Indian Pharmacopoeia- Latest edition & USP,BP,EP, Pharmaceutical Index

Indian Pharmacopoeia LATEST EDITION THEPHARMAPEDIA
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The word Pharmacopoeia is derived from Greek words ‘pharmakon’ means a drug (both remedy and poison) and ‘poiein’ means to make or create. Pharmacopoeia is a book containing directions for the identification of samples and the preparation of compound medicines, and published by the authority of a government or a medical or pharmaceutical society. For this reason Pharmacopoeia is a legislation of a nation which sets standards and mandatory quality indices for drugs, raw materials used to prepare them and various pharmaceutical preparations.

Each country has legislation on pharmaceutical preparations which sets a standards and required quality indices for medicament, raw materials and preparations employed in the manufacture of drugs.  These regulations are presented in separate articles. General and specific matters relating to individual drugs are published in the form of a book called a Pharmacopoeia.

On 15th  December 1820, the first United States Pharmacopoeia (U.S.P) was released.

In 1864, the first British Pharmacopoeia (B.P) was published.

In 1955, the first Indian Pharmacopoeia (IP) was published.

INDIAN PHARMACOPOEIA

  • British Pharmacopoeia was utilized as the official book of standards in India before independence.
  • The first Indian Pharmacopoeia started in the year 1944 under the chairmanship of Col. R. N. Chopra.
  • The Indian Pharmacopoeia list was first published in the year 1946.
  • The government of India constituted a permanent Indian Pharmacopoeia Committee in 1948 for the preparation of the Indian Pharmacopoeia and established a central Indian Pharmacopoeia Laboratory at Ghaziabad, Uttar Pradesh to keep it up to date.

Indian Pharmacopoeia

The drugs and cosmetics act 1940 stated that the Indian Pharmacopoeia is the book of standards for drugs included therein and the standards as included in the Indian Pharmacopoeia would be official Government of India, Ministry of Health and Family welfare publishes Indian Pharmacopoeia based on the recommendation of Indian Pharmacopoeia committee (in accordance with Drugs and Cosmetics Acts 1940, Dangerous Drugs Act 1930, and Poisons Act 1919 and the rules framed thereunder).

  • After independence, the first edition of the Indian Pharmacopoeia (I.P) was published in the year 1955 under the chairmanship of Dr. B. N. Ghosh. Supplement for first edition of Indian Pharmacopoeia was published in the year 1960.
  • After eleven years, under the chairmanship of Dr. B. Mukherji, the second edition of Indian Pharmacopoeia was released in 1966.
  • The third edition of the Indian Pharmacopoeia got published in 1985 under the chairmanship of Dr. Nityanand. Addendum/supplement I and II to the third edition has been published in 1989 and 1991 respectively.
  • The fourth edition of the Indian Pharmacopoeia was published under the chairmanship Dr. Nityanand in 1996. Addendum to the fourth edition has been published initially in 2000 followed by in 2002 and 2005. In addition, supplement 2000 for veterinary products are also released.

The Indian Pharmacopoeia Commission (IPC) has been established in the year 2005. The IPC provided a systematic approach and practices for publication of Indian Pharmacopoeia 5th edition with a focus on those drugs and formulations that over the National health care programs and the national essential medicines.

  • The sixth edition of Indian Pharmacopoeia published in accordance with the principles and designed plan decided by the scientific body of the IPC. The principle of openness, justice and fairness is kept in mind during compiling and editing the contents of this edition. Sixth edition (Indian Pharmacopoeia 2010) was published by the IPC.
  • The Indian Pharmacopoeia 2010 comprises of three volumes. Each one volume has got different features.
    • Volume I comprises notices, preface, about Indian Pharmacopoeia Commission, acknowledgements, introduction, general chapters and reference data.
    • Volume II contains general notices, dosage forms (general monographs), drug substances, dosage forms and pharmaceutical aids (A to M).
    • Volume III includes general notices, drug substances, dosage forms and pharmaceutical aids (N to Z), vaccines and immunosera for human use, herbs and herbal products, blood and blood-related products, biotechnology products, veterinary products and index.

