Final Cadila Report

download Final Cadila Report

of 54

Transcript of Final Cadila Report

  • 7/28/2019 Final Cadila Report

    1/54

  • 7/28/2019 Final Cadila Report

    2/54

    Internationally the companies are facing short term as well as long-term pressures. To

    live auto the past growth rates they are truing to different things. Strengthening of

    Research marketing seams to be the focus :

    Top companies are merging.

    Divesting non-core healthcare businesses.

    Spending more on research to bring NCEs faster.

    Partnering with genomic and drug discovery companies.

    Increasing sales forces.

  • 7/28/2019 Final Cadila Report

    3/54

    Indian Scenario

    The Indian Pharmaceutical Industry today is in the front rank of Indias 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 ofmedicines, 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

  • 7/28/2019 Final Cadila Report

    4/54

    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.

    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 53 year old democracyand hence has a solid legal framework and strong

    financial markets. There is already an established international industry and business

    community.

    Information & Technology:

    It has a good network of world-class educational institutions and established

    strengths in Information Technology.

    Globalisation:The country is committed to a free market economy and globalization. Above all, it

    has a 70 million middle class market, which is continuously growing.

    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.

  • 7/28/2019 Final Cadila Report

    5/54

    THE GROWTH SCENARIO

    India's US$ 3.1 billion pharmaceutical industry is growing at the rate of 14 percent

    per year. It is one of the largest and most advanced among the developing countries.

    Over 20,000 registered pharmaceutical manufacturers exist in the country. The

    domestic pharmaceuticals industry output is expected to exceed Rs.260 billion in the

    financial year 2006, which accounts for merely 1.3% of the global pharmaceutical

    sector. Of this, bulk drugs will account for Rs. 54 bn (21%) and formulations, the

    remaining Rs. 210 bn (79%). In financial year 2005, imports were Rs. 20 bn while

    exports were Rs.87 bn.

    STEPS TO STRENGTHEN THE INDUSTRY

    Indian companies need to attain the right product-mix for sustained future growth.

    Core competencies will play an important role in determining the future of many

    Indian pharmaceutical companies in the post product-patent regime after 2005. Indiancompanies, in an effort to consolidate their position, will have to increasingly look at

    merger and acquisition options of either companies or products. This would help them

    to offset loss of new product options, improve their R&D efforts and improve

    distribution to penetrate markets.

    Research and development has always taken the back seat amongst Indian

    pharmaceutical companies. In order to stay competitive in the future, Indian

    companies will have to refocus and invest heavily in R&D.

    The Indian pharmaceutical industry also needs to take advantage of the recent

    advances in biotechnology and information technology. The future of the industry will

    be determined by how well it markets its products to several regions and distributes

    risks, its forward and backward integration capabilities, its R&D, its consolidation

    through mergers and acquisitions, co-marketing and licensing agreements.

  • 7/28/2019 Final Cadila Report

    6/54

    The Indian pharmaceutical industry is highly regulated. The Government controls

    prices of a large number of bulk drugs and formulations. Profit margins of players

    vary widely in both domestic and export sales due to many factors.

    Over 20,000-registered pharmaceutical manufacturer exist in the country. The market

    share of MNCs has fallen from 75% in 1971 to around 35% in the Indian

    Pharmaceuticals market, while the share of India companies has increased from 20%

    in 1971 to nearly 65%.

    The domestic pharmaceuticals industry output is expected to exceed Rs. 247 billion in

    FY 2006, which account for merely 15.6 % of the global pharmaceutical sector. Out

    of the bulk drugs will account for Rs. 54bn (21%) and formulations the remaining Rs.

    210bn (79%). In 2005, imports were Rs. 20bn while exports were Rs. 87bn.

    The Indian Pharmaceutical sector has increased drastically in the last two decades.

    The leading 250 pharmaceutical companies control 70% of the market with market

    leader having nearly 7% of the market share. It is an extremely fragmented market

    with severe price competition and government price control.

    External Trade:

    Indias pharmaceutical exports are to the tune of Rs. 87 bn, of which formulations

    contribute nearly 55% and the rest 45% comes from the bulk drugs. In FY 2005

    exports grew by 21%. Indias pharmaceuticals imports were to the tune of Rs. 20.3bn

    in FY 2006. Imports have registered a CAGR of only 2% in the past 5 years. Imports

    of bulk drugs have slowed down in the past 2-3 years.

    The Indian pharmaceutical industry is highly regulated. The Government controls

    prices of a large number of bulk drugs and formulations. Profit margins of players

    vary widely in both domestic and export sales due to many factors.

  • 7/28/2019 Final Cadila Report

    7/54

    Future Prospects:

    As per WTO, from the year 2005, India will grant product patent recognition to allNew Chemical Entities (NCEs) i.e. bulk drugs develop then onwards. This leaves

    another 3 years of MNCs research output open to process piracy. But, long-term

    prospects for MNCs are good.

