Professional Documents
Culture Documents
Perception of New Medicine Among Gynaecologists
Perception of New Medicine Among Gynaecologists
SUBMITTED BY:
YASHI VAJPEYI
It is a pleasure to record my thanks and gratitude to persons whose generous help and
support enabled me to complete this project within the stipulated time period. I feel indebted
and place my special thanks to Mr. C. Ganeshan, Marketing Manager of Micro Labs,
Bangalore for his active guidance and support from time to time during the training and
project.
I would also like to place my sincere thanks to Mr. D.V Dixit and Mrs. Monica for providing
me the required inputs for the completion of the project and always being there whenever
required. I would also like to thank other staff members of the organization for their
generous help.
I am also thankful to my faculty mentor Mr. Somil Mishra, for guiding me throughout the
summer internship project. I am also thankful to the Library and Computer lab staff of the
Institute, who provided great help.
My family and friends also deserve the praise for all their help, support, interest and valuable
suggestions.
Lastly I cannot forget the generous people of Bangalore without whom the project would not
have been a success.
Yashi Vajpeyi
CONTENTS
1. Preface
4. Understanding Blood
5. What is anaemia?
7. Research Objective
8. Research Methodology
10.Suggestions
11.Limitations
INDIAN PHARMACEUTICAL INDUSTRY
“The Indian pharmaceutical industry is a success story providing employment for millions
and ensuring that essential drugs at affordable prices are available to the vast population of
this sub-continent.”
Richard Gerster
The Indian Pharmaceutical Industry today is in the front rank of India’s science-based
industries with wide ranging capabilities in the complex field of drug manufacture and
technology. A highly organized sector, the Indian Pharma Industry is estimated to be worth $
4.5 billion, growing at about 8 to 9 percent annually. It ranks very high in the third world, in
terms of technology, quality and range of medicines manufactured. From simple headache
pills to sophisticated antibiotics and complex cardiac compounds, almost every type of
medicine is now made indigenously.
Playing a key role in promoting and sustaining development in the vital field of medicines,
Indian Pharma Industry boasts of quality producers and many units approved by regulatory
authorities in USA and UK. International companies associated with this sector have
stimulated, assisted and spearheaded this dynamic development in the past 53 years and
helped to put India on the pharmaceutical map of the world.
The Indian Pharmaceutical sector is highly fragmented with more than 20,000 registered
units. It has expanded drastically in the last two decades. The leading 250 pharmaceutical
companies control 70% of the market with market leader holding nearly 7% of the market
share. It is an extremely fragmented market with severe price competition and government
price control.
The pharmaceutical industry in India meets around 70% of the country's demand for bulk
drugs, drug intermediates, pharmaceutical formulations, chemicals, tablets, capsules, orals
and injectibles. There are about 250 large units and about 8000 Small Scale Units, which
form the core of the pharmaceutical industry in India (including 5 Central Public Sector
Units). These units produce the complete range of pharmaceutical formulations, i.e.,
medicines ready for consumption by patients and about 350 bulk drugs, i.e., chemicals
having therapeutic value and used for production of pharmaceutical formulations.
Following the de-licensing of the pharmaceutical industry, industrial licensing for most of
the drugs and pharmaceutical products has been done away with. Manufacturers are free to
produce any drug duly approved by the Drug Control Authority. Technologically strong and
totally self-reliant, the pharmaceutical industry in India has low costs of production, low
R&D costs, innovative scientific manpower, strength of national laboratories and an
increasing balance of trade. The Pharmaceutical Industry, with its rich scientific talents and
research capabilities, supported by Intellectual Property Protection regime is well set to take
on the international market.
The pharmaceutical market intelligence company, ORG IMS, says that the Indian
pharmaceutical industry is expected to see high growth this year, as it is the world’s second
largest pharmaceutical market by volume and consumption, as reported by Pharmaceutical
online.
Further, the Indian pharmaceutical market surged 13% last year while it grew 14.80% in the
fiscal 2008, with the domestic market reached Rs 32,095 Crore. Tier II cities with total
population below 100,000 along with rural areas represent 40% of the market, and are
anticipated to see faster growth than the rest of the country.
The Indian pharmaceutical industry is expected to grow on account of rising volume of the
industry and launch of new products. Moreover, both domestic and export segments of the
industry are rapidly expanding owing to the strong domestic pharmaceutical market which is
supported by large population base of more than one billion and booming Indian economy.
Further, India is a preferred destination for contract services in the field of research and
manufacturing as it has skilled manpower and efficient manufacturing capability, low
operation costs and a large number of USFDA approved plants. In addition, the
pharmaceutical industry is getting strong support from various facilities provided by
domestic service providers, such as Active Pharmaceutical Ingredient (API) manufacturing,
basic research and clinical research.
Moreover, the value of prevalent diseases is likely to scale up with rising population and
urbanization in coming years. The Indian pharma industry has a critical role in the growth of
global pharmaceutical industry as both domestic and MNCs are greatly benefited.
The Indian pharmaceutical companies are performing quite well overseas, partly on account
of depreciation in the Indian rupee. Despite this, the return from pharma industry depends on
the market growth. In face of weak rupee and high inflation and interest rates, the overall
industry is anticipated to be range-bound for a short period of time.
According to a Research Analyst at RNCOS, “Investors in the Indian pharmaceutical
industry are under intense pressure though exports are increasing and domestic market is
expected to grow well. If decline in rupee continues, it will boost the earning of the industry
players. Under such conditions, the pharma sector, a defensive and under-owned sector, is
expected to outperform the broad market.”
ADVANTAGE INDIA
Competent workforce: India has a pool of personnel with high managerial and technical
competence as also skilled workforce. It has an educated work force and English is
commonly used. Professional services are easily available.
Cost-effective chemical synthesis: Its track record of development, particularly in the area
of improved cost-beneficial chemical synthesis for various drug molecules is excellent. It
provides a wide variety of bulk drugs and exports sophisticated bulk drugs.
