PHARMACOPOEIA
Pharmacopoeia can be defined as a book of standards applicable to drugs and their common dosage forms and pharmaceutical aids published in a country under the authority of its own Government. Many advanced countries publish their own Pharmacopoeias, e.g., Indian Pharmacopoeia (IP), British Pharmacopoeia (BP), United States Pharmacopoeia (USP) etc., which are published by the authority or commission of their respective countries.
INDIAN PHARMACOPOEIA (IP)
Indian Pharmacopoeia (IP) is an official document meant for overall quality control and assurance of pharmaceutical products marketed in India by way of contributing to their safety, efficacy, and affordability. IP contains a collection of authoritative procedures of analysis and specifications for drugs. The IP or any part of it has got legal status under the Second Schedule of the Drugs & Cosmetics Act, 1940 and Rules 1945 thereunder. IP prescribes standards for identity, purity, and strength of drugs essentially required from healthcare perspective of human beings and animals.
IP standards are authoritative in nature. They are enforced by the Regulatory authorities for quality control of medicines in India. During quality assurance and at the time of dispute in the court of law, the IP standards are legally acceptable. The Indian Pharmacopoeia is published by the Indian Pharmacopoeia Commission (IPC) on behalf of the Ministry of Health and Family Welfare, Government of India.
History of Indian Pharmacopoeia
The history of IP began in the year 1833 when a committee of the East Indian Company’s Dispensary recommended the Publication of a Pharmacopoeia and Bengal Pharmacopoeia. The General Conspectus of Medicinal Plants was published in 1844, which mainly listed most of the commonly used indigenous remedies. This was followed by IP 1868, which covered both the drugs of British Pharmacopoeia (BP) 1867 and indigenous drugs used in India, with a supplement published in 1869 incorporating the vernacular names of indigenous drugs and plants. However, from 1885 the BP was made official in India. A Drug Enquiry Committee appointed in 1927 by the government, recommended the publication of a National Pharmacopoeia.
Editions of Indian Pharmacopoeia
| Edition | Year of Publication | Addendum(s) Released |
|---|---|---|
| First | 1955 | 1960 |
| Second | 1966 | 1975 |
| Third | 1985 | 1989 (1st), 1991 (2nd) |
| Fourth | 1996 | 2000 (1st), 2002 (2nd), 2005 (3rd) |
| Fifth | 2007 | 2008 |
| Sixth | 2010 | 2012 |
| Seventh | 2014 | 2015 |
| Eighth | 2018 | 2019 |
| Ninth | 2022 | Not released yet |
Salient Features – 1st Edition (1955)
- Monograph titles in Latin language
- Abbreviated titles below Latin titles
- English titles below abbreviated titles
- Weights and measures in metric system
- Doses expressed in metric and English system
- Descriptive terms (free soluble, very soluble, sparingly soluble) used where precise solubility unknown
- List of preparations at the end of some monographs
Salient Features – 2nd Edition (1966)
- Monograph titles changed from Latin to English
- Doses expressed in metric system only
- Solubility expressed in parts of solvent per unit part of solute
- Drug preparations provided below monograph of parent drug
- New analytical techniques: non-aqueous titrimetry, column chromatography
Salient Features – 3rd Edition (1985)
- New analytical techniques: Flame Photometry, Fluorimetry, Electrophoresis, Photometric Haemoglobinometry
- Gas Liquid Chromatography for alcohol determination in preparations
- Dissolution test for evaluation of tablets
- Disintegration test modified
- Name changes: “Acetylsalicylic acid” to “Aspirin”
- Microbial limit test for pharmaceutical aids and oral liquid preparations
Salient Features – 4th Edition (1996)
- 1149 monographs and 123 appendices in 2 volumes
- Computer generated structural formulae
- Renamed substances: Hyoscine Hydrobromide for Scopolamine Hydrobromide
- HPLC broadly used (e.g., Insulin assay by HPLC)
- Bacterial endotoxin test as alternative to pyrogen test
- ORS-citrate formula (WHO) instead of ORS-bicarbonate
Salient Features – 5th Edition (2007)
- General chemical tests replaced with IR and UV spectrophotometric tests
- Tests for bacterial toxins included
- Labelling and storage provided at end of monograph
- General monographs for dosage forms grouped at beginning of Volume II
- Separate section for vaccines, herbs, blood products, biotechnology products in Volume III
- Limit of bacterial contamination for all medicinal products
Salient Features – 6th Edition (2010)
- 3 hard bound volumes
- Total 1918 monographs (287 newly added)
- Categorisation, dosage, and available strength added
- Traditional tests replaced with IR and UV spectrophotometry
- Cross-referencing eliminated
- Chromatography applied extensively
- Pyrogen testing eliminated up to certain limits
- Herbal drug monographs added
- Authenticity certificate included
Salient Features – 7th Edition (2014)
- Total 2548 monographs (577 new monographs)
- 19 monographs and 1 general chapter on radiopharmaceuticals
- 4 hard bound volumes + DVD
- Veterinary monographs as vital portion
- Chromatographic methods extensively mentioned
- Pyrogen testing virtually eliminated
- Irrelevant monographs eliminated
- Herbal monographs added
- Authenticity certificate included
Salient Features – 8th Edition (2018)
- General chemical tests and TLC almost eliminated; IR, UV, HPLC given more importance
- Chromatographic methods more comprehensive
- Liquid chromatography upgraded for harmonisation with International Pharmacopoeias
- Bacterial Endotoxin Test (BET) replaced Pyrogen test
- Index introduced in Volume-I for user-friendly access
- 53 new Fixed Dose Combination (FDC) monographs (25 not found in any other Pharmacopoeia)
- Revision of general chapters (volumetric glassware, conductivity, dissolution test, disintegration test, etc.)
