Orientation Report

COMPANY PROFILE Macleods pharmaceuticals is one of the fastest growing company in India with a sales turnover of Rs 1.3 billion by the close of financial year in March 2002. The company aims to become a strong and independent pharmaceutical company providing quality health care to the masters, specially the essential and difficult to manufacture drugs. Macleods pharmaceutical focuses on various products ranging from anti tuberculosis, cardiovascular, thyroid and antithyroid drugs corticosteroids, antiAIDS, antiinflammatory drugs and others. Under the flagship of Macleods pharmaceutical there are four divisions with 1400 field force serving towards improving the health care standards.

RESEARCH AND DEVELOPMENT  Formulation & Development Department  Analytical Method Development Department  Active Pharmaceutical Ingredient Department  Bioequivalence study Centre

A strong R&D team consisting of over 120 extremely diligent and committed scientists support marketing efforts of Macleods. A team committed to develop formulations that are bio-equivalent to innovators and designed to offer increased efficacy through newer drug delivery systems. At Macleods lot of breakthroughs have occurred and milestones been achieved sine year 1986 - one of which is our in-house development of estimation of Rifampicin bioavailability through urine excretion method. It is a simple non-invasive and rapid

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technique for such estimation. It is internationally accepted as a benchmark for such estimation after our presentation at the International Union Against Tuberculosis & Lung Diseases held in Philippines Manila, Year 2001. All in all, in the last 5years Macleods has carried out 40 clinical trial studies and 40 bioequivalence studies. Our proposed objectives for R & D centre are: •

To develop and transfer technology for Novel drug Delivery Systems (NDDS)

•

To chemically synthesize niche pharmaceutical products.

•

To develop formulations for export markets; Generics for regulated markets and Innovative for non-regulated markets.

•

To develop formulations to enable New Drug Application with the Drug Controller of India in the Ministry of Health.

•

To develop and validate analytical procedures to support development of bulk drugs and formulations.

•

To conduct bio-equivalence studies to assure high level of confidence and meet with time-lines.

At Macleods, innovations and quality up-gradation programs are the essential ingredients with R & D playing a pivotal role. Our large team of zealous scientists are at work day and night in this R & D centre that is fully equipped with state-of-the-art equipments, facilitating the development of innovative products, processes, NDDS, new dosage forms and packs, analytical methods, stability studies and process validation with many more to come.

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Macleods R & D centre is located in Mumbai, spread over an area of 35,00 sq. meters. The R & D facility, which was setup in the year 2000, is approved by the Department of Scientific and Industrial Research, Govt. of India, and since then, till Dec. 2004, has made several significant progresses. Macleods is the first in the world to have developed sustained release granules of “Sodium Salt of Salicylic Acid (known as PAS)”. Formulation & Development Department: Macleods Formulation and Development section is well equipped with lab-scale equipments to enable proper Formulation & Development of tablets, capsules, liquids, injectables and topical formulations Analytical Method Development Department: The Analytical Method Development department supports all the developmental work providing support for Active Pharmaceutical Ingredients and Formulation and Development. The department is equipped with the most modern sophisticated instruments. Walk in stability chambers having capacity of 8000 liters and with data logger software new analytical method development by HPLC for APIs and dosage forms is with respect to:  Stability indicating methods for assay  Impurity profile  Dissoution  Residual solvents and organic volatile impurities by Gas Chromatograph

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 This analytical method development is having a team of 50 qualified and experienced scientists. The department is well equipped with highly sophisticated instruments like High Performance Liquid Chromatography, Gas Chromatography, Differential scanning calorimeter, UV spectrophotometers, infra red spectrophotometer, walk-in stability chambers and dissolution apparatus. Method validation and stability studies are carried out as per ICH guidelines. Active Pharmaceutical Ingredient Department The API process development lab at Macleods is equipped with capabilities to handle multi-step chemical synthesis involving reaction types like, Catalytic Hydrogenation & Hydride Reductions, Heterocycle & Aminoacid Synthesis, and Optical Resolution & Reactions involving the use of Chiral Substrates.The well-equipped Lab. at the R & D Centre strives to develop competitive and cost effective commercial processes for the production of APIs. Macleods is the first pharmaceutical company in the country to have developed production technologies for a number of APIs like: •