Legal & Financial Framework: India has a 60 year old democracy and hence has a solid
legal framework and strong financial markets. There is already an established international
industry and business community.
Consolidation: For the first time in many years, the international pharmaceutical industry is
finding great opportunities in India. The process of consolidation, which has become a
generalized phenomenon in the world pharmaceutical industry, has started taking place in
India. Pharma MNCs turn to India for cost management. If you can’t beat them, collaborate
with them. That seems to be the latest buzz in the global pharmaceutical industry. It is the
larger Indian companies that first set the trend in the last decade, with Ranbaxy-Eli Lilly and
Lupin-Cynamid signing among the first major contract manufacturing deals in the country.
Now, as the pie is getting bigger, other, smaller companies are getting into the fray. Some of
the MNC activity in India are :
• Novartis AG seeking tie ups with Indian companies.
• Bristol Mayers to enter India again
• Pfizer India doubles research investment in India
SWOT Analysis
It is often said that the pharma sector has no cyclical factor attached to it. Irrespective of
whether the economy is in a downturn or in an upturn, the general belief is that demand for
drugs is likely to grow steadily over the long-term.
Strengths:
1. India with a population of over a billion is a largely untapped market. To put things
in perspective, per capita expenditure on health care in India is US$ 93 while the
same for countries like Brazil is US$ 453 and Malaysia US$189.
2. The growth of middle class in the country has resulted in fast changing lifestyles in
urban and to some extent rural centers. This opens a huge market for lifestyle drugs,
which has a very low contribution in the Indian markets.
3. Indian manufacturers are one of the lowest cost producers of drugs in the world. With
a scalable labor force, Indian manufactures can produce drugs at 40% to 50% of the
cost to the rest of the world.
2. Indian pharma sector has been marred by lack of product patent, which prevents
global pharma companies to introduce new drugs in the country and discourages
innovation and drug discovery.
3. Due to very low barriers to entry, Indian pharma industry is highly fragmented. This
makes Indian pharma market increasingly competitive. The industry witnesses price
competition, which reduces the growth of the industry in value term.
Opportunities:
1. The migration into a product patent based regime is likely to transform industry
fortunes in the long term. The new product patent regime will bring with it new
innovative drugs.
2. Large number of drugs going off-patent in Europe and in the US during 2005 - 2009
offers a big opportunity for the Indian companies to capture this market. Since
generic drugs are commodities by nature, Indian producers have the competitive
advantage, as they are the lowest cost producers of drugs in the world.
3. Being the lowest cost producer combined with FDA approved plants; Indian
companies can become a global outsourcing hub for pharmaceutical products.
Threats:
1. Threats from other low cost countries like China and Israel exist. However, on the
quality front, India is better placed relative to China.
2. The short-term threat for the pharma industry is the implementation of VAT. Though
this is likely to have a negative impact in the short-term, the implications over the
long-term are positive for the industry.
The deciding factors for profitable growth and survival of this industry will be
Headquarters- Bengaluru
Key People- Mr. Dilip Surana (Managing Director) and Mr. Anand Surana (Director)
Industry-Pharmaceuticals
Micro Labs is one of the leading pharmaceutical companies in India, rated the
15 t h largest in India as per ORG-IMS study as on March 2006. The company was
started in 1973 by Mr. G. C. Surana a visionary entrepreneur.
Micro Labs began to expand in the early eighties when increased thrust was given to the
branded prescription market. Greatly encouraged by the wide acceptance and positive market
response, the company expanded its products range to various other more vital segments like
cardiovascular, psychotropic, neurological, anti diabetic, gynecological, gastro-enterological,
dermatological, ophthalmologic and veterinary products.
The company later became a multi-divisional group to suit changing market trends and
customer profiles. In 2002 Micro Labs acquired EROS Pharma a Bangalore-based
formulations company. Micro Labs has 10 overseas offices, 12 formulation manufacturing
plants, a strong distribution network and about 5000 plus dedicated employees.
Being one of the leading Indian healthcare providers in India, we aim to be a prominent
pharmaceutical player in regulated and non-regulated markets across the globe. Our vision
is to be among the top 10 pharmaceutical companies in India by 2010.
Business Objectives:
Quality Objectives:
The driving factors at the MICRO group are their core values:
• Strategic Partnerships
• Quality and Service
• Transparency in conduct at all times
• Innovation to provide added value to customers
• Committed employees to make a difference
Their core values are based on respect for people, integrity, networking, diversity,
creativity, empowerment and customer care.
Group Foray:
The Micro Group’s success in India has opened up new vistas and given them new wings.
While providing quality healthcare solutions to Asia and most other Eastern countries, the
company is forging ahead in areas like Latin America and Eastern Europe. The group is
currently operational in the Asian, European, Latin American and African continents.
Highlights:
• Presence in 50 countries
• Exporting all major dosage forms in every therapeutic segment
• Corporate offices in ten countries including UK, Thailand, Russia, Vietnam &
Ukraine
• Independent marketing operations with fullfledged sales teams
• Focus on ethical promotion (brand building) - sale of branded Generic drugs
• Strategic marketing alliances with local transnational marketing companies
• Site/plant approvals from Health Canada (PICS countries)
• Approved by the MCC South Africa, Health Canada and UK MHRA
Micro Labs manufactures and markets a wide range of products for a wide range of
therapies and age groups. With over 300 widely accepted brands under its label and
many more in the pipeline, Micro Labs is clearly set to lead the pharma revolution
in the years to come.
Therapy Areas:
• Cardio vascular
• Gynaecology
• Gastroenterology
• Dermatology
• Ophthalmology
• Neuro psychiatry
• Anti diabetic
• Antimicrobials
• Antiseptics
• Nutraceticals
• Analgesics/Antipyretics
• Anti malarials and more
Understanding blood
Blood is a fluid connective tissue
• In an average healthy adult, the volume of blood is one-eleventh of the body weight,
or between 4.5 and 6 liters.