    Strategies of Domestic players:

    Most of the domestic companies are expanding the therapeutic reach through new

    product launches in high margin segments, thus enhancing the product portfolio

    (proper basket of products helps in convincing the medical fraternity) and increasing

    the critical mass. The long-term objective will be to enter into a higher platform of

    biotechnology and drug delivery systems.

  • 7/28/2019 Final Cadila Report

    8/54

    CADILA PHARMACEUTICALS

    THE INDIAN PHENOMENON

    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 pharmaceutical scenario in India consists of a host of varied companies. All

    compromising of a wide mix of organizational structures, climates and cultures.

    Running the gamut from the deeply traditional to the radically modern. Each

    advocating its special parameters for corporate success factors that differentiates

    between the merely good and the truly exceptional.

    And every once in a while, there comes along one, which is just that, truly

    exceptional. An organization that takes its work dead seriously and its word even

    more so. A work that stands for its deep-rooted commitment to its end-users,

    markets, employees and associates. An organization like CADILA PHARMA

    CEUTICALS LIMITED (CPL).

    A company that came into being shortly after independence, (1951) when India

    wasnt considered capable of handling something as crucial as health care and as

    critical as life saving drugs. It wasnt long before the detractors were proven wrong.

    Within a year, CADILA became the first pharmaceutical company in the world to

    provide Vitamin B1, B6 and B12 together, in a compatible form.

    Climbing steadily, from one triumph to another, crossing milestones in rapid

    succession, CADILA PHARMACEUTICALS LTD., over the years has established

    itself as a major pharma player.

    Having emerged successfully with largest range of therapeutic groups, spanning 45

    segments, with offices in four countries, exports to 90 nations and a wide range of

    products registered oversees, CADILA PHARMACEUTICALS is a top 20 ranking

    Indian Pharmaceuticals Group. Backed by world-class R&D and manufacturing

    facilities, CADILA PHARMACEUTICALS covers the largest range of therapeutic

    groups, in the Indian Pharmaceuticals Industry.

  • 7/28/2019 Final Cadila Report

    9/54

    Sphere of Activities

    Research &Development Travel & Tea Estate HospitalHuman Branded Pharmaceutical Disposables

    Formulations Machinery Mfg. Critical Care

    Generics SpecialtyVeterinary Chemicals &

    Herbal Lab care

    Ago Business

    Bulk Drugs

    International Business

  • 7/28/2019 Final Cadila Report

    10/54

    SPHERE OF ACTIVITIES

  • 7/28/2019 Final Cadila Report

    11/54

  • 7/28/2019 Final Cadila Report

    12/54

    COMPANY PROFILE

    Name of the concern Cadila Pharmaceuticals Limited

    Constitution Public Limited Company

    Date of Incorporation February 28, 1991

    Business Group Cadila Pharmaceuticals

    (Modi Group)

    List of companies under Cadila Pharmaceuticals Ltd.Same management Casil Health Products Ltd.

    Karnavati Engineering Ltd.Green Channel Travel ServicesLtd.IRM Labs Ltd.

  • 7/28/2019 Final Cadila Report

    13/54

    Corporate office

    Cadila Pharmaceuticals Limited

    "Cadila Corporate Campus"

    Sarkhej-Dholka Road,

    Bhat, Ahmedabad-382 210, INDIA.

    Phone : +91-2718-225001 (15 Lines)

    Fax :+91-2718-225039

    e-mail :[email protected]

    Situated in the close vicinity of Ahmadabad, yet away from the hustle and bustle of

    the city life, is a serene location called Bhat. And their new Corporate Complex at

    Bhat has already sensationalized the location! Spread over 15 Acres piece of verdant,

    lush green land free from any kind of pollution, CADILA PHARMACEUTICALS

    New Corporate Complex is setting an example, in the corporate history of India.

    Cadila vision

    mailto:[email protected]:[email protected]:[email protected]
  • 7/28/2019 Final Cadila Report

    14/54

    Our aim, to be a global player, will lead to the establishment of operations

    in the key markets of the world, including the developed countries.

    We shall seekjoint ventures with partners who are major players in their

    country or region.

    We aspire to enrich our people - our driving force to become highly

    competent professionals and technology based.

    By the turn of this decade, we shall be amongst the most admired

    companies in India."

    Cadila mission

  • 7/28/2019 Final Cadila Report

    15/54

    "We strive for a happier, healthier tomorrow. We shall provide

    total customer satisfaction and achieve leadership in chosen

    markets, products and services across the globe, through

    excellence in technology, based on world-class

    Research and Development.

    We are responsible to the society. We shall be good

    corporate citizens and will be driven by high

    Ethical standards in our practices."