Salient Features – 9th Edition (2022)
- 92 new drug monographs; 27 new APIs added
- 3 new biotechnology-derived therapeutic products
- 2 new herbs and herbal products
- 33 new dosage forms (chemicals); 4 new vaccines and immunosera
- 12 new general chapters
- Aligns with National Health Programmes and NLEM of India
BRITISH PHARMACOPOEIA (BP)
The British Pharmacopoeia (BP) is published annually and comprises the standards required for maintaining the quality of medical substances of United Kingdom (UK). BP is normally employed by professionals as well as organisations related to pharmaceutical research, development, manufacturing, and testing.
History of BP
- 1864: 1st edition of BP published (compiled from Pharmacopoeia Londinensis 1618, Edinburgh Pharmacopoeia 1699, and Dublin Pharmacopoeia 1807)
- 1874: 2nd edition
- 1885: 3rd edition (addendum 1890)
- 1898: 4th edition
- 1914: 5th edition
- 1928: Commission made
- 1932: 6th edition (diagnostic materials integrated; standard tests for antitoxins and insulin)
- 1948: 7th edition (generic names; disintegration tests; sterilisation methods; sex hormones and penicillin monographs)
- 1953: 8th edition (titles in English)
- 1958: 9th edition (160 new monographs; tranquilisers; spectrophotometry)
- 1963: 10th edition
- 1970: Medicines Order passed
- 1980: 13th edition (first prepared under Medicines Act; two volumes)
- 1993: Authoritative standards for 130 years
- 2007-2010, 2013, 2014, 2016, 2018, 2020: Further editions
- 2021: Latest edition
BP 2021 – Key Features
- 30 new BP monographs, 20 new Ph. Eur. monographs
- 171 amended BP monographs
- All monographs from Ph. Eur. 10th edition plus supplements 10.1 and 10.2
- New Tracked changes functionality
- Streamlined Timeline functionality and cleaner design
- Archive access through improved navigation
- 8 new BPCRS added
Volumes of BP
- Volumes I & II: Medicinal substances
- Volume III: Formulated preparations, blood-related preparations, immunological products, radiopharmaceutical preparations, surgical materials, homeopathic preparations
- Volume IV: Appendices, infrared reference spectra, index
- Volume V: Veterinary preparations
- Volume VI: CD-ROM version, BP, BP (veterinary), British Approved Names
UNITED STATES PHARMACOPOEIA (USP)
The United States Pharmacopoeia (USP) is a pharmacopoeia for the United States published annually by the United States Pharmacopoeial Convention (USP), a non-profit organisation that owns the trademark and copyright. The USP is published in a combined volume with the National Formulary as the USP-NF.
History of USP
- 1817: Dr. Lyman Spalding proposed plan for National Pharmacopoeia
- 1820: 1st edition of USP (217 drugs, 272 pages)
- 1905: 9th edition (titled USP VIII – 8th revision)
- 1974 (5th July): USP and NF unified; single volume published
- 1990: USP 22 combined with NF 17
- 2013 (November): USP 37 and NF 32 published (adopted May 2014) – 4700+ monographs, 270+ general chapters
- 2016: USP 39-NF 34 – 4900+ monographs, 300+ general chapters
- 2018: USP 41-NF 36 – 4900 monographs, 350 chapters
- 2020: USP 43-NF 38 – last edition in print/USB format; now online only
USP-NF Benefits and Applications
- Ensure compliance with required US quality standards
- Work to world-recognised standards of precision and accuracy
- Validate test results against proven benchmarks
- Establish and validate in-house SOPs and specifications
- Expedite new product development and approvals
NATIONAL FORMULARY OF INDIA (NFI)
The National Formulary of India is an authoritative guide to prescribing, dispensing and administering medicines for healthcare professionals. It is useful for framing national drug policies in the country.
Chronology of NFI
- First Edition – 1960
- Second Edition – 1966
- Third Edition – 1979
- Fourth Edition – 2011
- Fifth Edition – 2016
- Sixth Edition (Current) – 2021
