ENVIRONMENTAL MANAGEMENT IN BULK DRUG AND PHARRMA

INDUSTRY

Dr W G Prasanna Kumar

Social Scientist

AP Pollution Control Board

Pharmaceuticals

• Pharmaceuticals are synthetic chemicals belonging to a wide group of different chemical families and may also react different in the environment.

• Pharmaceuticals are special kinds of chemicals. They are manufactured to be biologically active in living organisms, to be persistent to biodegradation and to have long half-lives. This makes them more risky in nature. Release is ongoing always and everywhere, diffuse and impossible to control. They cannot be forbidden.

Overview - Pharmaceutical Sector In AP

• Pharmaceutical Industry in India has history for more than 60 years.

• Govt. of India has promoted Indian Drugs and pharmaceuticals Ltd. (IDPL) for bulk

drugs, injectables and medical devices.

• IDPL has shown declining in the manufacturing activities from 1985.

• Today in India, in general, the pharmaceutical industry is controlled by the private

sector.

• The growth of pharmaceutical industry in Govt. of A.P has really taken momentum

from 1980 onwards.

• In the state of A.P, the pharmaceutical industry has really grown and seen the

heights of achievement. Today, A.P. state is the bulk drug capital of India.

• In the State of A.P. there are about 5,000 manufacturing units, out of which about

4,500 Active Pharmaceutical Ingredients (API) Manufacturing, about 300 drug

formulation units and about 200 other products.

Rank, Company, Revenue 2011(USD millions)

• 1, Abbott india ltd, 1348.51 • 2, Ranbaxy, 1327.56 • 3, Dr. Reddy's Laboratories, 1178 • 4, Lupin Ltd, 929.84 • 5, Aurobindo Pharma, 865.19 • 6, Dabur, 700.3 • 7, Sun Pharmaceutical, 673.99 • 8, Cadila Healthcare, 629.45 • 9, Jubilant Lifesciences, 561.03 • 10, Piramal Healthcare, 480.26 • 11, GlaxoSmithKline Pharmaceuticals Ltd, 475.8 • 12, Ipca Laboratories, 390 • 13, Wockhardt, 381.23 • 14, Torrent Pharmaceuticals, 380.2 • 15, Sterling Bio, 358.1 • 16, Biocon, 340.38 • 17, Orchid Chemicals & Pharmaceuticals Limited, 320.62 • 18, Alembic, 270.62 • 19, Aventis Pharma, 263.75 • 20, Glenmark Pharmaceuticals, 260.14

Survey Covered in Pharma and Private Health Care Sectors

• The survey covers 3 Zones; Zone-I : Kakinada & Visakapatnam cities (Visakapatnam, East Godavari, West Godavari Districts)

Zone-II : Guntur & Vijayawada cities (Krishna, Guntur and Nellore , Prakasham districts)

Zone-III : Hyderabad, Ranga Reddy, Medak and Mahaboob Nagar Dist.

Zones

Sectors Zone - I Zone - II Zone - III Total

A) Pharmaceutical Sector

a) Large Scale Industries 17 --- 09 26

b) Medium Scale Industries 10 19 10 39

c) Small scale Industries ---- 10 20 30

Additional information

e) API’s units 84

f) Formulation Units 07

g) Others 04

B) Private Health Care Sector

a) Private Hospitals 28 31 19 78

b) Prescriptions 62 100 65 227

Macro level findings in Pharmaceutical Sector

•The common disposal of waste from small to medium organizations through these common

treatment plants is not only a great relief but also justified for huge capital investment otherwise

required.

•The manufacturing of drug products and distribution to ultimate customers (human beings) as

required is generally being carried out through marketing net work and medical representatives in

the front line.

•The every organization’s target to maximize sales and increase customer base with an ultimate

aim to achieve maximum profit while gaining the product reputation in the market and establish

the product brand.

• Overall Good Manufacturing Practices (GMP) understanding level and

implementation to the required regulatory requirements in Zone-I & Zone-III

sectors is almost about 80 to 85% satisfactory level. About 15 to 20 %, though

understanding is fairly satisfactory found gap in the implementation. This

observation is mostly applicable in the small to medium scale industries.

• In Zone-I and Zone-III sectors, the information reveals that, the practices that are

being currently followed is about 50% satisfactory level only.

• In Zone-II sector, the information reveals that, the practices that are being currently

followed is about 30% satisfactory level only.

• The poor environmental management practices implementation from small to

medium scale industries is mainly due to financial constraints.

