Executive Summary

ABOUT PROJECT

Name of Project :Viva Drugs Pvt. Ltd.

Location :Village Phirour, Tehsil- Khamano,

Distt- Fatehgarh, Punjab

Product :Atenolol, Atorvastatin calcium, Diclofenac

Sodium, Mefenamic acid, Losartan potassium

Clopidogrel bisulfate, Fexofenadine HCl,

Terbinafine hydrochloride & Fluconazole

Nitazoxanide

Capacity (TPA):15-20

Total

Type of Project:Bulk Drug & Intermediates

Cost of the Project:Rs. 2Crore

Total Land:2.2 Acres

Power Requirement:421 KW

Source of power: From Pb. State Power Corporation Ltd

& DG Sets

Source of Water Supply :Own bore well

Quantity of Water (KLD):TotalFresh Water Recycle

26 KLD8 KLD18 KLD

Effluent treatment :Domestic= ETP cum STP

Process= ETP cum STP

Alternate source of power: 1 No. DG Set (85KVA), 1 No. DG Set

(25KVA), 1 No. DG Set (5KVA)

Air Pollution Control :Cyclones, Scrubber & Stack

Solid Waste :Common storage, Treatment & Disposal

Facility (NIMBUA)

Hazardous:Used oil by GOLDEN PETRO (authorized recycler)

1. INTRODUCTION:

M/s Viva Drugs Pvt. Ltd. is proposing to enhance capacity of the unit & addition of chemical products like Atenolol, Atorvastatin calcium, Diclofenac Sodium, Mefenamic acid, Losartan potassium,Clopidogrel bisulfate, Fexofenadine HCl, Terbinafine hydrochloride & Fluconazole, Nitazoxanide at Village Phirour, Tehsil Khamano, Distt. Fatehgarh Sahib, Punjab.As per MOEF, GOI Notification dated 14-09-2006 they are required to have Environmental Clearance of their project before establishing the same. As per schedule of the Notification the Organic Chemical Industries are listed at S. No. 5(f) and general condition given in the Notification is applicable to the unit. Further, the project is to be treated as Category A and thus the Environmental clearance is to be given by the Central Govt. MOEF for which necessary documents were submitted to the SEIAA who have desired to submit an E.I.A. report as per TOR laid out by them. One of the conditions of the TOR is to have Public Hearing. Accordingly a Draft E.I.A report had been prepared to assess the likely impact of the proposed project on various factors which may be affected with the implementation of the programme and to suggest remedial/ precautionary measures, if any, which has been submitted separately. This is a summary of the main Draft EIA Report.

2. NEED OF PROJECT:

The proposed expansion project Viva Drugs Pvt. Ltd. aims to manufacture Bulk Drugs & its Intermediates.

Cardiovascular diseases (CVD) continue to be the major cause of mortality representing about 30% of all deaths worldwide. Lifestyle diseases like hypertension, diabetes mellitus, dyslipidaemia and overweight/obesity are the major risk factor for the development of CVD. With rapid economic development and increasing westernization of lifestyle in past few decades prevalence of those diseases has reached alarming proportion among Indians in the recent years. Many studies from different Indian States showed that the prevalence of prehypertension in the country is about 40-50% therefore there is high demand of drugs to treat cardiovascular diseases in India.

Non-steroidal anti-inflammatory drugs provide analgesic and antipyretic (fever-reducing) effect, and in higher doses anti-flammatory effects, this class of drug is always in demand due to anti-inflammatory effects.

Allergies bring more than the misery of a stuffy nose, watery eyes, and sneezing. If we do not treat allergies, they can aggravate or lead to other conditions such as asthma and sinusitis. Treatment for allergies can involve several different medications, including steroids and allergy shots, but usually the first line of attack is with antihistamines and so far Fexofedine is the best available medicine in Indian market.