Ethionamide

•

Prothionamide

•

Rebamipide

4

Bioequivalence study Centre In order to conduct bio-equivalence studies to assure high level of confidence and meet with time-lines has created the bio-equivalence study center. It strives to ensure high quality clinical, bio-analytical, statistical and pharmacokinetic data necessary to create international harmonization in bioequivalence testing. The harmonization in the requirements and standards for bioequivalence testing would be achieved by conducting all the studies as per the GCP and GLP regulations and other regulatory guidelines. The center has 28 bed facility with in house well equipped Emergency care unit, well developed bio-analytical section with state of art equipments such as LC /MS MS, HPLC, Low Temperature Freezers and Centrifuges. The facility is well enabled with IT systems such as SAS version 9.1 for statistical computation, bio-enable software for volunteer registration and access control system for prevention of unauthorized movement of personnel. The bio-equivalence study center operates as per the well-established quality system supported by set of written standard operating procedures pertaining to specific activities and equipments in the facility. The center will be conducting activities such as – • Bioanalytical method development and validation • Pilot BA/BE Studies • Pivotal BA/BE studies • Pharmacokinetics study in special population • Multiple dose effect study • Food effect study • IVIVC (In-vitro In-vivo co-relation) 5

HUMAN RESOURCES HR Vision To consolidate the sense of belonging in order to strengthen the culture of Macleods. To become one of the best companies in Human Resource Management by assimilating and internalizing latest HR practices, methods and techniques to remain at par with developing global competitiveness. Enable organization to attract, train and maintain a pool of talented professionals. HR Mission Systematically endeavor to develop a highly motivated, productive and committed work force

to

achieve

quantitative,

qualitative

edge

in

all

our

operations.

Respond consciously to the dynamic needs of the organization, to ensure perpetual enhancement of knowledge & skills facilitating a constantly appreciating human resource base. Our Human Resource Values We cherish human values. They are as important as our products and services. We would like to be known and acclaimed for our core values, we value and trust our people and believe that continuous investment in development of people pays off. Our style of operation is Participative and the organization thrives on Performance coupled with integrity, loyalty and commitment Transparency across the organization forms the basis of our communication Objectivity and fairness are the key criteria for performance evaluation. Creativity and new ideas are encouraged and change is welcomed. Business Philosophy

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The business Philosophy of Macleods is to focus on the Essential Drugs as prescribed by WHO & providing Generics in developed and regulated markets. Towards realizing this objective Macleods has established its R&D Centre, manufacturing facilities and a strong marketing team Focus will remain on innovation & production of quality medicines to ensure a predictable and superior response across all patient groups.

PRODUCTS Macleods has been the first in the world to have developed and launched: FORECOX: A four-drug fixed dose combination of RHZE for TB. RABEMAC-DSR : Combination of Rabeprazole plus Domperidone SR tablets) ZITHROX : Azithromycin in Intestinal Transport Modulation (ITM) Technology TRENAXA MF: Combination of Tranexamic Acid and Mefenamic acid for the treatment of Menorrhagia. OMNACORTIL : Prednisolone with BCD CEFOLAC : Cefixime plus Lactic acid bacillus , and many more formulations which have attained leadership in their respective therapeutic categories.

ANTI - DIABETIC Glitage Tablets 15/ 30 Each Uncoated Tablets Contains Pioglitazone Hydrochloride equivalent to Pioglitazone

7

15mg / 30 mg

ANTI - DIARRHOEAL Loperamide HCl tablets 2 mg Each uncoated tablet contains Loperamide Hydrochloride Racedot Sachets 10/30 Each sachet contains Racecadotril Racedot Capsules 100mg Each Hard Gelatin Capsule contains Racecadotril

2 mg

10 mg / 30 mg

100 mg

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ANTIBIOTICS Acudrox 250 / 500 Each film-coated tablet contains Cefadroxil ' equivalent to anhydrous Cefadroxil Cefdinir & Lactobacillus Capsules Each capsule contains Cefdinir Lactic Acid Bacillus Cefdinir with Lactic Acid Bacillus Oral Drops Each ml contains Cefdinir Lactic acid bacillus

Cefolac 50/ 100 / 200 DT Each film-coated tablet contains Cefixime Lactobacillus sporogens

250 /500 mg

300 Mg 60 Million Spores

75 mg 20 million spores

50mg/100mg/200mg 20/40/60 million spores

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Gatimac 200/ 400 Each film-coated tablet contains Gatifloxacin Kefpime 500 / 1 gm / 2gm

200 mg / 400mg 500mg / 1 gm / 2 gm Inj dry

Cefipime powder Levomac 250/500 Each film-coated tablet contains Levofloxacin Hemihydrate equivalent to 250 mg / 500 mg Levofloxacin

Levomac Infusion Each 100 ml contains Levofloxacin Hemihydrate equivalent to 500 mg Levofloxacin Anhydrous Dextrose

5% w/v Water for Injection q.s.