• Blood is about 55% plasma and 45% cells
Red blood cells
Haemoglobin
• Part of the immune system and defend the body from infection.
Platelets
What is Anaemia?
Anaemia means reduction in oxygen carrying capacity of the blood. This can be due to
• Increased blood loss due to accident, menstruation etc
• Infections like malaria
• Decreased iron intake
• Decreased iron absorption
• Decreased Vitamin B12, Folic acid & Protein
• Increased demand of RBC as in pregnancy
• You have fewer red blood cells than normal
• You have less haemoglobin than normal in each red blood cell
In all cases, a reduced amount of oxygen is carried around in the bloodstream. The most
common cause of anaemia is a lack of iron. Anaemia caused by a lack of iron is called iron
deficiency anaemia. The bone marrow (in the center of the bone) needs iron to make
haemoglobin. Without adequate iron, the body cannot produce enough haemoglobin for red
blood cells.
Iron deficiency Anaemia usually develops gradually, in stages. Symptoms develop in the
later stages. And, there are basically 5 stages:
Stage 1:
• Iron loss exceeds intake, depleting iron reserves, primarily in bone marrow.
• Blood levels of ferritin (a protein that stores iron) progressively decrease.
Stage 2:
• Because depleted iron reserves can't meet the needs of developing red blood cells,
fewer red blood cells are produced.
Stage 3:
• Anaemia begins to develop. Early in this stage, the red blood cells appear normal, but
there are fewer of them.
• Hemoglobin levels are reduced
Stage 4:
• The bone marrow tries to compensate for the lack of iron by speeding up cell division
and producing very small (microcytic) red blood cells, which are typical of iron
deficiency Anaemia .
Stage 5:
• As iron deficiency and Anaemia progress, the symptoms of iron deficiency may
develop and symptoms of Anaemia worsen.
A normal balanced diet will usually contain enough iron for the body's needs. A low level of
body iron leading to anaemia can result from various causes. Some are more serious than
others, and include the following:
Heavy menstrual periods
Anaemia is common in women of all ages who have heavy periods. About 1 in 10 women
will become anaemic at some stage due to heavy periods. The amount of iron that you eat
may not be enough to replace the iron that you lose with the blood each period. Having
heavy periods does not always lead to anaemia. Anaemia is more likely to develop if you
have heavy periods and eat a diet that contains little iron.
Pregnancy
A growing baby needs iron and will take it from the mother. Anaemia is common in pregnant
women. It is more likely to develop during pregnancy if you eat a diet that has little iron.
Poor absorption of iron
Some conditions of the gut (intestine) lead to poor absorption of various foods, including
iron. Coeliac disease is an example.
Bleeding from the gut (intestine)
Several conditions of the gut can lead to 'internal bleeding'. Sometimes this is sudden, for
example, after a burst duodenal ulcer. Vomiting or passing blood is then obvious.
However, often the bleeding is not obvious. A constant trickle of blood into the gut can be
passed unnoticed in the stools (faeces). The iron that you may lose with the bleeding may be
more than you eat. Conditions causing this include: stomach or duodenal ulcers, colitis
(inflammation of the large intestine), inflammation of the oesophagus (gullet), piles
(haemorrhoids), cancers of the bowel, and other rare bowel disorders. If you have one of
these problems, you may have other gut symptoms such as stomach pains, constipation, or
diarrhoea. However, in the early stages of these conditions, you may not have any symptoms,
and anaemia may be the first thing that is noticed. For example, iron deficiency anaemia in
an older person is a common first indication that bowel cancer has developed.
Medication
Some medicines which you may take for other conditions can sometimes cause bleeding into
the gut without causing symptoms. The most common example is aspirin. Other anti-
inflammatory painkillers such as ibuprofen, naproxen, diclofenac, etc, also have this side-
effect in some people. (The reason anti-inflammatories may cause bleeding is because they
sometimes irritate the stomach lining which can lead to bleeding.)
Bleeding from the kidney
A small but regular trickle of blood from diseases of the kidney or bladder may not be
noticed in the urine. However, enough may be lost to cause anaemia.
Dietary factors
Not eating foods with enough iron is sometimes the cause of iron deficiency anaemia. This is
uncommon in non vegetarians as iron is in meat, liver, green vegetables, flour, eggs, and
other foods. However, some people who may have a poor diet with 'just enough' iron to get
by normally may slip into anaemia if other factors develop. For example, a barely adequate
diet combined with a growth spurt in children, with pregnancy, or with heavy periods may
lead to anaemia.
A restricted diet such as a vegan or a limited vegetarian diet sometimes does not contain
enough iron.
Traditional diets in some parts of the world contain a high level of chemicals such as
phytates and polyphenols. For example, certain types of unleavened breads (such as chapatis)
may contain a high level or phytates, and tea can contain a high level of polyphenols. These
chemicals interfere with the way iron is absorbed from the gut. So, if you eat a lot of these
foods, it can lead to iron deficiency. For example, in parts of India where chapatis are a
staple food, iron deficiency anaemia is common.
Hookworm infection
This gut infection is the most common cause of iron deficiency anaemia world-wide. It
affects people living in, and visiting, certain tropical countries. The worm feeds off blood
inside the gut.
What are the symptoms of iron deficiency anaemia?
• Common symptoms are due to the reduced amount of oxygen in the body. These
include: tiredness, lethargy, feeling faint, becoming easily breathless.
• Less common symptoms include: headaches, palpitations, altered taste, sore mouth,
and ringing in the ears (tinnitus).
• You may look pale.
• IDA may produce its own symptoms, such as
○ pica (craving for non foods such as ice,dirt or pure starch),
○ tongue irritation (glossitis), and
○ cracks at the sides of the mouth (cheilosis) and
○ spoonlike deformity in the fingernails.
