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Environmental Impact Assessment
of Proposed 420 TPA
Bulk Drugs & Intermediates Manufacturing
with R&D facility
at APIIC Industrial Park, Annarugudem Village,
Khammam District, Andhra Pradesh
Executive Summary
Sponsor :
M/s. Varun Laboratories Private Limited,
Hyderabad
EIA Consultant:
KKB Envirocare Consultants Pvt. Ltd.,
Tarun Plaza, 1st Floor, 3-5-244, NFC Main Road, Krishna Nagar
Colony, Moula-Ali, Hyderabad–500 040
October 2013
M/s Varun Laboratories Pvt. Ltd. –EIA report Executive Summary 1.0 Introduction
M/s. Varun Laboratories Pvt. limited proposes to establish bulk drugs & Intermediates manufacturing with R&D facility at Plot No. 20, (Sy.no. 44(Part), 48/2 (part) &49/2 (part)) in APIIC Industrial Park, Annarugudem Village, Tallada Mandal, Khammam District, A.P., in an area of 2.274 acres (0.92 Ha) with an investment of Rs.6.0 crores. The Industry will allocate an amount of about Rs. 1.5 crores for environmental protection measures (Pollution Control Equipment) and Recurring cost (operation and maintenance) of Rs. 1.3 Crores / annum. The proposal is to obtain Environmental Clearance from the Ministry of Environment and Forests (MoEF) and Consent for Establishment from APPCB to manufacture total 19 Bulk Drugs and intermediates on Campaign basis (any 4 products will be manufactured at a time) with a total production capacity of 420 TPA. Draft EIA report is prepared considering the Terms of Reference (ToR) issued by MoEF vide F.No. J-11011/33/2013-IA II (I) dated 4th June 2013. 2.0 Project Description
The salient features of the proposed site are presented below. APIIC Industrial Park, Plot No. 20, Annarugudem Village, Tallada Mandal, Khammam District, A.P. 19 Bulk Drugs and Intermediates with R&D facility on Campaign basis (any 4 products will be manufacture at a time) 1 x 3.0 TPH & 1x1.5 TPH Boiler 2 x180 KVA D.G. sets 1 x 2 lac K.cal thermic fluid heater 142.4 KLD (Fresh water 99.9 and Reuse water 42.5 KLD)
2.1 Process Description
The proposed project is Bulk Drugs & Intermediates manufacturing facility. The manufacturing process consists of chemical synthesis extending to a maximum of eight stages and minimum of one stage of processing, involving different types of chemical reactions. These drugs are mainly used for human medication after formulation activity for various diseases. Technology for manufacturing proposed products is available from R&D and private consultants. Industry will implement the proven technologies in the R&D for the cost effective & environmental friendly practices. The process description, flow chart, route ES.1 KKB Envirocare Consultants Pvt.Ltd.
M/s Varun Laboratories Pvt. Ltd. –EIA report Executive Summary of synthesis and material balance, etc. for the products manufacturing are presented in In the manufacturing process various kinds of solvents will be used, so the quantity of different solvents used, recovered, lost and solvent balance cycle is described in EIA report. List of Products with their Production Capacity
Quantity
Therapeutic Category /
Product Name
Bulk Drug Intermediate
Maximum production on various combinations
(any 4 products at a time)
3.0 Description of Environment
3.1 Topography
The topography of the area is a part of flat terrain with less number of bushes and shrubs. The study area has mostly plain topography and lies about 126 m above MSL. The area is surrounded by plots of the APIIC industrial Park. This proposed site is located at an aerial ES.2 KKB Envirocare Consultants Pvt.Ltd.
