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1.1 COMPANY HISTORY 1954 was a milestone year in the history of the pharmaceutical industry. The history of dates back to 1954 when a proprietorship firm was conceived to manufacture ethical drugs. It started with the modest introduction of a few oral liquid products. Late Hamidur Rahman Sinha was the founder of the firm and had been the main visionary of the organization since its inception until his sad demise in February, 1994. After its initial years of trials and tribulations, the firm was converted into a private Limited Company in the year 1976 and the Balancing Modernization, Replacement and Expansion (BMR&E) work on the small old unit started in 1976 at a large new premise at Dhamrai, Dhaka. Commercial Operation at the new modernized plant equipped with sophisticated and advanced facilities began toward the end of 1983. Many challenges were faced and overcome successfully to transform the company from a very small unit to what it is today a giant in its field. ACME continuously seeks to expand its production facilities, add employees, and increase it sales and marketing efforts. According to the latest statistics, out of 250 to 300 pharmaceutical companies in the country, ACME is one of the top two.

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1.1

COMPANY HISTORY

1954 was a milestone year in the history of the pharmaceutical industry. The history of dates back to 1954 when a proprietorship

firm was conceived to manufacture ethical drugs . It started with the modest introduction of a few oral liquid products. Late Hamidur Rahman Sinha was the founder of the firm and had been the main visionary of the organization since its inception until his sad demise in February, 1994. After its initial years of trials and tribulations, the firm was converted into a private Limited Company in the year 1976 and the Balancing Modernization, Replacement and Expansion (BMR&E) work on the small old unit started in 1976 at a large new premise at Dhamrai, Dhaka. Commercial Operation at the new modernized plant equipped with sophisticated and advanced facilities began toward the end of 1983. Many challenges were faced and overcome successfully to transform the company from a very small unit to what it is today a giant in its field. ACME continuously seeks to expand its production facilities, add employees, and increase it sales and marketing efforts. According to the latest statistics, out of 250 to 300 pharmaceutical companies in the country, ACME is one of the top two. ACME has also endeavored to strengthen its network of international marketing operations to export its products abroad. We are optimistic about our perpetual growth and success. Over the years, the efforts made by the competent staff coupled with customer confidence has fuelled our growth, prompting ACME to overcome hindrances and

progress towards its ultimate goal i.e., attaining success which indeed is what literally ACME stands for.

1.2 Founder and Management of the CompanyEstablishment of ACME was a great entrepreneurial effort of Late Hamidur Rahman Sinha way back in 1954 and is a vivid example of a great minds vision and its materialization. Post colonial Bengal was a place of great uncertainty and hardship. Industrialization facilities were meager and inadequate. One man came forward with his vision, amidst the political turmoil and utter lethargy of the then-new Government. It's not an easy task to set up a highly sophisticated industry, and moreover do it without bank loans and governmental assistance. So it demanded immense effort, strong determination along with vision and dreams.

Nasir-ur Rahman Sinha (Chairman )Mr Nasir-ur Rahman Sinha, Chairman of the The ACME Laboratories Ltd., obtained M.A. in political science from Dhaka University in 1965 and is a pioneer manufacturing industrialist having vast entrepreneurial foresightedness of business. He is also the Chairman of "Sinha Printers Ltd" engaged as a pharmaceutical packers and printers unit. He is connected with Dhaka Stock Exchange Ltd. since 1969 and is also a member of D.S.E. He is the Managing Director of National Equities and Financial Promoters Ltd. (Securities and Investment Advisor). He is also the Director of "Sinha Fabrics Ltd", "Sinha Wool Wears Ltd", ACME IT Ltd" and "The ACME Agrovet and Beverage Ltd" Besides, he sponsored the first Internet Service Provider of the country 'Information Services Network Ltd.' (Bangla Net) as it's Director. He is also a sponsor director of "Holiday Publication Ltd." engaged in publishing 'Weekly

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Holiday' and 'Daily New Age'. He is widely connected with many socio-cultural and philanthropic organizations.

Mizanur Rahman Sinha (Managing Director)Mr. Mizanur Rahman Sinha obtained his graduation degree in Commerce in 1962. He started his career as a banker in Habib Bank Ltd. of then Pakistan. After eleven years of service in different senior positions, he left to join ACME as its Marketing Director in 1975. He is also the founder Chairman of J. K. Fashions Ltd., Sinha Knitting Ltd. and Sinha Fabrics Ltd. All companies are export-oriented in scope.

Afzalur Rahman Sinha (Deputy Managing Director)

Mr. Afzalur Rahman Sinha graduated from the University of Dhaka with a degree in Science in 1973. He then proceeded to the United States to further his studies in Business Administration in 1980. During his studies he worked as an Analytical Chemist at the University of Missouri in the United States. He then returned to Bangladesh in 1982 to join ACME as its Deputy Managing Director. He is also the Managing Director of Sinha Wool Wears Ltd., a Director of Sinha Fabrics Ltd. and J. K. Fashions Ltd.

Jabilur Rahman Sinha,

Ph.D. (Deputy Managing Director)

Dr. Jabil R. Sinha has a B.S. in Chemistry from University of Dhaka, Dhaka, Bangladesh, a M.S. in Pharmaceutical Chemistry from North Dakota State

3

University, Fargo, North Dakota and a Ph.D. in Organic Medicinal Chemistry from University of Georgia, Athens, Georgia.

1.3 The Mission ofThe ACME Laboratories Ltd have holistic approach is to ensure Health, Vigor and Happiness for all by manufacturing of ethical drugs and medicine of the highest quality at affordable price and reaching out even to the remotest areas by proper distribution network. We view ourselves as partners with doctors, our customers, our employees, and our environment.

1.4 Vision ofThe vision of The ACME Laboratories is to reach out even to the remotest areas of Bangladesh and improve lives with quality products at an affordable price. Since its inception in 1954, The ACME Laboratories has been working relentlessly with a vision to ensure Health, Vigor and Happiness for all and is on a perpetual quest for excellence.

1.5 ObjectivesThe main objective of the company is to achieve the maximum market share along the whole country within very short time by utilizing good reputations and providing better quality products.

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1.6 The Quality policy of Absolute commitment to the highest obtainable standard of quality product and service through excellence and concerted efforts of both employer and employee.

The Company shall improve its market share and productivity to enhance profitability through monitoring of its performance on a regular basis and identify opportunity for continual improvement.

The Company has adopted the ISO-9001 and WHO cGMP (Current Good Manufacturing Practice) standards. All employees must adhere to the documented procedures and SOPs (Standard Operating Procedure).

The Quality Management System shall be adequately resourced with competent personnel, suitable premises, up-to-date technology and requisite facilities.

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1.7 The Culture of the Organization :Total Quality Assurance (TQA) is ACMEs avowed people oriented commitment for ensuring the highest obtainable quality and total customer satisfaction. Under the umbrella of Quality Assurance, manufacturing process in ACME is carried out stringently in accordance with the provisions of ISO-9001 and WTO, CGMP standard. Accordingly all employee and functions adhere to the well documented Standard Operating Procedure for achieving the prime objective of ensuring high quality. The quality department of ACME has outstanding facilities equipped with most modern instrument and staffed with trained and highly qualified personnel. All procedure for testing, sampling and inspecting are clearly written, approved, implemented and recorded. Manpower training being the essence of good performance the Total Quality Management system is given due to importance at ACME. Through in-house and external training program the company ensures that the key personnel remain abreast of the latest of QA & GMP. The management of ACME decided to embrace the 9000 series of standard developer by International Organization for Standardization (ISO) in order to provide assurance that the company operates a specified Quality Management System (QMS). After a couple of years of hard work lead to certification after formal Validation by Orion Register, Inc. USA. Finally ACME becomes an ISO certified company in June 08, 1999.

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1.8 The Philosophy of the Organization:The success of ACME in the domestic market prompted it to explore the international market as well. In 1995, it started its first journey to international operation by exporting medicines to Bhutan. Since then it has been expanding worldwide. The volume of sales increased substantially with an average growth rate of 50% almost every year. At present, ACME is exporting medicines to several countries in neighboring South-East Asia, Africa, Middle East and the EU, maintaining a philosophy to ensure 'Health, Vigor and Happiness' for the whole mankind within its means and resources. Sales wise Afghanistan is the top among the 11 countries ACME is exporting to with a growth rate of 55%. Among the medicines exported, Antibiotic, Antihypertensive, Antiulcerant and Vitamin are remarkable. The international marketing section is active in exploring the joint venture production possibilities, establishment of pharmacies, agents or distributors in the Central Asia, the Middle East, Africa, CIS countries and other parts of the world. ACME has started its operation in Pakistan and early reports of success are encouraging for us. ACME has also planning to set up a manufacturing plant there within a few years.

