SOP Pharmaceutical Industries EMPRI 2005 12

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Standard Operating Proceduresfor Pharmaceutical Industries

inal ReportDecember 2 5

nvironmental Managementand

Pol Research Institute

1


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TABLE OF CONTENTS

ITEM CHAPTER PAGE NUMBER

1 INTRODUCTION ----- 11.1 Background ----- 1

1.2 Gist Of Environmental Acts, Rules And Notifications ----- 1

2 LEGAL AND REGULATORY FRAMEWORK ----- 22.1 Fundamental Rights And Duties Of A Citizen ----- 2

2.2 State Policy ----- 2

2.3 Legislative Authority ----- 2

2.4 Relevant Legislations ----- 3

2.4.1 Environment Protection Act 1986. ----- 3

2.4.2 The Water (Prevention And Control Of Pollution) Act, 1974

And Rules----- 3

2.4.3 The Water (Prevention And Control Of Pollution) Cess Act,

1977 And Rules

----- 4

2.4.4 The Air (Prevention And Control Of Pollution) Act, 1981 And

Rules----- 4

2.4.5 The Environment Impact Assessment Notification 1994 &

1997----- 4

2.4.6 The Noise Pollution (Regulation And Control) Rules, 2000 ----- 4

2.4.7 The Hazardous Waste (Management & Handling Rules), 2000 ----- 4

2.4.8 The Manufacture, Storage and Import of Hazardous Chemical

Rules, 1989----- 5

2.4.9 Rules for the Manufacture, Use, Import, Export and Storage

of Hazardous Micro organism/ Genetically engineered

Organisms or Cells, 1989

----- 5

2.4.10 The Chemical accidents (Emergency planning, Preparedness

and Response) Rules,1996----- 5

2.4.11 Forest Conservation Act 1980. ----- 6

2.4.12 The Drugs and Cosmetics Act, 1940 and Rules, 1945 ----- 6

2.4.13 The Drugs and Magic Remedies (Objectionable

Advertisements) Act, 1954----- 6

2.4.14 The Drugs Prices (Control) Order, 1995 ----- 6

2.5 Relevant Policies ----- 6

2.5.1 The National Forest Policy ----- 7

2.5.2 The National Environmental Policy ----- 8

2.5.3 The National Industrial Policy-----

9

2.5.4 Draft National Rehabilitation & Resettlement Policy ----- 10

2.5.5 The Pharma Policy 2002: The Positives and Negatives ----- 10

2.6 Regulatory Concerns on Nutraceuticals ----- 11

2.6.1 Mashelkar Committee Recommendations ----- 11

2.7 Relevant Institutions ----- 12

2.7.1 Ministry Of Environment And Forest, Government Of India ----- 12

2.7.2 Department Of Ecology And Environment, Government Of

Karnataka----- 12

2.7.3 Karnataka State Pollution Control Board ----- 12

2.8 Guidelines for setting up of Pharmaceutical Industries from

Karnataka State Pollution Control Board

12

3 RESPONSIBILITIES OF THE PHARMACEUTICAL AUTHORITIES ----- 15


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ITEM CHAPTER PAGE NUMBER

3.1 Approvals ----- 15

3.2 Responsibilities ----- 15

4 WATER AND AIR (PREVENTION & CONTROL OF POLLUTIONACTS

----- 16

4.1 Consent Procedure ----- 165 WATER (PREVENTION & CONTROL OF POLLUTION) CESS

ACT----- 17

6 ENVIRONMENTAL IMPACT ASSESSMENTNOTIFICATION ----- 18

7 ENVIRONMENTAL STATEMENT PROCEDURES ----- 20

7.1 Contents Of Environmental Statement ----- 20

8 ENVIRONMENTAL AUDITING ----- 218.1 Features Of A Good Environmental Audit ----- 21

8.2 Audit Procedure ----- 22

9 ENVIRONMENTAL PERFORMANCE VERIFICATION EXERCISE ----- 2310 TYPES, SOURCES ANDNATURE OF POLLUTION FROM

PHARMACEUTICAL INDUSTRY

----- 24

10.1 Introduction ----- 24

10.2 Pharmaceutical Manufacturing Process ---- 24

10.3 Composition Of Pharmaceutical Products ----- 26

10.4 Composition Of Pharmaceutical Process Wastes ----- 27

10.5 Treatment Control Technologies ----- 28

10.5.1 Physical Treatment Process ----- 29

10.5.2 Chemical Treatment Process ----- 29

10.5.3 Biological Process ----- 29

10.5.4 Thermal Destruction Process ----- 30

10.5.5 Fixation And Stabilization Process ----- 3010.6 Pollution Prevention: Best Demonstrated Practices ----- 30

10.6.1 Source Reduction ----- 30

10.6.2 Material Substitution ----- 31

10.6.3 Process Modulation ----- 31

10.6.4 Good Operating Practices ----- 31

10.6.5 Recovery and Recycle ----- 33

10.6.6 Solvent Waste Recycling ----- 33

10.6.7 Waste Exchanges ----- 33

10.7 Summary ----- 34

11 CHARTER ON CORPORATE RESPONSIBILITY FOR

ENVIRONMENTAL PROTECTION (CREP)----- 35

12 EROS PHARMA A CASE STUDY ----- 36

12.1 Objectives of the project work ----- 36

12.2 Identification Of Various Wastestreams And Their

Characterization----- 36

12.3 Evaluation Of ETP ----- 37

12.4 Recommendations ----- 38


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1 INTRODUCTION

1.1 BACKGROUND

The Pharmaceutical (Bulk & Formulation) industry in Karnataka is

one of the major sectors of the state. The processes in the pharmaindustries vary from company to company making the unit specific

industry disastrous to the environment if proper care is not taken. Some of

the environmental hazards include:

The diverse manufacturing process, reactions and hazardous materials

produces a wide range of chemical and biological waste.

The waste from purifying and packaging drug products.

Though the pharmaceutical owners, regulators and auditors have been addressing the

issues of environmental safeguards, it has been noticed that most to times they have to grope

through various acts, rules, documents to understand the various details of environmental

compliances. Thus, it was felt necessary to bring out a booklet that gives all the relevantinformation for the Pharma sector.

Presently, as per Rule 14 of the Environment Protection Rules, 1986, it is mandatory for

persons carrying out an industry or operation or process which require consent under Water Act,

1974 or Air Act, 1981 or authorization under the Hazardous Waste Rules, 1989, to submit every

year an Environmental Statement to the concerned State Pollution Control Board. However, the

existing mechanism does not provide for rigorous analysis of Environmental Statement by the

industries. Hence, it was felt that an effective institutional arrangement for implementing the

Environmental Audit is necessary.

1.2 GIST OF ENVIRONMENTALACTS,RULES AND NOTIFICATIONS

Pharmaceutical Industry is regulated by various legislations related to manufacturing andenvironment.

Environmental Legislations:

1. The Water (Prevention and Control of Pollution) Act, 1974 and Rules

2. The Water (Prevention and Control of Pollution) Cess Act, 1977 and

Rules

3. The Air (Prevention and Control of Pollution) Act, 1981 and Rules

4. Relevant provisions under Environmental Protection Act and Rules, 1986

The Environment Impact Assessment Notification 1994 & 1997

The Noise Pollution (Regulation and Control) Rules, 2000

The Municipal Solid Waste (Management & Handling Rules), 2000 Hazardous waste (management and Handling) Rules 1989

The manufacture, Storage and Import of Hazardous Chemical Rules, 1989

The Rules for the Manufacture, use, Import, Export and storage of Hazardous Micro-

organisms/Genetically Engineered Organisms or cells, 1989.

The Chemical accidents (Emergency planning, preparedness and Response) Rules, 1996


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Standard Operating Procedure for Pharmaceutical Industry

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2 LEGAL AND REGULATORY FRAMEWORK

To put the whole regulatory framework of India in perspective, a gist of constitutional

provisions that relate to the environment is given below.

2.1 FUNDAMENTALRIGHTS AND DUTIES OF A CITIZEN

1. Under the Indian Constitution, Part III [Fundamental Rights]

Article 21 states the fundamental right of protection of life and

personal liberty of an individual, No person shall be deprived of

his life or personal liberty except according to procedure

established by law. It should be noted that though this Article

does not explicitly mention the term environment, it is a

fundamental norm recognized by the court that every person

enjoys the right to a wholesome environment, which is a facet of right

to life under the above-mentioned Article.

