Industry profile:

The pharmaceutical industry was buffeted by significant scientific, medical, political, and market forces between 1960 and 1980. Approaches to drug discovery and early-stage testing changed as medical advances made it possible to identify compounds that block specific physiological processes Pharmaceutical manufacturers have long operated on the boundary between, on the one hand, acting as free-market inventors and sellers of drugs, and on the other, serving the public interest by providing an essential health service. Thanks to this unique market position, the industry has played a leading role in globalization, developed innovative scientific advances in a wide range of medical fields, and pioneered academic-industrial research collaborations. Since 2001 the pharmaceuticals has grown rapidly into a $600million company which employs almost 2,000 people offering a full range of pharmaceutical services to Pharma, biotech and virtual organizations. They work in the fields of drug discovery, research and development, patient diagnostics, clinical trials for new drugs, formulation and packaging of drugs and the commercialization of pharmaceutical product. These services have grown to the point where we now offer an unparalleled range of pharmaceutical services on a global scale." The Indian Pharmaceutical industry, valued at $46.2 billion has been witnessing Attractive growth rate of 15% to 20% consistently over the past decade. (Strategist Quarterly 1998). This growth was build by India's large population, increasing allocation of income to healthcare spending and exports. Exports which currently accounts for 20% of the production value has grown by a compound annual growth rate of 34% in the past few years due to competitive price advantages from India's low labor and other input cost

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The Indian market for pharmaceutical products stands at an enormous $58.8 billion. The big 10 companies account for over 30% of that, take away 45 marketer and average sales don't even come any where near the $2.5 million marks, that's how fragmented its is some 50,000 brands from over 20,000 companies growing fast enough to embraces rainy day

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Company profile a) Brief information of the firm:

Name of the Firm: Elegant Drugs Pvt Ltd. Established: 1992 Founder: Gautam Ostwal (C.E.O) Type of Industry: S.S.I Phone no: 0836-2252007, 235060 Source of Finance: Punjab National Bank Products: Pharmaceuticals and Formulation Address: R.S. NO. 59/3A, Chalmatti - 581 204. Dist: Dharwad

State: Karnataka Office: Elegant Drugs Pvt Ltd New Cotton Market Hubli.

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Company Background: Elegant Drugs Pvt Ltd was started in the year 1992 the company since have developed more than 200 pharmaceutical formulations in form of tablets, capsules, oral liquids and dry syrups. As per revised Schedule M the manufacturing premises has been renovated and constructed in month December 2005 and completed in first week of February 2006. Dedicated manufacturing sections for Beta-lactum group of products have been developed and all the facilities are provided as per norms of revised Schedule M. The manufacturing facility of General sections i.e., Tablets, Capsules, and Liquid Orals and the manufacturing facility for Beta-lactum group of products i.e. Schedule M. The firm has a plot area approx, up to 89,418.73 sq ft. out of which approx 8,000.00 sq ft. is built up area & about 81,418.73 sq ft is left as surrounding area, for road and garden and equipped with technically sophisticated facilities as per WHO norms to manufacture complete range of Pharmaceutical formulations of Tablets, Capsules, Liquids, Orals both in General & Beta-lactum Departments Elegant Drugs Pvt. Ltd. managed with efficient and experienced man power with installed manufacturing capacity of: 17.28 Crores of Tablets 8.64 Crores of Capsules 34.56 Lakhs Liters of Liquids 14 Lakhs Bottles of Orals For Tablets, Capsules, and Dry Syrups are segregated and developed as per revised norms of

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Nature of business: Elegant enjoys the reputation of being the registered Supplier of Drugs & Medicines to most of the renowned Central, State and Semi-Government Institutions and Hospitals of our country. Elegant lays great emphasis on timely delivery of drugs within given time frames. Safeguarding the competitive interests of customers with the highest professional integrity has built up a partnership of trust to satisfy the needs of customers, they are working to enhance and strengthen the research capabilities as well as to expand their manufacturing facilities. Vision: The company has an aim to reach the optimum level in the field of manufacturing and marketing quality pharmaceutical formulations. The management endeavors in future to expand to global markets. Quality policy: We at Elegant Drugs Pvt Ltd aim to provide satisfaction our customers in domestic and export market, by fully meeting their requirements in terms of quality, cost and delivery. We will create a company, committed to quality by bringing about involvement of all employees at all levels, for continual improvement in quality. Single unique product: Product refers to unique product like single cartoon of Brand-X medicine. Eg: the paracetmol tablet manufactured by elegant as Brand name ELEMOL base this brand is registered with elegant. So nobody else in India can manufacture this product.

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Batch Numbers: For each and every production manufacturing pharmaceuticals production batch no is assigned by production department. It will be in serial no and assigned as per SOP. As each and every batch is analyzed by quality control department .The control number or analytical number will be issued by quality department along with certificate of analysis and release order Size and color: Color of tablet will be as per the product approvals or permission received from drugs control department. Size: If tablet in house specification Eg: 8mm diameter tablet, 10mm diameter tablet, 12.5mm diameter tablet, elongated tablet etc. Size and colour of capsule is choice of manufacturer Eg: 00size of capsule, Size and colour of capsule is choice of manufacturer Eg: 00size of capsule, Zero capsule, size 1, 2, 3 etc Brand Name: A Brand is the name, term, symbol, sign, design, or a combination of them, intended to Identify the good or services of one seller or group of seller and to differentiate them from those of competitors. Generic: Generic products are the products manufactured on the generic name. Generic name is the chemical of the materials

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Types of products manufactured by the company 1. Antibiotics 2. Antidiarrhoels 3. Antibacterial 4. Antiemetic 5. Analgesics 6. Antiulcer 7. Sedative 8. Anti Inflammatory 9. Antidiabetic 10. Vitamin