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1.9 Sister Concerns of ACME The ACME Laboratories Ltd. ACME IT Ltd. ACME Aggravate & Beverage Ltd. ACME distribution Ltd. ACME Overseas Ltd Sinha Fabrics Ltd & Sinha Wool Wears Ltd MARS Aviation Ltd. MARS Universal Ltd MARS Air Ltd Sinha Printers Ltd AMBE Clearing Ltd

1.10 GROWTH, DEVELOPMENT & FUTUREIn the backdrop of a large population base and wider awareness of Medicare among the rank & file, the pharmaceutical industry and increase in awareness of Medicare among every strata of society. Bangladesh has strong growth prospects. Since 1990 the company has achieved an average growth rate of 25% compared to 13% registered by the pharmaceutical sector of the country. The catalyst for the growth rests with the people who work for ACME. Today's research is the basis for future success. This applies in particular to the innovative files of pharmacy. Novel ideas and development of the highest quality manufacturing facilities will continue to form the basis for newer products. The

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company's commitment will continue to generate new products to meet the demands of consumers at home and abroad. Our aspiration in attaining the acme (apex), the efforts of our r & d, the confidence in our capabilities to produce, the alertness of our quality assurance, the commitment of our team to excel. And above all, the trust of our doctors community and customers is our inspiration

1.11 Address of the companyCorporate Office: Court De La ACME , Kallayanpur, Dhaka -1207

Plant: The ACME Laboratories Ltd.9

Dhamri, Dhaka, Bangladesh Phone: 88-02-9352901-02; 06222-88035, 88042, 88047; Fax: 88-02-0340146 Email: [email protected] [email protected]

2.1 Marketing Division of the ACME Laboratories Ltd:In this organization have different types of division. Marketing division is one of them. Their marketing division divided into six departments. Thats are- Sales Department, Product Management Department (PMD), Medical Service Department, International Marketing, Marketing Service Department and Marketing Information System Department.

2. 1.1 Fundamental Task of Marketing Department:

MAIN RESPONSIBILITY OF MARKETING DIVISION:Marketing plan: To prepare the marketing plan of the assigned products emphasizing on positioning, target group analysis, promotional plan (promotional material allocation, sales target fixation etc.)

Sales analysis To monitor the sales data and analyze them as feed back of the marketing plan and to take the corrective measures when required. 10

Identification of new product: Being a product officer, incumbent is also a member of Technical Sub Committee (TSC), hence will identify new products and conduct feasibility study of those particular products, and will place an official proposal to TSC for commercially viable products. Developmental work To prepare Marketing brief, DML Inclusion paper To forecast the sales and to set a price proposal of the product. To select the brand name of the product. To design the strip/blister/tube bottle label/others. To design the commercial carton, catch cover, box label.

Promotion materials (for both old and new product) To prepare the literature, pad, doctors letter, sticker, poster, multimedia, gift item selection, etc. To prepare the action plan for Field personnel. To prepare the training manual.

Users Feed back To maintain the users feed back report for product validation. 11

Training: To conduct the training of trainee MR's To conduct the short course training on new products at different sales centers. Scientific Seminar: To provide scientific papers and other supports to arrange scientific seminar.

Doctor's Query: To help the medical services department providing information on products

ROUTINE WORK: Library work for development of promotional materials Correspondence with different departments of the company Browsing the Internet for recent information.

ADDITIONAL TASK: To conduct the MR/SR Recruitment test

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2. 1.2 Strategies of Marketing Division:

Sl. Objectives No01 Prescription share

Responsible DepartmentSales

Evaluation SystemPrescription shear will be evaluated on the basis of the prescription collected from the chemist shops from different corner of the country. Yearly sales (Growth) compared to last year. Five Field Persons (Whose work stations previous year) of every sales center will be taken as sample to count doctors call. Current year report of identified new products Report on launching new products

02 03

Increasing in overall market Sales share (Growth) Increase in doctors call Sales

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To identify new products/molecules for launching. New product launch

Product Management Department Product Management Department

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06

No. of specific seminar Medical Service Total no. of scientific arranged to increase Department arranged over the year. customers satisfaction. No. of specific publication

seminar

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Medical Service Total no. of specific publication Department over the year.

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08

On time delivery for better Distribution customer satisfaction Department Increase in annual sales in International international market Marketing Number of newly registered International products in international Marketing market.

No. of the orders returns due to late delivery all over the year. Yearly sales (growth) compared to last year. Current year report on product registration.

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2. 1.3 Flow Chart of Marketing DepartmentMarketing Division

Sales Department (SD)

Product Management Department (PMD)

Medical service Department (MSD)

International Marketing (IM)

Marketing Service Department (MKSD

Marketing Information System Department (MISD)

Human Section

Brand Section -1

Brand Section -2

Brand Section -3

Training Section

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Marketing Director

2. 1.4 Marketing Division Order Line:

Marketing Manager

Head Of PMD

Veterinary & Agro Manager

Group In charge

Product Officer

Marketing Manager

Sales Manager

Assistances Sales Manager

Regional Sales Manager

Area Manager 15 Medical Representative

2. 1.1 S ales Department :Sales department is a part of the marketing department. The main objective of this department is to increase the sales. The marketing manager is responsible for this. He has to maintain a responsibility on -

Expense budget Justify territory designing Target share allocation Timely recruitment Sales forecast Control mechanism Handling donation Visiting the critical customers.

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The sales department is divided in to two parts.i) ii) Human Products Veterinary Products

The

job

descriptions

under

sales

department

for

Human

&

Veterinary products are: To achieve the sales target in a particular market. To maintain regular contact with doctors & chemists to keep up to date products information.

To implement companys policy, plan and objectives and generate prescription of ACMEs products and selling for their products.

To cover all the areas of each territory and also transform potential customers into customers.

To keep in touch with market and competitors activity, monthly report, special report, sample statement in due time to reach timely to destination and also doctors profile property.

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The National and Export Sales report for the last five years:Year Month

2003160453669 167837902 199351761 221850817 215512994 223157039 192680337 192606025 211885992 228431965 198493736 195522379 22817852

2004182741099 214326939 218981281 240173549 251142018 227995750 209151594 210729761 231076505 237136083 217298656 230453451 29231394

2005195226848 214621727 213878912 224232998 252149916 28757639 231882282 215139081 299028498 298344595 276634236 270966684 31801222

2006243310028 275965490 259536542 256337606 260561470 323251445 271038922 281534700 278230886 303671172 308553190 262353342 43542594

2007253488887 297867903 354511578 331079862 368352983 383639412 311570584 308830165 341017743 348173155 327124322 346827875 48045401

February March April May June July August September October November December JanuaryExport Sales

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Yearly collect Yearly Target Yearly Achievement % Growth Rate %

2430602468 28744925876

2700438080 3404285356

3007664638 4007131848

3367887387 4794249053

4020529870 4538673058

85

79

75

70

89

16

11

11

12

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2. 1.2 P roduct M anagement D epartment:The ACME's Product Management Department is of prime significance for round-the-year operation of a pharmaceutical company and is indispensable for its steady growth. Since inception, ACME faced the challenges of introducing new and effective drugs to compete with other competitors in the business. ACME recognizes the need for progressive approach in order to lead the ever competitive trends in the health care market. Our ACME's Product Management Department is painstakingly involved in research, which goes on unceasingly for medically innovative therapies. The ACME's Product Management Department equipped with latest instruments to support various stages optimizations and technology transfer to the plant. Personnel are trained and highly qualified pharmacists and chemists, engaged constantly in improving upon the formulation so as to make the drugs safer and more effective. Our process is well established and has properly documented quality management systems as per CGMP guidelines.

In short form, this department does pricing, designing and targeting all types of product developing jobs like planning.

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The following functions performed by this department:

To prepare the literature Generates sales information Arranges conferences Prepare product leaflets Conducting research in fields Collect information about competitors Perform sales trend analysis To control and look after the sales representative teams.

Major Functions of PMD deals are as follows: 1. 2. 3. Formulation of New Products Reformulation (Where required) Reprocessing (If Required)

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4.

Problems

solving

related

to

formulation

and

manufacturing. (Where required) or Trouble Shooting. 5. Preparation of tentative master formula for a new product/revision of existing master formula. 6. Development of new product.

1. Formulation of a new product: PPD is responsible for the establishment of formulation and for the preparation of the recipe of the drugs. Steps involved in a new product development: i) Product information from marketing department along with necessary attributes. ii) iii) iv) v) vi) vii) viii) ix) x) xi) Preparation of recipe by the help of relevant references. Requisition for purchase department for new materials. To perform laboratory trail (Pre-formulation study) Finalization of formulations. Analysis of the sample by QC and approval. Accelerated stability testing. Drug administration formalities. Selection of primary packaging materials. Forecast from marketing department. Preparation of provisional product data sheet.

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xii)

Provisional

data

sheet

sent

to

production

planning

department for new materials. xiii) Preparation of tentative master formula comparing with product data sheet. xiv) xv) xvi) Pilot batch production (Successive three batches) QC analysis and approval. Preparation amendments. xvii) Final master formula to product planning department of final master formula with necessary

2. Reformulation: Reformulation is necessary for the following three reasons: i) ii) iii) For further improvement of product quality. For increase productivity For more cost effective formulation maintaining quality.

3. Reprocessing: If the chemical assay by QA for a particular batch dont comply the standard, then PPD wilt check the batch and take necessary action following approved SOP and discussion with QA.

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4. Trouble Shooting: During production PDD, QA, Product department investigate the case of formulation defects and take necessary steps accordingly.

5. Preparation of Master Formula: Among many important functions, preparation of master formula is very important duty of PD department. This document contains all the record regarding raw materials, production procedure, packaging and quality assurance profile of product.

6. Development of Existing Products: PPD also deals with the development of the existing product formulations. The objectives are:

Improve the quality of a product. Prevention of any type of problem existing in the product. To minimize process time and cost maintaining quality.

