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, anti-

inflammatory 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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http://www.macleodspharma.com/rd.htm#link4




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

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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)

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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 15mg / 30 mg

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ANTI - DIARRHOEAL

Loperamide HCl tablets 2 mg

Each uncoated tablet contains

Loperamide Hydrochloride 2 mg

Racedot Sachets 10/30

Each sachet contains

Racecadotril 10 mg / 30 mg

Racedot Capsules 100mg

Each Hard Gelatin Capsule contains

Racecadotril 100 mg

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ANTIBIOTICS

Acudrox 250 / 500

Each film-coated tablet contains

Cefadroxil ' equivalent to anhydrous Cefadroxil 250 /500 mg

Cefdinir & Lactobacillus Capsules

Each capsule contains

Cefdinir 300 Mg

Lactic Acid Bacillus 60 Million Spores

Cefdinir with Lactic Acid Bacillus Oral Drops

Each ml contains

Cefdinir 75 mg

Lactic acid bacillus 20 million spores

Cefolac 50/ 100 / 200 DT


Cefixime 50mg/100mg/200mg

Lactobacillus sporogens 20/40/60 million spores

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Gatimac 200/ 400


Gatifloxacin 200 mg / 400mg

Kefpime 500 / 1 gm / 2gm

Cefipime 500mg / 1 gm / 2 gm Inj dry

powder

Levomac 250/500


Levofloxacin Hemihydrate equivalent to

Levofloxacin 250 mg / 500 mg

Levomac Infusion

Each 100 ml contains

Levofloxacin Hemihydrate equivalent to

Levofloxacin 500 mg

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

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Linezolid Tablets 400 mg


Linezolid 400 mg

Macspar 200/400

Each film coated Tablet contains

Sparfloxacin 200 mg

Moximac


Moxifloxacin Hydrochloride equivalent to

Moxifloxacin 400 mg

Oflomac 100 /200/ 400


Ofloxacin 100 mg / 200 mg /400 mg

Ofloxacin IV

Each 100 ml Of Injection contains

Ofloxacin 200 mg

Sodium Chloride 0.9% w/v

Water for Injection qs

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Oflomac TZ


Ofloxacin 200 mg

Tinidazole 600 mg

Spiramycin tablet 3.0 m.i.u.


Spiramycin 3.0 m.i.u.

Zedocef DT 50 /100

Each dispersible uncoated tablet contains

Cefpodoxime proxetil equivalent to Cefpodoxime 50 / 100 mg

Zithrox Tablets

Each tablet contains

Azithromycin 100 mg / 250 mg /

500mg

Zithrox Capsules

Each hard gelatin capsules contains

Azithromycin dihydrate Equivalent to Azithromycin 250 mg/500 mg

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ANTI-HIV PRODUCTS

Didanosine dispersible Tablets 200 mg

Each dispersible uncoated tablet contains

Didanosine 200 mg

Efavirenz tablets 200 mg

Each film coated tablet contains

Efavirenz 200 mg/600mg

Efavirenz solution

Each ml Contains

Efavirenz 30 mg

Indinavir Capsules 400 mg

Each hard Gelatin capsules contains

Indinavir sulphate equivalent to Indinavir 400 mg

Lamivudine 150 mg + Stavudine 30 mg Tablets


Lamivudine 150 mg

Stavudine 30 mg

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Primaquine phosphate Tablets


Primaquine phosphate equivalent to Primaquine 7.5 mg/15 mg

Lamivudine, Stavuidne, Nevirapine tablets (LSN 30)


Lamivudine 150 mg

Stavudine 30 mg

Nevirapine 200 mg

Nevirapine s'ension (50mg/ 5 ml)

Each 5 ml s'ension contains

Nevirapine 50mg

Nelfinavir tablets 250 mg


Nelfinavir Mesylate equivalent to Nelfinavir 250 mg

Stavudine Capsules 15 /20/30/40

Each Hard Gelatin Capsules contains

Stavudine 15 mg/20mg/30mg/40mg

Stavudine for oral solution 1 mg/ml

Each ml of reconstituted solution contains

Stavudine 1mg

Sulfadoxine & Pyrimethamine Tablets


Sulfadoxine 500 mg

Pyrimethamine 25 mg

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CORTICOSTEROIDS

Primacort 100/200/400/500

Each vial contains

Hydrocortisone Sodium Succinate (Lyophilized

buffered) equivalent to Hydrocortisone 100 mg/ 200mg / 400 mg

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


Deflazacort 1 mg / 6 mg /30 mg

Omnacortil Drops

Each 5 ml contains

Prednisolone Sodium Phosphate equivalent to Prednisolone 25 mg

Omnacortil Syrup

Each 5 ml contains

Prednisolone Sodium Phosphate equivalent to Prednisolone 5 mg

CARDIOVASCULARS

Amlodipine Besilate and Lisinopril Tablets


Amlodipine Besilate equivalent to Amlodipine 5 mg

Lisinopril 5 mg

Amlovas LS Tablets


Losartan potassium 50 mg

Amlodipine besilate ' equivalent to Amlodipine 5 mg

Amlovas AT 25 mg tablets


Amlodipine Besilate equivalent to Amlodipine 5 mg

Atenolol 25 mg

Clopidogrel and Aspirin Capsules

Each Hard Gelatin Capsule contains

Clopidogrel hydrogen sulphate equivalent to Clopidogrel 75mg

(as enteric Coated tablets)

Aspirin 150mg

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ANTI TUBERCULOSIS DRUGS (FIRST LINE)

