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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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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
Each film-coated tablet contains
Cefixime 50mg/100mg/200mg
Lactobacillus sporogens 20/40/60 million spores
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Gatimac 200/ 400
Each film-coated tablet contains
Gatifloxacin 200 mg / 400mg
Kefpime 500 / 1 gm / 2gm
Cefipime 500mg / 1 gm / 2 gm Inj dry
powder
Levomac 250/500
Each film-coated tablet contains
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
Each film-coated tablet contains
Linezolid 400 mg
Macspar 200/400
Each film coated Tablet contains
Sparfloxacin 200 mg
Moximac
Each film-coated tablet contains
Moxifloxacin Hydrochloride equivalent to
Moxifloxacin 400 mg
Oflomac 100 /200/ 400
Each film-coated tablet contains
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
Each film-coated tablet contains
Ofloxacin 200 mg
Tinidazole 600 mg
Spiramycin tablet 3.0 m.i.u.
Each film-coated tablet contains
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
Each uncoated tablet contains
Lamivudine 150 mg
Stavudine 30 mg
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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 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
Each film coated tablet contains
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
Each uncoated tablet contains
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
Each uncoated tablet contains
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
Each uncoated tablet contains
Amlodipine Besilate equivalent to Amlodipine 5 mg
Lisinopril 5 mg
Amlovas LS Tablets
Each uncoated tablet contains
Losartan potassium 50 mg
Amlodipine besilate ' equivalent to Amlodipine 5 mg
Amlovas AT 25 mg tablets
Each uncoated tablet contains
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
Each film coated tablet contains
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
Rifampicin B.P. 450 mg
Isoniazid B.P 300 mg
1 Ethambutol Hydrochloride Tab Each film coated tablet contains
Ethambutol HCI B.P. 800 mg
RHE FD
Each film coated tablet contains
Rifampcin B.P. 450 mg
Isoniazid B.P. 300 mg
Ethambutol HCI B.P. 800 mg
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Ecox 400/800
Each film coated tablet contains
Ethambutol HCI B.P. 400 mg/800 mg
Econex 400/800
Each film coated tablet contains
Ethambutol HCI B.P. 400 mg/ 800 mg
Isoniazid B.P. 150 mg/ 300 mg
Macox 150/300
Each film coated tablet contains
Rifampicin B.P. 150 mg/ 300 mg
Macox Plus 300
Each capsule contains
Rifampicin B.P. 300 mg
Isoniazid B.P. 200 mg
Macrozide 400/ 500/ 750
Each uncoated tablet contains
Pyrazinamide B.P. 400 mg/ 500 mg/ 750 mg
Solonex T 50/ 75/ 150
Each film coated tablet contains
Thiacetazone 50 mg/ 75 mg/ 150 mg
Isoniazid 100 mg/ 300 mg / 300
mg
Solonex 50/ 100/ 300
Each uncoated tablet contains
Isoniazid B.P. 50 mg/ 100 mg/ 300 mg
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ANTI TUBERCULOSIS DRUGS (SECOND LINE)
Protomid
Each film coated tablet contains
Prothionamide 250 mg
Coxerin
Each hard gelatin capsules contains
Cycloserine 250 mg
Monopas / Monopas 0.5
Each film coated tablet contains
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
Each film coated tablet contains
Levofloxacin Hemihydrate equivalent to Levofloxacin 250 mg / 500 mg
Moximac
Each film coated tablet contains
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
Each soft gelatin capsule contains
Calcitriol 0.25mcg
Bio D3 Plus
Each soft gelatin capsule contains
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
Each uncoated tablet contains
Artemether 160 mg
Artesunate Tablets 50 mg
Each uncoated tablet contains
Artesunate 50 mg
Amodiaquine Tablets 153.1 mg
Each uncoated tablet contains
Amodiaquine 153.1 mg
Artemether 20 mg + Lumefantrine 120 mg tablets
Each uncoated tablet contains
Artemether 20 mg
Lumefantrine 120 mg
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Chloroquine phosphate Tablets
Each film coated tablet contains
Chloroquine phosphate 250 mg
Chloroquine 155 mg
Mefloquine Tablets
Each film coated tablet contains
Mefloquine hydrochloride equivalent to Mefloquine 250 mg
Primaquine phosphate Tablets
Each film coated tablet contains
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
Each uncoated tablet contains
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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