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New product Development Strategy:o o o o o o o o o o i) ii) iii) iv) v) o Market Study & Sample Collection. Proposal Approval of proposal by Management. Marketing Brief/ Data Sheet Trade Name Selection. Letter to PD for Recipe. Sale Forecast to Costing. DML Inclusion Paper. Competitors Prices to Costing. Development of Packing Materials: Inner Leaflet Blister/Strip/Label Design Commercial Carton Design Catch Cover Design Box Label

Development of Promotional Materials i) ii) iii) iv) o Literature Gift Items Doctors Letter Others Promotional Materials Allocation. 24

o o o o o

Multimedia. Training Material/ Action Plan. Product Launched. Sales evaluation. User feedback.

2 .1.3 M arketing S ervice D epartment (MSD)The job descriptions of Marketing Service Department are: To ensure tender submitting (Govt. & Non Govt.). To check different sorts of official letter. To draft circular. To ensure different sorts of Deport related works such as Dispatch, Collection etc.

To check Transfer/Posting. To assist Marketing Director, Marketing Manager, Sales Manager, Distribution Manager, Asst. Sales Managers, RSMs & ZMs.

2.1.4 I nternational M arketing D epartmentThis department deals with all sorts of marketing activities in the overseas market. They ensure smooth and regular export of ACME medicines in foreign

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countries. It has overseas offices in Pakistan, Singapore, and Myanmar etc countries. It exports ACMEs medicines in 18 countries.

The job descriptions of I nternational marketing department are Marketing Concept: International Marketing department will

explore Promotion Bureau, Bangladesh Pharmaceutical Association, Chambers of Commerce in foreign countries or all possible sources to approach the overseas pharmaceutical importers/companies. To developing International Business Plan. To ensure the International Legal & regulatory consideration. To determine Method or channels of export. Making Pricing, Quotations & Method of Payment. Take necessary steps for Product Adaptation, Registration, Marketing, and Promotion & Redesign.

Globalization:ACMEs success in the domestic market prompted it to explore the international market. With the philosophy of ensuring health, vigor and happiness for the whole mankind, ACME started its international operations in 1995 by exporting medicines to Bhutan. Since then, ACME made a strong presence in the international market and export is increasing every year. Now ACME is successfully exporting to Nepal, Bhutan, Myanmar, Afghanistan, Pakistan, Sri Lanka, Philippines, Vietnam, Hong Kong, East Timor, Gambia, Papua New Guinea and CIS. 26

Now ACME is trying to expand its international operations by stepping into untapped market and strengthening its presence in existing markets. International marketing is trying to develop new markets in Ethiopia, Kenya, Sudan, Ghana, Yemen and other countries of Africa and Asia. The future promises greater prospects for the international marketing of ACME. Bangladesh being an LDC will enjoy waiver from patent protection until 2016 according to WTO TRIPS agreement, while developing countries have to implement TRIPS compliant patent rules from 2005. This has created immense opportunities for Bangladeshi companies to export pharmaceuticals especially to LDCs. ACME being aware of these opportunities is relentlessly trying to bolster its international presence by capacity building, quality products and superior services.

Export:

Export is our top corporate priority now. Their achievements so far: Established ACMEs overseas office in Pakistan with a view to set up a manufacturing plant within a few years.

MOU signed for mutual business interest with the Himalaya Drug Company of India.

ACMEs Export Markets:27

Regular Export Market Myanmar Sri Lanka Afghanistan Hong Kong Nepal Pakistan Philippines Vietnam

Irregular Export Marketi) East Timor ii) Uzbekistan iii) Yemen iv) Malta v) Cambodia vi) Gambia vii) Bhutan

Market Development Ethiopia Myanmar Cambodia Nigeria (Vet) Taiwan Yemen Kenya KSA

Export Sales report for the last two yearsCountry 2006 2007

Market Increase Rate

Afghanistan Sri Lanka Nepal Hong Kong Pakistan Vietnam

52,786.00 191,091.50 115,602.85 21,542.40 16,995.00 18,600.00

34,670.00 278,219.00 129,518.75 49,075.60 8,202.00 23,700.00

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Myanmar Philippines Kenya Bhutan East Timor PNG Grand Total

41,.85.96 110,264.00 11,375.00 6,904.69 6,439.73 7,192.50 599,879.63

44,608.89 106,371.50 14,245.00

688,610.94

2 .1.5 M edical S ervices D epartment:The main work of this department is to communicate with the doctors and to collect feedback from them. When a new product is launched, the medical services department arranges seminars with the help of product department and invites the doctors to attend. This department also arranges many clinical meetings. In these meetings, they are shown video presentations, which helps increasing the company image. It is also supplied to the foreign countries.

Job Summary of Medical Service Department: To present the pharmaceutical products and conduct the scientific seminars. To prepare presentation and other necessary works for arranging scientific seminars To prepare papers and audio visual aids for doctors as per their needs for specific seminars and other purpose. To develop and publish quarterly Medical Newsletter. To develop booklets, information cards, brochures, leaflet, posters and other promotional items on different types of diseases, which are relevant to ACMEs pharmaceuticals products.

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To handle the queries from doctors and prepare answers related to their queries. To conduct training classes for the Trainee MRs.

To visit different stalls and collect doctors opinion.

To help in providing ideas and selection of gift items for the attending doctors of scientific seminar.

To arrange seminars on pharmaceutical products with PCs (village doctors).

2 .2 Q uality A ssurance D epartment :Acme's stated belief that, "No compromise on quality can be made in a business that involves human lives," is the cornerstone of the company's Quality Assurance program. Total Quality Assurance (TQA) is ACME's avowed people oriented commitment for ensuring the highest quality products and customer satisfaction. The Company has adopted ISO-9001 and WHO CGMP (Current Good Manufacturing Process) Standards and has been accredited with ISO-9001 certification in 1999. The entire manufacturing procedure, starting with the incoming raw materials, through stringent intermediate manufacturing process and packaging of products, to the dispatching of finished goods, requires that analysts, pharmacists and instructors monitor and control each step. Even after the release of finished goods, the quality control lab tracks post-distribution spot checks of all batches.

The Quality Assurance Department of ACME has outstanding facilities, equipped with latest instruments such as HPLC, GLC, AAS, UV-VIS, FTIR, particle size analyzer polarimeter, potentiometric titrator with KF, Liquid particle counter Laminar Air Flow, microscopes etc. Personnel are trained and highly qualified. All procedures for testing, sampling and inspecting are clearly written, approved, 30

implemented and recorded and all process, equipments or systems are validated that reduce the cost of product with ensuring quality requirements, systems and procedures to meet CGMP. Manpower training being the essence of good performance, the Total Quality Management System is given due importance at ACME. Through in-house and external training programs, we ensure that our key personnel remain abreast of the latest concepts of CGMP needs. The Management of ACME decided to embrace the 9000 series of standards developed by the International Organization for Standardization (ISO) in order to provide assurance that the company operates a specified Quality Management System (QMS). After a couple of years of hard work, led to Certification after formal Validation by Orion Registrar Inc., USA. Finally, ACME became an ISO certified company in June 08, 1999. Acme's Quality Assurance Department is equipped with the most modern instruments and is staffed with well trained and qualified personnel. All procedures for testing, sampling and inspecting are clearly approved, implemented and documented. All instruments are regularly calibrated and processes, machinery and premises validated. Through training programs (inhouse and abroad), the key personnel of the company remain abreast of the latest concepts of Quality Assurance. Quality Assurance Department monitors each step of manufacturing operation and adopted Good Laboratory practice (GLP) to ensure reliability and accuracy of the pharmaceutical product. The department is subdivided into different section so as to ease and facilitate documentation and proper operations. The sections are:

Raw materials section Oral liquid section Tablet section 31

MDI and DPI &HPLC section IR section Capsules, Ointment, Cream section Microbiology section Packaging section

Activities of Quality (QA) Department:

QA laboratory has to perform the following major responsibilities. Sampling adequate for testing purpose (physical, chemical, biological). Issuing release, reject or quarantined advice for each batch of raw materials,

Packaging materials and finished products. Assessment of intermediate products for further processing. Storing retained samples from each batch produced. Maintaining batch wise fully quality control test records and signature of the person(s) who performed the test.

Batch documentation. Ensuring precision and accuracy for all testing methods. Performing environmental monitoring tests. Calibration and standardization of laboratory equipments. Control of lab, reagents. Testing of any retained goods. Stability test for finished products. 32

2 .3 R esearch and D evelopment D epartment:The ACME Pharmaceutical Limited employs a significant potion of its resources in its R&D. It wants to retain its position as a major player in the Bangladesh pharmaceutical market through introduction of new products with the aid of their R&D team. The team comprises of academically sound and professionally competent diversified professionals who has the commitment towards new product development. R&D team of ACME pharmaceutical Ltd is consistently striving towards Developing new formulations Simplifying manufacturing processes Minimizing product costs Doing pilot trial of new drug formulation.

