The quintessential report for international pharmaceutical companies and investment agencies entering the Indian market.
Written by one of the most respected Indian pharmaceutical experts, Dr Mohan Nair, The Indian Pharmaceutical Market Guide 1998 provides the insight you need to invest wisely. It enables international pharmaceutical companies and investment agencies to make an appraisal of the opportunities and challenges that India offers.
In addition to a comprehensive summary of India's social, political and economic environment, this report supplies business intelligence which will help you to assess foreign investment in Indian pharmaceuticals and biotechnology; identify potential joint ventures and alliances; evaluate the merits of establishing contract laboratory, units for R&D and clinical research; pinpoint possible investment opportunities in the health insurance sector and understand marketing practices for ethical pharmaceuticals.
This authoritative report contains extensive, up-to-date market data. It proves an accurate source of statistical information on a wide variety of pharmaceutical markets and products � including forecasts to help you plan future strategies.
CONTENTS
LIST OF TABLES
LIST OF FIGURES
EXECUTIVE SUMMARY
GLOSSARY AND ABBREVIATIONS
SCOPE AND METHODOLOGY
INTRODUCTION
CHAPTER 1 INDIA - A COUNTRY ON THE MOVE
1.1 Social and political environment
1.1.1 The country and its people
1.1.2 Population of India
1.1.3 Social and political milieu
1.1.4 Political environment
1.1.5 Organisation of the government
1.2 Dimensions of the Indian economy
1.3 The reforms of 1991
1.4 Indian economy in the 1990s
1.4.1 The banking sector in India
1.5 Foreign trade
1.6 Regional trade blocs
1.7 Tapping the international financial markets
1.8 Indian priorities on the economic front
1.9 Aspects of economic reform - 1991
1.10 Performance of the Indian economy in 1997-1998
CHAPTER 2 INDIA'S INDUSTRIAL DEVELOPMENT
2.1 Industrial policies
2.2 Impact of the 1991 reforms on Indian industry
2.3 Foreign direct investments in India
2.4 The Indian chemical industry
2.4.1 Strengths of the Indian chemical industry
CHAPTER 3 SCIENCE AND TECHNOLOGY IN INDIA
3.1 Development of science and technology in India
3.2 Organisation of science and technology in India
3.3 Government outlay for science and technology
3.4 Technology development funding agencies
3.5 R&D expenditure in India
3.6 Industrial R&D units
3.7 Government incentives for R&D in India
3.8 Manpower for R&D
3.9 Academic scientific societies
3.10 Indian Nobel Laureates
3.11 Indian honours
3.12 Strengths of Indian science and technology
CHAPTER 4 HEALTHCARE IN INDIA
4.1 Healthcare in developing countries
4.2 The Indian healthcare scene
4.3 Primary health centres
4.4 Health indicators and infrastructure
4.5 Disease burden
4.6 Public health and its importance
4.7 Government policies on providing healthcare in India
4.8 Allocation of resources
4.9 Issues of population growth and fertility control
4.10 Financing healthcare in India
4.11 Health insurance - potential in India
4.12 Corporate hospitals in India
4.13 Healthcare in Mumbai city
4.14 Infectious diseases - patterns in developing countries
4.15 Prophylaxis through immunisation
4.15.1 The market for vaccines
4.15.2 Vaccine research in India
4.16 Role of traditional systems of medicine in healthcare in India
4.16.1 Current status
4.16.2 Contributions of traditional systems of medicine
4.16.3 Regulations on the manufacture and marketing of ayurvedic products
