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INDIAN PHARMA
INTRODUCTION


 India is today recognized as one of
  the leading global players in
  pharmaceuticals.
 Indiian pharma industry has shown
  tremendous progress in terms of
  infrastructure
  development, technology base &
  wide range of products.
Contd….
    The industry now produces bulk drugs

    belonging to all major therapeutic
    groups requiring complicated
    manufacturing processes and has also
    developed excellent GMP (Good
    Manufacturing Practices) compliant
    facilities for the production of different
    dosage forms.
    The strength of the industry is in

    developing cost effective technologies
    in the shortest possible time for drug
    intermediates and bulk activities
    without compromising on quality.
THE DOMESTIC PHARMA
INDUSTRY pharma industry has
  Domestic
  recently achieved some historic
  milestones through a leadership
  position and global presence as a
  world class cost effective generic
  drugs' manufacturer of AIDS
  medicines.
 Many Indian companies maintain
  highest standards in Purity, Stability
  and International Safety, Health and
  Environmental (SHE) protection in
  production and supply of bulk drugs
  even to some innovator companies.
Contd…
 Many Indian companies are part of
  an agreement where major AIDS
  drugs based on Lamivudine,
  Stavudine, Zidovudine, Nevirapine
  will be supplied to Mozambique,
  Rwanda, South Africa and Tanzania
  which have about 33% of all people
  living with AIDS in Africa. Yet
  another US Scheme envisages
  sourcing Anti Retrovirals from some
  Indian companies whose products
  are already US FDA approved.
Contd…
  Increasing       number       of    Indian

  pharmaceutical companies have been
  getting international regulatory approvals
  for their plants from agencies like
  USFDA (USA), MHRA (UK), TGA
  (Australia), MCC (South Africa), Health
  Canada etc.
 Indian companies are now seeking more
  Abbreviated New Drug Approvals
  (ANDAs) in USA in specialized segments
  like anti-infective, cardio vascular and
  central nervous system groups.
FACTS &
FIGURES
  The     annual    turnover     of   Indian

  pharmaceuticals industry in 2006-07
  was approx $17 billion (over 68,000
  crore).
 The      share        of     export       of
  drugs,     pharmaceuticals,       &    fine
  chemicals was more than 24,000
  cr.(around us $ 6 billion) .
Contd…
  Europe accounts for the highest share of

  over 23% of Indian Pharma exports
  followed by North America and Asia.
  Exports to USA have crossed the land
  mark figure of US $1 billion during 2006-
  07.
 It is estimated that by the year 2010, the
  Indian pharmaceutical industry has the
  potential to achieve over Rs.1,00,000
  crore production of formulations and bulk
  drugs.
PRODUCTION
    During 2007-08 several proposals for

    technology     transfer  including   joint
    ventures, proposals for foreign direct
    investment,     setting   up    of   new
    undertakings/expansion of existing units
    (manufacture of new articles in the
    existing units) have been received and
    processed. Following the de-licensing of
    the pharmaceutical industry, industry is
    now required to submit Industrial
    Entrepreneurial Memorandums (lEMs) for
    the manufacture of various bulk
    drugs/drug intermediates /formulations.
EXPORTS
            Year             Exports(Rs. In             Growth(%)
                             crore)
          2003-04                  15213                    18.61

          2004-05                  17857                    17.38

          2005-06                   22216                    24.41

          2006-07                   24942                    12.27

    Source: Directorate General of Commercial Intelligence and Statistics

    (DGCIS) Kolkata
INDUSTRY
STRENGTHS
 Knowledge based Industry
 Large  manufacturing base for high
  quality drugs and formulations
 Developing cost effective
  technologies for drug
  intermediaries and bulk actives
  without a compromise on quality
Contd…..
  Cost advantage in terms of drug

  production,    maintenance       of    high
  standards in terms of purity, stability and
  international    safety,    health      and
  environment protection
 Tremendous export potential
 Major driver of growth in the future
 Strong     scientific    and      technical
  manpower
Contd….
  World class national laboratories in

  process development
 Increasing balance of trade in the sector
 An excellent centre for clinical trials
 Competencies in chemistry and process
  development
THANK
YOU