2. Part IV A [Fundamental Duties] Article 51 A (g) states that It shall

be the duty of every citizen of India to protect and improve the naturalenvironment including forests, lakes, rivers and wildlife and to have

compassion for living creatures. This Article was inserted by the Constitutional (42nd

Amendment) Act, 1976.

2.2 STATE POLICY

The States responsibility has been laid down in the Part IV Directive Principle of

State Policy of the Constitution. The Article 48 A concerns the Environmental responsibility

of the State and was inserted by the Constitutional (42ndAmendment) Act, 1976. The Article

states that The State shall endeavour to protect and improve the environment and to safe guard

the forests and wild life of the country.

2.3 LEGISLATIVE AUTHORITY

The Part XI of Constitution states the relationship between the Union and the States for

sharing the legislative and administrative powers. Under this Part, the Article 245 of the

Constitution gives the extent of the laws made by the Parliament and the State Legislatures. The

Parliament has the power to legislate for the whole country while the State legislatures are

empowered to make laws for their respective states. The Article 246 of the Part XI of

Constitution divides the areas of legislation (subject wise) between the Union [List 1 or Union

List in 7thSchedule, 97 subjects], State Legislatures [List II or State List in 7thSchedule, 66

subjects] and both Parliament and State Legislatures [List III or Concurrent List in 7thSchedule,

52 subjects]. The subjects related to environment in the 7

th

Schedule under the three lists aresummarized below:

LIST

NO.

NAME SUBJECT NO. IN

LIST

SUBJECT

I Union 52 Industries

List 53 Regulation and development of oil fields and mineral oil

resources

54 Regulation of mines and mineral development

55 Regulation and development of Inter-State rivers and river

valleys

56 Fishing and fisheries beyond territorial waters

II State 6 Public health and sanitationList 14 Agriculture, protection against pest and prevention of plant

diseases


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LIST

NO.

NAME SUBJECT NO. IN

LIST

SUBJECT

18 Land, colonization, etc.

21 Fisheries

23 Regulation of mines and mineral development subject to the

provision of List I

24 Industries subject to the provision of List IIII Concurren

t

17 A Forests

List 17 B Protection of wild animals and birds

20 Economic and social planning

20 A Population control and family planning

The Parliament has powers to legislate on subjects not covered by the three Lists [Article

248].

The Parliament is also empowered to legislate in the national interest on matters

enumerated in the State List [Article 249].

In event of a conflict between the Central law and State law on a concurrent subject the

former prevails [Article 254 (1)].

In case of a State law passed subsequent to the Central law, the State law shall prevail in

that State only if it has received Presidential Assent under Article 254 (2) of Part XI of

Constitution.

From an environmental standpoint, the allocation of legislative authority is an important

one as some environmental problems such as sanitation and waste disposal are best tackled at

local level, while others like water pollution and wildlife protection are better regulated by

uniform national laws.

2.4 RELEVANT LEGISLATIONS

As stated earlier, the working environment within the pharma are regulated by the

Pharmaceutical legislations while the environment (air & water emissions, noise, waste) outside

the pharma are governed by environmental legislations.

2.4.1 Environment Protection Act 1986

An Act to provide for the protection and improvement of

environment and for the matter connected therewith. It is an

Umbrella Act covering all the activities leading to any environmental

impact including water, air and land. It confers powers to take all

such measures as it deems necessary or expedient for the purpose ofprotecting and improving the quality of the environment and

preventing, controlling and abating environmental pollution.

2.4.2 The Water (Prevention and Control of Pollution) Act, 1974 and Rules

The water (Prevention and Control of Pollution) Act, 1974, is an Act to provide for

prevention and control of water pollution and maintaining or restoring of wholesomeness of

water. The discharge of any trade effluent or sewage shall be regulated as per the consent of the

state Board. Such discharge has to meet the standards prescribed by the State Board.

Section 23:Empowers the Board Officials to inspect the industry, effluent treatment

plant and sewage treatment plant etc. Also empowers to seize documents, register, record or

other material object for the purpose of establishing evidence of the commission of an offence

punishable under this Act.


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Section 24:Prohibits the pollution of stream or well or sewer or on

land by disposal of pollution matter etc., or no person shall knowing cause or

permit any poisonous, noxious or polluting matter into any stream or well or

sewer or on land.

2.4.3 The Water (Prevention and Control of Pollution) Cess Act, 1977 and Rules

The purpose of Water (Prevention & Control of Pollution) Cess Act is levy and collectcess on water consumed by 16 categories of industries specified in the act and also by local

bodies with a view to augment the resources of the Central and State Pollution Control Boards.

Water cess is levied based on the water consumed for domestic and specified industry.

2.4.4 The Air (Prevention and Control of Pollution) Act, 1981 and Rules

The Air (Prevention and Control of Pollution) Act, 1981, has (14 of

1981), is a specialized legislative measures, meant to tackle one facet of

environmental pollution. Its main objectives are the following:-

a) to provide for the prevention, control and abatement of air pollution;

b) to provide for the establishment of Central and State Boards, with a

view to implement the aforesaid purpose;

c) to provide for conferring on such Boards, the powers and assigning to

such Boards and functions relating thereto; and

d) for matters connected therewith.

2.4.5 The Environment Impact Assessment Notification 1994 & 1997

The Bulk Drugs and Pharmaceutical Industry require environmental clearance from the

Central Government. The Central and/or the State Government, with the following objectives

for environment clearance of polluting or degrading development activities:

- Optimal utilization of finite natural resources through use of better technologies and

management packages.- Incorporating suitable remedial measures at the project formulation stage.

2.4.6 The Noise Pollution (Regulation and Control) Rules, 2000

The State Government shall categorize the area into industrial,

commercial, residential or silence area/zones for the purpose of

implementation of noise, standards for different area. The ambient air quality

standards in respect of noise for different areas/zones shall be such as specified in

the Schedule annexed to these rules.

The noise levels in any area/zone shall not exceed the ambient air quality standards in

respect of noise as specified in the Schedule.The authority shall be responsible for the enforcement of noise pollution control

measures and the due compliance of the ambient air quality standards in respect of noise.

2.4.7 Hazardous Waste (Management and Handling) Rules 1989

These rules are applicable for hazardous wastes specified in Schedule and do not apply

to wastewater and air emissions covered under Air and Water Acts, and also radio-active wastes

and wastes arising out of ship operations beyond 5 Kms distance in Sea. Some of the

responsibilities of the industry include:

a) The Occupier and the Operator of a facility shall be responsible for proper collection,

reception, treatment, storage & disposal of hazardous waste listed in Schedule-1, 2 & 3.

b) It shall be the responsibility of the Occupier and the Operator of a facility to take allsteps to ensure that the wastes listed in Schedule-I, 2 & 3 are properly handled and


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disposed off without any adverse effect to the environment.

c) The Operator of a facility to take adequate steps while handling hazardous waste to:

i contain contaminants & prevent accident and limit their consequences on human and

the environment, and

ii provide persons working on the site with information, training and equipment

necessary to ensure their safety.2.4.8 The Manufacture, Storage and Import of Hazardous Chemical Rules, 1989

(1) These rules shall apply to,-

a) an industrial activity in which a hazardous chemical is or may be involved (part I of

Schedule I) and

b) isolated storage of a hazardous chemical in a quantity equal to more than the threshold

quantity (Schedule 2, in column 3)

(2) An occupier who has control of an industrial activity in terms of sub-rule (1) shall provide

evidence to show that he has,-

a) identified the major accident hazards; and

b) taken adequate steps to-

i. prevent such major accidents and to limit their consequences to persons and theenvironment;

ii. provide to the persons working on the site with the information, training and

equipment including antidotes necessary to ensure their safety.

2.4.9 The Rules for the Manufacture, Use, Import, Export and Storage of Hazardous Micro-

organisms / Genetically Engineered Organisms or Cells, 1989.

These rules are applicable to the manufacture, import and storage of

micro-organisms and gene-technological products. These rules shall apply to

genetically engineered organisms/micro-organisms and cells and

correspondingly to any substances and products and food and stuff, etc., of

which such cells, organisms or tissues thereof form part.These rules shall also apply to new gene-technologies apart from those referred to in

clauses (ii) and (iv) of rule 3 and these rules shall apply to organisms/micro-organisms and cells

generated by the utilization of such other gene technologies and to substances and products of

which such organisms and cells form part.

2.4.10 The Chemical accidents (Emergency planning, Preparedness and Response) Rules,

1996

1. The Central Crisis Group shall be the apex body to deal with major chemical accidents

and to provide expert guidance for handling major chemical accidents.