4.16.4 Validation of the traditional Indian systems of medicine
4.16.5 Plants as a source of chemicals with medicinal uses
4.16.6 Medicinal plants in India
4.16.7 Traditional systems of medicine in primary healthcare
4.16.8 Exports
4.16.9 Some selected Indian plants
4.16.10 Vanishing plant species
4.16.11 What are the lessons?
4.16.12 Topics that require in-depth study
CHAPTER 5 THE INDIAN PHARMACEUTICAL INDUSTRY
5.1 India in the world pharmaceutical market
5.2 Evolution of the Indian pharmaceutical industry
5.3 Organisation of the Indian pharmaceutical industry
5.3.1 Undertakings in the public sector
5.3.2 Other sectors
5.3.3 The multinational sector
5.3.4 Rules for foreign equity in the Indian pharmaceutical sector
5.3.5 The Indian sector
5.3.6 The small-scale sector
5.4 Drug policy changes
5.4.1 National pharmaceutical pricing authority
5.4.2 Fixing the prices of bulk drugs
5.4.3 Fixation of formulation prices
5.4.4 Scheduled drugs
5.4.5 Drug prices in India
5.5 Indian pharmaceutical industry - performance parameters
5.6 Brand equity in the Indian pharmaceutical market
5.7 Over-the-counter markets in India
5.8 Spurious drugs
5.9 Guidelines on marketing practices for ethical pharmaceuticals in India
5.10 Drug procurement and supply in the government sector - the case of Tamil Nadu
5.11 Pharmaceutical promotion in India
5.12 Market research for pharmaceuticals in India
5.12.1 ORG approach
5.13 Import and export of drugs and pharmaceuticals
5.14 Estimated demand for selected bulk drugs and drug intermediates
5.15 Registration of new drugs in India
5.16 Introduction of new brands
5.17 R&D in the Indian pharmaceutical industry
5.17.1 Funding of pharmaceutical R&D in India
5.17.2 R&D spending by industry
5.17.3 Alternate strategies for new drugs development
5.17.4 Need for collaborative R&D
5.17.5 New drug discovery research in India
5.17.6 Factors aiding process development R&D
5.17.7 Export of bulk drugs
5.17.8 Production of bulk drugs
5.17.9 Production of advanced drug delivery sytems
5.17.10 R&D collaborations
5.18 Restructuring of the Indian pharmaceutical industry
5.18.1 Utilising Indian facilities for contract R&D by international companies
CHAPTER 6 INTELLECTUAL PROPERTY PROTECTION IN INDIA
6.1 Legislation in India
6.1.1 Designs
6.1.2 Trademarks
6.1.3 Copyright
6.1.4 Patents
6.2 GATT and the WTO
6.3 Current status
6.4 Procedure for patent grant in India
6.5 Patent filing in India
6.5.1 Recent trends in patents filing
6.6 The future for intellectual property protection
6.7 Infringement suits
6.8 Impact of the Indian Patents Act 1970, on the Indian pharmaceutical industry
6.9 Sources of patent information in India
CHAPTER 7 BIOTECHNOLOGY IN INDIA
7.1 Contribution of the Department of Biotechnology
7.2 Current state of biotechnology in India
7.3 Antibiotics production in India
7.3.1 Penicillin and rifampicin
7.3.2 Production costs for antibiotics
7.3.3 Support of the local industry
7.3.4 Penicillin and rifampicin - move from a sellers' to a buyers' market
7.4 Insulin demand
7.5 Other r-DNA products
7.6 Vaccine production in India
7.6.1 Vaccine market in India
CHAPTER 8 LAWS PERTAINING TO THE MANUFACTURE AND SALE OF
DRUGS IN INDIA
8.1 Prevailing legislation
8.2 Drugs and Cosmetics Act 1940
8.2.1 The Drugs and Cosmetics (Amendment) Act 1964
8.2.2 Drugs standards
8.2.3 Policies on drug combinations
8.2.4 Banning of drugs in India
8.2.5 Legislation on blood and blood products and diagnostic kits
8.2.6 Biotechnology products
8.2.7 Impact of Schedule Y of the Drugs and Cosmetics Act on new drug introductions
