Vol 3, Issue 1, 2021 (9-19)

http://journal.unpad.ac.id/idjp

*Corresponding author,

e-mail: luthfia16003@mail.unpad.ac.id (L. Azzahra)

https://doi.org/10.24198/idjp.v3i1.33383

Pharmaceutical Industrial Waste Regulation in Five Countries in Asia

Luthfia Azzahra

, Nyi Mekar Saptarini

Apothecary Programme, Faculty of Pharmacy, Padjadjaran University, Sumedang, Indonesia

Department of Pharmaceutical Analysis and Medicinal Chemistry, Faculty of Pharmacy,

Padjadjaran University, Sumedang, Indonesia

Received: 14 Jan 2021, Revised: 16 Feb 2021, Accepted: 28 Feb 2021, Published: 1 March 2021

ABSTRACT

The pharmaceutical industry produces a various toxic wastes. Generated waste increases

the risk of environmental and ecosystem pollution. It is necessary to have proper waste

management to prevent waste pollution to the environment. In 1999, WHO published

“Guidelines for the Safe Disposal of Unwanted Pharmaceuticals in and after

Emergencies”, that contain treatments and safe disposal method, which is appropriate for

any country. Many countries had developed and published regulations and guidelines on

waste management. This article aimed to review the handling of pharmaceutical industrial

waste in five countries in Asia. This review included studies from ProQuest, Crossref,

and Google Scholar. The pharmaceutical industries in Indonesia, India, Japan, Thailand,

and China has their own state regulations in order to protect the environment. They also

had implemented pharmaceutical industrial waste management following their regulation

and guidelines. The method used to treat the waste is similar with WHO guideline. Some

factors affecting the country regulations are the insufficient of land and waste

management facilities, lack of awareness, low penalties, limited infrastructures, lack of

waste testing facilities. The challenge in the future to handle pharmaceutical waste are

increasing waste volume, decreasing land for waste management, sewer methods may

contaminate water, possible air pollution due to incineration, so it is necessary to have

more advanced methods in waste management that are safe for the environment and

humans.

Keyword: Industry, Pharmaceutical, Waste Regulation, Asia

1. Introduction

The pharmaceutical industries produce

hazardous and toxic waste, which contains

organic and inorganic compounds derived from

the formulation process of pharmaceutical

products, the washing process of production

equipment, laboratory activities, and product

residues which out of specifications (1).

Pharmaceutical industrial waste produced is

various, it can be in the form of acid, alkaline,

salt, and potentially toxic residues or solvents,

furthermore, pharmaceutical industrial

products, such as antibiotics can cause bacterial

resistance (2).

Industrial waste has the risk of damaging the

environment and the ecosystem. Therefore, it is

necessary to have proper waste management to

prevent harmful impacts on the product,

L. Azzahra et al / Indo J Pharm 3 (2021) 9-19

human, environment, and ecosystem. There are

mainly four types of industrial waste, i.e. solid

waste, liquid waste, air pollution, and sound

pollution. WHO published “Guidelines for the

Safe Disposal of Unwanted Pharmaceuticals in

and after Emergencies” in 1999. This guideline

consists of particular attention to how

pharmaceutical wastes are disposed, including

incineration, landfill, encapsulation, sewer, and

chemical decomposition. The guidelines

outline a variety of strategies for disposing of

pharmaceuticals safely. There are approaches

that carry the smallest risks to public health and

the environment, including those that are

appropriate for countries with limited resources

and equipment. The WHO guidelines

recommend a range of slightly less-safe

treatments and disposal methods, when

weighed against the risks of excessive or non-

disposal, are appropriate to relative risk (3).

Some countries with limited resource and/or

equipment still has some problem, for example

in Indonesia, there are still unsupervised open

burning site that pollutes air (4). In India where

there are still illegal waste management

practices that pollute the air and water due to

lack of supervision and the lack of land

provision (5, 6, 7). In Thailand, poor waste

material handling, the lack of land provision led

to environment pollution such as leachate and

hazardous waste (8, 9, 10, 11). This affects each

country regulation and additional requirements

of waste management. Due to the problems

mentioned above, it is important to adopt

alternative strategies, to ensure that

municipalities play their role correctly, to

ensure that government fulfil their roles and

responsibilities on waste management, and to

give penalties to those who violate the

regulations. (4, 12).