2. Without prejudice to the functions specified under sub-rule (1), the central Crisis Groupshall,-

a) continuously monitor the post-accident situation arising out of a major chemical

accident and suggest measures for prevention and to check recurrence of such

accidents;

b) conduct post-accident analysis of such major chemical accidents and evaluate

responses;

c) publish a statewise list of experts and officials who are concerned with the handling

of chemical accidents;

d) render, in the event of a chemical accident in a state, all financial and infrastructural

help as may be necessary.


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2.4.11 The Forest (Conservation) Act, 1980

This act was enacted to provide for the conservation of forests and for ancillary matters

connected with it. The act sets restriction on the dereservation of forests or use of forest land for

non-forest purpose for the State Government or other authority except with the

prior approval of the Central Government, for

i. To de-reserve any reserved forest;

ii. Use forest land for any non-forest purpose;

iii. Any forest land cleared of trees which have grown naturally in that land or portion, for

the purpose of using it for reafforestation.

2.4.12 The Drugs and Cosmetics Act, 1940 and Rules, 1945

Drugs and Cosmetics Act, 1940 is enacted to regulate the import, manufacture,

distribution and sale of drugs and cosmetics with the main object being the ensurance of

availability of standard quality drugs and cosmetics to the consumer and to prevent substandard

of medical treatment. In order to achieve the objects of the Act, drug is defined

comprehensively to include substances which are not only medicines but also substancesintended to be used for or in the treatment of diseases of human beings or animals. Also, the

legislative designedly extended the definition of drug so as to take in substances which are

necessary aids for treating surgical or other cases. The section 18 prohibits the manufacture for

sale, sale and distribution of adulterated, substandard and spurious drugs and cosmetics and the

manufacture for sale, sale and distribution of drugs or cosmetics except and in accordance with

conditions of licenses. Similar prohibitions are provided in respect of import of drugs and

Ayurvedic drugs. The amendments to the Drugs and Cosmetics Rules, 1945 was made by the

Central Government and now called the Drugs and Cosmetics (1stAmendment) Rules, 1998.

2.4.13 The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954

The main object and purpose of the Act is to prevent people from self-medication with

regard to various diseases as self medication in respect of diseases of serious nature has a

deleterious effect on the health of the Community and is likely to affect well being of the

people. The Act, has thus, been enacted with a view to control the advertisement of drugs in

respect of certain cases and to prohibit the advertisement for certain purposes of remedies

alleged to possess magic qualities.

2.4.14 The Drugs Prices (Control) Order, 1995

Drugs (Prices Control) Order, 1995 has been issued by the Central Government in

exercise of the powers under Section 3 of the Essential Commodities Act, 1955. The object of

the order is ensure availability of drugs at reasonable price, to prevent monopoly situation and togive effect to the New Drug Policy 1994.

2.5 RELEVANT POLICIES

The following list of the policies related to environment and pharma have been formed

since 1894:

1. Industrial Policy Resolution, 1948

2. National Forest Policy, 1894, 1952, 19883. Industrial Policy, 1956


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4. Industrial Policy Resolution, 1948

5. The Industrial Policy, 1991

6. The Policy Statement for Abatement of Pollution, 1992

7. The Export-Import Policy, 1997

8. National Health Policy, 2002

9. Pharma Policy, 2002

It is evident that the Policies being pursued presently have been evolved with experience

and with the considerations of various national and international developments and the country's

requirements for development. The Policies outline the guiding principles for the various

developmental and industrial activities. In addition to the National Policies some of the

pharmaceutical companies have formulated their own policies.

2.5.1 The National Forest Policy

The concern for the conservation and management of the forest wealth in the country is

almost 150 years old and the first effort on this account was made in the year 1855 with the

issuance of the 'Charter of Indian Forestry' and then the first Forest Policy in 1894. The firstForest Policy of the independent country was formulated as the National Forest Policy, 1952.

The National Forest Policy, 1988 was formulated and issued on 7 thDecember, 1988. This

Policy laid stress on the following.

1. Maintenance of environmental stability through preservation and, if necessary,

restoration of ecological balance that had been adversely affected by serious depletion of

the forests in the country.

2. Conserving the natural heritage of the country by preserving the remaining natural

forests having a vast variety of flora and fauna, which represent the remarkable

biological diversity and genetic resources of the country.

3. Checking soil erosion and denudation in the catchment areas of rivers, lakes,reservoirs, etc. in the interest of soil and water conservation, for mitigating floods and

draughts, and for the retardation of siltation of the reservoirs.

4. Checking the extension of sand dunes in the desert areas of Rajasthan and along

coastal tracts.

5. Increasing substantially the forest/tree cover in the country through massive

afforestation and social forestry programs, especially on all denuded, degraded and

unproductive land areas.

6. Meeting the requirements of fuel wood, fodder, minor forest produce and small

timber of the rural and tribal population.

7. Increasing the productivity of the forests to meet the essential national needs.

8. Encouraging efficient utilization of forest produce and maximizing substitution of

wood.

9. Creating a massive people's movement with the involvement of women for achieving

the above objectives and to minimize pressure on the existing forests.

It is noted from the outlines of the National Forest Policy 1988 that there is now a greater

emphasis on the expansion, conservation and preservation of the forests and ecology.

2.5.2 The National Environmental Policy

Although since long there was a concern for the environmental management in the

country as evident from the various Policies and Legislation the lead was given in the Sixth Plan

when a Chapter on 'Environment and Development' was included in the Plan document. The


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Chapter laying emphasis on the problems of environmental degradation provided guidelines to

the administrators for formulating and implementing the development programs incorporating

environmental concerns and laying down the institutional arrangements for environmental

management, administration and protection. The Eighth Plan on the basis of the overview of the

environmental and forest scenario identified the eight major tasks to meet the challenge of

environmental degradation.To complement the Constitutional sanctions, outlines earlier, MoEF in 1992 brought out

a Policy Statement for Abatement of Pollution and the National Conservation Strategy and

Policy Statement on Environment and Development which provides instruments in the form of

legislation and regulation, fiscal incentives, voluntary agreements, educational programs and

information campaigns for preventing, controlling and reducing environmental pollution. The

overall objective of the Policy was to integrate environmental considerations into decision

making at all levels and to achieve this, the following specific steps were identified.

1. Prevent pollution at source.

2. Encourage, develop and apply the best available practical solutions.

3. Ensure that polluter pays for the pollution control arrangements.4. Focus protection on heavily polluted areas and river stretches.

5. Involve public in decision making.

6. Increase the safety of industrial operations.

The MoEF issued the Environmental Action Programme in 1993 with the objective of

integrating the environmental concerns into the process of development. The various issues

addressed were reducing pollution at source, assistance for adaptation of the best available and

practicable technologies, mass based standards, fiscal measures, environmental audit,

environmental statistics, and public participation.

The National Conservation Strategy and Policy Statement on Environment and

Development, 1992 formulated with a view to reinforcing traditional ethos and to building up aconservation society living in harmony with nature and making efficient use of the resources

guided by the best available scientific and technical knowledge aimed at the following.

1. Ensuring sustainable and equitable use of the resources for meeting the basic needs of

the present and future generations without causing damage to the environment.

2. Preventing and controlling the future deterioration of the life support systems.

3. Taking steps for restoration of ecologically degraded areas and for environmental

improvement in the rural and urban settlements.

4. Ensuring that the developmental projects are correctly cited with least adverse

environmental consequences.

5. Conserving and protecting the coastal areas and marine eco-systems.

6. Protecting the scenic landscapes, areas of geomorphological significance, unique and

representative bio-mass and eco-systems and wild life habitats, heritage sites/structures and

areas of cultural heritage/importance.

For achieving the above the following actions were envisaged in the Policy.

1. Environmental impact assessment of all the developmental projects right from the

planning stage and integrating it with their cost-benefit considerations.

2. Compulsory prior environmental clearance of all projects above a certain size and for

those proposed to be constructed in ecologically sensitive and fragile areas.


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3. Incorporation of environmental safeguards and protection measures in policies, planning,

site selection, choice of technology and implementation of the developmental projects,

i.e., industries, mining and mineral processing, forestry and human settlements.

4. Encouraging research and developmental activities, adaptation of environmentally

compatible technologies, and to promote application of the modern tools of science and

technology for conservation, bridging of large gaps in supply and demand as well ascontrolling and monitoring of the natural resources.