M/s Varun Laboratories Pvt. Ltd. –EIA report Executive Summary distance of about 30 km NE of Khammam (district headquarters), 35 km SW of Kothagudem and 200 km East of Hyderabad (State Capital). National Highway (NH-221) Connecting Kothagudem with Vijayawada is at a distance of 35 km (by road) from the site. The nearest habitation is Narasimharaopeta (0.7 km NNW). 3.2 Climate Condition
The minimum temperature during the study period is around 20.4°C and the maximum temperature is around 44.2°C. The Southwest monsoon brings rainfall to this region. Rains usually start in June and end in September. Temperatures gradually decrease after the 3.3 Study period
Baseline environmental data generation of study area was carried out during the period April 2013 to June 2013. Data has been generated by MoEF approved laboratory by following the approved procedures of the Ministry of Environment & Forests and the Central Pollution Control Board guidelines. Study area of 10 km radial distance around the site has been 3.4 Meteorology
The meteorological data from April to June was recorded near the site by installing Weather Monitoring Station. The predominant wind direction during the study period is from Southeast direction. The maximum wind speed was 21.6 kmph whereas minimum was zero. The ambient temperature varied from 20.4 - 44.2°C during study period, while the relative 3.5 Ambient Air Quality
The PM2.5, PM10, SO2, NOx, HC and VOC levels were monitored at eight locations during the study period. The 98th percentile concentrations of PM10 and PM2.5 concentrations were in the range of 26-43 µg/m3 and 14-23 µg/m3 respectively. The maximum 24 hourly PM10 and PM2.5 concentrations at individual allocations varied between 26-44 µg/m3 and 14-24 µg/m3 respectively. The 98th percentile concentrations of Sulphur dioxide were in the range of 8 -13 µg/m3. Maximum value of 13 µg/m3 was recorded near the sampling station located at Annarugudem village. The 98th percentile concentration of nitrogen oxides were in the range of 10-16 µg/m3. Maximum value of 16 µg/m3 was recorded near the sampling station located at Annarugudem Village. The concentrations of hydro carbons (HC) at all locations are minimum detectable limit and the concentrations of volatile organic compounds (VOC) recorded below detectable limit at all locations. ES.3 KKB Envirocare Consultants Pvt.Ltd.
M/s Varun Laboratories Pvt. Ltd. –EIA report Executive Summary 3.6 Ambient Noise Levels
Noise levels have been monitored at eight locations within the study area. The observed noise level in the study area ranges from 47.9 – 53.9 dB (A) during daytime and 37.1 – 44.1 dB (A) during nighttime. The equivalent noise levels in residential areas during study period were found within the ambient noise standards. 3.7 Water Quality
Seven samples of surface water and eight samples of ground water have been collected from surrounding villages. The water quality is found to be satisfactory. No metallic contamination or significant pollutants has been found in the surface and ground water 3.8 Soil Quality
Eight soil samples from surrounding villages were collected and analyzed. The predominant texture of soil in study area is silt, clay and sand. Potassium availability is good in neutral and alkaline soil. The pH values in the study area are varying from 8.6-9.0 showing alkaline during study period. The soil contains moderate amount of organic matter, nitrogen, 3.9 Sensitive Ecosystem
There are no ecologically sensitive areas like national park, wildlife sanctuary, wetland, archaeological monuments are present within 10 km radius of the project site. The Kannegiri reserve forest boundary is located at 4.8 km (aerial distance) in east direction from project site. The Gobbagurti reserve forest boundary is located at 8.6 km (aerial distance) in west direction from project site. None of the plant species and animals present in the study area belongs to threatened or endangered categories. 3.10 Biological Environment
Flora: The plant resources in core area consisted of 39 species belonging to 36 genera and
18 families. The predominant life forms include Herbs (21sp), followed by Trees (11sp) Fauna: Among the Mammals, only Squirrels, Mongoose, Rats, Bandicoots and Rabbits were
seen frequently during the survey. Monkeys were also rare. Among the reptiles, Lizards, Garden lizards were very common. Rat snake and Monitor lizard were seen once during the survey. Other reptiles were very rare. The amphibians were also rare. There were no resident birds other than Crows, Parrots, Doves, Weaverbirds, Swifts, Quails and Mynas. Fish collection was made with the help of hand operated nests of varying sizes by randomly netting different areas of the Wyra reservoir and at two streams one at Pedda ramapuram & another at Billupadu. In total 23 species were recorded belonging to different orders. ES.4 KKB Envirocare Consultants Pvt.Ltd.
