Standard Operating Procedures for Pharmaceutical Industries Final Report

December 2005

Environmental Management and Pol Research Institute

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T ABLE OF C ONTENTS
ITEM 1
1.1 1.2

CHAPTER INTRODUCTION
Background Gist Of Environmental Acts, Rules And Notifications

2
2.1 2.2 2.3 2.4 2.4.1 2.4.2 2.4.3 2.4.4 2.4.5 2.4.6 2.4.7 2.4.8 2.4.9 2.4.10 2.4.11 2.4.12 2.4.13 2.4.14 2.5 2.5.1 2.5.2 2.5.3 2.5.4 2.5.5 2.6 2.6.1 2.7 2.7.1 2.7.2 2.7.3 2.8

LEGAL AND REGULATORY FRAMEWORK

Fundamental Rights And Duties Of A Citizen State Policy Legislative Authority Relevant Legislations Environment Protection Act 1986. The Water (Prevention And Control Of Pollution) Act, 1974 And Rules The Water (Prevention And Control Of Pollution) Cess Act, 1977 And Rules The Air (Prevention And Control Of Pollution) Act, 1981 And Rules The Environment Impact Assessment Notification 1994 & 1997 The Noise Pollution (Regulation And Control) Rules, 2000 The Hazardous Waste (Management & Handling Rules), 2000 The Manufacture, Storage and Import of Hazardous Chemical Rules, 1989 Rules for the Manufacture, Use, Import, Export and Storage of Hazardous Micro organism/ Genetically engineered Organisms or Cells, 1989 The Chemical accidents (Emergency planning, Preparedness and Response) Rules,1996 Forest Conservation Act 1980. The Drugs and Cosmetics Act, 1940 and Rules, 1945 The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 The Drugs Prices (Control) Order, 1995 Relevant Policies The National Forest Policy The National Environmental Policy The National Industrial Policy Draft National Rehabilitation & Resettlement Policy The Pharma Policy 2002: The Positives and Negatives Regulatory Concerns on Nutraceuticals Mashelkar Committee Recommendations Relevant Institutions Ministry Of Environment And Forest, Government Of India Department Of Ecology And Environment, Government Of Karnataka Karnataka State Pollution Control Board Guidelines for setting up of Pharmaceutical Industries from Karnataka State Pollution Control Board RESPONSIBILITIES OF THE PHARMACEUTICAL AUTHORITIES

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ITEM
3.1 3.2

CHAPTER
Approvals Responsibilities WATER AND AIR (PREVENTION & CONTROL OF POLLUTION ACTS Consent Procedure WATER (PREVENTION & CONTROL OF POLLUTION) CESS ACT ENVIRONMENTAL IMPACT ASSESSMENT NOTIFICATION ENVIRONMENTAL STATEMENT PROCEDURES Contents Of Environmental Statement

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4.1

PAGE NUMBER 15 ----15 ----16 -----------------------------------------------------------------------------------------------------------------------------------------------16 17

5 6 7
7.1

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20 20

8
8.1 8.2

ENVIRONMENTAL AUDITING
Features Of A Good Environmental Audit Audit Procedure ENVIRONMENTAL PERFORMANCE VERIFICATION EXERCISE TYPES, SOURCES AND NATURE OF POLLUTION FROM
PHARMACEUTICAL INDUSTRY

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21

9
10 10.1 10.2 10.3 10.4 10.5 10.5.1 10.5.2 10.5.3 10.5.4 10.5.5 10.6 10.6.1 10.6.2 10.6.3 10.6.4 10.6.5 10.6.6 10.6.7 10.7 11 12 12.1 12.2 12.3 12.4

22 23
24 24 24 26 27 28 29 29 29 30 30 30 30 31 31 31 33 33 33 34 35 36 36 36 37 38

Introduction Pharmaceutical Manufacturing Process Composition Of Pharmaceutical Products Composition Of Pharmaceutical Process Wastes Treatment Control Technologies Physical Treatment Process Chemical Treatment Process Biological Process Thermal Destruction Process Fixation And Stabilization Process Pollution Prevention: Best Demonstrated Practices Source Reduction Material Substitution Process Modulation Good Operating Practices

Recovery and Recycle Solvent Waste Recycling Waste Exchanges Summary

CHARTER ON CORPORATE RESPONSIBILITY FOR ENVIRONMENTAL PROTECTION (CREP) EROS PHARMA A CASE STUDY Objectives of the project work Identification Of Various Wastestreams And Their Characterization Evaluation Of ETP Recommendations

1
1.1

INTRODUCTION

BACKGROUND The Pharmaceutical (Bulk & Formulation) industry in Karnataka is one of the major sectors of the state. The processes in the pharma industries 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 relevant information 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 ENVIRONMENTAL ACTS, RULES AND NOTIFICATIONS Pharmaceutical Industry is regulated by various legislations related to manufacturing and environment. 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 Microorganisms/Genetically Engineered Organisms or cells, 1989. The Chemical accidents (Emergency planning, preparedness and Response) Rules, 1996

Standard Operating Procedure for Pharmaceutical Industry

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 FUNDAMENTAL RIGHTS 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 natural environment 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 (42nd Amendment) 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 7th Schedule, 97 subjects], State Legislatures [List II or State List in 7th Schedule, 66 subjects] and both Parliament and State Legislatures [List III or Concurrent List in 7th Schedule, 52 subjects]. The subjects related to environment in the 7th Schedule under the three lists are summarized below:
LIST NO. I NAME Union List SUBJECT NO. LIST 52 53 54 55 56 6 14
IN

SUBJECT Industries Regulation and development of oil fields and mineral oil resources Regulation of mines and mineral development Regulation and development of Inter-State rivers and river valleys Fishing and fisheries beyond territorial waters Public health and sanitation Agriculture, protection against pest and prevention of plant diseases

II

State List

Standard Operating Procedure for Pharmaceutical Industry

LIST NO. NAME SUBJECT NO. LIST 18 21 23 24 17 A 17 B 20 20 A
IN

SUBJECT Land, colonization, etc. Fisheries Regulation of mines and mineral development subject to the provision of List I Industries subject to the provision of List I Forests Protection of wild animals and birds Economic and social planning Population control and family planning

III

Concurren t List

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 of protecting 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. 3

Standard Operating Procedure for Pharmaceutical Industry 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 collect cess 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 all steps to ensure that the wastes listed in Schedule-I, 2 & 3 are properly handled and 4

Standard Operating Procedure for Pharmaceutical Industry 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 toi. prevent such major accidents and to limit their consequences to persons and the environment; 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 Microorganisms / 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. 2. 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. Without prejudice to the functions specified under sub-rule (1), the central Crisis Group shall,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.

Standard Operating Procedure for Pharmaceutical Industry 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 substances intended 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 (1st Amendment) 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 to give 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. 3.

National Forest Policy, 1894, 1952, 1988 Industrial Policy, 1956

Standard Operating Procedure for Pharmaceutical Industry Industrial Policy Resolution, 1948 The Industrial Policy, 1991 The Policy Statement for Abatement of Pollution, 1992 The Export-Import Policy, 1997 National Health Policy, 2002 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 first Forest Policy of the independent country was formulated as the National Forest Policy, 1952. The National Forest Policy, 1988 was formulated and issued on 7th December, 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 7 4. 5. 6. 7. 8. 9.

Standard Operating Procedure for Pharmaceutical Industry 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 a conservation 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.

Standard Operating Procedure for Pharmaceutical Industry 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 as controlling 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).

Standard Operating Procedure for Pharmaceutical Industry 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 account its 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 hardly any 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 no minimum or maximum production levels have been prescribed, automatic approvals for import 10

Standard Operating Procedure for Pharmaceutical Industry of technology for bulk drugs allowed and foreign investments even up to 100% equity permitted. 2.6 REGULATORY CONCERNS ON NUTRACEUTICALS: 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 health rejuvenators 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 consumers including 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 of Health 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 Industry through 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 agents should be considered as Drugs and would come under the purview of the Rules & regulations under the Drugs & Cosmetics Act. 11

Standard Operating Procedure for Pharmaceutical Industry 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 Good Manufacturing 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 GUIDELINES SET BY KARNATAKA STATE POLLUTION CONTROL BOARD FOR SETTING UP PHARMACEUTICAL INDUSTRIES 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 to the standards stipulated. The treatment of effluents shall ensure that the effluents are free from toxic and hazardous effects. 12

Standard Operating Procedure for Pharmaceutical Industry 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. The application 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 13

Standard Operating Procedure for Pharmaceutical Industry pollution control systems function uninterruptedly. Separate energy meters shall be provided for the pollution control, systems. 19. A fully equipped laboratory shall be established by the factory with appropriate equipments to monitor the performance of pollution control systems and to test the effluents, emissions and soil for pollution related parameters. 20. The factory shall conduct continuous bio-monitoring and bio-assay tests regularly to ensure that the treated effluents are non-toxic. 21. Every new large and medium factory and those proposed to be expanded shall submit Environmental Impact Assessment Report and Environment Management Plan to the State Pollution Control Board and to Department of Ecology and Environment and obtain prior consent and Environment Clearance respectively.

