PRE FEASIBILITY REPORT. For PROPOSED BULK DRUG PRODUCTS MANUFACTURING UNITS. M/s. M.K. DRUGS. F-10, Industrial Area, Focal Point, Tehsil: Derabassi

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1 PRE FEASIBILITY REPORT For PROPOSED BULK DRUG PRODUCTS MANUFACTURING UNITS Of M/s. M.K. DRUGS F-10, Industrial Area, Focal Point, Tehsil: Derabassi Dist: Mohali, Punjab

2 INTRODUCTION M/s. M.K. Drugs is proposing a new unit & Proposed of chemical products like Betamethasone Sodium Phosphate, Betamethasone Dipropionate, Betamethasone Valerate, Beclomethasone Dipropionate, Clobetasol Propionate, Dexamethasone Sodium Phosphate, Methyl Prednisolone, Prednisolone Acetate, Deflazacort, Methylcobalamin, Prednisolone Sodium Phosphate and Budesonide at Plot No. F-10, Industrial Area, Focal Point, Derabassi, District: Mohali, in the state of Punjab. The proposed capacity of the project is 15 TPA. The proposed project is to be located within the premises of notified industrial area. These drugs are used in the formulation of medicines. The company has been promoted by Dr. Manav Malhotra, Ankit Malhotra and Manoj Malhotra experienced entrepreneur who has business interest in pharmaceuticals. Dr. Manav Malhotra has done (M. Pharm, Ph. D) in Pharmaceutical Sciences in the field of Steroids. He has research experience of 7 yrs in Drug Synthesis. Ankit Malhotra has done B.Com and along with Manoj Malhotra experienced entrepreneur having keen interest in Pharmaceuticals. DEMAND - SUPPLY GAP The Indian pharmaceutical Industry has witnessed a robust growth of around 14% since the beginning of the 11th Plan in 2007 from about Rs crores to over Rs 1 lac crores in comprising some Rs 62,055 crores of domestic market and exports of over Rs 42,154 crores. This also amounts to around 20% of total volume of global generics. However, the Industry is quite fragmented and comprises of nearly 10,500 units with majority of them in unorganized sector. Of these, about units are categorized as belonging to medium to large organized sector with the top 10 manufacturers accounting for 36.5% of the market share. As regards the Bulk drugs component of the industry, the market is around Rs 42,000 crores giving it a share of around 50% of the total domestic market. This gives the Indian Bulk Drug industry a share of about 9% of the global bulk drug market. As the demand of drugs are increasing day by day due to various reasons is the reason continuous growth in this sector. OBJECTIVE The demand for pharmaceutical products in India is significant and is driven by low drug penetration, rising middle-class & disposable income, increased government & private spending on healthcare infrastructure, increasing medical insurance penetration etc. The role of Indian bulk drug

3 manufacturers in the global pharmaceutical supply chain is gradually evolving with increasing presence in synthesis and manufacture of late stage intermediates and APIs. Globally, India ranks third in terms of manufacturing Pharma products by volume. India is having very good engineering & research scientist pool and long proven expertise of producing quality bulk drugs. The bulk drug market has a fast progressing growth and there is ample opportunity in indigenous as well as export market. With an ever-changing market scenario influenced by the impending new patent laws and the opening up of international trade, the companies are undergoing a continuous process of diversification these days. And it has to be seen how the industry is going to survive this period of transition and attain its critical mass, which has to serve as one of the crucial factors for its future growth. VISION To set an example in the area by becoming a leading organization in the business of Bulk Drugs. To become a well known and reputed organization as a manufacturing company with strong focus on research. MISSION To achieve growth in business by Attaining globally competitive cost levels Enhancing the value we deliver to stakeholders Commitments to corporate responsibility To Deliver the customer satisfaction Create an environment that fosters achievement, innovation and teamwork. GOAL The main goal of the company is to be a major player in the manufacture of Bulk Drugs and to Serve the Indian and International demand. PROJECT PROMOTERS Dr. Manav Malhotra is the Director of the Company. He has wide research experience in Drug Synthesis and Ankit Malhotra and Manoj Malhotra looks after marketing and general administration of the unit.

PROJECT The project proponent proposes to set up its manufacturing activity at F-10, Industrial area, Focal Point, Tehsil-Derabassi, District-Mohali (Punjab), using the state of art technology,

4 PROJECT The project proponent proposes to set up its manufacturing activity at F-10, Industrial area, Focal Point, Tehsil-Derabassi, District-Mohali (Punjab), using the state of art technology, adopting modernized machineries and equipment and novel process technologies, with waste minimization techniques. The total capacity of the proposed project to manufacture API Bulk Drugs shall be 15 TPA. Project Site at Google Image In order to meet growing market demand, M/s M.K. DRUGS proposed Bulk Drug Products (API) manufacturing unit. The list of proposed products alongwith their productions capacity is given in Table 1.1.