3. BASELINE SETTING:

Prevailing Baseline Conditions in the study area of 10 km around the unit have been studied. Primary data has been collected through visits & discussion with local people Secondary data has been taken from the IMD record for Chandigarh station. Thus information regarding climatic conditions like climate, rainfall, humidity, cloudiness, winds etc. are based on IMD data for the years 2004-2009. Other information regarding drainage, land use, cropping pattern & demographic structure has been obtained from the revenue record of Punjab Govt. Details of Forests; Flora & Fauna have been checked from Forest Deptt. & site visits.

4. ENVIRONMENTAL BENCH MARK CONDITIONS:

In order to know the impact of the project on various parameters, it is necessary to know their existing levels. The anticipated effect of the pollutants from the project, if any, shall be superimposed on this to assess the final levels as compared to the permissible limits.

Monitoring stations were established at eight different places within the study area and the existing levels of various parameters in respect of the following were observed to see their quality.

I) Ambient Air

II) Ground & Surface water

III) Noise

IV) Soil

It has been seen that all parameters are well within the permissible limits. Demographic, Socio Economic aspects & Eco Biodiversity angles were also studied & results documented.

5. PROJECT DESCRIPTION:

The project involves manufacture of Atenolol, Atorvastatin calcium, Diclofenac Sodium, Mefenamic acid, Losartan potassium, Clopidogrel bisulfate, Fexofenadine HCl, Terbinafine hydrochloride & Fluconazole, Nitazoxanide.

EMPLOYMENT GENERATION (Direct and Indirect) DUE TO THE PROJECT:

Direct Employment:

Employment generation has been one of the important objectives of development / industrialization. Employment growth is a primary economic development goal of most small communities. More jobs generally mean more residents, more spending at local businesses, and more tax revenues for local governments. Thus job growth permits the expansion and improvement of public goods and services, leading to an improved local quality of life and enhanced prospects for future employment growth. Hence considering the technicality and complexity involved in the Drug Manufacturing, the staffing and employment is critical therefore local people will be given employment based on appropriate knowledge, qualification and expertise.

Small and medium pharma enterprises have played a key role in driving the growth and current status of the Indian pharmaceutical sector. In terms of number of units and employment generation, the SME sector is at the forefront.

Proposed Employment Generation in various departments viz.:-

Production Department

Maintenance Department

Quality Control Department

Quality Assurance

Research and Development / IPM

Purchase Department

EHS

ADMINISTRATION

Indirect Employment:

There is lot of places in-which employment generates indirectly:

Transportation and warehousing

Travel & Tourism Sector

Packaging and printing sector

Information Technology

Agency employment

Telecom Sector

Automobile Sector

Courier Sector

6. RAW MATERIAL USED IN PROCESS:

The raw materials consumption norms involved with respect to products is given below:

TABLE: RAW MATERIAL CONSUMPTION NORMS OF ATENOLO

RAW MATERIALs

CON.

PHPA (Para Hydroxy Phenyl Acetamide)

0.71

Epichlorohydrin

0.91

Mono Iso Propylamine

0.71

Caustic Flakes

0.43

Activated Carbon

0.10

Hyflo

0.02

Hydrochloric acid (CP)

0.53

Sod. Bi Carbonate

0.02

FOR 1.0 KG OF BCFI

1.0

TABLE: RAW MATERIAL CONSUMPTION NORMS OF DICLOFENAC-Na

RAW MATERIALs

CON.

N-CHLOROACETYL-N-PHENYL-2, 6-DICHLOROANILINE

1.46

ALUMINIUM CHLORIDE

0.915

POT WATER

15

SODIUM HYDROXIDE

0.45

SODIUM DITHIONITE

0.004

METHANOL

0.125

FOR 1.0 KG OF DICLOFENAC-Na

1.0

TABLE: RAW MATERIAL CONSUMPTION NORMS OF BCFI

RAW MATERIALs

CON.