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List of domestic and exports products: Tablets 1 Acarbose Tablets 50 mg 2 Acarbose Tablets 100 mg 3 Atorvastatin Tablets 10 mg 4 Albendazole Tablets 400 mg 5 Riboflavine Tablets 5 mg 6 Salbutamol & Bromhexine Tablets 7 B complex with Vit C Tablets 15 mg 9 Ambroxol Hydrochloride Tablets 30 mg 10 Citalopram Tablets 10 mg 11 Citalopram Tablets 20 mg 12 Citalopram Tablets 40 mg 13 Chlorpheniramine Maleate Tablets 4 mg 14 Clarithromycin Tabets USP 500 mg 15 Clopidogrel Tablets 75 mg 16 Paracetamol & CPM Tablet Capsules Syrups/Dry Syrups 1 Celecoxib Capsules 100 mg 1 Albendazole Suspension 2 Celecoxib Capsules 200 mg 2 Salbutamol & Bromhexine 3 Ampicillin & Cloxacillin Capsules 4 Tramadol HydrochlorideCapsules 100 mg 5 Tramadol Hydrochloride 150 mg 200 mg 6 Tramadol Hydrochloride Capsules 7 Piroxicam Capsules 20 mg 9 B Complex Forte with Vitamin C Capsules 10 Haemetenic Capsules 11 Cefadroxil Capsules 500 mg 12 Ampicillin Capsules 250 mg 13 Ampicillin Capsules 500 Syrup 3 Cefixime for Oral Suspension 4 Anticold Suspension 5 Trimethoprim & Sulphamethoxazole Suspension 6 Cough Syrup 7 Cough Expectorant 8 Ofloxacin Suspension 10 Ampicillin for Oral Suspension 11 Roxthiromycin Suspension 12 Amoxycillin for Oral Suspension 13 Amoxycillin & Clavulanate for Oral

8 Ambroxol Hydrochloride Tablets Capsules

8 Cloxacillin Capsules 20 mg 9 Cefadroxil Suspension

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17 Amlodepine Tablets 2.5 mg 18 Amlodepine Tablets 5 mg 19 Amlodepine Tablets 7.5 mg 20 Amlodepine Tablets 10 mg 21 Tinidazole Tablets 500 mg 22 Carvidelol Tablets 3.125 mg 23 Carvidelol Tablets 6.25 mg

mg 14 Amoxycillin Capsules 250 mg 15 Amoxycillin Capsules 500 mg 16 Amoxycillin & Cloxacillin Capsules Acid Bacillus

Suspension 14 Amoxycillin & Clavulanate for Oral Suspension 15 Erythromycin Oral Suspension 16 Metronidazole & Suspension 17 Azithromycin Suspension

24 Sulphadiazine Tablets 500 mg 17 Amoxycillin, Cloxacillin and Furazolidone 25 Sulphadimidine Tablets 500 mg Lactic 26 Glibenclamide Tablets 5 mg 27 Glibenclamide Tablets 10 mg 28 Nalidixic Acid Tablets 500 mg 29 Ibuprofen & Paracetamol Tablets 30 Ciprofloxacin Tablets 250 mg 31 Ciprofloxacin Tablets 500 mg 32 Ciprofloxacin & Tinidazole Tablets 33 Cisapride Tablets 10 mg 34 Cetirizine Hydrochloride Tablets 10 mg 35 Anticold Tablets 36 Anticold Plus Tablets 37 Trimethoprim & Sulphamethoxazole Tablets SS 38 Trimethoprim & Sulphamethoxazole Tablets DS 39 Trimethoprim & Sulphamethoxazole Tablets Capsules 18 Omeprazole Capsules 20 mg 19 Omeprazole & Domperidone mg 21 Cephalexin Capsules 500 mg 22 Rifampicin Capsules 450 mg 23 Ramipril Capsules 2.5 mg 24 Ramipril Capsules 5 mg Capsules 20 Cephalexin Capsules 250

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Kid 40 Doxycycline Tablets 100 mg 41 Aspirin & Paracetamol Tablets 42 B Complex with Vit C Tablets 43 Ofloxacin Tablets 100 mg 44 Ofloxacin Tablets 200 mg 45 Ofloxacin Tablets 400 mg 46 Diclofenac Tablets 50 mg 47 Diclofenac & Paracetamol Tablets 48 Fluconazole Tablets 50 mg 49 Fluconazole Tablets 100 mg 50 Fluconazole Tablets 150 mg 51 Fluconazole Tablets 200 mg 52 Cefadroxil Dispersible Tablets 125 mg 53 Cefadroxil Dispersible Tablets 250 mg 54 Ketoconazole Tablets 200 mg 55 Ampicillin Dispersible Tablets 125 mg 56 Paracetamol Tablets 500 mg 57 Paracetamol Tablets 650 mg 58 Aluminium Hydroxide Tablets 500 mg 59 Roxithromycin Tablets 150 mg 60 Roxithromycin Tablets 50 mg 61 Cefixime Tablets USP 100 mg 62 Cefixime Tablets USP 200 mg 63 Mebendazole Tablets 100 mg

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64 Metformine Tablets 500 mg 65 Ethambutol Hcl Tablets 400 mg 66 Ethambutol Hcl Tablets 800 mg 67 Amoxycillin & Clavulanate Tablets 68 Amoxycillin Dispersible Tablets 125 mg 69 Amoxycillin Dispersible Tablets 250 mg 70 Atenolol Tablets 50 mg 71 Atenolol Tablets 100 mg 72 Norfloxacin Tablets 200 mg 73 Norfloxacin Tablets 400 mg 74 Norfloxacin Tablets 800 mg 74 Norfloxacin & Tinidazole Tablets 75 Norfloxacin & Metronidazole 125 mg 77 Cephalexin Dispersible Tablets 250 mg 78 Cephalexin Dispersible Tablets 500 mg 77 Serratiopeptidase Tablets 5 mg 78 Serratiopeptidase Tablets 10 mg 79 Serratiopeptidase Tablets 20 mg 80 Erythromycin Tablets 250 mg 81 Sparfloxacin Tablets 100 mg Tablets 76 Cephalexin Dispersible Tablets

