Transcript India - Pharmexcil

INDIA-CIS PHARMA & HEALTH
CONFERENCE
MUMBAI
3rd MARCH, 2006
Department of Chemicals & Petrochemicals
Ministry of Chemicals & Fertilizers
Government of India
1
Agenda
India – Overview of
the Country
Indian Pharmaceutical
Industry
India’s Strengths in
Pharma Sector
Status of Pharma
Exports to CIS
2
India – Overview of the
Country
3
India – Largest democracy in the world
Gained independence in 1947
Current population over 1 billion
English is the language of business
4th largest economy globally on PPP basis
6th largest energy consumer
Predicted by Goldman Sachs to be the 3rd
largest economy in the world by 2050
4
India finds harmony – Even with all its
diversity
29 states & 6 UTs with 22 official languages
3.3 million square kilometers area
Religions: 81% Hindus, 12% Muslims, remaining
are Christians, Sikhs, Jains, Buddhists, Parsis,
Jews
Per capita income ~US$ 750
GDP ~ US$ 650 billion
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INDIA RISING
Some Indicators
 GDP growth rate – 8.1% (twice that of USA & UK)
 Manufacturing sector growth rate – 9.4%
 Exports growth rate – 23 ( compounded growth rate
over last 10 years)
 Inflation Rate - 4.1 % (5% a year ago)
 Credit growth- ~25% (22% last year)
 Foreign Exchange Reserve - US $ 142 billion (1991-US $
5.8 billion)
6
Capital Market
Equity Index at the highest level ever close to
10500 (BSE)
India’s market capitalisation US$ 550 billion
Registered FIIs – 667
This Year’s flow of portfolio investment- US $ 10
billion
Volume of public issues rose by 5 times in 2005
Introduction of book-building process
7
RECENT FISCAL REFORMS
 Income Tax simplified - 10%, 20% and 30% rates
 Corporate Tax rate - Reduced to 30% from 35%
 Peak Import Duty on non-agricultural items
reduced from 15 to 12.5 %
 Import duty on specified Capital Goods
(including those for Pharma & biotech. Sector) 5%
 Import duty on IT items (217) – Nil
 State Value Added Tax - introduced w.e.f. 1st
April 2005 (4% rate for pharma)
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Some of the world’s best academic
and healthcare institutes are in India
14,000 hospitals
700,000 hospital beds (85% urban)
More than 500,000 doctors
737,000 nurses
171 medical colleges
17,000 medical graduates/year (MBBS/MD)
300 life sciences colleges produce over
700,000 graduates annually
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Indian Pharmaceutical Industry
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Indian Pharma Industry Profile
Number of companies
Large : 300
SMEs : 6000
According to Mckinsey & Co., Indian
pharma market to be US$ 25 billion by
2010, out of which US$ 11 billion to be
domestic sales
PHARMEXCIL formed to facilitate exports
of pharmaceuticals and related mattersplan to set up warehouse facility in Russia
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Indian Pharma Industry Profile
contd.
 Worth US$ 8 billion ; globally # 4 in volume, # 13 in value
 Exports of US$ 3.7 billion in FY 2004, increasing @
22.9% CAGR 1994-2003 years.
 India among top-5 bulk manufacturers and top-20
exporters world-wide
 India now files highest number of DMF’s
 India has largest number of US FDA approved plants
outside US.( 75 now)
 US Pharmacoepia INDIA office opened at Hyderabad first such office ouside USA
 Domestic market growing at 8-10% p.a.
 R&D spending to increase from 5% of sales to 8% by
2007
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India: The Pharma Outsourcing Hub
 India – emerging as the hub for
Collaborative & contract research
Contract manufacturing
Co-development
Co-marketing
 Cost of developing an NCE – over US$ 1 billion
whereas, in India it can be as less as US$ 50 million
 Several MNCs like Pfizer, Merck, GSK, Roche, Bayer,
Aventis, etc. making India a hub for APIs and bulk
supplies
 Pfizer, Eli Lilly, Novartis carrying out clinical trials in
India
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India: The Pharma Outsourcing Hub
contd.
Several CROs (about 22) like Quintiles, Simbee,
RCC, Omnicare, etc. set up liaison/marketing
offices in India
Indian CROs commenced trials since 1996
Cos. like GSK Biological lined up global trial of
4 vaccines in India during 2005. Also clinical
R&D for AIDS, dengue, malaria, TB vaccines
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Regulatory Framework
Drugs and Cosmetics Act, 1940 – a Central Act
to regulate manufacture/ import/sale of drugs
New drugs, imports, clinical trials, drug
standards approved by Central Govt.
