3. PHARMACOPOEIA

PHARMACOPOEIA: A TEACHER’S COMPREHENSIVE GUIDE

Welcome, future pharmacists and pharmaceutical scientists!

The word “Pharmacopoeia” comes from Greek—‘pharmakon’ meaning drug and ‘poieo’ meaning to make. A pharmacopoeia is a book prepared under the authority of the government of a country. It contains a list of medicinal substances, crude drugs, and formulas for making preparations from these substances. It also provides information about sources of drugs, descriptions and standards, tests for quality, formulations, therapeutic actions and uses, dosage, and storage conditions.

As a pharmacy educator with years of experience teaching pharmaceutical analysis and quality control, I have observed that students often find pharmacopoeias intimidating. Let me tell you: Pharmacopoeias are the legal standards of drug quality—they ensure that the medicines you take are safe, pure, and effective.

In this comprehensive guide, I will walk you through the history, features, and importance of pharmacopoeias—with special emphasis on the Indian Pharmacopoeia (IP), British Pharmacopoeia (BP), United States Pharmacopoeia (USP), National Formulary of India (NFI), and Martindale: The Extra Pharmacopoeia. By the end of this article, you will have a thorough understanding of these essential reference books. Let us begin!

Dpharmguru’s exam insights:

Pharmacopoeias are frequently tested in pharmacy exams. Remember: The word Pharmacopoeia comes from Greek—pharmakon (drug) + poieo (to make). Pharmacopoeias are legal standards of purity, quality, and strength. The Indian Pharmacopoeia (IP) is the official pharmacopoeia of India. The first edition of IP was published in 1955. The British Pharmacopoeia (BP) was first published in 1864. The United States Pharmacopoeia (USP) was founded in 1820. These are classic exam questions!

INTRODUCTION TO PHARMACOPOEIA

Definition

A Pharmacopoeia is a book prepared under the authority of the government of a country. It contains:

• A list of medicinal substances
• Crude drugs
• Formulas for making preparations from these substances

It also provides information about:

• Sources of drugs
• Descriptions and standards
• Tests for quality
• Formulations
• Therapeutic actions and uses
• Dosage
• Storage conditions

Features of a Pharmacopoeia

• Pharmacopoeia is revised periodically to include the latest information
• To keep the book manageable:
  • Less frequently used drugs or excipients may be omitted
  • New monographs may be added
  • Some existing monographs may be amended
• Prepared by experts—medical practitioners, teachers, and pharmaceutical manufacturers
• Recognized as legal standards of purity, quality, and strength by government agencies

Types of Pharmacopoeias

National pharmacopoeias are prepared under the authority of a country’s government. Examples:

• IP (Indian Pharmacopoeia)
• BP (British Pharmacopoeia)
• USP (United States Pharmacopoeia)

These books are legally recognized as reference standards. In case of disputes regarding drugs, these books are the primary reference.

Importance of Pharmacopoeia

1. Pharmaceutical Industry

• Developing a new drug requires huge investment in research and development
• Drugs listed in pharmacopoeias can be marketed without further extensive research, as they are already tested for safety and efficacy
• Provides authentic standards for raw materials used in drug formulations

2. Drug Administration

• Industries often prioritize profit, sometimes ignoring drug quality
• Drugs affect human and animal health, so negligence is unacceptable
• Governments prepare drug-related laws and regulations
• In case of disputes between industries and authorities, pharmacopoeia serves as the first legal reference regarding drug quality

3. Academics and Research

• Pharmacopoeias are reliable sources of drug information
• Researchers use them for developing assay methods and testing the quality of dosage forms
• Appendices provide detailed microbiological and bioassay information
• Covers drug usage, raw materials, adverse reactions, and more

INDIAN PHARMACOPOEIA (IP)

Historical Background

• 1563: Garcia da Orta, a Portuguese physician-teacher, is credited with early work on medicinal plants in India
• 1833: East India Company’s dispensary committee recommended the publication of a pharmacopoeia
• 1844: Bengal Pharmacopoeia and General Conspectus of Medicinal Plants by W. B. O’Shaughnessy was published
• 1868: Indian Pharmacopoeia by Edward John Waring—covered BP 1867 drugs and indigenous drugs
• 1869: Supplement added vernacular names of indigenous drugs
• 1885: British Pharmacopoeia (BP) became the official book of standards in India
• 1900–1901: Colonial addendum of BP published; Bengali and Hindi versions of London Pharmacopoeia made available