• Various other symptoms may develop, depending on the underlying cause of the
anaemia (see below).
Possible complications:
Complications may develop if the anaemia becomes severe and is not treated. For example,
you can develop: fragile and broken nails, heart failure, and hair loss. You may also be more
prone to develop infections as a lack of iron can affect the immune system.
Anaemia in pregnancy increases the risk of complications in both mother and baby. For
example, there is an increased risk of: having a low birthweight baby, preterm (premature)
delivery, postnatal depression, and low iron reserves in the baby which may possibly lead to
anaemia in the newborn baby.
How is iron deficiency anaemia diagnosed?
A blood test can confirm that you are anaemic. A test called the full blood count (FBC) is the
main test. For this test the blood sample is put into a machine which automatically:
• Counts the number of red cells, white cells, and platelets per ml of blood.
• Measures the size of the red blood cells and calculates their average (mean) size.
• Calculates the proportion of blood made up from red blood cells (the haematocrit).
• Measures the amount of haemoglobin in the red blood cells.
This test can determine if you are anaemic, and often give a good idea as to the cause of
anaemia. But, as there are many different causes of anaemia, there may be some doubt as to
the cause of the anaemia.
Therefore, you may need another blood test to confirm that the cause of the anaemia is due to
lack of iron. A blood test that measures a protein called ferritin may be done. The level of
this protein usually reflects the total body iron stores. A low level usually indicates that you
have a lack of iron. (However, the test is sometimes difficult to interpret if infection or
inflammation is present, as levels of ferritin can be high even in the presence of iron
deficiency.)
It is important to find the cause of the iron deficiency. The cause may be obvious in some
people. For example, anaemia is common in pregnancy, and in women with heavy periods.
In these situations, if you are otherwise well and have no other symptoms, then no further
tests may be needed. However, further tests may be advised if the cause is not clear. Every
case is different and your doctor will assess if you should have further tests.
Iron tablets are usually prescribed to correct the anaemia. Other treatments may also be
advised, depending on the underlying cause.
Iron tablets
Various iron tablets and liquid medicines are available. A doctor will advise on one. The
length of course will vary depending on how bad the anaemia is. A blood test after a few
weeks will show if the treatment is working. Once the blood level is back to normal, you
should continue to take iron for at least three further months. This will ensure that reserves of
iron are built up in your body.
Side-effects from taking iron occur in some people. These include: feeling sick (nausea), an
upset stomach, constipation, or diarrhoea. Tell a doctor if side-effects are a problem. Don't
stop the iron, as the anaemia will not get better. Possible ways that a doctor may suggest to
reduce the problem with side-effects are:
• Take the iron tablets with meals. Food reduces the absorption of the iron and so you
may need to take a longer course to correct the anaemia.
• Take a lower dose, but again a longer course will be needed to correct the anaemia.
• Drink plenty of fluids if constipation develops.
Iron tablets may make your stools (faeces) black. This is normal and nothing to worry about.
However, it is sometimes confused with blood in the stools from internal bleeding which can
also make your stools black.
Anaemia in Pregnancy
As already told the normal haemoglobin (Hb) concentration in the body is between 12-14
grams percent. WHO has accepted up to 11gm percent as the normal haemoglobin level in
pregnancy. Therefore any haemoglobin level below 11gm in pregnancy should be considered
as anaemia. However in India and most of the other developing countries the lower limit is
often accepted as 10 grams percent.
However according to WHO, the prevalence of Anaemia in pregnancy in south East Asia is
around 56%. In India incidence of anaemia pregnancy has been noted as high as 40-80%. As
there is reduction in Haemoglobin of blood
Magnitude of the problem: According to the National Family Health Survey, India has
among the highest number of cases of anaemia in the world. As many as 79.1% of India’s
children between the ages of three and six, and 56.2% of married women in the age-group
15-49 were found to be anaemic in 2006. Almost 20 per cent of maternal deaths are caused
directly because of iron deficiency anaemia and it is a contributory factor in 20 per cent more
deaths. Apart from this, there is the huge Productivity Loss: Anemia and iron deficiency
cause weakness, fatigue, and reduced physical ability to work. Pregnancy anaemia is one of
the important public health problems not only in India but also in most of the south East
Asian countries. About 4-16% of maternal death is due to anaemia. It also increases the
maternal morbidity, foetal and neonatal mortality and morbidity significantly.
Anaemia in pregnancy is a condition with effects that may be deleterious to mothers and
foetuses. Indeed, it is a known risk factor for many maternal and foetal complications.
Maternal risk during Antenatal period: poor weight gain. Pre term labours, PIH, placenta
previa, accidental Hg, eclampsia, premature rupture of membrane (PROM) etc.
Maternal risk during intranatal period: Dysfunctional labour, intranatal hemorrhage, shock,
anaesthesia risk, cardiac failure
Maternal risk during postnatal period: Postnatal sepsis, sub involution, embolism
Foetal and Neonatal risk: Complications include prematurity, low birth weight, poor Apgar
score, foetal distress, neonatal distress requiring prolonged resuscitation, and neonatal
anaemia due to poor reserve. Infants with anaemia have higher prevalence of failure to
thrive, poorer intellectual developmental milestones, and higher rates of morbidities and
neonatal mortalities than infants without anaemia. Moreover, babies whose mothers had AIP
during their first trimester in utero experienced higher rates of cardiovascular morbidities
and mortalities in their adult lives than babies whose mothers did not have AIP.
Causes:
1) Physiological
Pregnancy causes a state of hydraemic plethora. There is disproportionate increase of plasma
volume during pregnancy leading to apparent reduction of RBC, haemoglobin and
haematocrit value. Hb is consequently reduced to a varying extent occasionally as low as
80%. The dilution picture is normochromic and normocytic. This is so called physiological
anaemia.
