PHARMACOPOEIA

Pharmacopoeia The term Pharmacopoeia comes from the Greek word “Pharmakon” meaning ‘drug’ and ‘Poiein’ meaning ‘make’, and the combination means any recipe or formula or other standard required to make or prepare a drug. The term ‘Pharmacopoeia’ was first used in 1580 in a book on drug standards printed in Bergamo, Italy. After that a number of national pharmacopoeias were published by various European Pharmacopoeias- the London, the Edinburgh and the Dublin pharmacopoeia were official throughout the kingdom. Each pharmacopoeia described different strength and method of preparation for the same preparation. Hence there was a lot of confusion. To overcome this difficulty, the first British Pharmacopoeia came into existence in 1864.

Indian Pharmacopoeia In the United States, the first pharmacopoeia was published in December 1820 both in English and in Latin. Later on a National Formulary was also published in addition to U.S.P. (United States Pharmacopoeia). The object of the U.S.P.ws to select from substances the ones which possess medicinal power, converted them into preparation of suitable composition in order to enhance their power to the maximum advantage. The first International Pharmacopoeia was published by the World Health Organization in 1951 (Volume I) and in 1955 (Volume II). The object of this was to provide a uniform list which would avoid the confusion caused by different national standards, strengths and names especially for the use of travelers who might need to use the same prescription in different countries.

Indian Pharmacopoeia List of Pharmacopeias: a) Argentine b) Austrian c) Belgian d) Brazilian e) British f) Chinese g) Egyptian h) European i) French j) German k) Hungarian l) Indian m) International n) Italian o) Japanese p) Yugoslavian q) Mexican r) Netherlands s) Nordic t) Polish u) Portuguese v) Rumanian w) Russian x) Spanish y) Turkish z) United state.

Indian Pharmacopoeia HISTORY OF THE PHARMACOPOEIA OF INDIA The Government of India through its letter No H(C)/43 dated 26 January, 1944, directed the Drugs Technical Advisory Board list the drugs used in India, which are not mentioned in British Pharmacopoeia and also recommend the standards to be prescribed to maintain uniformity and the chemical tests to be used to establish identity and purity. The Government of India published the Indian Pharmacopoeial List in 1946, as a supplement to the British Pharmacopoeia. The term “List” in the title was “misleading” in that, the book not only contained a list of drugs which were of substantial medicinal value but also laid down standards.

Indian Pharmacopoeia The Indian Pharmacopoeial List contained about 180 monographs and a number of appendices prepared on the lines of the British Pharmacopoeia. Approximately 100 monographs were on vegetable drugs growing in India and on their galenicals. The drugs of plant origin such as cannabis, rauwalfia, vasaka etc. were included in it. Similarly several oils such as ajowan, cassia, neem and pudina were included in it. The Pharmaceuticals and Drug Research Committee of the Council of Scientific and Industrial Research decided in February 1947 to compile a “Brochure” to highlight the information and clinical uses of the important indigenous drugs of India. Later on it was decided to prepare a “Codex” instead of Brouchure.

After the publication of the Indian Pharmacopoeial List, the Government of India, constituted an eleven-member Indian Pharmacopoeial Committee in 1948, in their notification No. F.1-1/48-DS dated 23 rd November, 1948, for preparing the Pharmacopoeia of India. The tenure extended by one year vide Government notification No. F.6-10/53-DS dated the 21 st November, In compiling the monographs of the first pharmacopoeia of India, help was taken from all available established scientific data in the modern pharmacopoeia, such as British Pharmacopoeia, the United States Pharmacopoeia, the International Pharmacopoeia products. The first edition of Pharmacopoeia of India was compiled and then published in Indian Pharmacopoeia

Salient Features of the First Edition of Pharmacopoeia of India(1955) 1.The title of monographs have been given in Latin language. Abbreviated titles for use in prescription have been given immediately below the Latin title. 2.The English title has also been given below the abbreviation title. 3.The weights and measures have been given in metric system. 4.All statements contained in the individual monographs have been considered as constitute standards for the official substances. 5.Doses are expressed both in the metric system as well as in the English system. 6.A list of preparations has been given at the end of some of the monographs. 7.The temperature has been expressed in Celsius thermometric scale. 8.The descriptive terms (very soluble, freely soluble, sparingly soluble, slightly soluble, very slightly soluble, practically insoluble) have been used where the exact solubility of a pharmacopoeial substance is not known. Indian Pharmacopoeia

The tenure of the first Indian Pharmacopoeial Committee expired in 1954, and the Committee was reconstituted under the chairmanship of Dr. B.N. Ghosh, Professor of Pharmacology, R. G. Kar Medical College Calcutta. The Committee compiled a supplement to the first edition of the Indian Pharmacopoeia. The supplement was published in The composition of the Committee entrusted with the compilation of the second edition of Pharmacopoeia was as follows: Chairman Members – 11 in number Member – Secretary Assistant – Secretary The committee appointed the following Subcommittees to assist it in the compilation work: Pharmacology & Bioassay Subcommittee Biological Products Subcommittee Antibiotics, Vitamins & Hormones Subcommittee Pharmacognosy Subcommittee Pharmacy Subcommittee Pharmaceutical Subcommittee General Chemistry Subcommittee Analytical Subcommittee Physical Standards, Weights, measures and Nomenclature Subcommittee Indian Medicinal Plants Subcommittee Indian Pharmacopoeia

In order to expedite the compilation of the second edition of Pharmacopoeia, the Indian Pharmacopoeia Committee constituted a “Working Group” to examine the comments received on the draft monographs and then submitted suitable recommendations to the Committee in the light of their comments. The second edition of the Pharmacopoeia of India was published in 1966 and later on its supplement was published in Salient Features of the Second Edition of Pharmacopoeia of India (1966) 1.The titles of monographs have been changed from Latin to English. 2.The words of the title have been transposed to give the name of the drug first e.g. Injection of Aminophylline has been changed to Aminophylline Injection. 3.Doses are expressed in the metric system only. 4.Solubility is expressed in parts of solvent per unit part of solute. 5.The preparations of a drug have been given immediately after the monograph on the parent drug. 6.The test for sterility has been modified to provide for detection of fungi in addition to aerobic and anaerobic bacteria. 7.New analytical techniques such as non-aqueous titrimetry, column chromography have been included. 8.In the monographs of “Tablets” and “Injections”, a new sub-heading “Usual Strength” has been given to represent the strength of the tablet or injection in which it should be generally marketed. Indian Pharmacopoeia

The Government of India, Ministry of Health and Family Welfare, vide their resolution No.X19014/1/77-D & M.S., dated 30 th June 1979, reconstituted the Indian Pharmacopoeia Committee for a period of five years for the preparation of the third edition of Pharmacopoeia Committee for a period of five years for the preparation of the third edition of Pharmacopoeia of India. The composition of the committee was as follows: Chairman Members – 13 in number representing academic, research and industry Member – Secretary Assistant – Secretary The committee appointed the following Subcommittees: Clinical Medicines & Pharmacology Subcommittee Biological Products & Bioassay Subcommittee Antibiotics Subcommittee Synthetic Drugs Subcommittee Medicinal Plants, Galenicals & Surgical-Dressings Subcommittee Chemicals & Pharmaceutical Aids Subcommittee Parenteral & Sterile Products Subcommittee Non parenteral Products Subcommittee Analytical Methods, Reagents, Diagnostic Aids & Containers Subcommittee Nomenclature & Formulae Subcommittee Indian Pharmacopoeia

The Indian Pharmacopoeia Committee also constituted a “Working Group” for the purpose of preparing draft monographs and appendices, to examine the comments received on these from various sources and then make suitable recommendations to the Committee. The monographs, Appendices and General Notes as prepared by the “Working Group” and finalized by the committee were then published in the form of third edition of the Pharmacopoeia of India in 1985 by the Government of India. Indian Pharmacopoeia

Salient Features of the Third Edition of Pharmacopoeia of India (1985) 1.The new analytical techniques such as Flame Photometry, Flurometry, Electrophoresis and Photometric Haemoglobinometry have been introduced as official method for certain chemical analysis. 2.Dissolution Test has been introduced in the case of certain tablets. 3.Disintegration Test has been amended by modifying the design of the apparatus and method of testing. 4.A microbial limit test has been prescribed for certain pharmaceutical aids and oral liquid preparations. 5.The Pyrogen Test has been revised to make the test less time-consuming than the previous method. 6.Gas Liquid Chromatography has been recognized as an alternative method for the determination of alcohol concentration in various preparations. 7.The test for determination of viscosity has been modified by the introduction of other methods involving the use of Ostwald Viscometer. 8.The new appendix on “Water for Pharmaceutical Use” use been introduced to clearly indicate the different official standard in respect of purified water, water for injection and sterile water for injection. 9.Some of the drugs have been renamed in this edition e.g. “Acetylsalicylic Acid” has been changed to “Aspirin”. 10.Many drugs have been omitted from the third edition and many new drugs have been included in the third edition. Indian Pharmacopoeia

The Government of India, Ministry of Health and Family Welfare vide their resolution No. X19020/1/89-DMS and PFA dated 12 th August 1991, reconstituted the Indian Pharmacopoeia Committee for a period of five years for the preparation of the fourth edition of Pharmacopoeia of India. The composition of the committee was as follows: Chairman Members – 18 in number representing academic, research and industry Member – Secretary Assistant – Secretary The Committee appointed the subcommittees and working groups in order to expedite the preparation of the new edition of the Indian Pharmacopoeia. The Monographs, Appendices and General Notes as prepared by the “Working Group” and finalized by the Committee were then published in the form of fourth edition of the Pharmacopoeia of India in 1996 by the Government of India. Indian Pharmacopoeia

Salient Features of the Fourth Edition of Pharmacopoeia of India(1996) 1.It contains 1149 monographs and 123 appendices and available in two volumes. 2.The computer-generated structural formulae have been introduced. 3.Some titles have been changed to include the more commonly accepted names of India. E.g. Hyoscine Hydrobromide for Scopolamine Hydrobromide 4.Infra-red and ultra-red absorption spectrophotometric tests for identification of drug substance have been introduced as alternative tests to the classical chemical tests. The infra-red reference spectra of a number of drug substances has been included in an appendix. 5.The high performance liquid chromatography (HPLC) has been widely used as a method to analyse many formulations which can otherwise be analysed only by more difficult and less accurate method e.g. biological assay of Insulin has been replaced by HPLC. 6.The test for bacterial endotoxins as a more suitable substitute for the test for pyrogens has been introduced for some articles. 7.A quantitative method for determining particulate matter in injectable preparations has been replaced by the quantitative test of the previous edition. The test is applicable solutions that are supplied in containers with 100 ml or more. 8.The specific biological assays and tests provided for a vaccines; hormones, blood products and enzymes have been transferred from an appendix to the individual monographs. 9.In the monographs for Oral Rehydration Salts (ORS), ORS-Bicarbonate formula has been dropped due to its stability problem, whereas ORS_Citrate formula recommended by WHO is retained. Indian Pharmacopoeia

After the publication of fourth edition of the Indian Pharmacopoeia in 1996, an addendum was published in Addendum 2002 was published to incorporate the latest developments made in pharmaceutical sciences. The numbering of pages in this Addendum is continuous with that of Volume I and II of Indian Pharmacopoeia 1996 and Addendum The following changes are made:- 1.A number of tests and standards in monographs have been amended and replaced with old monographs. 2.The test on bacterial endotoxins replaces the pyrogen test. 3.A new appendix on ‘residual solvent’ has been incorporated to monitor the content of organic volatile impurities that are used or produced in the manufacture of an active pharmaceutical substance, excipient or medicinal products. 4.An appendix on HPLC has been replaced by a revised version covering ion chromatography. 5.Monographs of a number of antiretroviral activities and their formulations have been introduced in this Addendum. 6.Monographs on vaccines for Hepatitis B and that for Rabies have been revised. Government of India has constituted the Indian Pharmacopoeia Commission (IPC) on 22 nd March, The Commission has its headquarters at the Central Indian Pharmacopoeia Laboratory (CIPL). Sector-23, Raj Nagar, Ghaziabad U.P. The Indian Pharmacopoeia Commission has a Governing Body of 8-10 members and Scientific Body of members from different related scientific fields. Various expert committees were also made to prepare various monographs. Indian Pharmacopoeia

Salient Features of the Fifth Edition of Pharmacopoeia of India(2007) 1.The Indian Pharmacopoeia 2007 is presented in three volumes. Volume I contains the general notes, preface, the structure of the IPC, Introduction and general chapters. Volume II deals with the general monographs on drug substances, dosage forms and pharmaceutical aids. Volume III contains monographs on drug substances, dosage forms, pharmaceutical aids, vaccines and immunosera for human use, herbs and herbal products, blood and blood related products, biotechnology products and veterinary products. 2.General chemical tests for identification have been almost eliminated and more specific infrared and ultraviolet spectrophotometric tests have been given. 3.The test for pyrogens involving the use of animals has been virtually eliminated. The test for bacterial endotoxins has been introduced. 4.The test for abnormal toxicity is now confined to certain vaccines. 5.The use of chromatographic methods has been extended in assays to large number of pharmaceutical products. Indian Pharmacopoeia

6. Labeling and storage are featured at the end of a monograph. 7. The general monographs for dosage forms of active pharmaceutical ingredients are grouped together at the beginning of Volume II followed by the monographs for active pharmaceutical ingredients, pharmaceuticals aids and individual dosage forms, all in alphabetical order. 8. Monographs for other articles of a special nature such as vaccines and immunosera for human use, herbs and herbal products, blood and blood related products, biotechnology products and veterinary products are given in separate section in Volume III. 9. Limit of bacterial contamination has been introduced for controlling the microbial quality of all medicinal products. 10. Analytical methods are in general in harmony with those adopted internationally for monitoring the quality of drugs. Indian Pharmacopoeia