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2 .4 H uman R esource D epartment:One of the fundamental aspects of our Corporate Objective is that our people are our prime asset. It is not the machine or the technology alone, but the invaluable mix of man-machine interface that makes technology work. We believe that whereas the capacity of machine is limited, human potential is unlimited. As such, ACME has been placing utmost importance on the continuous development of its human resources. We train people not only to do their jobs well, but also give them an environment which fosters personal and professional development. Being one of the most dynamic pharmaceutical companies in Bangladesh, we are adequately staffed with highly qualified, experienced and innovative personnel. Over 3200 young, energetic and highly motivated employees from diverse disciplines are working untiringly with ACME at home and abroad. ACME's objective in this respect is to develop its human resources by way of imparting training both in-house and external institutions. With a field force of over 1300 highly professional marketing personnel, ACME is represented in every part of Bangladesh to ensure promotion and distribution of its products at every level of consumer. With the sustained efforts of our aggressive marketing team a good number of our products have become the brand leaders in their respective therapeutic segments.

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Team work is the secret of ACME's success which has become part of ACME culture.

2 .5 R aw M aterials D epartment:This section deals with the potency of each and every raw material that is imported by the ACME Laboratories Ltd. The raw materials range from active ingredients, acceptances to packaging material. This section deals not only the potency but also determine the percentage of impurities in the material, which provides the basis of cross-examination. According to the observation made by this section a material is either rejected or accepted for use.

Various test involved in raw materials analysis:

Identification Solubility Appearance of the solution PH Melting point limit Loss on drying Bulk density Mesh size IR spectroscopy UV spectroscopy HPLC Operational rotation Water content

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Potency determination Microbiological Test

2 .6 P ackaging & P acking S ectionThis section deals with the checking of procured packaging and packing materials as well as monitors the proper packing of finished products for their correct label, batch number, manufactured and expiry date. The tests that are exercised by this section for packing materials are:

Product PVC and PVDC Cotton Shipping Carton Inner cartoon

Test Color, width, thickness, weight par unit area etc Appearance, weight, moisture content sulfated Weight, dimensions and thickness Height & level, description (text, color, general appearance) weight etc

Plastic Cap Dropper

Appearance, weight, length, diameter, volume capacity Appearance, weight, length, capacity, adaptability, with bottle cartoon & plastic cover

Mask type

Appearance, width, adhesiveness

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Bottle, ampoules vials

Height, neck diameter, weight, volume capacity, light transmission test etc

3 .1 H istory of P harmaceutical M arketing:The marketing of medication has a long history. The selling of miracle cures, many with little real potency, has always been common. Marketing of legitimate non-prescription medications, such as pain reliever or allergy medicine, has also long been practiced. Mass marketing of prescription medications was rare until recently, however. It was long believed that since doctors make the selection of drugs, mass marketing was waste the resources, when specific ads targeting the medical profession would be cheaper and jus as effective. This would involve ads in professional journal, and visits by sales staff to doctors office and hospital.

3.2 Concept of Pharmaceutical MarketingPharmaceutical marketing is a subspecialty of marketing. It can define as process by which market for pharmaceutical care is actualized. The emphasis pharmaceutical marketing is on pharmaceutical care, and not just on drugs. The marketing of many is as such a part of pharmaceutical marketing as is the marketing of drug products. So, pharmaceutical marketing is not synonymous with significantly broader than, the marketing of pharmaceutical.

Parties involve with Pharmaceutical marketing:Parties who are involved with pharmaceutical marketing are given below; 37

o Hospital pharmacies o Community pharmacies o Third party insurance company o Consulting pharmacies o Pharmaceutical manufacturers o Drug wholesaler o Drug retailer

Levels of Pharmaceutical marketing system:Marketing of Pharmaceuticals Pharmaceutical organizational system Pharmaceutical marketing system Health care marketing system General marketing system

Exchange Functions

flow

and

Relocated

Pharmaceutical

Marketing

Pharmaceutical Production/Care Organization System* Manufactures * Repackages * Pharmaceutical care Right providers

Product Information Payment Dispensing Right

Distribution system* Drug wholesaler * Community Pharmacies * Institutional Pharmacies * Others

Product

Utilization Information SystemPayment Dispensing Right * Patients * Purchasers * Decision Makers: physician, others 38

External System* Control System * Health Care System * Economic System * Sociopolitical System

3 .3 Direct and indirect marketing to health care providers:Physicians are perhaps the most important players in pharmaceuticals sales. They write the prescriptions that determine which drug will be used by the patient. Influencing the physicians is key to pharmaceutical sales. Historically, this was done by the large pharmaceutical sales forces. A medium size pharmaceutical company might have sales forces of 1000 representatives. The largest companies have tens of thousand of representatives. Sales representatives calls upon physicians regularly providing information and free drug sample to the physicians. This still the approach today, however economic pressures on the industry are causing pharmaceutical companies to rethink the traditional sales process to physicians. Pharmaceutical companies are developing process to influence the people who influence the physicians. There are several channels by which a physician may be influenced, including self-influence through research, peer influence, direct interaction with pharmaceuticals companies, and patient.

3.3.1Physician Targeting:

39

Identify the universe of physicians most likely to prescribe a given drug. Historically this is done by measuring the number of total prescriptions (TRx) and new prescriptions (NRx) per week that each physician writes. This information is collected by the commercial vendors. The physicians are then deciled in to ten groups based on their writing pattern. Higher deciles are targeted. Some pharmaceutical companies use additional information to deciles physicians such as Profitability of a prescription (script). Accessibility of the physician. Tendency of the physicians to use the pharmaceuticals companys drug. Effect of managed care formularies on the ability of the physician to prescribe a drug. The adoption sequence of the physicians.

3.3.2 Sales force size and structure:Decide on the appropriate size of a sales force needed to sale a particular portfolio of a drug to the target universe. Design the optimal reach (how many physicians to see) and frequency (how often to see them) for each individual physician. Decide how many sales representatives to devote to office and group practice and how many to devote to hospital accounts.

3.3.3 Sales force optimization:

40

Design sales territories in a manner that evenly spreads the work load across territories, districts, and regions. Minimize the amount of time a sales representative spends driving and maximize the time the representative has to meet with physicians. Call planning: Designing the optimal timing for each individual physicians sales call. Forecast each physicians prescribing response to a sale call over the next few weeks. Minimize the annoyance factor.

3.3.4 Sales force effectiveness:Monitor the performance of the sales force in the target universe of physicians. Adjust market message, reach, frequency, timing, territories or other actions in order to increase sales.

3 .4 SWOT analysis of Bangladesh Pharmaceutical Industry is asbellow:Strength: 1. Large protection of domestic industry by Drug Policy, 1982. 2. A good growth of market, around 15%-20% increase par year. 3. Availability of raw materials from nearest source location. 4. Least presence of multinational giants. Weakness: 1. High price sensitive target group. 2. Need broad distribution network. 3. Need continuous monitoring for prescription generations. 4. Strong promotion of chemist group. 5. Bureaucratic drug approval procedure.

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Opportunity: 1. Acceptability of new molecules to the doctor is high. 2. New market for meeting existing demands can be created. Threat: 1. Identification of Indian Drug which is cheaper. 2. Trend of copying of highly prescribed drugs. 3. Price variation among different companies.

3 .5 Facts of Pharmaceutical Sector in Bangladesh The pharmaceutical market size in Bangladesh in terms of manufacture (manufactured in Bangladesh by both locally owned companies and multi nationals) selling price without the deduction of VAT, in 1981 was Tk.1730 million. In 1996 it rose to Tk. 10200 million. The average yearly growth of the sector in these 15 years therefore is tk. 688 million.

The average growth percentage over the same period is 12.81, the highest yearly growth being in 1984 (25.22% over the previous year) and the lowest in 1996 (1.5% over the previous year). At present there are about 250 300 pharmaceutical companies operating in Bangladesh. Twelve top companies together control about 70% of the market. 42

Twenty companies out of them control 85% of the market.

3.6 Marketing Activities of ACMEMarketing is the core of a company. The entire activity of a pharmaceutical company is basically pivoted around marketing of its produces. No pharmaceutical company today can succeed nationally or internationally unless the marketing is geared to meet successfully the challenges of modern day pharmaceutical selling. Marketing thus represents more than just satisfying the customers needs. It represents an intrinsic capability to meet customers satisfaction to the highest degree through uninhibited innovation. Today because of the high level of competence, the marketing team of ACME represents the best that a pharmaceutical company can strive for. it represents a unique mix of experienced professionals with solid background in marketing, sales and medicines. Many of the companys products now hold coveted positions with the major market shares in their respective therapeutic groups. Traditional marketing activities like advertisements in medical journals, participation min medical & scientific seminars & symposia are complemented with personal detailing by a highly trained and motivated field force of about 500 people.

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The marketing Division of ACME consists of the products management responsible for all aspects of innovative marketing and is manned by number of Product Officers including a Senior Product development Manager responsible for business unit based on the therapeutic groups. The other important element of marketing is the Marketing Information Services Department, which oversees field matters in close co-operation with the sales personnel. Another important area is marketing research &Information Department working under Marketing Division headed by a Senior Manager who is assisted by a group of young, intelligent & self motivated persons responsible for collecting information &data on the competitors activities, doctors prescribing habits, the market trends and the customers opinion. The Marketing Division has been instrumental in teamwork within & outside the organization. Distribution is one of the vital parts of any marketing organization. It plays a very significant role for achieving the desired sales growth. A very good and effective distribution system consisting of 18 (sixteen) sales centers throughout the country including the Central Sales Center located in Dhaka that are operated and controlled by the highly skilled and professional people. A Senior Manager under the direct supervision of the Sales Manager heads the overall distribution. Teamwork is the secret of ACMEs marketing success, which has become a part of the companys culture. Teamwork shapes the future of the companys marketing and for that matter the future of ACME itself.