ACRYLONITRILE

1.5

HYDROCHLORIC ACID

0.4

POCL3

6

TOLUENE

1

DIMETHYL FORMAMIDE

2

SODIUM CARBONATE

1

METHANOL

4

GLYCINE

0.6

TETRA BUTYL AMMONIUM BROMIDE

0.1

AMMONIA

1

CAUSTIC

1.6

FOR 1.0 KG OF BCFI

1.0

TABLE: RAW MATERIAL CONSUMPTION NORMS OF LOSARTAN-K

RAW MATERIALs

CON.

BCFI (2-butyl-5-chloro-1H-imidazole-4-carbaldehyde-)

0.6

OTBN(2-Cyano-4-methylbiphenyl)

0.7

AIBN(Azobisisobutyronitrile)

0.03

DBH(5,5-Dimethyl-1,3-dibromohydantoin)

0.6

DICHLORO METHANE

3

TOLUENE

12

METHANOL

7

SODIUM BOROHYDRIDE

0.1

TETRA BUTYL AMMONIUM BROMIDE

0.12

SODIUM HYDROXIDE

0.75

N-METHYL PYROLIDONE

1

TEA.HCl

1.5

SODIUM AZIDE

0.7

SODIUM METABISULPHITE

0.11

CARBON

0.2

ETHYL ACETATE

0.7

ACETIC ACID

1.4

POTASSIUM HYDROXIDE

0.2

SODIUM BICARBONATE

0.04

FOR 1.0 KG OF LOSARTAN

1.0

TABLE: RAW MATERIAL OF MEFENAMIC ACID

RAW MATERIALs

Qty

2-Chloro-benzoic acid

1

2,3-Dimethyl-phenylamine

0.88

Cuprous chloride

0.025

DMF

0.1

Toluene

0.75

Potassium carbonate

0.88

TABLE: RAW MATERIAL OF ATORVASTATIN CALCIUM

RAW MATERIALs

Qty

4-Fluoro-alpha-(2-methyl-1-oxopropyl)-gamma-oxo-N,beta-diphenylbenzene butaneamide

