comparative study of nutramuscular agent inb the city consisiting of doctors

7/27/2019 comparative study of nutramuscular agent inb the city consisiting of doctors

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1.1 OVERVIEW OF THE INDUSTRY1.1.1 Indian Pharmaceutical Industry:

The demand for pharmaceutical products in India is significant and is driven

by low drug penetration, rising middle-class & disposable income, increased

government & private spending on healthcare infrastructure, increasing medical

insurance penetration etc.

The Indian pharmaceutical industry is growing at about 8 to 9 percent annually

according to A Brief Report Pharmaceutical Industry in India, published in January

2011. 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 injectable. There are approximately 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).

1.1.2 Current Scenario:

India's pharmaceutical market grew at 15.7 per cent during December 2011.

Globally, India ranks third in terms of manufacturing pharma products by volume.

According to McKinsey, the Pharmaceutical Market is ranked 14th in the world. By

2015 it is expected to reach top 10 in the world beating Brazil, Mexico, South Korea

and Turkey. More importantly, the incremental market growth of US$ 14billion over

the next decade is likely to be the third largest among all markets. The US and China

are expected to add US$ 200bn and US$ 23bn respectively. McKinsey & Companys

report, India Pharma 2020: Propelling access and acceptance, realizing true

potential, predicted that the Indian pharmaceuticals market will grow to US$55

billion in 2020; and if aggressive growth strategies are implemented, it has further

potential to reach US$70 billion by 2020. While, Market Research firm Cygnus

report forecasts that the Indian bulk drug industry will expand at an annual growth

rate of 21 percent to reach $16.91 billion by 2014. The report also noted that India

ranks third in terms of volume among the top 15 drug manufacturing countries.


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Further, McKinsey reports Healthcare grew from 4 per cent of average

household income in 1995 to 7 per cent in 2005 and is expected to grow to 13 per cent

by 2025.

Diagnostics Outsourcing / Clinical Trials: According to the estimates, the

Indian diagnostics and labs test services, in view of its growth potential, is expected to

reach Rs159.89 billion by FY2013. The Indian market for both therapeutic and

diagnostic antibodies is expected to grow exponentially in the coming years. Further,

more than 60% of the total antibodies market is currently dominated by diagnostic

antibodies. Some of the major Indian pharmaceutical firms, including Sun Pharma,

Cadilla Healthcare and Piramal Life Sciences, had applied for conducting clinical

trials on at least 12 new drugs in 2010, indicating a growing interest in new drug

discovery research.

Generics: India tops the world in exporting generic medicines worth US$ 11

billion. The Indian generic drug market is to grow at a CAGR of around 17 per cent

between 2010-11 and 2012-13.Over the next few years, it is expected that the patent

laws will provide impetus to the launch of patent-protected products. Such products

have the potential to capture up to a 10% share of the market by 2015, implying the

market size of US $2bn.

R&D: According to Battelle R&D magazine, gross expenditure on R&D

(GERD) by India for 2012 was projected to be US$ 41 billion in purchasing power

parity terms, which works out to 0.8 per cent of GDP. This is low both in absolute

terms and as a proportion of GDP compared to other countries. This is partly because

the size of the R&D base and absorption capacity is not commensurate with

requirements. As per estimates in 2010-11, largest R&D expenditures attracted from

pharmaceutical sector. R&D intensity for the pharmaceuticals sector was much higher

than that for other sectors. Although there have been substantial increases in growth

rates of patents filed in India during the last decade, the share of patents filed for work

in India through indigenous research is less than 20 per cent of the total. A White

Paper on R&D prepared by consultancy firm Deloitte in July 2011 estimates that

more than 300 MNCs have set up R&D centers in India.


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Demand: The demand for pharmaceutical products in India is significant and

is driven by many factors like low drug penetration, rising middle-class & disposable

income, increased government & private spending on healthcare infrastructure,

increasing medical insurance penetration, changing demographic pattern and rise in

chronic lifestyle-related diseases; adoption of product patents, and aggressive market

penetration driven by the relatively smaller companies.

According to CARE research demand triggers for the growth are:

Between 2010 and 2015 patent drugs worth US$171 bn are estimated to go off-

patent leading to a huge surge in generic products.

High margin pharma export business is expected to grow at a higher rate than

domestic market given increased in outsourcing activities.

Increased M&A activities is set to consolidate the market which widens

geographic reach, strengthens distribution network and venture into new

therapeutic segments.

Indian companies files the highest number of ANDAs with USFDA leading to

greater chances of approvals and thereby increasing export to regulated markets

especially the US.

There are currently approximately 175 USFDA and nearly 90 UK-MHRA

approved pharma manufacturing plants in India which can supply high quality

pharma products globally.

Growth from rural markets will outstrip overall pharma market growth, albeit at

lower margins, given lower penetration of 18-19% coupled with rising income

level and awareness.

Biopharmaceuticals is another potential high growth segment for Indian pharma

growing at double digit driven by the vaccines market.


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1.1.3 Major Pharmaceutical Companies

India based pharmaceutical companies are not only catering to the domestic

market and fulfilling the countrys demands, they are also exporting to around 220countries. They are exporting high quality, low cost drugs to countries such as the US,

Kenya, Malaysia, Nigeria, Russia, Singapore, South Africa, Ukraine, Vietnam, and

more. Currently, the US is the biggest customer and accounts for 22 percent of the

sectors exports, while Africa accounts for 16 percent and the Commonwealth of

Independent States (CIS) places around eight percent of orders, as per Research and

Market report.

Leading Indian Players by Sales

Company Sales in US $Mn Year End

Cipla 6,368.06 March 2011

Ranbaxy Lab 5,687.33 December 2010

Dr. Reddy's Labs 5,285.80 March 2011

Sun Pharma 1,985.78 March 2011

LupinLtd 4,527.12 March 2011

Aurobindo Pharma 4,229.99 March 2011

Piramal Health 1,619.74 March 2011

Cadila Health 2,213.70 March 2011

Matrix Labs 1,894.30 March 2010

Wockhardt 651.72 December 2011


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Trends:

All companies, including MNCs, have increased their field force in the last one

year.

Indian companies are entering into strategic tie-ups with MNCs to strengthen

their product portfolio.

Companies are expanding their presence in rural markets.

Acquisitions by MNCs to gain quick foothold in the fastest growing Indian

pharma market.