10

Linezolid Tablets 400 mg Each film-coated tablet contains Linezolid Macspar 200/400 Each film coated Tablet contains Sparfloxacin Moximac Each film-coated tablet contains Moxifloxacin Hydrochloride equivalent to

400 mg

200 mg

400 mg Moxifloxacin Oflomac 100 /200/ 400 Each film-coated tablet contains Ofloxacin Ofloxacin IV Each 100 ml Of Injection contains Ofloxacin Sodium Chloride Water for Injection

100 mg / 200 mg /400 mg

200 mg 0.9% w/v qs

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Oflomac TZ Each film-coated tablet contains Ofloxacin Tinidazole

200 mg 600 mg

Spiramycin tablet 3.0 m.i.u. Each film-coated tablet contains Spiramycin Zedocef DT 50 /100 Each dispersible uncoated tablet contains Cefpodoxime proxetil equivalent to Cefpodoxime

3.0 m.i.u.

50 / 100 mg

Zithrox Tablets Each tablet contains 100 mg / 250 mg / Azithromycin 500mg Zithrox Capsules Each hard gelatin capsules contains Azithromycin dihydrate Equivalent to Azithromycin

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250 mg/500 mg

ANTI-HIV PRODUCTS Didanosine dispersible Tablets 200 mg Each dispersible uncoated tablet contains Didanosine Efavirenz tablets 200 mg Each film coated tablet contains Efavirenz Efavirenz solution Each ml Contains Efavirenz Indinavir Capsules 400 mg Each hard Gelatin capsules contains Indinavir sulphate equivalent to Indinavir Lamivudine 150 mg + Stavudine 30 mg Tablets Each uncoated tablet contains Lamivudine Stavudine

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200 mg

200 mg/600mg

30 mg

400 mg

150 mg 30 mg

Primaquine phosphate Tablets Each film coated tablet contains Primaquine phosphate equivalent to Primaquine

7.5 mg/15 mg

Lamivudine, Stavuidne, Nevirapine tablets (LSN 30) Each uncoated tablet contains Lamivudine Stavudine Nevirapine

150 mg 30 mg 200 mg

Nevirapine s'ension (50mg/ 5 ml) Each 5 ml s'ension contains Nevirapine Nelfinavir tablets 250 mg Each film coated tablet contains Nelfinavir Mesylate equivalent to Nelfinavir Stavudine Capsules 15 /20/30/40 Each Hard Gelatin Capsules contains Stavudine Stavudine for oral solution 1 mg/ml Each ml of reconstituted solution contains Stavudine Sulfadoxine & Pyrimethamine Tablets Each uncoated tablet contains Sulfadoxine Pyrimethamine

50mg

250 mg

15 mg/20mg/30mg/40mg

1mg

500 mg 25 mg

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CORTICOSTEROIDS Primacort 100/200/400/500 Each vial contains Hydrocortisone Sodium Succinate (Lyophilized 100 mg/ 200mg / 400 mg buffered) equivalent to Hydrocortisone Omnacortil 5 /10/ 20/ 40 Each Dispersible Tablet Contains Prednisolone

5 mg / 10 mg / 20 mg /40 mg

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Defcort 1 / 6 /30 Each uncoated tablet contains Deflazacort

1 mg / 6 mg /30 mg

Omnacortil Drops Each 5 ml contains Prednisolone Sodium Phosphate equivalent to Prednisolone Omnacortil Syrup Each 5 ml contains Prednisolone Sodium Phosphate equivalent to Prednisolone

CARDIOVASCULARS Amlodipine Besilate and Lisinopril Tablets Each uncoated tablet contains Amlodipine Besilate equivalent to Amlodipine Lisinopril Amlovas LS Tablets Each uncoated tablet contains Losartan potassium Amlodipine besilate ' equivalent to Amlodipine Amlovas AT 25 mg tablets Each uncoated tablet contains Amlodipine Besilate equivalent to Amlodipine Atenolol Clopidogrel and Aspirin Capsules Each Hard Gelatin Capsule contains Clopidogrel hydrogen sulphate equivalent to Clopidogrel (as enteric Coated tablets) Aspirin

