Orientation Report
Orientation Report
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
health care to the masters, specially the essential and difficult to manufacture drugs.
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.
A strong R&D team consisting of over 120 extremely diligent and committed scientists
are bio-equivalent to innovators and designed to offer increased efficacy through newer
At Macleods lot of breakthroughs have occurred and milestones been achieved sine year
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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
All in all, in the last 5years Macleods has carried out 40 clinical trial studies and 40
bioequivalence studies.
• To develop and transfer technology for Novel drug Delivery Systems (NDDS)
• To develop formulations for export markets; Generics for regulated markets and
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
Macleods is the first in the world to have developed sustained release granules of
The Analytical Method Development department supports all the developmental work
Development.
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:
Impurity profile
Dissoution
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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
Method validation and stability studies are carried out as per ICH guidelines.
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
• 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
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
personnel.
The bio-equivalence study center operates as per the well-established quality system
and equipments in the facility. The center will be conducting activities such as –
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HUMAN RESOURCES
HR Vision
and internalizing latest HR practices, methods and techniques to remain at par with
HR Mission
base.
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
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
PRODUCTS
Macleods has been the first in the world to have developed and launched:
TRENAXA MF: Combination of Tranexamic Acid and Mefenamic acid for the
treatment of Menorrhagia.
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
Levomac Infusion
Each 100 ml contains
Levofloxacin Hemihydrate equivalent to
500 mg
Levofloxacin
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
400 mg
Moxifloxacin
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
Zithrox Tablets
Each tablet contains
100 mg / 250 mg /
Azithromycin
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
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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 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
100 mg/ 300 mg / 300
Isoniazid
mg
Solonex 50/ 100/ 300
Each uncoated tablet contains 18
Isoniazid B.P. 50 mg/ 100 mg/ 300 mg
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
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Each vial contains
Kanamycin Acid Sulphate equivalent to Kanamycin base 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 250 mg / 500 mg
Moximac
Each film coated tablet contains
Moxifloxacin Hydrochloride equivalent to Moxifloxacin 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
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
20
200mg (1,25 - Dihydroxy -
Elemental Calcium
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 21
Artemether 20 mg
Lumefantrine 120 mg
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
22 7.5 mg/15 mg
Sulfadoxine & Pyrimethamine Tablets
Each uncoated tablet contains
Sulfadoxine 500 mg
Pyrimethamine 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
together generate dosage forms which include Tablets, Capsules, Dry Powder for
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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
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
Macleods is committed to ensure that every product it manufactures and distributes meets
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
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
Today Macleods is not only among the leaders in anti-TB range but also leading in
Macleods has earned a reputation of the fastest growing company* in the Indian
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
At Macleods we believe in building brands. Owing to this Macleods has achieved No.1
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Brand Segment
4 Drug (RHEZ) Fixed Drug
Forecox Macleods
Combination
RHE-FD 3 Drug (RHE) Fixed Drug Combination has a
Macox-ZH 2 Drug (ZH) Fixed Drug Combination
Oflomac Ofloxacin dedicated
Levomac Levofloxacin
Cefrine Cefdinir field force
Trenaxa Tranexamic Acid
of over
Rabeprazole + Domperidone
Rabemac-DSR
combination 1600 people
Omnacortil Prednisolone
divided into
Second line Anti-TB
4 divisions viz.
Pharma: Pharma division, the largest business unit of Macleods caters to the masses
TB-Care: TB-Care is a dedicated business unit to address the emerging needs in the
treatment of tuberculosis.
Gencare: Gencare was launched with a purpose to spread healthcare across all
INTERNATIONAL BUSINESS
The export range of Macleods are manufactured in a unit that has QSM certification from
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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
Macleods pursues its International business through various business modules like
In all Private markets Macleods carries out extensive marketing activities through its field
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
developing formulations that are bio-equivalent to innovators. Over the years this
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
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
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South East Asia
Africa
Latin America
objective of achieving a critical mass. Macleods is exploring marketing tie-ups with local
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.
consistent in their intended use with respect to Quality, Purity, Safety, Efficacy and
Stability.
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Our “Quality” is mandated and supported by executive management and though is
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
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
Today Macleods is a company with world class manufacturing, strong R&D and is
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
MOH – Belarus, INVIMA – Colombia, National Drugs Authority - Uganda, Food and
Drugs Board - Ghana, MCAZ – Zimbabwe, Pharmacy and Poisons Board Kenya,
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Owing to a high degree of technological advancements, Macleods offers quality
healthcare worldwide.
INDIAN BUSINESS
Course Objectives
1. Describe what HSR is and understand the contribution it can make towards
results
3. Implement this proposal in your own working situation during a period of 4-6
months.
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4. Analyse and interpret the results.
recommendations for solving the problem and a plan of action for their
implementation.
The health systems research (HSR) course has been developed for mid- and higher- level
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
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
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.
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
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.
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.
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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,
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
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.
A number of basic steps have to be taken when developing a research proposal. These
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
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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
Executive Summary
1. Introduction
2. Objectives
3. Methodology
3.2 Sampling
3.6 Pre-test
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4. Work Plan (including description of project staff)
References
List of abbreviations
In the second workshop for data analysis and report writing, a similar approach will be
followed.
The course has been organised in such a way that each module can be dealt with
carry out this specific step in proposal development or data analysis and report
• Group work during which groups, with assistance of their facilitator, utilise these
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.
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
Materials
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• Name tags for participants and trainers
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
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
course will be structured and how the training document will be used. Show the
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