14

Standard Operating Procedure for Pharmaceutical Industry

3
3.1

RESPONSIBILITIES OF THE PHARMACEUTICAL AUTHORITIES

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 waste generated, 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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Standard Operating Procedure for Pharmaceutical Industry

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 of monitoring based on the classification of industries.

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Standard Operating Procedure for Pharmaceutical Industry

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 Pollution Control 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 5th of 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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Standard Operating Procedure for Pharmaceutical Industry

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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Standard Operating Procedure for Pharmaceutical Industry

Obtaining Environmental Clearance

Investor Submits Project questionnaire to concerned SPCB Review by SPCB Is the Environmental Management Plan satisfactory Scoping by investor

Submission of the project to the Min. of Env. &. Forests along with all documents listed at Part I of the handbook Initial scrutiny by staff of Min. of Env.&.Forests Yes Review by Environmental Appraisal Committee of the Min. of Env. &. Forests Reject

Is the project site acceptable No EAC Members undertake site visits Is site acceptable No Investors advised to look for alternate site Prepare comprehensive EIA or any specific study suggested by the committee

No Can Issues be resolved

Yes SPCB issues NOC

Apply also to CCF in case of forest land is involved.

Is the information provided adequate Yes Is there a public outcry against the project No

Does the Project fall under scheduleI of EIA notification

Yes Yes Apply to Union Min. of Env. & Forests in prescribed questionnaire No Can Issues be resolved?

Apply to state DOEn for Environmental Clearance

Public hearing arranged

No

Is the project acceptable Yes Recommended by EAC

Reject Environmental Clearance issued by Min. of Env. &. Forests along with Stipulations

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Standard Operating Procedure for Pharmaceutical Industry

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 13th March, 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 31st March in the prescribed form [Form V] to the concerned State Pollution Control Boards on or before 30th day 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 ENVIRONMENTAL STATEMENT 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 other significant 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 pharma authorities 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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Standard Operating Procedure for Pharmaceutical Industry

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 ENVIRONMENTAL AUDIT

A good Environmental Audit defines 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.

21

Standard Operating Procedure for Pharmaceutical Industry 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-Assessment

AUDIT 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

Phase 2: Material Balance

PROCESS INPUTS Step 4 Determine inputs Step 5 Record water usage Step 6 Measure current levels of waste reuse/recycling 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

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 ti

Phase 3: Synthesis
WASTE REDUCTION ACTION PLAN Step 20 Design and implement a waste reduction action plan to achieve improved process efficiency

Quick Reference Audit Guide

22

Standard Operating Procedure for Pharmaceutical Industry

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 submit Environmental 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.

23

Standard Operating Procedure for Pharmaceutical Industry

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 pharma industries 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 wastes after 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 PHARMACEUTICAL MANUFACTURING PROCESSES 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.

24

Standard Operating Procedure for Pharmaceutical Industry

Figure 1: General manufacturing processes used in the pharmaceutica1 industries

Chemical substances Micro organic cultures Fermentation Synthesis Dilution in liquids Pharmacologically active substance Proportioning Freeze drying Syrups drops phials Extraction Vegetable or animal tissues

Mixing with solid excipients Pastes Ointments Suppositories Powders

Freeze -dried products

Direct use (antibiotics in powder form)

External cleaning (Washing, dust removal)

Capsules Granules Tablets Pills

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 product from 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. 25

Standard Operating Procedure for Pharmaceutical Industry

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, the pharmaceutical manufacturing industry discharges significant quantities of organic compounds in their raw wastewaters as the industry primarily uses organic compounds as raw materials or solvents. 10.3 COMPOSITION OF PHARMACEUTICAL PRODUCTS 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 composition
DOSAGE FORM Liquid solutions Aromatic waters Liquors or solutions Syrups Elixirs Spirits, essences Tinctures Colloidions Liniments Mucilages Parenteral solution Ophthalmic Nasal Otic Mouthwash, gargles Inhalations Enemas, douches Liquid dispersions Suspensions Emulsions, lotions Gels, jellies, magma Semisolid and Plastic Dispersions Ointments Pastes and cerates Suppositories Solids CONSTITUENTS & PROPERTIES Volatile solids and oils, water Water, chemicals Sweetener, solvent, medicinal agent Sweetened hydro alcoholic solution, may be medicated Alcohol, water, volatile substances Natural drugs, extracted with appropriate solvents Pyroxylin in ether, medicinal agent, castor oil, camphor Oily or alcoholic solutions, suspensions Colloidal polymer solutions Sterile, pyrogen-free, isotonic, pH close to that of blood; oily or aqueous suspension Sterile, isotonic, pH close to that of tears; viscosity builder Aqueous, isotonic, pH close to that of nasal fluid; sprays or drops Glycerol based Aqueous, antiseptic Administered with mechanical devices Aqueous solution or suspension, may include medicinal agent Powder suspended in water, alcohol, glycol, or an oil; viscosity builder, wetting agents, preservatives Oil-in-water or water-in-oil Viscous, colloidal dispersions Hydrocarbon (oil), absorptive water-washable or watersoluble bases; emulsifying agents; glycol, medicating agent Ointments with high-dispersed solids or waxes, respectively Theobroma oil, glycerinated gelatin, or polyethylene glycol base plus medicinal agent

26

Standard Operating Procedure for Pharmaceutical Industry

Bulk powder Effervescent powder Dusting powder Insufflation Lyophilized powders Capsules Masses or molded solid pills Trouches, lozenges, pastilles Tablet triturates Granules Compressed tablets Pellets Coated tablets Comminuted or blended, dissolved, or mixed with water Comminuted or blended, dissolved in or mixed with water Contains adsorbents Insufflator propels medicated powder into body cavity Reconstitution by pharmacist of unstable product Small-dose bulk powder enclosed in gelatin shell; active ingredient plus diluent Adhesive or binding agents facilitate compounding; prepared by massing and piping Prepared by piping and cutting or disk candy technology; compounded with glycero-gelatin Small molded tablets intended for quick complete dissolution (e.g., nitroglycerin) Particle size larger than powder Dissolved or mixed with water; great variety of shapes and formulations For prolonged action Coating protective; slow release

10.4 COMPOSITION OF PHARMACEUTICAL PROCESS 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 liquors Spent fermentation broth Spent natural product, raw materials Spent aqueous solutions Leftover raw material, containers Scrubber water from pollution control equipment Volatile organic compounds Off-spec or out-dated products Spills Wastewater Spent solvents Used production materials Used chemical reagents PROCESS ORIGIN Organic synthesis Fermentation processes Natural product, extraction processes Solvent extraction processes Unloading of materials into process equipment Dust or hazardous vapor generating processes Chemical storage tanks, drums Manufacturing operations Manufacturing and lab operations Equipment cleaning, extraction residues Solvent extraction or wash practices Manufacturing operations R & D operations COMPOSITION Contaminated solvents Contaminated waters Leaves, tissues Contaminated water Bags, drums (fiber, plastic, metal), plastic bottles Contaminated water Solvents Miscellaneous chemicals Miscellaneous chemicals, mercury, other metals Contaminated water, pheno-based Contaminated solvents Filters, tubing, diatomaceous earth Miscellaneous chemicals, solvents, acid/alkaline wastes, radioisotopes, formaldehyde, photographic chemicals, silver Ethylene oxide Waste lube oils, vacuum pump oils, cleaning solvents, paint stripping wastes, leftover paints and accessories, spent fluorescent lamps,

Spent ethylene oxide Miscellaneous wastes

Sterilization operations Maintenance operations

27

Standard Operating Procedure for Pharmaceutical Industry

trash Plastic, wood, cardboard, foam products Vials, biomass, blood products, human animal specimens Metals, oxides Carbon compounds, oxides of nitrogen and sulfur, boiler blowdown, cooling tower sludges, and sediments

Used packaging material Infectious/medical wastes Incinerator exhaust Natural gas combustion products

Packaging operations R & D, manufacturing operations, off-spec products On-site incinerators Steam boilers

10.5 TREATMENT CONTROL 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, concerns about 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 wastewaters
SR. NO 1 2 3 TECHNOLOGY Equalization Neutralization Primary treatment Coarse settleable solids removal Primary sedimentation Primary chemical flocculation/ clarification Dissolved air flotation Biological treatment Activated sludge Pure oxygen Powdered activated carbon Trickling filter Aerated lagoon Waste stabilization pond Rotating biological contactor Other biological treatment Physical/chemical treatment Thermal oxidation Evaporation Additional treatment Polishing ponds Filtration Multimedia Activated carbon Sand Other polishing Secondary chemical flocculation/ clarification Secondary neutralization Chlorination