M/s Varun Laboratories Pvt. Ltd. –EIA report Executive Summary 4.0 Anticipated Environmental Impacts and Mitigation Measures
4.1 Air Environment
4.1.1 Process Emissions
Manufacturing Bulk Drugs could result in gaseous emissions. Proposed gaseous emissions like HCl, SO2, H2, CO2 and O2 will be generated and these gases will be sent to scrubber / diffused with flame arrestor / dispersed into atmosphere to control the gaseous emissions. Multi cyclone separator and bag filters will be provided for control of particulate matter from the boiler emissions. Greenbelt development within the plant premises will help in attenuating the pollutants emitted by the plant. 4.1.2 Fugitive Emissions
Various types of solvents are used in the bulk drug manufacturing process. The solvents will be stored in drums and bulk quantities will be stored in above / underground storage tanks of suitable capacities. Solvents are handled in closed conditions thereby reducing the losses in the form of evaporation. The industry will take measures for reduction of fugitive emissions by providing vent condensers to the tanks. Chilled brine circulation will be used to condensate the solvent vapor in receivers which ensures the maximum recovery and also controlled by closed operations and handling methods. Good ventilation will be provided to reduce the workroom concentrations. The reactor generating solvent vapors will be 4.1.3 Emissions – Utilities
Boilers, Thermic fluid heater and DG sets are the main sources contributing emissions from the plant. The plant proposed coal fired boilers of 3 &1.5 TPH, HSD fired 2 lac K.cal thermic fluid heater to meet the steam and heating requirements. Proposed 2x180 KVA DG Sets will be used as standby power during power failure. The emissions from the boiler are given Stack and Emission Sources
Thermic Fluid
Boilers:
Parameters
3 & 1.5 TPH
2 Lac K.Cal
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M/s Varun Laboratories Pvt. Ltd. –EIA report Executive Summary Coal is being used for steam generation, particulate matter (PM), sulphur dioxide (SO2) and oxides of nitrogen (NOx) will be the important pollutants. The proposed measure to minimize the pollution from the boiler is installation of multi cyclone separator and bag filters to control the particulate (PM) emission within statutory limit of 115 mg/Nm3. To facilitate wider dispersion of pollutants, 30 m height common stack will be installed for 1x3 TPH boiler & 1x1.5TPH boiler and 15m height for 2 lac K.Cal thermic fluid heater. The GLC predictions for the same are envisaged as per ISC_AERMOD-View as: Pollutant
Baseline
Resultant
(µg/m3)
Incremental level
(µg/m3)
Standard
(µg/m3)
(µg/m3)
From the above prediction, it is clear that maximum ground level concentrations of PM2.5, PM10, SO2 and NOx emissions from the plant emissions will be marginal. Also, the maximum impact zone for all the pollutants is at 0.5 km radial zone from the proposed stack. Hence, the expected impact can be termed as of insignificant. Besides, GLC’s prediction on the location of baseline monitoring stations also shows insignificant increment as a result of proposed project over the existing ambient air quality. 4.2 Noise Environment
DG sets, boiler and compressors will be the major noise generating units in the plant. Provision of acoustic barriers for DG sets. The DG sets generators are operated at the time of power failure. There is no need for the workers to be near this unit continuously. PPEs will be provided at high noise zones. However the workers in this area will always provide with ear muffs. The project site is 0.7 km(aerial) from nearest habitation. Hence, no impact of noise will be felt at this village. Under the general health checkup scheme as per factory act, the workers will however be checked up for any Noise induced Hearing Loss (NIHL) by a 4.3 Water Environment
The sources of effluent generation from the plant are from the process, floor & reactor washes, cooling tower bleed, DM regeneration, quality control, R&D, scrubber and plant domestic wastewater will be about 44 KLD. This individual effluent will be pumped to the above ground level R.C.C. lined tanks for storage and neutralization. The effluent treatment scheme proposed for each stream i.e., HTDS / HCOD and HTDS effluent of 29.9 KLD will be collected and treated separately in full- fledged Effluent Treatment Plant with Zero Liquid Discharge (ZLD) concept consisting of steam stripper, MEE system & ATFD. Condensate along with LTDS / LCOD effluent will be ES.6 KKB Envirocare Consultants Pvt.Ltd.
M/s LR Life Sciences –EIA report Executive Summary 4.3 Water Environment
The sources of effluent generation from the plant are from the process, floor & reactor washes, cooling tower bleed, DM regeneration, quality control, R&D, scrubber and plant domestic wastewater will be about 43.6 KLD. This individual effluent will be pumped to the above ground level R.C.C. lined tanks for storage and neutralization. The effluent treatment scheme proposed for each stream i.e., HTDS / HCOD and HTDS effluent of 28.6 KLD will be collected and treated separately in full- fledged Effluent Treatment Plant with Zero Liquid Discharge (ZLD) concept consisting of steam stripper, MEE system & ATFD. Condensate along with LTDS / LCOD effluent will be sent to biological ETP and tertiary treatment including R.O system for treatment and reuse. There will be no discharge of effluent outside the plant premises, the unit will be treated as ZLD unit. Spent Mixed unrecoverable solvent from the steam stripper will be sent to Authorized Cement industries for incineration. ATFD Salts and sludge from the ETP will be The LTDS / LCOD effluent consists of washings, Q. C & R&D, domestic wastewater of about 15 KLD will be collected separately and treated in Effluent Treatment Plant. Effluent characteristics, segregation and Treatment Flow
Effluent
Treatment Flow
28.6 2 to 12 <100000 <35000 Collection Equalization  Neutralization  Settling  Steam stripper  MEE along with HTDS effluent  Condensate to secondary treatment (Biological) in ETP  Concentrate to ATFD. Collection Equalization  Neutralization ETP (Biological Treatment)  Pressure Sand Filter  Activated Carbon Filter  Cooling 4.4 Land Environment
The proposed site is plain land and allotted by the APIIC on outright sale basis for establishing bulk drug Industry. Therefore, the proposed plant activities are unlikely to alter the land-use pattern in the project site. The organic residues and spent carbon will be disposed to cement industries for use as alternate fuels either in the solid or liquid form. Inorganic salts will be sent for landfill at TSDF. Other waste will be sent to APPCB authorized agencies / recyclers. ES.7 KKB Envirocare Consultants Pvt.Ltd.
M/s Varun Laboratories Pvt. Ltd. –EIA report Executive Summary 4.4.1 Solid Waste
Solid waste generated from the various stages of Bulk Drug manufacturing is given below. Solid Waste Generation from the Proposed Project
Proposed
Handling
Disposal
Handling
Disposal
Quantity
Other Solid Waste
* Maximum Solid Waste quantities on various combinations (any four products will be
manufactured at a time).
Solid waste will be segregated, detoxified and collected in the HDPE Drums / Bags and will be stored in the Covered and raised Platform with Leachate collection system before 4.5 Socio-Economic Aspects
The total population of the Mandal with in 10 km radius of the study area as collected from 2009-2010 (Data collected from District hand book) in the study area. Tallada Mandal is the major contributor with population of 54266 (rural) with males constituting about 27698 and females about 26568. Scheduled Castes and Scheduled Tribes population constitute about 25.51% and 5.3% of the total population.Literacy pattern of the study was reported to be ES.8 KKB Envirocare Consultants Pvt.Ltd.
M/s Varun Laboratories Pvt. Ltd. –EIA report Executive Summary around 47.9% of the total population of the study area. The literacy levels of male and female are about 28.64 % and 19.31 % respectively. The project will generate employment direct (50 nos) and indirect (50 nos); preference will be given to local people. Under the Corporate Social Responsibility the Industry will develop a policy of developing the villages in the vicinity by identifying the requirements. The social requirements will be identified such as drinking water requirement, promotion of educational institutions, medical facilities to the villagers (especially Senior Citizens and infants or pregnant ladies) etc. will also be developed as part of social responsibility. 4.6 Handling of Hazardous Chemicals, Waste and Risk Assessment
A Bulk Drug manufacturing industry has to handle many such chemicals that are hazardous in nature. Once these chemicals are used for some reactions, same hazardous wastes are generated. The industry will provide special training to the workers handling Hazardous chemicals / wastes. The industry engaged safety consultants to prepare a Risk Assessment and suggest safe handling and safe storage of Hazardous wastes. Only highly trained personnel with personal protective equipment’s (PPE’s) will be allowed to handle such chemicals or wastes under strict supervision. 4.7 Occupational Health Hazards
The principle of occupational health hazards posing danger to the health of personnel are coal handling area (for boiler feed), reactors area, boiler area, loading and unloading sections in the store area, acid and alkali handling/storage areas, oil storage areas, Handling storage and disposal of Hazardous wastes etc., Working in these areas without proper precautions and PPEs may cause skin diseases, chemical burns, respiratory diseases, electric shock and electrocution leading to permanent disability. Various measures will be implemented to encounter health hazards to the working personnel. 5.0 Greenbelt development
The total area to be developed as greenbelt is (0.77 acres) 33.9%. The plant species are based on the guidelines for developing greenbelts by the CPCB considering the local conditions. The green cover proved beneficial such as retention of soil moisture, prevention of soil erosion, recharge of ground water and moderation of the micro-climate of the area. 6.0 Post- Project Environmental Monitoring
A environmental management cell with necessary infrastructure will be developed at proposed project. The environmental management cell comprising experienced and qualified personnel reporting to the Vice President regarding environmental performance and monitoring of environmental quality will be created. ES.9 KKB Envirocare Consultants Pvt.Ltd.
M/s Varun Laboratories Pvt. Ltd. –EIA report Executive Summary Construction Phase:
The proposed project envisages construction of production blocks, Effluent treatment plant, setting up of machinery, storage facilities etc., are expected to last for about 2 - 3 years. Generic environmental monitoring measures during construction stage are given below. • Ambient air quality parameters viz., PM, SO2, NOx and HC will be monitored regularly to ensure that ambient air quality standards would be met all the time. • Basic amenities such as drinking water, sanitation & lighting will be provided to the Operation Phase:
Air emissions from process areas, Boiler, DG sets, wastewater reuse, hazardous and non- hazardous waste generation are envisaged. The attributes which merit regular monitoring based on the environmental setting and nature of project activities are listed below: • Source emissions and ambient air quality • Groundwater levels and ground water quality in surrounding bore wells • Water and ETP effluent quality • Hazardous and solid waste characterisation (process hazardous waste, ash, ETP • Soil quality • Noise levels (equipment and machinery noise levels, occupational exposures and • Health checkup will be made as per the guidelines prescribed by the statutory body. 7.0 Project Benefits
Establishment of Bulk drugs and intermediates manufacturing facility not only increases the market availability of therapeutic drugs but also reduces the import burden on the country and also support the government by paying the taxes to the exchequer. In addition to this certain social contributions will help in economic growth of the area. Adequate plantation is proposed inside and outside the plant. The trees will maintain regional ecological balance and conform to soil and hydrological conditions. Indigenous species would be preferred. The management will support the local administration and other form of assistance for the development of public amenities in this region. The social requirements will be identified such as drinking water requirement, promotion of educational institutions, medical facilities to the villagers (especially senior citizens and infants or pregnant ladies). Transport, will improve in this area due to rapid industrialization. The health programme outlines a routine monitoring of health and safety of the work force. Proponent will generate direct and indirect employment preferably from the nearby villages and unavailable technical persons from outside. Employment will be 50 persons as direct & 50 persons indirect. Industry proposes to allocate Rs. 12 lakhs towards Corporate Social ES.10 KKB Envirocare Consultants Pvt.Ltd.

4.7 Occupational Health Hazards

4.7 Occupational Health Hazards

Source: http://appcb.ap.nic.in/public%20hearing/ph/to_be_conducted/many/Varun%20Laboratories%20Pvt.%20Ltd.,%20Khammam%20Dist.,%20EXE%20SUM%20ENG.pdf