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82 Sparfloxacin Tablets 200 mg 83 Fexofenadine Tablets 120 mg 84 Fexofenadine Tablets 180 mg 85 Cefuroxime Tablets 250 mg 86 Cefuroxime Tablets 500 mg 87 Pioglitazone Tablets 15 mg 88 Pioglitazone Tablets 30 mg 89 Glimepiride Tablets 1 mg 90 Glimepiride Tablets 2 mg 91 Glimepiride Tablets 3 mg 92 Glimepiride Tablets 4 mg 93 Granisetron Tablets 1 mg 94 Granisetron Tablets 2 mg 95 Enalapril Maleate Tablets 2.5 mg 96 Enalapril Maleate Tablets 5 mg 97 Loratidine Tablets 10 mg 98 Levofloxacin Tablets 250 mg 99 Levofloxacin Tablets 500 mg 100 Losartan Potassium Tablets 25 mg 101 Losartan Potassium Tablets 50 mg 102 Mefloquine Tablets 250 mg 103 Meloxicam Tablets 7.5 mg 104 Meloxicam Tablets 15 mg 105 Imipramine Tablets 50 mg 106 Imipramine Tablets 200 mg 107 Mosapride Citrate Tablets 2.5 mg

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108 Mosapride Citrate Tablets 5 mg 109 Nifedipine Tablets 10 mg 110 Nimesulide Dispersible Tablets 50 mg 111 Nimesulide Tablets 50 mg 112 Nimesulide Dispersible Tablets 100 mg 113 Nimesulide Tablets 100 mg 114 Nimesulide & Paracetamol Tablets 115 Gatifloxacin Tablets 200 mg 116 Gatifloxacin Tablets 400 mg 117 Olanzapine Tablets 2.5 mg 118 Olanzapine Tablets 5 mg 119 Olanzapine Tablets 10 mg 120 Pantoprazole Tablets 20 mg 121 Pantoprazole Tablets 40 mg 122 Calcium with Vit D3 Tablets 500 123 Calcium with Vit D3 Tablets 625 124 Theophylline Tablets 400 mg 125 Theophylline Tablets 600 mg 126 Esomeprazole Tablets 20 mg 127 Esomeprazole Tablets 40 mg 128 Ornidazole Tablets 500 mg 129 Rabeprazole Sodium Tablets 15 mg 130 Rabeprazole Sodium Tablets 30 mg

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131 Isosorbide Mononitrate Tablets Tablets 20 mg 40 mg 132 Isosorbide Mononitrate 133 Rosiglitazone Tablets 2 mg 134 Rosiglitazone Tablets 4 mg 135 Rosiglitazone Tablets 8 mg 136 Salbutamol Tablets 2 mg 137 Salbutamol Tablets 4 mg 138 Salbutamol & Theophylline Tablets 139 Secnidazole Tablets 500 mg 140 Secnidazole Tablets 1000 mg 141 Simvastatin Tablets 10 mg 142 Simvastatin Tablets 20 mg 143 Artesunate Tablets 50 mg 144 Ticlopidine Hcl Tablets 250 mg 145 Ranitidine Tablets 150 mg 146 Ranitidine Tablets 300 mg 147 Gliclazide Tablets 40 mg 148 Gliclazide Tablets 80 mg 149 Gliclazide & Metformine Tablets

Fast moving products: Tablet:

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CONSOLE-ED-2.5 Each uncoated tablet contains Amoldipine Besylate BP Equivalent to Amoldipine 5mg

ECOLD Each uncoated tablet contains Chlorpheniramine Maleate I.P 4mg Caffeine(Anhydrous) I.P5mg Phenylephrine Hydrocholoride I.P 5mg paracetamol I.P 400mg

Capsule: EDOXY-100 Each hard gelatin capsule contains Doxycycline Hydrochloride I.P Equivalent to Doxycycline 100mg EMOX-500 Each capsule contains Amoxycylline Trihydrate I.P Equivalent to Amoxycillin 500mg

Dry Syrups: EMOX DRY SYRUP For oral suspension Each 5ml of reconstituted Suspense contains ELECILLIAN DRY SYRUP For Oral Suspension I.P Each 5ml of reconstituted Suspense contains Amphicillin trihydrate I.P

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Amphicillin trihydrate I.P Equivalent to ampicillin 125mg

Equivalent to ampicillin 125mg Each 5ml contains Paracetamol I.P 125mg

Area of operation: The elegant drugs supply the products to local areas, government hospitals, and private hospitals. It has also expanded its services to the other countries like Cambodia, Myanmar, Vietnam & Nigeria.

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List of top authorities: Elegant Drugs Pvt Ltd. is expertise by experienced technocrats. Mr. Gautam S. Oswal : CHIEF EXECUTIVE OFFICER

Mr. Bharat B.Oswal : CHAIRMAN Mr. Rajashekhar C. Pattanshetty: MANAGING DIRECTOR Mr. Ramesh B. Oswal: FINANCE MANAGER Mr. Vinod P. Oswal: PURCHASE MANAGER Mr. Jeetendra .M. Oswal: MARKETING EXECUTIVE Mr. Arun G. Pawar: PLANT MANAGER Mr. S. B. Takked: QUALITY CONTROL MANAGER Mr. Abdul S. Guthal : PRODUCTION EXECUTIVE Mr. Karuna Vijay: PRODUCTION CHEMIST Mr. Vishwanth S. Chinnadakai: STORES INCHARGE Mr. Kumbar : STORES ASSISTANT