5 6

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

28

Standard Operating Procedure for Pharmaceutical Industry 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 4 presents the treatment technologies under each of these groupings. Table 10.4: Physical treatment processes and technologies. GRAVITY DISSOLUTION PHASE CHANGE SIZE/ ADSORPTIVE/ IONIC SEPARATION CHARACTERISTICS Sedimentation Soil washing/ flushing Evaporation Filtration Centrifugation Chelation Air stripping Carbon adsorption Flocculation Liquid/liquid Steam stripping Ion exchange extraction Oil/water Supercritical solvent Distillation Electrodialysis separation extraction 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 or precipitation 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 Rotating biological contactors Activated sludge Bioreclamation 29

Standard Operating Procedure for Pharmaceutical Industry 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: Infrared incineration Liquid injection incineration Circulating bed combustor Rotary kiln incineration Supercritical water oxidation Fluidized bed incineration Advanced electric reactor Paralysis Molten Salt destruction Wet air oxidation Molten glass Industrial boilers Plasma torch Industrial kilns (cement kiln, aggregate, clay) Blast furnaces (iron and steel) 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 DEMONSTRATED PRACTICES Companies are moving away from compliance-driven activities, to Pollution Prevention (PP) activities through either cleaner production, waste minimisation, recycle or reuse strategies. This trend is augmented by increasing pressures from government agencies, international competition, and consumer interest groups. PP efforts are fast becoming a strategic necessity for cost containment in the pharma industry. PP efforts not only include practices that minimize waste production from the use of solvents and bulk raw chemicals in drug and cosmetic manufacturing, but also practices that involve suppliers to assist in decreasing waste generation. 10.6.1 Source Reduction You can achieve source reduction of hazardous wastes through changes in products, raw materials, process technologies, or procedural and organizational practices. Pharmaceutical manufacturing is a diverse and very competitive industry. Because of the highly specific and often confidential nature of each company's specific operations, only a very general description of material substitution and process modification can be obtained off the shelf. Industry specific studies need to carried to arrive at source reduction. 30

Standard Operating Procedure for Pharmaceutical Industry 10.6.2 Material Substitution Material substitution is a change in one or more of the raw materials used in production to reduce the volume or toxicity of waste generated. For the pharma industry, however, product reformulation is likely to be very difficult due to the testing required to ensure that the reformulation has the same therapeutic or cosmetic effect as well as stability and purity profile as the original drug or cosmetic. Furthermore, a considerable amount of time is required for FDA approval of the reformulated drug. An additional concern is the effect the reformulation might have on the product's aesthetic qualities. Changes in characteristics such as taste, color, or dosage form could result in customer rejection of the product. However, many companies have used material substitution successfully in pharmaceutical tablet coating operations to reduce hazardous waste generation. Other material substitutions that may be suited to pharmaceutical manufacturing include the use of aqueous-based cleaning solutions instead of solvent-based solutions, and the replacement of chlorinated solvents with nonchlorinated solvents. Because of the reformulation difficulties encountered in the production phase, it is best to introduce waste minimization at the research and development phase. For these reasons, as an integral part of R&D activities you should carefully examine all materials that can be used in manufacturing or formulating a pharmaceutical with the aim of reducing residual toxicity. 10.6.3 Process Modulation Besides investigating material substitution options, you can look for source- reduction opportunities that can be accomplished through modification or modernization of the existing process. In most cases the product/process yield determines the product/waste ratio. Reasons for high byproduct yield include inadequate feed-rate control, mix-up, or temperature control. By controlling reaction parameters, you can improve the reactor efficiency and reduce the byproduct formation. Increased automation can also reduce operator errors. For example, automated systems for material handling and transfer, such as conveyor belts for bagged materials, can help reduce spillage. Crystallization, sedimentation, polymerization, and corrosion can cause fouling deposits on interior equipment surfaces. These deposits reduce process-operating efficiencies and increase waste generation. Proper agitator design and optimizing operating temperatures can inhibit fouling deposits. Another process modification option is to redesign chemical transfer systems to reduce physical material losses. Other design considerations for waste minimization include modifying tank and vessel dimensions to improve drainage, installing internal recycle systems for cooling waters and solvents, selecting new or improved catalysts, switching from batch to continuous processes for solvent recovery, and optimizing process parameters to increase operating efficiency. While process modification can result in significant waste reduction, there may be major obstacles to this approach. Extensive process changes can be expensive; production must be stopped for new equipment installation; and new processes must be tested and validated to ensure that the resulting product is acceptable. In addition, to the extent that processes and process equipment are specified in an approved drug application, FDA approval is likely to be required prior to instituting any changes. 10.6.4 Good Operating Practices Good Operating Practices (Gaps) are procedures and policies that result in a reduction of wastes. The following is a list of some key overall operating strategies: Keep individual waste streams segregated. Keep hazardous waste segregated from non hazardous and infectious wastes. Keep recyclable wastes segregated from non recyclable wastes. Minimize dilution of hazardous wastes. 31

Standard Operating Procedure for Pharmaceutical Industry Assure that the identity of all chemical and wastes is clearly marked on all containers. To improve management and control practices you can do the following: Centralize purchasing and dispensing of drugs and other hazardous chemicals. Monitor drug and chemical flow within the facility from receipt of raw materials to disposal as hazardous wastes. Use computer systems and computer-readable bar coded labels for incoming chemicals, such as those used in supermarkets. Apportion waste management costs to the department that generate the wastes. Improve inventory control by requiring users of chemicals with limited shelf-life to use up old stock before ordering or using new stock; ordering hazardous chemicals only when needed and in minimal quantities to avoid outdated inventory; and asking suppliers to take back expired chemicals. Implement a facility-wide PP program. Management initiatives can encourage new ideas from knowledgeable employees, which can result in the reduction or recycling of waste. The following is a list of some management initiatives: Provide employee training in hazardous materials management and waste minimization. Train employees on handling hazardous materials and PP Employees should be aware of waste disposal costs and liabilities, and they should understand the causes of waste generation and potential process upsets. Closer supervision of plant personnel and operations can increase production efficiency and reduce waste generation by reducing material costs, spins, and production of offspec products. Coordination within the overall plant operation can, in turn, increase the opportunity for early detection of mistakes. Effective production and maintenance scheduling can help reduce waste generation. Proper scheduling ensures raw materials are used before expiration and products are recovered and processed efficiently, while maintenance scheduling makes sure that work is done on equipment at a time least likely to result in product losses. Minimization of equipment cleaning requirements should be one of the objectives of production scheduling. Spillage or leakage of hazardous chemicals generates hazardous wastes in the form of liquid waste from washing the spilled toxic chemicals or solid waste from cleanup using absorbent materials. Spill and leak prevention is critical to waste minimization, and a properly trained and spill control team is needed to prevent or contain spills. Methods of reducing or preventing spills include conducting hazard assessment studies, using proper storage tanks and process vessels, equipping all liquid containers with overflow alarms, and testing alarms periodically. Also, you should take steps to maintain the physical integrity of containers, set up administrative controls, and install sufficient secondary containment. Other preventive measures include having a good valve layout, having interlock devices to stop the flow to leaking sections, not allowing operators to bypass interlocks or alter set points, and isolating equipment or process lines that are not in service. Finally, consider documenting all spills and their related dollar value in relation to overall operating efficiency. Preventive maintenance programs can reduce the incidence of equipment breakdown through routinely cleaning, making minor adjustments, lubricating, testing, measuring, and replacing minor parts. Typically, equipment data cards, master preventative maintenance schedules, deferred preventive maintenance reports, equipment history cards, and equipment breakdown reports are used as record keeping documents. Corrective maintenance repairs the unexpected failures as they occur and collects data for use in determining maintenance demands. It is important that you prepare maintenance and operating data sheets for each piece of equipment. 32