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25 mg

5 mg

5 mg 5 mg

50 mg 5 mg

5 mg 25 mg

75mg 150mg

ANTI TUBERCULOSIS DRUGS (FIRST LINE) Forecox Each film coated tablet contains Rifampicin B.P. Isoniazid B.P. Pyrazinamide B.P. Ethambutol HCl B.P. RHE Kit Each Kit contains 1 Rifampicin with Isoniazid Tab.Each flim coated tablet contains Rifampicin B.P. Isoniazid B.P 1 Ethambutol Hydrochloride Tab Each film coated tablet contains Ethambutol HCI B.P. RHE FD Each film coated tablet contains Rifampcin B.P. Isoniazid B.P. Ethambutol HCI B.P.

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225 mg 150 mg 750 mg 400 mg

450 mg 300 mg 800 mg

450 mg 300 mg 800 mg

Ecox 400/800 Each film coated tablet contains Ethambutol HCI B.P. Econex 400/800 Each film coated tablet contains Ethambutol HCI B.P. Isoniazid B.P.

400 mg/800 mg

400 mg/ 800 mg 150 mg/ 300 mg

Macox 150/300 Each film coated tablet contains Rifampicin B.P. Macox Plus 300 Each capsule contains Rifampicin B.P. Isoniazid B.P. Macrozide 400/ 500/ 750 Each uncoated tablet contains Pyrazinamide B.P. Solonex T 50/ 75/ 150 Each film coated tablet contains Thiacetazone

150 mg/ 300 mg

300 mg 200 mg

400 mg/ 500 mg/ 750 mg

50 mg/ 75 mg/ 150 mg 100 mg/ 300 mg / 300

Isoniazid mg Solonex 50/ 100/ 300 Each uncoated tablet contains Isoniazid B.P.

18 50 mg/ 100 mg/ 300 mg

ANTI TUBERCULOSIS DRUGS (SECOND LINE) Protomid Each film coated tablet contains Prothionamide Coxerin Each hard gelatin capsules contains Cycloserine Monopas / Monopas 0.5 Each film coated tablet contains Aminosalicylate Sodium Mycopas granules Each 100 gms enteric coated granules contains Aminosalicylate Sodium Isonaizid B.P. Kanamycin Acid Sulphate Injection 500/750/1 g 19 Each vial contains Kanamycin Acid Sulphate equivalent to Kanamycin base

250 mg

250 mg

1 g /500 mg

80 gms 2.33 gms

0.500 G / 0.750 G / 1 g

Coflox 250/500/750/1000 Each Film Coated Tablet Contains 250 / 500/ 750 / Ciprofloxacin Hydrochloride equivalent to Ciprofloxacin 1000 mg Ethomid Each Film Coated Tablet Contains Ethionamide

250 mg

Levomac 250/500 Each film coated tablet contains Levofloxacin Hemihydrate equivalent to Levofloxacin Moximac Each film coated tablet contains Moxifloxacin Hydrochloride equivalent to Moxifloxacin

250 mg / 500 mg

400 mg

ANTI - OSTEOPOROTICS Alenost 10/35/70 Each uncoated tablet contains: Sodium alendronate ' equivalent to Alendronic 10 mg / 35 mg / 70 mg acid Alfacal 0.25mcg/ 0.5mcg Each soft gelatin capsule contains 0.25 mcg (1a - hydroxy Alphacalcidol Elemental Calcium Bio D3 Each soft gelatin capsule contains Calcitriol Bio D3 Plus Each soft gelatin capsule contains Calcitriol

vitamin D3 ) 200mg

0.25mcg

20

0.25mcg 200mg (1,25 - Dihydroxy -

Elemental Calcium vitamin D3 )

ANTI- MALARIAL PRODUCTS Artesunate suppositories 50 mg Each suppository contains Artesunate Artemether suppositories 40 mg Each suppository contains Artemether Artemether tablets 160 mg Each uncoated tablet contains Artemether Artesunate Tablets 50 mg Each uncoated tablet contains Artesunate Amodiaquine Tablets 153.1 mg Each uncoated tablet contains Amodiaquine Artemether 20 mg + Lumefantrine 120 mg tablets 21 Each uncoated tablet contains Artemether Lumefantrine