Most of the Pharma companies have shown considerable decline in growth in the

first half of 2011. The slowdown is widely visible in the Chronic and Acute

categories. Anti-invective, pain and gastro together contribute 1/3rd of the total

pharma market. The pharma companies have started facing challenges in domestic

market due to increase in competition from unlisted MNCs in this segment.

They are rapidly expanding their field force to extend their geographical reach.

Companies like Cipla, Torrent and IPCA which are mainly focused on Indian market

are already feeling the heat. Growth rates of companies such as Cadila, Dr. Reddy and

Ranbaxy have already come down. On the other hand Lupin and Sun are showing

growth due to the shift of focus towards specialty therapies, where competition is

relatively low.

Basing on the changing macro factors and economic growth Emkay Research

has expected the growth estimates of the pharma companies to decrease. It cut down

the domestic growth estimates for Cadila, Cipla, Dr. Reddy, IPCA, Torrent and

Unichem for FY12 and FY 13 by 2% to 5% and retained the growth estimates for

Lupin, Ranbaxy, Sun, GSK and Pfitzer.


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Indian PharmaDomestic Growth Expectations

Company FY12 Domestic Growth Earlier growth estimates

Cadila 12% 15%Cipla 10% 15%

Dr. Reddys 10% 15%

Glenmark 16% 16%

IPCA 10% 17%

Lupin 19% 19%

Ranbaxy 12% 12%

Sun Pharma 15% 18%

Torrent 12% 12%

Unichem 5% 9%

GSK 13% 13%

Pfizer 14% 14%

Source: Emkay Research

Major recent M&As:

Sun-Merck JV: Sun and Merck have formed JV to develop, manufacture and

commercialize new combinations and formulations of innovative, branded

generics in the Emerging Markets. Under the JV, Sitagliptin and

Sitagliptin+Metformin have already been commercialized in the Indian markets.

Lupin-Lilly JV: They entered into collaboration to promote and distribute Lillys

Huminsulin range of products in India and Nepal. Cadlia_Bayer JV: The venture will sell brands from both companies in Indian

markets.

Biocon-Pfizer JV: This collaboration will give Pfizer exclusive rights to

commercialize Biocon products globally including co-exclusive rights with

Biocon in Germany, India and Malaysia.


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1.2 Government Initiatives:

Government initiatives in the public health sector have recorded some

noteworthy successes over time with focus on investments related to better medicalinfrastructure, rural health facilities etc.

100 per cent FDI is permitted for health and medical services under the automatic

route.

The National Rural Health Mission (NHRM) had allocated US$ 10.15 billion for

the up gradation and capacity enhancement of healthcare facilities.

Moreover, in order to meet revised cost of construction, in March 2010 theGovernment allocated an additional US$ 1.23 billion for six upcoming AIIMS-

like institutes and up gradation of 13 existing Government Medical Colleges.

As a result, FDI inflow in hospital and diagnostic centers was US$ 1.1 billion

during April 2000 and November 2011, according to st. Department of Industrial

Policy & Promotion (DIPP) data. FDI inflow in medical and surgical appliances stood

at US$ 472.6 million during the same period. And the drugs and pharmaceuticals

sector has attracted FDI worth US$ 5.0 billion between April 2000 and November

2011.

Budget 2012: Union Budget 2012-13, as expected, is positive for the

pharmaceutical sector. The government has again increased budgetary allocation for

healthcare spending, which would be an overall positive for the sector. Indian

pharmaceutical companies have been investing on the R&D front to tap opportunities

in the domestic and global markets. To encourage the same, the weighted deduction

on R&D expenditure to 200% (in-house research) was extended for a further period of

five years. R&D sops would continue to be positive for the sector as a whole.


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Budget Proposal Impact

Proposal to extend weighted deduction of

200% for R&D expenditure in an in-house

facility for a further period of five years

beyond March 31, 2012.

Positive for all Indian pharmaceutical

companies.

Allocation for NRHM proposed to be

increased from Rs 18,115cr in FY2011-12

to Rs 20,822cr in FY2012-13.

Positive for all pharmaceutical

companies.

Proposal to continue to allow repatriation

of dividends from foreign subsidiaries of

Indian companies at a lower tax rate of

15% up to March 2013.

Positive for all pharmaceutical

companies, mainly Indian companies,

as they generate the highest revenue

from export markets.

Introduced MAT on partnership firm. Would negatively impact Cadila

Healthcare and Sun Pharmaceuticals.

Since we have already factored in

higher

tax provision for FY2013, we are not

changing our FY2013 estimates for

both the companies.


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2 ABOUT SOUL LIFE SCIENCE:

2.1 Introduction

Soul Life Science limited is an Indian pharmaceutical company dedicated to

the development, and marketing of research-based products and therapies of world-

class quality for acute illness and surgical situations.

Soul life science was established in 2007. First they make only OTC product

and market them. In 2008 they make collaboration with UNICHEM. So from 2007

they manufacture they medicine in their production plant.

Soul life science is a marketing based pharmaceutical company offering

products and delivery systems of world class quality, to achieve the objective of

saving lives. Soul life science serves the needs of Indian consumers with products backed

by science and R&D.

The architects of Soul life science are a team comprising of pharmaceutical

experts and management professionals, who bring to the company a combination of

Vision, R&D capabilities, technological know-how, International exposure and

manufacturing expertise. The companys range of products and delivery systems

extends across Critical care, External and parental Nutrition, Renal care including

Transplant Therapy and medical Equipment.

The company enjoys Market Leadership position in several product categoriesin India. Soul life science has marketing operations in whole India, through its

subsidiaries, offices and distributors, with a customer profile including institutions,

major corporate hospitals and international aid agencies.


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2.2 Business Profile:

Soul life science provides healthcare solutions through its four business units:

1. Primary Care - This markets products in the areas of Pain Management,

Gastroenterology etc.

2. Specialty Care - Metabolomics & Urology provides solutions in the areas of

Thyroid, Diabetes.

3. Hospital Care - Offers products in the field of anesthesiology and neonatology

namely.

Nutrition

The link between malnutrition and increased risk of complications in patients

is a proven one. Good nutrition practice makes a vital difference in quality and time of

recovery of such patients.

Nutrition solutions from Soul life science include Enternal Nutritional

products and delivery systems. Soul life science make tablet and powder formulation

of food product their product name are gymin-cl and gypro.