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Market Program Decision of ACME:A. Product napping boundaries

Every field person should inform that Generics is highly effective in treating scabies, safe & highly effective for all ages, treatment of choice in children, better than any other conventional anti-scabies drugs.

B. Pricing policy

The pricing of generic is based on competitors price. ACMEs pricing objective is to out of compete our closest rivals by snatching some of their market share and to penetrate new market.

C. Distribution policy

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Depot wise distribution of the product to fifteen depots will be ensured by the help of distribution network.

D. Sales Force Strategy

To stimulate our sales force we should fix up and declare yearly bonus and awards for top five sellers, frequent and extensive training should be imparted to our field force.

4.0 IntroductionThe product represents a bundle of expectation of the customer. The product satisfies the new of society. A successful product insures its promotion to satisfy the need of customer that is right to the market. A good product should be able to generate extra amount of enthusiasm, which is important markets organization.

According to the Philip kotler, A product is any thing that con be offered to a market for attention, acquisition, use or consumption that might satisfy a want or need. It includes physical objects, service persons, organization and Ideas

According to the Alderson, A product is a bundle of utilities consisting of various product features and accompanying services

Products of ACME:

46

In order to meet the requirements by the WTO regulations and heavy competition from 2016 resulting from globalization/ liberations of trade and strict compliance of Intellectual Property Right, the company has been trying to develop new products every year. At present ACME has over 300 products existing in the market. The various products of ACME are given in the following table according to the position of existing, discarded and new products during the year 2006-2007.

SI.NO

Product Categories Tablet Capsules Liquids Indictable Paed Drop Ointment Dry Syrup Suppository Inhaler E&N Drops Powder Cream

Position as on 145 31 36 40 3 8 20 12 16 5 1 9

Adding during year

Discarded

Total Net

1 2 3 4 5 6 7 8 9 10 11 12 Herbal 13 14 15

Capsule Tablet Liquid

1 1 3

47

Total

331

Output / Capacity UtilizationSI.NO Product Categories Units Production Thousand in % Increase/ Decrease Capacity Utilization

1 2 3 4 5

Tablet Capsules Liquids Injectables ENT Preparation and other Opthal preparation and other Dry Syrup Suppsitory Inhaler Basic Chemicals

Pcs Pcs Bottle Pcs Phials

6

Phials

7 8 9 10

Bottle Pcs Van Kg

48

11 12 13 14 15

Tablet- Agro Vet PowderAgro Vet InjectionAgro Vet Liquid- Agro Vet AerosolAgro Vet

Pcs Gm Pcs Bottle Pcs

Human Pharmaceutical Products IndexOf The ACME Laboratories Ltd Analgesic & Antipyretic Antacid Anthelmintic Anticancer Antiamebic Antianginal Antiasthmatic & Bronchodilator Antibiotic & Chemotherapeutic Antidiabetic Antidiarrhoeal Antiemetic Antifungal Antihistaminic & Antiallergic Antihemorrhoidal Antihypertensive & Cardioprotective Antihyperlipidamic Antimigraine Antiplatelet Antispasmodic Antituberculous Antivertigo Anxiolytic and Antidepressant Diuretic 49

Electrolytic Enzyme Expectorant Eye Product H2 Receptor Antagonist Hematinic Immunosuppressant Laxative Nasal Product Nonsteroidal Anti-Inflammatory Proton Pump Inhibitor Scabicidal Steroid, Vitamin & Mineral

MONAS the Product for Asthma:AsthmaAsthma is defined as a disorder characterized by air way inflammation and increased airway responsiveness resulting symptoms of wheeze, cough, chest tightness and dyspnea. In another way Bronchial Asthma is characterize by paroxysms of dyspnea accompanied by wheezing resulting from reversible narrowing of the bronchial air ways by muscle spasm mucosal swelling or visid secretion.

The effect of Asthma All over the WorldIn Bangladesh there are millions of patient sufferings from Asthma, Other Allergic disease, environmental disorders, immunological disorders etc. IACIB has been working on these disorders. IACIB has introduced health card system for registration of patient attending IACIB and its different service centers. IACIB has enlisted more than 40,000 patients suffering from Asthma, various allergic diseases and immunological disorders for consultation, diagnostic, therapeutic and prophylactic 50

Asthma is a very common disease in the United States, where more than 17 million people are affected. A third of these are children. In 2002, 478,000 hospitalizations and 4,657 deaths were attributed to asthma.

> Asthma affects all races and is slightly more common in African Americansthan in other races

> Asthma affects all ages, although it is more common in younger people. Thefrequency and severity of asthma attacks tend to decrease as a person ages.

> Asthma is the most common chronic disease of children.Applied Anatomy and Physiology:The upper respiratory tract includes the nose, nasophararynx, larynx and liaed by ciliated columnar epithelium. The lower respiratory tract includes the trachea bronchi. These form interconnecting tree of conducting air ways eventually joining, via around 64,000 terminal bronchioles with the alveoli to from the acini. The acinuses are the gas exchange unit of the lung and comprise branching respiratory bronchioles lading to clusters of alveoli. The alveoli are lined mostly with flattened epithelial cells (type I preumocyte and type II preumocytes)

Normal defense of lung:Physical defense: - Most large particles are removed from inspired air by the upper respiratory tract. Mucociliary clearance: - Particles a diameter > 0.5 m that survive passage through the nose will be trapped by the lining fluid of the trachea and bronchi and cleared by the mucociliary escalator. Surfactnat & other defensive proteins: - With out surfactant lung will be clopsed. Other defensive proteins including immunoglobins, complement, 1 antrypsin which play an important role in protecting healthy tissues from damage tissues 51

which would be incurred by the release of protineases from inflammatory cells during the inflammatory process. Alveolar Macrophages:- These multipotent cells normally patrol the interior of the alveoli where they display a formidable array of mechanisms by which they recognize and destroy bacteria and other foreign particalls. The remarkably versatile resident macrophase can also call in reinforcement by genetering mediators which cause an inflammatory response and attract granulocytes and monocytes. It may also generate and immune respons by presenting antigens and by releasing specific lymphokines. But uncontrolled release of some of these powerful macroface products may cause disordered inflammation or scarring responses which are likely to be important in the phathogenesis of a variety of inflammatory disease including Asthma.

Probable causes of Asthma: Genetic susceptibility Specially a topic asthma runs in the family. Environmental Factors Urban, Modern and economically develop

populations are commonly sufferer. House dust from carpets, mites, pollen nitrogen, dioxide from gas cooking, sulphur dioxide are mainly responsible for Asthma. Drugs Beta blockers, saliency lets and other NASD. Smoking Definite relationship with Asthma and COPD in chronic smoker. Anxiety and psychosocial factors have relation for the development of Asthma.

Management of Asthma:Preventive measures Patient education and avoidance of precipitating factors. Management of chronic persistent:

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Treat mental Steps: 1. Occasional use of inhaled short-acting 2- adernoceptor agonists 2. Low-dose inhaled steroids (or other anti-inflammatory agents) 3. High-does inhaled steroids or low-does inhaled steroids plus long acting inhaled 2 - adernoceptor agonist. 4. High-does inhaled steroids and regular bronchodilators. 5. Addition of regular oral steroid therapy.

All the drugs used in the traditional treatment of Asthma are not without side effect, previously it was thought that histamine is responsible for contracting the bronchial air way and produce Asthma. Recent studies show those products of arachidonic metabolism and 1000 times more potent than histamine in producing Asthma.

Product of Arachidonic acid metabolism:More recent management plan shows that if we can successfully block the products of Arochidonic acid metabolism CysLT1 leukotriens receptor including C4, D4 and E4 by any mean which will be more effective in preventing and managing Asthma.

Description of the Products:MONAS (Montelukast) the Asthma Manager: Monas is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene receptor. The cysteinyl leukotrienes are products of

53

arachidonic acid metabolism and are released from various cells, including mast cells and eosinophils. Cysteinyl leukotrienes and leukotriene receptor occupation have been correlated with the patho-physiology of asthma, including airways edema, smooth muscle contraction, and altered cellular activity associated with the inflammatory process, which contribute to the signs and symptoms of asthma. 85% of childhood and 50% of adult Asthma attacks are due to common cold and Respiratory Tract Infections (RTIs) are usually caused by viruses. These viruses are the most frequent triggers of Asthma attacks. During Asthma attack, bronchial epithelial cells and macrophages increase Leukotrience production leading to bronchospasm. According to PREVIA (Prevention of Virally Inducted Asthma) MONAS is the first treatment option in Virally Induced Asthma (VIA).

Mode of ActionIgE Antibody + Antigen

To stimulate the mast cell

Rupture the cell membrane of the mast cell

Release of cysteinyl leukotriene

Monas blocks CysLT receptor CysLT binds with CysLT receptor

leukotriene leukotrieneleukotriene

54

1. Eosinophil recruitment 2. Permeability of bronchial wall edema 3. 4. Mucous secretion Broncho constriction

MONAS- the first line treatment option VIA The international PERVIA (Prevention of Virally Inducted Asthma) study involved 529 children with VIA. The children were given MONAS (Montelukast) 4 or 5mg chewable tablet once daily for 12 months. The average rate of Asthma attacks was reduced by almost 1/3 rd (31.90%) compared to placebo. The time of first Asthma exacerbation was seen after 207 days in Montelukast group and 147 days in placebo group. The use of inhaled corticosteroids was reduced by 38.90% in the Montelukast group compared to the placebo group.