Pre-Independence Challenges

• Post WW-I (1914–1920): No restrictions on imported drug quality; foreign manufacturers exploited this
• Few existing laws were insufficient to control drug quality
• 1927: Government appointed Drug Enquiry Committee (DEC)—recommended publication of a national pharmacopoeia
• 1930: Government of India (GOI) established Indian Pharmacopoeia Commission (IPC), chaired by Col. R. N. Chopra
• 1931: Reported no recognized pharmacy profession existed in India
• 1940: Drugs Bill introduced, later became Drugs & Cosmetics Act (D&C Act) 1940
• 1941: First Drugs Technical Advisory Board (DTAB) formed
• 1946: Central Drugs Laboratory (CDL) established at Calcutta
• 1946: Indian Pharmacopoeia List (IPL) published by Col. R. N. Chopra and team—foundation for official IP

Post-Independence IP Development

First Edition (1955)

• Chairperson: Dr. B. N. Ghosh
• Consulted: British, European, US, USSR, Japan pharmacopoeias, National Formulary (USA), Merck Index
• Participation: Industry professionals, research, teaching institutions
• Published by: Controller of Publications, Delhi
• Cost: Rs. 5/-
• Language: English (official monographs in Latin)
• Coverage: 986 monographs
• Purpose: Fulfill D&C Act 1940 requirements
• Supplement published in 1960

Second Edition (1966)

• Chairperson: Dr. Nityanand
• Language: English; doses in metric system
• Updates: Deleted 274 monographs from first edition, added 93 new monographs
• Supplement (1975): Added 126 monographs, amended 250, cholera vaccine deleted

Third Edition (1985)

• Chairperson: Dr. Nityanand
• Presented in 2 volumes + 9 appendices
• Changes: 261 new monographs, 450 deleted
• Addendum I (1989): 46 new monographs, 126 amended
• Addendum II (1991): 62 new monographs, 110 amended
• Herbal drugs included with quality control standards

Fourth Edition (1996)

• Effective: 1st December 1996
• Presented in 2 volumes:
  • Vol-I: Legal notices, preface, general notices, monographs A–O
  • Vol-II: Monographs P–Z, appendices, index
• Coverage: 1149 monographs, 123 appendices
• New additions: 294 monographs, deleted 110
• Addendums (2000, 2003, 2005): Included antiretroviral drugs, veterinary products, herbal drugs

Fifth Edition (2007)

• IPC re-established in 2005
• Published in 3 volumes:
  • Vol-I: General notices and chapters
  • Vol-II & III: Drug monographs, dosage forms, pharmaceutical aids
• Updates: Advanced testing methods, Indian disease relevance, international quality standards
• Addendum (2008): 72 new monographs
• IPC became fully autonomous in 2009 (Ghaziabad, NCR)

Sixth Edition (2010)

• Published: 1st September 2010
• Presented in 3 volumes:
  • Vol-I: Notices, preface, IPC structure, general chapters
  • Vol-II: General monographs, dosage forms A–M
  • Vol-III: Monographs N–Z, vaccines, herbs, biotech, veterinary products
• Addendum (2012): 52 new monographs

Seventh Edition (2014)

• Published in 4 volumes + DVD-ROM
• Effective: 1st January 2014
• Chairperson: P. K. Pradhan
• Coverage: 2548 drug monographs, including 577 new ones
• First time: 19 radiopharmaceutical monographs
• Separate volume for veterinary products
• Addendums: 2015, 2016; total standards ~3000

Eighth Edition (2018)

• Released: 29th September 2017, effective 1st Jan 2018
• Published in 4 volumes
• Updates:
  • 220 new monographs (chemical, herbal, vaccines, blood products, radiopharmaceuticals, biotech, veterinary)
  • 366 revised monographs
  • 7 omissions
• Addendum: 2019

Dpharmguru’s exam insights:

IP editions are frequently tested. Remember: First IP (1955) had 986 monographs and cost Rs. 5. Second IP (1966) had English titles and metric doses. Third IP (1985) introduced new analytical techniques. Fourth IP (1996) had 1149 monographs. Fifth IP (2007) was in 3 volumes. Sixth IP (2010) had 3 volumes. Seventh IP (2014) had 2548 monographs. Eighth IP (2018) had 220 new monographs. These are classic exam questions!