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Quality management: The total management is quality conscious and has formed quality policies keeping in a mind the constructive effect of quality products which pays permanent growth of the business in the long run. This proves the fact that. 1. Quality assurance is active & efficient 2. Production department is operated by highly trained experienced and qualified technocrats. 3. General Manager visits the unit frequently to solve the problems if any and visualizes the quality aspects by taking personal rounds of all the departments. He also takes into account for requirement of space for the development and new construction also comes into existence as and when required with his efforts. He assesses the capacity of unit and suggests the management for the addition of new products. 4. Production department, quality control department, Administration department. And stores department work with team spirit to achieve desired goal of production Quality and quantity. 5. Products are designed and developed in such a way that it takes account of CGMP

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and to obey good stability. 6. Production and quality control operations are clearly specified in written form. 7. Departmental heads are well aware of their responsibilities which are clarified in systems and procedures (Job description column). 8. a. Raw materials are analyzed as per pharmacopoeias as well as in house standards. b. Bulk sample analysis is carried out by Q. C. during the processing stages. c. In process control is carried out by Q. C. as well as by production dept separately d. Calibration and validation is carried out by production department with the Help of Q. C. and maintenance staff. e. The finished products are correctly processed and checked by production and Q. C. according to the defined procedures and specifications. f. After the certification by Q. C. and production authorities, the product is released for dispatch. g. There is a procedure of self inspection and quality audit once in six months which regularly appraises the effectiveness and applicability of quality assurance system. 9. All manufacturing procedures are clearly defined and systematically reviewed. 10. Critical steps of manufacturing processes are supervised by production and Q. C Head 11. All necessary facilities are provided in production which includes, a) Qualified and trained personnel

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b) Adequate space. c) Suitable equipments. d) Correct materials and packaging. e) Approved procedures and instructions f) Suitable storage. g) Adequate personnel 12. Instructions and procedures are described in clear and simple language. 13. Operators are trained to carry out process correctly. 14. Stage wise records are maintained. 15. Manufacturing records can trace history of the batch. 16. Complaints from market are examined and defects are investigated with appropriate measures if required, including recalls of materials

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CUSTOMER PROFILE OF Elegant Drugs: Domestic customer: Government medical stores State and central government institutions like railway hospitals, state government etc. Distribution of products through doctors that is marketing as progangda come distribution.

Export market Combida Canopus combida Ltd Vietnam Canopus Nigeria Myanmar Sri Lanka

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Future Growth and Prospectus:

Globalization, more exports and collaboration with foreign countries to improve overall turnover facilities. More investment in RND, RND formulation and labs. Focus on talent acquisition, motivation, reward management and retention. Strong growth is expected in domestic market.

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Organization structure

Managing director

Director

C.E.O

Finance manager

Manufacturing unit

Purchase

Factory Manager

QC Manager

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Stores

Maintenance

Production shift chemist

RESPONSIBILITIES AND AUTHORITIES OF KEY PERSONNEL:

C.E.O.
To formulate future strategic plan & policy decisions. To chair meetings relating to the future policies Participate in finalization of the budget for all activities To nominate MR & authorized contract M.D Is responsible for implementation of QSM Ensure complete understanding of quality policy & quality objectives in the whole organization Is in charge of complete maintenance and housekeeping of the factory Organize work force when necessary Is responsible for meeting complete Health policy requirements of the workers Participates with FM and QC manger training programmed for the workers Is to conduct self inspection audits in the factory with the management team at regular intervals Maintains stores & stock registers

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Verify the Purchase Request and received items as per Purchase Order To initiate purchase when the stocks finished To initiate the sundry purchase requirements Supervise the quality system

PLANT MANAGER Supervises the quality system Allocates responsibilities and authorities to group needs To review meetings with group heads and MR of QSM periodically Coordinate with the departments for smooth functioning of Group as a whole Make the employees turnover reports and appraise the higher authority Participate in product design process activities Manage time, Resources and schedule within the manufacturing unit To plan for weekly production plans & to be submitted to chairman on every Monday To arrange for daily production report to the chairman Responsible for all activities carried out in production dept To issue all requisition for raw materials To ensure all operations running strictly as per master card To ensure stores & stocks of materials for day to day production To maintain all records as per drug and excise rules & regulations To report for achievements and deviation regularly as per requirement Initiate to conduct interviews for the requirement of new candidates. Conducts management reviews of the quality system

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To develop the policy guidelines for the employees Motivate the relation between the management and the employees by bringing the popular policies Finalization of loans & advance salaries to the factory employees

Purchase/Marketing Manager
1 Take decisions on matters relating to contracts & agreements with the clients 2 Interact with client as and when necessary 3 Review Proposals & Contracts 4 Provide resources during the progress of contract 5 Is to conduct self inspection audits in the factory along with the management team every quarterly 6Contributes in analyzing customer complaints and assists in resolving them 7Invites quotations from vendors

Q.C Manager
Coordinates all quality related activities in the Organization Is responsible for monitoring of all products raw material, in process and finished Goods stage. Is also responsible for signing all release notes irrespective of analysis by

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internal or external lab. Conducts analysis on products at all stages and record it Ensure adherence to Master cards (Quality plans) Ensure usage of laboratory practices It responsible for calibration of all equipments in the laboratory Has sole authority to release or reject raw materials and finished products Is responsible for preservation of samples of all products and their records as per the drug rules Maintains library of all external referral document for analysis To arrange for routine Q.C. activities To authorize written procedures and documents of Q.C To approve and monitor analysis carried out in-house To check and calibrate all the equipments in Q.C.

Shift Chemist
Is responsible for all production activities Is responsible for getting raw material issued from the stores Is then to coordinate issue of batch no for the particular batch Inspects cleaning of machines and initiates production process Records all activities in the batch manufacturing record Is all responsible for calibration of all measuring equipment in production area Notes down in process testing of products in BMR and is present there while the testing is carried out Ensure healthy work environment & discipline amongst workers Reports of any deviations or abnormalities to the Factory manger.

