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    Dr. A. Puratchikody: Problems and Prospectus of Pharmaceutical Industries in India

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    1) India has a large and growing pharmaceutical industry, particularly in generics, but still faces issues providing affordable healthcare and regulating intellectual property. 2) While Indian companies have expertise in low-cost production, the domestic market remains very price sensitive and improvements are still needed in infrastructure and the regulatory environment. 3) Global pharmaceutical companies can tap into India's expertise and market potential through collaborative networks that manufacture products locally with Indian partners.

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    Dr. A. Puratchikody: Problems and Prospectus of Pharmaceutical Industries in India

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    irfan
    72 views14 pages
    1) India has a large and growing pharmaceutical industry, particularly in generics, but still faces issues providing affordable healthcare and regulating intellectual property. 2) While Indian companies have expertise in low-cost production, the domestic market remains very price sensitive and improvements are still needed in infrastructure and the regulatory environment. 3) Global pharmaceutical companies can tap into India's expertise and market potential through collaborative networks that manufacture products locally with Indian partners.

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    Pharma Industries

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    1) India has a large and growing pharmaceutical industry, particularly in generics, but still faces issues providing affordable healthcare and regulating intellectual property. 2) While Indian companies have expertise in low-cost production, the domestic market remains very price sensitive and improvements are still needed in infrastructure and the regulatory environment. 3) Global pharmaceutical companies can tap into India's expertise and market potential through collaborative networks that manufacture products locally with Indian partners.

    Copyright:

    © All Rights Reserved
    Download as PPT, PDF, TXT or read online from Scribd
    Download as ppt, pdf, or txt
    72 views14 pages

    Dr. A. Puratchikody: Problems and Prospectus of Pharmaceutical Industries in India

    Uploaded by

    irfan
    1) India has a large and growing pharmaceutical industry, particularly in generics, but still faces issues providing affordable healthcare and regulating intellectual property. 2) While Indian companies have expertise in low-cost production, the domestic market remains very price sensitive and improvements are still needed in infrastructure and the regulatory environment. 3) Global pharmaceutical companies can tap into India's expertise and market potential through collaborative networks that manufacture products locally with Indian partners.

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    of 14

    PROBLEMS AND PROSPECTUS OF PHARMACEUTICAL INDUSTRIES IN INDIA

    Dr. A. Puratchikody

    Drug Discovery and Development Research group


    University College of engineering
    Anna University, BIT Campus
    Tiruchirappalli-620024
    Generic drug status in India

    71% Largest segment of the Indian pharmaceutical sector

    largest global generic API merchant market, with a 7.2 per cent market
    3rd share

    2nd largest number of Abbreviated New Drug Applications (ANDAs)

    DMF World’s leader in Drug Master Files (DMFs) applications

    foreign direct investment worth US$ 15.57 billion between April 2000 –
    FDI September 2017
    Generic drug status in India

    API More than 1600 API manufacturers operating in India & China

    GlaxoSmithKline, Teva Active Pharmaceutical Ingredients


    Leading API (TAPI), Dr. Reddy's Laboratories, Aurobindo, Lupine, Ipca,
    manufacturers Cipla, Divi's Laboratories, Sandoz, Ranbaxy, Matrix, Sun
    Pharma, BASF and Pfizer.
    Research status in India

     The Government of India plans to set up a US$ 640 million


    venture capital fund to boost drug discovery and strengthen
    pharmaceutical infrastructure.
     The ‘Pharma Vision 2020’ by the government’s Department of
    Pharmaceuticals aims to make India a major hub for end-to-end
    drug discovery
     India’s existing knowledge capital in IT provides a natural base for
    the development of bioinformatics research and operations.
     India has made considerable progress in stem cell research and is
    well positioned to leverage growing capabilities in this area.
    How Indian companies excel in exporting generic products to foreign Cost efficiency

