Pharmaceutical Industr

Meghana Deshpande (Roll

No. 4 )
Rupa Singh (Roll No. 12 )
 Agenda
• History & Evolution
• Statistics
• Classification
• Indian Patents Act
• Intellectual Property Rights
• Top 10 Players
• SWOT Analysis
 Pharma Industry of India
• 80 years history in India
• Bengal Chemicals – 1930
• Patents Act in 1970 with
amendment in 2005 regarding
Intellectual Property Rights
 Indian Pharmaceutical
Evolution
Phase V
Phase IV
Innovation and
Growth Phase Research
Phase III
Development •Rapid •New IP law
Phase expansion of •Discovery
Phase II domestic market Research
•Process
Government development •International
Phase I Control market
•Production
development
Early Years •Indian Patent infrastructure
Act –1970 creation •Research
•Market share
orientation
domination by •Drug prices •Export
foreign capped initiatives
companies •Local companies
•Relative begin to make an
absence of impact
organized
Indian
companies

1970 1980 1990 2000 2010

 Statistics
• 2% of world’s Pharma Market
• 4th ranking in production
• 400 bulk drugs and around 60,000
finished medicines
• Around 3 % of country’s FDI
• Growth Rate about 9 – 12%
• USD 10 Billion market – estimated to
reach USD 40 Billion by 2020
Classification
 Patent Act 1970
• The first Indian Patent Act was enacted in 1856
which was replaced by a more comprehensive
Patents and Design Act in 1911. The Act of 1911
allowed for product-patents for drugs and
medicines.
• Having strong intellectual property laws in place,
the foreign companies or the MNCs enjoyed a
complete monopoly and charged exorbitant
prices, and thus dominated the Indian drug
market.
Cont..
• The Indian Patents Act, 1970 was a
response to the Patents Act, 1911.
• The Act of 1970 not only excluded drugs
from the product claims category but also
redefined the working of the patent as its
commercial exploitation within India, and
excluded any importation from abroad.
• It also introduced safeguards like the
Automatic Right to License in the case of
life-saving drugs.
 Intellectual Property Rights
• IPRs provide certain exclusive rights
to the creators of IP, in order to
enable them to get commercial
benefits from their creative efforts or
reputation.
• The purpose of IPR legislation is to
protect against unauthorized
imitation, copying or deceptive usage
of identifying marks.
 Regulatory Authority
Central Drugs Standard Control Organization

• Laying down standards of drugs, cosmetics,

diagnostics and devices.

• To regulate market authorization of new

drugs.

• To regulate clinical research in India.

• Testing of drugs by Central Drugs Labs.

 Top 10 Indian Pharma
Companies
IPCA
Aventis
Cadila 4% Ranbaxy
4%
7% 18%

Glaxo smithkline
7%

Aurobindo
9%

Lupin
9%
Sun Cipla
10% 15%
 Biotechnology Industry
• Sister of pharmaceutical industry.
• Research on life saving vaccines, enzymes.
• USD 1 Billion market
• Major Players
– Serum Institute of India
– Wockhadrt limited
– GlaxoSmithkline
– Biocon
 SWOT Analysis
STRENGTHS
• 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
• World-class process development labs
• Excellent clinical trial centers
• Chemical and process development competencies
Cont…
WEAKNESSES
• Low Indian share in world pharmaceutical
market (about 2%)
• Lack of strategic planning
• Fragmented capacities
• Absence of association between institutes and
industry – Biotechnology and Pharmaceuticals
• Low healthcare expenditure
• Production of duplicate drugs
Cont…
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
Cont…
THREATS
• Small number of discoveries
• Competition from MNCs
• Trade related aspects of Intellectual
property rights (TRIPS)
• Outdated Sales and marketing
methods
Thank You !!