Assistant Shift Chemist

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Is responsible for all production activities Inspects cleaning of machines and initiates production process Records all activities in the batch manufacturing record book Ensure adherence to the Production plan Master cards and any other product Notes down in process testing of products in BMR and is present there while the testing is carried out. Ensure healthy work environment & discipline amongst workers Assign task to workers Supervises workers at all times Reports status to FM.

QC Assistant
Conducts analysis on products at all stages and record it Ensures adherence to Master cards (quality plans) Ensures usage of good laboratory practices Ensures that equipment is calibrated before usage Responsible for maintenance upkeep, and housekeeping of the lab.

Maintenance Operator
Ensures upkeep of all equipment Maintains all equipment as per the maintenance plan Ensures no breakdown results in loss of production Maintains critical spares of machine

Stores Keeper (BSR)

Ensures only products with a release note are stored in BSR

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Maintains inventory and stocks of BSR On receipt of orders verbal or written from the marketing manager organizes all excise, sales and other related documents Ensure products are duly packed before dispatch Follows FIFO and ensure no expired product leaves BSR Also is responsible to maintain products at required room condition.

Departmentalization: PRODUCTION DEPARTMENT

Drug manufacturing for overseas markets is a highly competitive field and only the very best can survive. It takes a strong infrastructure with a great deal of manufacturing expertise to bring out the finest quality finished formulations. We have a long track record of manufacturing pharmaceutical dosage forms for worldwide pharmaceutical markets and we are proud to be able to provide high quality products that can improve the health and quality of life of many people across the India at reasonable prices We have a very good manufacturing infrastructure consisting of modern GMP Certified facilities. We use state-of-the-art equipment and have a team of qualified professionals who ensure that every product that rolls out of our factory will meet WHO and other world class standards. This allows us to bring out the finest quality finished formulations to cater to your every need.

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Flow chart of tablet preparation

Weighing

Sieving

Mixing and paste making

Granulation

Tablet compress QA2 Lubrication

QA1 Dry sizing

Drying

QA3

Coating solution preparation

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QA4 Tablet checking . Coating and polishing Tablet checking Coated

Tablet striping

QA5 Tablet packing Final release

QA1:

Water content, QA2:

Bulk assay, Bulk density, weight variations appearance,

colour and shape, QA3: Hardness, Physical parameters, Assay, Friability identification

Manufacturing process of capsule and packing Stage1: Dispensing of raw materials as per requirement of batch using B.MR. It consists of ingredients like the main drugs, Excepients, Hard Gelatin Capsule Shells size as per mentioned in the B.M.R. STAGE 2: Sieving of all ingredients (Raw Materials).

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STAGE 3: Mixing of all sieved ingredients as per specification given in the batch manufacturing record. STAGE 4: Mixed sample will be collected by Q.C dept for analysis. STAGE 5: Capsule Filling:

Setting of capsule filling machine for the requirement size of capsule. The empty capsule is put in loading machine and the capsule is separated by the plate (cap and bottom) by rotating the plate for twice/thrice. Machine can take 5-6kg of powder, after that the capsule will be filled and cap is installed by the automatic machine, after that the capsule are weighed.

The weight of capsule should be for 20 capsules it must be 6.30gm-6.50gm, if weigh is less than this it will be rejected.

STAGE 5: Capsule Wiping:

All filled capsule will handed over to capsule wiping dept, there capsule inspection and wiping will be done with capsule wiping machine. Samples will be collected by Q.C dept for analysis (80-100 capsules from each batch).

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STAGE 5: Capsule Blister Packing: After the release of Q.C dept available polished capsule will be issued for blister packing. Blister packing of capsule will be done by blister packing machine simultaneously secondary packing will be carried out on the conveyor Belt. All the packed cartoons will be packed in a shipper as per the requirement

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Flowchart of capsule preparation

Weighing

Sieving

lubrication

QA1 Filling QA2

Capsule packing QA3 Final product release

Capsule inspection and wiping

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QA1: Bulk density, water content QA2: Complete testing as per STD procedure, QA3: pathogen, dissolution. Assay detection of

Manufacturing process of liquid orals :

Dissolve the preservative separately and add sugar syrup. Add the solution of sweetening agent like sibtole, glycerine etc. Add buffering agent if needed. Add flavours and colours and mix for required time set up the volume and mix for fixed time according to master formula. Filter the product with help of filter platter Collect the liquid for testing then connect the storage tank to the filling machine. Set up the volume of syringe required to fill per bottle. Start filling and put the pp cap then seal.

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Take the bottle for visual inspection fitted with black and white tiles. Discard the rejected bottle and send selected bottle for labeling cartooning and final packing.

Flow chart of liquid orals Weighing Preparation of sugar syrup mixing QA1 Checking QA2 Volume making Filtration

Labeling QA1: QA2: QA3:

QA3

Packing

Transfer to BSR

Distribution

Ph check, Clarity if necessary. Bulk analysis Pack finishes analysis

QUALITY CONTROL DEPARTMENT

We believe it's a challenge to be a manufacturer of finished pharmaceutical formulations. In our quest for perfection, we have left no stone unturned right from the selection of the finest raw material, using state-of-the-art technology and processes to bringing out the finished formulations. Helping us produce the finest quality pharmaceutical products. All our products are manufactured as per the regulations and guidelines of the World Health Organization's Good Manufacturing Practice (WHO - GMP). We implement

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this through our quality management system that is based on planning, implementation and control with independent controls that guarantee safety and reliability ensuring that only the finest quality pharmaceutical products rollout of our facility. Our credentials include an ISO 9001: 2000 certification from the Orion Registrar USA who is internationally accredited by the United States ANSI-RAB NAP, the Standards Council of Canada (SCC), and the Dutch Council for Accreditation (RvA). Each of these national accreditation bodies are recognized throughout the world for Quality and Environmental Programs. This establishes firmly that we are manufacturer of finished pharmaceutical formulations of high quality. The above initiatives are backed by an independent unit that analysis evaluates and reports the status of quality control and quality assurance. They give accurate and accountable results that help us produce the finest quality pharmaceutical products always.