Survey Findings in Pharmaceutical sector

Figure (A): No. of Pharmaceutical units in Andhra

Pradesh (30%)

Zone Location Industry

Type

Employme

nt status Turnover

status

Zone -

I

Vizag Medium to

Large

25,000 to

30,000

8,000 to

10,000

crores

Zone-

II

Guntur,

Krishna

and West

Godavari

districts.

Small to

Medium

9,000 to

10,000

500 to 700

crores

Zone-

III

Hyderabad,

Rangareddy

, Medak

and

Sangareddy

districts

Small to

medium

and Large

scale

35,000 to

40,000

15,000 to

16,000

crores

Table 1: Nature and status of Pharma sector in the

state of Andhra Pradesh Fig. (C) : Different types of environmental problems in three zones

Figure (B) : Industries surveyed in three zones

Total Prescriptions-227.No diagnosis, No age/sex, no Generic drugs prescription.

ZONE-I(62) ZONE-II(100) ZONE-III(65)

• Male 23 46 33

• Female 33 43 30

• No Gender 0 07 02

• No Diagnosis 36 47 14

• Illegible Prescription 76 56 19

• Not in Therapeutic 26 59 03

Drugs Index.

• Antibiotic- 55 Prescriptions, Analgesics- 34 Prescriptions, Vitamins/Tonics-32 , PPI -34 , H2 Blockers-23.

• Per Prescription cost Rs 332.00 its on higher side & of costly drugs for 392 prescription. Total value Rs 1,34,090.00

Survey findings in Pvt. Health Care Sector

Prescription Analysis :

Prescription Analysis :

•

i) Multiple Antibiotics Pro-biotic Used Along With most of the

Antibiotics.

ii) Non-Steroidal Anti-Inflammatory Drugs, arthritis (NSAIDs)

iii) PPI & H2 blockers used along with all Analgesics .

iv) Vitamins used with Antibiotics

v) Medication with no diagnosis is an irrational prescription/

drugs not in Therapeutic Index/Illegible Prescription also an Irrational

Prescription( Medication error high).

vi) No banned drugs were prescribed.

Most irrationally prescribed drugs were:

Figure A- Hospital Beds in Zones I,II & III Figure B – No. of private hospitals surveyed in Zones I,II & III

Figure C – No. of Prescriptions collected in Zones I,II & III

Pharmaceuticals and Environment

• There exists very well documented evidence that some pharmaceuticals enter and persist in the environment, some are endocrine disruptors (synthetic hormones), some are designed to kill bacteria and viruses (antibiotics) and may affect microorganism and wild life in severe and unexpected ways. Little is known on the possible negative effects and impacts of EPPP in humans and the environment by diffuse and systematic exposure, for long periods of time, especially during the vulnerable periods of development.

Environmental Pharmaceutical Persistent Pollutant (EPPP)

• EPPPs are already found in water all over the world. The diffuse exposure might contribute to

• extinction of species and imbalance of sensible ecosystems, as many EPPPs affect the reproductive systems of for example frogs, fish and mussels;

• genetic, developmental, immune and hormonal health effects to humans and other species, in the same way as e.g. oestrogen-like chemicals;

• development of microbes resistant to antibiotics, as is found in India.

How do Pharmaceuticals reach the environment

Mainly in three ways: • They are excreted from humans and animals,

intact or metabolized, mainly into the urine, passing on to the environment directly or via sewage plants.

• Unused reach the environment either via household water or via urban solid garbage handling.

• Manufacturing plants producing the active substances might unintentionally release pharmaceuticals into the environment.

Where do they go to

• Some pharmaceuticals are degraded to various extents in sewage treatment plants, but others leave the plant in active forms. Active residues of pharmaceuticals have been detected in surface water, and they may persist in the environment for long periods of time. Large amounts of antibiotics and other pharmaceuticals have been found downstream from sewage plants for pharmaceutical industries. EPPPs from sewage sludge used as fertilizer are absorbed by soya, and antibiotics have been found in the leaves.

In Drinking Water • Which Environmental Pharmaceutical Persistent Pollutant EPPPs are found in drinking

water depends on what resources and detection methods are available. Atenolol (beta blocker), citalopram (antidepressant drug), diclofenak (analgesic),ibuprofen (analgesic), metoprolol (beta blocker), naproxen (anti-inflammatory) and trimetoprim (antibiotic) have been found in drinking water of Stockholm, Sweden. Fish caught downstream from the sewage plants of Stockholm contain EPPPs like citalopram (antidepressant drug) and propoxyphene (narcotic/anesthetic).