Standard Operating Procedure for Pharmaceutical Industry 10.6.5 Recovery and Recycle Recovery and recycling includes direct reuse of waste material, recovering used materials for a separate use, and removing impurities from waste to obtain relatively pure substances. The goal is to recover materials for reuse in a different application. The strict quality-control requirements of the pharmaceutical and cosmetic industry often restrict reuse opportunities, though some do exist. Usually recycling is a much easier option, which you can perform either on- or off-site. 10.6.6 Solvent Waste Recycling Solvents are used for equipment cleaning, reaction media, extraction media, and coating media. Processes to recover solvents from concentrated waste streams include distillation, evaporation, liquid-liquid extraction, sedimentation, decantation, centrifugation, and filtration. Some commonly used solvents are: Ethanol Acetone Isopropanol Cyclohexane Butanol Methylene chloride Pyridine Ethyl acetate Methyl ethyl ketone Butyl acetate Tetrahydrofuran Methanol An important first step in determining the feasibility of on-site distillation and recovery of waste solvents is to separate waste streams according to specific chemical components. This may allow you to use simple batch distillation equipment, which is less expensive than fractional distillation equipment. Many companies have developed individual solvent recycling units suitable for small facilities. In the event that one of the distillation methods is not feasible for your company, you should consider off-site distillation or waste exchange. You can also use solvent wastes with sufficiently low chlorine content as a fuel supplement in cement kilns and some industrial boilers. The following steps can improve solvent waste recyclability: Segregate solvent wastes as follows: chlorinated from nonchlorinated solvent wastes, aliphatic from aromatic solvent wastes; chlorofluorocarbons from methylene chloride; and water wastes from flammables. . Minimize the solids concentration in solvent wastes. Label all solvent wastes and keep records on their compositions and methods of generation. 10.6.7 Waste Exchanges An alternative to recycling is waste exchange, which involves the transfer of a waste to another company for use as is or for reuse after treatment. Waste exchanges are private or governmentsubsidized organizations that help to identify the supply and demand of various wastes. Three types of waste exchanges are available to you: information exchanges, material exchanges, and waste brokers. Information exchanges are clearing houses for information on supply and demand, and typically publish a newsletter or catalog. Material exchanges take temporary possession of a waste for transfer to a third party, in contrast to waste brokers, who do not take possession of the waste, but charge a fee to locate buyers or sellers. Waste exchanges frequently recycle metals and solvents because of their high recovery value. The most commonly recycled wastes include acids, alkalis, salts and other inorganic chemicals, organic chemicals, and metal sludges. 10.7 SUMMARY 33

Standard Operating Procedure for Pharmaceutical Industry Pharmaceutical manufacturing is a complex industry. Each manufacturer has its own unique set of circumstances. However, some of the general concerns of the pharma industries stem from the technology used for manufacturing drugs as well as the composition of the manufactured products as they greatly influence the diversity of a. Manufacturing processes and the resulting waste streams b. Regulations affecting the manufacturers c. Treatment control technologies used to manage the wastes d. Pollution prevention techniques that can be used to contain costs of waste production For burgeoning environmental professionals dedicated to serving the pharma industries, it is important to understand the environmental concerns particular to these industries. To serve these industries well, you need two types of information. a. Industry factors: You need to be familiar with the terminology and technology found in the pharma industry. b. Industry objectives: You need to understand what these industries are trying to achieve; that is, the nature of their products, and how to control the costs of waste resulting from production without deleteriously impacting the quality of the product.

34

Standard Operating Procedure for Pharmaceutical Industry

11 CHARTER ON CORPORATE RESPONSIBILITY FOR ENVIRONMENTAL PROTECTION (CREP)

As it is necessary to comply with the regulatory norms for prevention and control of pollution, it is also imperative to go beyond compliance through adoption of clean technologies and improvement in management practices. Commitment and voluntary initiatives of industry for responsible care of the environment will help in building a partnership for pollution control. For this very purpose a Charter on Corporate Responsibility for Environmental Protection (CREP) was prepared by a series of industry-specific interaction meetings organised by the Ministry of Environment and Forests. During interaction meetings, the representatives of some industrial sectors sought extension of time to meet the regulatory norms because of techno-economic constraints. In case of units falling in such industrial sectors, time bound action has been proposed in the Charter. This measure has been agreed on the understanding that a bank guarantee would be furnished by the concerned units indicating the commitment to the action plan. However, this is without any prejudice to the stipulations made in the existing standards and action already taken/initiated for non-compliance and area-specific requirements warranting stringent actions. The industrial units which are not complying with the national standards notified under the Environment (Protection) Act, 1986, will submit action plan to meet the standards and bank guarantee to respective State Pollution Control Board within 3 months (by June, 2003). The consultation for pharmaceutical industries was held at Hyderabad by the Andhra Pradesh Pollution Control Board on 11.12.2002. Following are the stipulations for pharmaceutical industries. Water pollution Waste streams should be segregated into high COD waste, toxic waste, low COD waste, inorganic waste etc. High COD streams should be detoxicated and treated in ETP or thermally destroyed in incinerator; the implementation should be March 2004. Consent for establishment and consent for operation under the Water Act will be based on pollution load and concentration of pollutants. Each industry will submit pollution load, concentration of final discharge along with water balance to SPCB/CPCB for formulation of strategy-action plan. Air pollution Industry will take up on priority, the control of hazardous air pollutants (such as benzene, carbon tetrachloride, 1-4 dioxane, methanol. toluene, methyl chloride etc.) and odorous compounds (mercapatan and hydrogen sulphide) and should implement the same by December 2004. Management of Solid Waste Proper facilities should be provided for handling and storage of hazardous waste. For final disposal of hazardous waste, recycling and reuse should be given priority, either within the premises or outside with proper manifest system and the industry should implement the by March 2004. Monitoring and Environmental auditing: Industries on their own will carry out monitoring of environmental parameters, audit it at regular interval and submit the same to SPCB. Hazardous chemicals: The information regarding hazardous chemical should be submitted to SPCB regularly alongwith rational-action plan to be submitted to SPCB.

35

Standard Operating Procedure for Pharmaceutical Industry

12 EROS PHARMA A CASE STUDY

Eros Pharma is a pharmaceutical formulations company, manufacturing a wide range of products including antibiotics, anti-asthmatics, analgesics, anti-pyretic and anti-inflammatory, etc. The company is located in the Peenya Industrial Area in Bangalore and was facing non-compliance of Bioassay test. Eros Pharma approached EMPRI to provide expertise for evaluating and if necessary designing a suitable Effluent Treatment Plant (ETP). 12.1 OBJECTIVES OF THE PROJECT WORK While defining the problem of non-compliance of Bioassay test it can be assumed that the same could be due to: i. Improper design of the ETP ii. Improper maintenance of the ETP iii. Introduction of very toxic substances into the ETP, which are not biodegradable Thus keeping the probable reasons in mind the objectives of the project work carried out were identified as: 1) Identification of Various Waste Streams and their Characterization 2) Evaluation of ETP 3) Pilot scale studies (if necessary); and 4) Suggestions for Modification of ETP. 12.2 IDENTIFICATION OF VARIOUS WASTE STREAMS AND THEIR CHARACTERIZATION 1. Identification of Sampling Spots A total of 8 sampling spots were identified of which 7 were in conjunction with the 7 waste streams generated and one spot at the collection tank in the ETP. The details and remarks of sample collections is tabulated below. Sr. No Name of Waste Stream Location 1 General Wash Just behind the wash area 2 Topical At ETP 3 Dental and Liquid Wash Near Incinerator 4 Capsule Wash Near Old DM plant 5 Bottle Wash Near Old DM plant 6 QC Wash Near Old DM plant 7 Canteen At ETP 8 ETP 2. Volume of wastewater generated It was decided to estimate the total volume of effluent generated from each of the 7 waste streams. On scrutinizing the plant layout it was found not to be feasible. Hence, the total volume of effluents entering the ETP per day was measured for a period of one month to take into account the lean period and the peak period of production. Volume collected averaged to 17,000 L/d, while the ETP was designed for 14,000 L/d capacity with a peak load of 17,000 L/d. The ETP now runs at the peak load of 17,000 and hence it should be noted that any further increase in the wastewater volume would lead to hydraulic over loading of the ETP

