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Porus Laboratories Pvt. Ltd. Unit I Sy PORUS LABORATORIES PVT. LTD. UNIT I SY. NO. 339, NALLABANDAGUDEM VILLAGE, KODAD MANDAL, SURYAPET DISTRICT, TELANGANA EXECUTIVE SUMMARY SUBMITTED TO TELANGANA STATE POLLUTION CONTROL BOARD, REGIONAL OFFICE, NALGONDA Executive Summary EXECUTIVE SUMMARY Introduction M/s. Porus Laboratories Pvt. Ltd. Unit I (formerly known as Porus Drugs & Intermediates Pvt. Ltd.) was established in 2003 to manufacture bulk drug intermediates vide CFE order no. 5030/ PCB/ZO /RCP/CFE/ 2003-297 dated 31.05.2003, obtained from the state pollution control board. The unit renewed consent and authorization (CFO) vide Letter No. TSPCB/CFO/NLG/HO/2016-1204 dated 04.08.2016 valid till 31.08.2021. It is proposed to expand the API manufacturing capacity from 6.33 TPD to 13.5 TPD in existing site area of 6.1 acres, by expanding bulk drug intermediate manufacturing and including bulk drug manufacturing. The capital cost for the proposed expansion project is Rs. 25 crores. Prior environmental clearance is mandated for synthetic organic chemical manufacturing activity vide SO 1533, dated September 14, 2006 issued by Ministry of Environment, Forest and Climate Change (MoEFCC), Government of India. The terms of reference for the environmental impact assessment studies was obtained from MoEFCC, vide letter no. F.No. IA-J-11011/62/2019-IA II (I) dated 06.04.2019 as part of environmental clearance process. Location of the Project: The plant site is located at Sy. No. 339, Nallabandagudem village, Kodad mandal, Suryapet district, Telangana. The site is located at the intersection of 16°57'30.25" (N) latitude and 80°02'32.62" (E) longitude. The site is surrounded by open agricultural lands in north and south directions, a drain connecting to palleru, a seasonal stream flows in the eastern side of the site at a distance of 10 m and the service road of national highway (NH- 65) is passing adjacent to the site in west direction. The nearest habitation from the plant site is Nallabandagudem village at a distance of 1.07 km in west direction. The nearest town Kodad is at a distance of 8.5 km in northwest direction. The nearest railway station of Khammam railway station is at a distance of 33 km in northeast direction and the nearest airport at Shamshabad is located at a distance of 175 km in northwest direction. Palleru a seasonal stream is flowing from north to south at a distance of 1 km from the site. Kottagudem canal is at a distance of 0.5 km in northeast direction, flowing from northwest to southeast. Redlakunta canal stream is at distance of 1.4 km in southwest E-1 Team Labs and consultants Executive Summary direction, flowing from southwest to southeast direction, Nandigama canal stream is at a distance of 8.5 km in northeast direction, flowing from northeast to southeast direction. There are two reserve forests in the impact area of 10 km surrounding the project site; Gandrayi RF at a distance of 4.2 km in west direction, and Balusupadu RF at a distance of 4.7 km in southeast direction. Telangana - Andhra Pradesh interstate boundary is at a distance of 0.9 km in southeast direction. There is no national park, sanctuary, biosphere reserves, ecologically sensitive area and critically polluted area within 10 km from the site. Product Profile The manufacturing capacity and list of by-products after expansion is presented in following table; Manufacturing Capacity - After Expansion S.No. Name of Product Capacity (Kg/Day) (TPA) 1 N-Acetyl sulfonilyl chloride 3333.33 1200 2 Isobutyl Acetophenone 3000 1080 3 4-Hydrazino-N-methylbenzene ethane sulfonamide HCl 500 180 4 4-Chlorobutyraldehyde Sodium bisulfite Adduct 166.67 60 5 4-Chlorobutyraldehyde Diethyl acetal 66.67 24 6 4-Dimethylamino Butyraldehyde Diethyl acetal 166.67 60 7 4-Hydrazino-N-methylbenzene ethane sulfonamide HCl 33.33 12 8 4,5,6,7-Tetrahydrothieno [3,2-C] pyridine HCl 333.33 120 9 Sumatriptan Succinate 33.33 12 10 Ibuprofen 3333.33 1200 11 Almotriptan 16.67 6 12 Naratriptan 16.67 6 13 Rizatriptan Benzoate 16.67 6 14 Carvedilol 33.33 12 15 Efavirenz 33.33 12 16 Quinapril Hydrochloride 16.67 6 17 Montelukast Sodium 16.67 6 18 Pregabalin 16.67 6 19 Irbesartan 833.33 300 20 Pramipexole Dihydrochloride 16.67 6 21 Valsartan 16.67 6 22 Prasugrel Hydrochloride 16.67 6 23 Tolterodine Tartrate 833.33 300 24 Omeprazole 833.33 300 25 Clopidogrel Hydrogen Bisulfate 16.67 6 26 Losartan Potassium 833.33 300 27 Risedronate Sodium 16.67 6 28 Vigabatrin 40 14 29 Lurasidone Hydrochloride 50 18 30 4,4’- Oxydiphthalic Anhydride (ODPA) 33.33 12 Total Worst Case 8 Products on Campaign Basis 13500 4860 E-2 Team Labs and consultants Executive Summary List of By-products – After Expansion S. Name of By-Product Quantity Stage Name of Product No (TPD) 1 Spent Sulfuric Acid 9.33 I N-Acetyl sulfonilyl chloride 2 Sulphanilic Acid 0.4 I N-Acetyl sulfonilyl chloride 3 Spent Aluminium Chloride (25%) 10 I Isobutyl Acetophenone 4 Hydrochloric Acid (25%) 2.6 I Ibuprofen 5 Aluminium Hydroxide Gel (18%) 14.5 I Ibuprofen 6 Chromic Sulfate Solution 6.34 III Ibuprofen 7 Tributyltin Chloride 6.83 V Irbesartan 8 Hydrochloric Acid (25%) 6.3 From Scrubbers Manufacturing Process Chemical synthesis produces majority of bulk drugs and intermediates currently in the market. Chemical synthesis consists of four process steps - reaction, separation, purification, and drying. Large volumes of solvents are used during chemical syntheses as medium, extractions, and solvent interchanges. The manufacturing process of all the compounds, reactions involved, material balance are presented at separate annexure of EIA report. Utilities The proposed expansion requires additional steam for both process and effluent treatment system. It is proposed to establish coal fired boiler of capacity 1 x 10 TPH to meet the steam requirement for process, in addition to existing 1 x 5 TPH coal fired boiler, 1 x 2 Lakh K. Cal/hr oil fired thermic fluid heater. Existing 1 x 5 TPH coal fired boiler will be kept as standby after expansion. The total power requirement is estimated to be 1500 kVA. The DG sets required for emergency power during load shut down is estimated at 1500 kVA and accordingly 2 x 500 kVA proposed in addition to existing 2 x 250 kVA and 1 x 180 kVA. Existing 1 x 180 kVA DG set will be dismantled after expansion. The list of utilities is presented in following table; E-3 Team Labs and consultants Executive Summary List of Utilities S.No Utility Unit Existing Proposed After Expansion 1 Coal fired boilers (TPH) TPH 1 x 5 1 x 10 1 x 10 1 x 5* 2 LDO fired thermic fluid heater K.cal/hr 1 x 2 Lakh -- 1 x 2 Lakh 2 DG Sets kVA 2 x 250 2 x 500 2 x 500** 1 x 180# 2 x 250** * Standby ** DG sets will be used during load shutdown # Dismantled after expansion Water Requirement Water is required for process, scrubbers, washing, QC and R&D, cooling tower makeup, steam generation and domestic purposes. The total water requirement after expansion increased from 71.47 KLD to 434 KLD. The fresh water consumption is optimized by reusing treated wastewater to an extent of 170 KLD, thus reducing fresh water consumption to 264 KLD during operation. The fresh water shall be drawn from ground water in addition to reuse of treated wastewater. The water balance for daily consumption is presented in following table; Water Balance INPUT KLD OUTPUT KLD Purpose Fresh Water Recycled Water Loss Effluent Process 105.5 32.7** 81* Washings 10 10 QC and R&D 2.5 2.5 Scrubber 8 8 Boiler 50 15 50 15 Cooling Tower 55 155 173 37 RO/DM Rejects 15 15 Domestic 13 1 12 Water for gardening 5 5 Gross Total 264 170 261.7 180.5 Total 434 442.2 * Effluents contains unreacted raw materials, water formed in reaction, soluble solvents, by-products etc. ** Carried with by-products (Spent Sulfuric acid, aluminium chloride, hydrochloric acid, aluminium hydroxide gel. Baseline Environmental Data The baseline data was collected in the study area during March -May 2019. The baseline data includes collection of Samples of ground water, surface water and soil, monitoring of ambient air quality, noise levels, ecological status and meteorological parameters. The analytical results show that the values are within the prescribed limits for air quality. The ground water quality is observed to be above the limits for potable purpose when compared to the prescribed standards of IS: 10500 – 2012 at few locations. E-4 Team Labs and consultants Executive Summary Identification and Quantification of Impacts The impact assessment report has identified various sources of pollution and quantified the pollution loads due to proposed project. The sources of pollution are air emissions from utilities and process; liquid effluents from process, utilities and domestic usage; solid wastes from process, treatment systems and utilities; and noise pollution from utilities, and process equipment. A detailed impact assessment was made using rapid impact assessment matrix method. The salient features are presented as follows. Impacts on Air quality: The impacts on air quality shall be due to the emissions from, coal fired boilers, and standby DG sets. The incremental concentrations are quantified using ISC-AERMOD model based on ISCST3 Algorithm for proposed utilities of Porus Laboratories Pvt. Ltd. Unit I. The results indicate marginal increase in ambient air quality concentration. The predicted values for SPM, PM10, PM2.5, SO2 and NOx are 1.86, 0.75, 0.34, 2.17 and 2.79 g/m3 respectively and the maximum values are observed at a distance of 0.8 km in north direction, and the cumulative values of baseline air quality combined with predicted values are found to be within the prescribed limits of National Ambient Air Quality Standards.
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