8.3 Good clinical practice regulations in India
8.3.1 ICH and Indian regulations
8.3.2 Potential for setting up contract research organisations in India
8.3.3 Advantages of conducting clinical trials in India
8.4 Guidelines for drug imports
CHAPTER 9 INDIA AND CHINA - EMERGING GIANTS
9.1 Economic indicators
9.2 China's reform
9.3 Public sector in India and China
9.4 Impact of reforms in China and India on industry
9.5 Slowdown of economic growth
9.6 Healthcare in China and India
9.7 The pharmaceutical industry in India and China
9.8 Traditional systems of medicine in China and India
9.9 Biotechnology in China and India
CHAPTER 10 INDIAN PHARMACEUTICAL INDUSTRY IN THE NEW
MILLENNIUM
CHAPTER 11 COMPANY PROFILES
11.1 Alembic Chemical Works
11.2 Ambalal Sarabhai Enterprises
11.3 Cadila Healthcare
11.4 Cipla
11.5 Dr Reddy's Laboratories
11.6 Glaxo India
11.7 Gujarat Themis Biosyn
11.8 Hoechst Marion Roussel
11.9 ICI India
11.10 IPCA Laboratories
11.11 Knoll Pharmaceuticals
11.12 Kopran
11.13 Lupin Laboratories
11.14 Nicholas Piramal India
11.15 Novartis India
11.16 Orchid Chemicals & Pharmaceuticals
11.17 Parke-Davis
11.18 Pfizer
11.19 Ranbaxy Laboratories
11.20 Rhône-Poulenc (India)
11.21 Roche Scientific Company (India)
11.22 Sun Pharmaceutical Industries
11.23 Torrent Pharmaceuticals
11.24 Unichem Laboratories
11.25 Wockhardt
11.26 Zandu Pharmaceutical Works
APPENDIX 1 DIRECTORY
D1 Major companies not covered under company profiles
D2 Addresses of other companies mentioned in the text
D3 R&D centres involved in pharmaceutical and medical research
D4 Important addresses of pharmaceutical industry related agencies and associations
D5 Addresses of ministries and departments of the Indian Government
APPENDIX 2 ESSENTIAL DRUGS RECOMMENDED BY THE DRUGS
CONTROLLER GENERAL (INDIA)
APPENDIX 3 SELECTED INDIAN PUBLICATIONS ON THE
PHARMACEUTICAL AND ALLIED INDUSTRIES
REFERENCES
LIST OF TABLES
Table I.1 Exchange rate - devaluation of the rupee, 1985-1990
Table I.2 Exchange rate - devaluation of the rupee, 1991-1998
Table 1.1 The world's largest countries and their populations
Table 1.2 Growth in population density per km2 in India, 1901-1996
Table 1.3 Growth of the rural and urban population in India, 1901-1991
Table 1.4 Indian languages and number of people speaking them
Table 1.5 Religions in India
Table 1.6 The States and Union Territories, ranked according to area and population
Table 1.7 Indian cities with a population of over two million
Table 1.8 Evolution of India's economic progress, 1950s-1990s
Table 1.9 GDP, population and GDP per head, 1987-1992
Table 1.10 GDP, population and GDP per head, 1993-1998
Table 1.11 The Indian economy among some of the Asia-Pacific countries, 1997
Table 1.12 Aggregate deposits and advances in selected banks
Table 1.13 List of national banks with deposits and net profits, 1996-1997
Table 1.14 List of foreign and Indian private banks with deposits and net profits,
1996-1997 (Rs./million)
Table 1.15 Disbursements by financial institutions, 1995-1996
Table 1.16 Key indicators of the Indian economy, 1994-1998
Table 1.17 The Indian budget at a glance (Rs./million)
Table 1.18 How the rupee is earned
Table 1.19 How the rupee is spent
Table 1.20 Source and application of funds as proposed by The Indian Finance Bill,
1998-1999
Table 2.1 Index of industrial production (base 1980-1981=100)
Table 2.2 India's share of world trade, 1991
Table 2.3 Industrial sectors - foreign direct investments approved and used, 1991-1997
