| CHAPTER I | HISTORY AND OVERVIEW | |
| 1 | History of Pharmaceutical Industry in India | 1 |
| 2 | Drug Industry overview in India | 3 |
| CHAPTER II | LAWS RELATED TO DRUGS | |
| 1 | The Drugs and Cosmetics Act of 1940 | 4 |
| 2 | Drugs & Cosmetics Rules 1945 as Amended | 6 |
| 3 | Import/Manufacture of “New Drug” for Test or Marketing | 22 |
| 4 | Drug Policy 1994 | 24 |
| 5 | Drug (Price Control) Order, 1995 | 37 |
| 6 | Pharmacy Act | 56 |
| 7 | The Drugs and Magic Remedies (Objectionable Advertisement) Act of 1954 | 57 |
| 8 | The Narcotic Drugs and Psychotropic Substance Act, 1885 | 57 |
| 9 | Poisons Act of 1919 | 58 |
| 10 | The Medicinal & Toilet Preparation (Excise Duties) Act of 1956 | 58 |
| 11 | The Epidemic Disease Act of 1897 | 59 |
| CHAPTER III | OTHER ALLIED LAWS | |
| 1 | Highlights of Exim Policy | 60 |
| 2 | Patents (Amendment) Rules 1999: Draft Rules | 63 |
| 3 | The Industries Development & Regulation Act of 1951 | 73 |
| 4 | The Trade & Merchandise Marks Act of 1970 | 74 |
| 5 | The Factories Act of 1948 | 74 |
| 6 | The Minimum Wages Act of 1948 | 76 |
| 7 | The Payment of Wages Act 1936 | 77 |
| 8 | The Employees State Insurance Act 1948 | 78 |
| 9 | The Payment of Bonus Act, 1965 | 79 |
| 10 | The Employees Provident Fund and Miscellaneous Provisions Act, 1952 | 80 |
| 11 | Contract Labour (Regulations and Abolition) Act 1970 | 81 |
| 12 | Industrial Disputes Act | 83 |
| CHAPTER IV | WORLD MARKET DATA | |
| 1 | Top Branded Pharmaceuticals Worldwide | 85 |
| 2 | Leading Pharmaceuticals Companies Worldwide | 86 |
| 3 | Pharma Companies in 1998 Global FT 500 | 87 |
| 4 | Leading Therapy Classes in 1998 Global Pharmaceutical Sales | 88 |
| 5 | Pharma Sales in 12 Leading Markets ($ billion) | 89 |
| 6 | World's Most Profitable Companies | 90 |
| 7 | NCEs Introduced Worldwide in 1995 | 91 |
| 8 | Patent Expiry Dates of Some Drugs and Pharmaceuticals | 92 |
| CHAPTER V | INDIAN PHARMA INDUSTRY | |
| 1 | Annual Drug Expenditure Per Capita: 1997 | 94 |
| 2 | Production of Bulk Drugs and Formulations | 95 |
| 3 | Estimated Demand of Bulk Drugs during Ninth Plan Period | 93 |
| 4 | Production of Monitored Bulk Drugs of elected companies in the Organised Sector and Targets for demand during 1997-98 and 1998-99 | 101 |
| 5 | Estimated Demand of certain Chemicals and Intermediates by the year 2002 AD | 105 |
| 6 | Total Value of Import & Export of Drug & Pharmaceuticals from 1988-89 to 1998-99* | 107 |
| 7 | Imports of Essential Drugs: 1994-95 to 1996-1997 | 108 |
| 8 | Bulk Drugs which have Export Potential | 109 |
| 9 | Value of Exports of Drugs, Pharmaceuticals and Fine Chemicals for the years 1995-96, 1996-97 & 1997-98 | 110 |
| 10 | Top Ten Exporting Companies and Their Exports (1998) | 115 |
| 11 | Top Products Exported During the Last Three Years | 116 |
| 12 | Top Ten Pharmaceutical Companies in India with Addresses | 117 |
| 13 | Raw Materials Required for the Manufacture of Antibiotics | 119 |
| 14 | List of Antimicrobial Preservatives Used in Pharmaceutical Industry | 120 |
| 15 | List of Various Antioxidants Used in Pharmaceuticals | 120 |
| 16 | List of Colours Permitted to be Used in Drugs | 121 |
| 17 | Revised Prices of Bulk Drugs by DPCO Order, 1995 | 122 |
| 18 | Growth in Whole Sale Price Index of Drugs & Medicines | 125 |
| 19 | List of Drugs Appearing in the Indian Pharmacopoeia but where the Major Use Is Not for Medicinal Purpose | 126 |
| 20 | Raw Materials Required for the Manufacture of Drugs | 127 |
| 21 | Raw Materials & Intermediates Required for the Manufacture of Drugs | 137 |
| 22 | Drugs Permitted by DCGI for Marketing from Jan. 96 to Jun. 98 | 151 |
| 23 | Process Technology for various forms of Drugs | 154 |
| CHAPTER VI | GOVERNMENT POLICIES | |
| 1 | Specific Life Saving Medicaments totally Exempt from Excise Duty | 164 |
| 2 | Tolerance Limit for Industrial Effluents | 164 |
| 3 | Indian Standards for Chemicals | 165 |
| 4 | Colour Code for General Services | 166 |
| CHAPTER VII | USEFUL INFORMATION & ADDRESSES | |
| 1 | Drug Control Administration | 168 |
| 2 | Important Addresses & Telephones useful to Drugs & Pharmaceutical Industry | 172 |
| 3 | Leading Importers and Exporters | 174 |
| 4 | Journals & Books useful to the Pharmaceutical Industry | 175 |
| 5 | Details of Government Laboratories | 177 |
| 6 | Essential Bulk Drugs – Sources of Supply | 179 |
| 7 | Directory of Suppliers and International Trading Houses dealing in Pharmaceuticals and Chemicals | 181 |
| 8 | List of Manufacturers of Equipment | 182 |
| 9 | Useful Information | 184 |
| 10 | Analytical Laboratories | 185 |
| CHAPTER VIII | SAFETYFIRE FIGHTING FIRST AID | |
| 1 | SAFETYFIRE FIGHTING FIRST AID | |
| 2 | First Aid | 196 |
| 3 | Hazardous Chemicals a. Storage b.Transportation |
198 198 202 |
| 4 | Schedule V of Hazardous Chemical Rules (1989) | 204 |
| CHAPTER IX | GUIDE TO ENTEPRENEURS | |