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 Phase III Development Phase Phase II Phase I Early Years Government Control •Indian Patent Act –1970 •Process development •Production infrastructure creation Growth Phase Innovation and Research

•New IP law •Rapid expansion of •Discovery domestic market Research •International market development •Research orientation

•Market share domination by •Drug prices •Export capped foreign initiatives companies •Local companies begin to make an •Relative impact 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
Cadila 7% Glaxo smithkline 7% Aventis 4% IPCA 4% Ranbaxy 18%

Aurobindo 9% Lupin 9% Sun 10%

Cipla 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 !!