Composition of MONAS MONAS 4: Each chewable tablet contains 4.2 mg Montelukast Sodium INN equivalent to 4 mg Montelukast, which was approved by FDA. The tablet is prescribe 55

for prevention and chronic treatment of asthma in children aged 2 to 5 years. MONAS 5: Each chewable tablet contains 5.2 mg Montelukast Sodium INN equivalent to 5 mg Montelukast, which was approved by FDA. The tablet is prescribe for prevention and chronic treatment of asthma in children aged 6 to 14 years. MONAS 10: Each chewable tablet contains 10.4 mg Montelukast Sodium INN equivalent to 10 mg Montelukast, which was approved by FDA. The tablet is prescribe for prevention and chronic treatment of asthma for adolescents, adults and older.

Benefit and Features of MONAS: MONAS appears effective and safe for the treatment of children toadults with Asthma.

MONAS is well tolerable and cost effective. MONAS reduces the need for inhaled cortricosteroids. MONAS is generally well tolerated with a safety profile similar tothe placebo.

MONAS is the better alternative to salmeterol. MONAS is the more convenient compared with cromoloyn. MONAS has a very promising antiasthma drug, delivers a balanceof efficacy and safety.

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MONAS is generally well tolerated with a safety profile similar to the Placebo. MONAS average reactions (1%) MONAS 10mg / day (n =1955) Headache Dizziness Dyspepsia Trauma Asthenia / Fatique Pyuria Cough Congestion, nasal Abdominal pain Rash 18.4 1.9 2.1 1 1.8 1 2.7 1.6 2.9 1.6 Placebo (n = 1180) 18.1 1.4 1.1 0.8 1.2 0.9 2.4 1.3 2.5 1.2

Dosage and Administration: Adults 15 years of age and older: Single tablet (10mg) once daily at bed time. Children 6 to 14 years of age: Once chewable tablet (5mg) once daily at bed time. Children 2 to 5 years of age: Once chewable tablet (4mg) once daily at bed time.

Indications: MONAS is indicated for the prophylaxis and chronic treatment of asthma in adults and children two years of age and others.

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Contraindication: MONAS is Contraindicated in patients who are hypersensitive to any component of this product.

Advice for the patients:

>> If the patients take corticosteroid s/he should continue to take them,while taking the MONAS, even if their symptoms improve.

>> Pediatric should be taken MONAS one hour before or two hoursafter food. MONAS for adults can take with or without food. Advantages of MONAS over other Medicine used in the treatment of Asthma: Efficacy: The onset of action of MONAS is rapid and sustains with improvement occurring within the first day and persisting throughout the 12 weeks of treatment. Tolerance: MONAS is well tolerable. Safety: No significant difference in adverse events compared with placebo. Patients satisfaction Patients satisfaction is optimum.

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Dosage frequency & clinical benefit: Dosage frequency & clinical benefit are also optimum.

In this particular view Monas (Montelukast) acts as a magic bullet. It acts MONAS leads to improved clinical symptoms in RSV (Respiratory Syncytial Virus) postbronchiolitis. Improvement of eczema or urticaria with MONAS, treatment in patients who had history of long-standing eczema or urticaria. MONAS has beneficial effect with cetirizine on a range of daytime symptoms in the prevention of allergic rhinitis symptoms. MONAS is efficacious in chronic obstructive pulmonary disease (COPD). MONAS is efficacious in EIA (Exercise-Induced Asthma)

Precautions:MONAS isnt indicated for use in acute Asthma attacks. Therapy with MONAS can be continued during acute exacerbations of Asthma. MONAS should be use as monotherophy of the treatment and management of exercise induced bronchospasm. There are no adequate and well controlled studies in pregnant women. MONAS should be used during pregnancy only if clearly needed. MONAS is excreted in milk. So caution should be exercised when montelukast is given to a nursing mother.

Drug Interactions:It is reasonable to employ appropriate clinical monitoring when potent cytochrome P450 enzyme inducers, such as Phenobarbital or rifampin, are coadministered with montelukast.

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Side-Effects:MONAS has been generally well tolerated. Side-effects, which usually are mild, including gastro-intestinal disturbances, dry mouth, thirst; hypersensitivity reactions including anaphylaxis, angioedema and skin reactions; asthenia, dizziness, irritability, restlessness, headache, sleep disorders, upper respiratory tract infection, fever, arthralgia, mylgia. The overall incidence of side effects reported with montelukast was comparable to placebo.

Pack Size:Marketing division has decided to change the pack size and carton design of Monas catch cover for reducing packing cost and enhance profitability grade of product. The existing and proposed pack size is given below.

Product

Profit Grade.

Unit price Tk. 7.0 10.0 20.0

Existing Pack size 1X5s 1X5s 1X 5s Paper Board SBD SBD SBD

ProposedPack size 3 X10s 3 X10s 3 X5s Paper Board Grey Back Duplex

Price/ Carton210.0 300.0 300.0

Remarks

Monas 4 Monas 5 Monas 10

A A A

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Asthma has many costs to society as well as to the individual affected

Many people are forced to make compromises in their lifestyle to accommodate their disease

Asthma is a major cause of work and school absence and lost productivity.

Asthma is one of the most common reasons for emergency department visits and hospitalization.

Asthma costs the US economy nearly $13 billion each year. Approximately 5000 people die of asthma each year in this country

SMART Objectives of MONAS launchingShort-term objective 1. Want to prepare the FPs for the promotion of MONAS. 2. To create a great share of voice in the market with MONAS 3. T o ensure availability of the product in all chemist self by first month of launching 4. To ensure all doctors are well informed about the brand MONAS by the very first month of launching 5. To earn prescription from the very first visit to a target doctor

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Long-term objectives 1. MONAS is the Brand Leader to beat MONTENE (Square) & MONOKAST (Beximco), Hold 44% of Prescription share. 2. Want to sale 10 crore Tk on the year 2008 3. Want to get 70% Prescription share within the year of 2015

Product ProfileProduct Name Beneficial Class Generation Generic Name Dosage form : MONAS 4mg, 5mg & 10mg. : Asthma Patients : First : Montelukast : MONAS 4mg & 5mg are Chewable Tablet.MONAS 10mg - Tablet

Strength

: MONAS 4mg (2 to 5 Years),MONAS 5mg (6 to 14 Years) & MONAS 10mg (15 to adults)

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Pack Size

: MONAS 4mg : Each box contains 3X10s tablet in alu-alu blister stripsMONAS 5mg : Each box contains 3X10s tablet in alu-alu blister strips MONAS 10mg : Each box contains 3X5s tablet in alu-alu

blister strips

Price

: MONAS 4mg Tk. 7/Unit, MONAS 5mg Tk. 10/Unit &MONAS 10mg Tk. 20/Unit

Market Share Indication Doses

: Around Tk 7.5 Crores out of 17 Crores. : It has three USFDA approved indications. : Once daily

Features & benefits

Featuresfirst time in Bangladesh for the

Benefits

MONAS is FDA Approved which is the Proof of efficacy for the prescribers treatment of two indications For Adult Children over 2 years. Efficacy of oral tablets is high/same as Can be used as an alternative to some parenteral antibiotics Long half life Competitive price different aged person Once daily dosing; ensures patients compliance Reduce treatment cost

63

MONAS

is

the

more

convenient MONAS reduces the need for inhaled cortricosteroids

compared with cromoloyn.

MONAS is the approved drug for the Can be prescribed against penicillin treatment of penicillin resistant resistant bacteria Ensure stability infections Alu-Alu blister packing

Improved get-up Brand name is short, attractive, & Will create positive impression in the meaningful market

5.1 PriceThe amount of money changed for a product or service or the sum of the values that consumer exchange for the benefit of having or using the products or services.

5.2 Why Pricing:

Price is the only element in the marketing mix that produces revenue the other elements produce cost. Yet many companies cannot or do not pricing well. Pricing communicate the products perception, feature and quality in the consumer mind so, its a vital element of marketing mix.

5.3 Importance of Pricing:64

The basic importance of pricing given below; Price is the only one of several tools available for influencing demand and therefore sales.

Flexibility in setting prices is limited as a rule. There is often little margin for price variations between inevitable and irreducible cost on the one hand, and the establish price level in a market on the other.

Any pricing decision can become invalid or superseded at any moment as a result of cost changes in consumer habit and attitude.

It may be very difficult to correct a bad-pricing decision without serious harm. Sudden reversals of policy whether upwards or downwards are liable to create major problem in with the customer.

There is no universally valid and correct way to set a price: awareness of the possible choices and options, and analysis of the factor involved and the clear understanding of the objectives to be achieved are needed to make intelligent pricing decision.

5.4 Pricing Strategy65

To set the price company takes the following three strategies; Setting the price for the first time.