5. Encouraging public participation in environmental improvement programs and integrating

the environmental concerns in planning and implementation of the developmental

programs.

6. Creating environmental consciousness through education and mass awareness programs.

7. Aiming at the modernization of the process of demand unleashed by the development

process itself by taking measures to recycle waste materials and natural resources,

conserving energy and the use of the natural resources in the industrial products by

measures like wood substitution and generally trying to reach moderation in life style

consistent with the sustainable development and the human dignity.8. Developing appropriate organizational structure and a pool of professional manpower to

serve as the cadre for environmental management services.

9. Efficiently implementing the various environmental laws and regulations for

environmental protection through creation or strengthening of requisite enforcement

machinery.

It is evident that the Policy directives mean effective protection and management of

environment in all the developmental and industrial activities while keeping the goal of

sustainable development in view.

2.5.3 The National Industrial Policy

The New Industrial Policy, 1991 was formulated to provide an impetus to the pace of

industrialization in the country. This resulted in abolition of all industrial licensing for all the

industries except some specified industrial sectors. The Policy addresses the environmental

concerns along with objectives of sustainable development and states:

The major objectives of the new industrial policy package will be to build on the gains

already made, correct the distortions or weaknesses that my have crept in, maintain sustained

growth in productivity and gainful employment and attain international competitiveness. The

pursuit of these objectives will be tempered by the need to preserve the environment and ensure

the efficient use of available resources.

The New Industrial Policy lays stress on the following for the sustained development and

growth of the industry in the country.

1. Substantial reduction in the scope of industrial licensing.

2. Simplification of procedures, rules and regulations.

3. Reforms in the Monopoly and Restrictive Trade Practices Act.

4. Reduction of the areas reserved exclusively for the public sector.

5. Disinvestment of selected public sector enterprises.

6. Enhancing limits of foreign equity participation in domestic industrial undertakings.

7. Liberalization of trade and exchange rate policies.

8. Rationalization and reduction of customs and excise duties.9. Extension of the scope of modified value added tax (MODVAT).


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2.5.4 National Health Policy - 2002

A National Health Policy was last formulated in 1983, with the following noteworthy

initiatives:

i. A phased, time-bound programme for setting up a well-dispersed network of

comprehensive primary health care services, designed in the context that

elementary health problems can be resolved by the people themselves;

ii. Intermediation through Health volunteers having appropriate knowledge, simple

skills and requisite technologies;

iii. An integrated net-work of evenly spread speciality and super-speciality services;

encouragement of such facilities through private investments for patients who can

pay, so that the draw on the Governments facilities is limited to those entitled to

free use.

NHP-1983, in a spirit of optimistic empathy for the health needs of the people,

particularly the poor and under-privileged, had hoped to provide Health for All by the year

2000 AD, though in retrospect, it was observed that the financial resources and public health

administrative capacity which it was possible to marshal, was far short of that necessary to

achieve such an ambitious and holistic goal. Against this backdrop, the recommendations of

NHP-2002 make an attempt to maximize the broad-based availability of health services to the

citizenry of the country on the basis of realistic considerations of capacity.

The main objective of this policy is to achieve an acceptable standard of good health

amongst the general population of the country. The approach would be to increase access to the

decentralized public health system by establishing new infrastructure in deficient areas, and by

upgrading the infrastructure in the existing institutions.

2.5.5 The Pharma Policy 2002:

Any analysis of the recently announced Pharmaceutical Policy need to take into accountits role in ensuring the welfare of all the stakeholders that the stated Policy will affect in future

years. That includes the patients, who should be the ultimate beneficiaries, the Country and its

economic well being and the Indian Pharmaceutical Industry.

It is significant that the National Health Policy-2001 was announced a few months

earlier to the Pharmaceutical Policy-2002. One would have expected that the National Health

Policy would have devoted a section on the role of the Pharmaceutical Industry in providing

healthcare to the millions of Indians who have to have drugs as a basic need. In fact, the drugs

component of healthcare is higher in developing countries than in the developed World, since

due to the very slow improvements in public health measures witnessed in these countries, use

of drugs constitutes the most cost-effective approach to health care. And yet, there are hardlyany serious references in the National Health Policy on the role of drugs in reducing morbidity

and mortality, resulting from preventable diseases. Ideally, the two policies should have been

dovetailed, since their objectives have a high degree of commonality. For example, while

discussing and quantifying the goals and targets to be achieved in health, nutrition and disease

areas during the coming decade and a half, there is no analysis in the Health Policy of the

strategies to be adopted by the Pharmaceutical Industry to achieve those targets.

A plethora of new challenges face the Indian Pharmaceutical industry in the wake of

Indias commitment under the GATT and WTO, of which TRIPS is the most relevant part

affecting the industry. And it is in this context the present policy document is evaluated.

According to the Policy, on the licensing front, all shackles are being removed for all sectors of

the industry, reservations for the Public and Small Scale sectors have been abolished, and nominimum or maximum production levels have been prescribed, automatic approvals for import


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11

of technology for bulk drugs allowed and foreign investments even up to 100% equity

permitted.

2.6 REGULATORY CONCERNS ONNUTRACEUTICALS:

The class of products christened 'Nutraceuticals' had a relatively late entry into the

Indian Healthcare scene, even though diverse preparations originating from Indian Systems of

Medicine (ISM), notably Ayurveda have been marketed by several Companies, mostly as healthrejuvenators for decades. The approval for marketing these products are granted by State

Governments' Regulatory Agencies under the advise of experts in ISM.

The general principle adopted is that the constituents of the preparation should have been

mentioned as therapeutically useful in one or more of classical texts of ISM or in published

Pharmacopoeias. In such cases no additional clinical validation of their safety or efficacy is

required to be provided. The products are marketed as ISM drugs under the OTC category. To

encourage the revival and promotion of such products, the Government of India has provided

incentives in the form of tax benefits, and relief from administered prices, in addition to much

less stringent licensing or regulatory controls and standards.

The confusion not only among the regulatory agencies but also among the consumersincluding the medical profession as well as the patients arise out of the lack of clarity in defining

the precise nature, function and utility of these products as well as ambiguities with regard to

their safety and efficacy.

2.6.1 Mashelkar Committee Recommendations

India has specific Food Laws, of which only the Prevention of Food Adulteration (PFA)

comes under the purview of the Drugs & Cosmetics Act. Certain types of Nutraceuticals, which

fall under "Patent & Proprietary Medicines", which may or may not claim therapeutic properties

and Cosmetics, which have no therapeutic utility, are included under the Drugs & Cosmetics

Act. Even though there have been earlier recommendations by Committees constituted by the

Director General of Health Services (DGHS) and the Department of ISM & H of the Ministry ofHealth in 2000 and 2002 respectively, no decisions have been taken so far on their

implementation by the Government.

The processes of manufacture include extraction and fractionation, fermentation using

product-specific micro organisms and chemical synthesis. Even the same dietary supplement

manufactured by different manufacturers do not often meet the same standards and

specifications Thus it is obvious that evolving a uniform standard for the Dietary Supplement of

identical composition whether classified under the Food or Drug category is not easy.

Considering all these issues and taking into account the various earlier recommendations

during the last five years by different agencies on the subject, it was considered prudent to

recommend a regulatory system to streamline the activities of the Nutraceuticals Industrythrough appropriate legislations under the Drugs & Cosmetics Act or under the Food Act,

prevailing in the Country. The following recommendations when implemented will ensure that

the Industry will provide quality products manufactured under Good Manufacturing practices

and supported by adequate and sound evidence for their safety and efficacy.

1) All Nutraceuticals in the market or to be marketed to be classified as either Dietary (Food)

Supplements or as Drugs as defined under the Food Acts or the Drugs & Cosmetics Act.

2) Food Supplements, which do not have on their labels and /or are not promoted as having

therapeutic properties should be regulated under Food Laws, which need to be amended if

necessary to include them.

3) Products which claim to have utility as prophylactics, diagnostics or therapeutic agentsshould be considered as Drugs and would come under the purview of the Rules & regulations

under the Drugs & Cosmetics Act.


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4) Whether they should be under Schedule H, Schedule K or under a new category of OTC

drugs is to be determined by their safety profiles and track record of use.

5) In both cases, adequate evidence consistent with the claims made should be provided to

establish their safety and efficacy in humans.

6) If retrospective data is not adequate, prospective studies should be carried out.

7) All products regardless of the categorization should meet minimum current GoodManufacturing Standards (cGMPs).