Pharmaceutical industrial waste is one of the

alarming issues. Many countries had developed

and published guideline on how to handle

pharmaceutical waste. This article reviews the

handling of pharmaceutical industrial waste in

five countries in Asia namely Indonesia, India,

Japan, Thailand, and China. These five

countries were chosen to see differences in the

management of pharmaceutical waste in

countries with different industrial

developments.

2. Method of Article Searching

This review included regulations, guidelines

and articles from ProQuest, Crossref, and

Google Scholar. Keywords were used to find

articles was “pharmaceutical industrial waste”

OR “pharmaceutical waste”, AND “asia” OR

“asean”. Inclusion criteria were used as

mentioned on flowchart. Systematic reviews

and unrelated studies such as incomplete

sources and non-pharmaceutical waste studies

were all excluded from the study.

3. Results and Discussion

Table 1. Articles Searching Results

engine

Number of

Articles

Articles used

for review (n)

ProQuest

247

Google

Scholar

863

Crossref

370

From the article searching results, it was found

that five countries in Asia had sufficient

information. The information includes the

regulation and handling of their pharmaceutical

industry waste, passed the screening, and fit

into the inclusion criteria. The process of waste

management based on the WHO’s guideline on

handling waste which is used as a reference by

countries (3):

1) Chemical disinfection

Liquid wastes are best treated with chemical

disinfection. Chemical disinfection may also be

used to destroy or inactivate bacteria in waste,

microbiological cultures, mutilated sharps, or

shredded solids by adding powerful oxidants,

such as chlorine compounds, ammonium salts,

aldehydes, or phenol compounds. The type and

L. Azzahra et al / Indo J Pharm 3 (2021) 9-19

amount of chemical used, as well as the degree

and length of contact between the disinfectant

and the waste, all affect disinfection

performance (3, 13)

Figure 1. Flowchart of Methodology

2) Secure land filling

Secure land filling is the process of disposing

of solid wastes in a landfill that is specifically

built and managed to handle hazardous wastes.

In most countries, burying waste in a landfill is

still the standard method of waste disposal. In

abandoned or unused quarries, mining voids,

and borrow pits, landfills were frequently

created. A well-designed and well-managed

landfill can be a sanitary and relatively

inexpensive way to dispose of waste. A modern

landfill's design features include methods for

containing leachate, such as clay or plastic

lining content. Waste is compacted and coated

to maximize its density and stability and to

deter vermin (mice or rats) from attracting it

(3).

3) Inertization

Inertization is a form of encapsulation that

involves removing the packaging materials

from the pharmaceuticals, such as paper,

cardboard, and plastic. The blister packs of pills

must be withdrawn. After that, the wastes are

ground and mixed with water, cement, and lime

to make a homogeneous paste. The paste is then

transported to a landfill in a liquid condition by

a concrete mixer truck and decanted into

regular municipal waste. The paste then

solidifies into a solid mass that is spread

throughout municipal solid waste. The

procedure is relatively low-cost and can be

completed with basic equipment (3, 13)

4) Sewer

Any liquid pharmaceuticals, such as syrups and

intravenous fluids, may be diluted with water

and flushed into sewers in limited amounts over

time without causing damage to public health

or the environment. Tiny amounts of well-

diluted liquid pharmaceuticals or antiseptics

may also be flushed by fast-flowing

watercourses (3).

5) Incineration

Incineration is a waste disposal process that

involves combusting solid organic wastes to

produce residue and gaseous materials. This

method can be used to dispose of solid waste

management residue as well as solid waste

management residue from waste water

management. It can be carried out on a small

and large scale. It is accepted as a viable

method of disposing of such hazardous wastes.