Emotional Pharmacopoeia

The quality philosophy of Soul life science is the commitment to achieve a

level of perfection that surpasses every pharmacopoeias standard. Its final test for

quality is a very simple question that they ask themselves without fail, Would we use

it to treat our dearest ones?


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If the answer is an unhesitant Yes the product has passed final quality test.

At Soul this is called Emotional Pharmacopoeia. Manufacturing processes and

systems are oriented for consistent batch quality. This focus on quality begins with the

housing of the central laboratory facilities within clean rooms.

Soul life science has an advanced laboratory set up equipped with facilities for

chemical and instrumental analysis. The laboratory is capable of undertaking the most

comprehensive tests for various pharmacopoeia parameters.

Soul life science believes in building quality through every step of production

& marketing. This is done by having a separate team for in process quality checks

(QA) and finished products testing (QC) at the end. Separate managers head both

these functions. This total commitment to quality, coupled with international exposure

to technology, aids them in their efforts to help save human lives worldwide.

Pharmaceutical generics

Soul Life Science offers oral dosage forms across various therapeutic groups

with focus on antibiotics, antibacterial, antinfectives, etc. The companys most

product marketing covers OTC practice supply. They offer good quality to

government hospital supply.

2.3 Working Profile:

Soul life science gives job work to GMP manufactures. And provide goodquality. This company provides good marketing facility to other pharmaceutical

company. They try to reach to every consumer of medicine.

Soul life science is an equal opportunity employer and provides a congenial

and professional work environment for all its employees, with great emphasis on

teamwork. They stimulate innovation, encourage calculated risk taking and accept

mistakes as a part of the learning process.


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They encourage experiential learning, and believe in clear delegation of

authority and acceptance of personal accountability. They value the involvement of all

colleagues in bringing the best to their organization in a spirit of understanding, trust

and appreciation of cultural differences. We are open to discussing alternative views

and build on constructive feedback.

Areas of Expertise:

Pharmaceuticals Medical Products Nutritional Products

-infective

Pain Care


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2.4 SOUL LIFE SCIENCE Brand Promise:

We are here for the people we serve in their pursuit of healthy lives. This has

been the way of SOUL for more than a century passionately and thoughtfully

translating science into lasting contributions to health.

Our products encircle life, from newborns to aging adults, from nutrition and

diagnostics through medical care and pharmaceutical therapy.

Caring is central to the work we do and defines our responsibility to those we

serve:

We advance leading-edge science and technologies that hold the potential for

significant improvements to health and to the practice of health care.

We value our diversity that of our products, technologies, markets and

people and believe that diverse perspectives combined with shared goals inspire

new ideas and better ways of addressing changing health needs.

We focus on exceptional performance a hallmark of SOUL people

demanding of ourselves and each other because our work impacts people's lives.

We strive to earn the trust of those we serve by committing to the highest

standards of quality, excellence in personal relationships, and behavior characterized

by honesty, fairness and integrity.

We sustain success for our business and the people we serve by staying

true to key tenets upon which our company was founded over a century ago:

innovative care and a desire to make a meaningful difference in all that we do.

The promise of our company is in the promise that our work holds for health

and life.


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3.1 INTRODUCTION TO TOPIC

3.1.1 Market Analysis:

A market analysis studies the attractiveness and the dynamics of a

special market within a special industry. It is part of the industry analysis and this in

turn of the global environmental analysis. Through all of these analyses the

opportunities, strengths, weaknesses and threats of a company can be identified.

Finally, with the help of a SWOT analysis, adequate business strategies of a company

will be defined. The market analysis is also known as a documented investigation of a

market that is used to inform a firm's planning activities, particularly around decisions

of inventory, purchase, work force expansion/contraction, facility expansion,

purchases of capital equipment, promotional activities, and many other aspects of a

company.

2.1.2 Overview of Perception:

It is a process by which individuals organize and interprets their sensory impressions

in order to give meaning to their environment.

Thus perception what a person feels and analyses about anything by knowing what is

happening around him/her.

Here perception of surgeon and anesthesiologist is being tested about cisatracurium.

Physicians might be prescribing or knows about these drug and through their

experience they may have gathered information about the drugs which we need to

know.
https://en.wikipedia.org/wiki/Markethttps://en.wikipedia.org/wiki/Global_environmental_analysishttps://en.wikipedia.org/wiki/SWOT_analysishttps://en.wikipedia.org/wiki/Work_forcehttps://en.wikipedia.org/wiki/Work_forcehttps://en.wikipedia.org/wiki/SWOT_analysishttps://en.wikipedia.org/wiki/Global_environmental_analysishttps://en.wikipedia.org/wiki/Market


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3.2 Cisatracurium besylate

Cisatracurium besylate is a nondepolarizing skeletal muscle relaxant for intravenous

administration. Compared to other neuromuscular blocking agents, it is intermediate

in its onset and duration of action. Cisatracurium besylate is one of 10 isomers ofatracurium besylate and constitutes approximately 15% of that mixture.

3.2.1 Abstract

Cisatracurium is a neuromuscular-blocking drug or skeletal muscle relaxant in the

category of non-depolarizing neuromuscular-blocking drugs, used adjunctively in

anesthesia to facilitate endotracheal intubation and to provide skeletal muscle

relaxation during surgery or mechanical ventilation. It is abisbenzyltetrahydroisoquinolinium agent with an intermediate duration of action.

It is the R-cis, R'-cis isomer of atracurium besilate and is approximately 3-fold more

potent than the mixture of isomers that constitute the parent drug. The ED95 for

cisatracurium besilate (dose required to produce 95% suppression of twitch response

to nerve stimulation) in adults is 0.05 mg/kg during N2O/O2 opioid anesthesia. As for

atracurium besilate, the primary route of elimination of cisatracurium besilate is by

spontaneous degradation. Cisatracurium besilate is not associated with dose-related

histamine release (at bolus doses of < or = 8 x ED95) and, consistent with this, has

demonstrated cardiovascular stability in both healthy patients (< or = 8 x ED95) and

those with coronary artery disease (< or = 6 x ED95). In clinical trials, cisatracurium

besilate has been used successfully to facilitate intubation (at 2 to 4 x ED95) and as a

muscle relaxant during surgery and in intensive care. Compared with Vecuronium,

cisatracurium besilate was associated with a significantly faster recovery after

continuous infusion in patients in intensive care. Relative to atracurium besilate,

cisatracurium besilate has a lower propensity to cause histamine release is more

potent but has a slightly longer onset time at equipotent doses. It also offers a more

predictable recovery profile than Vecuronium after prolonged use in patients in

intensive care. Thus, comparative data provide some indication of the potential of

cisatracurium besilate as an intermediate-duration neuromuscular blocking agent but

further comparisons with other like agents are required to define precisely its relative

merits.