8) The labels should have list of contents, their composition, warnings on safety and possible

adverse reactions and shelf life where relevant.

2.7 RELEVANT INSTITUTIONS

Five departments are directly involved in the protection of environment due to Pharma

Industries and quarrying activity in the state, including the Ministry of Environment and Forest,

Govt. of India; The Department of Forests, Ecology and Environment, Govt. of Karnataka; and

Karnataka State Pollution Control Board

2.7.1 Ministry of Environment and Forest, Government of India

Ministry of Environment and Forest (MoEF) is the nodal agency at national level, in the

administrative structure for environmental protection and forest conservation. MoEF is assisted

by the Central Pollution Control Board (CPCB), a statutory authority at the central level in

executing responsibilities of prevention and control of pollution. Implementation of relevant

Acts and Rules and policy issues at the State level is overseen by the State Pollution Control

Boards (SPCB) and the State Department of Environment and Forest (DOEF). The governing

Acts and Rules are: Environment Protection Act-1986, Forest Conservation Act-1980 and rules

there under.

2.7.2 Department of Ecology and Environment, Government of Karnataka

Department of Ecology and Environment (DEE) is the state nodal regulating agency

responsible for environmental management of the state and can exercise promotional and

regulatory functions in pharma sector under the Air, Water and Environment Protection and

Forest Conservation Acts. The department also houses the State Environmental Clearance

Committee (SECC) which gives clearances to mining projects (major minerals) with lease area

less than 5 ha and mining projects (minor minerals) above 0.5 ha. The applications seeking

environmental clearances as per the EIA notifications are routed through DEE.

2.7.3 Karnataka State Pollution Control Board

KSPCB has regulatory and enforcement responsibilities with respect to air, water

pollution control and hazardous waste management in pharmaceutical under the Water(Prevention & Control of Pollution) Act, 1974, the Air (Prevention & Control of Pollution) Act,

1981 and rules there under, the Environment Impact Assessment Notification, 1994 & 1997 and

Hazardous Waste (Management & Handling) Rules, 1989 & amendments rules 2000. KSPCB

is responsible for conducting public hearing under Environmental Impact Assessment (EIA)

2.8 GUIDELINESSET BY KARNATAKASTATE POLLUTION CONTROL BOARD FOR SETTING

UP PHARMACEUTICALINDUSTRIES

1. The factory shall segregate the waste streams as biodegradable, non-biodegradable,

and inorganic streams etc., based on their characteristics and adopt appropriate methods of their

treatment and disposal.

2. A state of the art effluent treatment system shall be installed to treat the effluents tothe standards stipulated. The treatment of effluents shall ensure that the effluents are free from

toxic and hazardous effects.


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3. Transportation .of toxic effluent from one stage to another, only for the sake of

disposal by dilution is prohibited.

4. The discharge of effluents into streams, rivers or surface water bodies is strictly

prohibited

5. The treated effluent conforming to stipulated standards shall be used on land for

agriculture. The factory shall own/acquire sufficient area of land for this purpose. Theapplication of effluent shall be controlled in such a manner as not to cause either flooding of

land or underground water pollution. Before allowing the use of treated effluent for irrigation,

the State Pollution Control Board shall ensure that the factory submits a report on geophysical

characteristics and assimilation capacity of land and suitability of effluents for agriculture

through recognized institutions. Adequate number of observation bores/test wells shall be

proved by the factory in and around the effluent irrigated area to monitor ground water quality.

The factory shall get the soil, leachate and ground water in the area analyzed at regular intervals

for parameters based on raw materials used and characteristics of effluent discharged to verify

the fate and effect of any persistent chemical.

6. Boilers, Diesel generating sets etc., shall be provided with chimneys of prescribed

height.7. The general exhaust from different sections shall be collected, and scrubbed to

control emissions. The reactor emissions shall be scrubbed to control emission of different

gases/vapours/fumes.

8. All solvent tanks located above ground level shall be blanketed with Nitrogen, there

by preventing any solvent evaporation and consequently minimizing odorous emissions.

9. State of art incinerator shall be provided wherever feasible to incinerate all

combustible effluents, solids, gases, toxic substances etc. The incinerator shall be fitted with a

chimney of prescribed height and scrubbers to clean the flue gases.

10. The factory shall ensure that the noise levels are within the stipulated limits and the

factory shall conduct periodic monitoring of noise levels at designated location at specified

intervals.11. Solid waste and sludge generated in the factory shall be collected, treated and

disposed of in a scientific manner so as not to cause environmeta1 pollution.

12. The factory shall install water maters to measure the water consumed for different

purposes as per the Water (Prevention and Control of Pollution) Cess Act, 1977, as amended,

and pay water cess.

13. The factory shall submit an Environmental statement Report for the financial year

ending the 31" March in the prescribed form to the State Pollution Control Board on or before

the 15th day of September every year.

14. The factory shall comply with the provisions of the:

i Hazardous wastes (Management and Handling), Rules, 1989.ii Manufacture, Storage and Import of Hazardous Chemicals Rules, .1989.

iii Public liability insurance Act and Rules, 1991

as amended from time to time, if applicable

15. All tanks used for the collection and treatment of effluents shall be made impervious

by providing adequate cement concrete/stone masonry/stone slab lining with leak-proof joints at

the bottom and sides. 1 observation bores with pipes shall be provided around such tanks and

monitored for leakage.

16. The factory shall upgrade the pollution control systems as and when new

technologies become available.

17. The factory shall ensure continuous and effective operation and maintenance of

pollution control systems by employing qualified Environmental Engineers/Scientists.18. The factory shall ensure continuous and uninterrupted power supply to see that the


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3 RESPONSIBILITIES OF THE PHARMACEUTICAL AUTHORITIES

3.1 APPROVALS

Approval for setting up Pharmaceutical Industries includes:

1 Should obtain the Environmental Clearance Certificate as per

Environmental Impact Assessment Notification, 1994 and its

amendments from the Ministry of Environment and Forests, GoI. The

application seeking environmental clearance (Schedule II of EIA

Notification) should be routed through Department of Forest, Ecology and

Environment for consideration after mandatory public hearing.

2 All the entrepreneurs before establishing an industry have to obtain consent for

establishment.

3 Any person who is likely to establish or take any steps to establish any Industrial Plant or

process or any treatment and disposal system or any extension or addition which is likely to

discharge sewage or trade effluent into any stream or well or sewer or on land has to obtain

consent of the Board.

4 Similarly any person who is likely to establish or operate any industrial plant in any air

pollution control area (Entire Karnataka has been declared as air pollution control area) is

not permitted to discharge or cause or discharges the emission of any air pollutant in excess

of the standards laid down by the State Board. These emissions shall be with prior consent

of the State Board.

3.2 RESPONSIBILITIES

Should comply with the consent conditions laid down by State Pollution Control Board

Should maintain relevant log books for daily water consumption, raw material used and

products manufactured, energy use and consumption, hazardous and solid wastegenerated, waste water generated, air emissions, etc.

Should submit yearly Environmental Statement to the concerned State Pollution

Control Board

Should submit yearly Water Cess Returns to the concerned State Pollution Control

Board

Should provide for wastewater treatment facility, air pollution control devices.

Should provide for safe drinking water and proper sanitation amenities for the workers

and also take into considerations the health and safety of the workers.


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4 WATER AND AIR (PREVENTION & CONTROL OF POLLUTION) ACTS

The Water (Prevention & Control of Pollution) Act is an act to provide for prevention of

control of water pollution and maintaining or restoring of wholesomeness of water while, the

Air (Prevention & Control of Pollution) Act provides for the prevention, control and abatement

of air pollution. Under these two acts any new industry prior to commissioning should obtain

consent of the concerned State Pollution Control Board to establish and to operate.

4.1 CONSENT PROCEDURE

All new establishments like industries, water and wastewater treatment

systems, sewage treatment systems are required to obtain Consent for

Establishment and subsequently obtain Consent for Operation under the Air

and Water Acts. All the consent applications received will be subject to technical

evaluation and conditions imposed to protect the environment. Application Form I

and Form XIII, under the Air and Water Act, respectively, to be filled by the

applicant along with the consent fee and relevant documents. Pass Book system has

been introduced for renewal of consents.Depending upon the industries varying in pollution potential (red, orange, and green) and

capital investment (small scale, medium scale, and large scale) the consent fees varies.

The industries under large scale and medium scale RED category are required to obtain

consent every year.

Medium scale ORANGE and GREEN category industries are required to obtain consent

every year with an option for once in two years by paying two years fee.

