Pre- Feasibility Report PRE FEASIBILITY REPORT OF M/S. Sri Karthikeya Bio & Pharma Projects Pvt. Ltd Proposed Synthetic Organic Chemical Manufacturing Industry AT SY.NO. 203/A1 OF MIRZAPALLE VILLAGE, SHANKARAMPET (R), MANDAL, MEDAK DISTRICT, TELANGANA 1.0 EXECUTIVE SUMMARY M/s. Sri Karthikeya Bio & Pharma Projects Pvt. Ltd was incorporated to produce Synthetic Organic Chemical Manufacturing Industry with registered address at 2-22-93 Ground Floor, Vijayanagar Colony, Near Patelkunta Park, Montessori school, Kukatpally Hyderabad Telangana State 500072 The company proposes for its proposed Synthetic Organic Chemical Manufacturing Industry at Sy.No. 203/A1 of Mirzapalle village, Shankarampet (r) mandal, Medak district, Telangana State. S. No Parameter Description 1. Category of Project as per EIA Notification & Amendments 5 (f) “A” 2. Project cost 5 Crores 3. Plot area 9469.65 sq.m 4. Geographical coordinates Latitude: 18° 0’50.06"N Longitude: 78°24’39.07"E 5. Proposed Products Proposed : 4.5 MT/M The details of products& Quantities are mentioned in Section 3.1 6. Resources (I)Electricity Requirement 1000 KVA Source of electricity TSSPDCL D. G. Sets 2 X 250 KVA (II) Water consumption 150 KLD Source of water Bore well water Waste water generation 97.0 KLD 7. Mode of disposal Zero Liquid Discharge System (III)Boiler 2000 KG/Hr; 1 no. (V)Fuel Coal – 5.0 MT / Day 8. Solid waste generation Mentioned in Para 3.3 of report 9. Work force Construction phase: 100 No.s Operation phase: 50 No.s 10. Highway No.7 (Hyderabad Nizamabad ) - 2.5Kms – Nearest Highway in E 11. Nearest Railway Station Chegunta Railway Station – 6.5 Kms in SE 12. Nearest Air Port Rajivgandhi International Air Port – 85 Kms in S M/S. Sri Karthikeya Bio & Pharma Projects Pvt. Ltd. 1 As per EIA Notification 2006, and its amendments thereof, the proposed industry requires environmental clearance from MoEF&CC under the project or activity 5(f), Category A for Synthetic organic chemicals industry (dyes & dye intermediates; bulk drugs and intermediates excluding drug formulations; synthetic rubbers; basic organic chemicals, other synthetic organic chemicals and chemical intermediates). The project will run on Zero Effluent Discharge (ZLD) scheme. Generated effluent will be treated in inhouse ETP followed by Multi-Effect Evaporator system. Solid waste will be categorized as hazardous & non-hazardous on the basis of its characteristics. Hazardous waste will send to CHWTSDF and non-hazardous waste to the authorized vendor for its disposal. Keeping in consideration the Environment & Social safety, proposed project activity will involve following studies such as Environment Impact Assessment (EIA), Environment Management Plan (EMP), Disaster Management Plan (DMP), Risk & Hazards study, Solid waste management, Public Consultation. M/S. Sri Karthikeya Bio & Pharma Projects Pvt. Ltd. 2 Pre- Feasibility Report 2.1 INTRODUCTION OF THE PROJECT 2.2 Identification of project The proposed project activity falls under 5(f) for Synthetic organic chemicals industry (dyes & dye intermediates; bulk drugs and intermediates excluding drug formulations; synthetic rubbers; basic organic chemicals, other synthetic organic chemicals and chemical intermediates). As the project is located outside the notified industrial area/ estate, hence falls in „A… Category and will require Environmental Clearance (EC) from the Expert Appraisal Committee (EAC-Industry2), MoEF&CC, New Delhi as per Environmental Impact Assessment (EIA) Notification, September 14, 2006 and amendments thereof. 2.3 Project Proponent Sri. Rangineni Karthik a MBA graduate and having 15 years experience in the field of pharma and synthetic organic chemical industry. Under his able guidance, supervision and technological skills, successful implemented a unit in Hyderabad. A part from the above is also having enough innovating marketing experience in trading of Bulk Drugs Intermediates. Has been involved in developing a growing portfolio of best-in-class pharmaceutical formulations in the health care arena. 2.4 Brief description of nature of the project. Proposed unit will be involved in API manufacturing, which are used in drug formulation mainly Anti- Hypertensive, Antidepressant, Antiulcer drug, Gastric Acid, Secretion Inhibitor, Anti-ulcerative, Anti- adrenergic. The proposed production quantity is 4.5 MT/Month. 