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.
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.Contents
- Indian Pharmacopoeia
- All Editions of Indian Pharmacopoeia
- Highlights of IP 2014
- EXTRA PHARMACOPOEIA (MARTINDALE)
- BRITISH PHARMACOPOEIA
- Highlights of British Pharmacopoeia 2014
- EUROPEAN PHARMACOPOEIA
- PHARMACOPOEIA INTERNATIONALS (INTERNATIONAL PHARMACOPOEIA)
- UNITED STATES PHARMACOPOEIA (USP)
- PHARMACEUTICAL INDEX
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.
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.