Small scale RED, ORANGE and GREEN category have to obtain consent every year

with an option of once in three years by paying three year fee.

Tiny industries have to renew consent once in ten years by paying one year consent fee.

See Annexure II for Consent fee, frequency of consent application and the periodicity ofmonitoring based on the classification of industries.


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5 WATER (PREVENTION & CONTROL OF POLLUTION)

CESS ACT

The purpose of Water (Prevention & Control of Pollution) Cess Act is levy and collect

cess on water consumed by 16 categories of industries specified in the schedule I of the act and

also by local bodies with a view to augment the resources of the Central and State PollutionControl Boards. Water cess is levied based on the water consumed for domestic and specified

industry. Cess is calculated on rate specified in Schedule II of the Act for different water users.

As per section 4 of the act the concerned industries are required to install standard water meters

at such places as may be required by the concerned authority for measuring and recording the

quantity of water consumed by the industry. The industry consuming water shall furnish the

cess returns in the prescribed form on or before 5thof every month to the Member Secretary of

the State Pollution Control Board. The authority assesses the returns filed after due verification

and amount payable is intimated to the user, which should be paid by demand draft by the user.

If the industry complies with the regulation by providing effluent treatment plant which

meets the standards prescribed in terms of quantity and quality, it is entitled to a rebate of 25%.


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6 ENVIRONMENTAL IMPACT ASSESSMENT NOTIFICATION

Under the Environmental Impact Assessment Notification of 27/1/1994 and subsequent

amendments made on 04/05/1994, 10/04/1997, 27/1/2000, 13/12/2000, 01/08/2001 and

21/11/2001, powers are conferred on the Central Government by sub-section (1) and clause (v)

of sub-section (2) of section 3 of the Environment (Protection) Act, 1986 (29 of 1986) read with

clause (d) of sub-rule (3) of rule 5 of the Environment (Protection) Rules, 1986. Any expansion

or modernization of any activity (if pollution load is to exceed the existing one), or new project

listed in Schedule I to this notification, should be accorded environmental clearance by the

Central Government in accordance with the procedure specified in this notification.


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Obtaining Environmental Clearance

nd is

No

Yes

Yes

Yes

No

Yes

No

No

Yes

Environmental Clearance issuedby Min. of Env. &. Forests

along with Stipulations

Recommended

by EAC

Public hearingarranged

Is the project

acceptableCan Issues be

resolved?

Investors advised

to look for

alternate site

Apply to Union

Min. of Env. &Forests in

prescribed

questionnaire

Apply to stateDOEn for

Environmental

Clearance

Does the Project

fall under schedule-

I of EIA

notification

Apply also

to CCF in

case of

forest la

involved.SPCB issues

NOC

RejectCan Issues be resolved

Submits Project questionnaire to

concerned SPCB

Investor

Is the project

site acceptable

Is the informationprovided adequate

Review by

Environmental Appraisal

Committee of the Min.

of Env. &. Forests

Initial scrutiny by staff of

Min. of Env.&.Forests

Submission of the project to the Min. of Env. &. Forestsalong with all documents listed at Part I of the handbook

Scoping by investor

Yes

No

Reject

Prepare comprehensive

EIA or any specific

study suggested by the

committee

Is site

acceptableNo

EAC Members

undertake site

visits

Is there a

public outcry

against the

project

Is the Environmental

Management Plan satisfactory

Review by SPCB


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7 ENVIRONMENTAL STATEMENT PROCEDURES

Environmental Management in industries hitherto based on and off pipe waste treatment,

is now based on the emerging philosophy of waste prevention and reduction. In order

to prevent or reduce waste generation, one needs to examine the production processes,to identify the origins of wastes, the operational problems associated with the

process and the areas requiring improvement. As per the notification issued by the

Ministry of Environment & Forest, Government of India on 13thMarch, 1992

(amended vide notification no. GSR 386 (E) dtd. 22.04.1993) under the

Environment (Protection) Act, 1986, all those carrying on an industry, operation or process

requiring consent to operate under section 25 of the Water (Prevention & Control of Pollution)

Act, 1974 and / or under section 21 of the Air (Prevention & Control of Pollution) Act, 1981

and/ or authorization issued under the Hazardous Waste (Management & Handling) Rules, 1989

and the Environment (Protection) Act, 1986 are required to submit the environmental statement

for every financial year ending 31stMarch in the prescribed form [Form V] to the concerned

State Pollution Control Boards on or before 30thday of September every year beginning 1993.Non-compliance with this mandatory requirement amounts to violation of the Environment

(Protection) Act, 1986.

7.1 CONTENTS OF ENVIRONMENTALSTATEMENT

A statement prepared by the industry shall include the following;

a. A description of the companys activities at site considered

b. An assessment of all the significant environmental issues relevant to there

activities

c. A summary of the figures on energy consumption, water consumption, raw

materials consumption, pollutant emissions, waste generation and othersignificant environmental aspects.

d. The industrys environmental policy objectives and targets

e. Details of the programme to be followed and the environmental management

system.

Environmental Statement helps industry to take a comprehensive role at their industrial

operations and facilities, understandings of material flows and focus on areas where waste

reduction and consequently saving input costs, if possible. Environmental Statement is to be

prepared by every industry by filling up one Environmental Statement Form V (enclosed vide

Annexure ) supplied by Pollution Control Board.

For the preparation of Environmental Statement, log book need to be maintained by the pharmaauthorities in their premises which would make the statement summarising easier. The log book

list is provide below

a. Water log book

b. Raw Material log book

c. Energy log book

d. Pollutant log book

e. Hazardous log book

The day to day summary from the log book can be summarised on monthly basis. A sample log

book is provided in Annexures.


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8 ENVIRONMENTAL AUDITING

Environmental Audit has become a step to comply with the requirement to furnish the

Environmental Statement, though the importance of environmental audit lies in achieving

increased productivity and reduced waste generation. Auditing in general is a methodical

examination involving analysis, tests and confirmation of local procedures and practices whose

goal is verify whether they comply with legal requirements, internal polices and accepted

practices. Auditing differs from assessment in that it requires collection and documentation of

competent and sufficient evidence rather than an opinion based primarily on professional

judgement.

Environmental Audit is a technique being introduced for integrating

the interest of the industry and the environment so that there could be

mutually supportive. This technique is basically a part of industrys

internal procedures to meet their responsibilities towards better

environment. Environment Auditing is a management tool comprising a

systematic documented periodic and objective evaluation of how well the

management systems are performing with the aim of: Waste preventive and reduction

Assessing compliance with regulatory requirements

Facilitating control of environmental practices by a companys management, and

Placing environmental information in the public domain.

Environmental Audit in India is different from that in developed countries and the

definition of International Chamber of Commerce (ICC) is accepted. ICC defines

Environmental Audit is It is a management tool comprising a systematic, documented, periodic

and objective evaluation of how well environmental organization, management and equipment

are performing with the aim of helping to safe guard the environment by:

Facilitating management control of environmental practices.

Assessing compliance with company policies, which would include meeting,

regulatory requirement.

Environmental Statement which is a part of the Environmental Audit.

Environment Policy means a statement of a companys overall aims and principles of

action with respect to the environment.

8.1 FEATURES OF A GOOD ENVIRONMENTALAUDIT

A good Environmental Auditdefines sources, quantities & types of waste generation

Collates information on unit operations, raw materials, products, water usage and

wastes and increases knowledge of the process.

Highlights process and poor management

Helps to set targets for waste reduction

Permits the development of effective waste management strategies.

Rises awareness in the workforce regarding the benefits of waste reduction

Helps to improve process efficiency

Enables legislative compliance & avoids litigation.


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8.2 AUDIT PROCEDURE

A step-by-step methodology for Environmental Audit as recommended by the United

Nations Environment Programme and the United Nations Industrial Development Organisation

(UNIDO) is illustrated in figure 1.

Phase 1: Pre-AssessmentAUDIT PREPARATION

Step 1 Prepare and organise audit team and resources.