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Indian Pharma

  • 2. INTRODUCTION  India is today recognized as one of the leading global players in pharmaceuticals.  Indiian pharma industry has shown tremendous progress in terms of infrastructure development, technology base & wide range of products.
  • 3. Contd…. The industry now produces bulk drugs  belonging to all major therapeutic groups requiring complicated manufacturing processes and has also developed excellent GMP (Good Manufacturing Practices) compliant facilities for the production of different dosage forms. The strength of the industry is in  developing cost effective technologies in the shortest possible time for drug intermediates and bulk activities without compromising on quality.
  • 4. THE DOMESTIC PHARMA INDUSTRY pharma industry has  Domestic recently achieved some historic milestones through a leadership position and global presence as a world class cost effective generic drugs' manufacturer of AIDS medicines.  Many Indian companies maintain highest standards in Purity, Stability and International Safety, Health and Environmental (SHE) protection in production and supply of bulk drugs even to some innovator companies.
  • 5. Contd…  Many Indian companies are part of an agreement where major AIDS drugs based on Lamivudine, Stavudine, Zidovudine, Nevirapine will be supplied to Mozambique, Rwanda, South Africa and Tanzania which have about 33% of all people living with AIDS in Africa. Yet another US Scheme envisages sourcing Anti Retrovirals from some Indian companies whose products are already US FDA approved.
  • 6. Contd… Increasing number of Indian  pharmaceutical companies have been getting international regulatory approvals for their plants from agencies like USFDA (USA), MHRA (UK), TGA (Australia), MCC (South Africa), Health Canada etc.  Indian companies are now seeking more Abbreviated New Drug Approvals (ANDAs) in USA in specialized segments like anti-infective, cardio vascular and central nervous system groups.
  • 7. FACTS & FIGURES The annual turnover of Indian  pharmaceuticals industry in 2006-07 was approx $17 billion (over 68,000 crore).  The share of export of drugs, pharmaceuticals, & fine chemicals was more than 24,000 cr.(around us $ 6 billion) .
  • 8. Contd… Europe accounts for the highest share of  over 23% of Indian Pharma exports followed by North America and Asia. Exports to USA have crossed the land mark figure of US $1 billion during 2006- 07.  It is estimated that by the year 2010, the Indian pharmaceutical industry has the potential to achieve over Rs.1,00,000 crore production of formulations and bulk drugs.
  • 9. PRODUCTION During 2007-08 several proposals for  technology transfer including joint ventures, proposals for foreign direct investment, setting up of new undertakings/expansion of existing units (manufacture of new articles in the existing units) have been received and processed. Following the de-licensing of the pharmaceutical industry, industry is now required to submit Industrial Entrepreneurial Memorandums (lEMs) for the manufacture of various bulk drugs/drug intermediates /formulations.
  • 10. EXPORTS Year Exports(Rs. In Growth(%) crore) 2003-04 15213 18.61 2004-05 17857 17.38 2005-06 22216 24.41 2006-07 24942 12.27 Source: Directorate General of Commercial Intelligence and Statistics  (DGCIS) Kolkata
  • 11. INDUSTRY STRENGTHS  Knowledge based Industry  Large manufacturing base for high quality drugs and formulations  Developing cost effective technologies for drug intermediaries and bulk actives without a compromise on quality
  • 12. Contd….. Cost advantage in terms of drug  production, maintenance of high standards in terms of purity, stability and international safety, health and environment protection  Tremendous export potential  Major driver of growth in the future  Strong scientific and technical manpower
  • 13. Contd…. World class national laboratories in  process development  Increasing balance of trade in the sector  An excellent centre for clinical trials  Competencies in chemistry and process development