2) Acquired- Nutritional
a) Iron deficiency anaemia (60%),
b) Macrocytic anaemia (10%) due to deficiency of folic acid and/or vitaminB12
c) Dimorphic and protein deficiency anaemia (30%) both due to deficiency of iron and folic
acid and /or vitaminB12
d) Protein deficiency due to protein deficiency in extreme malnutrition. Haemolytic or
Haemorrhagic (due to acute blood loss) ; chronic (hook worm, bleeding piles)
Iron and folate deficiency is by far the most important aetiological factor. Haemolytic
anaemia may be caused by haemoglobinopathies, drug reaction or infestation with malaria
parasites.
Risk factors
Socio demographic factors (age, level of formal education, marital status, areas and cities of
residence)
Obstetrical factors (gravidity, parity, history of previous preterm or Small-forgestational- age
deliveries, plurality of pregnancy multiple Or singleton)
Behavioural factors (smoking or tobacco usage, alcohol usage, utilization of prenatal care
services)
Medical conditions (diabetes, renal or cardio-respiratory diseases, chronic hypertension AIP
anaemia in pregnancy
Clinical presentation:
To start with the pregnant women with anaemia may not have any symptom as the body
system get adjusted to reduce haemoglobin mass. However she may represent with vague
complain of ill health, fatigue, loss of appetite, digestive upset, dyspnoea, palpitation etc.
Clinical examination may reveal pallor, pale nails, koilonychias, pale tongue etc. In severe
cases there may be oedema also.
Management:
A pregnant woman requires about 2 to 4.8 mg iron every day. To have it from the dietary
sources she must consume 20-48 mg of dietary iron. This is practically impossible in India
because of average vegetarian diet does not contain more than 10-15 mg of iron and the
phytate content in it further reduces iron absorption. Moreover majority of Indian women
enter pregnancy already with iron depleted condition. The iron store is markedly diminished
when there is fall in Hb values. Therefore in India there is a need for routine iron
supplementation to all pregnant women
Prophylaxis:
It is advisable to build up iron store before a woman marries and becomes pregnant. This can
be achieved by
1) Routine screening for anaemia for adolescent girls form school days
2) Encouraging iron reach foods
3) Fortification of widely consumed food with iron
4) Providing iron supplementation from school days
5) Annual screening for those with risk factors
Iron rich foods: Pulses, cereals, jaggery, Beet root, Green leafy vegetables, meat, liver, egg,
fish, legumes, dry beans, and iron reached white breads etc.
Haematinic:
Haematinics are agents which improve the quality of the blood, increasing the haemoglobin
level and the number of erythrocytes. They are used in the treatment of anaemia.
A doctor expects a set of features and benefits from a haematinic:
• Good absorption
• Significant increase in haemoglobin levels
• Rapid rise in RBC counts
• No release of free radical generation
• Increase patient compliance with less GI disturbances
• Effective and well tolerated regimen
Ferrous Ascorbate
Ferrous Ascorbate is a synthetic molecule of ascorbic acid and iron. Ascorbic acid enhances
absorption of iron. Major brands of Ferrous Ascorbate in the market are:
Brand Company
• Orofer XT Emcure
• Dexorange FI
• Autrin Wayeth
• Raricap J&J
• Ferium XT Emcure
• Fesovit GSK
• C-Pink Warnberry
• Livogen Z GSK
• Fefol GSK
• Feronia XT Zuv
• Biofer XT Micro Labs
Parenteral Iron:
The indications for parenteral iron therapy are as follows
1. Cannot tolerate side effects of oral iron
2. Suffers from inflammatory bowel disease
3. Patient does not comply
4. Patient near term
The defaulting rate with oral iron therapy in pregnant women is fairly high because of
gastrointestinal side effects like nausea, vomiting, diarrhoea and abdominal pain. Sometimes
pregnant women present with severe anaemia after 30-32 weeks of pregnancy and in those
cases time is an important factor to improve haemoglobin status. In such situations parenteral
iron therapy is indicated. Parenteral iron can be given by intramuscular or intravenous
route. Iron- sorbitol -citric acid complex (jectofer (1.5ml) 75mg is used for intramuscular
route only. On the other hand iron-dextran can be used both by intramuscular and
intravenous route. The main drawback of intramuscular iron is the pain and staining of the
skin at injection site, myalgia, arthralgia and injection abscess. Intravenous route should be
reserved for those who do not wish to have frequent intramuscular injections.
Iron can be given intravenously at one shot as total dose infusion (TDI). Utmost caution is
needed for total dose iron therapy via intravenous route because of severe anaphylactic
reaction that may occur.
How to calculate TDI: total dose of infusion of iron is calculated as: (15- patient s Hb%) x
body weight in Kg x3 =Mg.
But in case of pharmaceutical company it is a little bit different as not only customer but
doctors’ satisfaction is much more important. If doctor won’t be satisfied with the drug he
wouldn’t prescribe it to the patients. So the sale depends on doctors’ prescription.
Continuous improvement for a pharma company implies that business philosophies must
change to meet the increasing expectations of not only the customer but also the doctors.
Hence a research should be a step towards the awareness of the expanding and ever changing
needs of the customer and thereby to meet them. Just as many dissatisfied customers do not
register formal complaints, satisfied customers may not provide the feedback necessary to
understand what made them satisfied. Hence a detailed research is required to know what is
lacking in the products and how can they be improved.
A recent study has clearly established the fact that only those corporations survive which
give their customer maximum value for their money. Only such of these companies that have
gone beyond the stages of satisfying the customer into delighting them by exceeding their
expectations have really grown beyond one’s wildest dreams.
Research Objective:
Keeping the above things in mind, the survey was done to find the perception of solid ferrous
ascorbate in pregnancy. Ferrous ascorbate is a new formulation and is a improved haematinic
launched in the market. So it was essential to know how the formulation has been accepted
by the doctors and what their perception is. The objective of the research is to find out the
“Position of oral solid ferrous ascorbate in Pregnancy.”
