Indian Pharmaceuticals Industry Report

Publication Date	December 2005
Publisher	Cygnus
Product Type	Report
Pages	175
ISBN Number	not applicable
Product Code	CYG00011

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Summary

Pharmaceutical business is a blend of commerce and public service. Globally, the pharmaceutical industry grew at a compounded annual growth rate (CAGR) of 9.1 per cent in the last 23 years- powered by a string of innovative blockbusters. It is an industry characterized by huge investments in drug discovery and development. In the recent past, falling research productivity triggered off a series of mega mergers. Multinationals fixated upon mergers and acquisitions as a way of fattening their research pipelines. Indian Pharmaceuticals Industry is in the limelight. Regarded as a high-quality and low-cost producer, Indian pharmaceutical industry has made a mark in the global arena. It is seen not only as a manufacturing base, but also as the center for research and clinical trials.

The report gives a picture of the Indian industry status covering major segments, therapeutic areas, major players, major products and the industry trends like export and demand-supply. It also covers global scenario in brief, thorough analysis of growth drivers and issues and challenges countered by the industry. The report gives profiles of top 20 players in India, covering their business as well financial aspects along with the clear picture of the major segments (bulk drugs and formulations) coupled with in-depth analysis. The chapter on outsourcing opportunities is one the much-talked about aspects of Indian pharmaceutical industry under our expert scanning. The trend and the future direction on Outsourcing have been covered. Regulatory aspects like regulatory bodies, rules and acts governing the industry and various issues have been discussed. There is a special focus on India entering the product patent era. Critical success factors section discusses the factors that make the difference between success and failure in this business. The report throws light on the future direction of the industry.

