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INDIAN PHARMA INDUSTRY

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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


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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 Indiansub-continent

-RICHARD GESTER

(Economist)


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CLASSIFICATION-1

SECTORS

ORGANIZED UNORGANIZED

NDIAN COMPANIES NC s

330 organized players

contribute to 70% of

total sales.

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CLASSIFICATION-2

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CLASSIFICATION-3

PATENT

BRANDEDthical formulations

repared using a bulk drugnder product patent

re marketed by a single.harmaceutical company

GENERICSormulations that do not contain any patente

ulk drugs and can be manufactured by mor1han company.

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FACTS & FIGURES

Globally, India is

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

13th in terms of value

Manufactures over 400 bulk drugs & 60,000 formulations

Highly fragmented with 30,000 players

330 companies holds 70% of the market share

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

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

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

patents

Governments can cancel the patents during health emergency.

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EFFECTS OF PATENT ACT 2005

Increase in drug prices

Small firms having little R&D support suffering

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 institutesand industry

Production of duplicate drugs

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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

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THREATS

Small number of discoveries

Competition from MNCs

Transformation of process patent to productpatent (TRIPS)

Outdated Sales and marketing methods

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