• Several broad-spectrum antibiotics in very high concentrations, as well as bacteria resistant to all known antibiotics, were found downstream from a sewage plant in India. Also in Indian drinking water cetirizin (antihistaminic), ciprofloxacin (antibiotic), enoxacin (antibiotic), terbinafin (antimycotic), and citalopram (antidepressant drug) were found. Up to 14 different pharmaceuticals have been found in the drinking water of big cities around the world. There also exist publications reporting the presence of cancer drugs in surface water in some countries.

• Some of these environmental pharmaceuticals chemicals are well known to have serious genotoxic effects in humans. Many are not very well studied for their toxic effects on human periods of development. Half-life in nature varies depending on the environment (air, water, soil, sludge), but is more than one year for several compounds.[2][3] [4]

• Clofibric acid, a metabolite of the lipid-lowering agent clofibrate, can still be found in surface as well as well water, although clofibrate long ago has been withdrawn. Concentrations of EPPPs can vary from 1 ng to 1 mg per litre (2). Serious effects of EPPPs on water-living organisms, especially on reproductive systems, have been already shown, as well as on microbial communities

In Drinking water

• Atenolol (beta blocker), citalopram (anti depressant drug), diclofenac (analgesic),ibuprofen (analgesic), metoprolol (beta blocker), naproxen (anti-inflammatory) and trimetoprim (antibiotic) have been found in drinking water. Fish caught downstream from the sewage plants of Stockholm contain EPPPs like citalopram (antidepressant drug) and propoxyphene (narcotic/anesthetic).

• Several broad-spectrum antibiotics in very high concentrations, as well as bacteria resistant to all known antibiotics, were found downstream from a sewage plant in India. Also in Indian drinking water cetirizin (antihistaminic), ciprofloxacin (antibiotic), enoxacin (antibiotic), terbinafin (antimycotic), and citalopram (antidepressant drug) were found. Up to 14 different pharmaceuticals have been found in the drinking water of big cities around the world. There also exist publications reporting the presence of cancer drugs in surface water in some countries.

• Some of these environmental pharmaceuticals chemicals are well known to have serious genotoxic effects in humans. Many are not very well studied for their toxic effects on human periods of development. Half-life in nature varies depending on the environment (air, water, soil, sludge), but is more than one year for several compounds.

• Clofibric acid, a metabolite of the lipid-lowering agent clofibrate, can still be found in surface as well as well water, although clofibrate long ago has been withdrawn. Concentrations of EPPPs can vary from 1 ng to 1 mg per litre (2). Serious effects of EPPPs on water-living organisms, especially on reproductive systems, have been already shown, as well as on microbial communities.

Exposure • Concentrations in surface waters, groundwater and partially treated water are

typically less than 0.1 µg/l (or 100 ng/l), and concentrations in treated water are generally below 0.05 µg/l (or 50 ng/l).(ny 8 WHO) However, all water on the earth is part of the same stable pool, and as larger amounts of pharmaceuticals are consumed, there is a risk that the concentration of pharmaceuticals in drinking water will increase. The tendency of bio-accumulation in fish is alarming, as fish is an important nourishment.

• The impact of pharmaceutical chemicals, due to diffuse exposure by their presence in the water environment, might contribute to the wide chemical exposure of all species and to their possible extinction, as well as to the imbalance in sensitive eco-systems. Consequences for human health and the equilibrium of the biological environmental system may be irreversible.

• Multiple human exposures to EPPP may start at conception and may be combined with a cocktail of other chemicals present in the environment. The effects of exposure to these mixtures are difficult to understand due the complexity of the situation during a period of special vulnerability and sensitivity, but can not be denied. Another very serious threat is development and spread of bacteria, viruses and other microbes resistant to the antibiotics present in the environment, with possible unpredictable important consequences.

Assessment • The levels of pharmaceuticals in surface or drinking water are generally below

1 mg per litre, often measured in ng per litre (2, 8). This low concentration might appear to guarantee that they hardly pose any problem to public health. Assuming a concentration of 100 ng/l of a pharmaceutical that in humans has DDD (defined daily dose) of 10 mg implies that a volume of 100,000 litres would be required to make up one single DDD. Such calculation, however, is an over-simplification that does not take into account several important dynamic aspects of the low chronic exposure to concentrations of pharmaceuticals in the water or the vulnerable population exposure for example during the period of development.

