PRE FEASIBILITY REPORT

Transcription

1 PRE FEASIBILITY REPORT for PROPOSED EXPANSION OF BULK DRUGS IN EXISTING UNIT IN GIDC, ANKLESHWAR of M/s. RUSAN PHARMA LTD. PLOT NO. 6406, NEAR HOECHEST CHOWKADI, G.I.D.C., ANKLESHWAR, DIST.: BHARUCH, GUJARAT Prepared By: NABL Accredited Testing Laboratory ISO 9001:2008 Certified Company Aqua-Air Environmental Engineers P. Ltd. 403, Centre Point, Nr. Kadiwala School, Ring Road, Surat

2 CONTENTS Sr. No. Description Page No. 1. Executive Summary 3 2. Introduction of the Project/Background information 8 3. Project Description 9 4. Site Analysis Planning Brief Proposed Infrastructure Rehabilitation and resettlement (R& R) Plan Project Schedule & Cost Estimates Analysis of Proposal (Final Recommendations) 20 2

3 1.0 EXECUTIVE SUMMARY 1.1 Company Profile Introduction M/s. Rusan Pharma Ltd. is a technology driven pharmaceutical company with interests in research and development, manufacturing and marketing of formulations, APIs and their intermediates. We specialize in opioid de-addiction, critical and acute pain management, anti-tuberculosis and psychotropic drugs. The business spectrum of Rusan Pharma Ltd. includes: Pharmaceutical Research & Development Manufacturing and Marketing of Formulations Synthesis of niche APIs Synthesis of Drug Intermediates Providing contract research and analytical services to our partners Preventing HIV by providing substitution treatment to opioid dependents and injecting drug users. At Rusan, we are guided by professional leadership and experience, commitment towards quality and delivery and a good understanding of business complexities. We work with exemplary business practices and work ethics, and implement new ideas efficiently and effectively. Rusan also believe that success is often achieved through close collaboration with partners who share a common vision and possess complementary strengths. With the ever changing industry trends we are ready to take on fresh challenges by embracing original technologies, novel drug delivery systems, and biocatalysts. That is why we are confident that with strong leadership, motivated partners and new technologies we can provide a better quality service to our customers. 3

4 Sr. No Project Details Proposed expansion is in existing unit. List of products with their production capacity; Name of the Products CAS No. Quantity (KG/Month) Existing Additional Total Apomorphine Bisoprolol Fumarate Buprenorphine / Buprenorphine Base Eflornithine Fentanyl Citrate/ Fentanyl Base Nalbuphine / / End-use of product Treatment of Parkinsonism. Treat High Blood Pressure (Hypertension). Treat Moderate to Severe Pain/ Used as an Analgesic, in Long- Term Replacement Therapy in Opioid Dependency. Treating Unwanted Hair on the Face, Around the Lips and Chin. Treats "Breakthrough" Cancer Pain that is not Controlled by other Medicines/ Fentanyl is used as part of anesthesia to help prevent pain after surgery or other medical procedure Painkiller Used for the Complete or Partial Reversal of Opioid Overdose, including Respiratory Depression. and also Naloxone used for Diagnosis of Suspected or known Acute Opioid Overdose and also for Blood Pressure support in Septic Shock. 8 Naltrexone Painkiller and Treat 4

5 Alcohol Abuse. 9 Promodol Painkiller 10 Tramadol Painkiller 11 Methadone Nalmefene Noroxymorphone Painkiller 14 n- Butyl Cyano Acrylate Carvedilol Nalfurafine Mesalamine Duloxetine Azilsartan Medoxomil Paroxetine Bupivacaine Bupropion Treat Addiction to Opioids as Part of an approved Treatment Program. Helps prevent Withdrawal Symptoms Caused by stopping other Opioids Management of Alcohol Dependence. Use as the Main Component of Medical Cyanoacrylate Glues Treat Heart Failure and Hypertension (High Blood Pressure). Use as Antipruritic (Anti- Itch Drug) Treat a Certain Bowel Disease. Reduce Symptoms of Ulcerative Colitis such as Diarrhea, Rectal Bleeding, and Stomach Pain. Treat Depression and Anxiety. Treat High Blood Pressure (Hypertension). Treat Depression, Panic Attacks, Obsessive- Compulsive Disorder (OCD), Anxiety Disorders, and Post- Traumatic Stress Disorder Anesthetic for a Spinal Block. Treat Major Depressive Disorder and Seasonal 5