    33% Cost of production- 33 % lower than- US

    50- Labor costs - 50–55 % cheaper than western countries


    55%

    40% Cost of setting up a production plant - 40% lower than in Western countries

    Cost-efficiency - create opportunities for Indian companies


    Skilled workforce -high managerial & technical competence in comparison to
    its peers in Asia
    India has the 2nd largest number of USFDA-approved manufacturing plants outside
    2nd the US
    India has 2,633 FDA-approved drug products. India has over 546 USFDA-approved company
    FDA
    sites, the highest number outside the US
    How Indian companies excel in exporting generic products to foreign Cost efficiency

    Leading pharma producer globally

    3.1 Indian pharmaceutical sector accounts - 3.1 – 3.6 % of the global pharmaceutical
    3.6% industry in value terms
    10% 10 per cent in volume terms

    $100 Expected to grow to US$ 100 billion by 2025

    2nd largest share of pharmaceutical and biotech workforce in the world

    Regulatory oversight is currently a barrier.

    Overall costs - only 50% of comparable US-based programmes - should spur


    50%
    dramatic growth in clinical testing in the next 2-5 years.
    Advantage India,

    Indian pharma companies have solid expertise in contract manufacturing

    Scrutiny around quality issues is driving significant improvement in manufacturing


    standards & quality drugs.
    Economic drivers

    OTC sales are on the increase, offering opportunities to achieve high volumes and
    enhance pharma brands in India.
    Diversified portfolio

    2008 Mergers and Acquisitions


    Pharma sector in India more than double against the previous year, despite
    the challenges posed by the global recession.
    2015 Mergers and Acquisitions (M&A)
    468 announced deals involving therapeutic drug assets, devices, diagnostics
    and insurance companies,
    Thomson Reuters Data
    10% increase over 2014 and a 90% increase over 2012, .
    Policy support

    Pharma Vision 2020 making India a global leader in


    2020 end-to-end drug manufacture

    Reduced approval time for new facilities to boost


    Boost
    investments

    100% FDI is allowed under automatic route


    Problems

    • Increased buying power and epidemiological changes should spur dramatic


    growth in sales volumes, but India remains a price sensitive market.

    • India’s healthcare system is struggling to meet the needs of its vast population
    • Government programmes and reforms -improve the situation.

    • Medical devices market- lacks the regulatory and R&D support necessary to
    achieve its full potential and faces stiff competition from Europe and China.
    Problems

    • Practical issues
    • Infrastructure deficits need to be addressed

    • Intellectual property protection -improved substantially -but some holes remain


    • Regulatory environment improved substantially - Industry still faces a number of
    question marks.

    • Government policies around drug price control, access to OTC drugs, tax policy,
    Finalization intellectual property protection and infrastructure spending is still pending
    Summary
    Approach
    -Call on India’s increasing expertise in biotechnology, bioinformatics and
    clinical testing.
    -Tap into the growing domestic market.

    Foreign companies bringing newer products in India by - collaborative


    networks across the value chain, from sourcing and manufacturing to
    marketing and distribution.
    Summary
     India’s pharma market is highly fragmented and remains extremely price sensitive.
     Affordable healthcare continues to pose a challenge,
    - although there are a number of healthcare initiatives by the Government
    underway to improve the situation for India’s vast population.
     Indian courts and regulatory authorities are very sensitive to pricing issues in
    making decisions around intellectual property.
    - Pharma companies coming into India - need to consider a differential pricing.
    - They need to evaluate in future, access to medicines, a volume-based pricing
    strategy -gradually increasing per capita incomes to come up with acceptable
    price levels for their drugs
    Summary
     Global pharma companies will then need to decide how to manufacture their
    products, and identify and develop strong local partners.

    Pharmaceutical business model


     witnessing a paradigm shift,
     moving from a fully integrated company structure towards a future where
    companies use a wide range of outsourcing,
     Partnership initiatives and other contractual
     Relationship arrangements to create networks of collaboration and
    discovery.

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