Pharmaceutical Industry

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
• De-licensed Industry
 Indian Pharmaceutical Evolution

Phase V
Phase IV
Innovation and Research
Growth Phase •New IP law
Phase III
Development Phase •Rapid expansion of •Discovery Research
domestic market
•Process
Phase II development •International market
Government Control development
•Production
Phase I •Indian Patent Act – infrastructure •Research orientation
Early Years 1970 creation
•Market share •Drug prices capped •Export initiatives
domination by •Local companies begin
foreign companies to make an impact
•Relative absence
of 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 Dr Reddy's
9% 17%

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
• Non-infringing processes of Active Pharmaceutical Ingredients
(APIs)
• 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 !!