substance, like used coffee grounds or
kitty litter. Putting them in impermeable, non-descript containers, such as empty cans
or sealable bags, will further ensure the drugs are not diverted.

 Throw these containers in the trash.

 Flush prescription drugs down the toilet only if the accompanying patient information
specifically instructs doing so.

 Community drug take-back programs that allow the public to bring unused drugs to a
central Location for proper disposal.

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There are various disposal methods which are described here and summarized in Table 1.
Table 3.1Summary of disposal methods in and after emergencies Source: Kadam et al., (2016)
Disposal methods
Return to donor or
manufacturer, trans frontier
transfer for disposal
High temperature incineration with
temperatures greatly in
excess of 1200°C
Medium temperature Incineration with
two-chamber incinerator with minimum
temperature of 850°C. Cement kiln
incineration
Waste encapsulation
Inertization
Highly engineered sanitary
landfill
Engineered landfill plastics.
Open uncontrolled non engineered dump
Sewer
. fluids, small quantities of diluted
Fast-flowing watercourse
Burning in open containers
Chemical decomposition
Types of pharmaceutical Comments
All bulk waste pharmaceuticals, Usually not practical-transfrontier
particularly antineoplastics. procedures
may be time consuming
Solids, semisolids, powders, Expensive.
Antineoplastics, controlled substances.
In the absence of high temperature Antineoplastics best incinerated at high
Incinerators, solids, semi-solids, powders. temperature.
Controlled substances.
Immobilization
Solids, semi-solids, powders, liquids, antineoplastic, controlled
substances.
Solids, semi-solids, powders,
Antineoplastic, controlled substances.
Landfill
Limited quantities of untreated solids, semi-solids and powders.
Disposal of waste pharmaceuticals after
Immobilization preferable. PVC plastics.
Waste solids, semi-solids and powders, preferably after
immobilization. PVC
As last resort untreated solids, semisolids, Not for untreated
powders-must be covered immediately Controlled substances.
with municipal waste. Immobilization of
solids, semi-solids, powders is preferable.
Diluted liquids, syrups, intravenous Antineoplastics, and
undiluted disinfectants
disinfectants (supervised). and antiseptics not
recommended
Diluted liquids, syrups, intravenous Antineoplastics, and
fluids; small quantities of diluted undiluted disinfectants
Disinfectants (supervised). and antiseptics not
Recommended.
As last resort, packaging, paper, Not acceptable for PVC
Cardboard. plastics or
Pharmaceuticals.
Not recommended unless special Not practical for quantities over 50 kg.
chemical expertise and materials
available.

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3.4.3 Methods of disposal of various pharmaceutical dosage form

Methods of disposal of various pharmaceutical dosage forms are summarized here in

Table 3.2
Table 3.2: Methods of disposal of various pharmaceutical dosage form Kadam et.al (2016)

Tablets Capsules
Up to 50 tablets or capsules soak in about 100 ml of water and collect the same in a polyethylene
bag containing used Tea/Coffee grind. Seal the bag and put in trash. Big quantity-Pulverize using
heavy duty crusher. Collect in a poly bag and seal. Dispose it in high temperature incinerator
(Temp. 850°C to 1200°C)/approved site for solid waste disposal by the Pollution Control Board of
the State.
Injectables ampoules/vials:
Up to 50 Injectables-ampoules/vials: Ampoules/Vials (up to 10 ml)-break ampoules/ open vials
and collect liquid in a polyethylene bag containing used Tea/Coffee grind. Seal the bag and put in
trash. For bigger quantities, use heavy duty crusher to separate liquid and dilute it with water and
transfer it to Effluent Treatment Plant (ETP) of the manufacturing unit. Broken glass/vials (after
removal of label), rubber stoppers and seals should be disposed off as scrap. Powder Injectables
(in Vials/Ampoules) to be disposed off in an incinerator as indicated above.
Oral liquids and Intravenous fluids
Small quantity–Dilute the liquid with water and drain it. For bigger quantity, dilute collected liquid
with water and transfer it to ETP of the manufacturing unit. Liquids with high solid contents to be
disposed off in an incinerator as indicated above.
Semi solids:
Small quantity, mix it with used Tea/Coffee grind in a polyethylene bag. Seal the bag and put in a
trash. De-shape the containers/remove the label and discard the containers. Semisolids in bigger
quantity to be disposed off in an incinerator mentioned earlier. Containers- Tubes to be de-shaped
and remove the label from glass/plastic container before disposal as a scrap.
Anti-infectives-β-lactams:
Small quantity of all β-lactam antibiotics to be destroyed by soaking in 1N Sodium Hydroxide for
30 mins or 1% Hydroxylamine in Water for 10 mins and trash. Bigger quantity to be disposed off
in an incinerator (Temp. 850°C to 1200°C) indicated above.
Anti-infectives-others:

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Tetracyclines-Small quantity to be soaked in 10% of Calcium Hydroxide/any other Calcium salt in

Water for 30 mins and trash. Macrolides- (Erythromycin, Clarithromycin etc.)-Small quantity,
soak in 1N Hydrochloric Acid and trash. Amino glycosides (Gentamycin, Amikacin etc.)-Small
quantity dilute with large volume of water and drain it. Bigger quantity of all the above anti-
infective should be disposed of in an incinerator as mentioned above.
Steroids:
Small quantity-Soak in 1N Sodium Hydroxide for 30 mins and trash. Bigger quantity-all dosage
forms (taken out from the primary packing materials) to be incinerated at the temperature range
indicated above.
Hormones:
Small quantity-Aqueous solution to be exposed to UV for 20 minutes and trash. Estrogens-small
quantity in aqueous solution should be exposed to ultrasound at 0.6 and 2 kw in a sonicator for 60
mins. and trash. Bigger quantity-all solid dosage forms (taken out from primary packaging
materials) to be incinerated as indicated above.
Disinfectants:
Small quantity-use it. Bigger quantity-Not more than 50L. Dilute with enough quantity of water to
ensure dilution with loss of activity and drain it in ETP.
Controlled substances:
Small quantity-Flush down the toilet to avoid misuse. Bigger quantity-All dosage forms (take out
from primary packaging material) to be incinerated as mentioned above.
Reuse of Expired Pharmaceutical Products:
In the event of Emergency situation, Regulatory Agencies do allow Revalidation, after Analysis of
Expired Pharmaceutical Drug Products, if found satisfactory, for Human/Animal consumption.
Education and Training
Continuing education and training at every level is desirable to generate awareness of hazards
associated with indiscriminate Disposal of unused/expired pharmaceutical products–an emerging
environmental issue.
Take Back Programme by company
The expired products are taken from retailer by wholesaler and then to company need to be
implement effectively and efficiently.

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3.4.4 Precaution to be taken at the time of disposal

 Contamination of drinking water must be avoided. Landfills must be sited and

constructed in a way that minimizes the possibility of leaching entering a ground
water, surface water or drinking water system.

 Non-biodegradable antibiotics, antineoplastics and disinfectants should not be

disposed into the sewage system as they may kill bacteria necessary for the treatment
of sewage. Antineoplastics should not be flushed into watercourses as they may
damage aquatic life or contaminate drinking water. Similarly, large quantities of
disinfectants should not be discharged into a sewage system or watercourse. They can
be introduced if well diluted.

 Burning pharmaceuticals at low temperatures or in open containers results in release

of toxic pollutants into the air. Ideally this should be avoided.

 Inefficient and insecure sorting and disposal may allow drugs beyond their expiry date
to be diverted for resale to the general public. In some countries scavenging in
unprotected insecure landfills is a hazard.