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3.2.2 What Cisatracurium is and what it is used for

Cisatracurium belongs to a group of medicines called muscle relaxants.

Cisatracurium is used:

To relax muscles during a wide range of surgical procedures in adults and

children over 1 month of age,

To help insert a tube into the windpipe (tracheal intubation), if a person needs

help to breathe,

To relax the muscles of adults in intensive care.

3.2.3 What you need to know before Cisatracurium is used

Cisatracurium must not be used if

Before Cisatracurium is used, patient must not have:

Muscle weakness, tiredness or difficulty in co-ordination of your movements

(Myasthenia gravis),

A neuromuscular disease, such as a muscle wasting disease, paralysis, motorneuron disease or cerebral palsy,

A burn which requires medical treatment,

A severe acid-base and/or electrolyte disorder,

Ever had an allergic reaction to any muscle relaxant which was given as part of an

operation.

Children under the age of one month (new-born infants) should not receive

Cisatracurium.

Other medicines and Cisatracurium

This is especially important with the following medicines as they may interact with

Cisatracurium:

Other muscle relaxants, such as suxamethonium.

Antibiotics (used to treat infections, such as aminoglycosides, polymyxins,

spectinomycin, tetracycline, lincomycin and clindamycin).


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Antiarrhythmic (used to control the heart rhythm, such as propranolol, oxprenolol,

calcium channel blockers, lidocaine, procainamide and quinidine)

Medicines to treat high blood pressure, such as trimethaphan and hexamethonium

Diuretics (water tablets, such as furosemide, thiazides, mannitol andacetazolamide)

Medicines to treat rheumatism, such as chloroquine or d-penicillamine

Steroids

Anti-epileptic medicines, such as phenytoin or carbamazepine

Medicines to treat mental illness, such as lithium, or chlorpromazine

Medicines containing magnesium

Medicines to treat Alzheimers disease (anticholinesterases e.g. donepezil)

3.2.4 How to use Cisatracurium?

How injection is given?

Cisatracurium must only be given by or under the supervision of an experienced

doctor who is familiar with the use and action of this type of medicine. It will always

be given under carefully controlled conditions, where emergency equipment isavailable.

Dosage:

Doctor will decide the dose of Cisatracurium will be given. The amount of

Cisatracurium need depends on:

Body weight

The amount and duration of muscle relaxation required

Your expected response to the medicineMethod of administration:

Cisatracurium will be given

As a single injection into your vein (intravenous bolus injection),

As a continuous infusion into your vein (intravenous infusion or drip).


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3.2.5 Possible side effects:

Like all medicines, this medicine can cause side effects, although not everybody gets

them.As all muscle relaxants cisatracurium can cause allergic reactions although serious

allergic reactions are very rare (may affect up to 1 in 10,000 people). Any sudden

wheeziness, difficulty in breathing, swelling of the eyelids, face or lips and rash or

itching (especially affecting your whole body) should be reported to a doctor

immediately.

The following side effects have been reported:

Decrease in heart rate

Decrease in blood pressure

A rash or redness of your skin

Bronchospasm (asthma-like symptoms)

Muscles weakness or failure

3.2.6 How to store Cisatracurium:

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and label

after EXP.. The expiry date refers to the last day of that month.

Store in a refrigerator (2 - 8 C).

Do not freeze.

Keep the ampoules in the outer carton in order to protect from light.

For single use only. Cisatracurium should be used immediately after opening and/or dilution.

Unused solution should be discarded.

Do not use this medicine if you notice the solution is not clear and free of particles

or if the container is damaged.


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4.1 RESEARCH METHEDOLOGY

Research Topic:A COMPARITIVE STUDY ON USAGE OF CISATRACURIUM

AND OTHER NEURO MUSCULAR BLOCKING AGENT AMONG SURGEONS

AND ANESTHETISTS OF AHMEDABAD CITY

4.1.1 Marketing Research:

Marketing Research is the function which links the consumer, customer and the

public to the marketer through informationinformation used to identify and define

the marketing opportunities and problems; generate, refine and evaluate marketing

actions; monitor marketing performance; and improve understanding of market as a

process. Marketing research specifies the information required to address these

issues; designs the method for collecting information; manages and implements the

data collection process; analyses the results; and communicates the findings and their

implications. My Marketing Research is on a comparative study between

cisatracurium and other NMBs.

4.1.2 The Research Process:

The Marketing research process involves a number of interrelated activities which

dont rigidly follow a particular sequence. Followings are the various steps in the

research methodology process:

[1] Formulating the research problem.

[2] Choice of research design.

[3] Determining sources of data.

[4] Designing data collection forms.

[5] Determining sampling design and sampling size.

[6] Organizing and conducting the field survey.

[7] Processing and analyzing the collected data.

[8] Preparing the research report.


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4.1.3 Need For The Study:

The need for the study occurred to analyze the market interest toward

Cisatracurium. This drug is new molecule in the Indian market but it has beenavailable in international market for years. We need to analyze market preference for

this drug.

4.2 Research Objective:

The main objective to conduct this research is to understand the NeuromuscularBlocker (NMB) market & develop the medical positioning for new product launch i.e.

Cisatracurium.

To measure the preference of doctors, customers, and chemists towards different

NMBs Agent.

To find what will be preference if new formulation of Cisatracurium will

introduce.

4.3 Research Design:

4.3.1Definition:

It is a frame work or blue print for conducting the marketing research project.

It is a frame it specifies the details of the procedures necessary for

obtaining the information needed to structure and solve marketing research

problems.

A research design lays the foundation for conducting the project. A good research

design will ensure that the marketing research project is conducted

effectively and efficiently.

Typically a research design involves the following tasks:

1. Design exploratory, conclusive and or descriptive phase of the project.

2. Define the information needed.

3. Specify the measurement and scaling procedure.

4. Construct and present an appropriate form of data collection.

5. Specify the sampling process and sample size.

6. Develop a plan for data analysis.


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This research has been conducted in the following phases:

1) Exploratory Research

2) Conclusive Research

4.3.2 Exploratory research design:

It is a type of research design, which has its primary objective of getting an insightinto and understanding of the problem situation confronting the researcher.