• Aquatic organisms may bio-concentrate and bio-accumulate lipid soluble chemicals, including pharmaceuticals. It is well known that certain fish species, like herring, may contain very high concentrations of the persistent and lipophilic chemicals DDT (dichlorodiphenyl-trichloroethane, an insecticide) and PCB (polychlorinated biphenils, a group of industry chemicals earlier used in e.g. building materials). The same mechanism may also be applied for chemicals synthesized for pharmaceutical uses. Bioackumulation of citalopram (SSRI, antidepresssivum) and propoxyfen (painkiller) has been found in perche in the Baltic Sea. Therapeutic levels of levonorgestrel (a sex hormone) has been found in Rainbow trout downstream a sewage plant.[9]

Assessment • Pharmaceutical chemicals are not thought or designed to enter in the environment and persist there but

for a clear pharmaceutical purpose. Pharmaceutical are synthetic chemicals, they belong to a wide group of different chemical families and may also react differently in the environment. When a new medicine is developed, it’s pharmacological and toxicological effects is tested in acute trials, before being accepted for marketing. However, clinical test procedures are not entirely sufficient to completely guarantee that a new pharmaceutical is devoid of unacceptable side effects when used in large cohorts of patients for a long time. Furthermore, there are currently no test methods to assess whether such effects may occur after long-term use in human, during periods of development, on aquatic microorganisms or how they may affect other animals. Based on this, the persistent and diffuse exposure to low doses of pharmaceutical synthetic chemicals, for long periods of time, is not currently well known or studied.

• The diffuse dissemination of the EPPP in the environment may indiscriminately expose vulnerable populations: embryos/foetuses, children and adolescents, men and women of reproductive age, and elderly or weak persons. Some of the pharmaceuticals found in surface water are prescribed to patients under special controlled conditions for short periods of time due the risk of side effects. Others are prohibited from prescription to pregnant women or children. These chemicals were not synthesized to expose the general population in a diffuse manner. This presents a new and emerging issue under the chemical safety global pollution.

Assessment

• It can be assumed that a large portion of excreted or disposed medicines reach the public sewage treatment plants (STP’s) . Today, the sewage plants do not have the capacity to clean the water from pharmaceutical chemicals. This is sometimes also the case for the industries’ own sewage plants. In many parts of the world, the sewage plant water is reused as drinking water, not always after cleaning treatment. To add a step for cleaning sewage water from pharmaceuticals means more energy, more chemicals and higher costs. - Alternatively, the sewage is directly let out into various surface waters like rivers, lakes, streams or the open sea. - Detection and monitoring at global scale of EPPPs in drinking and surface water as in animals and plants is necessary to understand the magnitude of the problem. The first step is to recognize EPPP as an emerging issue to be able to invest the necessary human and financial resources and develop effective environmental detection methods.

Laws and regulations

• Pharmaceuticals differ from other anthropogenic chemicals with respect to legal requirements. They are regularly excluded in laws and regulations which control manufacture, marketing, use, and disposal of other consumer products of a chemical character (solvents, paints, glues etc.). As a consequence the possible negative environmental impact of pharmaceuticals is much less documented, in comparison to other consumer chemicals.

• In the European Union, the new directive for human pharmaceuticals explicitly requires that all member states should establish collection systems for unused or expired medicines. Such systems were already in use in several member countries at the time the new legislation went into action in 2004. Nevertheless, the extent to which such systems have been established and made publicly known, varies between regions. Furthermore, the directive does not regulate how the collected pharmaceuticals should be handled. Disposal into the sewage system is still a legally accepted route of elimination. However, incineration at high temperature (1200°C) is a preferred alternative to avoid environmental pollution.

• For pharmaceuticals approved for marketing in EU before 1995, there are no requirements for documentation of environmental effects. Hence, pharmaceuticals which have been on the market for decades may have serious environmental effects that have not been detected.

Known effects of pharmaceuticals in the environment

Estradiol (estrogen, synthetic hormone)

• Concentrations in surface water alone are not sufficient to assess the risk of negative environmental effects in the aquatic environment. Synthetic hormones are endocrine disruptors. Thus, estrogenic compounds like ethinyl-estradiol (estrogen hormone) at concentrations < 1 ng per litre may cause both vitellogenin production (a frequently used index for feminization of male fish), and structural change in their sex organs. It has also been demonstrated that fish exposed to sewage treatment plant (STP) effluent can take up and concentrate estrogenic compounds, including ethinyl-estradiol, to very high internal levels. These observations on feminization of fish by estrogenic compounds in STP effluents have been observed in many countries, and have also been observed in other species, like frogs, alligators and molluscs.

Cardiovascular medicines

• Other examples of environmental impact in the aquatic environment of human medication concern both cardiovascular and neuro-psychiatric medicines. The non-selective beta-blocking agent propanolol was found to cause a significant decrease in egg production in medaka fish, at a concentration close to that demonstrated in the sewage treatment plants (STP) effluents. Gemfibrozil (cholesterol and triglycerides lowering drug) often appears in the effluent from STPs. At concentrations close to those reported in STP effluent, gemfibrozil lowers the blood levels of testosterone in fish.

Known effects of pharmaceuticals in the environment

Citalopram / Fluoxetine (serotonin reuptake inhibitor anti depressants, SSRI’s)

• Some SSRI’s have been shown to accumulate in exposed fish. Citalopram has been detected in liver from wild perch in low µg per kg levels, and fluoxetine affects the serotonin system in the same way that it does in humans. Fluoxetine has also been shown to affect swimming activity in shellfish; whether this is linked to a disturbance of serotonin function in the brain is still unknown.

Known effects of pharmaceuticals in the environment

Antibiotics • High levels of antibiotics in the water are a cause for alarm as there is an increased risk of selecting

resistant bacteria, an issue of global concern. This can lead to some highly effective antibiotics becoming ineffective. There are several examples: In India, bacteria resistant to ciprofloxacin have been found downstream pharmaceutical plants, genes for multi resistance were found in drinking water, and multi resistant Salmonella in water sprayed on vegetables. From Europe we know about the epidemic with multi resistant EHEC in summer 2011, originating from water sprayed vegetables.

• The term "eco-shadow" has been introduced to describe the ecological impact of antibiotics. Antibiotics with a wide spectrum that are also stable will have a greater impact on the bacterial flora (a long eco-shadow) than those with a narrow antibacterial spectrum which disintegrates more rapidly (a short eco-shadow).

• The ecological effects of tetracyclines and quinolones have been observed. They are not metabolized in the human body and are therefore excreted unmodified. When entered into the environment they are poorly degraded. They can be toxic to other animals, affecting particularly microorganism and fish. In the effluent from a sewage plant in India, several broad spectrum antibiotics were found in concentrations toxic to bacteria and plants. In the sewage plant itself, there were enterococcae resistant to all known antibiotics.

• The development of resistant bacteria in sewage plants is stimulated by high concentration of antibiotics (e.g. in plant sewage), large amounts of bacteria (e.g. from human sewage water that is added in plant sewage), and selection of Information that can be used to assess the nominated issue have been observed.

The Challenge

• Industries in the SME sector often lack knowledge and know-how on how to profitably increase the productivity and to reduce emissions and discharges.

• Achieving improved productivity and reducing emissions/effluents/wastes within affordable investments appears to be an uphill task for the SMEs.

Rank, Company, Revenue 2011(USD millions)

• 1, Abbott india ltd, 1348.51 • 2, Ranbaxy, 1327.56 • 3, Dr. Reddy's Laboratories, 1178 • 4, Lupin Ltd, 929.84 • 5, Aurobindo Pharma, 865.19 • 6, Dabur, 700.3 • 7, Sun Pharmaceutical, 673.99 • 8, Cadila Healthcare, 629.45 • 9, Jubilant Lifesciences, 561.03 • 10, Piramal Healthcare, 480.26 • 11, GlaxoSmithKline Pharmaceuticals Ltd, 475.8 • 12, Ipca Laboratories, 390 • 13, Wockhardt, 381.23 • 14, Torrent Pharmaceuticals, 380.2 • 15, Sterling Bio, 358.1 • 16, Biocon, 340.38 • 17, Orchid Chemicals & Pharmaceuticals Limited, 320.62 • 18, Alembic, 270.62 • 19, Aventis Pharma, 263.75 • 20, Glenmark Pharmaceuticals, 260.14

Hazardous Waste characteristics

• HW can be categorized based on CRIT

• Criteria i.e.

• – Corrosive

• – Reactive

• – Ignitable

• – Toxic

Incinerator

WASTE MINIMISATION

• In a pharmaceuticals company, the effluent was preheated with hot vapour formed inside the evaporator. After evaluation it was suggested to use a heat exchanger which later saved Rs. 1,20,000 annually.