Adapting the price

Initiating and Responding to price changes

5.4.1 Setting the price:

Before setting the price of a new product a firm decides where to position its product on quality and price. Consideration in setting the price: After setting its product in its market a firm sets its pricing policy. The factor that consider in setting the price are Selecting the price objective Determining Demand Estimating costs Analyzing competitor price and offers Selecting a pricing Method Selecting the final price

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5.4.2 Adapting the price:

Geographical Pricing

Geographical pricing may include FOB Origin Pricing Uniform Delivered Pricing Zone Pricing

Price discount and Allowances (physiological pricing) Cash discount Quality discount Seasonal discount Functional discount Allowances

Promotional Pricing Loss Leader pricing Special event pricing Cash rebate pricing Warranties and service contracts

Discriminatory pricing Customer segment pricing

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Location pricing Time pricing

5.4.3 Initiating & Responding to price changeAfter developing their pricing strategies, companies may face situation where they may need to cut or raise prices.

Initiating price cuts Reason for price cut a) Excess capacity b) Decline market share c) Drive to dominate the market through lower cost

Risk in assuming this strategy a) Low quality trap: Consumer may think that quality is low. b) Fragile market share trap: Its buys market share but brand loyalty. Customer will shift to the next lower price firms that come alone. c) Sallow pockets trap: the higher price competitor may cut their prices and have longer staying power because of deeper cash revenue.

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6.5 Price Elasticity TheoryA decrease in the price of a good, all other things held constant, will cause an increase in the quantity demanded of the good. An increase in the price of a good, all other things held constant, will cause a decrease in the quantity demanded of the good.

Price

P2 P1

Q 69 uantity

Q2 Elasticity:

Q1

Elasticity is a measure of how much buyers and sellers respond to changes in market conditions allows us to analyze supply and demand with greater precision. Elasticity is a measure of how much buyers and sellers respond to changes in market conditions allows us to analyze supply and demand with greater precision. Price Elasticity of Demand is the percentage change in quantity demanded in response to a percent change in the price. It is a measure of how much the quantity demanded of a good responds to a change in the price of that good. Computing the Price Elasticity of Demand the price elasticity of demand is computed as the percentage change in the quantity demanded divided by the percentage change in price.

Point definition:

EP =

Q / Q P Q = P / P Q P

Linear definition

EP = 1 aArc definition:

P Q

EP =Here

Q2 Q1 P2 +P 1 P2 P1 Q2 +Q1

Q = Change in demand P = Change in price

1= Coefficient of price elasticity

P2 = Price after change70

Q1 = demand before price increase Q2 = demand after price increase P1 = Price before change

Ep = Elasticity of price

Competitors priceProduct Montair 4 Montair 5 Montair 10 Monocast 4 Monocast 5 Monocast 10 Montene 4 Montene 5 Montene 10 Company Incepta Incepta Incepta Beximco Beximco Beximco Square Square Square Pack Size 3X10s 3X10s 2X10s 2X10s 2X10s 1X10s 1X10s 1X10s 1X10s Unit price (Tk.) 7.0 10.0 20.0 7.0 10.0 20.0 7.0 10.0 20.0

Considering the competitor price we are not favoring the price increase of Monas. 71

6.0 Different Methods of Sales Promotion:In the pharmaceutical industry, companies cannot market their product directly to the final consumer for obvious reasons. Instead, they have to promote their products through its channel of distribution. The main parties who are in the receiving end of promotional activities of pharmaceutical companies are doctors, physicians and chemist in drug stores. In ACME Laboratories Ltd, several promotional methods are used. They are (1) Samples, (2) Writing Pads, (3) Gift Items, (4) Literature, (5) Discounts.

1. Samples:These are samples of new products that a company plans to introduce. In traditional style pharmaceutical marketing, the company generally promotes its new product by providing free samples to doctors and physicians who can read about it, learn about its features and are free to test it on their patients.

2. Writing Pads:72

This is a useful form of promotion in that it helps to inform, convince and remind the doctors about the products and its features every time they open the writing pad to write something down.

3. Gift Items:This can be of a wide variety starting from pens, mugs, and paperweights to decoration pieces. These products are usually given as presents to doctors, physicians and sometimes pharmacists to serve as an incentive, reminder about the product. These gift items are given along with the literature and / or the pad.

4. Literature:This gives a detailed description of the various features of the product, its contents, recommended dosage, advantages and disadvantages a user can get from using the product etc. It aims to differentiate the product from other competition and emphasize the products differentiating features.

5. Discounts:This promotional measure is directed towards chemists or pharmacist. These discounts are given at various times during the life cycle of a product. They are given to encourage the chemist to increase orders for the product. There are many ways this can work for the pharmaceutical company. On the one hand, the price advantage entices chemists to buy this product instead of its competitors. Once they stock up on a particular product they will recommend the product to customers and even convince customers to buy that particular product instead of any other product of the same use. Chemists do this because they would want to finish its stock of that product which they bought to take advantage of the 73

discount and also because they would make more profit by selling the discounted product rather than a non-discounted one. Another bonus given to chemists comes in the form of gifts. For example, if a chemist buys TK. 10,000 worth of goods from the company, they are given a dinner set or a wall clock as a gift. There is also the chemist-doctor effect that comes into play when a company gives a discount for a certain product. Doctors usually know what products fill the shelves of the drug stores adjoining their chambers. Another measure taken can be artificially stopping supply of a certain product to generate demand or to see how popular the product is in the market

7.0 Channel of DistributionTo ensure internal & external Distribution of medicine both Human & Veterinary including other products and to full-fill the demand of ACMEs valued customer they supply fresh medicine in right time. To do so they follow their Deport manual, through monitoring of all activities, they extent their cooperation in order to develop relation with their valuable customer and work of customers satisfaction. ACME also use their competent personnel, several Sales including central Sales centre, up to date technology and requisite facilities.

Target Doctor:1) Medicine Specialist 2) Chest Specialist 3) General Physician

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4) Child Specialist 5) Cardiologist 6) ENT Specialist 7) Hospital Practitioner

SWOT ANALYSIS OF MONAS

8.1 SWOT analysisStrength Quality of Acme's antibiotic. Large sales team Doctors faith on Weakness Late in the market not giving price benefit to the end users. Doctors mind set Acme's Lots of new Antiasthmatic are coming (cromoloyn, placebo now

Antiasthmatic

MONAS appears effective and safe available in the market)for the treatment of children to adults There are no adequate and well with Asthma. effective. controlled studies in pregnant women. including dry gastro-intestinal mouth, thirst; reactions including 75

MONAS is well tolerable and cost Side -effects, usually are mild, MONAS is generally well tolerated disturbances,with a safety profile similar to the hypersensitivity

placebo. salmeterol. compared with cromoloyn

anaphylaxis, angioedema and skin asthenia, restlessness, dizziness, headache, irritability,

MONAS is the better alternative to reactions;

MONAS is the more convenient sleep disorders, upper respiratory tractinfection, fever, arthralgia, mylgia.

Opportunity

Threat Montene (Square), Monokast

Established & Growing market segments MONAS is well tolerable and cost effective.

(Beximco)

&

Montair

(Incepta)

already created their market Promotional strategy of

Well penetration in the market. MONAS has a very promisingantiasthma drug, delivers a balance of efficacy and safety.

competitor companies. Increasing Price

MONAS reduces the need forinhaled cortricosteroids.

MONAS has a very promisingantiasthma drug, delivers a balance of efficacy and safety.

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8.2 Strategy taken/ to be taken get successSO Strategy WO Strategy

Growing market segment if we ACME is late in markets; It may be an can promote properly we will be advantage because doctors already know able to cut a good share in this about the generic. We will have to just generic. have to establish our brand. establish our brand. Also we have to highlight patients. New molecule will come but it can be overcomed by vigorous promotion & market segmentation. ST Strategy WT Strategy Well-accepted generic we will the price benefit, which we are giving to

Competitors have a created market We are very late in the market on the other and we have a large number of F.P hand Square, Incepta, Beximco have created s to achieve our objective we will a market. We can overcome the late entry by have to create new markets & have our corporate image & proper utilization of to snatch market share from promotional materials. competitors also have to utilize

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ACME friendly doctors.

Competitive promotional strategy will be taken in favor of MONAS (Sam, Lit, Pad, Gift,

Our promotional strategy will be Discount etc.) competitive of the rival competitors to fight back them.

9.1 Problem Definition9.1.1 Background of the study: A successful marketing strategy begins with the proper understanding why and how the consumers behave as they do. Behind the every visible act of consumers making purchase lays an important decision process that need to be investigated by the marketers. And on fact this decision process is influenced by the different factor like physiological factor, which include motivation personality characteristics, perception, value benefits, attitude and life style. Situation factors such as purchase task, temporal effort and attended states. In addition of these factors, one more important factor that basically has a great effect on the buying process of a consumer is the marketing wise effects of an organization. The marketing effects are a combination of various strategies based on which the success of the product in the market lays. These strategies are about the product, price, place and promotion.

9.2 Development of an Approach to the Problem

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9.2.1 Objective of the study: Major objective The major objective of this study to show the effective of the product MONAS and comparison of sales promotion activities among the leading pharmaceutical companies so that effective strategies can be applied by ACME.

Specific objectives To find out the proper promotional strategy for the MONAS To know the sales promotion strategies and determined the attractiveness of the competitors. To formulate a master marketing plan. To analyze the SWOT of the sales promotion activities of the generic MONAS To know the customer preference for this brand. To determine the quality of product from the doctor perception To determine the increase market coverage. To determine the field persons motivation.