Secondary data collection has being used as a tool for performing exploratory

research.

Various secondary data tools such as books, research papers, and websites have been

used for to device literature review.

Research

Design

Exploratory

research

Secondary

Data

Conclusive

research

Descriptive

research

Cross sectional

design

Single cross

sectional design


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4.3.3 Conclusive research design:

It is conducted using descriptive research in which single cross sectional

research has been chosen.

4.3.3.1 Descriptive research:

It is a type of conclusive research that has its major objective the description of

something usually market characteristics or functions. Descriptive research is

preplanned and structured. It is based on large amount of representative samples. For

the descriptive research I have used the survey method in which single crosssectional design has been adopted.

4.3.3.2 Single cross sectional design:

It is a cross sectional design in which one sample of respondents is drawn

from the target population and information is obtained from this sample only once.

In this project I have surveyed doctors only once.

4.4 Data collection tool:

Questionnaire (structured).

Questionnaire is a structured technique for data collection that consists of a

series of questions, written or verbal, that a respondent answers.

4.4.1 Target population definition:

Unit- Surgeon and anaesthesiologist of Ahmedabad City.

Element- A doctor of Ahmedabad City.

Sampling Frame: Available

Extent: Ahmedabad, Gujarat.


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4.4.2 Sampling method:

Non-Probability samplingconvenience sampling

Sample size = 60 There is no particular statistical technique used. As per the time and cost

constraints the sample size is taken as 60.


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5. DATA ANALYSIS AND INTERPRETATION

5.1 Data Analysis:

Data analysis is a practice in which raw data is ordered and organized so that useful

information can be extracted from it. The process of organizing and thinking about

data is key to understanding what the data does and does not contain.

In the course of organizing the data, trends often emerge; modeling the data with the

use of mathematics and other tools can sometimes exaggerate such points of interest

in the data, making them easier for the researcher to see. Charts, graphs, and textual

write-ups of data are all forms of data analysis.

5.1.2 Data Analysis process:

Once the necessary data collected, the next task is to aggregate the data in a

meaningful manner. A number of tables are prepared to bring out the main

characteristics of the data. The researcher should have a well thought out framework

for processing and analyzing data, and this should be done prior to the collection.

It includes the following activities:

I. Editing

The first task in data processing is the editing. Editing is the process of examining

errors and omissions in the collected data and making necessary corrections in the

same.

II. Coding

Coding is necessary to carry out the subsequent operations of tabulating and analyzing

data. If coding is not done, it will not be possible to reduce a large number of

heterogeneous data into meaningful categories with the result that the analysis of data

would be weak and ineffective, and without proper focus.


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III. Tabulation

Tabulation comprises sorting of the data into different categories and counting the

number of cases that belong to each category. This is also called universal tabulation.

Where two or more variables are involved in tabulation, it is called vicariate or

multivariate tabulation.

IV. Analysis

After the all three above steps, the most important step is analysis of the data.


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5.2 Data analysis and interpretation:

QUE.1. Do you practice in Urban or Rural area?

a. Urbanb. Rural

Interpretation:

Respondents included equally doctors from urban and rural areas.

LOCATION OF PRACTICE

Frequency Percent Valid Percent

Cumulative

Percent

Valid URBAN 30 50.0 50.0 50.0

RURAL 30 50.0 50.0 100.0

Total 60 100.0 100.0

Table-4.2.1

Chart-4.2.1


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QUE.2. How many years would you like to practice at one demographic area?

a. 0 to 5 years

b. 5 to 10 years

c. 10 to 15 years

d. more than 15 years.

PRACTICE AT ONE DEMOGRAPHIC AREA


Cumulative

Percent

Valid 0 -5 5 8.3 8.3 8.3

5-10 15 25.0 25.0 33.3

10-15 16 26.7 26.7 60.0

MORE THAN 15 24 40.0 40.0 100.0

Total 60 100.0 100.0

Interpretation:

From above chart its quite obvious that doctor would like to practice longer time at

one demographical area as we found in our data.

Table-4.2.2

Chart-4.2.2


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QUE.3. How many times do you use NMBs per weak in your clinical practice?

____________.

PARTICULARS USE OF NMBs/WEEK PERCENTAGE

0 to 10 23 38.33%

11 to 20 26 43.33%

21 to 30 11 18.33%

Interpretation:

Here 43.33% doctors prescribe or use NMBs between 11 to 20 times and 38.33%

doctor prescribe NMBs between 0 to 10 times per week. And only 18.33% doctors

prescribe NMBs per week. So we can say overall usage of NMBs in clinical practice

is good.

38.33%

43.33%

18.33%

PERCENTAGE

0 to 10

11 to 20

21 to 30

Table-4.2.3

Chart-4.2.3


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QUE.4. Kindly mention the NMBs that you use in your clinical practice and the % of

GA procedures in which they are used?

NMB Molecule Name Percentage of Consumption

Atracurium

Pancuronium

Vecuronium

Rocuronium

Succinylcholine

55%

30%33.33%

26.66%

28.33%

PERCENTAGE

ATRACURIUM

PANCURONIUM

VECURONIUM

ROCURONIUM

SUCCINYLCHOLINE

NMB MOLECULE

NAME

NO. OF DOCTOR

PREFFERED PERCENTAGE

% OF CONSUMPTION

60%

ATRACURIUM 33 55% 18% 15.15% 66.66%

PANCURONIUM 18 30% 16.66% 27.77% 55.56%

VECURONIUM 20 33.33% 50% 15% 35%

ROCURONIUM 16 26.66% 37.50% 25% 37.50%

SUCCINYLCHOLINE 17 28.33% 58.82% 29.41% 11.76%

Table-4.2.4

Chart-4.2.4.1


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Interpretation:

55% of doctors preferred Atracurium than any other available molecule and their

percentage of consumption ranged above 60%, some of them were using 100% only

Atracurium.

The 2nd and 3rd preference by doctors were consecutively Vecuronium and

Pancuronium, with 33.33% and 30% respectively.

Other molecules, like Rocuronium & Succinylcholine too stand in the preferred list of

molecules but their percentage of consumption is too less than others.