All Editions of Indian Pharmacopoeia

S. No. of Edition

 

Year of publication

Year of addendum released

 

Features of edition

First

1955

1960

Contains both western and traditional system drugs  commonly used in India.

Second

1966

1975

Contains both western and traditional system drugs  commonly used in India.

Third

1985

1989 (1st)

1991 (2nd)

In this Pharmacopoeia inclusion of traditional system of drugs was limited. However, most of the new drugs manufactured and/or marketed were included while only those herbal drugs which had definite quality control standards had got place in it.

Fourth

1996

2000 (1st)

2002 (2nd)

2005 (3rd)

Which included a large number of antiretroviral drugs, and raw plants commonly used in making medicinal products not covered by any other Pharmacopoeias and attracted much global attention. The  Indian  Pharmacopoeia  Committee  decide  to  delete  the obsolete or less used product monographs and added monographs based on the therapeutic merit, medicinal need and extent of use of such articles in the country.

Fifth

2007

2008

It focuses on those drugs and formulations that cover the National health care programmes and the national essential medicines. It contained monographs on antiretroviral, anticancer, anti-tubercular and herbal drugs. It further emphasized on biological monographs such as vaccines, immunosera for human use, blood products, biotechnological and veterinary (biological and non biological) preparations.

Sixth

2010

2012

It comprises of three volumes. Each volume has got different features. Volume I comprises notices, preface, about Indian Pharmacopoeia Commission, acknowledgements, introduction, general chapters and reference data. Volume II contains general notices, dosage forms (general monographs), drug substances, dosage  forms  and  pharmaceutical  aids  (A  to  M).  Volume  III includes general notices, drug substances, dosage forms and pharmaceutical aids (N to Z), vaccines and immunosera for human use, herbs and herbal products, blood and blood related products, biotechnology products, veterinary products and index.

Seventh

2014

2015

It  is  presented  in  four  volumes.  Included  products  of biotechnology, indigenous herbs and herbal products, veterinary vaccines and additional antiretroviral drugs and formulations, inclusive of commonly used fixed-dose combinations. Standards for new drugs and drugs used under National Health Programmes are added and the drugs as well as their formulations which are not in use now a days are deleted from this edition. The IP 2014 incorporates 2548 monographs of drugs among this  577 are new monographs   consisting      of      APIs,   excipients,   dosage   forms, antibiotic monographs, insulin products and herbal products etc.

19 New Radiopharmaceutical Monographs and 1 General chapter is first time being included in this edition.

Eighth 

2018

2019

  • General Chemical tests and TLC for identification of an article have been almost eliminated and more specific infrared, ultraviolet spectrophotometer and HPLC tests have been given emphasis. 
  • The use of chromatographic methods has been greatly extended to cope with the need for more specificity in assays and in particular, in assessing the nature and extent of impurities in ingredients and products.
  • Most of the existing Assays and Related Substances Test methods are upgraded by liquid chromatographic technique in view to harmonize with other International Pharmacopoeia. 
  • Pyrogen test have been replaced by Bacterial Endotoxin test (BET) in parenteral preparations and other

Generally in India products corresponding to the British Pharmacopoeia (BP) and United States Pharmacopoeia (USP) are marketed. Other better-known Pharmacopoeias are International Pharmacopoeia (IP), European Pharmacopoeia (EP) and Union of Soviet Socialist Republics Pharmacopoeia (USSRP). The various other compendia prescribing standards for pharmaceuticals are British Pharmaceutical Codex (BPC) and National Formulary (NF). In the interest of proper health, any substance which fails to correspond to any official standard should not be used.

Official substances:

In the latest edition of the Pharmacopoeia, those drugs and pharmaceuticals are termed as official substances in that country of Pharmacopoeia. It is very important to understand the difference between an official substance and chemical individual with the same name. The individual chemical can be pure to any specified purity. The official substance is a commercial product which is required to comply with standards specified in the Pharmacopoeia and may often have some other substances added for specific reasons.