5 STUDY AREA AT A GLANCE

6 Table 1.1. LIST OF PROPOSED PRODUCTS ALONG WITH PRODUCTION CAPACITY SR. NO. NAME OF PRODUCT QUANTITY (TPA) 1. Betamethasone Sodium Phosphate Betamethasone Dipropionate Betamethasone Valerate Beclomethasone Dipropionate Clobetasol Propionate Dexamethasone Sodium Phosphate Methyl Prednisolone Prednisolone Acetate Deflazacort Methylcobalamin Prednisolone Sodium Phosphate Budesonide 0.7 Total 15 RAW MATERIAL It is proposed to procure raw materials from the domestic market and certain quantity of some raw materials can be imported from China or any other country. The mode of transport will be by Air or Sea for Imported raw materials. FINAL PRODUCTS The final product will be Bulk Drugs an Active Pharmaceutical Ingredients which will transported in India by Rail / Road or Air while the same will be exported to out-side by Air or Sea.

7 PLANT Total land requirement for the proposed project is 4500 feet 2. It provides adequate space for the following areas of working:- 1. Stores for raw material and finished goods. 2. Production halls 3. Quality Assurance / Control Deptt. 4. Offices 5. Utility Section RESOURCE UTILIZE & RECYCLING Water requirement of the project for domestic and industrial activity during operation phase will be 6.7 KLD. The water requirement will be met through from municipal supply. The detailed water requirement shown in below. WATER CONSUMPTION DETAIL Sr. No. Purpose Water Requirement in KLD 1. Process 2 2. Reactor and Floor Washing 1 3 Chiller 2 4 DM Plant Domestic 1 6 Green Belt 0.5 Total 6.7 PROJECT COST & FEASIBILITY PROJECT COST The total capital investment of Proposed Project is Rs. 85 Lakhs. It includes Land and Building, Plant & Machinery, Environment Protection Measures and its installation and Environment protection measures cost.

8 BREAK UP OF PROPOSED INVESTMENT SR. NO. PARTICULARS AMOUNT (RS. IN LAKHS) 1. Land and Building Plant & Machinery Environment Protection Measures 15 Total 85 ENVIRONMENT MANAGEMENT PLAN AIR QUALITY MANAGEMENT It is proposed to have a Green Belt plantation along the boundary of the plot, which will intercept the dispersing particulates. The sprinkling of water is recommended in areas where dust emission is expected within the plant. The internal roads of plant are asphalted and hence dust emission shall be to minimum. WATER MANAGEMENT The total effluent shall be treated in a full-fledged Zero Discharge Effluent Treatment Plant within the complex comprising of Primary, Secondary and Tertiary treatment facility with Evaporator and DMF Sump, Sand Filter, Carbon Filter for reuse of treated. NOISE MANAGEMENT The occasional noise has been attenuated by the development of Green Belt around the industrial complex, and ear-protecting devices will be provided to personnel working in high noise generating zones. Anti-vibrating pads and acoustic enclosure shall be provided to the DG set. SOLID WASTE MANAGEMENT The solid wastes shall be segregated according to their properties, packed, transported and stored in a separate impervious storage area demarcated for them. They will then be disposed off according to the requirements of statutory authorities. HAZARDOUS WASTE MANAGEMENT The Hazardous wastes generated from the unit are Sulphur Sludge, Catalyst dust and used DG

9 Set oils. The Sulphur sludge & Catalyst Dust will be sent to TSDF site Nimbuan Dera Bassi which is developed by PPCB for final disposal & used oil from D.G. Set shall be sold to recyclers. There are no other hazardous wastes. OCCUPATIONAL HEALTH & SAFETY Masks and other PPE s will be provided as additional personal protection equipment to the workers. Workers are informed, kept aware and trained about occupational health hazards, due to such activities and preventive measures. Workers health related problem if any, will be properly addressed. BUDGETORY COST OF ENVIRONMENT PROTECTION MEASURES S.No. Particulars Capital Cost (Rs. In Lakhs) Recurring Cost/annum (Rs. In Lakhs) 1. Effluent Treatment Plant Evaporator Reverse Osmosis Rain Water Harvesting Air Pollution Control Solid Waste Disposal/Green 7 7 Belt Development THE ENVIRONMENT MANAGEMENT CELL shall include: Representative of Management (Head of Environment Cell) Process Incharge Incharge Maintenance Department A representative of Environmental Consultants

4. The ambient air quality monitoring stations We are monitoring the ambient air quality

4. The ambient air quality monitoring stations We are monitoring the ambient air quality GLOBAL CALCIUM PRIVATE LTD., 125&126, SIPCOT COMPLEX, HOSUR 635 126 Ref : No. J-11011/411/2006-IA-II(I) dated 1 st August 2007. Compliance Report for the Period ending 31.3.2015 Sl. Specific Conditions