Apart from this consumption of Succinylcholine is below 30%.

QUE.5. What are the characteristics you expect to be in an ideal Neuromuscular

Blocker (NMB)? Put the numbering as per your preference.

18% 16.66%

50%

37.50%

58.82%

15.15%

27.77%

15%

25%29.41%

66.66%

55.56%

35%37.50%

11.76%

0%

10%

20%

30%

40%

50%

60%

70%

60%

Chart-4.2.4.2


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Parameters Preference

Onset of action

Duration of action

SafetyRecovery time

Potency

Interpretation:

As per above chart mean value for safety is 1.8667, so Safety is 1st ranked

characteristic for ideal NMBs.

Than mean value for duration of action, recovery time, potency and onset of actin is

2.7667, 3.2000, 3.5000 and 3.6667 respectively. From that value we found that

duration of action got 2nd rank followed by recovery time as 3rd rank than potency got

4th rank and finally onset of action got 5th rank.

So we can conclude that doctor gives more preference to safety, duration of action

and recovery time as characteristic for ideal NMBs.

Statistics

IDEAL

NMB_ONSET

OF ACTION

IDEAL

NMB_DURATIO

N OF ACTION

IDEAL

NMB_SAFETY

IDEAL

NMB_RECOVE

RY TIME

IDEAL

NMB_POTENC

Y

N Valid 60 60 60 60 60

Missing 0 0 0 0 0

Mean 3.6667 2.7667 1.8667 3.2000 3.5000

Table-4.2.5.1


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QUE.6. Among the given parameters, which parameter you consider, best defines the

below mentioned NMB? (Kindly mark only one molecule with [], against each

parameter)

Neuromuscular

Blocker Agents

Onset of

Action

Duration

of

Action

Recovery

Time

Safety Potency

Atracurium

Vecuronium

Rocuronium

Succinylcholine

Cisatracurium

Pancuronium

ONSET OF ACTION


Cumulative

Percent

Valid ATRACURIUM 7 11.7 11.7 11.7

VECURONIUM 18 30.0 30.0 41.7

ROCURONIUM 10 16.7 16.7 58.3

SUCCINYLCHOLINE 7 11.7 11.7 70.0

CISATRACURIUM 3 5.0 5.0 75.0

PANCURONIUM 15 25.0 25.0 100.0

Total 60 100.0 100.0

Table-4.2.6.1


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Interpretation:

As per data found 30% of doctors are with Vecuronium & 25% of doctors are with

Pancuronium, in terms of onset of action. So Rocuronium and Pancuroniums onset of

action is better than other.

DURATION OF ACTION


Cumulative

Percent


VECURONIUM 14 23.3 23.3 43.3

ROCURONIUM 14 23.3 23.3 66.7



PANCURONIUM 9 15.0 15.0 100.0

Total 60 100.0 100.0

Table-4.2.6.2

Chart-4.2.6.1


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Interpretation:

While considering the Duration of action aspect of NMB, 23.33%% doctors consider

Vecuronium and Rocuronium as the safest NMB followed by Atracurium.

RECOVERY TIME


Cumulative

Percent


VECURONIUM 9 15.0 15.0 40.0

ROCURONIUM 11 18.3 18.3 58.3



PANCURONIUM 4 6.7 6.7 100.0

Total 60 100.0 100.0

Table-4.2.6.3

Chart-4.2.6.2


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Interpretation:

While considering the Recovery Time aspect of NMB, 30.00% and 25.00% doctors

consider succinylcholine and Atracurium respectively as the safest NMB followed by

Rocuronium.

SAFETY


Cumulative

Percent


VECURONIUM 11 18.3 18.3 43.3

ROCURONIUM 9 15.0 15.0 58.3



PANCURONIUM 3 5.0 5.0 100.0

Total 60 100.0 100.0

Table-4.2.6.4

Chart-4.2.6.3


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Interpretation:

As per data found 25% of doctors are with Atracurium & 20% of doctors are with

Succinylcholine, in terms of Safety aspect followed by Vecuronium and

Cisatracurium. So Pancuronium is lowest safe molecule than others.

POTENCY


Cumulative

Percent


VECURONIUM 6 10.0 10.0 26.7

ROCURONIUM 9 15.0 15.0 41.7



PANCURONIUM 18 30.0 30.0 100.0

Total 60 100.0 100.0

Table-4.2.6.5

Chart-4.2.6.4


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Interpretation:

As per above chart 30% doctors are with Pancuronium & 16.67% doctors are with

Cisatracurium and Atracurium, in terms of Potency aspect followed by Rocuronium.

So Vecuronium is lowest safe molecule than others.

Most interesting fact came in the study is that, before the launch of Cisatracurium- it

has positioned itself as the safe molecule and also holds a position with good potency.

QUE.7. Under the following parameters, what is your preference of the NMB

molecule? Mention the quantity of the molecule used along with the reason for the

choice.

Surgery

DurationNMB Agent

Preference

Quantity Used in

single Procedure

(No. of Vials)

Reason for the

Choice

60

minutes

Chart-4.2.6.5


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SURGERY

DURATION

ATRACURIUM VECURONIUM ROCURONIUM SUCCINYLCHOLINE PANCURONIUM

60 MIN 30% 25% 26.66% 8.33% 10%

50%

13.33%

11.66%

8.33%

16.66%


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Interpretation:

In the process of survey, further remarks were collected from doctors for the use of

the molecule. Though no. of vials used for the single surgical procedure couldnt be

determined.

Atracurium is the most commonly used molecule about 50% in < 30 minutes surgery

procedure while 38.33% in 30-60 minutes procedure and 30% in >60 minutes

procedure.

Succinylcholine is the least preferred molecule for 60 minutes surgery

procedure about 8.33% and 10% in 30-60 minutes procedure.

The positioning of Rocuronium and Vecuronium is best in terms of long surgery

procedures with an hour or more than that. 26.66% and 25% of doctors prefer

Rocuronium and Vecuronium over other molecule in >60 minute surgery procedures

but it is less in term of Atracurium.

Vecuronium is the second most preferred molecule in the 30-60 minutes surgery

procedure.

Pancuronium and Succinylcholine are very less in clinical practice these days. But

still least number of doctors prefers it in whole procedures.

From the above facts, it is quite clear that choice of NMB in GA is also dependent of

the surgery duration.