Step 2 Divide Process into unit operation

Step 3 Construct process flow diagram linking unit

operations

PROCESS OUTPUTS

Step 7 quantify products / by-products

Step 8 Account for waste water

Step 9 Account for gaseous emissions

Step 10 Account for offsite wastes

PROCESS INPUTS

Step 4 Determine inputs

Step 5 Record water usage

Step 6 Measure current levels of

waste reuse/recycling

DESERVE A MATERIAL BALANCE

Step 11 Assemble input and output Information

Step 12 Derive a preliminary material balance

Step 13 and 14 evaluate and refine material balance

IDENTIFY WASTE REDUCTION OPTIONS

Step 15 Identify obvious waste reduction measures

Step 16 target and characterize problem wastes

Step 17 Investigate the possibility of waste segregation

Step 18 Identify the long term waste reduction measures

EVALUATE WASTE REDUCTION OPTIONS

Step 19 Undertake environmental and economic

evaluation of waste reduction options, list viable

WASTE REDUCTION ACTION PLAN

Step 20 Design and implement a waste reduction

action plan to achieve improved process efficiency

Phase 3: Synthesis

Phase 2: Material Balance

Quick Reference Audit Guide


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9 ENVIRONMENTAL PERFORMANCE

VERIFICATION EXERCISE

The Pharma authority is required to seek Environmental Clearance from the Ministry of

Environment and Forest, GoI, for a new or proposed expansion / modernisation and submitEnvironmental Impact Assessment report while applying for Environmental Clearance. The

authorities are also required to submit yearly Water Cess Returns and Environmental

Statement to the concerned State Pollution Control Boards. As of now, though the

Environmental Impact Assessment report is submitted through the State Pollution Control

Board, there is no provision to link the EIA report with the Environmental Statement which is

submitted yearly. However, this is an important step which would not only give the yearly

compliance but also the status of the environment over a period of time.

In this chapter we are suggesting the following activities which would provide a rigorous

analysis of environmental statement submitted by the Pharma authorities and develop an

effective institutional arrangement for implementing Environmental Audit in the state.

Verification of Environmental Audit by the Regulatory Authorities

Verification of Environmental Audit by the Third Party

For the verification process the following steps are suggested:

Step 1: Verification of maintenance of Log Books

Step 2: Verification of maintenance of Yearly Resource Auditing Books

Step 3: Verification of compliance Consent Aspects

Step 4: Verification of Environmental Aspects

Step 5: Verification of Environmental Statement in line with the data provided with the data

submitted with Environmental Impact Assessment report.


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10 TYPES, SOURCES AND NATURE OF POLLUTION FROM PHARMACEUTICAL

INDUSTRY

10.1 INTRODUCTION

This chapter dea1s with the current environmenta1 issues in the manufacturing processes

of the pharmaceutica1 (bulk and formulations) industries. The processes in the pharmaindustries vary from company to company and therefore, for burgeoning environmental

professionals it is necessary to have an accurate knowledge of general manufacturing process,

waste streams, available technology, and regulatory issues affecting the pharma industries. This

chapter helps in

Understanding the diverse nature of pharmaceutical processes, and their varied

operations for manufacturing, purifying, and packaging drug products.

Learn about the typical ingredients used to manufacture pharmaceutical products.

Discover how the diverse manufacturing processes, reactions, and hazardous materials

produce a wide range of chemical and biological wastes.

Become familiar with the treatment technologies the industry is using to manage wastesafter they are generated.

Identify the pollution prevention efforts that companies can use for cost containment in

the pharmaceutical industry.

It is impractical to list the exact interpretations for individua1 manufacturing situations;

therefore, when in doubt about the impact of a particular process, it is essential that you consult

with appropriate agencies, and legal in house experts.

10.2 PHARMACEUTICALMANUFACTURINGPROCESSES

The pharmaceutica1 manufacturing industry encompasses the manufacture, extraction,

process, purification, and packaging of chemica1 materia1s to be used as medication or have a

therapeutic va1ue for humans or anima1s. A broad range of products that include natura1

substances from plants or anima1s, metals, organics, and wholly inorganic materia1s

characterizes the industry. The industry is a1so characterized by diversity of processes and

plant sizes, as well as waste quantity and qua1ity.

Pharmaceutical production operations may be batch, semi-continuous, or continuous.

However, batch methods are the most common. Many of the processes encompassed are

proprietary, but the general processes are identified and describing the broad range of

manufacturing processes used in the pharmaceutica1 industries is Figure 1.


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Figure 1: General manufacturing processes used in the pharmaceutica1 industries

Chemical substances Micro organic cultures

External cleaning

(Washing, dust removal)

Synthesis

Direct use(antibiotics in powder

form)

Syrups

drops

phials

Vegetable or animal tissues

ExtractionPharmacologically active

substance

Freeze drying

Fermentation

Capsules

Granules

Tablets

Pills

Proportioning

Ointments

SuppositoriesFreeze -dried

products

Mixing with solid

excipients

Pastes

Dilution in liquids

Powders

Packaging

Manufacturing in the industry can be characterized by four processes namely fermentation,extraction, chemical synthesis, and formulation and packaging.

Fermentation is usually a large-scale batch process and involves fermentation, or

controlled growth of specific micro organisms, in a reactor vessel to produce a desired

product. The desired product is then recovered from the fermentation broth using

solvent extraction, adsorption, precipitation and filtration, or ion exchange. Wastewater

streams generated from fermentation processes include discharges from reactor cleanings

and sterilizations, off-gas scrubber effluents, and occasional off-specification batches.

Solvents used in extracting the product from the broth in the recovery process may be

discharged into the sewers in the wastewater streams as well.

Extraction refers to the extraction and recovery of a small volume of desired productfrom naturally occurring sources such as plant roots and leaves, animal glands, and

parasitic fungi. Extraction operations are usually either batch or semi-continuous.

Wastewater discharges from extraction processes include spent raw materials, solvents

used in extractions, and spills and equipment wash waters.

Chemical synthesis, either through batch or continuous processes (usually batch), is the

most common method of preparing pharmaceuticals. Synthesis of pharmaceuticals

involves reaction of the appropriate raw materials and recovery of the desired product.

Effluents from synthesis operations are highly variable as are the processes by which

they are generated. Process solutions, vessel wash waters, filtrates, concentrates, spent

solvents, and scrubber effluents are all sources of wastewater. Pump seal water, spills,and cleaning wash waters are additional sources. Any of these sources may contain

significant concentrations of volatile organics.


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Mixing, compounding, and formulating operations involve preparation of the active

ingredients into a dosage form for consumer use. The primary sources of wastewater

from these processes are from equipment washings, scrubber effluents, and spills.

Although wastewater streams from all four processes have the potential to contain high organic

loadings, fermentation and synthesis operations usually generate larger volumes of wastewater,

and the wastewaters generated usually contain higher organic loadings. Thus, thepharmaceutical manufacturing industry discharges significant quantities of organic compounds

intheir raw wastewaters as the industry primarily uses organic compounds as raw materials or

solvents.

10.3 COMPOSITION OF PHARMACEUTICALPRODUCTS

To understand the treatment of wastewaters it is very important to know the composition of

wastewaters, which in turn depends on the products that are manufactured either in the bulk or

in the formulations industries. This section outlines the various dosage forms and their rough

compositions, which later express themselves as pollutants in wastewaters. Table 1 outlines

dosage forms of pharmaceutical products and composition.

Table 10.1:Dosage forms of pharmaceutical products and compositionDOSAGE FORM CONSTITUENTS & PROPERTIES

Liquid solutions

Aromatic waters Volatile solids and oils, water

Liquors or solutions Water, chemicals

Syrups Sweetener, solvent, medicinal agent

Elixirs Sweetened hydro alcoholic solution, may be medicated

Spirits, essences Alcohol, water, volatile substances

Tinctures Natural drugs, extracted with appropriate solvents

Colloidions Pyroxylin in ether, medicinal agent, castor oil, camphor

Liniments Oily or alcoholic solutions, suspensions

Mucilages Colloidal polymer solutions

Parenteral solution Sterile, pyrogen-free, isotonic, pH close to that ofblood; oily or aqueous suspension

Ophthalmic Sterile, isotonic, pH close to that of tears; viscosity

builder

Nasal Aqueous, isotonic, pH close to that of nasal fluid;

sprays or drops

Otic Glycerol based

Mouthwash, gargles Aqueous, antiseptic

Inhalations Administered with mechanical devices

Enemas, douches Aqueous solution or suspension, may include

medicinal agent

Liquid dispersionsSuspensions Powder suspended in water, alcohol, glycol, or an oil;

viscosity builder, wetting agents, preservatives

Emulsions, lotions Oil-in-water or water-in-oil

Gels, jellies, magma Viscous, colloidal dispersions

Semisolid and Plastic

Dispersions

Ointments Hydrocarbon (oil), absorptive water-washable or water-

soluble bases; emulsifying agents; glycol, medicating

agent

Pastes and cerates Ointments with high-dispersed solids or waxes,

respectively

Suppositories Theobroma oil, glycerinated gelatin, or polyethyleneglycol base plus medicinal agent