Indian Pharmacopoeia 2014

  • Highlights of IP 2014
    • It is effective from 1st January, 2014
    • Presented in 4 hard bound volumes with DVD
    • Total monographs 2548, 577 new Monographs included.
    • For the first time in this edition 19 new Radiopharmaceutical monographs and 1 general chapter is included.
    • Presented in user friendly format and cross referencing has been avoided
    • Veterinary products monographs are the integral part of this edition
    • Use of chromatographic methods has been greatly extended
    • More specific IP and UV Spectrophotometer tests have been introduced and classical chemicals tests for identification of an article have been almost eliminated.
    • Test for pyrogen almost eliminated
    • Obsolete monographs have been omitted
    • More herbal drugs monographs has been added
    • Included several new monographs not included in any other major pharmacopoeias of the world.

EXTRA PHARMACOPOEIA (MARTINDALE)

From the extra Pharmacopoeia (Martindale), one can obtain most complete information on every type of pharmaceutical or drug. This book was rich especially with therapeutic and clinical information of the drugs. For inorganic pharmaceuticals there are several other useful literature references are included.

A practicing pharmacist William Martindale in the year 1883 published the extra Pharmacopoeia.

Due to the accumulation of information up to the year 1910 the subject matter to be divided into two volumes in the initial editions of Martindale. The first double volume edition was published in 1912. In December 1933, the pharmaceutical society of Great Britain acquired the copy right of the Extra Pharmacopoeia upon the death of Dr W.H Martindale son of William Martindale. Thereafter the society is continuing to issue it under the editorship of the director of pharmaceutical sciences department. 23rd edition of volume II was published in 1955 and the 24th edition of volume I was published in 1958. Supplement for 24th  edition was published in 1961. In February 1967 the 25th  edition was published by the pharmaceutical society of Great Britain. While the 26th edition was released in July 1972.

The 30th edition of Martindale contains up to date authoritative information on drugs and medicine which are used throughout the world was published in 1993. It is written for all those involve in use of drugs and medicines including practicing pharmacists and physicians.

In order to meet the requirements of today’s reader the latest edition of Martindale has been markedly changed. It includes a significant shift to a more clinical emphasis an increase in the number of referenced reviews and a massive increase information on proprietary medicines. In addition usual period between editions was shorten to meet the need for up to date information.

BRITISH PHARMACOPOEIA

The section 54 of Medical Act of 1858 stressed the need of publication of a book having a list of medicines and compounds, and the manner of preparing them together with true weights and measures by which they are to be prepared and mixed. Hence the British Pharmacopoeia was decided to publish. In the year 1864 the first British Pharmacopoeia was published by combining the three old and reputed Pharmacopoeias namely Pharmacopoeia Londinensis (1618) Edinburgh Pharmacopoeia (1699) and Dublin Pharmacopoeia (1807). New editions and addendum was released quickly. The 2nd edition was released in 1867. The

3rd  and 4th  edition was published in the year 1885 and 1898 respectively. Addendum to 2nd and 3rd edition was released in the year 1874 and 1890 respectively.

Separate parts such as preparation of compounds are included in the 1864 British Pharmacopoeia. As per practice of several other Pharmacopoeias in this edition of British Pharmacopoeia the contents had been arranged alphabetically. A gap in revision belated the next edition of British Pharmacopoeia until 1914.

In Britain it was realized that technical complexity of the drug specifications was increasing and a different kind of set up was needed to prepare the Pharmacopoeias after publication of the British Pharmacopoeia 1914. Hence the further edition was published in

1928  and  1932.  There  after  the  commission  was  recommended  to  revise  the  British Pharmacopoeia every ten years once.