Table 2.4 Foreign direct investment in India, 1991-1998
Table 2.5 The Indian chemical industry in relation to all industry sectors
Table 3.1 Budget allocation for scientific departments/agencies ($/million)
Table 3.2 Technology development funding agencies
Table 3.3 Expenditure on R&D in India as a % of GNP, 1989-1996 (Rs./million)
Table 3.4 Expenditure on R&D in selected countries as a % of GNP, 1993
Table 3.5 Numbers working full-time in R&D
Table 3.6 Indian Nobel Laureates
Table 4.1 Causes of mortality due to diseases in the developed and developing world,
1996
Table 4.2 Health indicators for India, 1960-1961 to 1999-2000
Table 4.3 The Indian health infrastructure, 1955-1956 and 1995-1996
Table 4.4 People per doctor in various countries
Table 4.5 Selected health indicators for India and other Asian countries
Table 4.6 Estimated deaths (thousands) in India and their causes, 1990
Table 4.7 Assignment of priorities by respondents to a survey by TIFAC
Table 4.8 Health expenditure in India, 1951-1997
Table 4.9 Statistics from India's family planning programme
Table 4.10 India's population breakdown
Table 4.11 Health insurance in India - business potential
Table 4.12 Some healthcare statistics for the city of Mumbai
Table 4.13 HIV prevalence (estimated numbers)
Table 4.14 Reported cases of selected diseases during the specified year
Table 4.15 Diseases targeted for eradication or elimination by the WHO
Table 4.16 Availability in India of vaccines and active immunisation
Table 4.17 Availability of sera in India for passive immunisation and immunotherapy
Table 4.18 Percentage coverage of infants under one year for measles, DPT, polio and
BCG
Table 4.19 Vaccine requirements in 1995 and 2000
Table 4.20 Some companies manufacturing and marketing vaccines and sera in India
Table 4.21 Major vaccine suppliers in India and their market shares
Table 4.22 Current status of vaccine R&D in India, 1997
Table 4.23 Some statistics on the Indian systems of medicine and homeopathy
Table 4.24 Some commonly used Ayurvedic medicines, their indications and their prime
ingredients
Table 4.25 Important plant-derived drugs
Table 4.26 Current status of product development from plants at CDRI, Lucknow
Table 4.27 Exports of crude drugs and essential oils, 1985-1995 ($ million)
Table 4.28 Selected list of plants and their therapeutic use
Table 4.29 Some endangered plant species
Table 5.1 India's position in the world pharmaceutical market, 1995
Table 5.2 Growth in the world pharmaceutical market
Table 5.3 Pharmaceutical markets of some developing countries
Table 5.4 World consumption of pharmaceuticals per capita, 1975-1990
Table 5.5 Top-20 selling therapeutic classes in India and worldwide
Table 5.6 Evolution of the Indian pharmaceutical industry
Table 5.7 Major international companies in India
Table 5.8 CAGR of Indian companies and MNCs - 1996 over 1995
Table 5.9 List of companies approved for foreign equity above 51%
Table 5.10 Time lag between introduction of a new drug in the world and its introduction to
India
Table 5.11 Launching of products in India by Indian companies and by MNC subsidiaries
Table 5.12 Number of licensed (central and state governments) pharmaceutical
manufacturers in India
Table 5.13 Number of Indian manufacturers of selected bulk drugs
Table 5.14 Drugs currently under price control
Table 5.15 Comparative prices of selected drugs - number of times costlier than in India
Table 5.16 Price trends - bulk drugs (Rs./kg)
Table 5.17 Drug prices - an inter-country comparison, 1996 (Rs.)