6 Total Affective Disorder. 1.3 Green Belt Development Company has developed green belt within the factory and on periphery of the factory. In addition to this, majority of the vacant land shall be planted with trees, shrubs and grasses. Total Plot Area: 1,888 m 2 (Green Belt: 170 m 2 approx. 9% of total area ) 1.4 Power & Fuel Requirement Fuel: Natural Gas: 1500 SM 3 / Day High Speed Diesel: 90 Lit/Hr (Proposed) Energy: 275 KVA from GEB (Existing) 125 KVA from D. G. Set (Emergency power back up) (Existing) 400 KVA from D. G. Set (Emergency power back up) (Proposed) 1.5 Water Requirement and Wastewater Generation & Treatment Water requirement is met through GIDC water supply. After expansion total water requirement will be 26 KL/day (Industrial: 24.5 KL/day + Domestic: 1 KL/day + Gardening: 0.5 KL/day) KL/day (Industrial: 11.4 KL/day + Domestic: 1 KL/day) effluents will be generated after the expansion. 9.5 KL/day will be treated in ETP consisting of primary treatment and will be sent to common MEE for further treatment & disposal and 1.7 KL/day will be reused for cooling purpose. Domestic Effluent (1 KL/day) will be sent to septic tank & soak pit. 1.6 AIR POLLUTION SOURCE AND CONTROL MANAGEMENT There will be flue gas emission from Thermic fluid heater (2 Lac Kcal/ Hr), IBR Boiler (1500 kg/hr) and D. G. Set (2 Nos.). Company will provide adequate stack height and Caustic Scrubber to reduce air pollution. 6

7 1.7 HAZARDOUS WASTE MANAGEMENT Sr. No Type/Name of Hazardous waste Used/Spent Oil Spent Catalyst/ Spent Carbon Discarded and off specification drugs Spent Organic Solvent Discarded Bags/ Containers/ Barrels Distillation Residue Inorganic Solid Waste Source of Generation Equipment and machinery Category and Schedule as per HW Rules 5.1 Process 28.2 Expired drugs 28.4 Process 28.6 Raw material and storage 33.3 Process 36.1 Process - Quantity/Annum Existing Additional KL 300 Nos KL 3000 Nos ETP sludge ETP Total KL 3300 Nos Disposal Method Collection, Storage, Transportation & sent GPCB approved recyclers/reused as lubricant. Collection, Storage, Transportation & sent to cement industries for co-processing or common incineration site. Collection, Storage, Transportation & sent to cement industries for co-processing or common incineration facility. Collection, Storage, Transportation & Recovery or sent to solvent recovery unit. Collection, Storage, Transportation & sent back to supplier/ approved recycler. Collection, Storage, Transportation & sent to cement industries for co-processing or common incineration facility. Collection, Storage, Transportation & sent to TSDF site for disposal. Collection, Storage, Transportation and disposal at common TSDF. 7

8 9 Organic Residue Process Collection, Storage, Transportation and sent to cement industries for coprocessing or common incineration facility. 2.0 INTRODUCTION OF THE PROJECT/BACKGROUND INFORMATION 2.1 Identification of the project and project proponent. In case of mining project, a copy of mining lease/letter of intent should be given. Identification of the project Proposed Expansion of Bulk Drugs in existing unit. Identification of the project proponent Sr. No. Name of Authorized Person Designation Contact Details 1 Dr. Vijay Srivastava Managing Director Mr. Ajay saxena Director Mr. B. A. Patel Director Brief description of nature of the Project Proposed expansion of Bulk Drugs in existing unit. 2.3 Need for the project and its importance to the country and or region The objective is to be achieved by: Consolidating Specialty chemical Business. By constantly upgrading the product range of Specialty Chemicals. Continuously reducing the Costs & improving Quality. To generate local employment 8

9 2.4 Demands-Supply Gap Based on our informal survey of the market with our current customers and various traders, we have found that there is a big potential for the range of the products we are planning. These products will be expansion of the current range of our products as well as new products. 2.5 Imports vs. Indigenous production Based on the current cost of indigenous raw materials and the non availability of some materials, we will have to import some of the key raw materials as they are not available indigenously. This will make us very competitive against imported finished products and we will be able to increase the export of our finished products. 2.6 Export possibility We shall explore the possibility to export the products. 2.7 Domestic/Export Markets We shall sale our products in domestic & international markets. 2.8 Employment Generation (Direct and Indirect) due to project. Employment would be as per prevailing norms of state government for skilled and unskilled people after the proposed expansion project. 3.0 PROJECT DESCRIPTION 3.1 Type of Project including interlinked and interdependent projects, if any. Proposed expansion of Bulk Drugs in existing unit. Category: B-5(f) 9

10 3.2 Location (map showing general location, specific location and project boundary & project site layout) with coordinates. Map showing general location 10