A range of diagnostic materials was included in 1932 revision. An important addition was inclusion of standards and tests for antitoxins and insulin. Seven addenda covered the interim between 1932 and next edition of 1948. In this 1948 edition (7th), for substances newly introduced into medicine, generic names were provided. Methods of analysis such as disintegration tests for tablets and sterilization methods were expanded. Many new monographs related to sex hormones and penicillin’s were included. Due to the rapid development of pharmaceutical and pharmacological progress at this time it was decided that the normal interval between new editions should be five instead of ten years.

The next edition was released in the year 1953.  In this edition of British Pharmacopoeia, the titles of drugs and preparations were given in English instead of Latin. Abbreviated Latin title was retained as a synonym. Capsules, constituted as new group of formulation and the implant methods for sex hormones and their standards were also described in this edition. The 9th  edition (1958) contains 160 new monographs. Spectrophotometric analysis and inclusion of tranquillizing drugs are the other features of this edition. The next i.e., tenth edition was published in 1963.

The duties of the British Pharmacopoeia commission were defined clearly in medicines order 1970. The first edition of British Pharmacopoeia that was prepared strictly under the provisions of Medicines Act was the thirteenth edition which was published in the year 1980. Due to an expansion of drug information latter the British Pharmacopoeia was decided to publish in two volumes.

Authoritative standard for the quality of many substances preparation and articles used in medicine and pharmacy for some 130 years was provided in 1993 edition of British Pharmacopoeia. For the convenience of user this edition consolidates and extends the 1988 edition with its 1989, 1991, and 1992 addenda. Moreover monographs of the European Pharmacopoeia were also included in this particular edition.

The last year edition of the British Pharmacopoeia i.e., British Pharmacopoeia 2013 comprises six volumes which contain nearly 3,000 monographs for drug substances, excipients and formulated preparation, together with supporting general notices, appendices (test methods, reagents etc.) and reference spectra used in the practice of medicine. All are comprehensively indexed and cross-referenced for easy reference. Items used exclusively in veterinary medicine in the UK are included in the BP (Veterinary).

The volume I and II deals with medicinal substances, whereas volume III describes about formulated preparations, blood related preparations, immunological products, radiopharmaceutical preparations, surgical materials and homeopathic preparations. The volume IV contains appendices, infrared reference spectra and index. The volume V is for veterinary purpose i.e., British Pharmacopoeia (Veterinary). The volume VI is the CD-ROM version of British Pharmacopoeia, British Pharmacopoeia (Veterinary) and British approved names.

The 2013 edition of British Pharmacopoeia is available as a printed volume and electronically  in  both  on  line  and  CD-ROM  versions,  the  electronic  products  use sophisticated search techniques to locate information quickly. For example, pharmacists referring to a monograph can immediately link to other related substances and appendices referenced in the content by using 1,30,000 plus hypertext links within the text.

The British Pharmacopoeia 2013 package comprises five volumes of the British Pharmacopoeia 2013 and a single volume of the British Pharmacopoeia (Veterinary) 2013, along with a fully searchable CD-ROM and online access which provided flexible resources.

The British Pharmacopoeia 2013 was legally effective from 1 January 2013 and contains 41 new British Pharmacopoeia monographs, 40 new European Pharmacopoeia monographs, 619 amended monographs, 6 new and 1 amended infrared reference spectra and European Pharmacopoeia 7th edition material up to and including Supplement 7.5. In addition updates in  January,  April  and  July  to  harmonise  with  the  European  Pharmacopoeia  was  also provided.

The current edition of the British Pharmacopoeia i.e., British Pharmacopoeia 2014 comprises five volumes and a single volume of the British Pharmacopoeia (Veterinary) 2014, along with a fully searchable CD-ROM and online access to provide with flexible resources.