Table 5.18 Maximum retail prices in India and the UK for selected formulations, 1998
Table 5.19 Price increase in drugs in India compared with WPI and CPI, 1983-1995
Table 5.20 Profitability in the Indian pharmaceutical industry, 1969-1995
Table 5.21 Pharmaceutical industry turnover, 1948-1998
Table 5.22 Production value of bulk drugs and formulations, 1988-1998
Table 5.23 The Indian pharmaceutical industry key statistics
Table 5.24 Estimated employment in the Indian pharmaceutical industry
Table 5.25 Investments in the Indian pharmaceutical sector, 1973-1996
Table 5.26 Ninth five-year plan projections for bulk drugs and formulations 2001-2002
Table 5.27 India's most valuable pharmaceutical companies
Table 5.28 Indian pharmaceutical industry sales and profits, 1996
Table 5.29 Ranking of pharmaceutical companies in India in the domestic market
Table 5.30 Leading pharmaceutical brands in India
Table 5.31 Some popular leading brands in India
Table 5.32 Leading companies with leading brands
Table 5.33 Common OTC drugs in India
Table 5.34 Market share of the four most popular products used to treat liver conditions
Table 5.35 Manpower deployment in some Indian pharmaceutical companies
Table 5.36 Total value of Indian imports and exports of drugs and pharmaceuticals,
1988-1998 (Rs./million)
Table 5.37 Exports of drugs, pharmaceuticals and fine chemicals (Rs./million)
Table 5.38 Export of drugs and pharmaceuticals, 1986-1997 (Rs./million)
Table 5.39 Import of drugs, pharmaceuticals and allied products, 1986-1997 (Rs./million)
Table 5.40 Principal countries from which India imports drugs and pharmaceuticals
(Rs./million)
Table 5.41 Production, exports and imports of bulk drugs and formulations (Rs./million)
Table 5.42 Major items of formulation exports from India ($ million)
Table 5.43 Export of some miscellaneous pharmaceutical products ($ million)
Table 5.44 Major bulk drug items of export ($ million)
Table 5.45 Export figures for selected Indian pharmaceutical companies, 1996-1997
(Rs./million)
Table 5.46 Estimated demand for selected bulk drugs to 2002
Table 5.47 Estimated demand for selected drug intermediates by 2002
Table 5.48 New drugs approved by the Drugs Controller General - July 1996 to June
1997
Table 5.49 New drugs approved by Drugs Controller General - July to December 1997
Table 5.50 New drugs approved by Drugs Controller General - 1 January to 31 March
1998
Table 5.51 Brand launches of roxithromycin in India
Table 5.52 Market shares of major brands of roxithromycin in India
Table 5.53 R&D expenditure in the Indian pharmaceutical industry, 1996-1997
Table 5.54 Status of Indian R&D institutions
Table 5.55 R&D spending by selected Indian pharmaceutical companies (Rs./million)
Table 5.56 Indian involvement in modern drug discovery
Table 5.57 R&D activity of Indian pharmaceutical research centres
Table 5.58 Major patented drugs manufactured in India
Table 5.59 Some controlled dosage forms of drugs marketed in India
Table 5.60 Examples of some R&D collaborations in India
Table 5.61 New strategic alliances between Indian companies
Table 6.1 Legislation on intellectual property protection
Table 6.2 Major changes required in the Indian Patents Act 1970
Table 6.3 Some Indian patent statistics, 1992-1996
Table 6.4 Pharmaceutical patents accepted, 1995-1997
Table 6.5 Pharmaceutical patent applications, 1996 and 1997
Table 6.6 Patented products sold on the Indian market
Table 6.7 Major patented drugs manufactured in India
Table 7.1 Consumption of biotechnology-based products in 1995 and demand projections
for 2000
Table 7.2 Projections for domestic requirements of antibiotics by 2000
Table 7.3 Production volumes and demand estimates for major antibiotics
Table 7.4 Imports of penicillin G against indigenous production, 1989-1996
Table 7.5 Domestic demand and supply of penicillin G first crystals and rifampicin,
1994-1998
Table 7.6 Major producers of penicillin G and their installed capacities, 1997-1998
Table 7.7 Selling prices of penicillin G first crystals and rifampicin (Rs.)