In a nutshell, the factors that have made us successful in drug manufacturing for overseas markets are: High quality products Flexible responsive service On-time delivery Competitive pricing. Excellent compliance record Efficient technical transfers Modern GMP Certified facilities FDA approved site Regulatory support.

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Efficient inventory coverage

Organization of quality control department consists of Q.C managers, chemist, and executive lab assistants.

Marketing Department
A marketing program in order to be successful must have a right mixture of marketing Mix, not to mention market research, a quality product, an extensive distribution network. Acceptability, strong dose of promotion coupled with a right price. A unique feature of the Pharmaceutical market is that it is one of the most fragmented markets in the country.

Marketing Strategy of Company

Their core marketing strategy is to supply to government institutions.

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The state government gives tender notice (Ads) in newspaper. The Elegant Drugs are going to apply for tender (Open tender) through quotation (rate contract).

If the price bided by Elegant Drugs is lower than others they will get the contract. and Usually this contract will be for 2-3 years They have even appointed distributors in states who distribute product on behalf of Elegant Drugs; the distributor promotes the product ethically. The company also distributes the product through contact with doctors, and through the mails for other countries distributors. The company also participates in tenders of other states like Andrapradesh, Rajasthan, and Punjab etc. They also have sales agency called noble Health care which is run by the one of their family member, who distributes the product in local areas.

Packing Department
Pharmaceutical products are typically susceptible to the damaging effects of moisture. As such, it is imperative to use the right pharmaceutical packaging products, whether they are being transported or simply stored. The company does not go for the packing of products until Q.C and Q.A department releases the finished products. Packing and marking are most important stages with regard to recognition of companys product. As their will be label entached to the shippers, which consists of name and address of the company, name of the product , batch no, manufacturing date, expiry date, with brand name and generic name

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Application of 7s SKILL
The skill refers to capabilities and competencies that exist within the company. What it does best, distinctive competences what the company does best, ways of expanding or shifting competences. A skill captures a companys crucial attributes or capabilities. Companys each divisions having ISO 9002 certificate and it has adopted

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excellent quality policies and all modern safety and security measures all the levels. All the manufacturing process is computerized and latest facilities and technologies. The organization provides both on the job and off the job training for its staff officers, technical assistance for every month. There will be 2 to 3 speakers , who speaks regarding good manufacturing practices, technical aspects for technical people .The trainee is been tested for every month by issuing question papers of 100 marks , the different questions papers are formulated for different level employees. After setting the question it is been circulated to employees and then evaluation is carried out.

STYLE
The leadership approach of top management and the organizations overall operating approach; also the way in which the organizations employees present themselves to the outside world, to suppliers and customers. Style is pattern of actions that are more decisive than words. People may listen to what managers say, but they believe what managers do. The appropriate style is participative, allowing people to collaborative and supports each other, take calculated risk and innovative improvements. It will not work for the management to say that it is the organizations policy

To encourage participation and innovation, if at the same time they also punish those who make mistakes. The management style of functioning is PARTICIPATIVE production unit, Elegant Drugs. Any issue of significance is discussed with members of management representatives and workmen to find an amicable solution. Besides these, any policy implementation is done after threadbare discussion among various groups of employees. In case of any confusion, reservation stroke of any issues, matter is referred to corporate office for guidelines.

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STRATEGY
Actions, a company plans in response to or anticipation of changes in its external environment. The Strategies of the company are developed on the basis of an analysis of external and internal environment. Consequently the values, preferences, attitude towards risks have been carefully examined while formulating strategies. Business strategy is the choice of direction and the action and the company adopts to achieve its objectives. It integrates the vision and direction of the company so as to achieve its objectives and goals in a competitive situation The company is having a long term objective to develop the entire spectrum of manufacturing of tablets , capsule, dry syrup and syrup and the strategies also includes exporting the products and services to several countries in the world and provide qualitative products and services.

Finance Department
The company is having good personnel with plenty of knowledge & experience in finance department. The finance consists of Chief of Accounts, Asst. Accountant & Accountant. The finance department performs its activities as per the instructions of Director Finance & Chief of Accounts.

SOURCES OF FUNDS

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Since funds can be obtained from different sources therefore their procurement is always considered as a complex problem by business concerns. Funds procured from different sources have different characteristics in terms of risk, cost and control.

SHARE CAPITAL
Funds raised by issue of shares are the best source of procurement of funds from the point of view of the company. Because the company will not going to face any problem of repayment of share capital until & unless the company is under liquidation. However, equity share capital is usually the most expensive source of funds. This is because the dividend expectations of shareholders are normally higher than prevalent interest rate and also because dividends are an appropriation of profit and are not allowed as expense under the Income Tax Act. M/s. Elegant Drugs Pvt. Ltd. is a small scale industry. The company raised funds of Rs. 20, 00,000/- by issue of 2000 fully paid Equity shares of Rs.1, 000/- each.

DEBENTURES
Procurement of funds by issue of Debentures is comparatively cheaper since the interest is paid out of profits before tax. However debentures entail a high degree of risk as they have to be repaid as per the terms of agreement and interest payment have to be made whether or not the company makes profits.

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M/s. Elegant Drugs Pvt. Ltd. is not having any funds procured in the form of debentures as the same are to be repaid on expiry of lock in period or validity of debentures

Terms & Conditions of Term Loan for purchase of Machineries: 1. Estimations of Machineries:
Before applying for term loan for the purchase of machineries an estimation is to be attached with the loan application form.

2. Quotations from different suppliers:

Quotations are to be collected from different vendors or suppliers for proposed machinery purchases. Quotations collected from various vendors or suppliers are to be submitted to the bank along with application for term loan.