Solids


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Bulk powder Comminuted or blended, dissolved, or mixed with

water

Effervescent powder Comminuted or blended, dissolved in or mixed with

water

Dusting powder Contains adsorbents

Insufflation Insufflator propels medicated powder into body cavity

Lyophilized powders Reconstitution by pharmacist of unstable productCapsules Small-dose bulk powder enclosed in gelatin shell;

active ingredient plus diluent

Masses or molded solid

pills

Adhesive or binding agents facilitate compounding;

prepared by massing and piping

Trouches, lozenges,

pastilles

Prepared by piping and cutting or disk candy

technology; compounded with glycero-gelatin

Tablet triturates Small molded tablets intended for quick complete

dissolution (e.g., nitroglycerin)

Granules Particle size larger than powder

Compressed tablets Dissolved or mixed with water; great variety of shapes

and formulations

Pellets For prolonged actionCoated tablets Coating protective; slow release

10.4 COMPOSITION OF PHARMACEUTICALPROCESS WASTES

For a broad understanding of the treatment of wastewaters a typical pharmaceutical

process wastes is summarised below in Table 2.

Table 10.2: Typical pharmaceutical process wastes.

WASTE DESCRIPTION PROCESS ORIGIN COMPOSITION

Process liquors Organic synthesis Contaminated solvents

Spent fermentation broth Fermentation processes Contaminated waters

Spent natural product, rawmaterials Natural product, extractionprocesses Leaves, tissues

Spent aqueous solutions Solvent extraction processes Contaminated water

Leftover raw material,

containers

Unloading of materials into

process equipment

Bags, drums (fiber, plastic, metal),

plastic bottles

Scrubber water from pollution

control equipment

Dust or hazardous vapor

generating processes

Contaminated water

Volatile organic compounds Chemical storage tanks, drums Solvents

Off-spec or out-dated products Manufacturing operations Miscellaneous chemicals

Spills Manufacturing and lab

operations

Miscellaneous chemicals, mercury,

other metals

Wastewater Equipment cleaning, extractionresidues

Contaminated water, pheno-based

Spent solvents Solvent extraction or wash

practices

Contaminated solvents

Used production materials Manufacturing operations Filters, tubing, diatomaceous earth

Used chemical reagents R & D operations Miscellaneous chemicals, solvents,

acid/alkaline wastes, radioisotopes,

formaldehyde, photographic

chemicals, silver

Spent ethylene oxide Sterilization operations Ethylene oxide

Miscellaneous wastes Maintenance operations Waste lube oils, vacuum pump oils,

cleaning solvents, paint strippingwastes, leftover paints and

accessories, spent fluorescent lamps,


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trash

Used packaging material Packaging operations Plastic, wood, cardboard, foam

products

Infectious/medical wastes R & D, manufacturing

operations, off-spec products

Vials, biomass, blood products,

human animal specimens

Incinerator exhaust On-site incinerators Metals, oxides

Natural gas combustion products Steam boilers Carbon compounds, oxides ofnitrogen and sulfur, boiler

blowdown, cooling tower sludges,

and sediments

10.5 TREATMENTCONTROL TECHNOLOGIES

From the earlier discussion of pharmaceutical (bulk and formulations) manufacturing processes,

it is apparent that pharmaceutical manufacturing is costly and complex. As already mentioned,

there may be ten to fourteen stages in the manufacture of a single new chemical entity, each

involving many chemicals and generating several waste products. Moreover, the pharma

industry is heavily impacted by QA/QC regulations. Though there are many cleaner production

and waste minimisation options possible for recycling and reuse of some of material, concernsabout quality of the products may drive the industry to use end-of-the-pipe treatment

technologies rather than in-process systems. Table 3 lists treatment control technologies that

can be /have been employed by the pharmaceutical industry to treat process wastewaters.

Table 10.3:Summary of probable end-of-pipe treatment processes for pharmaceutical

wastewatersSR. NO TECHNOLOGY

1 Equalization

2 Neutralization

3 Primary treatment

Coarse settleable solids removal

Primary sedimentation

Primary chemical flocculation/ clarificationDissolved air flotation

4 Biological treatment

Activated sludge

Pure oxygen

Powdered activated carbon

Trickling filter

Aerated lagoon

Waste stabilization pond

Rotating biological contactor

Other biological treatment

5 Physical/chemical treatment

Thermal oxidationEvaporation

6 Additional treatment

Polishing ponds

Filtration

Multimedia

Activated carbon

Sand

Other polishing

Secondary chemical flocculation/

clarification Secondary neutralization

Chlorination

The pharma industries create many different types of waste streams; therefore, it is

impossible to list all the control technologies they use. The pharma industries use a wide variety


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of treatment processes: physical, chemical, biological, thermal, and stabilization. A brief

summary of the treatment processes available to the pharma industries is outlined here.

10.5.1 Physical Treatment Processes

Physical treatment processes are those using physical characteristics to effect a

separation or concentration in a waste stream. The processes are organized into four groupings:

gravity separation, phase change, dissolution, and size/adsorptive/ionic characteristics. Table 4presents the treatment technologies under each of these groupings.

Table 10.4:Physical treatment processes and technologies.

GRAVITY

SEPARATION

DISSOLUTION PHASE CHANGE SIZE/ ADSORPTIVE/

IONIC

CHARACTERISTICS

Sedimentation Soil washing/ flushing Evaporation Filtration

Centrifugation Chelation Air stripping Carbon adsorption

Flocculation Liquid/liquid

extraction

Steam stripping Ion exchange

Oil/waterseparation Supercritical solventextraction Distillation Electrodialysis

Dissolved air

flotation

Heavy media

separation

10.5.2 Chemical Treatment Processes

The chemical treatment processes are the most commonly used waste treatment practices. These

include:

pH adjustment for neutralization orprecipitation

Hydrolysis and photolysis

Oxidation and reduction

Ozonation

Hydrogen peroxide oxidation

Alkaline chlorination

Hypochlorite chlorination

Electrolyte oxidation

Chemical dechlorination

10.5.3 Biological Processes

Biological degradation is fast becoming a viable approach to waste management.

Originally, environmental engineers used biological degradation of hazardous organic

substances in the treatment of municipal wastewater, especially processes based on aerobic

bacteria or anaerobic bacteria. Aerobic biological treatment is a treatment technology

applicable to wastewaters containing biodegradable organic constituents and some nonmetallic

inorganic constituents including sulfides and cyanides. Anaerobic digestion is best suited to

wastes with moderate to high pH non-halogenated hydrocarbons, moderate to low organic

loadings, and low to zero biological oxygen demands. Some of the biological processes include:

Aerobic biological treatment

Activated sludge

Rotating biological contactors

Bioreclamation


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Anaerobic digestion White-rot fungus

10.5.4 Thermal Destruction Processes

Thermal destruction processes include several energy recovery processes, traditional

incineration processes, and several innovative thermal processes. These processes include:

Liquid injection incineration

Rotary kiln incineration

Fluidized bed incineration

Paralysis

Wet air oxidation

Industrial boilers

Industrial kilns (cement kiln,

aggregate, clay)

Blast furnaces (iron and steel)

Infrared incineration

Circulating bed combustor

Supercritical water oxidation

Advanced electric reactor

Molten Salt destruction

Molten glass

Plasma torch

You can incinerate any waste at some cost. Technical limits exist for specific

incineration technologies, but there are no technical limits on incineration for any waste type.

10.5.5 Fixation and Stabilization Processes

Fixation and stabilization involves immobilization of the toxic and hazardous

constituents in the waste. You can immobilize constituents by either changing the constituents

into insoluble forms, binding them in an immobile, insoluble matrix, and/ or binding them in a

matrix that minimizes the material surface exposed to solvent exposure. Often the immobilized

product has structural strength sufficient to help protect it from future fracturing and leaching.

Most of these processes are proprietary. They include:

Lime-based pozzolan processes

Portland cement pozzolan process

Sorption

Vitrification

Asphalt-based (thermoplastic) micro encapsulation

Polymerization

10.6 POLLUTION PREVENTION: BEST DEMONSTRATEDPRACTICES

Companies are moving away from compliance-driven activities, to

Pollution Prevention (PP)

SOP Pharmaceutical Industries EMPRI 2005 12

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