30%

25%

26.66%

8.33% 10%

>60 MIN

ATRACURIUM

VECURONIUM

ROCURONIUM

SUCCINYLCHOLINE

PANCURONIUM

Chart-4.2.7.3


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Remarks Sided by Doctors for their Preference of NMB

Atracurium

Short Acting, Less recovery time Short duration & safe

Early and easy Recovery

Self-reversal

Recovery is good

Adaptable for any duration

Vecuronium

Longer duration of action

Intermediate acting

Potent NMB agent

Potency & Safety

Succinylcholine

Recovery is complete & good

Potent & Safe

Pancuronium

Longer acting

Rocuronium

Duration Safe

Longer duration of action

QUE.8. Do you need to use the Reversal agent with the following NMB molecules?

If yes, what is the percentage of surgery procedure in which you have to use reversal

agent? Also give the remarks for its need of use.


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NMB Agents Reversal Agent? What % of

Procedures?

Remarks if any?

Yes No

Atracurium

VecuroniumRocuronium

Succinylcholine

Cisatracurium

Pancuronium

NMB AGENT Reversal Agent?YES NO

ATRACURIUM 70% 30%

VECURONIUM 63.33% 36.66%

ROCURONIUM 60% 40%

SUCCINYLCHOLINE 13.33% 86.66%

CISATRACURIUM 47.05% 52.95%

PANCURONIUM 45% 55%

0%

10%

20%

30%

40%50%

60%

70%

80%

90%

100%

70% 63.33% 60%

13.33%

47.05% 45%

30% 36.66% 40%

86.66%

52.95% 55%

NO

YES

Table-4.2.8

Chart-4.2.8


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Note: - In terms of Cisatracurium, most of the doctors resisted in providing opinions

about it since they werent using it. Hence, total sample size is only 34 in the case of

Cisatracurium. Out of which, 52.95% of doctors believed it dont need any reversal

agent.

Interpretation:

In case of Atracurium 70% of doctors have a belief that a patient must be reversed,

even though if it is a self-reversal agent.

Though, it is not true in the case of Succinylcholine, 86.66% dont use any reversal

agent with it.

Rocuronium & Vecuronium stands at nearer situation having 60% & 63.33%

respectively doctors using reversal while used in GA.

Most important concept in the analysis came out as, Cisatracurium is considered as

self-reversal agent as likes of Succinylcholine.

Reasons for the Need of Reversal Agent as mentioned by Doctors:

The patient should be reversed even though it is a self-reversal agent, to rule out

residual blockade if any.

There has been common belief that, reverse all patients.

Used to be sure of reversal.

Hoffmans elimination.

Just as a safety, major though not mandatory.

Cannot avoid reversal.

QUE.9. Do you use the same agent for intubation and maintenance of neuro muscular

blockade? If No, what are the different combinations of NMBs that you use clinically?

Intubation NMB Maintenance NMB % of procedures?


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PARTICULARS NO. OF RESPONDENT PERCENTAGE

SAME AGENT 38 63.33%

DIFFERENT AGENT 22 36.66%

Interpretation:

From the above facts & feedbacks collected in research process, it can be said mostly

Succinylcholine is used in intubation and continued by any of the muscle relaxant

available or the muscle relaxant of their choice. But, as the above chart shows 63.33%

doctors dont mix the molecules in surgery procedures. If Atracurium/Rocuronium is

used in intubation than it is followed by same molecule in maintenance. Only in few

cases, Rocuronium is followed by Atracurium & Atracurium is followed by

Vecuronium and Atracurium followed by Pancuronium.

Different Combination of NMB which doctors prefer:

Succinylcholine - Atracurium/Vecuronium/Rocuronium/Pancuronium

Rocuronium - Atracurium

Atracurium - Vecuronium

Vecuronium - Atracurium

Atracurium - Rocuronium/Pancuronium

63.33%

36.66%SAME AGENT

DIFFERENT AGENT

Table-4.2.9

Chart-4.2.9


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QUE.10. According to you, which of the following is the most vital characteristic of

the Cisatracurium?

a. More potent than available NMB agents

b. Less risk associated with the molecule

c. Very Less histamine release than Atracurium

d. Among other intermediate acting NMB, it has slower onset of time

MOST VITAL CHARACTRISTIC OF CISATRACURIUM


Cumulative

Percent

Valid MORE POTENT THANAVAILABLE NMB AGENTS

8 13.3 13.3 13.3

LESS RISK ASSOCIATED

WITH THE MOLECULE

18 30.0 30.0 43.3

VERY LESS HISTAMINE

RELEASE THAN

ATRACURIUM

30 50.0 50.0 93.3

AMONG OTHER

INTERMEDIATE ACTING

NMB, IT HAS SLOWERONSET OF ACTION

4 6.7 6.7 100.0

Total 60 100.0 100.0

Table-4.2.10

Chart-4.2.10


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Interpretation:

As per above analysis 50% doctor thinks most vital characteristic of Cisatracurium is

very less histamine release than Atracurium followed by less risk associated with the

molecule is 30% and more potent than available NMG agents. Fewer doctor said that

Cisatracurium has slower onset of action among other intermediate.

So from above analysis we can say that Cisatracurium has positive response among

available NMBs.

QUE.11. Considering the above advantages, which of the following will be the ideal

condition for the use of Cisatracurium?

a. All the GA procedures with duration below 30 min

b. All the GA procedures with duration between 3060 min

c. All the GA procedures with duration above 60 min

IDEAL CONDITION FOR USE OF CISATRACURIUM


Cumulative

Percent

Valid ALL THE GA

PROCEDURES WITH

DURATION BELOW 30 MIN

22 36.7 36.7 36.7

ALL THE GA

PROCEDURES WITH

DURATION BETWEEN 30-

60 MIN

16 26.7 26.7 63.3

ALL THE GA

PROCEDURES WITH

DURATION ABOVE 60 MIN

22 36.7 36.7 100.0

Total 60 100.0 100.0

Table-4.2.11


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Interpretation:

From the above chart, it can be derived that:-

36.67% of doctors out of total sample size, thinks Cisatracurium can be used in all

GA procedures with duration 60 minutes.

26.67% of doctors feel it will be useful only in GA procedures between 30-60 minutes

of surgery duration.

One of the major findings, from the above analysis is that majority of doctors feel it

can be used in all the GA procedures.