0.76

Butylester side chain

0.6

Pivalic acid

0.2

DMF

1.0

Heptane

2.0

Caustic

0.227

Toluene

2.0

Potassium carbonate

0.2

FEXOFENADINE-HCl

Stage : I

Raw Material

Unit

Qty

Benzyl Cyanide

Kg

1.00

DNS

Kg

3.00

Potassium Hydroxide

Kg

2.50

DMSO

Ltr

1.50

Con.HCl

Ltr

2.00

Toluene

Ltr

5.00

Output

Kg

1.2

Stage : II

Raw Material

Unit

Qty

FEX-I

Kg

1.00

EDC

Ltr

2.00

Sodium Hydroxide

Kg

0.80

Con. HCl

Ltr

2.00

Output

Kg

1.1

Stage : III

Raw Material

Unit

Qty

FEX-II

Kg

1.00

Methanol

Ltr

3.00

Sodium Bicarbonate

Kg

0.10

Toluene

Ltr

4.00

Output

Kg

1.00

Stage : IV

Raw Material

Unit

Qty

FEX-III

Kg

1.00

Sodium Borohydride

Kg

0.70

Aluminium Chloride

Kg

0.02

1,2-DME

Ltr

1.50

Con. HCl

Ltr

0.80

Toluene

Ltr

3.00

Output

Kg

0.8

Stage : V

Raw Material

Unit

Qty

FEX-IV

Kg

1.00

Acetic anhydride

Kg

0.80

Hexane

Ltr

3.00

Sodium Bicarbonate

Kg

0.15

Output

Kg

1.1

Stage : VI

Raw Material

Unit

Qty

FEX-V

Kg

1.00

4-CBC

Kg

0.80

Aluminium Chloride

Kg

1.50

MDC

Ltr

5.00

Con.HCl

Ltr

1.50

Output

Kg

1.5

Stage : VII

Raw Material

Unit

Qty

FEX-VI

Kg

1.00

Sodium Hydroxide

Kg

0.30

DMF

Ltr

1.00

Toluene

Ltr

3.00

Output

Kg

0.7

Stage : VIII

Raw Material

Unit

Qty

FEX-VII

Kg

1.00

Potassium permanganate

Kg

1.20

Sodium Hydroxide

Kg

0.40

Sodium metabisulphite

Kg

0.10

MDC

Ltr

1.50

Toluene

Ltr

4.00

Con.HCl

Ltr

1.00

Output

Kg

0.9

Stage : X

Raw Material

Unit

Qty

FEX-VIII

Kg

1.00

Azacyclonol

Kg

0.90

MIBK

Kg

1.00

Potassium iodide

Kg

0.01

Potassium bicarbonate

Kg

1.00

DNS

Kg

1.50

Methanol

Kg

0.20

Methanol-HCl

Kg

4.50

Sodium chloride

Kg

0.10

Sodium bicarbonate

Kg

0.10

Sodium Hydroxide

Kg

0.10

Output

Kg

1.5

Stage :XI

Raw Material

Unit

Qty

FEX-X

Kg

1.00

Methanol

Kg

2.50

Sodium borohyride

Kg

0.06

Sodium Hydroxide

Kg

0.20

Con.HCl

Kg

0.60

Acetone

Kg

0.30

DNS

Kg

4.00

Output

Kg

0.5

Stage : XII

Raw Material

Unit

Qty

FEX-XI

Kg

1.00

Con.HCl

Kg

0.50

Sodium Hydroxide

Kg

0.10

Hyflow

Kg

0.10

Output

Kg

0.9

Stage :API

Raw Material

Unit

Qty

FEX-XII

Kg

1.00

IPA

Kg

2.50

Ethyl acetate

Kg

3.00

Hyflow

Kg

0.05

A. carbon

Kg

0.02

Output

Kg

0.90

CLOPIDOGREL BIDULPHATE

Stage:1

Sr.No

Name

Unit

Qty

1

2-Chloro Phenyl Glycine

Kg

1.00

2

Methanol

Kg

5.00

3

Thionyl Chloride

Kg

1.00

4

MDC

Ltr

2.00

5

Water

Ltr

1.00

6

Aq.Ammonia

Ltr

0.60

Stage : 1 Output(Oily mass)

Kg

1.00

Stage:2

1

Stage 1

Kg

1.00

2

Methanol

Kg

5.00

3

L-(+)-tartaric acid

Kg

0.75

4

Acetone

Ltr

0.35

Stage : 2 Output

Kg

1.40

Stage:3

Purification

1

Stage 3

Kg

1.40

2

Water

Ltr

7.00

3

MDC

Ltr

3.30

4

Aq.Ammonia

Ltr

0.30

Stage : 3 Output(Oily mass)

Kg

0.77

Stage:4

1

Thiophene-2-ethanol

Kg

0.71

2

Toluene

Ltr

4.30

3

PTSChloride

Kg

1.45

4

Water

Ltr

5.70

5

Caustic lye

Ltr

1.40

6

PTC

Kg

0.04

Stage : 4

Kg

1.50

Stage:5

1

Stage 3

Kg

0.77

2

Acetonitrile

Ltr

4.00

3

Sodium Bicarbonate

Kg

1.15

4

Stage 4

Kg

1.50

5

Ethyl acetate

Ltr

2.70

6

Con.HCl

Ltr

0.57

7

Hexane

Ltr

0.77

8

Water

Ltr

1.50

Stage:5 Output

Kg

1.00

Stage:6

1

Stage 5

Kg

1.00

2

Methanol

Ltr

0.30

3

Toluene

Kg

2.70

4

Water

Ltr

1.00

Stage:6 Output

Kg

0.90

Stage:7

1

Stage 6

Kg

0.90

2

IPA

Ltr

4.50

3

Para formaldehyde

Kg

0.20

4

Con.HCl

Ltr

0.01

5

Hexane

Ltr

7.20

6

Aq.Ammonia

Ltr

0.15

7

Sodium Bicarbonate

Kg

0.25

8

Act. Carbon

Kg

0.10

9

Celite

Kg

0.20

Stage:7 Output (Oily mass)

Kg

0.72

Stage:8

1

Stage 7

Kg

0.72

2

Acetone

Ltr

2.16

3

Con.Sulfuric acid

Kg

0.22

Stage:8 Output

Kg

0.86

Source of Raw Material

It is proposed to procure raw materials from the domestic market and certain quantity of some raw materials can be imported from China / any other country. The mode of transport will be by Air or Sea

Final Products

The final product will be Bulk Drugs, Active Pharmaceutical Ingredients & its Intermediates which will transported in India by Rail / Road or Air while the same will be exported to out-side by Air or Sea.

7. BUILDINGS IN PLANT

The firm has already acquired 2.2 acres of land where part factory building has been constructed and no other building required for expansion. It provides adequate space for the following areas of working:-

1.Stores for raw material and finished goods.

2.Production hall

3.Store

4.Offices

5.Engineering workshop

Open space will be landscaped and trees will be planted in due course of time.

8. EMISSIONS:-

There are no emissions from the process as no gaseous material is generated. All materials which become vapors during process are condensed through series of condensers, as all process occur in tightly closed system. However there may be some secondary emissions due to moving of vehicles which will be controlled through sprinkling of water.

9. WASTE HANDLING TREATMENT:-

SOLID WASTE:-

There is no generation of Solid wastes from process.

HAZARDOUS WASTE:-

The Hazardous wastes generated from the unit send to NIMBUA which is a Common Storage, Treatment, & Disposal Facility.

10.0 POLLUTION CONTROL MEASURES:-

i)AIR POLLUTION:-

DG SET:-

There are three DG sets proposed of 85KVA, 25 KVA and 5 KVA. As per guidelines of CPCB/PPCB a stack height of 3.5mt from roof level has been provided to control the pollutants from the diesel fuel to be used.

ii)WATER POLLUTION:-

Requirement Daily fresh water demand will be 8.0 KLD.

The industrial water demand for the proposed expansion will be 22.0 KLD and domestic water demand will be 4.0 KLD. The total water demand in the plant will be 26.0 KLD, out of which we will recycled 18.0 KLD in the industrial process.

The industrial wastewater will be recycled and reused in cooling towers, boilers, scrubbers and where ever possible. An ETP cum STP for the waste water generated is installed to reduce water requirement thus indirectly help the out-put of the plant.

iii) NOISE POLLUTION:-

There is no noise producing machinery. Thus no noise of significant level shall go outside the working area which may disturb the general noise environment. DG set installed shall be noise less type & with canopy.

11.0 ENVIRONMENT IMPACT ASSESSMENT & MITIGATION MEASURES:

GENERAL:

Impact of the project on various Environmental Factors in the project area has been checked on short term & long term basis. Short term impacts are during construction development stage. Long term impacts relate to the operation stage. In both the cases following factors have been considered.

Ambient Air Quality

Water Quality

Noise Quality

Land use pattern

Demographic & Socio economic pattern

ENVIRONMENTAL

FACTORS

SHORT TERM

(CONSTRUCTION STAGE)

LONG TERM

(OPERATIONAL STAGE)

Ambient Air Quality

During the construction no air pollution will be generated. The development stage impacts will not be of any significance. Since there is no point source of air pollution and the fugitive dust generation will be suppressed with sprinkling of water, there will be no effect on this account.

There is only one source of likely pollution which is vapours from the manufacturing process. All the process are closed circuits as such emission to the open atmosphere will be minimum, however, APCD, will be provided at the exit point to neutralize the pollutants. So there will be not any effect on the Air Environment.

