INDIAN PHARMA INDUSTRY

SECTION 1A

Ajay Munjal
Rajendra Singh
Garima Kalra
Megha Ahlowalia
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Ashu Negi
 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
SECTORS
total sales.

ORGANIZED UNORGANIZED

INDIAN COMPANIES MNC’ s

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CLASSIFICATION-2

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CLASSIFICATION-3

PATENT

BRANDED
ethical formulations
prepared using a bulk drug GENERICS
under product patent Formulations that do not contain any patented
are marketed by a single Bulk drugs and can be manufactured by more
pharmaceutical company. Than 1 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 institutes

and 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 product

patent (TRIPS)
 Outdated Sales and marketing methods

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