50 mg

40 mg

160 mg

50 mg

153.1 mg

20 mg 120 mg

Chloroquine phosphate Tablets Each film coated tablet contains Chloroquine phosphate Chloroquine Mefloquine Tablets Each film coated tablet contains Mefloquine hydrochloride equivalent to Mefloquine Primaquine phosphate Tablets Each film coated tablet contains Primaquine phosphate equivalent to Primaquine 22

250 mg 155 mg

250 mg

7.5 mg/15 mg

Sulfadoxine & Pyrimethamine Tablets Each uncoated tablet contains Sulfadoxine Pyrimethamine

500 mg 25 mg

MANUFACTURING Macleods manufacturing units are located, designed, constructed, adapted and maintained to meet with the guidelines of UK MHRA, US FDA, TGA, MCC & WHO. The two manufacturing sites of Macleods at Palghar and Daman in the vicinity of Mumbai together generate dosage forms which include Tablets, Capsules, Dry Powder for Injection, Granules and Liquids.

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Our facility at Daman has GMP certification from WHO-Geneva, MOH – Belarus, INVIMA – Colombia, National Drugs Authority (NDA) Uganda, Food and Drugs Board (FDB) Ghana, MCAZ – Zimbabwe, Pharmacy and Poisons Board Kenya, Pharmacy Board Tanzania etc. Infrastructure and procedures that support the quality policy are in place. Well documented systems are rigorously implemented and monitored by trained staff working to ensure acceptable product quality.Infrastructure and procedures that support the quality policy are in place. Well documented systems are rigorously implemented and monitored by trained staff working to ensure acceptable product quality. Macleods is committed to ensure that every product it manufactures and distributes meets with internationally accepted standards of quality, purity, efficacy and safety. Quality Assurance and Quality Control systems help ensure a consistently high-quality of the finished dosage forms. Each manufacturing site is well equipped analytical instruments to carry out the tests to conform to various In-house Quality Standards. In-house quality checks, which are detailed in our Standard Operating Procedures (SOP), have been drawn up in addition to the recommendations specified in the US, British & Indian Pharmacopoeias and cGMP guidelines for each of our operations commencing from the raw material audit to in-process checks through finished product release, self audits,

annual

product

reviews,

validation,

Our dosage forms include: Dosage Form

Monthly Capacity

Tablets Capsules Dry Powder for Injection Granules Liquids

15 Million 20 Million 7.5 Million 2500 Kg 1 Million 24

qualification

and

others.

INDIAN BUSINESS Macleods Pharmaceuticals ventured into the Indian market with a mission to provide difficult to manufacture essential drugs. Tuberculosis at that time, was a dreaded disease in India, hence Macleods took a commitment towards providing quality anti-tubercular drugs for the masses. Today Macleods is not only among the leaders in anti-TB range but also leading in various therapeutic segments in the Indian pharmaceuticals Industry with a turnover of Rs. 3 billion ($ 65 million) Macleods has earned a reputation of the fastest growing company* in the Indian Pharmaceutical Industry jumping 26 ranks in 5 years.

Growth of Macleods Year Jan'01 Jan'02 Jan'03 Jan'04 Jan'05

Rank as per ORG IMS 50 37 32 30 24

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Macleods has an enviable growth of 31% compared to the industry growth of 5.7%. In the fiercely competitive market Macleods has a strong presence in various therapeutic segments

Therapeutic segment Anti-TB Second line Anti-TB Corticosteroids Quinolones Hypotensive combinations Cephalosporins Anti peptic ulcerants

Rank 2 1 3 4 7 7 14

At Macleods we believe in building brands. Owing to this Macleods has achieved No.1 position in various molecule segments:

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Brand

Segment 4 Drug (RHEZ) Fixed Drug

Forecox RHE-FD Macox-ZH Oflomac Levomac Cefrine Trenaxa

Combination 3 Drug (RHE) Fixed Drug Combination 2 Drug (ZH) Fixed Drug Combination Ofloxacin Levofloxacin Cefdinir Tranexamic Acid Rabeprazole + Domperidone

Rabemac-DSR Omnacortil Second line Anti-TB

combination Prednisolone

Macleods has a dedicated field force of over 1600 people divided into

4 divisions viz.

