Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products At B-1124 RIICO industrial area,phase-III Bhiwadi Tehsil-Tijara, District-Alwar, State- Rajasthan For M/s Alka Laboratories Pvt. Ltd Environment Consultant Vardan Environet (QCI and NABET/EIA/1619/RA 0037) D-142, Sushant Lok-III, Sector 57 Gurgaon (Haryana) Contact no.- 9810355569 11 Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd PRE-FEASIBILITY REPORT 1. INTRODUCTION Earlier, the assessment of the projects was done on Technical feasibility reports and Cost- Benefit-Ratio which mainly considered financial & technical resources. But no consideration was given to the environment protection in this evaluation and these flaws became apparent with continuous deterioration of environment. Thus in order to have more realistic evaluation, and keeping in view the deteriorating conditions, another dimension was added which is now called as “Environmental Impact Assessment” (E.I.A.). This forms an integral part of the project and is taken into account while appraising the project at different stages. Thus in the new comprehensive approach all considerations like, Technical, Financial & Environmental are given due weightage. M/s Alka Laboratories Pvt Ltd is proposing a project for manufacturing of following products at Plot no. B-1124 RIICO industrial area, phase-III Bhiwadi, Tehsil-Tijara, District- Alwar, State- Rajasthan. The location of proposed unit is ideal for the point of view of market of the Finished Goods & raw materials for manufacturing of such types of Bulk Drugs & intermediates. Location wise, the site is well connected with Gurgaon through NH-8. There are lots of organized and un-organized manufacturer situated in these area. The availability of raw materials and marketing of finished goods will be no problem for proposed industry. Table-1 List of Raw Material and Products Product Raw materials Quantity (MT/Annum) Existing 12 Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd 6 Aminopenicillin Ammonium Hydroxide, Hydrochloride Acid, Methanol, 150 Pen G Potassium, Sodium Hydroxide, Toulene Trimethoprim Trimethoxybenzaldehyde, Acetic Acid, Acrylonitrile, 75 Activated Carbon, Ammonium Hydroxide, Aniline, Dimethyl Sulfoxide, Dimethylamine, Guanidine Nitrate, Hyflo, Methanol, Potassium Hydroxide, Sodium Hydroxide, Sodium Methoxide, Sulphuric Acid Proposed Nimesulide TrimethoxyBenzaldehyde,Acetic Acid, Acrylonitrile, 600 Activated Carbon, Ammonium Hydroxide, Aniline, Dimethyl Sulfoxide, Dimethylamine, Guanidine Nitrate, Hyflo, Methanol, Potassium Hydroxide, Sodium Hydroxide, Sodium Methoxide, Sulphuric Acid Pentaperazole 2-Chloromethyl 3,4dimethoxypyridine hydrochloride, 120 Sodium 2-mercato-5-difluoromethoxy benzimidazole, Tetra butyl ammonium bromide, Dichloromethane, Sodium hydroxide, Sodium hypochlorite, Acetone Diclofenac 2,6 DichloroPhenol, Toluene, Potassium Carbonate, 420 Sodium Sodium Methoxide Solution, Mono Methyl Chloro Acetate, Analine Oil,Chloro Acethyl Chloride, Ammonium Chloride, Potassium Flakes, Sodium Hydro Sulphate, Activated Carbon, Methanol Diclofenac 2,6 Dichloro Phenol, Toluene, Potassium Carbonate, 180 Potassium Sodium Methoxide Solution, Mono Methyl Chloro Acetate, Analine Oil, Chloro Acethyl Chloride, Ammonium Chloride, Potassium Flakes, Sodium Hydro Sulphate, Activated Carbon, Methanol 13 Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd Ornidazole 2-Methyl 5- NitroImidazole, Ethyl Acetate, Ethylne 360 dichloride, Aluminium Chloride, Epichloro Hydrine, Ammonia Liaqur, Sulphuric Acid, Methanol, DM Water Mometasone 8DM, MSC, Lithum Chloride, TEA,2 Furolyl Chloride, 1.2 Furote Acetaone, IPA, MDC, THF, Alumina Oxide, HCL CP,Sodium BI Corbonate, KOH, Carbon, Hyflow Aceclofenac Diclofenac Sodium, T-Butyl Chloro Acetate, Formic 360 Acid, TBAB Mefenamic OCBA, Toluene, DM Water, Soda Ash, Sodium Hydro 420 Acid Sulphite, Cupric Chlorite, 2,3 Xylidine, DMF, HCL Mecobalamin Cynocobalamine, Methyl Iodide, SBH, 1.2 Phenol,Chloroform Acetone, Methanol, DM Water Disulfiram Diethyl Amine, Carbon disulfide, Sodium Hydroxide, 36 Ammonium Par Sulphate, Methanol Ofloxacin Ofloxacin Acid, N-Methyl Piperazine, Dimethyl 180 Sulphoxide,Methanol, Caustic Soda Flakes Deflazacort D-5, Iodine crystal, Calcium oxide, Calcium chloride, 1.2 potassium acetate, Acitic Acid, Acetone, As per EIA Notification dated 14th Sept., 2006 and amended from time to time, the proposed project falls under Category “A”, Project or Activity 