9.2.2 Analytical Model In the study the analytical model will be followed are given bellow: Identify the problem Research proposal and approval Questioner development and approval Conclude the fieldwork & Data collection 79

Data compiling Comparison with other sources of data Checking the error

9.3 Research Design Formulation: Research design is a framework or blue print for conducting the marketing research project. It species the detail of the procedures necessary for obtaining the information needed to structure and/or solve marketing research problem. The main research designs usually adopted in the various research programs are shown bellow: 1) Exploratory research design 2) Descriptive research design 3) Casual research design

In the study Descriptive Research Design has been used. Descriptive research design is a type of research, which has its major objective the description of something usually, market characteristics or functions.

To prepare the report product officer collected data from different sources and compiling the data to prepare the final report.

To prepare the report product officer will be collected the data about the present market condition about his product (MONAS), the promotional strategy for this 80

product is effective or not, which promotional strategy followed by the other competitors, which promotional strategy should be followed by the manager to increase the market share of MONAS.

9.4 Field work or Data collection:9.4.1 Sources of Data Two types of data have been collected for conducting this research. These are as follows: 1) Primary data & 2) Secondary data

Primary data has been collected through the following way: Interview with the Area Manager. Interview with the Field Persons. Interview with the Doctors. Interview with the chemist.

Secondary data has been collected through the following way: Company profile Internal reports

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9.4.2 Model of Primary Data Collection: The models followed by the Product officer to collect the primary data are given below; Model no.1 Area Manager/MR/Product officer (Surveyors) Doctor Present the Approach by Surveyors Response from Doctor

The model have shown that the Surveyors (AM/MR/PO) will go through the doctor and present their approach to the doctor about their subject matter of survey then the doctors think about the surveyor subject mater/ question for proper understanding, after that the doctor present his or her opinion about the surveyor question.

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Model 2.

Product officer Sales)Sales Center Zonal Manager Area Manager MR Market (Chemist/Doctor)

Director (Marketing and

The Brand manager will go through the sales center to collect the information about the product with the permission of Director marketing and sales. Where as Director Marketing and sales informed the zonal manager by mail or phone. After that zonal manager inform to the Area Manger to present the market situation where as Area Manager collect the necessary information from the MR or directly observed to the market.

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9.4.3 Secondary data collection process: Secondary data will be collected from the Company project profile and any other internal report. 9.4.4 Pilot study: In this part surveyor will try to know about the promotional effects, market position, others competitors position of the MONAS. The main study is to know about product promotional strategy, pricing effect, and promotional effect of the product. The report will be based on primary, Secondary, and tertiary data to prepare the report successfully. Surveyor will try to precede works systematically. To prepare an appropriate final report surveyor will collect data, analyze the data and compile the data.

9.5 Limitation of the study: The limitations of the study are given below; Negative aspect of the research technique of personal interview like personal bias and error might have affected of the data collection. The study is limited because of it conducted with limited product. Negative attitude toward market research in general also reflect upon the actuality of data. Wrong understanding the question by the field person/Doctor and others from where data are collected. Limited time period.

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9.5 Data preparation and Analysis: To conduct the research it has taken sample to find out the overall probable scenario of MONASs market.

9.5.1 Sampling Plan For the study I have selected four types population of interestChemist, Doctor, Area Manager, Field persons. I dont have the lists of those groups and they cannot be taken by unbiasness, though the company has a list but for statistic information it should better to use probability sampling. So I have to select probability sampling for my research. My sample frame, sample elements and sample unit should be biased and taken by judgment because everyone has no equal chance of being selected. 9.5.2 Sample Size I have got only 60 days for my study. Company has funded Tk2000 for me to conduct my study so it was impossible for me to take larger sample. Sample size Chemist 25 unit Doctors 25 unit Field Persons 20 unit After collected the data from the Doctor, Area Manager, Chemist, Field persons and companys internal sources about MONAS, it has been editing, coding, transcription and verifying of data for preparation of final report.

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9.6 Report Preparations and Presentation: After data preparation and analysiss it have prepared for final report. This is the overall scenario the ACMEs Product.

9.7 Research Budget: Items

Budget For Data collectionPer Person / Per Day Total Day Total Cost Tk

Convenes Refreshment

100 50

10 10

1000 500 1500 Tk

Total Budget for Data Collection ... Items Pen Drive Refreshment Budget for Data entry: Expenditure 1050 50 5 Total Budget for Data entry Budget for Report Analysis: Refreshment par day = 100 Tk Total = 100 x 4 = 400 Tk Budget for report prepare: Days

Total Cost (Tk) 1050 250 1250 Tk

Items Par Day Stationary 500 Refreshment 50 Total Budget for Report Prepared Total Research Budget:

Total Day Total Cost (Tk) 5 2500 5 250 2750 Tk

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Budget for Data Collection1500 Tk Budget for Data entry . 1250 Tk 500 Tk

Budget for Report Analysis

Budget for Report Prepared 2750 Tk Others Total .. 100 Tk 6000 Tk

Doctors Prescription AnalysisQ. 1. Please Rank the Companies Product you usually prescribe. (7= highest prescribed & 1= Lowest prescribed) After analyzing the survey question we go to rank of the seven pharmaceuticals companys. The ranks in Dhaka City for pharmaceutical Company are stated bellows: 1 st Position: SQUARE Pharmaceutical Company with 22% weight. 2 nd Position: BEXIMCO Pharmaceutical Company with 19% weight. 3 rd Position: INCEPTA Pharmaceutical Company with 15% weight. 4 th Position: ACME Pharmaceutical Company with 14% weight. 5 th Position: ACI Pharmaceutical Company with 13% weight. 6 th Position: NOVORTIES Pharmaceutical Company with 10% weight. 7 th Position: ARISTO Pharmaceutical Company with 7% weight.

Interpretation: According to the survey, we found that ACME Laboratories hold the 4 th position as because towards the Doctors prescription in Dhaka City, we knew that MPOs 87

are not effective enough to motivate the Doctors to prescribe ACME Laboratories Products.

Q. 2. Please Rank the Companies you usually prescribe for ASTHMA. (7= highest prescribed & 1= Lowest prescribed) After analyzing the survey question we go to rank of the five pharmaceuticals companys that Doctors are usually Prescribe for ASTHMA treatment. The ranks in Dhaka City are stated bellows: 1 st Position: Montene (SQUARE) with 30% weight. 2 nd Position: Monas (ACME) with 25% weight. 3rd Position: Montair (INCEPTA) with 18% weight. 4th Position: Monocast (BEXIMCO) with 12% weight. 5 th Position: Others Pharmaceuticals with 15% weight.

Interpretation: According to the survey, we found that ACME Laboratories hold the 2nd position for ASTHMA treatment as because towards the Doctors prescription in Dhaka City, we knew that, the product is very sound in quality, the price reasonable, the promotional activity & Product Literature are outstanding to hold increase the market share. and

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Q. 3. Based on what criteria you usually prescribe a companys Product. Please Rank. (7= highest prescribed & 1= Lowest prescribed) After analyzing the survey question we got some criteria that Doctors are usually prescribe based on it. The criteria are stated bellow according to their choice: 1 st Criteria: Quality weight with 35% 2 nd Criteria: Price weight with 20% 3 rd Criteria: Packaging weight with 18% 4 th Criteria: Promotional Items weight with 14% 5 th Criteria: MPOs Efficiency weight with 13%

Interpretation: According this Question survey we observed that Doctors are usually prescribed a Pharmaceuticals product based on its Quality. So, Quality is the prime concern.

Q. 4. What is your perception towards ACME Laboratories Product? (i) Very Good Poor Analysis: Very Good (5) Good (4) Average (3) Poor (2) Very Poor (1) 5 x 5 = 25 4 x 7 = 28 3 x 10 = 30 2x2=4 1x1=1 25 + 28 + 30 + 4 + 1 = 88 25 = 3.52 (Good) (ii) Good (iii) Average (iv) Poor (V) Very

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Interpretation: According this Question survey we determine all the pharmaceuticals of ACME Laboratories. So the position from the outcome of this survey is good. Q. 5. Please Rank Detailing of the following with regards to ACME Laboratories. (5=Highest Prescribed & 1=Lowest Prescribed) a) MPOs Detailing Capacity. b) MPOs Communication skill. (5) c) MPOs objection handling Capacity (5) d) Quality of gift materials (5) e) Quality of printed promotional material f) Quality of packaging materials (5) (1) (2) (1) (3) (2) (4) (3) (5) (4) (1) (2) (3) (4) (1) (2) (3) (4) (1) (2) (1) (3) (2) (4) (3) (5) (4)

5(a). Analysis of MPOs detailing Capacity: 1 1x1=3 2 3 4 2 x 6 = 12 3 x 13 = 39 4 x 3 = 12 3 + 12 + 39 + 12 + 10 = 76 25 = 3.04 5 5 x 2 = 10

Interpretation: According to the data analyzing we got about 3.04 = 3 Points. That indicates 3 rd rank for MPOs detailing capacity. That Means MPOs capacity is average.

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Q. 5(b). Analysis of MPOs Communication skill: 1 1x1=3 2 3 4 2 x 6 = 12 3 x 11 = 33 4 x 5 = 20 3 + 12 + 33 + 20 + 10 = 78 25 = 3.12 5 5 x 2 = 10

Interpretation: According to the data analyzing we got about 3.12 = 3 Points. That indicates 3 rd rank for MPOs communication skill. That Means MPOs communication skill is average. Q. 5(c). Analysis of MPOs objection handling Capacity: 1 1x1=3 2 3 4 2