    Our human resources will continue to be the most valuable

    asset in this pursuit of leadership and the prime

    driving force for our growth.

  • 7/28/2019 Final Cadila Report

    16/54

    CADILA PHARMACEUTICALS

    A True Life Sciences Company

    CADILA PHARMACEUTICALS, Ahmedabad, India is a top ranking

    pharmaceuticals group with an annual turnover of Rs. 5500 million.

    In tune with its corporate objectives, CADILA PHARMACEUTICALS is rapidly

    expanding its global presence. CADILA PHARMACEUTICALS envisages a sharp

    focus on product segments for growth, coupled with strategic alliances in key areas.

    CADILA PHARMACEUTICALS is an integrated healthcare solutions provider

    comprising Strategic Business Units: Human Branded Formulations, Generic &

    Ontological Products, Animal Health & Natural Products, Biotech, Bulk Actives and

    International Business.

    The Company aims to take its exports turnover. Last year, in an effort to tape the

    North and South American markets, the company set up a US subsidiary; CPL Inc.

    Besides the company has already applied for 40 patents in the US to grow into new

    categories.

  • 7/28/2019 Final Cadila Report

    17/54

  • 7/28/2019 Final Cadila Report

    18/54

    Manufacturing Excellence

    Pursuant to its corporate philosophy of striving for continuous improvement and

    betterment, the Company has re-located its manufacturing operations at the state-of-

    the-art plant at Dholka, located 50 km from Ahmedabad, the commercial capital of

    Gujarat. Spread over 44 acres of verdant, picturesque surroundings, amidst lush green

    lawns and thick foliage, the new locale is the most envied pharmaceutical installation

    in the Asian sub-continent.

    Truly unique in every sense of the term, the Plants standards and facilities can match any other,

    worldwide. Seven zones of cleanliness have been defined and adhered to, as per the 1997 GMPguidelines of the European Union. Some of the salient features of the design concepts:

    No wood or asbestos component.

    Each zone has separate AHUs (Air Handling Units), dehumidification unit and

    dust extraction systems.

    Segregation of every critical processing activity in each zone, to avoid cross-

    contamination.

    Adherence to stringent specifications of USFDA, MCA(UK), MCC(South

    Africa) and TGA(Australia).

  • 7/28/2019 Final Cadila Report

    19/54

    Respective zones, areas and even uniforms marked with specific colours of the

    rainbow (Indradhanush in the vernacular), to ensure total segregation.

    Air environment conditioned in each area with respect to temperature,

    humidity, filtration, particle counts, etc.

    Conformation of each processing stage with US Federal Standard 209E class

    of cleanliness; viz. 100, 1,000, 10,000, 100,000 with respect to room air

    changes, pressure, particle count, flow direction etc.

    Duo Pass Reverse Osmosis (RO) water system, multi-stage distillation plant,

    self-sanitizing, sanitary SS 31 6L loops water, water for injection with online

    monitoring of pH, temperature, conductivity and TOC requirements as per

    USP XXIV.

    Zero-discharge Effluent Treatment Plant constructed using technology from

    Advent Integrated System, USA.

    Environment-friendly VAHP chillers.

    Rigvent heat extraction devices and Natural Skylit system in raw material,

    packing material and finished good stores.

    Isolated and dedicated production facilities for B-Lactum and Cephalosporin

    dosage forms

    .

  • 7/28/2019 Final Cadila Report

    20/54

    Cadila Pharmaceuticals has also commissioned a modern, sophisticated

    manufacturing facility for Soft Gelatin Capsules at its Kadi Complex. Designed to

    meet the most stringent international standards, all operations in this plant from

    encapsulation to packaging, are carried out under class 100,000. All systems are

    validated to meet International FDA standards, and the present capacity of one million

    capsules per day can be doubled with marginal investments

    OTHER MANUFACTURING LOCATIONS

    Surgical Supplies, Halol

    Plant Tissue Culture, Hirapur

    Casil Health Products Ltd.,

    Pharma Machinery Manufacturing Facilities at Kadi

    Speciality Chemicals & Soft Gelatin Capsules Manufacturing Facilities at

    Kadi

    Active Pharmaceutical Ingredients (APIs), Ankleshwar

    New Facility in J & K

    Cadila Pharmaceuticals Ltd will commission its manufacturing facility for

    formulations in Jammu and Kashmir, by December this year. The Rs.600 Crore

    SOFT GELATIN MANUFACTURING

  • 7/28/2019 Final Cadila Report

    21/54

    Pharma company is investing Rs.45 Crore in bringing up this new facility at Samba to

    take advantage of the excise and income tax benefits being doled out by the Centre to

    promote investments in Jammu and Kashmir.