Pharma: Pharma division, the largest business unit of Macleods caters to the masses with anti-infective and gastro-intestinal products addressing the needs of General Practitioners, Gastroenterologists, Physicians and Pediatricians. TB-Care: TB-Care is a dedicated business unit to address the emerging needs in the treatment of tuberculosis. Procare: A speciality division focused on chronic care especially cardiology. This division also caters to the gynecology segment. Gencare: Gencare was launched with a purpose to spread healthcare across all generations. Gencare mainly focuses on products catering to the Orthopedicians, Surgeons, Physicians and Pediatricians.

INTERNATIONAL BUSINESS The export range of Macleods are manufactured in a unit that has QSM certification from WHO-Geneva, and approvals from various International Regulatory Authorities like,

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MOH – Belarus, INVIMA – Colombia, National Drugs Authority (NDA) Uganda, Food and Drugs Board (FDB) Ghana, MCAZ – Zimbabwe, Pharmacy and Poisons Board Kenya, Pharmacy Board Tanzania etc. Macleods pursues its International business through various business modules like Private

Markets,

Tenders,

Contract

Manufacturing

and

Joint

Ventures.

In all Private markets Macleods carries out extensive marketing activities through its field force

which

is

ably

supported

and

equipped

with

necessary

recources.

The strong R&D department of over one hundred research personnel is able to develop products as per the specific requirements of customers. The R&D department houses a fully equipped Bioequivalence centre. The R&D department is continuously engaged in developing formulations that are bio-equivalent to innovators. Over the years this department has made significant contributions in furnishing bio-equivalent formulations in the therapeutic categories of HIV AIDS, Tuberculosis, Malaria, Gastroenterology and Orthopedics. The Regulatory Affairs team with a high level of proficiency plays a key role in earning registrations of Macleods products across the globe. In record time Macleods today has over 300 registrations across the globe. Anti-TB

products

contribute

upto

75%

of

the

International

business.

Macloeds has established its Representative office in the CIS countries and has the plans of establishing similar offices in African countries, Latin America and Southeast Asia owing to the business potential and the necessity of being at the centre of action. CIS markets Russia, Ukraine, Kazakhstan, Azarbezan, Kyrgyzstan, Uzbekistan, Belarus

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South East Asia Malaysia, Vietnam, Myanmar, Thailand, Philippines, Srilanka, Hong Kong Africa Ethiopia, Kenya, Ghana, Malawi, Zambia, Tanzania, Ivory Coast, Nigeria Mauritius,Algeria, Sudan, Uganda, Zimbabwe, Mozambique, Botsowana Latin America Peru,

Colombia,

Chile,

Caribbean

Islands,

Venezuela,

Bolivia,

Ecuador

Macleods intends to initiate marketing operations in developed markets with the objective of achieving a critical mass. Macleods is exploring marketing tie-ups with local players in developed markets. Macleods intends to forge strategic business alliance to augment its presence and operations in the US, the UK & the rest of Europe.

QUALITY POLICY Our “Quality” philosophy is a synthesis of World Guidelines, Laws, Regulations and Best Human requirements, which enables us to cater to the best needs of our customers. The “Quality” system at Macleods is so Designed, Documented, Implemented and Controlled which is furnished with Instrumentation, Manpower and Management desire so as to give a guarantee that the products manufactured by the company will be consistent in their intended use with respect to Quality, Purity, Safety, Efficacy and Stability. This “Quality” is mission being complemented by various departments like R&D, Materials, Production, Engineering, Stores, Medical, Marketing, EDP, Quality Control and Quality Assurance.

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Our “Quality” is mandated and supported by executive management and though is coordinated by Quality Assurance, it is responsibility of everyone. It is monitored by a team responsible for Validation, GMP documentation, Self–audits, Training and Market complaints. The ultimate “Quality” goal is achieved by - everyone adhering to Quality policy and Principles.The ultimate “Quality” goal is achieved by - everyone adhering to Quality policy and Principles. Doctors join the medical profession to fulfill their dream to serve humanity. Macleods Pharmaceuticals is a dream come true for a medical doctor, Dr.R.Agarwal, the Managing Director, who had a vision to provide quality health care to humanity. Dr. R. Agarwal incorporated Macleods in 1986 with a mission to spread the wings of health globally. Macleods has a dedicated team of over 2500 personnel who diligently contribute towards the Rs.3 billion (US$ 65 million) turnover of the organization. Today Macleods is a company with world class manufacturing, strong R&D and is amongst the leading pharmaceutical companies in India.