3. Sampling Protocol 36

Standard Operating Procedure for Pharmaceutical Industry Having selected the various spots for sampling, Buckets / carbouys of 50 L were used to collect representative samples whenever washing was carried out throughout the day and mixed throughly to get a composite homogenous sample of each sampling spots. The sample at the ETP was collected at the end of the shift before the addition of alum and lime and raw wastewater collected from the collection tank on Day 1 and treated wastewater collected from the disposal tank on the morning of Day 4 were sent for Analysis for BOD, COD, TDS, TSS, Conductivity, TKN, P, Anionic Surfactants, pH parameters to Bangalore Test House. 12.3 EVALUATION OF ETP Visual inspection carried out to understand the operating procedure of ETP and following studies were carried out. Neutralisation and Coagulation The pH was measured at the end of shift at 4.30 p.m. and if the pH was less than 6 then the adjustment was carried out in the collection tank using NaOH. The NaOH was added in dry powder form along with Alum (dry powder form) for coagulation. The dosage of both Alum and NaOH can be maintained the same but they should be added in slurry form.Evaluation of Aeration Tank and Disposal Tank 1. Observations for raw wastewater The characterisation of effluents for each waste streams were carried out. The samplings were done for high production volumes and for low production volumes. This insures the characteristics of wastewaters for both high and low productions. i. For all the sampling dates irrespective of high or low production, the QC wastewater was the most concentrated in terms of BOD, COD, Conductivity, TDS, TKN, P, anionic surfactants and the pH was lower than other wastewater streams. ii. The COD: BOD ratio for QC wastewater ranged from 3.32 to 1.43 respectively. This states that depending upon the type of chemicals used for analysis the degree of degradation of this WW varies rather than the production levels. iii. However, nothing can be stated about the total pollution load from QC because the volume of WW generated from QC could not be ascertained. iv. The COD: BOD ratio for Topical wastewater ranged from 4.39 to 4.91 which makes the WW highly recalcitrant or nonbiodegradable v. The combined WW in the ETP has got BOD ranging from 200 to 650 mg/L while COD ranges from 500 to 1000 mg/L. vi. The homogenous WW of ETP is biodegradable in nature. 2. Observations for Treated Wastewater Raw wastewater from the collection tank on Day 1 and treated wastewater from the disposal tank on the morning of Day 4 analysed. This exercise helps in evaluating the efficiency of existing effluent treatment plant.The mixed liquour suspended solids (MLSS) and mixed liquour volatile suspended solids in the aeration tank on the same day was found to be 960 and 900 mg/L, respectively which is far below the operating stipulations. The BOD and COD removal were 71.94 and 55.82 % respectively. Keeping in this view, it was recommended to recycle the sludge in the disposal tank back into the aeration tank. It was found that the BOD and COD removal increased to 93.80 and 84.33 % respectively.

3. Bioassay Test

37

Standard Operating Procedure for Pharmaceutical Industry The toxicity test was carried out using the Zebra fish. In short, 2 L beaker with treated wastewater at different concentrations (100 %, 10 %, 1%, 0.1% wastewater) was taken and 5 zebra fishes were added to each beaker and the survival rate at the end of 48 hrs was seen. It was found that there was 100 % survival in all the samples at the end of 48 hrs. On extending the test to 96 hrs it was found that there was100% survival.RECOMMENDATIONS The following recommendation have been made Operation of ETP i. The existing system is the Batch Sequential Type of Reactor (Fill and Draw Type) can be used as it is. However, the ETP was designed for 14,000 L/d capacities with a peak load of 17,000 L/d and now it runs at the peak load of 17,000. Any further increase in the wastewater volume would lead to hydraulic over loading of the ETP. ii. To maintain the MLSS between 2000 to 5000 mg/L in the aeration tank, around 30% of the sludge in the disposal tank should be recycled back into the aeration tank everyday. Once in 3 days the MLSS of the aerator tank should be estimated so that the required amount of bacteria is maintained. iii. A routine monitoring of the three tanks is essential so that proper action can be taken in cases where the effluent water changes drastically. Day to day variations in the production may make the system undergo shock loading that may be manifested is loss of bacteria (as seen by low MLSS and MLVSS values). For proper monitoring of the influent wastewater (raw wastewater) the parameters that can be analysed include pH, BOD, COD (weekly) and for monitoring the efficiency of aeration tank Mixed Liquour Suspended Solids and Mixed Liquour Volatile Suspended Solids (MLSS and MLVSS respectively) can be analysed.

38

ENVIRONMENTAL IMPACT ASSESSMENT NOTIFICATION, 1994 SCHEDULE-II: APPLICATION FORM 1. (a) Name and Address of the project proposed: (b) Location of the project: Name of the Place: District, Tehsil: Latitude/Longitude: Nearest Airport/Railway Station: (c) Alternate sites examined and the reasons for selecting the proposed site: (d) Does the site conform to stipulated land use as per local land use plan? 2. Objectives of the project: 3. (a) Land Requirement: Agriculture Land: Forest land and Density of vegetation. Other (specify): (b) (i) Land use in the Catchment within 10 km radius of the proposed site: (ii)Topography of the area indicating gradient, aspects and altitude: (iii) Erodibility classification of the proposed land: (c) Pollution sources existing in 10 km radius and their impact on quality of air, water and land: (d) Distance of the nearest National Park /Sanctuary/ Biosphere Reserve/ Monuments/ heritage site/ Reserve Forest: (e) Rehabilitation plan for quarries/borrow areas: (f) Green belt plan: (g) Compensatory afforestation plan: 4. Climate and Air Quality: (a)Windrose at site: (b)Max/Min/Mean annual temperature: (c)Frequency of inversion: (d)Frequency of cyclones/ tornadoes/ cloud burst: (e)Ambient air quality data: (f)Nature & concentration of emission of SPM, Gas (CO, CO2, NOx, CHn etc.) from the project: 5. Water balance: (a)Water balance at site: (b)Lean season water availability; Water Requirement: (c)Source to be tapped with competing users (River, Lake, Ground, Public supply): (d)Water quality: (e)Changes observed in quality and quantity of groundwater in the last years and present charging and extraction details: (f) (i) Quantum of waste water to be released with treatment details: (ii)Quantum of quality of water in the receiving body before and after disposal of solid wastes: (iii)Quantum of waste water to be released on land and type of land: (g) (i) Details of reservoir water quality with necessary Catchment Treatment Plan: (ii) Command Area Development Plan: 6. Solid wastes: (a)Nature and quantity of solid wastes generated (b)Solid waste disposal method: 7. Noise and Vibrations: (a)Sources of Noise and Vibrations: (b)Ambient noise level: (c)Noise and Vibration control measures proposed: (d)Subsidence problem, if any, with control measures: 8. Power requirement indicating source of supply: Complete environmental details to be furnished separately, if captive power unit proposed: 9. Peak labour force to be deployed giving details of: -Endemic health problems in the area due to waste water/air/soil borne diseases: -Health care system existing and proposed: 10. (a) Number of villages and population to be displaced:

(c)Rehabilitation Master Plan: 11. Risk Assessment Report and Disaster Management Plan: Report prepared as per guidelines issued by the Central Government in the MOEF from time to time:

12. (a) Environmental Impact Assessment (b)Environment Management Plan: (c)Detailed Feasibility Report: (d)Duly filled in questionnaire 13. Details of Environmental Management Cell:

I hereby give an undertaking that the data and information given above are due to the best of my knowledge and belief and I am aware that if any part of the data/information submitted is found to be false or misleading at any stage, the project be rejected and the clearance given, if any, to the project is likely to be revoked at our risk and cost. Signature of the applicant With name and full address given under the seal of Date: Organisation on behalf Place: Whom the applicant is signing.
:

ii

GENERAL STANDARDS FOR DISCHARGE OF EFFLUENTS OF PHARMACEUTICAL INDUSTRY (Extracts From Environment Protection Rules, 1986)
STANDARDS SL . NO I 2 PARAMETER Colour and Odour Suspended Solids mg/l, Max. Particular size of Suspended Solids pH value Temperature INLAND SURFACE WATER See Note I 100 PUBLIC SEWERS --600 200 (a) For process wastewater 100 (b) For cooling water effluent, 10% above total suspended matter of influent (a) Floatable solids max. 3 mm (b) Settleable solids, max 850 microns 5.5 to 9.0 Shall not exceed 50C above the receiving water temperature ----LAND FOR IRRIGATION See Note I MARINE COASTAL AREAS See Note I METHOD No.2120 Visual comparison Method Spectrophotometeric Method No. 2150 Threshold odour test No. 2130 Nephlometric Method

3 4 5

Shall pass 850 micron IS Sieve 5.5 to 9.0 Shall not exceed 50C above the receiving water temperature 10 1.0 50 100 5.0 250

5.5 to 9.0

5.5 to 9.0

No. 4500- H+ Electrometric Method No. 2550 Laboratory and field methods

6 7 8 9 10 12

Oil and Grease mg/l, Max Total Residual Chlorine mg/l, Max. Ammonical Nitrogen (as N), mg/l, Max. Total Kjeldhal Nitrogen (as NH3), mg/l, Max. Free Ammonia (as NH3), mg/l), Max. Chemical Oxygen Demand, mg/l, Max.