Content

1. Executive Summary
2. Highlights
3. Industry Overview
- 3.1 Indian Pharmaceutical Industry
- 3.2 Pharmaceutical Market Size
- 3.3 Industry Segmentation
- 3.4 Major Players
- 3.5 Major Exporters
- 3.6 Demand-supply analysis
- 3.7 Foreign Direct Investments in Indian Pharma
4. Growth Drivers
- 4.1 Global Growth Drivers
  - 4.1.1 Innovation of Biotechnology
  - 4.1.2 Demographic Transition
  - 4.1.3 Rising real incomes
  - 4.1.4 Medical technology
  - 4.1.5 Generic and niche segments
  - 4.1.6 Unmet medical needs
- 4.2 Indian Pharma
  - 4.2.1 Ageing Population
  - 4.2.2 Life Style Drugs
  - 4.2.3 Healthcare Expenditure
  - 4.2.4 Upgradtion of Medical Devices & Equipment
  - 4.2.5 Export
  - 4.2.6 Generic Drugs
  - 4.2.7 Research & Development
  - 4.2.8 Contract Manufacturing Opportunities
5. Issues & Challenges
- 5.1 Sustaining exports
- 5.2 IPR issues
  - 5.2.1 Pricing
  - 5.2.2 Central excise on MRP of medicines
  - 5.2.3 Data protection
- 5.3 R&D focus
  - 5.3.1 Looming shortage of trained manpower
  - 5.3.2 Animal trials
  - 5.3.3 Regulatory Infrastructure
  - 5.3.4 Managing productivity
- 5.4 Exploiting generic opportunities
- 5.5 Price control
- 5.6 Infrastructure
  - 5.6.1 R&D Infrastructure
  - 5.6.2 Quality of marketing infrastructure
- 5.7 Fragmentation
- 5.8 Spurious drugs
6. Major Players
- 6.1 Ranbaxy Laboratories Ltd.
- 6.2 Cipla Ltd.
- 6.3 Dr. Reddy's Laboratories Ltd.
- 6.4 Glaxo SmithKline Pharmaceuticals Ltd.
- 6.5 Nicholas Piramal India Ltd.
- 6.6 Lupin Ltd.
- 6.7 Sun Pharmaceutical Industries Ltd.
- 6.8 Cadila Healthcare Ltd.
- 6.9 Aurobindo Pharma Ltd.
- 6.10 Wockhardt Ltd.
- 6.11 Aventis Pharma Ltd.
- 6.12 Ipca Laborataories Ltd.
- 6.13 Pfizer Ltd.
- 6.14 Biocon Ltd.
- 6.15 Orchid Chemicals and Pharmaceuticals Ltd.
- 6.16 Matrix Laboratories Ltd.
- 6.17 Alkem Laboratories Ltd.
- 6.18 Alembic Ltd.
- 6.19 Morepen Laboratories Ltd.
- 6.20 Torrent Pharmaceuticals Ltd.
7. Major Segments
- 7.1 Bulk drugs
- 7.2 Formulations
8. Outsourcing Opportunities
- 8.1 Factors driving outsourcing
  - 8.1.1 Weaker pipelines and rising approval times
  - 8.1.2 Pressure to cut prices
  - 8.1.3 Declining market exclusivity period
  - 8.1.4 Boosting marketing productivity
- 8.2 Outsourcing Market
  - 8.2.1 Contract Manufacturing
  - 8.2.2 Contract Research
9. Regulatory Issues
- 9.1 Overview
- 9.2 Regulatory environment
  - 9.2.1 General regulations
- 9.3 Entry strategies
  - 9.3.1 Importing pharmaceuticals
  - 9.3.2 Manufacturing under license
  - 9.3.3 Entry through joint venture/subsidiary
  - 9.3.4 Foreign Investment promotion board
  - 9.3.5 Approvals for foreign companies with prior Indian exposure
  - 9.3.6 Additional options
- 9.4 Key legislations
  - 9.4.1 The drugs and cosmetics act 1940
  - 9.4.2 The medicinal & toilet preparations act 1955 with rules 1956
  - 9.4.3 The drug policy 1986
  - 9.4.4 The essential commodities act 1955
  - 9.4.5 Indian patents act 1970
  - 9.4.6 The drugs price control order (DPCO) 1995
  - 9.4.7 Good manufacturing practices
  - 9.4.8 The pharmacy act 1948
- 9.5 Regulatory bodies
  - 9.5.1 The drugs controller of India (DCI)
  - 9.5.2 State food and drug administrations (FDAS)
  - 9.5.3 National pharmaceutical pricing authority (NPPA)
  - 9.5.4 Department of chemicals and petrochemicals
- 9.6 Price controls
  - 9.6.1 Pricing of scheduled bulk drugs
  - 9.6.2 Pricing of scheduled formulations imported into India
  - 9.6.3 Pricing regulations
- 9.7 Intellectual property rights
  - 9.7.1 Legal procedure
  - 9.7.2 Compulsory licensing and revocation of EMR
  - 9.7.3 Permission for residents to apply for patents outside India
  - 9.7.4 Trademarks
- 9.8 Manufacturing
  - 9.8.1 Industrial licensing
  - 9.8.2 Additional approvals/registration
  - 9.8.3 Reservation for public sector
- 9.9 Imports
  - 9.9.1 Imports of capital goods and raw materials
  - 9.9.2 Pharmaceutical Imports
- 9.10 New drug approval process
  - 9.10.1 Drug approval procedure
- 9.11 Product standards
  - 9.11.1 Labeling
- 9.12 Tariff structure
  - 9.12.1 Local manufacturing duty
  - 9.12.2 Sales tax
- 9.13 Marketing and distribution
  - 9.13.1 Licensing of sales outlets and stock holding
  - 9.13.2 Prescription drugs
  - 9.13.3 Advertisement and Promotion
  - 9.13.4 Regulations of advertising
  - 9.13.5 Packing and labeling
  - 9.13.6 Distribution
  - 9.13.7 Brands
  - 9.13.8 Restrictive trade practices
  - 9.12.9 Consumer protection
10. Critical Success Factors
- 10.1 Research & Development
- 10.2 New product development
- 10.3 Therapeutic coverage
- 10.4 Marketing
- 10.5 Exports
- 10.6 Critical mass
- 10.7 Low cost production through scale
- 10.8 World class practices
- 10.9 Conclusion
11. Outlook