Forecox


Rifampicin B.P. 225 mg

Isoniazid B.P. 150 mg

Pyrazinamide B.P. 750 mg

Ethambutol HCl B.P. 400 mg

RHE Kit

Each Kit contains

1 Rifampicin with Isoniazid Tab.Each flim coated tablet contains


Isoniazid B.P 300 mg

1 Ethambutol Hydrochloride Tab Each film coated tablet contains

Ethambutol HCI B.P. 800 mg

RHE FD


Rifampcin B.P. 450 mg


Ethambutol HCI B.P. 800 mg

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Ecox 400/800


Ethambutol HCI B.P. 400 mg/800 mg

Econex 400/800


Ethambutol HCI B.P. 400 mg/ 800 mg

Isoniazid B.P. 150 mg/ 300 mg

Macox 150/300


Rifampicin B.P. 150 mg/ 300 mg

Macox Plus 300

Each capsule contains



Macrozide 400/ 500/ 750


Pyrazinamide B.P. 400 mg/ 500 mg/ 750 mg

Solonex T 50/ 75/ 150


Thiacetazone 50 mg/ 75 mg/ 150 mg

Isoniazid 100 mg/ 300 mg / 300

mg

Solonex 50/ 100/ 300


Isoniazid B.P. 50 mg/ 100 mg/ 300 mg

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ANTI TUBERCULOSIS DRUGS (SECOND LINE)

Protomid


Prothionamide 250 mg

Coxerin

Each hard gelatin capsules contains

Cycloserine 250 mg

Monopas / Monopas 0.5


Aminosalicylate Sodium 1 g /500 mg

Mycopas granules

Each 100 gms enteric coated granules contains

Aminosalicylate Sodium 80 gms

Isonaizid B.P. 2.33 gms

Kanamycin Acid Sulphate Injection 500/750/1 g

Each vial contains

Kanamycin Acid Sulphate equivalent to Kanamycin base 0.500 G / 0.750 G / 1 g

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Coflox 250/500/750/1000

Each Film Coated Tablet Contains

Ciprofloxacin Hydrochloride equivalent to Ciprofloxacin 250 / 500/ 750 /

1000 mg

Ethomid

Each Film Coated Tablet Contains

Ethionamide 250 mg

Levomac 250/500


Levofloxacin Hemihydrate equivalent to Levofloxacin 250 mg / 500 mg

Moximac


Moxifloxacin Hydrochloride equivalent to Moxifloxacin 400 mg

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ANTI - OSTEOPOROTICS

Alenost 10/35/70

Each uncoated tablet contains:

Sodium alendronate ' equivalent to Alendronic

acid 10 mg / 35 mg / 70 mg

Alfacal 0.25mcg/ 0.5mcg

Each soft gelatin capsule contains

Alphacalcidol 0.25 mcg (1a - hydroxy -

vitamin D3 )

Elemental Calcium 200mg

Bio D3


Calcitriol 0.25mcg

Bio D3 Plus


Calcitriol 0.25mcg

Elemental Calcium 200mg (1,25 - Dihydroxy -

vitamin D3 )

ANTI- MALARIAL PRODUCTS

Artesunate suppositories 50 mg

Each suppository contains

Artesunate 50 mg

Artemether suppositories 40 mg

Each suppository contains

Artemether 40 mg

Artemether tablets 160 mg


Artemether 160 mg

Artesunate Tablets 50 mg


Artesunate 50 mg

Amodiaquine Tablets 153.1 mg


Amodiaquine 153.1 mg

Artemether 20 mg + Lumefantrine 120 mg tablets


Artemether 20 mg

Lumefantrine 120 mg

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Chloroquine phosphate Tablets


Chloroquine phosphate 250 mg

Chloroquine 155 mg

Mefloquine Tablets


Mefloquine hydrochloride equivalent to Mefloquine 250 mg

Primaquine phosphate Tablets


Primaquine phosphate equivalent to Primaquine 7.5 mg/15 mg

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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

Sulfadoxine & Pyrimethamine Tablets


Sulfadoxine 500 mg

Pyrimethamine 25 mg

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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.

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, qualification and others.

Our dosage forms include:

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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.

Dosage Form Monthly Capacity

Tablets 15 Million

Capsules 20 Million

Dry Powder for Injection 7.5 Million

Granules 2500 Kg

Liquids 1 Million

Growth of Macleods

Year Rank as per ORG IMS

Jan'01 50

Jan'02 37

Jan'03 32

Jan'04 30

Jan'05 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 Rank

Anti-TB 2

Second line Anti-TB 1

Corticosteroids 3

Quinolones 4

Hypotensive combinations 7

Cephalosporins 7

Anti peptic ulcerants 14

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At Macleods we believe in building brands. Owing to this Macleods has achieved No.1

position in various molecule segments:

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.

Brand Segment

Forecox 4 Drug (RHEZ) Fixed Drug

Combination

RHE-FD 3 Drug (RHE) Fixed Drug Combination

Macox-ZH 2 Drug (ZH) Fixed Drug Combination

Oflomac Ofloxacin

Levomac Levofloxacin

Cefrine Cefdinir

Trenaxa Tranexamic Acid

Rabemac-DSR Rabeprazole + Domperidone

combination

Omnacortil Prednisolone

Second line Anti-TB

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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,

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.

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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

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.

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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.

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.

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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 like-

MOH – Belarus, INVIMA – Colombia, National Drugs Authority - Uganda, Food and

Drugs Board - Ghana, MCAZ – Zimbabwe, Pharmacy and Poisons Board Kenya,

Pharmacy Board Tanzania etc

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

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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.

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

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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 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

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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

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.

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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.

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

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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

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

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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

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

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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

Name tags for participants and trainers

Flipcharts and markers

Course training materials for participants

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

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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.

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.

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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Orientation Report

Documents

macleods r d centre

years macleods

development of bulk

r d facility

marketing efforts of

macleods lot of breakthroughs

bioequivalence studies

niche pharmaceutical