20 50 -

10 -

20 1.0 50 100 5.0 250

No.5520 Partition Gravimetric method Extraction method for sludge samples No. 4500-Cl Iodometric methodAmperotric titration method No4500- NH3 Primary distillation steps Titrimetric method Phenate method No. 4500 N-org Macro kjeldhal Method Semimicro Kjeldhal Method No. 5220 Titrimetric method, Colorimetric method

iii

STANDARDS SL . NO 13 14 15 16 17 18 19 20 21 22 23 24 25 PARAMETER Arsenic (as As), mg/l, Max. Mercury (as Hg), mg/l, Max. Lead (as Pb), mg/l, Max. Cadmium (as Cd), mg/l, Max. Hexavalent Chromium (as Cr+6), mg/l, Max. Total Chromium (as Cr), mg/l, Max. Copper (as Cu), mg/l, Max. Zinc (as Zn), mg/l, Max. Selenium (as Se), mg/l, Max. Nickel (as Ni), mg/l, Max. Cyanide (as CN), mg/l, Max. Fluoride (as F), mg/l, Max. Dissolved Phosphates (as P), mg/l, Max. . Sulphide (as S), mg/l, Max. INLAND SURFACE WATER 0.2 0.01 0.1 2.0 0.1 2.0 3.0 5.0 0.05 3.0 0.2 2.0 5.0 0.2 0.01 1.0 1.0 2.0 2.0 3.0 15 0.05 3.0 2.0 15 PUBLIC SEWERS LAND FOR IRRIGATION 0.2 0.2 MARINE COASTAL AREAS 0.2 0.01 . 2.0 2.0 1.0 2.0 3.0 15 0.05 5.0 0.2 15 No. 3550-Cr, AAS Method, Colorimetric method, Ion Chromatographic method No. 3550-Cu, AAS Method, Neo cuproine Method No. 3550-Zn, AAS Method, Inductively coupled plasma method, Dithizone Method, Zincon method No. 3500- Se, Colorimetric method, Fluorometric method No. 3550-Zn, AAS Method, Inductively coupled plasma method No. 4500, Titrimetric method, CyanideSelective Electrode Method, Colorimetric method 4500- F-, Ion- selective electrode method Ion Chromatographic method No. 4500- P Vandomolybdo phosphori acid Colorimetric method Stannous chloride method Ascorbic acid method No. 4500- S2 Methylene blue method Iodometric method, Ion selective electrode method METHOD No. 3500- As Atomic absorption spectrometric method No. 3500- Hg, Cold Vapour Atomic absorption Method, Dithizone Method No. 3550-Pb AAS Method, Dithizone Method No. 3550-Pb AAS Method, Dithizone Method

26

2.0

5.0

iv

STANDARDS SL . NO 27 PARAMETER Phenolic Compounds (as C6H5OH), mg/l, Max. Radioactive materials: (a) Alpha emitter Micro curie/ml (b) Beta emitter Micro curie/ml Bio-assay test INLAND SURFACE WATER 1.0 10-7 10-6 90% survival of fish after 96 hours in 100% effluent 2 mg/l 3 mg/l 0.2 mg/l 10 mg/l 2100 1000 5.0 10-7 10-6 90% survival of fish after 96 hours in 100% effluent 2 mg/l 3 mg/l 0.2 mg/l 2100 1000 PUBLIC SEWERS LAND FOR IRRIGATION 10-8 10-7 90% survival of fish after 96 hours in 100% effluent 2100 1000 MARINE COASTAL AREAS 5.0 10-7 10-6 90% survival of fish after 96 hours in 100% effluent No. 3500- Mn AAS Method Inductively coupled plasma method Persulphate Method No. 3550-Fe AAS Method Inductively coupled plasma method Phenanthroline method No. 3550-V AAS Method Inductively coupled plasma method Gallic acid method 4500- NO2- Ion Chromatographic method Colorimetric Method 4500- NO2- Ion Chromatographic method Gravimetric method with ignition of residues Turbidimetric method METHOD No. 6420 Liquid Liquid extraction gas Chromatographic method Mass Spectrometric method No. 7110 Evaporation method for grass alpha, beta

28

29

30 31 32 33 34 35 40

Manganese (as Mn) Iron (as Fe) Vanadium (as V) Nitrate Nitrogen Dissolved Solids (Inorganic), mg/l, Max. Sulphate (as SO.), mg/l, Max. Pesticides: (microgm per lit. maximum) (i) Benzene hexacholoride (ii) Carboryl

2 mg/l 3 mg/l 0.2 mg/l 20 mg/l -

10 10

10 10

10 10

STANDARDS SL . NO PARAMETER (iii) DDT (iv) Endosulfan (v) Diamethoate (vi) Penitrothion (vii) Malathion (viii) Phorate (ix) Methyl Parathion (x) Phenthoate (xi) pyrethrums (xii) Copper oxychloride (xiii) Copper sulphate (xiv) Ziram (xv) Sulphur (xvi) Paraouat (xvii) Proponil (xviii) Nitrogen INLAND SURFACE WATER 10 10 450 10 10 10 10 10 10 9600 50 1000 30 2300 7300 780 PUBLIC SEWERS LAND FOR IRRIGATION 10 10 450 10 10 10 10 10 10 9600 50 1000 30 2300 7300 780 MARINE COASTAL AREAS 10 10 450 10 10 10 10 10 10 9600 50 1000 30 2300 7300 780 METHOD

NOTE: 1. All efforts should be made to remove colour and unpleasant odour as far as practicable. 2. Parameters at Sl.No.34 & 35 are retained by the State Board, exercising Rule 3(2) of Environment (Protection) Rules, 1986. 3. Hydraulic loading of effluent for application on land for different soils are as under: Sl.No. 1 2 3 4 5 Soil Texture Sandy Sandy Loam Loam Clay loam Clayey Loading Rate in m3/Ha/Day 225 to 280 170 to 225 110 to 170. 055 to 110 035 to 055

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GENERAL EMISSION STANDARDS I. CONCENTRATION BASED STANDARDS: Sl. Parameter Standard Concentration No. not to exceed (in mg/nm3) 1 1. [Particulate Matter 150 (PM)] 1 1 2. [Total Fluoride] [25] 1 3. Asbestos [4 Fibres/Cc And Dust Should Not Be More Than 2 Mg/Nm3] 4. Mercury 0.2 5. Chlorine 15 6. Hydrochloric acid 35 vapour and mist 7 Sulphuric acid mist 50 1 8. Carbon monoxide [1% max(v/v)] 1 9. Lead [10 mg/Nm3] II. Equipment Based Standards: 1 [For disposal of sulphur dioxide, a minimum stack height limit is accordingly prescribed as below:] 1. Sulphur dioxide (i) Power Generation capacity: - 500 MW And more - 200/210 MW and above to less than 500 MW - LESS THAN 200/210 MW (ii) Steam generation capacity - less than 2 1[tonne/hr] - 2 to 5 1[tonne/hr] - 5 to 101[tonne/hr] - 10-15 1[tonne/hr] - 15-20 1[tonne/hr] - 20-25 1[tonne/hr] - 25-30 1[tonne/hr] - More than 30 T/hr
1

Stack-height limit in [metre]

275 220 H=14 (Q)0.3 Coal consumtion per day

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ENVIRONMENTAL STATEMENT (TO BE SUBMITTED AS PER ENVIRONMENT PROTECTION ACT, 1986) FORM V Environmental Statement for the financial year ending the 31st March .. (i) (ii) (iii) (iv) (v) PART A Name and address of the owner/ occupier of the industry, operation or process. Industry category primary.- (STC Code) Secondary.- (SIC Code) Production Capacity.- Units.Year of establishment Date of the last environmental statement submitted PART B WATER AND RAW MATERIAL CONSUMPTION: (i) Water consumption m3/d Process Cooling Domestic Name of products

Process water consumption per unit of product output During the previous During the current financial year financial year (1) (2)

(1) (2) (3) (ii) Raw material consumption Name of products Consumption of raw material per unit of output during the previous during the current financial year financial year

Name of raw materials

* Industry may use codes if disclosing details of raw material would violate contractual obligations, otherwise all industries have to name the raw materials used.

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PART C Pollutants POLLUTION DISCHARGED TO ENVIRONMENT/ UNIT OF OUTPUT (Parameter as specified in the consent issued) Percentage of Concentrations of Quantity of variation from pollutants in pollutants prescribed discharges (mass/ discharged standards with volume) (mass/day) reasons

(a) Water (b) Air PART D HAZARDOUS WASTES (as specified under the Hazardous Wastes/ Management and Handling Rules, 1989) Hazardous wastes Total quantity (kg.) during the previous during the current financial year financial year (a) From process (b) From Pollution control facilities PART E SOLID WASTES Total quantity during the previous financial year (a) (b) (c) From process From pollution control facilities (1) Quantity recycled or reutilized within the units (2) Solid (3) Disposed during the current financial year

PART F Please specify the characterizations (in terms of composition and quantum) of hazardous as well as solid wastes and indicate disposal practice adopted for both these categories of wastes. PART G Impact of the pollution abatement measures taken on conservation of natural resources and on the cost of production. PART H Additional measures/ investment proposal for environmental protection including abatement of pollution, prevention of pollution. PART I Any other particulars for improving the quality of the environment.