GLOBAL BUSINESS Macleods has its presence in over 30 countries with more than 300 registrations. The export range of Macleods are manufactured in a unit that has QSM approval from WHO-Geneva, and certifications from various International Regulatory Authorities likeMOH – Belarus, INVIMA – Colombia, National Drugs Authority - Uganda, Food and Drugs Board - Ghana, MCAZ – Zimbabwe, Pharmacy and Poisons Board Kenya, Pharmacy Board Tanzania etc

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Owing to a high degree of technological advancements, Macleods offers quality healthcare worldwide.

INDIAN BUSINESS Macleods is a leader in various therapeutic segments in the Indian pharmaceutical Industry. Macleods is amongst the fastest growing pharmaceutical companies in India, jumping 26 ranks in 5 years. Currently Macleods is ranked 24th in the Indian pharmaceutical industry.At Macleods we believe in brand building, the result is attaining No.1 position in as many as 10 molecule segments. Course Objectives At the end of this course, you should be able to: 1. Describe what HSR is and understand the contribution it can make towards solving priority problems in health care within the local context. 2. Prepare a health systems research proposal by completing the following steps: o

Identification, analysis and description of a research problem

o

Review of relevant literature and other available information

o

Formulation of research objectives

o

Development of an appropriate research methodology

o

Preparation of a work plan for the study

o

Identification of resources required and preparation of a budget

o

Development of a strategy for distribution and utilisation of research results

3. Implement this proposal in your own working situation during a period of 4-6 months. 31

4. Analyse and interpret the results. 5. Prepare and present a final report of the research findings, including recommendations for solving the problem and a plan of action for their implementation.

Whom is the health systems research course aimed at? The health systems research (HSR) course has been developed for mid- and higher- level managers, health workers and health-related staff, as well as interested researchers. What training method is used in the HSR course? The training method applied is based on learning by doing. Course participants will themselves develop research proposals that they will actually carry out in the field. Each participant and trainer brings to this course his or her own experiences in applied research and in the management of health or health-related projects. Thus, the course should not be perceived as having a teacher-student orientation. It should rather provide a forum for sharing information where everyone can contribute the benefits of his or her own experience and knowledge. This sharing will add greatly to the richness and relevance of the course. What type of projects will be developed? Together with community leaders and other health decision-makers from the district, provincial or even national level, course participants will select priority problems in their own work situations that cannot be solved unless more information is collected. Preferably, the topics will have been selected before the training starts, although they may need more specification. In most cases, a team of course participants will carry out the

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planned research alongside their regular duties. Therefore, the project will have to be of modest size. For example, a maximum of 30 days for fieldwork and preliminary analysis per group member, and between 4,000 and 8,000 US$ per research project would be advisable. How long is the course? The course, which includes three main components, will cover a period of about 7 months, with an additional fourth component for the implementation of research results over 18-24 months. Thereafter the new activities resulting from the study are supposed to form part of the regular planning. Component 1. HSR proposal development The first 2-3 week workshop will provide an introduction to HSR. If modules 1-4 are implemented in the field with guidance from a facilitator, which we recommend, the proposal development workshop can be limited to two weeks or less. Participants will work in small groups and design research proposals, step by step, on the priority problems they have selected. As each new step is introduced, new concepts and research procedures will be presented. The participants will immediately apply these in the proposals they are developing. Modules 1-18 deal with proposal development. Component 2. Implementation of the proposal During the following 4-6 months, the same groups of participants will implement their proposals. It is therefore important that the groups are composed in such a way that they can easily cooperate during the fieldwork. Modules 19 and 20 give guidelines for the fieldwork and for writing a short fieldwork report - including preliminary results. Component 3. Analysis of the data and report writing

33

After project implementation, participants will meet again for a 2-week workshop to further analyse and interpret the data. At the end of this workshop, a research report with recommendations for action will be prepared and presented to health policy makers, health staff and communities. Modules 21-33 pertain to data analysis, report writing, dissemination of research results and preparing implementation of recommendations based on the findings. Component 4. Development and implementation of action plans Together with the relevant stakeholders, (policy makers, managers, staff, community members), teams will draft action plans to implement the recommendations that are agreed upon. Because many of the participants are in direct positions of managerial responsibility, and because higher-level decision-makers and community members have been involved, it is expected that action plans can be implemented soon after the studies are completed. The proposed activities will normally be integrated in the district, provincial or national health plan and be subjected to regular monitoring and evaluation. How will the research proposal be developed? A number of basic steps have to be taken when developing a research proposal. These steps are presented in the flowchart below. This flowchart appears on the back of each of the pages that mark the beginning of modules 3-18. The step in the proposal development process that the module addresses is indicated by double lines around the appropriate box in the flowchart. Flowchart: Steps in the development of a health systems research proposal NB: Development of a research process is a cyclical process. The double-headed arrows indicate that the process is never linear.