Hence the initial opinion about the molecule has positive response from doctors.

Some of doctors consider that Cisatracurium is more useful in Kidney disease

patients. One of the other positioning characteristics of Cisatracurium came in

research process is that, few doctors has belief that Cisatracurium may not require

reversal agent as complete recovery is possible out of it.

Chart-4.2.11


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6.1FINDINGS FROM THE RESEARCH

An important fact of research is the analysis and positioning of available

Neuromuscular Blocker (NMB), and discuss opinion about the Cisatracurium beforethe launch in the Indian market. Cisatracurium has been available in International

market for years, but the availability of the new molecule in India depends on licensed

to use by Indian companies.

In terms of the new molecule Cisatracurium, it holds monopoly in the market. But, it

is essential to study the detailed performance of available muscle relaxant in the

market, in the NMB category. This would determine the clinical positioning of

Cisatracurium.

From the research, it has been figured out that Safety is the most important

characteristics that individual seek in a NMB agent.

Atracurium has been in the top of the list in their clinical practice in any GA

procedures. This creates a good market for Cisatracurium, since most of the doctors

consider it as one of the potent and also somewhat safe molecule in the NMB

category.

Apart from this, use of reversal agent in GA procedure has been very often or

common. Though, the main reason cited for the need to use reversal has been lower

than Atracurium, Rocuronium and Vecuronium, here 52.95% of doctors believe the

patient dose not required any reversal agent in case of Cisatracurium.

But, it is not true for all the molecules. In terms of Succinylcholine, 86.66% doctors

believe it doesnt need any reversal, as it is considered as self- reversal agent. More

than 50% of doctors have similar belief about Cisatracurium, which gives it

competitive advantage over available NMB agents.

While considering the distribution of GA procedures, it has been found that

Atracurium dominates the market share when it comes to above 60 minutes surgery or

3060.

But less than 30 minutes surgery is controlled by higher market share of Vecuronium,

Rocuronium than Atracurium. Where, Vecuronium has edge over the other two.

From the above analysis it is evident that Atracurium is the most preferred molecule

by doctors and also holds larger market share than other competitors.


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6.2CONCLUSION

The pharmaceutical industry currently represents a highly competitive environment.

Pharmaceutical companies have to operate in a highly regulated environment; the

degree of regulation to a significant extent depends on the country and type of the

product. One of the most important aspects of government regulation for

pharmaceutical companies is price regulation, and different countries have different

policies on this issue. As the result of price control, prices of the same products can

significantly differ in different countries.

With the new product launch, Cisatracurium it wouldnt be wrong to say that

company will enjoy the similar situation, if price being the competitive factor.With the Atracurium occupying the maximum market shares in NMB category, it

would be easy to be replaced by Cisatracurium. Since, it is one of the 10 isomers of

original molecule atracurium besylate. Prior to its launch and clinical use

Cisatracurium has been well positioned as self-reversal agent. Hence, it has good

positioning in terms of need of reversal agent. Cisatracurium being one of the safest

molecules in the NMB category, it can pick up in the market quiet well. As in the

research it has been found that safety is the most important characteristics that

doctor seeks in an ideal NMB and it is found by clinical research that Cisatracurium is

a safe NMB agent. Apart from this, majority of doctors has a belief that it would be

essential for all GA procedures.

Hence, it can be considered that the market condition and initial opinion about the

product is ideal for the launch of Cisatracurium.


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6.3 SUGGETIONS

The main challenges for drug companies come from four areas. First, they must deal

with competition from within and without. Second, they must manage within a world

of price controls that dictate a wide range of prices from place to place. Third,

companies must be constantly on guard for patent violations and seek legal protection

in new and growing global markets. Finally, they must manage their product pipelines

so that patent expirations do not leave them without protection for their investment.

Lastly, in terms of Cisatracurium the market development is essential which would

help the company in creating increased market share. For this purpose Soul Life

Science should focus on following:Cisatracurium being one of the 10 isomers of original molecule atracurium besylate; it

should be market as that way. Its advantages over Atracurium should be counted in its

marketing strategy.

There is a need of self-reversal agent in the NMB category, since the Succinylcholine

is only muscle relaxant available hence Cisatracurium should be positioned as self-

reversal agent. Most of the respondents already believe that it doesnt need any

reversal.

Safety and most vital characteristics for an ideal NMB which doctors prefer and

Cisatracurium is considered to possess this characteristics. Thus, it should be counted

in the marketing strategy of the product.


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6.4 LIMITATIONS

The selected sample may not be representing the entire population. The results from

the entire populations may be different.

The responses given by the respondents may be biased. This may distort the results.

The sample is selected only from the city Ahmedabad .So the results may not reflect

the view of entire state or nation.


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7. BIBLIOGRAPHY

7.1 BOOKS:

1. Cooper, D.R. and Schindler P.S., Business research method, eighth edition

Rao S.S, Handbook for writers and editors, AMA

2. Kothari C.R, Research Methodology methods & techniques, New AgeInternational (p) ltd. publishers, 2nd edition. Pp 188-98

3. Kotler, P.,& Keller, K.L(2009)Marketing management, 11 th, edition,Pearson education Asia publication

4. Medical Journals

7.2 INTERNET WEBSITE:

1. en.wikipedia.org/wiki/Pharmaceutical_industry_in_India (2-6-2012)

2. http://www.drugs.com/uk/cisatracurium-2-mg-ml-solution-for-injection-

infusion-leaflet.html

3. www.generalanaesthesia.info

4. www.soullifescience.com

5. www.wiki-meds.com
http://www.drugs.com/uk/cisatracurium-2-mg-ml-solution-for-injection-infusion-leaflet.htmlhttp://www.drugs.com/uk/cisatracurium-2-mg-ml-solution-for-injection-infusion-leaflet.htmlhttp://www.drugs.com/uk/cisatracurium-2-mg-ml-solution-for-injection-infusion-leaflet.htmlhttp://www.drugs.com/uk/cisatracurium-2-mg-ml-solution-for-injection-infusion-leaflet.htmlhttp://www.soullifescience.com/http://www.soullifescience.com/http://www.soullifescience.com/http://www.drugs.com/uk/cisatracurium-2-mg-ml-solution-for-injection-infusion-leaflet.htmlhttp://www.drugs.com/uk/cisatracurium-2-mg-ml-solution-for-injection-infusion-leaflet.html

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