• In another pharmaceuticals company, the buffer tank height is elevated to make use of gravity for feeding effluent to the feeding tank. This arrangement is leading to savings @ Rs 70,000 per year due to stopping of using of the 3 HP pump.

• In the above company, it is suggested to replace leaking steam traps (3 nos.) with longer life and effective float type steam traps, this will save approximately Rs, 80,000 with investment of Rs. 20,000 only.

• In yet another pharmaceuticals company, the inflow air to the spray drier is being preheated upto 45 0 C with the hot exhaust air of 90 0 C from the same spray direr. This will save approximately Rs. 3,50,000 per year for the company.

• In the above company, the hot exhaust air of spray drier is directly fed into the fluidized bed drier, as the moisture content in this exhaust air of spray drier is very less. This will save approximately Rs. 1,50,000 per year for the company.

Green Chemistry

• Green Chemistry is a concept for scientists envisioned by scientists for higher efficiency, not a mandate or a condemnation from outside of the scientific community.

• Green Chemistry is a concept driven by efficiency coupled to environmental responsibility.

• If using a toxic reagent, one should inquire if a less toxic reagent might accomplish similar ends.

• 80% of waste generated during manufacture of a typical active pharmaceutical ingredient API is related to solvent use.

Benefits of Green Chemistry

At Raw Materials Stage reduction of POTENTIAL RISKS

• To workers

• To suppliers

• To shippers

• To communities near manufacturing site

• To local environment

• To global environment

Benefits of Green Chemistry

At Chemical Synthesis Stage reduction of OTENTIAL RISKS

• To workers

• To communities near manufacturing site

• To local environment

• To global environment

Benefits of Green Chemistry

At End Products Stage reduction of POTENTIAL RISKS

• To Waste Handlers

• To workers

• To suppliers

• To shippers

• To communities near manufacturing site

• To local environment

• To global environment

Benefits of Green Chemistry

At End of Life Management Stage reduction of POTENTIAL RISKS

• To workers

• To suppliers

• To shippers

• To waste sites and communities near them

• To communities near manufacturing site

• To local environment

• To global environment

Survey Findings in Pharmaceutical sector

• Currently, there are about 10 industries started implementation of Corporate Social Responsibility

(CSR) activities in the respective surrounding localities.

• The CSR programmes currently under implementation are sponsoring programmes to promote

education, to improve sanitary and hygiene environments, health camps etc,.

• The population covered under survey for manufacturing of pharmaceutical drug products is only

about 10%.

• All the industries manufacturing pharmaceutical drug products did express that the distribution of

drug products through medical representatives (MR’s) is the right channel.

• The Distribution of drug products by MR’s through their regular visits to Doctors, Chemists,

Hospitals administration management and through electronic media.

• Majority of the industries feel that the sales and marketing activity is purely proprietary and not

interested to disclose the actual practices.

• The Pharma industries in the state of A.P have obtained highest no. of US Food and Drug

Administration (USFDA) and other regulatory approvals and continue to maintain the lead.

• The pharma sector, from State of A.P contributes more than 25% of the turn over of the total

pharma sector turnover from Govt. of India.

• To improve the current environmental management practices, is a major concern.

Recommendations - Pharmaceutical Sector • To improve upon the GMP practices and environmental management practices in the

pharma sector (Which is mandatory), has to be promoted by frequent free training programmes from state and central drug department personnel to enlighten the need and depth of these requirements.

• Environmental pollution caused by the pharma industry and the associated negative impacts on the society in general, the surrounding localities in particular is an un-ending and un-resolved issue. May be Govt.of India, with revised industrial policies may insist and implement strictly by not promoting the creation of housing colonies with in the vicinity of the industries at any cost.

• Govt.of India, may control and provide the critical resources such as, coal, water, power and land at affordable prices to make small to medium scale industries viable and healthy. Upon creation of such a healthy environment, Govt. as well as local NGO’s and voluntary organisations can insist to contribute their mite for social cause to up lift the society for better living and social status.

• The current un-quantified and un-specified un-ethical practices in the marketing distribution chain, if identified and eliminated in a positive perspective can result in affordability for a common man for better health.

• The associations and NGO’s do feel that Govt. should recognize such bodies as arbitrators to create a conducive environment between industry, regulator and Govt. authority.

• The associations should voice out on critical issues facing by the industry such as power, VAT increase, coal etc,. to reduce the in put cost with an expectation to arrive a possible solution to the problem.