BRITISH PHARMACOPOEIA (BP)

Early History

• UK drug regulation dates back to King Henry VIII (1491–1547)
• 1618: First book of approved drugs and preparations published as London Pharmacopoeia
• 1699: First Edinburgh Pharmacopoeia by Royal College of Physicians of Edinburgh
• 1807: First Dublin Pharmacopoeia published

Formation of British Pharmacopoeia

• General Medical Council (GMC): Appointed commissioners under Medical Act 1858 to create a national BP
• 1864: London, Edinburgh, and Dublin Pharmacopoeias merged → first edition of BP published
• Includes: general notices, monographs (APIs, excipients, formulations, herbal drugs, homoeopathic materials, blood products, immunological products, radiopharmaceuticals, appendices)
• Companion BP (Veterinary): Standards for veterinary substances/products

Key Points

• BP Commission: Publishes BP on behalf of UK Health Ministers, under Medicines Act 1968
• Legal status: BP and BP (Veterinary), along with PhEur, have legal authority in the UK
• Global relevance: Used in 100+ countries worldwide
• Publication cycle: Annually in August, effective 1 January next year
• Modern editions: Include online access, CD-ROM, offline download, and updated monographs from PhEur

Key BP Editions & Milestones

UNITED STATES PHARMACOPOEIA (USP)

Overview

• Published annually by the United States Pharmacopoeia Convention (USPC)
• Combined with National Formulary (NF) as USP–NF
• Covers:
  • Human and animal drugs
  • Dietary supplements
  • Food ingredients
• USP sets quality, purity, strength, and labeling standards

Founding & Early Years (1800–1900)

• 1820: USP founded by 11 physicians in Washington, DC
  • Dr. Spalding proposed a national pharmacopoeia in 1817
  • First USP contained 217 medicines, authored mainly by Jacob Bigelow
• 1830: First revision published; decided to revise USP every 10 years
• 1848: Drug Import Act recognized USP as an official compendium
• 1850: US colleges of pharmacy invited to participate in revisions
• 1888: First NF published by the American Pharmacists Association

Key Points

• USP-NF is legally recognized in the US
• Includes: APIs, dosage forms, excipients, dietary supplements, biologics
• Covers 50 therapeutic classes, including oncology, cardiovascular, endocrine, infectious diseases, and mental health drugs
• USP has evolved from handbook of 217 drugs (1820) → >5,000 monographs (2020)
• Now available in print, CD-ROM, and fully online formats

NATIONAL FORMULARY OF INDIA (NFI)

Purpose

• Provides guidance to medical students, nurses, pharmacists, and hospital staff
• Helps in therapeutic decision-making and ensures the rational use of medicines
• Represents a consensus of medical opinion regarding drugs and formulations

Editions of NFI

EXTRA PHARMACOPOEIA (MARTINDALE)

Full Title

“The Extra Pharmacopoeia of Unofficial Drugs and Chemical and Pharmaceutical Preparations”—commonly known as Martindale: The Complete Drug Reference.

Purpose

• Covers drugs and related substances of clinical interest worldwide, including investigational, herbal, and complementary medicines
• Helps identify existing medications for patients from abroad, including alternate brand names and therapeutic equivalents
• Provides comprehensive drug information for pharmacists, doctors, and healthcare professionals

History

• First published in 1883 under the title Martindale: The Extra Pharmacopoeia
• Currently, there are 38 editions, with the 38th edition published in June 2014

Content Overview

• Monographs on Drugs and Ancillary Substances: Over 6,000 monographs, arranged in 49 chapters based on clinical use
• Preparations: Contains over 180,000 items from 43 countries and regions
• Indexes: Directory of Manufacturers (~20,000 entries), Pharmaceutical Terms in Various Languages (~5,600 terms), General Index (~175,000 entries)

SALIENT FEATURES OF INDIAN PHARMACOPOEIA (IP)

First Edition (1955)

• Monograph titles in Latin, with English titles below
• Weights and measures in metric system; doses in metric and English systems
• Statements in monographs considered official standards

Second Edition (1966)

• Monograph titles changed from Latin to English
• Doses in metric system only
• Solubility expressed as parts of solvent per unit of solute

Third Edition (1985)

• Introduced new analytical techniques: Flame Photometry, Fluorometry, Electrophoresis, Photometric Hemoglobinometry
• Dissolution test for certain tablets introduced
• Disintegration test updated

Fourth Edition (1996)

• Text available in two volumes
• Computer-generated structural formulae introduced
• IR and UV absorption spectrophotometry added as alternative identification tests

Fifth Edition (2007)

• Presented in three volumes
• General chemical identification tests largely replaced by IR/UV spectrophotometry
• Animal pyrogen test eliminated; replaced by bacterial endotoxin test

Sixth Edition (2010)

• Increased monographs for excipients, anticancer, herbal, antiretroviral drugs
• New chapter on Liposomal products
• NMR chapter added in appendices

Seventh Edition (2014)

• Includes advanced technology and experimental methods
• Presented in four volumes
• Incorporates 2,548 monographs, including 577 new monographs

Eighth Edition (2018)

• Brought out in four volumes
• 53 new FDC monographs included; 25 not available in any other pharmacopoeia
• Emphasis on more specific IR, UV spectrophotometry, and HPLC tests

Dpharmguru’s exam insights:

Salient features of IP editions are frequently tested. Remember: First IP (1955) had Latin titles. Second IP (1966) had English titles and metric doses. Third IP (1985) introduced Flame Photometry and Dissolution tests. Fourth IP (1996) had computer-generated structures. Fifth IP (2007) replaced animal pyrogen test with bacterial endotoxin test. Seventh IP (2014) had 2548 monographs. Eighth IP (2018) had 53 new FDC monographs. These are classic exam questions!

