An over view of Indian Pharmaceutical Industry. Can be used by B.pharm students to prepare for pharmaceutical Management subject.

1. Ruchi Singh
INDIAN PHARMACEUTICAL INDUSTRY
– AN EMERGING TRAILBLAZER
1/29/2018 1

2. What do you know about Indian
Pharmaceutical Industry???
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Size ????
Indian pharmaceutical sector accounts
for about 2.4 % of the global
pharmaceutical industry in value terms
and 10 % in volume terms
http://www.ibef.org/industry/indian-pharmaceuticals-industry-analysis
Leading Pharma producer

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One of the Major
exporters
India accounts for 20 per cent of global
exports in generics. In FY15,
pharmaceuticals industry of India exported
products worth USD15 billion and the
exports are expected to reach USD40 billion
by 2020

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Fastest Growing Industry
The country’s pharmaceutical industry is
expected to expand at a CAGR of 12.89
per cent over 2015–20 to reach USD55
billion

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Growing Generics
Market
The generics market is expected to grow
to USD26.1 billion by 2016 from USD21
billion in 2015.
Frost and Sullivan Report on Indian Pharmaceutical
Market,

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Ranked 5th in terms of
attracting FDI
Attracted 5 per cent of the total FDIs into
India from April 2000 to September 15
Cumulative FDI inflows worth USD13.32
billion from April 2000 to September 15
India Biz, PWC, Department of Industrial Policy and
Promotion

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Pharmaceuticals Advantage in India

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2015
Market
size: USD21
billion
2020
Market
size:
USD55
billion
COST EFFICIENCY
•Low cost of production and
R&D
• I60 per cent lower than that
of the US and almost half of
that of Europe
•India is emerging as a leading
destination for
medical tourism
Economic drivers
•Economic prosperity to
improve drug affordability
•Increasing penetration of
health insurance
• penetration of chemists,
in rural India, OTC drugs
will be readily available
Diversified portfolio
•10 % of the global
pharmaceutical production
• Over 60,000 generic brands
across 60 therapeutic
categories.
• More than 500 different APIs
• 49 % of all drug master
filings from India is registered
in the USA
POLICY SUPPORT
• ‘Pharma Vision 2020’
aimed at making India a
global leader in end-to-end
drug manufacture
• Reduced approval time for
new facilities to boost
investments
• 100 per cent FDI is allowed
under automatic route
Advan
tage
India
PwC, McKinsey, Pharmaceuticals Exports Promotion Council of India, TechSci Research

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“India`s own pharmaceutical industry has carved out a
place for itself in the world, because it invests
significantly in research.
Indeed, our long term global competitiveness will
depend not on replicating what others have done, but
through a process of sustained development and
innovation”
“To improve healthcare and develop medicines and
medical devices that is within the reach of poorest”

11. MARKET
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&

12. STRUCTURE OF PHARMA
SECTOR IN INDIA
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PHARMACEUTICALS
Formulations
Branded Generics
Active Pharmaceutical
Ingredients/ Bulk drugs
Chronic Acute
•Cardiovascular
• Anti-diabetes
• Gastro-
intestinal
• Neurological
•Anti-infectives
• Respiratory
•Pain
• Gynaecology
Dun & Bradsheet, TechSci Research

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EVOLUTION OF INDIAN
PHARMACEUTICAL SECTOR

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1970–90
•Indian Patent Act
passed in 1970
• Several domestic
companies start
operations
• Development of
production
infrastructure
• Export initiatives
1990–2010
•Indian companies
increasingly launch
operations in foreign
countries
• India a major destination
for generic drug
manufacture
• Approval of Patents
(Amendment) Act 2005,
product patents in India
2010
•Increased patent filings
• adoption of newer sales
models
• increased R&D
expenditure
on new costeffective
generic
• The National
Pharmaceutical Pricing
Policy, 2012 (NPPP-2012
2010-2015
•National Health Policy Draft 2015
•Patent Act Amendment 2015,
•2014: 100% FDI allowed in medical device industry.
• 2013: New Drug Pricing Control Order issued by
Directorate of Food and Drugs reduce d the prices of
drugs by 80%.
• Acquisition in domestic as well as international
market to increase their product portfolios.

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Pharmaceutical
Industry
Active Pharmaceutical Ingredients
(APIs)
Contract Research and
Manufacturing Services (CRAMS)
Formulations
Biosimilars

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INDIAN PHARMA SECTOR REVENUES TRENDING NORTH
0
10
20
30
40
50
60
2005
2013
2015
2020
Department of Pharmaceuticals, PwC, McKinsey,

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19. Ruchi Singh

20. The healthcare industry (also called the
medical industry or health economy) is an
aggregation and integration of sectors within the
economic system that provides
goods and services to treat patients with curative,
preventive, rehabilitative, and palliative care

22. Sixth largest in the world
Impressive growth prospects
Strong fundamentals
Cost advantage
Favourable investment
environment

23. Market Size
USD100
Billion

24. NOTABLE TRENDS IN
THE INDIAN
HEALTHCARE SECTOR
Shift from communicable to lifestyle
diseases
Expansion to tier-II and tier-III cities
Management contracts
Emergence of telemedicine
Increasing penetration of health
insurance
Technological initiatives
Luxury offering

25. LIFESTYLE DISEASES AND GROWING AWARENESS TO
INCREASE HOSPITALISATION
CAGR of hospitalized cases from 2008E – 18F:
Cardiac – 18 per cent
Oncology – 16 per cent
Diabetes – 19 per cent

27. Major Therapy Segments

28. Pharmaceutical manufacturing units

29. Pharmaceuticals
Active pharmaceutical
ingredients - API Formulations
77%
23%

30. Major Therapy
Segments
Therapy segment
Chronic
Cardiovascular
Neurological
Anti-diabetes
Oncology
Acute
Anti-infective
Gastro-intestinal
Respiratory
Analgesics/Pain management
Vitamins/Neutraceuticals

31. Oncology
Anti-diabetic
Pain
Autoimmune
Respiratory
Top 5 Therapeutic
Segment Based On Sales

32. Any Non Patented Molecule With A Brand Name
Other Than The Innovator‘s Name Is Termed As A
Branded Generic
Market Share Is Very Low- Lack Of Proper
Regulations And Guidelines And Doctor's Comfort
Jan Aushadi
Drugs Legally Allowed To Be Sold Over The Counter‘ By
Pharmacists
Market share is very small MNcs unwilling to introduce
patented products
Branded Generics
Generic Generics
Over the counter
Patented products
Market segment

33. Global API market
Regulated
Semi-Regulated

34. The Regulatory Process
Drug
Master File (DMF)
DMFs are confidential documents containing
information on the manufacturing
facility and processes used in the manufacture,
characterization, quality control, packaging and
storage of
an API.

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37. Research & Development
Operations
Sales & Marketing