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1. Effluent standards The standards for effluent discharge into sewer or stream or land, are given below: pH 5.5 to 9.0 Chemical Oxygen Demand (COD) 250 mg/l Total Suspended Solids (TSS) 100 mg/l 200 mg/l (Land for irrigation) Oil & Grease (0 & G) 10 mg/l (Monitoring frequency of these parameters shall be once in a fortnight) Optional parameters: All other parameters indicated in the general standards for discharge of environment pollutants under Schedule VI, shall be in addition to the effluent standards specified under clause 3. (Monitoring frequency shall be once in a year for the optional parameters) 2. Noise Level Standards 6.00 AM - 10.00 PM 10.00 PM - 6.00 AM Leq 75 dB (A) Leq 70 dB (A) (Monitoring frequency for noise level shall be once in fortnight) Occupational exposure limit of noise specified by Director General of Mines Safety (DGMS) shall be complied with by the coal mines. Schedule I: Sl No 91 Noise Limit for Generator Sets run with Petrol or Kerosene 1. Noise limit Noise limit for new generator sets run with petrol or kerosene shall be as given below: Noise Limit from September 1, 2001 September 1, 2002 90 dBA 86 dBA Noise Level

Sound Power Level Lwa 2. Applicability

These rules shall apply to all new generator sets using petrol or kerosene as fuel, manufactured in or imported into India: Provided that these rules shall not apply to: (a) Any genset manufactured or imported for the purpose of exports outside India, or (b) The genset is intended for the purpose of sample only and not for sale in India. 3. Requirement of certification Every manufacturer or importer (hereinafter referred to as supplier) of genset (hereinafter referred to as product) to which these rules apply must have a valid certificate of type approval for all the product models being manufactured or imported after the specified dates.

4. Verification of conformity of production (COP) Every supplier shall subject its products to the verification for conformity of production, by certification body specified in clause 8, every year. 5. Sale of generator sets not complying with. these rules The sale of a product model, not having valid type approval certificate, or not complying with the noise limits, as determined by the verification for conformity of production, shall be prohibited, in India. 6. Requirement of conformance labeling 6. (1) The supplier of the product must affix a conformance label on the product meeting the following requirements: a. The label shall be durable and legible, b. The label shall be affixed on a part necessary for normal operation of the product and not normally requiring replacement during the product life. 6. (2) The conformance label must contain the following information: a. Name and address of the supplier (if the address is described in the owners manual, it may not be included in the label) b. Statement that this product conforms to the Environment (Protection) Rules, 1986. c. Type approval certificate number and time phase (i.e. September 2001 or September 2002). 7. Nodal agency 1. The Central Pollution Control Board shall be the nodal agency for implementation of these rules. 2. In case of any dispute or difficulty in implementation of these rules the matter shall be referred to the nodal agency. 3. The nodal agency shall constitute a Standing Committee to advise it on all matters; including the disputed matters, related to the implementation of these rules. 8. Certification body The following agencies are authorized for type approval and for verification of conformity of production. Automotive Research Association of India, Pune; National Physical Laboratory, New Delhi; Naval Science & Technology Laboratory, Visakhapatnam; Fluid Control Research Institute, Palghat; and National Aerospace Laboratory, Bangalore. 9. Compliance and testing procedure The compliance and testing procedure shall be prepared and published by Central Pollution Control Board, with the help of the certification agencies. Noise Limit for Generator Sets Run with Diesel 1. Noise limit for diesel generator sets (upto 1000 KVA) manufactured on or after the 1st July, 2003. The maximum permissible sound pressure level for new diesel generator (DG) sets with rated capacity up to 1000 KVA, manufactured on or after the 1st July, 2003 shall be 75 dB(A) at 1 metre from the enclosure surface.

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The diesel generator sets should be provided with integral acoustic enclosure at the manufacturing stage itself. The implementation of noise limit for these diesel generator sets shall be regulated as given in paragraph 3 below. 2. Noise limit for DG sets not covered by paragraph 1. Noise limits for diesel generator sets not covered by paragraph 1, shall be as follows: 2.1 Noise from DG set shall be controlled by providing an acoustic enclosure or by treating the room acoustically, at the users end. 2.2 The acoustic enclosure or acoustic treatment of the room shall be designed for minimum 25 dB(A) insertion loss or for meeting the ambient noise standards, whichever is on the higher side (if the actual ambient noise is on the higher side, it may not be possible to check the performance of the acoustic enclosure/acoustic treatment. Under such circumstances the performance may be checked for noise, reduction up to actual ambient noise level, preferably, in the night time). The measurement for Insertion Loss may be done at different points at 0.5m from the acoustic enclosure/room, and then averaged. 2.3 The DG set shall be provided with proper exhaust muffler with insertion loss of minimum 25 dB(A). 2.4 These limits shall be regulated by the State Pollution Control Boards and the State Pollution Control Committees. 2.5 Guidelines for the manufacturers/users of Diesel Generator sets shall be as under: 01. The manufacturer shall offer to the user a standard acoustic enclosure of 25 dB (A) insertion loss and also a suitable exhaust muffler with insertion loss of 25 dB (A). 02. The user shall make efforts to bring down the noise levels due to the DG set, outside his premises, within the ambient noise requirements by proper siting and control measures. 03. Installation of a DG set must be strictly in compliance with the recommendations of the DG set manufacturer. 04. A proper routine and preventive maintenance procedure for the DG set should be set and followed in consultation with the DG set manufacturer which would help prevent noise levels of the DG set from deteriorating with use. 3. Limits of Noise for DG sets (upto 1000 KVA) manufactured on or after the 1st July, 2003. 3.1. Applicability 01. These rules apply to DG sets upto 1000 KVA rated output, manufactured or imported in India, on or after 1st July, 2003. 02. These rules shall not apply to a. DG sets manufactured or imported for the purpose of exports outside India; and b. DG sets intended for the purpose of sample and not for sale in India. 3.2. Requirement of Certification Every manufacturer or importer (hereinafter referred to as "supplier") of DG set (hereinafter referred to as "product") to which these regulations apply must have valid certificates of Type Approval and also valid certificates of

xii

Conformity of Production for each year, for all the product models being manufactured or imported from 1st July, 2003 with the noise limit specified in paragraph 1. 3.3. Sale, import or use of DG sets not complying with the rules prohibited No person shall sell, import or use of a product model, which is not having a valid Type Approval certificate and Conformity of Production certificate. 3.4. Requirement of Conformance Labelling i. The supplier' of the 'product' must affix a conformance label on the product meeting the following requirements: a. The label shall be durable and legible. b. The label shall be affixed on a part necessary for normal operation of the 'product' and not normally requiring replacement during the 'product' life. ii. The conformance label must contain the following information: a. Name and address of the supplier (if the address is described in the owner's manual, it may not be included in the label) b. Statement This product conforms to the Environment (Protection) Rules, 1986". c. Noise limit viz. 75 dB (A) at 1m d. Type approval certificate number. e. Date of manufacture of the product. 3.5. Nodal Agency i. The Central Pollution Board shall be the nodal agency for implementation of these regulations. ii. In case of any dispute or difficulty in implementation of these regulations, the matter shall be referred to the nodal agency. iii. The nodal agency shall constitute a Committee to advise it on all matters; including the disputed matters, related to the implementation of these regulations. 3.6. Authorized agencies for certification The following agencies are authorized to carry out such tests as they deem necessary for giving certificates for Type Approval and Conformity of Production testings of DG sets and to give such certificates: i. Automotive Research Association of India, Pune ii. National Physical Laboratory, New Delhi iii. Naval Science & Technology Laboratory, Visakhapatnam iv. Fluid Control Research Institute, Palghat v. National Aerospace Laboratory, Bangalore 3.7. Compliance and Testing Procedure The compliance and testing procedure shall be prepared and published by the Central Pollution Control Board, with the help of the certification agencies.