3. Performa Invoice of machineries:

Performa Invoices are to be collected from different suppliers or vendors for proposed machinery purchase. Performa Invoices collected from various suppliers or vendors are to be submitted to the bank along with application for term loan.

4. Rate of Interest:
The rate of interest will be 13% to 14% p.a.

5. Margin Money:
To avail the term loan facility for the purchase of machineries certain percentage of margin money is to be paid by the borrower. Presently 25% of cost of the machinery is to be paid as margin money by the borrower.

6. Board Resolution:
Public & private limited companies has to pass an resolution in board meeting by the board of directors & the copy of the board resolution is to be submitted to the bank.

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7. Agreement under Bond:

The company has to execute a agreement under bond for the purpose of term loans.

8. Processing & Documentation Charges:

The bank will charge certain percentage of term loan amount as processing & documentation charges for purchase of proposed machineries.

9. Disbursement of Term Loan:

After completion of the entire formalities bank will sanction the amount of loan for purchase of machineries on the basis of estimation, quotations & Performa invoices. The term loan sanctioned is going to be disbursed to the concerned vendor or supplier as per the Performa invoices directly by way of demand drafts. If the company has not paid the margin money earlier & the same is debited to the companys bank account.

10. Registration of Charges:

The term loan is normally provided against hypothecation machineries in the name of bank. The machineries so hypothecated are to be registered under the Companies Act. with the registrar of companies. After registration of charges under the Companies Act., a copy of registration is to be submitted to the bank. Before signing the agreement of term loan the proposal is going to be verified by the management of the company. It is the responsibility of the finance manager to explain the implications on the company activities to the management.

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INTRODUCTION OF THE STUDY Need for the study

The objective of this project is to co-ordinate the theoretical aspect learnt in the curriculum with the practical situation. This summer internship programme has given the much needed exposure for the study to the real organizational culture.

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In MBA course, the student study theoretical aspects of major functional areas of an organization and in summer internship programme the students need to observe the application of these theories in the organization. This study covers the Labor welfare measures of Elegant Drugs Pvt Ltd.

Scope of the study

The scope of the project study was initially limited to the staff of the Elegant Drugs Pvt Ltd. During the course of project it was felt necessary to include labors of the company and was further limited to them only as they were the main source behind our study. As the plant working conditions are to be studied, the workers of the company were selected, it was further found and decided that the labors should only be highlighted and targeted to get the required information.

Objectives of the study

To analyze whether the labors are provided and furnished with the primary requisites so they are satisfied in the organization. To assess whether the labors are catered with the statutory and non statutory allowances. Defined by the company. To examine the level of job satisfaction.

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Sources of methodology Type of data

In this study, primary as well as secondary data collection methods are used.

Sources of data
The primaries such as questionnaires are used to get the required information. The labors of the Elegant Drugs Pvt Ltd contacted and the study. The data related to company profile, financially indices and other quantitative information is collected by the way of secondary data collection method i.e., through the website and other previous document of the HR and administrative department. are been directly the required information is sought by interviewing them

personally i.e., structured questionnaires are used to get the core matter of

Method of extent of selection of small (source) of data

The source of primary data is selected on the basis of sample. Minimum of 50 labors have been contacted personally & the information is sought out..

Techniques of data collection

The primary data is collected by canvassing the structured questionnaires to the labors of the company.

System of Presentation & Data Analysis

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The so for collected primary data is presented in a tabular form with the help of graphs the descriptive analysis is made.

RESEARCH ON LABOUR WELFARE MEASURES Introduction

Land, labor, capital &organization are the factors of production among which. Labor occupies a pivotal place in the Economic Development of a Nation. To utilize the labor force to the maximum level, certain welfare measures are needed. Various welfare

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measures are in practice &new measures spring up quite often. Government & other agencies are advocating & striving for new measures in these days. Studies related to labor welfare are important in bringing about their right& privileges, of employees in the organization.

Definition of Labor Welfare Measures:

The oxford dictionary defines Labor Welfare Measures as Efforts to make worth living for workers. The report of the committee on Labor Welfare in 1969, defined Labor Welfare as such services, facilities &amenities as, Adequate canteen, rest &recreation, sanitary & medical facilities, arrangement of travel to & from work & for the accommodation of the workers employed at a distance from their homes &such other services, amenities & facilities including social measures, so as to contribute an improvement in the condition under which workers are employed.

Classification of labor welfare measures

The welfare measure may be classified along two basis, viz., Financial or Non financial. Here are presented the two classifications of welfare measures. Financial 0. Bonus Non-Financial 1. Canteen 2. Shelter, lunch room

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1. 2. 3. 4.

Gratuity House rent allowances Medical allowances Local traveling allowances 5. Scholarship for awards 6. Education allowances 7. Group insurance 8. Festival advance 9. Meritorious service award 10. Pension benefit

3. First-aid service 4. Welfare officers 5. Leave benefit 6. Suggestion box schemes 7. Sports and Games 8. Safety Committee 9. Vehicle shed 10. Drinking water 11. Library 12. Auditorium

Bibliography : 1. K. Aswathappa, Human Resource Management 2. Company documents 3. old project report

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4.website. www.elegantdrugs.com 5.Business research methods, zigmund.

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Index
S. No.
1 CHAPTER 1 INTRODUCTION OF THE STUDY 2 NEED FOR THE STUDY OBJECTIVES SOURCES OF THE DATA

Contents

LIMITATIONS OF THE STUDY CHAPTER 2 COMPANY PROFILE PRODUCTS PROFILE. ORGANIZATION CHART DEPARTMENTALIZATION CUSTOMER PROFILE MISSION STATEMENT CHAPTER 3 STUDY PROFILE RESEARCH ON LABOUR WELFARE MEASURES CHAPTER 4 PRESENTATION AND ANALYSES OF DATA TABULATED DATA GRAPHICAL REPRESENTATION CHAPTER 5 WINDING UP FINDINGS SUGGESTIONS CONCLUSIONS BIBLIOGRAPHY

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Findings

1. It was found that most of the workers are not having primary education in the organization. 2. Most of the workers who are educated are studied up to 12 & further they have completed ITI course. 3. It was found that company is providing all necessary facilities & good working conditions to workers 4. All most all the workers of the company are satisfied. 5. There is a good cooperation & cohesiveness within the workers & there is a good relation between the top management & the workers.