34

It should be stressed that designing a research proposal is not a linear but a cyclical process. Throughout the course there will therefore be opportunities to review and, when the need arises, to revise parts of the proposal that have already been drafted. When developing the research methodology, for example, the teams may find that the objectives and even the statement of the problem need to be revised to be made more specific. When finalising the work plan and budget, the teams may determine that the research design, for financial reasons, may need to be revised so the project is more modest and thus less costly. By the end of the first part of the course, each group will have developed a research proposal with the following chapters: Executive Summary 1. Introduction 1.1 Background information 1.2 Statement of the problem 1.3 Literature review 2. Objectives 3. Methodology 3.1 Study type, variables, data collection techniques 3.2 Sampling 3.3 Plan for data collection 3.4 Plan for data processing and analysis 3.5 Ethical considerations 3.6 Pre-test

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4. Work Plan (including description of project staff) 5. Budget (including explanatory note on major budget posts) 6. Plan For Administration, Monitoring, And Utilization Of Results References List of abbreviations Data collection instruments In the second workshop for data analysis and report writing, a similar approach will be followed. How may this set of modules be used? The course has been organised in such a way that each module can be dealt with independently. A module includes: •

A presentation of the necessary theory and concepts to enable the participants to carry out this specific step in proposal development or data analysis and report writing. Presentations last between 30 minutes and an hour and include opportunity for questions and discussion.

•

Group work during which groups, with assistance of their facilitator, utilise these concepts in the development of their proposal or in data analysis and report writing. The modules for proposal development, in particular, contain detailed instructions for group work. Group work may last from 1-4 hours per module, and sometimes longer.

•

Reporting of the results of the group work in plenary by a member of each group, so that other groups and facilitators can comment. Plenaries are of crucial importance during the first workshop. During the data analysis workshop they are

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less frequent as not all modules are relevant for all groups. On the average, each group has 15 minutes for presentation and discussion, but for important topics this may be 30 minutes. •

Sometimes a module contains an exercise, either using examples provided during the presentation or using the group work results of other groups.

Depending on the level of the groups, it may be possible to combine certain modules and to shorten or lengthen the time allocated for presentations and group work and the total workshop time. For programme managers, for example, one week may be sufficient to prepare a first draft of a research proposal. Provincial and district level staff with some research experience may need 2 weeks, whereas novices to research will need the full 2 ½ weeks. Note: Participants are advised to read the course materials beforehand so that they can benefit, as much as possible, from the presentations and group work. It may be extremely useful for the participants to read the course material after the presentation and group work as well, especially if they have had no previous research training or experience. Trainer’s Notes Module 1: Course Orientation Timing and training methods 1-1½ hours

Personal introductions of participants and facilitators

¾ -1 hour

Course orientation

½ hour

Administrative remarks

1-2½ hours

Total Time

Materials

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Name tags for participants and trainers

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Flipcharts and markers

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Course training materials for participants

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Overhead sheets for presentation

Personal introduction of participants and facilitators If you were unable to do the mutual introduction of participants on the evening before the course begins, have all the participants introduce themselves. Make certain everyone indicates his or her profession, major activities and research experiences and interests. This may be done by having participants interview each other in pairs and then each introduces the person he or she interviewed. Names and a summary of the interview could be put on a flipchart and stuck to the wall. The introduction may take 1 - 1½ hours. Course orientation •

Present the major objectives of the course and stress its practical orientation. It should be clear to all participants that they will each work as part of a small group to develop a research proposal which they themselves will carry out.

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Emphasise the uniqueness of each participant’s background and experience, pointing out how important it will be for everyone to contribute to the development of the proposal and to learn from each other.

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Distribute the course-training document to the participants. Describe how the course will be structured and how the training document will be used. Show the flowchart that appears at the beginning of each module.

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