5(f) due to interstate boundary of Haryana and Rajasthan at a distance of 1.6 km in NE direction from the project site. They have to submit Form-I along with Pre-Feasibility Report and other relevant documents for getting Environmental Clearance. This pre-feasibility report has, therefore, been prepared by the consultant to assess the likely impact of the proposed project on various factors which may be affected with the implementation of the program and to suggest remedial/precautionary measures, if any. 14 Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd 2. Profile of the Company & Promotors M/s Alka Laboratories Pvt Ltd was incorporated in 1998 as a Private Limited Company into the business of trading and manufacturing of chemicals, solvents, bulk drugs and APIs. Till FY 2009, the company was manufacturing 6-Aminopenicillin (6-APA) and Nimesulide in small quantities. In 2011, the company converted its plant from single product manufacturing unit into multi product manufacturing unit by installing the additional plant and machineries. The Company has also replaced and installed machineries incl. reactors, Q & A equipments etc. for better efficiency and quality of the products produced. Directors have vast experiences in this line. 2.1 Need for installation of project 6 Aminopenicillin- 6-APA is the chemical compound (+)-6-aminopenicillanic acid. 6-APA is the core of penicillins. It is obtained from the fermentation brew of the Penicillium mold and used as the main starting block for the preparation of numerous semisynthetic penicillins Trimethoprim- Trimethoprim (TMP) is an antibiotic used mainly in the treatment of bladder infections. Other uses include for middle ear infections and travelers' diarrhea. With sulfamethoxazole or dapsone it may be used for Pneumocystis pneumonia in people with HIV/AIDS. It is taken by mouth. Common side effects include nausea, changes in taste, and rash. Rarely it may result in blood problems such as not enough platelets or white blood cells. May cause sun sensitivity. There is evidence of potential harm during pregnancy in some animals but not humans. It works by blocking folate metabolism via dihydrofolate reductase in some bacteria which results in their death. 15 Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd Trimethoprim was first used in 1962. It is on the World Health Organization's List of Essential Medicines, the most effective and safe medicines needed in a health system. It is available as a generic medication and is not very expensive.[6] In the United States 10 days of treatment is about 21 USD. It is primarily used in the treatment of urinary tract infections, although it may be used against any susceptible aerobic bacterial species. It may also be used to treat and prevent Pneumocystis jiroveci pneumonia. It is generally not recommended for the treatment of anaerobic infections such as Clostridium difficile colitis (the leading cause of antibiotic-induced diarrhea). Trimethoprim has been used in trials to treat retinitis. Resistance to trimethoprim is increasing, but it is still a first line antibiotic in many countries. Nimesulide- Nimesulide is a non-steroidal anti-inflammatory drug (NSAID) with pain medication and fever reducing properties. Its approved indications are the treatment of acute pain, the symptomatic treatment of osteoarthritis, and primary dysmenorrhoea in adolescents and adults above 12 years old. It has a multifactorial mode of action and is characterized by a fast onset of action. It works by blocking the production of prostaglandins (a chemical associated with pain), thereby relieving pain and inflammation. Pentaperazole Sodium - Pantoprazole sodium is a proton pump inhibitor indicated for the following: Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD). Maintenance of Healing of Erosive Esophagitis. Diclofenac Sodium - Diclofenac (sold under a number of trade names) is a nonsteroidal anti-inflammatory drug (NSAID) taken or applied to reduce inflammation and as an analgesic reducing pain in certain conditions. Diclofenac is used to treat pain, inflammatory disorders, and dysmenorrhea. Diclofenac Potassium- Diclofenac (sold under a number of trade names) is a nonsteroidal anti-inflammatory drug (NSAID) taken or applied to reduce inflammation and 16 Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd as an analgesic reducing pain in certain conditions. Diclofenac is used to treat pain, inflammatory disorders,