 In the absence of suitable disposal sites and qualified personnel to supervise disposal,
unwanted pharmaceuticals present no risk, provided they are securely stored in dry
conditions. If stored in their original packing there is a risk of diversion and to avoid
this they are best stored in drums with the pharmaceuticals immobilized.

Pollution prevention establishes a hierarchy in the type of measures that should be

taken when dealing with an environmental risk. In the case of hazardous waste this
hierarchy is as follows:
• First: Minimization/reduction
• Second: Reuse
• Third: Recycling
• Last: Proper disposition (incineration – waste to energy facilities)

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CHAPTER 4
POLLUTION PREVENTION MEASURES
4.1 Minimization and Reduction
Waste minimization
Significant reduction of the waste generated in health-care establishments and research
facilities may be encouraged by the implementation of certain policies and practices,
including the following: WHO/CDS/VPH/92.104
Source reduction: measures such as purchasing restrictions to ensure the selection of
methods or supplies that are less wasteful or generate less hazardous waste.
Recyclable products: use of materials that may be recycled, either on-site or off-site.
Good management and control practices: apply particularly to the purchase and use of
chemicals and pharmaceuticals.
Waste segregation: careful segregation (separation) of waste matter into different categories.
Careful management of stores will prevent the accumulation of large quantities of outdated
chemicals or pharmaceuticals and limit the waste to the packaging (boxes, bottles, etc.) plus
residues of the products remaining in the containers. These small amounts of chemical or
pharmaceutical waste can be disposed of easily and relatively cheaply, whereas disposing of
larger amounts requires costly and specialized treatment, which underlines the importance of
waste minimization.

Waste minimization usually benefits the waste producer: costs for both the purchase of goods
and for waste treatment and disposal are reduced and the liabilities associated with the
disposal of hazardous waste are lessened.

Reducing the toxicity of waste is also beneficial, by reducing the problems associated with its
treatment or disposal. For example, the Supply Officer could investigate the possibilities of
purchasing PVC-free plastics that may be recycled or of goods supplied without unnecessary
packaging.
Examples of policies and practices that encourage waste minimization
WHO/CDS/VPH/92.104
Source reduction
• Purchasing reductions: selection of supplies that are less wasteful or less hazardous.

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• Use of physical rather than chemical cleaning methods (e.g. steam disinfection instead of
chemical disinfection).
• Prevention of wastage of products, e.g. in nursing and cleaning activities.
Management and control measures at hospital level
• Centralized purchasing of hazardous chemicals.
• Monitoring of chemical flows within the health facility from receipt as raw materials to
disposal as hazardous wastes.
Stock management of chemical and pharmaceutical products
• Frequent ordering of relatively small quantities rather than large amounts at one time
(applicable in particular to unstable products).
• Use of the oldest batch of a product first.
• Use of all the contents of each container.
• Checking of the expiry date of all products at the time of delivery.

4.2Reuse and Recycle

The Source is Extracted from WHO/CDS/VPH/92.104
Medical and other equipment used in a health-care establishment may be reused provided that
it is designed for the purpose and will withstand the sterilization process. Reusable items may
include certain sharps, such as scalpels and hypodermic needles, syringes, glass bottles and
containers, etc. After use, these should be collected separately from non reusable items,
carefully washed (particularly in the case of hypodermic needles, in which infectious droplets
could be trapped), and may then be sterilized by one of the processes listed. Although reuse
of hypodermic needles is not recommended, it may be necessary in establishments that
cannot afford disposable syringes and needles. Plastic syringes and catheters should not be
thermally or chemically sterilized; they should be discarded.

Long-term radionuclides conditioned as pins, needles, or seeds and used for radiotherapy may
be reused after sterilization. Special measures must be applied in the case of potential or
proven contamination with the causative agents of transmissible spongiform
encephalopathies (also known as prion diseases). These measures, which are capable of
reducing or eliminating infectivity, are described in detail in a WHO document In temperate
climates, the heat generated by on-site incinerators may be an attractive and cost-effective
option for heating hospital premises.