    This will not only help the company in fulfilling its corporate objective of making

    available quality medicines at affordable prices but also help in providing ample

    employment opportunities to the local population in Jammu, said Shri I. A. Modi,

    Cadila Pharmaceuticals Ltd.

    The unit will have a capacity to manufacture 1, 019.4 million tablets per annum, 1329

    million tablets and capsule packing (strips and blisters), 150 million capsules, 1500

    kiloliters liquid formulations and 14.4 million bottles.

    Several pharma companies from Gujarat have set up manufacturing facilities in tax-

    free zones such as Baddi in Himachal Pradesh, Uttaranchal and J&K. The facility will

    have a linear manufacturing structure with six manufacturing lines. Four lines will be

    for tablets, one for capsules manufacturing and sixth for liquid formulations.

    A company spokesman said that the total value of production from this unit is likely

    to be close to Rs.350 Crore per year. It would solely cater to the domestic market.

    The Jammu unit will also help us boost exports from the present facility at Dholka,

    near Ahmedabad, the spokesman said.

    The centre has exempted the payment of excise duty on the goods produced in Jammu

    and Kashmir for 10 years. They have also provided for income tax exemption for 10

    years from the year of commercial production, besides several other financial

    benefits. Samba is situated on the National highway and CPL's factory is only 1.5 km

    away from the national highway.

    Distribution Network

  • 7/28/2019 Final Cadila Report

    22/54

    The company has more than 1,10,000 retailers, 2200 stockiest, 25 C & F agents and

    36 full-fledged divisional agencies to keep the company in touch with the people in

    almost each and every part of the country. The countrywide distribution network is so

    strong that any new product launched by the company is available across the country

    within 72 hours.

  • 7/28/2019 Final Cadila Report

    23/54

    RESEARCH METHOD

    DEFINE THE RESEARCH PROBLEM

    DESIGN THE RESEARCH PROCESS

    CONDUCT THE PILOT SURVEY

    ANALYSIS & MODIFICATION

    CONDUCT THE MAIN SURVEY

    COLLECT PRIMARY DATA FROM CUISTOMER

    ANALYSIS & TABULATE THE DATA

    INTERPRETE & REPORT THE FINDING

  • 7/28/2019 Final Cadila Report

    24/54

    RESEARCH METHODOLOGY

    The research was conducted in the following stages.

    1. To define the research problem and identify the research objectives.

    A molecule which is new in the market and presence of other substitute antibiotics makes

    competition high, it is necessary to understand the Drs choices of treating infection. Hence the

    objective of the project was decided as Potential Of Linezolid In ICU / Hospital

    2. Design a research process.

    Research approach

    Personal interviews with a structured questionnaire with doctors was decided as the medium to

    collect data which would be first hand and unbiased, directly from the customer.

    Research instrument

    A sample of questions first made and than after consulting with person in-charge relevant

    questions were filtered out for pilot survey.

    Sampling plan

    The nature of research necessitated the use of doctors with sample size of 60 in Ahmedabad.

    Main hospitals of Ahmedabad were surveyed.

    Pilot survey

    Twenty-five doctors from Ahmedabad was visited to check the efficacy of the research

    questionnaire

    3. Analysis and modification.

    The finding of the pilot survey suggested no change in the questionnaire, so as to obtain

    maximum possible information from the customer. No change were require in the research

    approach.

  • 7/28/2019 Final Cadila Report

    25/54

    4. Main survey

    Some potential doctors were also surveyed from the private clinics and ICU in-charge in

    hospitals with the total sample size of 60 doctors.

    5. Data analysis

    The data was analyzed systematically to give the following information.

    No of doctors which are normally using particular antibiotics in ICU/critical caresetting.

    Preference of culture sensitivity test in percentage.

    Percentage of resistance gram(+)ve infection and resistance gram(-)ve infection. Top five choice of treatment for resistance gram(+)ve infection and resistancegram(-)ve infection.

    Effectiveness of different drugs in doctors point of view. Attributes for their prefrence. Brand that is in the top of doctors mind. Average no. of prescription given by doctors in a month.

    6. Present the major findings.

    The major findings of the survey have been highlighted. Certain suggestions and

    recommendation have been given to improve the sales.

  • 7/28/2019 Final Cadila Report

    26/54

    ABOUT LINEZOLID

    Linezolid is the leading agent in a new chemical class of antibiotics, the oxazolidinones,which have a novel structure. Oxazolidinones are protein synthesis inhibitors that prevent

    the formation of the bacterial 705 ribosomal initiation complex. Linezolid's unique

    targeting of the protein synthesis machinery has no pre-existing resistance mechanism in

    nature. During evaluation, there were no bacteria found that were resistant to linezolid.

    Thus, linezolid can be used as an empirical therapy when there is a known resistance to

    other classes of drugs.