Due to concerns such as the release of gaseous

emissions, incineration is a contentious waste

disposal process. Ash from these incinerators

must be disposed of in a secure landfill (3, 13)

Sources identified from Google Scholar,

Proquest, Crossref (n =1480 )

Keywords: Pharmaceutical Industrial Waste,

Pharmaceutical Waste, Asia, Regulation

Inclusion:

State Regulations

Non-Review Journals

Guidelines

Official Gov. Website

Exclusion:

Review Articles

Non-pharmaceutical waste studies

Incomplete sources

Countries Included:5

References included: 31

References excluded: 1449

S. R. Mita et al / Indo J Pharm 3 (2020) 89-100

Table 2. Summary of Waste Management Methods

No.

Method

Advantage

Suitability

Reference

Chemical disinfection

Efficient and drastic reduction in

waste volume

Liquid and

solid waste

(3, 13)

Secure land filling

Relatively simple

Solid waste

(3, 13)

Inertization

Relatively inexpensive

Waste with

high metal

content

(3, 13)

Sewer

Practical and easy

Liquid waste

(3, 13)

Incineration

Drastic reduction in waste

volume, efficient

Solid waste

(3, 13)

Encapsulation

relatively cheap, simple, and safe

Solid waste

(3, 13)

Deep burial

Low cost and safe (in restricted

area)

Solid waste

(3, 13)

Autoclaving

Low cost and efficient

Solid waste

(3, 13)

Microwaving

Good disinfection efficiency

liquid waste

(3, 13)

6) Encapsulation

The wastes are immobilized in a solid block

inside a plastic or steel drum during

encapsulation. They are filled to 75% capacity

with solid and semi-solid waste, with the

remaining space filled with cement,

cement/lime mixture, plastic foam, or

bituminous sand. After the drums have been

filled to 75% capacity, a 15:15:5 (by weight)

mixture of lime, cement, and water is applied

and the drum is filled to capacity (3, 13).

There are other methods apart from the WHO

guideline that is used by five countries which

reviewed in this article (14, 15, 16):

7) Deep burial

The deep burial site should be prepared by

digging a 2-meter deep pit or trench in a

location that is not vulnerable to flooding or

erosion, where the soil is relatively

impermeable. There are no nearby residents or

shallow wells, and the possibility of surface

water pollution is minimal (3, 13).

8) Autoclaving

Autoclaves are used to sterilize products, due to

saturated steam in direct contact with the

product in a pressure vessel for long enough

periods of time and at high enough

temperatures to destroy pathogens. Before

autoclaving, it is required shredding the waste

to an acceptable size which is an operation that

would involve frequent breakdown for waste

handling purposes. Autoclaving generates a

waste stream that can be used to fill landfills

with municipal waste. Autoclave operation

requires qualified technicians, and medium

investment and operating cost (3, 13).

9) Microwaving

Microwaves use an electric field to induce

liquid in the waste to oscillate and heat up,

killing infectious components by conduction.

The waste material has to be exposed to

ultraviolet radiation for this technology to be

useful in order to destroy pathogens (17). The

waste must be shred to an appropriate size and

humidified before being microwaved.

Microwaving generates waste that can be used

to fill landfills (3,13).

The waste management and procedure in each

country are similar to WHO. As for the

regulation for each country are slightly

different as discussed below.

Indonesia

Waste handling is a critical matter in the

pharmaceutical industry which must be

considered, managed properly, and reported to

the competent authority, i.e. the Ministry of

Environment and the Environmental Service.

Waste which managed properly can protect the

environment, personnel, and the quality of

products produced by the pharmaceutical

industry. Therefore, the pharmaceutical

industry is obliged to handle and inspect waste

so that the waste produced by the

pharmaceutical industry meets the

environmental quality standards set by the

Ministry of Environment. There are several

regulations governing industrial waste handling

in Indonesia, especially pharmaceutical

industrial waste (Table 3). The techniques used

in order to handle the waste are similar to the

WHO guideline. In Indonesia, pharmaceutical

industry waste management is generally carried

out by autoclaving, incinerators, microwave

irradiation, chemical disinfection, sewer,

encapsulation, inertization and safe

burial/landfilling. For liquid waste, many

pharmaceutical industries use wastewater

treatment plant. The WHO guideline is quite

relevant and all methods are suitable to be

applied in Indonesia but still need improvement

on discipline and supervising, it also need to

develop new methods (18).