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Examples of sterilization methods for reusable items

Thermal sterilization
• Dry sterilization
Exposure to 160 °C for 120 minutes or 170 °C for 60 minutes in a “Poupinel” oven.
• Wet sterilization
Exposure to saturated steam at 121°C for 30 minutes in an autoclave.
Chemical sterilization
• Ethylene oxide
Exposure to an atmosphere saturated with ethylene oxide for 3–8 hours, at 50–60°C, in a
reactor tank; the so-called “gas-sterilizer” tank should be dry before injection of the ethylene
oxide. Ethylene oxide is a very hazardous chemical; this process should therefore be
undertaken only by highly trained and adequately protected technical personnel.
• Glutaraldehyde
Exposure to a glutaraldehyde solution for 30 minutes. This process is safer for the operators
than the use of ethylene oxide but is microbiologically less efficient.

4.3 Regulatory framework and programs to prevent pollution

Regulations at National Level The source is extracted from (Rajpurohit.(2013)

FACTORY ACT 1948 Compliance

 Environment Protection Act 1986 Environmental Statements Submission to Pollution

Boards –Form V

 Public Liability Act & Insurance 1991

 MSDS for Hazardous materials and compliance

 CCOE ( PESO ) License for classified solvent storage

 Indian Electricity Act 1936 & rules

 Disaster Management Act -2005

 Drugs & Cosmetic Act –1940

 Indian Boiler Act 1923

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 Impact of Pharmaceutical Wastes on Human life and Environment:-A Review

 Hazardous Waste Management Act & Rules

 The Petroleum Act –1934 & Rules -2002

 The Explosives Act –1884 & rules -1983

 Central Motor Vehicles Act for HW or Goods carrying -

Regulations at State Level

Enforcement at state level

 State Level Factory Rules -1963 and further amendments

 Pollution Control Board Consent To operate –a) WATER ACT 1974 , b) AIR ACT -
1984

 Stack Monitoring Reports for emissions to Air

 Work Environment monitoring –Ventilation , Illumination ,Dust & fumes

 Noise Monitoring

 Formation of SAFETY COMMITTEE as per 73 L

 Hazardous Waste Disposal Records (manifest)

 Petroleum products storage on site –type ,storage , and License –class A solvents ,
Class B chemicals , HSD , LPG stock etc

 Fire Hydrant system & FIRE NOC

 Trained FIRST AIDERS

 EPR & ERT –Emergency Preparedness & Response , Emergency Response Team

 OHC –Occupational Health Centre , with Visiting Doctor & Male Nurse

 Approved Licensed Contractors

 ESI of Employees /Contractors / Sub Contractors

 Mock Drills –announced / un announced for Emergency Evacuation

 Safety Committee Meetings & MOM

 Safety & Environment Promotional Activities.

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 Impact of Pharmaceutical Wastes on Human life and Environment:-A Review

CHAPTER 5

CASE STUDY
The information in the report is collected, studied and extracted from the different sources
such as from “The Industrial Ecology of Pharmaceutical Raw Materials and Finished
Products with and Emphasis on Supply Chain Management” by Velagaleti, R. Burns, P
(2002).
The Case study consist of The Pharmaceutical waste Generation, their contents and
percentage in the various sources of environment. Their affect to the animal, plants, human
and the aquatic life. The brief methods to disposal of these pharmaceutical hazardous waste
using available latest technologies. Life cycle assessment and environmental pollution acts
and programs.
The presence of pharmaceuticals in the drinking water is studied and represented in the report
by extracting form WHO article. Environmental pollution prevention measures such as Waste
treatment consist of Waste generation, Waste Segrigation, Reduce, Reuse, Recovery
technique. Various Pollution prevention acts in the National level and state level are reported.