    Oxazolidinones are active against Gram-positive bacteria, including antibiotic-resistant

    strains, such as methi-cillin-resistant Staphylococcus aureus (MRSA), penicillin-resistant

    Streptococcus pneumoniae (PR5P), and vanco-mycin-resistant f nferococeus faecium

    (VREF). Linezolid is particularly useful in treating nosocomial infections that are resistant to

    other antibiotics. Linezolid is available in oral formulations, tablets, or oral suspensions,

    and is injectable. This gives linezolid an advantage over vancomycin, which can only be

    given by the intravenous (IV) route. Patients may be discharged from hospital early

    following IV linezolid therapy and continue oral therapy at home with no loss of efficacy.

    When administered to patients, a single 600 mg oral dose of linezolid results in a plasma

    concentration of up to 18 mg/L, which is higher than the minimal concentration required to

    inhibit the growth of S. aureus (4 g/L) for about 16 hours.3 This pharmacokinetic profile

    illustrates the effectiveness of linezolid in treating Gram-positive infections in humans.

  • 7/28/2019 Final Cadila Report

    27/54

    DRUG FOCUS

    Glycopeptlde-resistant enterococci The enterococci are normal commensals of the bowel

    with only moderate virulence in normals. They cause infections of the urinary and biliary

    tracts, sometime* wounds, and occasionally more serious and invasive disease in the

    compromised. They are becoming more common, probably because they are increasingly

    antibiotic resistant, especially to the cephulosporins. quinolones and aminoglycosidcs used

    against Gram-negative infections." Among the enterococci. Enterococcus fatcalis is the most

    common human pathogen; however, Enterococcta faecium, which is more inherently

    resistant, is being seen with increasing frequency. Furthermore, since the mid-1980s,

    VRE or ORE have appeared. This glycopeptide resistance is most commonly seen in K.faecium and usually occurs in renal, hepatic or haematological transplant patients. Some

    enterococci are thus now resistant to all commonly available antibiotics.

    GRE are most common in the US, where the percentage of enterococci resistant to

    vancomycin causing nosocomial infection increased from 0.4% to more than 10%

    between 1989 and 1995." GRE infections are less common in Europe, where, however,

    these organisms arc said to colonise the bowels of normal people in low numbers." This

    may be because, until recently, farm animals in many European countries were fed the

    growth-promoting glycopeptide avoparcin, which encourages colonisation with GRE

    and subsequent contamination of meat products." In the UK, GRE are being isolated

    from hospital patients in increasing numbers and several hospital outbreaks have besn

    seen.

    The most important and commonest type of glycopeptide resistance is called Van A,

    which is high-level resistance to both vancomycin and teicoplanin which can transfer

    between enterococci on plasmids and transposons.This resistance has been transferred in

    the laboratory to several other Gram-positive bacteria, including S. aureus." It is

    probably inevitable this will eventually happen in nature and the resulting high-level

    glycopeptide resistance in MRSA will be a much more serious problem than the present

    low-level resistance seen in sporadic isolates of VISA. Since we have become so

    dependent on the glycopeptides as the treatment of last resort for MAR Gram-positives,

    the transfer of high level Van A resistance from GRE to pneumococci and staphylococci

    could produce potentially untreatable and lethal infections.

  • 7/28/2019 Final Cadila Report

    28/54

    NEW ANTIMICROBIALS FOR RESISTANT GRAM-POSITIVE

    INFECTIONS

    The problem of increasing antibiotic resistance is now recognised as a global emergencyand

    has been recently addressed in the UK by the reports of the House of Lords Science andTechnology Committee (1998) and the Standing Medical Advisory Committee (1998).14

    The problem can be partly resolved by improvements in the control of hospital cross-infection

    and the reduction of unnecessary antibiotic usage, but it is also essential to have new agents

    to treat MAR staphylococci, streptococci and enterococci.

    Figure 1. The structure of linezolid

  • 7/28/2019 Final Cadila Report

    29/54

    Several new drugs for resistant Gram-positive infections are in development, including

    new derivatives of macrolidex, kctolidcs. sireptogramins, quinolones and glycopeptides.

    The new intravenous streptogramin combination quinupristin plus dalfopristin (Synercid) was

    licensed for clinical use in Europe in 1999. Synercid is active against MAR pneumococci,

    staphylococci and enlerococci, but not E.faecalis. Fortunately, E.faecalis usually remains

    susceptible to ampicillin. All these agents are developments or derivatives of older drugs. To

    these can now be added the oxazolidinoncs. the first new class of antibacterial compounds

    to be developed in more than two decades.