In the regulations, there are requirements that

must be met before the processed waste can be

disposed to the environment. Pharmaceutical

industries in Indonesia are required to report

the results of waste management inspections

to the authorities regularly.

In the Regulation of the State Minister for the

Environment of the Republic of Indonesia

Number 16 of 2012 Article 2 paragraph (2) it is

stated that the AMDAL, UKL-UPL and SPPL

are "Environmental Documents." Analisis

Dampak Lingkungan (AMDAL) or

Environmental Impact Analysis is a study of

the significant impacts of a business and / or

activity on the environment which is required

for the decision-making process regarding the

operation of a business and/or activity. Upaya

Pengelolaan Lingkungan Hidup dan Upaya

Pemantauan Lingkungan Hidup (UKL-UPL) or

Environmental Management Efforts and

Environmental Monitoring Efforts are

management and monitoring of businesses and

/ or activities that do not have a significant

impact on the environment required for the

decision-making process regarding the

operation of a business and/or activity. Surat

Pernyataan Pengelolaan Lingkungan (SPPL) or

Environmental Management Statement Letter,

is a form of commitment of business and/or

activity organizers to monitor and manage the

environment on the environmental impacts of

their business and/or activities outside of

businesses and/or activities that are mandatory

for AMDAL or UKL-PKL. Industries with

large and Significant Impacts must prepare

AMDAL, industries with Environmental

Impacts must prepare UKL-UPL (20, 21).

India

India is recognised as one of the most fast-

growing pharmaceutical industry globally.

India contributes 2.4% in terms of value and

10% in terms of quantity internationally. India

accounts for 20% of global exports in generics.

In 2016, the Indian pharmaceutical industry

exported USD 16.89 billion and is expected to

touch USD 40 billion by 2020 (22). Along with

the increased pharmaceutical industry in India,

so the amount of waste generated is bound to

increase. In India, the handling of

pharmaceutical waste generated has been

regulated since 1995 by Ministry of

Environment and Forests, Government of India

framed rules for managing Biomedical wastes.

The Biomedical Waste (Handling and

Management) Rules were published by India's

Ministry of Environment and Forests in 1998

(14, 15).

India’s Ministry of Environment and Forests

issued the Biomedical Waste (Handling and

Management) Rules in 1998 which has been

amended twice in 2000. The rules divide

biomedical waste into ten groups, each with its

own care and control requirements.

Table 3. Indonesia’s Regulation on waste handling (19)

Published Year

Regulation

1995

Minister of Environment Decree No. 50/MENLH/1995 regarding Odor Level

Quality Standards. Jakarta: Ministry of Environment.

1995

Ministry of Environment. 1995. Decree of the State Minister for the

Environment No. 13 of 1995 concerning: Emission Quality Standards for

Immovable Sources. Jakarta: Ministry of Environment.

1996

Decree of the State Minister for the Environment Number: Kep-

48/Menlh/11/1996 concerning Noise Level Standards. Jakarta: Ministry of

Environment.

2012

Ministry of Environment. 2012. Regulation of the State Minister for the

Environment of the Republic of Indonesia No. 05 of 2012 concerning Types

of Business Plans and / or Activities that Require an Environmental Impact

Analysis. Jakarta: Ministry of Environment.

2014

Ministry of Environment 2014. Regulation of the Minister of Environment of

the Republic of Indonesia Number 5 of 2014 concerning Wastewater Quality

Standards. Jakarta: Ministry of Environment.

It is stated that the operators must send an

annual report to the appropriate authority

detailing the amount of waste generated and the

methods used to handle it. Each operator is

required to keep records on the waste disposal

of the wastes, which can be inspected and

checked at any time by the authorized

authority.

