NEW EDITION OF IP : THE IP 2007 By Dr G N Singh Secretary-cum- Scientific Director Indian Pharmacopoeia Commission Ghaziabad

2 Substandard drugs are available in the market worldwide. WHO estimates that counterfeit drugs account for approximately 5-8% of the total worldwide trade in pharmaceuticals. MENACE OF SUBSTANDARD DRUGS

3 Chemical instability Inappropriate storage and transport Poor quality control during mfg. Those drugs which have been tampered with, Drug resistance adulterated, diluted, repackaged, relabelled Treatment failure Substandard/ Counterfeit drugs

4 Indian Pharmacopoeia is the compilation of official standards of drugs and pharmaceuticals manufactured in India and/ marketed in India. As per the Drugs and Cosmetics Act 1940, the Indian Pharmacopoeia is the legally recognized Book of Standards for the quality of drug substances and preparations included therein. IP PLAYS A VITAL ROLE IN QUALITY CONTROL OF DRUGS

The Standards of IP are legally enforceable. IP Contains the Standards in the form of Monographs.

6 EditionYear of Publication Main edition Addenda I 1955 Addendum to IP II 1966 Addendum to IP III 1985 Addendum to IP & 1991 IV 1996 Addendum to IP Vet. Suppl Chronology of Publication of IP

7 Addendum to IP V Edition 2007 (In Press)

8  The new edition of IP (IP 2007) has been prepared by the Indian Pharmacopoeia Commission in accordance with a plan and completed through the untiring efforts of its members & secretariat over a period of ~ 2 years.  It supersedes 1996 edition.

9  Upgradation General Notices contents Monographs of IP 1996: 1250 Appendices: 300 General Analytical Methods : 300 New Drugs Monographs : 250 (API + Dosage Forms) Omissions: 13 NEW EDITION IP 2007

10 3 Hard bound volumes bearing IPC seal and a book number representing the official print version. Printed by NISCAIR (National Institute of Science Communication and Information Resources), Pusa, New Delhi.PRESENTATION

11  Volume I Notice Preface Structure of IPC Acknowledgements Introduction General ChaptersCONTENTS

12  Volume II Monographs on Drug Substances, Dosage Forms and Pharmaceutical Aids (A to M).  Volume III Monographs on Drug Substances Dosage Forms and Pharmaceuticals Aids (N to Z) followed by Monographs on :

13 Vaccines and Immunosera for Human Use Herbs and Herbal Products Blood and Blood related Products Biotechnology Products Veterinary Products (form an integral part, previously these were published as a Supplement to IP 1996

14  Scope of Pharmacopoeia extended to include Products of Biotechnology, Herbs and Herbal Products, Viral Vaccines, Additional Antiretroviral Drugs & Formulations (inclusive of Fixed dose combinations)

15 2 Column format. More user friendly. Cross referencing avoided in monographs. No multiplicity of fonts. Uniformity of presentation of subject matter.FORMAT

16 The standards laid down represent the minimum with which the article must comply. It is incumbent on the manufacturer to ensure that the article is manufactured in accordance with GMP. BASIS OF PHARMACOPOEIAL REQUIREMENTS

17 It is essential that sufficient stringent limits are applied at the time of release of a batch of a material/product so that the pharmacopoeial standards are met until its expiry date under the storage conditions specified. Valid interpretation of any requirement of Pharmacopoeia is a must and General Notices will facilitate the correct application of the requirements.

18 Category of drugs, dosage and usual strength of dosage forms omitted. Solubility: Presented as separate section for all APIs and Pharmaceutical Aids. Title of monographs : Presented in shorter form.CHANGES

19 Classical chemical tests of identification of an article eliminated. Specific tests - IR & UV Spectrophotometric tests included. Chromatographic methods : Greatly extended to detect impurities in products. Pyrogen test : Virtually eliminated. Bacterial Endotoxin Test (BET)- Applicable to more items.