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Suggestions
Its known fact that Elegant Drugs Pvt Ltd is one of the top among Pharma companies which provides almost all facilities to its employee. But still it has not noticed some if the problems. So I would like to give some suggestions which ware the result of my survey undertaken.[Questionnaire& personal interview.] 1. As most of the workers are partially uneducated, the company should provide some education & training programme. 2. The organizations should conduct induction training programmes at least twice in a year to the workers whose performance is bad. 3. Around 40% of the workers are below SSLC & illiterate. Such workers may not understand the objectives & policies of the organizations. Therefore minimum qualification must be fixed by the company for appointing new employee.

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QUESTIONNAIRE
Section: I Personal Profile
Employee code: Designation: Age: a) 18-30 years [ ] Marital Status a) Married [ ] b) Unmarried [ ] b) 30-40 years [ ] c) 40-50 years [ ] d) 50-60 years [ ]

Section:II Study Profile

1. Elegant Drugs is working towards its employee welfare Strongly agree Agree Neither agree/Nor disagree Disagree Strongly disagree

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2.As an employee of Elegant Drugs, are you satisfied with the basic working conditions provided by the organization? Yes No

3 Financial and non financial benefits are must for an employee for his dedicated work, are you catered with the same? Yes No

4. How are the recreational facilities in the organization? Very good Good Average Satisfactory Bad

5.Family pension, Bonus, Meritorious awards are given to me Very good Good Average Satisfactory Bad

6.To increase the performance of the employees regular training is provided Strongly agree Agree Neither agree/Nor disagree Disagree Strongly disagree

7.Safety is given highest priority in your organization Strongly agree Agree Neither agree/Nor disagree Disagree Strongly disagree

8. What is your opinion about the grievance handling procedure?

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Very good

Good

Average

Satisfactory

Bad

9. What is your opinion about intensity of disciplinary action in the organization? High Medium Low

10. All these welfare measures provided to the employees have increased productivity Strongly agree Agree Neither agree/Nor disagree Disagree Strongly disagree

Thank you.

Section I Data analysis and presentation

1. Age: Age group 18-30 years 30-40 years 40-50 years 50-60 years No of workers 24 15 8 3

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Total

50

50 40 30 20 10 0 N ofwork o ers 18-30 y rs ea 30-40 y rs ea 40-50 y rs ea 50-60 y rs ea T l ota

2 Marital Status: Married Unmarried Total Number 37 13 50

M rita S tu a l ta s

4 0 3 5 3 0 2 5 2 0 1 5 1 0 5 0 M rrie a d U m rrie n a d

Section:II
1. Elegant Drugs is working towards its employee welfare Strongly agree Agree Neither agree nor disagree Disagree Numbers 11 29 9 1

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Strongly disagree Total

0 50

50 40 30 20 10 0 N bers um

S trong a ree ly g Ag ree N either a ree nor g dis g a ree D a ree is g S trong dis g ly a ree T l ota

2. As an employee of Elegant Drugs, are you satisfied with the basic working conditions provided by the organization? Numbers 40 10 50

Yes No Total

50 40 30 20 10 0 Num bers Yes N o T l ota

3 Financial and non financial benefits are must for an employee for his dedicated work, are you catered with the same? Numbers 35 15 50

Yes No Total

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50 40 30 20 10 0 Nu b m ers Y es No Total

4. How are the recreational facilities in the organization? Very good Good Average Satisfactory Bad Total
50 40 30 20 10 0 N bers um 3-DColum 1 n Good Av g era e S tis ctory a fa Bd a T l ota

Numbers 17 22 11 0 0 50

5. Family pension, Bonus, Meritorious awards are given to me Very good Good Average Satisfactory Bad Numbers 12 20 18 0 0

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Total

50

50 40 30 20 10 0 3-DColum 1 n G ood Avera e g S tis ctory a fa Bd a T l ota

6. To increase the performance of the employees regular training is provided Strongly agree Agree Neither agree nor disagree Disagree Strongly disagree Total Numbers 9 26 15 0 0 50

50 40 30 20 10 0

S trong a ree ly g Ag ree N either a ree nor g dis g a ree Dis g a ree S trong dis g ly a ree T l ota

7. Safety is given highest priority in your organization Strongly agree Agree Neither agree nor disagree Disagree Strongly disagree Numbers 8 21 3 0 0

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Total

32

35 30 25 20 15 10 5 0 Num bers

S trong a ree ly g Ag ree N either a ree nor g dis g a ree D a ree is g S trong dis g ly a ree T l ota

8. What is your opinion about the grievance handling procedure? Very good Good Average Satisfactory Bad Total
50 40 30 20 10 0 3-DColum 1 n Good Av g era e S tis ctory a fa Bd a T l ota

Numbers 13 24 13 0 0 50

9. What is your opinion about intensity of disciplinary action in the organization? High Medium Low Total Numbers 18 25 7 50

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50 40 3-DColum 1 n 30 20 10 0 Medium Low T l ota

10. All these welfare measures provided to the employees have increased productivity Strongly agree Agree Neither agree nor disagree Disagree Strongly disagree Total Numbers 14 24 10 2 0 50
S trong a ree ly g Ag ree Neither a ree nor g dis g a ree D a ree is g S trong dis g ly a ree T l ota

50 40 30 20 10 0

Executive summary Yet to type.

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