Table 4. India waste regulation (23)

Year Published

Regulation

1998

Bio-Medical Waste (Management & Handling) notified by Ministry of

Environment & Forests (amended on 2000)

2008

Hazardous Waste (Management, Handling & Transboundary Movement)

(amended on twice on 2009 and twice on 2010)

2016

Hazardous and other waste (Management and Transboundary Movement)

(amended on 2016, 2017, 2018, and 2019)

2016

Bio-medical waste management rules (amended on 2018 and twice on 2019)

Any misfortune related to waste management

must be recorded by each operator. According

to the India’s pharmaceutical waste rule, the

handling of pharmaceutical industrial waste

implemented in India are incineration,

autoclaving, microwaving, chemical

disinfection, deep burial, secure land filling,

encapsulation, inertization, and sewer (14, 15).

The WHO guideline is quite relevant and has

been applied in India but it still weak of

supervision and lack of awareness from the

government and the people to treat waste

properly (4).

Japan

Japan started implementing waste management

since 1970s. Japan’s regulations on handling

waste are stated in Table 5.

Since the 1970s, Nippon Keidanren has

continuously promoted CSR as an essential

component of Japanese corporate management.

Keidanren created a Corporate Behavior

Charter in 1991 and recently issued CSR

guidance. CSR requires all businesses to adhere

to its standards and file an annual report on

Resource Conservation and Waste

Management. The Federation of

Pharmaceutical Manufacturers Associations of

Japan (FPMAJ) is a trade association that

represents pharmaceutical manufacturers in

Japan. They investigate waste management

practices in Japanese pharmaceutical firms.

Table 5. Japan’s Early Regulation on Waste Handling (24, 25, 26)

Year Published

Regulation

1970s

Corporate Social Responsibility (CSR)

1991

Corporate Behavior Charter

1991

The Waste Disposal Law (amended in 2003)

2003

Subcommittee on Socially Responsible Management

2004

infectious waste management (revised regulation including new criteria)

published by Ministry of Environment

2012

The Situation of Illegal Dumping of Industrial Waste by Ministry of

Environment

2012

The Emissions and Treatment of Industrial Waste by Waste Management and

Recycling Department, Ministry of Environment

2013

Report on Survey of Discharge and Disposal of Industrial Waste by Waste

Management and Recycling Department, Ministry of Environment

Concerns about packaging waste prompted the

FPMAJ to form an investigational committee in

July 2006 to address issues such as amending

the Containers and Packaging Recycling Law,

managing healthcare waste such as aerosol cans

and self-injecting syringes, and revising the

recycling symbol and push-out symbol on PTP

(Press Through Pack) packaging for tablets and

capsules. In February 2005, FPMAJ initiated

the Healthcare Related General Waste Control

Project. The FPMAJ and other interested

parties collaborated to develop a method for

properly disposing of expired injection needles,

discarded medication, and aerosol medications.

An annual follow-up session to the Nippon

Keidanren's Environment Voluntary Action

Plan is also held. The sessions held under this

initiative are open to Japan Pharmaceutical

Manufacturers Association (JPMA) member

companies and institutions that are members of

FPMAJ. Pharmaceutical firms conduct a

follow-up audit, compile and analyse data, and

report the findings to FPMAJ (24). Up to now,

Japan applies the WHO method and continues

to develop rapidly by implementing other new

methods, Japan’s efforts to improve its

management of industrial waste have been

recognized internationally, and useful lessons

can be drawn from them, namely 3R (reduce

reuse recycle), updating regulations to hold

waste generators responsible, voluntary

measures for industries, market-based

instruments to subsidize city-level action, and

awareness-raising programmes were all part of

the mix that helped change attitudes and

practices in industrial waste management. The

results were soon apparent: between 1990 and

2010, landfill of industrial waste decreased by

84 per cent, while the resource productivity rate

between 2000 and 2010 increased by 51 per

cent. Japan’s efforts to improve its management

of industrial waste have been recognized

internationally, and useful lessons can be drawn

from them. All methods incineration,

autoclaving, microwaving, chemical

disinfection, deep burial, secure land filling,

encapsulation, inertization, and sewer are

applied in Japan (27).

Thailand

The Royal Thai Government, which is divided

into central, provincial, and local governments,

is in charge of municipal solid waste (MSW)

and industrial waste management in Thailand.