    LINEZOLID, THE FIRST OF THE OXAZOLIDONONES

    The oxazolidinones are entirely artificial compounds that were first discovered by the

    DuPont Company in the 1970s. Some early oxazolidinones had in vitro activity against

    Gram-positive bacteria, but they were not developed for human use because of serious

    animal toxicity. The Upjohn Company (now Pharmacia & Upjohn) revived oxidolidinone

    research in the 1990s and discovered new derivatives that retained good antibacterial

    activity but without animal toxicity. The first of these to be developed for clinical use is

    linezolid (Zyvox) (formerly U-100766), a synthetic 3-(fluoropbenyl)-2-oxazolidiiione that

    has a morpholin-1-yl group substitution (Figure 1). Linezolid was licensed for clinical use

    in the US in March 2000, but much of the information on linezolid has not yet been

    published in peer reviewed journals and is held on file by Pharmacia & Upjohn. However,

    a document produced by the manufacturers for the Anti-Infective Drug Products Advisory

    Committee meeting of the Food and Drug Administration (FDA) last March contains much

    of the relevant information.

    Antimicrobial activity, mechanism of action and development of resistance

    Linezolid is active against most clinically important Gram-positive cocci, including

    penicillin-resistant pneumococci, MRSA and GRE, with minimum inhibitory

    concentrations (MICs) ranging from 0.25 to 4 mg/1 and usually falling between 1 and 2

    29

  • 7/28/2019 Final Cadila Report

    30/54

    mg/1" . Breakpoints of 2-4 mg/l" have been suggested ( isolates with in vitro linezolid

    MICs of =

  • 7/28/2019 Final Cadila Report

    31/54

    No.of Doctor

    40%

    22%

    19%

    13%

    6%

    1 Cephalosporin

    2 Aminoglycocide

    3 Augmentin

    4 ceftazidine

    5 Amoxicillin

    Interpretation:

    In I.C.U./critical care setting majority of Drs. are Preferring

    cephalosporin.

    Reason :

    Cephalosporin good result (Cefotexin +Amikacin+metrogyl) combination. Cover all bacterialinfections.

    Aminoglycocide good response from patients.

    31

  • 7/28/2019 Final Cadila Report

    32/54

    Mainly ceftazidine for good result & both gram +ve and gram vecoverage.

    2) How many cases of infections do you investigate for culture sensitivity?

    (a) upto 25% (b) upto 50%

    (b) (c) upto 75% (d) upto 100%

    Finding:

    32

  • 7/28/2019 Final Cadila Report

    33/54

    Interpretation:

    All doctors preferring culture sensitivity test.

    33

    Sr .no Option No.of Drs

    1 (a)up to 25% 17

    2 (b)up to 50% 11

    3 (c)up to 75% 13

    4 (d)up to 100% 19

    18%22%

    32% 28%

    25%

    50%

    75%

    100%

  • 7/28/2019 Final Cadila Report

    34/54

    (3) From these what are % of resistant gram (+)ve and gram (-)ve infections?

    ______________________________________________________________________________________________________________________

    Finding:

    Average

    37%

    63%

    0%

    20%

    40%

    60%

    80%

    Gram +ve Gram -ve

    Average

    Interpretation:

    Cases of gram (+)ve infection is comparative low than gram (-)ve infection.

    34

  • 7/28/2019 Final Cadila Report

    35/54

    (4) Your choice of treatment for gram (+)ve infection.

    (a)_______________________________________________________.

    (b)_______________________________________________________.

    (c)_______________________________________________________.

    (d)_______________________________________________________.

    Finding:

    Top Five Choice of antibiotics

    Interpretation:

    35

    Sr. no Name No.of Doctor

    1 Cephalosporin 21

    2 Augmentin 13

    3 (Amoxicillin+clavulinic acid) 12

    4 Linezolid 11

    5 Vancomycin 11

    No.of Doctor

    31%

    19%18%

    16%

    16%

    1 Cephalosporin

    2 Augmentin

    3 (Amoxicillin + clavulinic

    acid)

    4 Linezolid

    5 Vancomycin

  • 7/28/2019 Final Cadila Report

    36/54

    IIIrd or IVth Cephalosporin, (Amoxicillin + Clavulinic acid) combination,

    Vancomycin, Linezolid.

    These are the main choice of doctors while treating gram positive infections,

    in that Cephalosporin is most preferable.

    (5) Your choice of treatment for gram (-)ve infection .

    (a)________________________________________________________.

    (b)________________________________________________________.

    (c)________________________________________________________.

    (d)___________________________________________________________.

    Finding:

    Top Five Choice of antibiotics

    Sr.no Name No.of Doctor

    1 Amikacin 24

    2 Cephalosporin 20

    3 Aminoglycocide 18

    4 (Piperaceline+Tazobactum) 75 Quinolone 6

    Interpretation:

    36

    32%

    27%

    24%

    9%

    8%

    1 Amikacin

    2 Cephalosporin

    3 Aminoglycocide

    4

    (Piperaceline+Taz

    obactum)

    5 Quinolone

  • 7/28/2019 Final Cadila Report

    37/54

    Aminoglycocide, (Amikacin/Tobramycin), (Piperaceline +

    Tazobactum) combation, IIIrd or IVth Cephalosporin.