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CHAPTER 6

SUMMARY OF THE SEMINAR

The occurrence of pharmaceuticals in the environment at trace levels is a fact. Reviewing the
life cycle of pharmaceutical products, it can be determined that releases from manufacturing
facilities are usually very low due to the fact that these processes are normally very well
contained. However, it has been determined that a large amount of these substances come
from the disposal of unwanted pharmaceuticals in the environment by the public.

Thousands of tons of unwanted pharmaceuticals may be generated annually in the part of that
amount is either disposed down the sink/toilet or sent to landfills. Even though the impact of
pharmaceuticals in the environment at trace levels has not been clearly determined, there are
many pollution prevention measures that could be implemented in a precautionary way.
These measures follow the hierarchy of: minimize/reduce, reuse/recycle and finally proper
disposal. Many of these measures would also contribute to the reduction of Health Care Cost.
Currently, pharmaceutical compounds are being merged into the environment in extremely
large quantities regularly and present system of regulations of their release is not able to
control the untreated or partially treated pharma effluents. The impacts of drugs are entering
into and occurring on ecosystems, biota and humans. The side effects on human, aquatic and
animal health need to be investigated through thorough safety and toxicological studies.
Sincere efforts are required to reduce the problem along with some adequate regulations to
monitor or to control them. Water quality guidelines enforced in India needs to include
analysis of most commonly used pharmaceutical compounds in drinking water sources.
Moreover, the latest remedial measures need to be adopted at large in effluent treatment
plants of pharmaceutical industrial units to check long term environmental and health
hazards.

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REFERENCES

 Bruni.P (2016): Impacts of pharmaceutical pollution on communities and

environment in India :RESEARCHED Management by changing markets and
ecostorm
 Daughton, C (2003). “Cradle to Cradle Stewarship of Drugs for Minimizing Their
Environmental Disposition While Promoting Human Health – Drug Disposal, Waste
Reduction and Future Directions”. Environmental Health Perspectives. 111 (5): 775-
785.
 G.M.Bruce, R.C.Pleus, S.A.Snyder (2010) Environment Science Technology, 44,
5619.
 Kadam et al, Pharmaceutical Waste Management: Indian Journal of Pharmacy
Practice, Vol 9, Issue 1, Jan-Mar, 2016
 Kumar.A Chang .B Irene Xagoraaki Int J on Human Health risk Assessment of
Pharmaceuticals in water: Issue and Challenge ahead (2010 Nov5) doi
10.3390/ijerph7113929
 M.J.Benotti, B.J.Brownawell (2009),: Environment Pollution, 157(3), 994.
 Patneedi C.B, Prasadu K.D (2015) :Impact of Pharmaceutical waste.
 Rajkumar P. Patil Production Manager Om Pharmaceuticals Ltd Environmental
Management Issues in the Pharmaceutical Industry: A Review
https://learnaboutgmp.com/gmp/environmental-management-issues-in-the-
pharmaceutical-industry-a-review/
 S. Gualtero (2005) Pollution Prevention Measures for Unwanted Pharmaceuticals
Industrial Ecology, December
 Sridhar Rajpurohit : Introduction to key environmental aspect of pharmaceutical
industry in India.
 Velagaleti, R. Burns, P (2002). “The Industrial Ecology of Pharmaceutical Raw
Materials and Finished Products with and Emphasis on Supply Chain Management
Activities”. Workshop on Industrial Ecology of Particulate Matter (Penn State, 2002).
 WHO Safe management of wastes from health-care activities Chapter 6 (Report of a
WHO consultation on public health issues related to animal and human
encephalopathies. Geneva, World Health Organization, 1992 (unpublished document
WHO/CDS/VPH/92.104,)

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 WHO/HSE/WSH/11.05 World Health Organization, 20 Avenue Appia, 1211 Geneva

27, Switzerland (tel.: +41 22 791 3264;fax: +41 22 791 4857; e-mail:
bookorders@who.int).

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