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SCHEDULE III (See rule 3) Ambient Air Quality Standards in Respect of Noise Area Code A B C D Note- 1 Note- 2 Note- 3 Category of Area Industrial area Commercial area Residential area Silence Zone Limits in dB (A) Leg. Day Time Night Time 75 70 65 55 55 45 50 40

Note- 4

Day time is reckoned in between 6 a.m. and 9 p.m. Night time is reckoned in between 9 p.m. and 6 a.m. Silence zone is defined as areas upto 100 metres around such premises as hospitals, educational institutions and courts. The Silence zones are to be declared by the Competent Authority. Use of vehicular horns, loudspeakers and bursting of crackers shall be banned in these zones. Mixed categories of areas should be declared as one of the four abovementioned categories by the Competent Authority and the corresponding standards shall apply.]

xiv

FORM XIII APPLICATION FOR CONSENT FOR ESTABLISHING OR TAKING ANY STEPS FOR ESTABLISHMENT OF INDUSTRY OPERATION PROCESS OR ANY TREATMENT DISPOSAL SYSTEM FOR DISCHARGE, CONTINUATION OF DISCHARGE UNDER SECTION 25 OR SECTION 26 OF THE WATER (PREVENTION AND CONTROL OF POLLUTION) ACT, 1974 (See Rule 32) From Date. To The Member Secretary, Central Pollution Control Board. Sir, I/We hereby apply for Consent/Renewal of Consent under section 25 or section 26 of the Water (Prevention and Control of Pollution) Act, 1974 (6 of 1974) for establishing or taking any steps for establishment of Industry/ operation/ process/ or any treatment/ disposal system to bring into use any new/ altered outlet for discharge of *sewage/ trade effluent*/ to continue to discharge *sewage/ trade effluent* from land/premises owned by.. The other relevant details are as below: 1. Full name of the applicant.. 2. Nationality of the applicant. 3. Status of the applicant: a. Individual b. Proprietary concern c. Partnership firm (Whether registered or unregistered) d. Joint family concern e. Private Limited Company f. Public Limited Company g. Government Company 1. State Government 2. Central Government 3. Union Territory h. Foreign Company (If a foreign company, the details of registration, incorporation, etc.). i. Any other Association or Body: 4. Name, Address and Telephone Nos. of the Applicant. (The full list of individuals, partners, persons, Chairman (full-time or parttime), Managing Directors, Managing Partners, Directors (full time or part-time), other kinds of office-bearers are to be furnished with their period of tenure in the respective office with telephone Nos. and address). 5. Address of the Industry (Survey No., Khasra No., location as per the revenue records, Village Firka,

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Tehsil, District, Police Station or SHQ, jurisdiction of the First Class Magistrate). 6. Details of commissioning, etc.: a. Approximate date of the proposed commissioning of work. b. Expected date of production: 7. Total number of employees expected to be employed. 8. Details of license, if any obtained under the provisions of Industrial Development (Regulation) Act, 1951: 9. Name of the person authorized to sign this form (the original authorization except in the case of individual/proprietary concern is to be enclosed). 10. (a) Attach the list of all raw materials and chemicals used per month. (b) Licensed Annual Capacity of the Factory/Industry. 11. State daily quantity of water in kilolitres utilized and its source (domestic/ industrial/ process/ boiler / cooling/ others). 12. (a) State the daily maximum quantity of effluents and mode of disposal (sewer or drains or river). Also attach analysis report of the effluents. Type of effluent quantity in kilolitres, mode of disposal. i. Domestic ii. Industrial (b) Quality of effluent currently being discharged or expected to be discharged. (c) What monitoring arrangement is currently there or proposed. 13. State whether you have any treatment plant for industrial, domestic or combined effluents. Yes/No If yes, attach a description of the process of treatment in brief. Attach information on the quality of treated effluent vis--vis the standards. 14. State details of sold wastes generated in the process or during waste treatment. Description Quantity Method of collection Method of disposal I/We further declare that the information furnished above is correct to the best of my/our knowledge. I/We hereby submit that in case of change either of the point of discharge or the quantity of discharge or its quality, a fresh application for CONSENT shall be made and until such CONSENT is granted no change shall be made. I/We hereby agree to submit to the Central Board an application for renewal of consent one month in advance of the date of expiry of the consented period for outlet/ discharge if to be continued thereafter. I/We undertake to furnish any other information within one month of its being called by the Central Board. I/We enclose herewith cash receipt No./bank draft No. dated ... for Rs..... (Rupees......) in favour of the Central Pollution Control Board, New Delhi, as fees payable under section 25 of the Act. Yours faithfully, Signature of the applicant. [Note: *Strike out which is not relevant.]

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NATIONAL
Pollutant Time Weighted average

[SCHEDULE VII] [See rule 3(3B)] AMBIENT AIR QUALITY STANDARDS

Method of measurement

Sulphur (SO2) Oxides of Nitrogen as NO2 Suspended Particulate Matter Respirable Particulate matter (size less than 10m) Lead (Pb)

Annual Average* 24 Hours** Annual Average* 24 Hours** Annual Average* 24 Hours** Annual Average* 24 Hours** Annual Average* 24 Hours** 8 hours** 8 hours**

Concentration in ambient air (in ug/m3 for all pollutants except carbon monoxide which is in mg/m3) Industrial Residential Sensitive Area Rural & Area Other areas 80 60 15 120 80 120 360 500 120 150 1.0 1.5 5.0 5.0 80 60 80 140 200 60 100 0.75 1.00 2.0 2.0 30 15 30 70 100 50 75 0.50 0.75 1.0 1.0

1. Improved West and Gaeke Dioxide method. 2. Ultraviolet fluorescence Jacob & Hochheiser Modified (Na-Arsenite) method. Gas Phase Chemiluminescence. (Average flow rate not less than 1.1 m3/minute)

AAS Method after sampling using EPM 2000 or equivalent filter paper. Non-dispersive infrared Spectroscopy.

Carbon Monoxide (CO)

* ** Note.

Annual Arithmetic mean of minimum 104 measurements in a year taken twice a week 24 hourly at uniform interval. 24 hourly/S hourly values should be met 9S% of the time in a year. However, 2% of the time, it may exceed but not on two consecutive days.

1. National Ambient Air Quality Standard: The levels of an air quality necessary with an adequate margin of safety, to protect the public health, vegetation and property. 2. Whenever and wherever two consecutive values exceed the limit specified above for the respective category, it shall be considered adequate, reason to institute regular/continuous monitoring and further investigations.].

xvii

FORM I (See rule 4 of Water (Prevention and Control of Pollution) Cess Act, 1974 RETURN REGARDING WATER CONSUMED DURING THE MONTH OF.......... Name and Address of the consumer 1 Quantity of water consumed in kilolitres Purpose for which water consumed Reading at the beginning of the first day of calendar month under report 3 Quantity of water qualifying for rebate according to the assessee Reading at the end of the last day of calendar month under report 4 Remarks*

2 If the meter was out of order the monthly average consumption of water for the previous 3 months of the working period 5 6 1. Industrial cooling spraying in mine pits or boiler feed.

2. Domestic purpose.

3. Processing whereby water gets polluted and the pollutants are easily bio-degradable. 4. Processing whereby water gets polluted and the pollutants are not easily bio-degradable and are toxic.

i. ii. iii. iv. v. i. ii. iii. iv. v. i. ii. iii. iv. v. i. ii. iii. iv. v.

7 8 from Municipal water supply mains from well/ tube-well from canal from river from any other source from Municipal water supply mains from well/ tube-well from canal from river from any other source from Municipal water supply mains from well/ tube-well from canal from river from any other source from Municipal water supply mains from well/ tube-well from canal from river from any other source

Signature of the consumer............................. Name.. Address.. * For claiming rebate under column 7 the assessee shall indicate in this column the analytical and other reports annexed to this return in support of this claim.

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ANNEXURE TO FORM I Report of Analysis of treated effluent showing performance of the treatment plant for the month of.................................................................... Sample collected on... Sample tested on. By the Laboratories ConcentraMaximum Date on which SI. Polluting parameters tion of range There was On which permissible No. as mentioned in the limits or ranges of conditions imposed under break under consent granted allowed as per parameters perfordown or as per report failure of consent under sections 25/26 mance of the Water (Preven- condition noticed the plant tion and Control of Pollution) Act, 1974 1 2 3 4 5 6 End. : Original Analysis report of Laboratory. Signature Date Name.. Address...

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C HECK L IST I (F OR I NTERNAL AND E XTERNAL A UDITORS )

Format 1 (VG1): Verification Guidelines on Resource Auditing Aspects A. Monthly Water Balance Sheet WATER INTAKE WATER CONSUMPTION [a] [b] Mode of Abstraction of Volume Mode of Use of Water Volume Water (m3) (m3) Tanker Process Surface Water Cooling Ground Water Domestic Piped Water Water Sprinkling systems Rain Water (harvested) Total Total Note: a = b + waste water generated + loss due to evaporation B. Monthly Raw material consumption RAW MATERIAL INTAKE [i] Type of Raw material Weight used (Kg) PRODUCT PRODUCED [ii] Type of Product Weight produced (Kg)

Total Total Note:i = ii + waste products + fugitive losses through air and water C. Monthly Energy Balance Sheet ENERGY INTAKE ENERGY CONSUMPTION [a] [b] Source of Energy Kilowatts Mode of Use of Energy Kilowatt Grid Process Diesel Generator Set Cooling Solar Energy Air Pollution Control Devices Any other Water Pollution Control Devices Water Sprinkling systems Total Total Note: a = b + loss due to heat
1