    Main preference of the doctors is Aminoglycocide and

    (Amikacin/Tobramycin) while treating gram ve infection .

    (6) While treating gram (+)ve infections how do you define effectiveness of

    these drugs.

    Not Good Ok Good Excellent

    (a) Linezolid

    (b)Vancomycin

    (c) Teicoplanin

    (d) Meropenam

    (e) __________

    (any other please specify)

    37

  • 7/28/2019 Final Cadila Report

    38/54

    Effectiveness

    1

    14

    26

    10

    6

    0

    13

    31

    14

    1 0

    13

    23

    12

    7

    2

    15

    20

    14

    9

    0

    5

    10

    15

    20

    25

    30

    35

    Performance

    cases

    Linezolid

    Vancomycin

    Teicoplanin

    Meropenam

    Interpretation:

    Vancomycin is Excellent one in case of effectiveness against

    gram(+)ve infection, than comes Meropenam.

    Linezolid and Teicoplanin are consider as a Good one.

    38

  • 7/28/2019 Final Cadila Report

    39/54

    (7) In ICU/ critical care setting which antibiotic do you feel is must and why ?

    ____________________________________________________

    ____________________________________________________

    Finding :

    Sr .no Option No. of Drs In Percentage

    1 Depend 36 60%

    2 Others 24 40%

    39

  • 7/28/2019 Final Cadila Report

    40/54

    Interpretation:

    60% doctors thinking depends upon culture sensitivity.

    40% doctors giving other antibiotics name.

    Some doctors preferring Cephalosporin for gram (+)ve infection and

    Aminoglycocide for gram ()ve infectionand some are preferring

    (Piperaceline + Tazobactum) combination.

    (8)Please rank the below given criteria for Rx in terms of their importance while

    treating resistant gram (+)ve infection.

    (a) Cost (b) Efficacy

    (c) Safety (d) Availability

    Finding:

    40

    Any must antibiotics

    60%

    40%Depend on culture

    sensitivity

    Others

  • 7/28/2019 Final Cadila Report

    41/54

    Ranking

    53

    18

    0 06

    41

    2 01 0

    24

    34

    0 0

    3326

    0

    20

    40

    60

    Factors

    Performance

    First

    Second

    Third

    Forth

    First 53 18 0 0

    Second 6 41 2 0

    Third 1 0 24 34

    Forth 0 0 33 26

    Efficacy Safety CostAvailabili

    ty

    Interpretation:

    Majority of Drs. preferring EFFICACY hence they are preferring SAFETY

    also, but the no. 1 ranking is EFFICACY.

    Very few doctors concerning with price, but the availability is in-evitable.

    9) Do you use Linezolid ? Yes No

    Why ?

    ___________________________________________________________________

    ___________________________________________________________________.

    41

  • 7/28/2019 Final Cadila Report

    42/54

    Using Linezolid

    Yes

    80%

    No

    20%

    Yes

    No

    Finding :-

    Sr. no Using No.of Drs

    1 Yes 48

    2 No 12

    Interpretation:

    80% doctors are using Linezolid so, great potential ofLinezolid was found.

    Reasons :-

    Good coverage.

    Economically and effective.

    To cover M.R S.A.

    I.V & oral available.

    10) Name one brand / company of Linezolid which come first to your mind. (a)

    _______________________

    Why ?

    42

  • 7/28/2019 Final Cadila Report

    43/54

    (i) Efficacy

    (ii) Regular M. R. visit

    (iii) CME attended

    (iv) Regular information provided by company

    (v) Price

    (vi) Discount

    (vii) Availability

    Finding:

    Sr. no Name of Brand No.of Doctor

    1 Linox 16

    2 Linid 16

    3 Lizolid 7

    4 Lizbid 5

    5 Targocid 1

    Interpretation:

    43

    No.of Doctor

    35%

    36%

    16%

    11% 2%

    1 Linox

    2 Linid

    3 Lizolid

    4 Lizbid

    5 Targocid

  • 7/28/2019 Final Cadila Report

    44/54

    Linox ( from Unichem) and Linid( from Cadila) both

    are equal positioning in the mind of doctors as shown

    in pie chart.

    Reason :

    EFFICACY and AVAILABILITY these are main

    reasons.

    Then comes the regular M.R visit.