20 Volume I Devoted to test methods applicable to all articles of Pharmacopoeia & General information. Reference spectra Typical Chromatogram Analytical methods included are internationally accepted methods to increase Global acceptance of a product. Section on Containers for Pharmaceutical use has been enlarged. GENERAL CHAPTERS

21 General monographs for dosage forms of API are grouped together at the beginning of Volume II. Monographs of API and their dosage forms are given in Volume II & III GENERAL MONOGRAPHS

22 Monographs General Chapter  Vaccines for Human Use 45 1  Blood Products 21  Biotechnology Products 04 1  Veterinary Vaccines 41 1  Veterinary Diagnostics 14 BIOLOGICAL PRODUCTS

23 VACCINES FOR HUMAN USE  Total monographs incorporated in IP 2007 : 45  Bacterial vaccines : 13  Viral vaccines : 16  Mixed Vaccines: 16

24 S. No.MonographsIP 1996IP Dried Human Antihaemophilic Fraction √√ 2Human Albumin √√ 3Anti-A Blood Grouping Serum √ 4Anti-B Blood Grouping Serum √ 5 Anti-Human Globulin Serum √ 6Anti-D Immunoglobulin Human for Intravenous Use √ BLOOD PRODUCTS MONOGRAPHS = 21

25 7Blood Grouping Serums Anti-D, Anti-C, Anti-E, Anti-c, Anti-e √ 8Cryoprecipitated Antihemophilic Factor √ 9Fibrin Sealant Kit √ 10Human Coagulation Factor IX √ 11Human Coagulation Factor VII √ 12Human Coagulation Factor VIII (rDNA) √ 13Human Normal Immunoglobulin √√ 14Human Prothrombin Complex √

26 15Human Plasma for Fractionation √ 16Human Plasma Protein Fraction √√ 17Concentrated Human Red Blood Cells √√ 18Anti-D (Rho) Immunoglobulin √ 19Platelet Concentrate √ 20Whole Human Blood √√ 21Normal Immunoglobulin for Intravenous Use √

27 S. No.MonographsIP 1996IP Erythropoietin Concentrated Solution x √ 2Filgrastim Concentrated Solution x √ 3Interferon Alfa-2 Concentrated Solution x √ 4Streptokinase Bulk Solution x √ BIOTECHNOLOGY PRODUCTS

28 Total Veterinary Vaccines Monographs :41 New Veterinary Vaccines :05 New Veterinary Drugs :02 Rest of the Veterinary Monographs have been put into new format. VETERINARY PRODUCTS

29 1.Clostridium Multicomponent Vaccine, Inactivated 2.Inclusion Body Hepatitis (IBH) Vaccine, Inactivated 3.Infectious Coryza Vaccine 4.Laryngotracheitis Vaccine, Live 5.Peste Des Petitis Ruminants Vaccine, Live 6.Ivermectin 7.Ivermectin Injection NEW VETERINARY VACCINES AND VETERINARY DRUGS MONOGRAPHS

30 1.Amalaki7.Coleus 2.Amra8.Gokhru 3.Arjuna9.Gudmar 4.Artemisia 10.Guduchi 5.Bhibhitaki 11.Haritaki 6.Bhringraj 12.Tulasi HERBS AND HERBAL PRODUCTS

31 13.Kutki19.Punarnava 14.Lasuna 20.Sarpagandha 15.Manjistha21.Shatavari 16.Maricha22.Shati 17.Pippali Large23.Kunduru 18.Pippali Small HERBS AND HERBAL PRODUCTS

32 1.Astemizole 2.Astemizole Tablets 3.Diazepam Capsules 4.Fenfluramine Hydrochloride 5.Fenfluramine Hydrochloride Tablets 6.Pectin OMISSIONS OMISSIONS

33 7.Phenformin Hydrochloride 8.Phenformin Hydrochloride Tablets 9.Succinylsulphathiazole 10.Succinylsulphathiazole Tablets 11.Sulphacetamide Sodium Eye Ointment OMISSIONS OMISSIONS

34 Supporting Structure for the Indian Pharmacopoeia Commission