Research Methodology:
This section of the report emphasizes on the procedure used to accomplish the project. To
accomplish the project some data have been collected. The data collected is basically of two
types:
• Primary data
• Secondary data
Primary Data:
Primary data generally means those raw data or data structures that are collected “first hand”
and have not had any previous meaningful interpretation. For my summer internship project
report, I have collected such primary data through observation method and through personal
interviews with gynaecologists.
1. Research Design: For this I had conducted structured interview. The aim of this
approach is to ensure that each interviewee is presented with exactly the same
questions in the same order. This ensures that answers can be reliably aggregated and
that comparisons can be made with confidence between sample subgroups or between
different survey periods.
2. Sampling Characteristics:
1. Target Population
The target population for the research is defined as follows:
• ELEMENTS- All the gynaecologists and P.G students of the gynaecology
department of the Bangalore city.
• SAMPLING UNITS- Sampling units are the hospitals and private clinics
where we can meet the doctors.
• TIME- 2009
1. Sampling Techniques:
The sampling technique applied here is sampling without replacement. Sampling
Technique used here is simple random sampling. I had visited different hospitals
and private clinics of Bangalore city to meet the doctors. The instrument which was
used to gather the required information was a questionnaire. The questions were
generally closed ended, and were framed in a way to be filled in minimum time.
Factors taken into account while framing the questions were to acquire maximum
possible information from the doctors about the formulation.
1. Sample Size: The total sample size was 100 and included the gynaecologists and
some P.G students. While taking the sample I have mainly taken a point into
consideration i.e., to design and obtain a sample in such a way that it will be
representative of the entire population.
2. Sample Area: The interviews were conducted in different hospitals and private
clinics of Bangalore.
Secondary Data:
Any data which have been gathered earlier for some other purposes are secondary data for
the current purpose. For my report, I have collected such data from various internet websites
and different reference books containing related topics.
From this research I had to find the perception of oral solid ferrous ascorbate in pregnancy.
By this data we can easily find out the perception of the new formulation in the doctors
mind, how is it progressing in the market and how it can be improved.
Cumulative
Frequency Percent Valid Percent Percent
Valid 0-2 4 3.8 3.8 3.8
2-4 19 18.3 18.3 22.1
4-8 35 33.7 33.7 55.8
>8 46 44.2 44.2 100.0
Total 104 100.0 100.0
Valid Cumulative
Frequency Percent Percent Percent
Valid 2-4 4 8.9 8.9 8.9
4-8 14 31.1 31.1 40.0
>8 27 60.0 60.0 100.0
Total 45 100.0 100.0
No. of pregnancies per week(pvt.)
Cumulative
Frequency Percent Valid Percent Percent
Valid 0-2 4 6.8 6.8 6.8
2-4 15 25.4 25.4 32.2
4-8 21 35.6 35.6 67.8
>8 19 32.2 32.2 100.0
Total 59 100.0 100.0
Findings:
• As we can see that around 45 percent of the total doctors see more than 8 patients per
week.
• Among the government doctors out of 45 doctors 27 see more than 8 patients ie
around 60 percent doctors.
• While in the private hospitals and clinics 19 out of 59 doctors see more than 8
patients ie 32.2 percent doctors.
• By looking at the data, we can say that government hospitals have a greater potential
for ferrous ascorbate.
Out of these how many are anaemic?
Cumulative
Frequency Percent Valid Percent Percent
Valid 0-20% 30 28.8 28.8 28.8
20-40% 50 48.1 48.1 76.9
40-80% 24 23.1 23.1 100.0
Total 104 100.0 100.0
Valid Cumulative
Frequency Percent Percent Percent
Valid 0-20% 15 33.3 33.3 33.3
20-40% 18 40.0 40.0 73.3
40-80% 12 26.7 26.7 100.0
Total 45 100.0 100.0
Out of these how many are anaemic? (pvt.)
Valid Cumulative
Frequency Percent Percent Percent
Valid 0-20% 15 25.4 25.4 25.4
20-40% 32 54.2 54.2 79.7
40-80% 12 20.3 20.3 100.0
Total 59 100.0 100.0
Findings:
• While looking at the data here its seen that 50 out of 104 doctors said that 20-40
percent of their patients are anaemic.
• When looking at the government practitioners 40 percent said that 20-40 percent of
their patients are anaemic while this number was 54.2 in private practitioners.
• But 27 percent of the government doctors said that their patients are 40-80 percent
anaemic while this number was only 20 percent in the private clinics.
• This indicates that number of anaemic patients are more in government clinics than in
private clinics.
Stage of anaemia
Valid Cumulative
Frequency Percent Percent Percent
Valid Mild 55 52.9 52.9 52.9
moderate 37 35.6 35.6 88.5
severe 2 1.9 1.9 90.4
very severe 2 1.9 1.9 92.3
mild to
7 6.7 6.7 99.0
moderate
All 1 1.0 1.0 100.0
Total 104 100.0 100.0
Stage of anaemia(gov.)
Cumulative
Frequency Percent Valid Percent Percent
Valid mild 24 53.3 53.3 53.3
moderate 13 28.9 28.9 82.2
severe 1 2.2 2.2 84.4
very severe 1 2.2 2.2 86.7
mild to moderate 5 11.1 11.1 97.8
all 1 2.2 2.2 100.0
Total 45 100.0 100.0
Stage of anaemia(pvt.)
Valid Cumulative
Frequency Percent Percent Percent
Valid mild 31 52.5 52.5 52.5
moderate 24 40.7 40.7 93.2
severe 1 1.7 1.7 94.9
very severe 1 1.7 1.7 96.6
mild to moderate 2 3.4 3.4 100.0
Total 59 100.0 100.0
Findings:
• When we see the stage of anaemia, generally all the doctors whether it be government
or private say that their patients have mild anaemia. The reason for this is increased
concern and awareness of the patients in metropolitan cities.