2.5 Need for the project and its importance to the country and or region In the last few decades, India’s population is skyrocketing and so is the demand for Drugs to support this population. In order to satisfy this need, more production of bulk drugs and active pharma ingredients is needed. Active pharmaceutical ingredients are the active substances that are used in the manufacture of a drug and have a pharmacological effect. They provide health benefits and play a vital role in disease diagnosis, prevention, and treatment. Active pharmaceutical ingredients may be synthesized either chemically or through biotechnological methods. They are used in a wide range of therapeutic areas such as oncology, respiratory disorders, and rheumatoid arthritis. The analysts forecast the API market in India to grow at a CAGR of 10.76 percent over the period 2014-2019. M/S. Sri Karthikeya Bio & Pharma Projects Pvt. Ltd. 3 Pre- Feasibility Report As per the report -Market Entry - Active Pharmaceutical Ingredients (API) Industry in India: Analysis of Growth, Trends and Progress (2016 - 2021),the API market is surging due to the increased demand for pharmaceutical drugs, which in turn is driven by the aging population, rising prevalence of chronic diseases such as cancer, diabetes, cardiovascular, neurological and infectious diseases. India and China are the major suppliers of APIs to North America due to their low production capacities, labor costs and the presence of a large number of global and domestic players. In order to cut down on expenses and increase profits, companies have begun outsourcing the creation of APIs to the developing countries in Asia, leading to growth in the Asian market. Apart from this there are several other challenges faced by the industry as Pricing, Remaining & Retaining Declining Markets, and Transparency in supply chain, Regulatory issues. Since there is a need to look at the API market from a sustainable and quality perspective as well as from a price perspective to exploit its potential to become a brand, M/S. Sri Karthikeya Bio & Pharma Projects Pvt. Ltd has come out to develop the API manufacturing industry at Telangana. To form an international reach through their commitment to customer satisfaction, comprehensive product range, unflagging attention to quality, and by building mutually beneficial business relationships. To be an eco-friendly in all our practices. The finished goods will be sold in domestic market and would be largely exported to the Regulated International Market as per demand all over the world. In view of future market demand, it is the best opportunity which may lead to employment generation to local youth and economical upliftment of local region. Hyderabad has developed as a major production center for bulk drugs due to the location if the many major Pharmaceutical Industries such as Dr. Reddys Laboratories, Aurobindo Pharma, Ravoos Labs, Neuland Laboratories, Siris, Hetaro Drugs, Divis Labs, Natco Pharma Limited, Matrix Labs, Nicholas Piramal etc., besides a large number of medium and small industries manufacturing bulk drugs of all kinds. In support of this growth in Hyderabad and Bangalore, many basic chemical units and drug intermediate units have also come up to meet the input requirements of Bulk Drug manufacturing Companies. Large numbers of these units are still dependent on supply of basic chemicals mainly from Mumbai, Gujarat and other parts of the country involving heavy expenditure on transport and transit risks. M/S. Sri Karthikeya Bio & Pharma Projects Pvt. Ltd. 4 Pre- Feasibility Report 2.6 Demand-Supply Gap The demand for APIs and API intermediates is a derived demand. It gets derived from the demand for various medicinal formulations (final administrable drugs) for the formulation industry. The APIs and API intermediates being manufactured by basic drug manufacturers are exported as such or used by domestic formulators in their production processes. The formulation firms further produce final medicines and export these as well as sell these in the domestic market. There is a wide gap in the demand and availability of cheap and quality medicines in India and the world over. Generic medicines and off patent drugs have significant potential to increase access to cheap and effective medicines to poor people and in general to bridge the demand supply gap. Indian basic drug manufacturers are playing a significant role in increasing access to affordable off patent drugs. The products envisaged include third generation antibiotics, anticancer, antipsychotic, etc drugs which address the problems associated with present day stressful lifestyles and demand for these outstrips their demand and is increasing by the day. 2.7 Pharmaceutical Industry – Domestic Scenario The Indian Pharmaceutical Industry today is in the front rank of India…s Science- based industries with wide ranging capabilities in the complex field of drug manufacture and technology. The Indian Pharmaceutical industry is estimated to be worth US $ 8.0 billion at present, growing at a CAGR of over 15 % annually. If India„ s high Economic growth rate holds steady, the pharmaceuticals market will triple to