11 Google image showing 10kms. radius Rusan Pharma Ltd. 11

12 Layout 12

13 3.3 Details of alternate sites considered and the basis of selecting the proposed site, particularly the environmental considerations gone into should be highlighted. Major factors involved in the selection of site are listed below: Site is very well connected by road Proximity to Raw Material suppliers Availability of sufficient land free from cultivation Availability of power evacuation facilities Availability of water for industrial use Modern infrastructure support and amenities at par with industrial estates in other global markets, including: Efficient transport facilities within the industrial estate and to & from the city area. Environment-friendly zone. Uninterrupted power supply. 3.4 Size or Magnitude of Operation The detail of product capacity & major raw material consumption are furnished in Annexure-1 of Form-1. (Page No. 14) 3.5 Project Description with process details (a schematic diagram/flow chart showing the project layout, components of the project etc. should be given) Please refer Annexure-III in Form-I (Page No. 25) 3.6 Raw material required along with estimated quantity, likely source, marketing area of final products. Mode of transport of raw materials and finished products. Please refer Annexure-I in Form-I (Page No. 16) 13

14 3.7 Resource optimization/recycling and reuse envisaged in the project, if any, should be briefly outlined. Entire quantity of industrial wastewater shall be sent to ETP consisting of primary treatment unit and then shall be sent to Common MEE plant, ACPTCL, Ankleshwar for further treatment & disposal. 3.8 Availability of water its source, energy/power requirement and source should be given. Power & Fuel Requirement Fuel: Natural Gas: 1500 SM 3 / Day (Existing) High Speed Diesel: 90 Lit/Hr (Proposed) Energy: 275 KVA from GEB (Existing) 125 KVA from D. G. Set (Emergency power back up) (Existing) 400 KVA from D. G. Set (Emergency power back up) (Proposed) Water Source The entire water requirement will be met through GIDC water supply. 3.9 Quantity of wastes to be generated (liquid and solid) and scheme for their management/disposal. Liquid Waste: The detail is furnished in Annexure-IV of Form-1 (Page No. 76) Solid Waste: The detail is furnished in Annexure-V of Form-1 (Page No. 79) 14

15 3.10 Schematic representations of the feasibility drawing which give information of EIA purpose. ACTIVITIES OVERVIEW OF E. I. A. STUDIES SOURCE OF INFORMATION RECONNAISSANCE SURVEY OF EXISTING PLANT INTRODUCTION ANNUAL REPORT MARKET ASSESSMENT FINANCIAL REPORT PROJECT REPORT MONITORING OF AIR, WATER & SOIL QUALITY & NOISE LEVELS. DATA ON METEOROLOGY SOCIO- ECONOMIC STATUS & BASIC AMENITIES. SITE VISITS BY AND INTERVIEWS WITH LOCALS BASELINE ENVIRONMENTAL STATUS SOCIOECONOMIC STATUS & INFRASTRUCTURE PROPOSED PLANT ENVIRONMENTAL INFORMATION CENTRE CENTRAL GROUND WATER BOARD GUJARAT POLLUTION CONTROL BOARD (GPCB) PUBLIC HEALTH ENGINEERING DEPT. AGRICULTURE DEPARTMENT FOREST DEPARTMENT IRRIGATION DEPARTMENT EMPLOYMENT EXCHANGE HEALTH CENTER CENSUS DEPT. INDIAN METEOROLOGICAL DEPT. IDENTIFICATION & ASSESSMENT OF IMPACTS EVALUATION OF IMPACTS BY MATRIX METHOD IMPACTS METHODOLOGY OF IMPACT ASSESSMENT FACILITY DESCRIPTION DESCRIPTION OF EFFLUENT TREATMENT PLAN, AIR POLLUTION CONTROL, HAZARDOUS WASTE MANAGEMENT, GREEN BELT DEVELOPMENT MONITORING PROGRAM ENVIRONMENTAL MANAGEMENT PLAN CONSEQUENCE ANALYSIS PREPARATION OF DISASTER MANAGEMENT PLAN RISK ANALYSIS STUDIES & DISASTER MANAGEMENT PLAN SAFETY, HEALTH & ENVIRONMENTAL POLICY, GUIDELINES BY DIRECTOR GENERAL OF FACTORY SAFETY, MINISTRY OF LABOR. 4.0 SITE ANALYSIS 4.1 Connectivity Site is very well connected by road Availability of power evacuation facilities Availability of water for industrial use 4.2 Land Form, Land Use and Land Ownership It will be incorporated in EIA Studies. 15