• One thing to notice here was that I met a doctor of the rural district hospital. She was
the only doctor who said that her patients are severely anaemic. This indicates that
great amount of improvement is still needed in the rural areas.
Prescription
Valid Cumulative
Frequency Percent Percent Percent
Valid Ferrous Sulphate 26 25.0 25.5 25.5
carbonyl iron 8 7.7 7.8 33.3
Ferrous ascorbate
42 40.4 41.2 74.5
with zinc
Ferrous ascorbate
2 1.9 2.0 76.5
without zinc
any other 3 2.9 2.9 79.4
1,4 8 7.7 7.8 87.3
1,2 5 4.8 4.9 92.2
2,4 8 7.7 7.8 100.0
Total 102 98.1 100.0
Missing System 2 1.9
Total 104 100.0
Prescription(gov.)
Valid Cumulative
Frequency Percent Percent Percent
Valid Ferrous Sulphate 20 44.4 45.5 45.5
carbonyl iron 5 11.1 11.4 56.8
Ferrous ascorbate
8 17.8 18.2 75.0
with zinc
Ferrous ascorbate
1 2.2 2.3 77.3
without zinc
any other 1 2.2 2.3 79.5
1,4 2 4.4 4.5 84.1
1,2 4 8.9 9.1 93.2
2,4 3 6.7 6.8 100.0
Total 44 97.8 100.0
Missing System 1 2.2
Total 45 100.0
Prescription(pvt.)
Cumulative
Frequency Percent Valid Percent Percent
Valid Ferrous Sulphate 6 10.2 10.3 10.3
carbonyl iron 3 5.1 5.2 15.5
Ferrous ascorbate
34 57.6 58.6 74.1
with zinc
Ferrous ascorbate
1 1.7 1.7 75.9
without zinc
any other 2 3.4 3.4 79.3
1,4 6 10.2 10.3 89.7
1,2 1 1.7 1.7 91.4
2,4 5 8.5 8.6 100.0
Total 58 98.3 100.0
Missing System 1 1.7
Total 59 100.0
Findings:
• The basic difference which was seen between the private and government doctors
were the prescription to the patients.
• 20 out of 45 doctors i.e., around 45 percent prescribe ferrous sulphate in government
hospitals while this number is only 10 percent in private clinics.
• While in private clinics 34 out of 59 doctors i.e., 58 percent of the doctors prescribe
ferrous ascorbate with zinc. This number was only 18 percent in government
hospitals.
• The basic reason behind this as told by the doctors was that ferrous sulphate is the
cheapest haematinic present in the market. So it is affordable by most of the patients.
Even patients from middle income don’t lie to spend much on iron tablets. With this
not only theoretically but practically also, it gives good results.
• With this 12 percent of the government doctors prescribe carbonyl iron; this number
is less among the doctors of private clinics.
• Some of the doctors said that they avoid prescribing oral iron tablets as they are less
tolerant. In place of that they prescribe diet regulation i.e., addition of spinach, apple
etc in case of mild to moderate anaemia or they use parenteral iron in severe anaemia.
• With this the prescription also depends on individuality, tolerability and affordability.
Perception of FA
Valid Cumulative
Frequency Percent Percent Percent
Valid Offers better
absorption and lesser 19 18.3 18.3 18.3
side effect
Offers good rise in
haemoglobin and RBC 9 8.7 8.7 26.9
levels
Both of the above 72 69.2 69.2 96.2
don't know 4 3.8 3.8 100.0
Total 104 100.0 100.0
Perception of FA(gov.)
Valid Cumulative
Frequency Percent Percent Percent
Valid Offers better
absorption and lesser 13 28.9 28.9 28.9
side effect
Offers good rise in
haemoglobin and RBC 3 6.7 6.7 35.6
levels
Both of the above 27 60.0 60.0 95.6
don't know 2 4.4 4.4 100.0
Total 45 100.0 100.0
Perception of FA(pvt.)
Cumulative
Frequency Percent Valid Percent Percent
Valid Offers better absorption
6 10.2 10.2 10.2
and lesser side effect
Offers good rise in
haemoglobin and RBC 6 10.2 10.2 20.3
levels
Both of the above 45 76.3 76.3 96.6
don't know 2 3.4 3.4 100.0
Total 59 100.0 100.0
Findings:
• When asked about the perception of ferrous ascorbate, the doctors of both
government and private hospitals said that not only they believe that ferrous
ascorbate offers better absorption and lesser side effect but it also offers good rise in
haemoglobin and RBC levels.
• The percentage here was 60 percent in government and around 77 percent in private
clinics.
Have you received any comm. from pharma comp. which propelled you to prescribe
FA?
Valid Cumulative
Frequency Percent Percent Percent
Valid Yes 69 66.3 66.3 66.3
No 35 33.7 33.7 100.0
Total 104 100.0 100.0
Have you received any comm. from pharma comp. which propelled you to prescribe
FA?(gov.)
Valid Cumulative
Frequency Percent Percent Percent
Valid Yes 24 53.3 53.3 53.3
No 21 46.7 46.7 100.0
Total 45 100.0 100.0
Have you received any comm. from pharma comp. which propelled you to prescribe
FA? (pvt.)
Valid Cumulative
Frequency Percent Percent Percent
Valid Yes 45 76.3 76.3 76.3
No 14 23.7 23.7 100.0
Total 59 100.0 100.0
Findings:
• When asked the question were the doctors propelled to prescribe ferrous ascorbate by
any communication given by any pharmaceutical company around 67 percent of the
doctors said, yes.
• When we look at government and private hospitals individually then the number was
54 percent in the government doctors and 77 percent in private clinics.
• This shows that the number is less in government hospitals, hence pharmaceutical
companies should focus more there.