Highlights of British Pharmacopoeia 2014

·   Legally effective from 1 January 2014

·   40 new BP monographs are included

·   272 amended monographs

·   Three new Supplementary Chapters are included

·   Four new BP (Vet) monographs are included

·   One new BP (Vet) Supplementary Chapter is included

·   Free in-year updates in April and July to harmonise with the European Pharmacopoeia

EUROPEAN PHARMACOPOEIA

An official book of standards adopted by Germany, France, Italy, Netherlands, Switzerland and Belgium is European Pharmacopoeia. In July 1964, the council of Europe issued an order, to frame out European Pharmacopoeia. 1969 onwards in the respective member countries it was appeared as official standard book for medicinal substances and other drugs. Later on it was revised continuously to keep the information up to date.

PHARMACOPOEIA INTERNATIONALS (INTERNATIONAL PHARMACOPOEIA)

In various countries there are no uniformity in terminology and strengths of pharmaceutical preparations used. In the year 1874, a view had been expressed that some world uniformity in the standards for potent drugs must necessary to overcome various problems. These views got further support in second international conference held in 1925 where an international agreement on the Unification of formulae for seventy seven potent drugs and preparations got  reached.  In  1936  the  Health  Organization of  the  League  of  Nations  established a technical commission of Pharmacopoeial experts. The work was undertaken by the WHO after the World War II which was ended in 1946. Finally volume I of the long awaited International Pharmacopoeia was published in 1951 by Latin with translation into English and French.  This International Pharmacopoeia contains monographs for over two hundred drugs and chemicals, with appendices on reagents tests and biological assays. Latter in the year  1955 the  second volume was  published which contains formulae for  preparations having various drugs and substances already present in volume I. In 1959 the supplement for first edition was released with incorporation of some newer drugs and substances with its method of preparations and the appropriate tests. In 1967 the second edition of International Pharmacopoeia got published, followed by a supplement in 1971. Third edition of International Pharmacopoeia was published in the form of several volumes, in which volume I appeared in 1979.

The Pharmacopoeial authorities of all countries are expected to give due considerations to its standards so as for achieving uniformity of standards as far as practicable even though the International Pharmacopoeia cannot be imposed legally on any country.

UNITED STATES PHARMACOPOEIA (USP)

In 1817, Dr. Lyman spalding proposed a plan to publish a National Pharmacopoeia to the medical society of the country at New York.  15th December 1820 the first edition of United States Pharmacopoeia was published with 217 drugs in about 272 pages. After the gap of ten years further editions of USP appeared.  The 19th edition of USP was published in the year

1905.  However, it was given the title of USP VIII as to show that it was 8th revision. Pharmacopoeia must be revised every 5 years was suggested in the 1940 convention.

On July 5 of 1974, unification of the USP and NF (National Formulary) was announced. Afterwards in the subsequent editions consolidated USP and NF into a single volume was published.  USP covers all drug substances and drug products; whereas NF covers only pharmaceutical ingredients.

In January 1990, the 22nd edition of USP combined with 17th edition of NF was published. The current version of USP–NF standards deemed official by USP are enforceable by the

United States Food and Drug Administration (US-FDA) for medicines manufactured and marketed in the United States. The latest edition, USP 36–NF 31, published on November 1,

2012 in English, and became official from May 1, 2013. The highlights and features are it contains more than 4,600 monographs with specifications for identity, strength, quality, purity, packaging, and labeling for substances and dosage forms. It also comprise more than

260 general chapters providing clear, step-by-step guidance for assays, tests, and procedures. More over it also focus, specific charts and a combined index which help us to find the information.

PHARMACEUTICAL INDEX

Its 12th  edition has been completely revised and incorporated updated material as well as entirely fresh subject areas. The new codex provides a reference source on all aspects of pharmaceutical science and technology. Part I covers the multidisciplinary nature of pharmaceutics and demonstrates how quality is built into medicines from conception ideas and to develop and for production and use. The chapters broadly encompass the pharmaceutics content of the syllabus for pharmacy undergraduates and also provide direction and support for the continuing education of graduates with special emphasis on the product development and the innovation. Part II includes an extensive collection of pharmaceutical data arranged in monograph form. It is edited by staff of the Royal pharmaceutical society by inviting known experts to write individual chapters.


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