Local governments are in charge of waste

disposal in their jurisdiction.

Table 6. Waste Management Acts (29)

Year Published

Regulation

1992

Public Health Act. B.E.2535

1992

Enhancement and Conservation of National Environmental Quality

Act.B.E.2535

1992

Industry Act

1992

Factory Act

1953

Municipality Act. B.E.2496

1994

Sub-District Council & Local Administrative Organizations Act. B.E.2537

1999

Provincial Administrative Organization Act. B.E.2542, Decentralization to

LAO Act. B.E.2542

2011

Occupational Safety, Health and Environment Act B.E 2554

2018

Enhancement and conservation of national environmental quality act

amendment 2

edition BE 2561

Local governments employ private companies

that have been given permission by Thailand's

Pollution Control Department (PCD) to dispose

of waste such as Better World Green Public

Company Limited (BGW), Bangpoo Industrial

Waste Management Center, Waste

Management Siam LTD (WMS), General

Environmental Conservation Public Company

Limited (GENCO), and SGS (formerly Société

Générale de Surveillance) Thailand. Local

governments are in charge of waste

management (28). PCD (Pollution Control

Department), under The Ministry of Natural

Resource and Environment (MONRE) is

managing waste management in Thailand.

Some of the Waste Management Acts that have

been enforced by local governments are listed

in Table 6. The WHO guideline is quite

relevant and all methods are suitable to be

applied, but still need improvement on

developing and implementing new methods

(4). All methods incineration, autoclaving,

microwaving, chemical disinfection, deep

burial, secure land filling, encapsulation,

inertization, and sewer are applied in Thailand.

China

In China, the Health Bureau, the Urban

Management Bureau, and the Environmental

Protection Agency are in charge of waste

management The Health of Bureau is primarily

responsible for managing disease prevention in

the entire phase of medical waste, as well as the

preparation of a Medical Waste Management

contingency plan; The Environmental

Protection Bureau is primarily responsible for

managing pollution prevention and control; the

Urban Management Bureau is responsible for

managing medical waste safely. Medical waste

disposal centre (such as Yuri International

Environmental Science and Technology

Company in Xinxiang) are in charge of the

timely processing, storage, and safe disposal of

medical wastes, as well as the planning of

medical waste disposal in accordance with

emergency response plans. Special

administration divisions, such as the Medical

Policy Department (in the Health Bureau) and

Solid Waste Management, have been

developed to increase the efficiency of waste

management. Quantitative and assessment

rules, a macro-control framework, a

management database interface, and a

recycling network in remote areas are among

the initiatives that have been implemented (30).

Indonesia, India, Japan, Thailand, and China

have implemented pharmaceutical industrial

waste management that follows the regulation

of their respective countries. The techniques

used in handling waste is similar to the WHO

guideline. It is obliged to report the results of

processing and inspection of waste produced

from the pharmaceutical industry.

Table 7. China Waste Regulation (31)

Year Published

Regulation

Amended 2017

Waste Disposal Act (Environmental Protection Adm.)

Amended 2013

Pharmaceutical Good Manufacturing Practice Regulations

Amended 2020

Standards for Defining Hazardous Industrial Waste

Amended 2021

Methods and Facilities Standards for the Storage, Clearance and Disposal of

Industrial Waste

China is a country that has implemented the

WHO method and developed the method with

renewable technology (14).

4. Conclusion

Pharmaceutical waste management in five

countries has been implemented following the

regulations of their own country. Each country

has its own additional requirements on how the

waste management. There is minor differential

regulation in each country such as waste

classification and waste treatment facilities

(public and/or private). Some factors affecting

the country regulations are the insufficient of

land and waste management facilities, lack of

awareness, low penalties, limited

infrastructures, lack of waste testing facilities.

The challenge in the future to handle

pharmaceutical waste are increasing waste

volume, decreasing land for waste

management, sewer methods may contaminate

water, possible air pollution due to incineration,

so it is necessary to have more advanced

methods in waste management that are safe for

the environment and humans.

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