Cumulative
Frequency Percent Valid Percent Percent
Valid 0-10% 49 47.1 47.1 47.1
10-20% 48 46.2 46.2 93.3
20-40% 5 4.8 4.8 98.1
>40% 2 1.9 1.9 100.0
Total 104 100.0 100.0
Patients going into preeclampsia(gov.)
Valid Cumulative
Frequency Percent Percent Percent
Valid 0-10% 19 42.2 42.2 42.2
10-20% 22 48.9 48.9 91.1
20-40% 3 6.7 6.7 97.8
>40% 1 2.2 2.2 100.0
Total 45 100.0 100.0
Valid Cumulative
Frequency Percent Percent Percent
Valid 0-10% 30 50.8 50.8 50.8
10-20% 26 44.1 44.1 94.9
20-40% 2 3.4 3.4 98.3
>40% 1 1.7 1.7 100.0
Total 59 100.0 100.0
Findings:
• As told by the doctors, number of cases going into preeclampsia has greatly reduced
over the years. As preeclampsia generally occur in severe or very severe anaemia.
And there are very rare cases of severe anaemia in metropolitan cities. This is due to
more awareness of the people there.
• 47 percent of the doctors said that only 0-10 percent of the patients go into
preeclampsia.
Valid Cumulative
Frequency Percent Percent Percent
Valid Yes 46 44.2 44.2 44.2
No 45 43.3 43.3 87.5
don't know 13 12.5 12.5 100.0
Total 104 100.0 100.0
Valid Cumulative
Frequency Percent Percent Percent
Valid Yes 16 35.6 35.6 35.6
No 22 48.9 48.9 84.4
don't
7 15.6 15.6 100.0
know
Total 45 100.0 100.0
Valid Cumulative
Frequency Percent Percent Percent
Valid Yes 30 50.8 50.8 50.8
No 23 39.0 39.0 89.8
don't
6 10.2 10.2 100.0
know
Total 59 100.0 100.0
Findings:
• When asked to the doctors, can ferrous ascorbate reduce risk of preeclampsia around
44 percent of the doctors said yes and 42 percent of the doctors said no.
• There were 12 percent of the doctors who didn’t know about it.
• More of the government doctors i.e., 49 percent of them don’t think that ferrous
ascorbate can reduce risk of preeclampsia.
Cumulative
Frequency Percent Valid Percent Percent
Valid Yes 31 29.8 29.8 29.8
No 73 70.2 70.2 100.0
Total 104 100.0 100.0
Has any pharma company communicated to you the use of FA in preeclampsia?(gov.)
Cumulative
Frequency Percent Valid Percent Percent
Valid Yes 11 24.4 24.4 24.4
No 34 75.6 75.6 100.0
Total 45 100.0 100.0
Cumulative
Frequency Percent Valid Percent Percent
Valid Yes 20 33.9 33.9 33.9
No 39 66.1 66.1 100.0
Total 59 100.0 100.0
Findings:
• When asked has any pharmaceutical company communicated to you the use of
ferrous ascorbate in preeclampsia, 71 percent of the doctors said, no.
• 76 percent of the government doctors said that they didn’t received any
communication from any pharmaceutical company regarding use of ferrous ascorbate
in preeclampsia.
• While only 67 percent of the doctors of private clinics didn’t received any
communication about ferrous ascorbate’s role in preeclampsia.
• This indicates that pharmaceutical companies have to work upon their
communication strategy regarding role of ferrous ascorbate in preeclampsia.
Valid Cumulative
Frequency Percent Percent Percent
Valid GI disturbances 26 25.0 25.0 25.0
Constipation 1 1.0 1.0 26.0
Black Stools 2 1.9 1.9 27.9
Vomiting 5 4.8 4.8 32.7
All of the Above 17 16.3 16.3 49.0
None of the Above 41 39.4 39.4 88.5
not used or not observed 12 11.5 11.5 100.0
Total 104 100.0 100.0
Side Effects of FA on patients(gov.)
Valid Cumulative
Frequency Percent Percent Percent
Valid GI disturbances 15 33.3 33.3 33.3
Black Stools 1 2.2 2.2 35.6
All of the Above 8 17.8 17.8 53.3
None of the Above 10 22.2 22.2 75.6
not used or not
11 24.4 24.4 100.0
observed
Total 45 100.0 100.0
Side Effects of FA on patients(pvt.)
Valid Cumulative
Frequency Percent Percent Percent
Valid GI disturbances 11 18.6 18.6 18.6
Constipation 1 1.7 1.7 20.3
Black Stools 1 1.7 1.7 22.0
Vomiting 5 8.5 8.5 30.5
All of the Above 9 15.3 15.3 45.8
None of the Above 31 52.5 52.5 98.3
not used or not
1 1.7 1.7 100.0
observed
Total 59 100.0 100.0
Findings:
• When asked about side effects around 40 percent of the doctors said that there were
no side effects noticed.
• The side effects generally seen was GI disturbance.
• Around 25 percent of the government doctors said that they have not used ferrous
ascorbate or have not observed the side effects in patients.
• So one of the improvement needed to be done in the formulation is to reduce the side
effect observed.
Is FA cost effective?
Valid Cumulative
Frequency Percent Percent Percent
Valid Yes 56 53.8 53.8 53.8
No 39 37.5 37.5 91.3
don't
9 8.7 8.7 100.0
know
Total 104 100.0 100.0
Is FA cost effective?(gov.)
Cumulative
Frequency Percent Valid Percent Percent
Valid Yes 21 46.7 46.7 46.7
No 17 37.8 37.8 84.4
don't know 7 15.6 15.6 100.0
Total 45 100.0 100.0
Is FA cost effective?(pvt.)
Cumulative
Frequency Percent Valid Percent Percent
Valid Yes 35 59.3 59.3 59.3
No 22 37.3 37.3 96.6
don't know 2 3.4 3.4 100.0
Total 59 100.0 100.0
Findings: