Pharmaceuticals - Be

INDIAN PHARMA INDUSTRY

SECTION 1A Ajay Munjal Rajendra Singh Garima Kalra Megha Ahlowalia Ashu Negi

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CONTENTS Definition Classification 1 2 3 Facts & figures Regulatory environment Patent laws Key players SWOT analysis

“Indian pharmaceutical industry can be defined as a success story providing employment to millions and ensuring that essential drugs are available at affordable prices to the vast population of Indian sub-continent” -RICHARD GESTER (Economist)

CLASSIFICATION-1 

330 organized players contribute to 70% of total sales.

SECTORS

ORGANIZED

INDIAN COMPANIES

UNORGANIZED

MNC’ s 4

CLASSIFICATION-2

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CLASSIFICATION-3

PATENT

BRANDED ethical formulations prepared using a bulk drug under product patent are marketed by a single pharmaceutical company.

GENERICS Formulations that do not contain any patented Bulk drugs and can be manufactured by more Than 1 company. 6

FACTS & FIGURES Globally, India is 

4th in terms of volume (8% of world's production)

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13th in terms of value

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Manufactures over 400 bulk drugs & 60,000 formulations

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Highly fragmented with 30,000 players

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330 companies holds 70% of the market share

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Witnessing a growth rate of about 10% over the last few years.

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Domestic consumption 57%

Export revenues 43%.

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EXISTING

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PATENT LAWS

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PATENT LAW 

IPA-1970 - allowed 7 yrs for Process patents

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The Patents (Amendment) Act, 2005 – allow 20 yrs of Product patents

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Governments can cancel the patents during health emergency.

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EFFECTS OF PATENT ACT 2005 

Increase in drug prices

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Small firms having little R&D support – suffering

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Higher R&D cost - effective entry barrier for new firms

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Key Players

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STRENGTH            

Cost effective technology Strong and well-developed manufacturing base Clinical research and trials Knowledge based, low- cost manpower in science & technology Proficiency in path-breaking research High-quality formulations and drugs High standards of purity Non-infringing processes of Active Pharmaceutical Ingredients (APIs) Future growth driver World-class process development labs Excellent clinical trial centers Chemical and process development competencies

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WEAKNESS  Low

Indian share in world pharmaceutical market (about 2%)  Lack of strategic planning  Fragmented capacities  Low R&D investments  Absence of association between institutes and industry  Production of duplicate drugs 14

OPPORTUNITIES          

Incredible export potential Increasing health consciousness New innovative therapeutic products Globalization Drug delivery system management Increased incomes Production of generic drugs Contract manufacturing Clinical trials & research Drug molecules 15

THREATS  Small

number of discoveries  Competition from MNCs  Transformation of process patent to product patent (TRIPS)  Outdated Sales and marketing methods

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