16 4.3 Topography (along with map) We will incorporate topography map in EIA Studies. 4.4 Existing land use pattern (agriculture, non-agriculture, forest, water bodies (including area under CRZ)), shortest distances from the periphery of the project to periphery of the forests, national park, wild life sanctuary, eco sensitive areas, water bodies (distance from HFL of the river), CRZ. In case of the notified industrial area, a copy of the Gazette notification should be given. It will be incorporated in EIA Studies. CRZ Clearance is not applicable. 4.5 Existing Infrastructure Processing Area (Processing Zone and Utility Area): m² Non Processing Area (Green belt, Raw material storage area, Finished storage area): m² 4.6 Soil Classification It will be incorporated in EIA Studies. 4.7 Climatic data from secondary sources. Primary source: Our own weather station and Secondary Source: Indian Meteorological Department, Ahmedabad. 4.8 Social infrastructure available. Depending on the growth of the company the required social infrastructure will be provided. 16

17 5.0 PLANNING BRIEF 5.1 Planning Concept (type of industries, facilities, transportation, etc.) Town and Country planning/development authority classification. Type of Industry: Proposed expansion of Bulk Drugs in Existing Unit. Facility: Canteen, Administration, Transportation 5.2 Population Projection It will be incorporated in EIA Studies. 5.3 Land use planning (breakup along with green belt etc.) Total Plot Area: 1888 m 2, (Green Belt: 170 m²,approx. 9% of total area) 5.4 Assessment of Infrastructure Demand (Physical & Social) Employment would be as per prevailing norms of state government for skilled and unskilled people for the proposed expansion project. Social Welfare Cordial relation with the industry shall be established and representation shall be made to villagers for help for creation of facilities related to health, education, etc. 5.5 Amenities/Facilities It will be incorporated in the EIA Studies. 6.0 PROPOSED INFRASTRUCTURE Total Plot Area 1,888 m 2 Total 1,888 m 2 land area is available at site; out of this 170 m 2 (i.e. approx 9 % of total area) greenbelt and other forms of greenery shall be developed. 17

18 6.1 Green Belt Company has developed green belt within the factory and on periphery of the factory. In addition to this, majority of the vacant land shall be planted with trees, shrubs and grasses. 6.2 Social Infrastructure Depending on the growth of the company the required social infrastructure will be provided. 6.3 Connectivity (Traffic and Transportation Road/ Rail/Metro/ Water ways, etc.) Major factors involved in the selection of site are listed below: Site situated in Notified Industrial Estate. Site is well connected by road & Rail Proximity to raw material suppliers Availability of power and cleaner fuel - natural gas. Availability of water from GIDC water supply Availability of common TSDF and common incineration sites in nearby area. Availability of skilled workmen Proximity to cities like Bharuch and Ankleshwar, ensure access to already existing social and commercial infrastructure. 6.4 Drinking water Management (Source & Supply of water) Water requirement is meeting through the GIDC water supply. 6.5 Sewerage System Sewage pipes are laid in entire company for the removal and disposal of mainly nonharmful liquid wastes from the offices, canteen and domestic waste coming from different sections. These liquid wastes are treated and disposed by septic tank and soak pit. 18

19 6.6 Solid Waste Management Details of Hazardous Waste Generation & Disposal are furnished in Annexure-V of Form-1 (Page No. 79). 6.7 Power Requirement & Supply/Source Energy: 275 KVA from GEB (Existing) 125 KVA from D. G. Set (Emergency power back up) (Existing) 400 KVA from D. G. Set (Emergency power back up) (Proposed) 7.0 REHABILITATION AND RESETTLEMENT (R & R) PLAN 7.1 Policy to be adopted (central/state) in respect of the project affected including home oustees, land oustees and landless laborers (a brief outline to be given) There is no habitation on the proposed expansion project area and it is industrial land which is purchased by company from GIDC for development of Company, so R & R policy is not applicable to this project. There shall be no displacement of any population in project area. 8. PROJECT SCHEDULE & COST ESTIMATES 8.1 Likely date of start of construction and likely date of completion (Time schedule for the project to be given). We are having valid CC&A. We will start expansion after getting environmental clearance and CTE Amendment. 8.2 Estimated Project cost along with analysis in terms of economic viability of the project. Total costs of the project = Existing Rs. 200 Lakhs & Proposed Expansion: Rs. 80 Lakhs. Capital cost of air & water pollution control system and environmental monitoring equipments will be Rs. 40 Lakhs. 19

20 Recurring cost of air & water pollution control system and environmental monitoring equipments will be Rs. 50 Lakhs per annum. 9. ANALYSIS OF PROPOSAL (FINAL RECOMMENDATIONS) 9.1 Financial and social benefits with special emphasis on the benefit to be local people including tribal population, if any, in the area. Employment would be as per prevailing norms of state government for skilled and unskilled people for the proposed expansion project. Social Welfare shall be done. Cordial relation with the industry shall be established and representation shall be made to villagers for help for creation of facilities related to health, education, etc. 20