    44

  • 7/28/2019 Final Cadila Report

    45/54

    Prescription in a month

    12

    117

    6

    6

    3 21

    2 to 3

    1 to 2

    4 to 5

    3 to 47 to 10

    10 to 15

    5 to 6

    15 to 20

    (11) Approx no of prescription given for Linezolid in a month ________________

    Finding:

    Sr. no Range No.of Doctor

    1 2 to 3 12

    2 1 to 2 11

    3 4 to 5 7

    4 3 to 4 6

    5 7 to 10 6

    6 10 to 15 3

    7 5 to 6 2

    8 15 to 20 1

    Interpretation:

    45

  • 7/28/2019 Final Cadila Report

    46/54

    2 to 3 prescription in a month found 12 times which is highest.

    Than comes 1 to 2 prescription in a month found 11 times.

    There is also not available or none prescription found in 11

    sample.

    We can say majority of doctors giving prescription in range of

    1 to 3.

    46

  • 7/28/2019 Final Cadila Report

    47/54

    FINDINGS

    Cephalosporins is mainly use as antibiotic in critical care setting due to good

    coverage.

    All the doctors go for culture sensitivity report.

    There are comparatively low cases of gram(+) infection found.

    Cephalosporins is mainly use for treating gram(+) infection.

    Amikacin is mainly use for treating gram(-) infection.

    Vancomycin and Teicoplanin these drugs are Execellentwhile treating gram(+)

    infections.

    Any antibiotics is not must this is depends upon culture sensitivity. But some

    doctors preferring Cephalosporin for gram (+)ve infection and Aminoglycocide

    for gram ()ve infection and some are preferring (Piperaceline + Tazobactum)

    combination.

    88% doctors giving the no.1 rank to Efficacy.

    80% doctors are using linezolid.

    Reason:

    Good coverage. Economically and effective. to cover M.R S.A. I.V & oral available.

    16 times Linox and 16 times Linezolid both are comes first in the mind ofdoctor.

    Reason:

    47

  • 7/28/2019 Final Cadila Report

    48/54

  • 7/28/2019 Final Cadila Report

    49/54

    CONCLUSION

    From the overall survey and findings it shows that the

    Potential of Linezolid is Good in ICU/hospitals. It is good in

    terms of effectiveness but from the doctors point of view

    vancomycin is excellent one. Now a days prescription of

    linezolid is increasing, so the usage of Linid for treating

    gram(+)ve infection is progressive.

    49

  • 7/28/2019 Final Cadila Report

    50/54

    ANNEXURE

    Name of Dr. ________________________________

    Qualification / Speciality _______________________

    Address ____________________________________

    ____________________________________________

    Ph . no ____________ email-id __________________

    POTENTIAL OF LINEZOLID IN ICU / HOSPITAL

    1) In ICU/critical care setting which antibiotics do you use and why ?

    ____________________________________________________________________

    ____________________________________________________________________

    __

    2) How many cases of infections do you investigate for culture sensitivity?

    (a) upto 25%

    (b) upto 50%

    (c) upto 75%

    (d) upto 100%

    50

  • 7/28/2019 Final Cadila Report

    51/54

    (3) From these what are % of resistant gram (+)ve and gram(-)ve infections?

    ___________________________________________________________

    ___________________________________________________________

    (4) Your choice of treatment for gram (+)ve infection.

    (a)_______________________________________________________

    (b)______________________________________________________

    (c)_______________________________________________________

    (d)_______________________________________________________

    (5) Your choice of treatment for gram (-)ve infection .

    (a)___________________________________________________________

    (b)__________________________________________________________

    (c)___________________________________________________________

    (d)___________________________________________________________

    (6) While treating gram (+)ve infections how do you define effectiveness of

    these drugs.

    Not Good Ok Good Excellent

    (b) Linezolid

    (b)Vancomycin

    (c) Teicoplanin

    (f) Meropenam

    (g) __________

    51

  • 7/28/2019 Final Cadila Report

    52/54

    (any other please specify)

    (7) In ICU/ critical care setting which antibiotic do you feel is must and why ?

    ____________________________________________________

    ____________________________________________________

    (8) Please rank the below given criteria for Rx in terms of their importance

    while treating resistant gram (+)ve infection

    (a) Cost

    (b) Efficacy

    (c) Safety

    (d) Availability

    9) Do you use Linezolid ? Yes No

    why ?

    ___________________________________________________________________

    ___________________________________________________________________.

    10) Name one brand / company of Linezolid which come first to your mind.

    (a) _______________________

    why ?

    (i) Efficacy

    52

  • 7/28/2019 Final Cadila Report

    53/54

    (ii) Regular M. R. visit

    (iii) CME attended

    (iv) Regular information provided by company

    (v) Price

    (vi) Discount

    (vii) Availability

    (11) Approx no of prescription given for Linezolid in a month _______________.

    BIBLIOGRAPHY

    Marketing Management by Philip kotler

    www.google.com

    www.cadilapharma.com

    53

    http://www.google.com/http://www.cadilapharma.com/http://www.google.com/http://www.cadilapharma.com/
  • 7/28/2019 Final Cadila Report

    54/54