COMPARISON: IP, BP, AND USP

FREQUENTLY ASKED QUESTIONS (FAQs)

1. What is a Pharmacopoeia?

A Pharmacopoeia is a book prepared under the authority of a country’s government that contains a list of medicinal substances, crude drugs, and formulas for making preparations. It provides information about sources, descriptions, standards, tests for quality, formulations, therapeutic actions, dosage, and storage conditions.

2. When was the first Indian Pharmacopoeia published?

The first edition of the Indian Pharmacopoeia (IP) was published in 1955, with 986 monographs, under the chairmanship of Dr. B. N. Ghosh.

3. What is the difference between IP, BP, and USP?

IP is the Indian Pharmacopoeia, official in India. BP is the British Pharmacopoeia, official in the UK. USP is the United States Pharmacopoeia, official in the USA. All three are legally recognized standards of drug quality in their respective countries.

4. What is the National Formulary of India (NFI)?

The National Formulary of India (NFI) provides guidance to medical students, nurses, pharmacists, and hospital staff. It helps in therapeutic decision-making and ensures the rational use of medicines. The first edition was published in 1960.

5. What is Martindale?

Martindale: The Complete Drug Reference (originally titled “The Extra Pharmacopoeia”) is a comprehensive drug reference book first published in 1883. It covers drugs and related substances of clinical interest worldwide, including investigational, herbal, and complementary medicines.

6. How many monographs does the current IP have?

The Seventh Edition of IP (2014) has 2,548 drug monographs, including 577 new ones. The Eighth Edition (2018) added 220 new monographs.

SUMMARY

Pharmacopoeias are essential reference books that establish legal standards for drug quality, purity, and strength. This guide covered:

• Definition and Features: Pharmacopoeias are government-authorized books containing drug standards, revised periodically by experts
• Indian Pharmacopoeia (IP): First published in 1955; currently in its 8th edition (2018) with over 2,500 monographs
• British Pharmacopoeia (BP): First published in 1864; currently with over 4,000 monographs, used in 100+ countries
• United States Pharmacopoeia (USP): Founded in 1820; combined with NF as USP-NF; currently with over 5,000 monographs
• National Formulary of India (NFI): First published in 1960; provides guidance for rational drug use
• Martindale: First published in 1883; comprehensive global drug reference

As I always tell my students: “Pharmacopoeias are the guardians of drug quality—they ensure that every medicine you take is safe, pure, and effective. Understanding them is essential for every pharmacy professional.”

REFERENCES AND FURTHER READING

• Indian Pharmacopoeia Commission (IPC). (2018). Indian Pharmacopoeia (8th ed.). Ghaziabad: IPC.
• British Pharmacopoeia Commission. (2020). British Pharmacopoeia. London: BP Commission.
• United States Pharmacopoeia Convention. (2020). USP-NF. Rockville: USPC.
• Government of India. (1940). Drugs and Cosmetics Act, 1940. New Delhi: GOI.
• Pharmacy Council of India (PCI). (2022). Pharmacopoeia Syllabus. New Delhi: PCI.
• Martindale: The Complete Drug Reference. (2014). 38th ed. London: Pharmaceutical Press.

Disclaimer: This article is for educational purposes only and does not constitute medical advice. Always consult qualified healthcare professionals for medical concerns. Pharmaceutical regulations and guidelines may vary by region—always refer to your local regulatory authorities for specific requirements.

written by:
Dr. N. Sujith Kumar

Dr. N. Sujith Kumar is a pharmacy educator, Pharm.D graduate, and academic content creator from Jawaharlal Nehru Technological University Kakinada (JNTUK), where he completed his Doctor of Pharmacy (Pharm.D) degree between 2015 and 2021. He has more than 7 years of experience creating pharmacy educational content, writing study materials, and reviewing academic articles for pharmacy students. He has also contributed guest articles to pharmacy education platforms, including PharmD Guru. At D.PharmGuru, his work focuses on simplifying complex Diploma in Pharmacy (D.Pharmacy) subjects into easy-to-understand notes, practical explanations, and exam-oriented educational resources for students across India. His areas of focus include Human Anatomy and Physiology, Pharmaceutics, Pharmacology, Pharmaceutical Chemistry, Hospital and Clinical Pharmacy, and other core D.Pharmacy subjects.

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