Table 7.8 Consumption of bulk insulin in India, 1986-1997
Table 7.9 r-DNA products - 1995 demand and estimated demand for 2000
Table 7.10 r-DNA products and leading companies marketing them in India
Table 7.11 Requirement of vaccines and actual production, 1991-1992 (in million doses)
Table 7.12 Availability and imports of immunological agents, 1991-1992 (in million doses)
Table 7.13 Retail market segments for vaccines
Table 8.1 Important schedules of the Drugs and Cosmetics Rules 1945
Table 9.1 Economic indicators of India and China
Table 9.2 Business culture comparisons - India and China
Table 9.3 Foreign trade - a comparison between India and China ($ million)
Table 9.4 Reassessed foreign direct investment in India and China, 1993 and 1994
Table 9.5 Comparative strengths of the Chinese and Indian petrochemicals industry
Table 9.6 Public sector units in India and China
Table 9.7 Impressions of India and China's attitudes towards foreign investment
Table 9.8 Pharmaceutical output in India and China, 1996 and 1997 ($ billion)
Table 9.9 Projections of the consumption of drugs in India and China for 2000 and 2020
Table 9.10 Consumption of drugs - India, China and the world at 1980 prices ($ million)
Table 9.11 India and China - a comparison of their pharmaceutical industries, 1997
Table 9.12 The largest pharmaceutical companies in India and China
Table 11.1 Alembic's financial results, 1996 and 1997
Table 11.2 ASE's financial results, 1996 and 1997
Table 11.3 Cadila Healthcare's financial results, 1997 and 1998
Table 11.4 Cipla's financial results, 1997 and 1998
Table 11.5 Dr Reddy's Laboratories' financial results, 1997 and 1998
Table 11.6 Glaxo India's financial results, 1996 and 1997
Table 11.7 Gujarat Themis Biosyn's financial results, 1997 and 1998
Table 11.8 HMRL's financial results, 1997 and 1998
Table 11.9 ICI India's financial results, 1997 and 1998
Table 11.10 IPCA's financial results, 1997 and 1998
Table 11.11 Knoll Pharmaceutical's financial results, 1996 and 1997
Table 11.12 Kopran's financial results, 1997 and 1998
Table 11.13 Lupin Laboratories' financial results, 1996 to 1998
Table 11.14 NPIL's financial results, 1997 and 1998
Table 11.15 Novartis India's financial results, 1997 and 1998
Table 11.16 Orchid's financial results, 1997 and 1998
Table 11.17 Parke-Davis's financial results, 1996 to 1998
Table 11.18 Pfizer's financial results, 1997 and 1998
Table 11.19 Ranbaxy's financial results, 1997 and 1998
Table 11.20 Rhône-Poulenc's financial results, 1997 and 1998
Table 11.21 Sun Pharmaceutical's financial results, 1997 and 1998
Table 11.22 Torrent's financial results, 1997 and 1998
Table 11.23 Unichem's financial results, 1997 and 1998
Table 11.24 Wockhardt's financial results, 1997 and 1998
Table 11.25 Zandu's financial results, 1997 and 1998
Table 11.26 Collaborations, strategic alliances and joint ventures between Indian
companies and foreign partners (set up or proposed)
Table 11.27 Performance of other major Indian pharmaceutical companies
Table A2.1 National list of essential drugs
LIST OF FIGURES
Figure 2.1 Transition paths of key countries (schematic)
Figure 3.1 Science and technology framework in India
Figure 4.1 Major vaccine suppliers in India and their market shares
Figure 5.1 Profitability in the Indian pharmaceutical industry
Figure 7.1 Imports of penicillin G against indigenous production, 1989-1996
Figure 7.2 Retail market segments for vaccines
PUBLISHED: OCTOBER 1998
REF: BS974E
PAGES: 250+
PRICE: £745/$1,500/¥179,000
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