Water Quality

Requirement of water during construction is hardly about 1 KLD which will be consumed. There will be no discharge outside the unit on this account. Labour working on the machinery will be provided with a toilet facility & the waste will go to the public sewer. Thus, there will be no impact of the unit on water Environment.

Requirement Daily fresh water demand will be 8.0 KLD. The industrial water demand for the proposed expansion will be 22.0 KLD and domestic water demand will be 4.0 KLD. The total water demand in the plant will be 26.0 KLD, out of which we will recycled 18.0 KLD in the industrial process. The industrial wastewater will be recycled and reused in cooling towers, boilers, scrubbers and where ever possible. An ETP cum STP for the waste water generated is installed to reduce water requirement thus indirectly help the out-put of the plant. This will have some positive effects.

Noise Quality

Since there is no large scale machinery, the installation of the same & movement of vehicles is not likely to have and significant effect over the noise environment.

There is no use of noise producing machinery. DG sets will be noiseless type with additional canopy. Noise Environment in the area thus, will not be affected.

Land

Developed land for the unit has been given to the proponent in the Industries dept. since no debris from the unit is thrown on any land; there will not be any effect on land environment.

The project is coming up in an existing Industrial land. No new land is being acquired. Since no waste is thrown on land, soil quality in the area will not be affected.

Demographic & Socio economic pattern

There is not any adverse impact on the local people of this project during construction phase.

It does not interfere in the life of the people in the study area. There will be no adverse impact on them due to this project. However, it will provide some direct & indirect employment to the local people for running the plant, maintenance of machinery, & security etc. This will have positive effects.

CONCLUSION:-

In view of the proper pollution control measure proposed for the unit as stated above it is concluded that there will be improvement in the development of commercial activities, generation of direct and indirect employment opportunities & the overall, improvement of Quality of life in the surrounding area.

13.0ENVIRONMENT MANAGEMENT PLAN:

To achieve the results as per the measures proposed for mitigation of the various pollutants, the following management practices have been suggested for various factors.

Air Environment

Vehicles shall be checked for their vehicular emissions. Drivers of the vehicles shall be asked to provide PUC certificates. During operation phase air pollution control devices shall be provided to neutralize pollutants from process, to keep it within permissible limits. Tree plantation shall be done along the boundary which will further improve the air Environment in general.

Water Environment

The fresh water will draw through tube-well. The domestic waste water will be use for irrigation purpose after passing through septic tank. Rain water harvesting shall be done for recharging of ground water.

Noise Environment

NO HORN signs shall be displayed at prominent places. Vehicle owners will be asked to maintain them in proper condition. Canopy shall be provided on noiseless types DG sets. Trees with thick foliage shall be planted all around.

Land Environment

No wastage from the unit shall be thrown on any land. Requirement of sand and aggregates during construction shall be obtained from approved vendors.

Solid Waste

There will be no source of solid waste generation in the industry.

Monitoring of various parameters will be done at frequent intervals in the study area, so as to ensure that no deterioration takes place. The results of the monitoring shall be documented and watched properly. The frequency of the checking is as under:

S.No

Item

Parameters to be checked

Frequency

1

Ambient Air

RSPM, SPM, NOX Silica & SO2

Every six months

2

Vehicles

PUC

Every Quarter

3

Noise Level

dB (A)

Once in a year

4

Ground water

As per IS 10500

Once in a year

In order to ensure the implementation of the EMP a structured Environment Management Cell (EMC) interwoven with the existing management system will be created. This will include:-

Representative of the management

Process in charge

In charge maintenance Dept.

A representative of Environment consultants.

All actions of the cell shall be documented.

14.0 COST OF ENVIRONMENT MEASURES:

The total cost of the pollution control measures in the unit is likely to be Rs. 8.0 Lacs. Another Rs. 1.0 Lacs per year shall be needed for their maintenance.

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