Enforcement by States
Drug (Price Control) Order, 1995 – for control of
prices of specified drugs
Indian Patents Act, 1970 – As on 1st January,
2005 provides product patent for drugs, food
and agro-chemicals
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Some Recent Changes in Drugs &
Cosmetics Act and Rules
Schedule “Y” amended for multi-centric
concurrent clinical trials as per GCP
GMP – realigned as per international guidelines
(particularly WHO & OECD)
GCP – India’s requirements on GCP published
as guidelines
GLP – monitoring authority set up for preclinical (toxicological) studies
Registration system streamlined for import of
drugs – both site and product registration
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Process Patents for pharmaceuticals
introduced in 1970
Prior to 1970
85% market with foreign companies
15% market with domestic companies
1970 – Process Patent introduced for
pharmaceuticals
At present
85% market with domestic companies
15% market with foreign companies
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India’s Strengths in Pharma
Sector
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Indian Pharma Industry: Strengths Policies
Product Patent regime in effect from January 1,
2005
Pro-business, Pro-IP Government – federal, state
& city
India bio/pharma clusters make it easy to set-up
and conduct business
Effective Check on spurious drugs- new law
being made
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Indian Pharma Industry: Strengths Infrastructure
Rich bio-diversity
Well-developed pharmaceutical, chemical &
healthcare industries
Complex capabilities in research, synthesis &
manufacturing
Quality conscious (cGMP, GLP, ISO)
CSIR= World renowned 42 national research
laboratories
Huge patient population
Information technology = core competence
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Indian Pharma Industry: Strengths Cost
Cheaper labour (cost to hire a Ph.D. scientist =
US$ 25K; as against US$ 65K/year in the US)
Employers receive loyalty, respect, dedication
& admiration from employees
40% cheaper to set up a plant in India than in
the US/EU
35-40% cost savings for conducting clinical
trials in India
Funds available for expansion and start-ups
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Indian Pharma Industry: Strengths - Talent
Huge pool of experienced scientific manpower
– fluent in English
Employees work 6 days/week & are willing to
work in all shifts
Reverse brain-drain : Non-resident Indian
scientific personnel moving back
New breed of managers (no longer family-run
businesses
Strong entrepreneural nature = Competition
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India is a proven source of quality and
cost-effective pharma materials
Fine chemicals
Intermediates
Advanced intermediates
APIs (Active Pharmaceutical Ingredients)
Formulations
23
Highest number of US FDA approved
Plants outside the US are in India
US FDA Approved Plants Outside the US
70
60
50
40
30
20
10
0
India
Source:FDA & Proximare
Italy
Spain
China
Israel
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Indians filed the highest number of
DMFs : 871% growth since 1987
140
120
100
80
60
40
20
0
196985
1990
1995
2000
2001
2002
2003
Source:FDA & Proximare
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Status of Pharma Exports to
CIS COUNTRIES
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Exports of Drugs, Pharmaceuticals, and
Fine Chemicals
Major Destinations in CIS
Country
2003-04
2004-05
($ million)
($ million)
Share of Dosage
Forms (%)
2004-05
Russia
146
164
94
Ukraine
47
73
90
Kazakistan
11
15
92
Azerbijan
2
9
98
Uzbekistan
4
6
89
Belarus
4
6
89
Turkmenistan
2
3
89
Kyrgystan
1
3
100
Georgia
1
2
94
Tazikistan
1
1
91
All figures rounded
of 1$ = Rupees 44
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India – world’s supplier of ARV drugs (AntiHIV/AIDS)
About 50% of the ARV drugs being exported to
developing countries from India – substantial
exports to Africa
Indian companies instrumental in drastic
reduction in ARV drug prices from over US$
10,000 per head/annum to US$ 150 per
head/annum
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CIS PHARMA MARKET (INCLUDING RUSSIA)
 US$ 7 billion - Share of Indian exports only 3 to 4% (aroud
$ 275 million) - Great scope to enhance exports from India
 India can help CIS to meet their health care needs in a
cost effective manner and cater to larger section of
population
 Joint Ventures possible provided certain issues like
convertibility to dollar mode are sorted out in some
countries
 Fast track registeration for Indian medicines would be
helpful
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Areas for India-CIS collaboration
 Sourcing of APIs & formulations from India
 Collaborations for manufacturing & marketing of drugs-Indian
companies are very strong in all therapeutic groups especially
in diabetic , respiratory, neuro, antiinfective and
cardiovascular groups and they can meet the requirements of
CIS countries in a cost effective manner
 Joint R&D work for pharmaceuticals
 Training of drug regulators at NIPER
 Cooperation for use of various testing facilities at NIPER with
respect to quality control/quality assurance, bio-availability ,
impurity profiling ,toxicology etc.
 Participation in INDIACHEM 2006 in Mumbai from 8-10
November, 2006
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Conclusion
The Indian Government and Industry would
welcome partnerships with CIS countries in
providing access to affordable, quality
medicines
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Thank You !
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