Introduction to Pharmacopoeia

Pharmacopoeias: Introduction to IP, BP, USP and Extra Pharmacopoeia

Word Pharmacopoeia is derived from two words “Pharmakon” and “Poeien”. Pharmakon means drug and Poien means make. "Pharmacopoeia is a comprehensive official reference book to provides information about the preparation, formulation and quality control of medicines and their dosage forms". It serves as a guide for healthcare professionals, pharmacists and pharmaceutical manufacturers to ensure the safety and efficacy of pharmaceutical products. Countries have their own pharmacopoeia published by the government of that country. The Government of India publish Indian pharmacopoeia (IP), USA publish United States Pharmacopoeia (USP). Some other pharmacopoeias are British Pharmacopoeia (BP), European Pharmacopoeia (Ph Eur), etc.

A detailed and standardized document in pharmacopoeia about a specific drug is called a monograph of the drug. It includes detailed information about drug properties, quality standards, testing methods, dosage forms, and any applicable regulatory information. Monograph is a reference to ensure quality safety and efficacy of pharmaceutical products.

History of Indian Pharmacopeia

In 1844, Bengal Pharmacopoeia was published on recommendation of the East Indian Company’s Dispensary. It contained mainly indigenous remedies. This was followed by Indian Pharmacopoeia in 1868. It contained all monographs included in British Pharmacopoeia 1867 and indigenous drugs and plants. In 1927, a drug enquiry committee was appointed by the British government in India. This committee recommended the publication of National Pharmacopoeia. Indian Pharmacopoeial List as a supplement to British Pharmacopoeia was published in 1946. It contained 180 monographs. Out of 180, approximately 100 monographs were on vegetable drugs.

After independence, the Government of India published Government of India published following pharmacopoeias.

1. The first Indian Pharmaceutical Codex was published in 1953. It had two parts. The first part contained 190 monographs related to natural drugs of plant and animal origin along with a few chemicals. The second part contained galenicals and other preparations.

2. The following addition of Indian Pharmacopoeia has been published till now

   • First edition: Indian Pharmacopoeia 1955, followed by a supplement in 1960;

   • Second edition: Indian Pharmacopoeia, Second edition, followed by a supplement in 1975;

   • Third edition: Indian Pharmacopoeia 1985, followed by its addendum in 1989 and 1991;

   • Fourth edition: Indian Pharmacopoeia 1996, followed by its addendum 2000, supplement 2000 for Veterinary Products, addendum 2002 and addendum 2005;

   • Fifth edition: Indian Pharmacopoeia 2007, in three volumes, followed by addendum 2008;

   • Sixth edition: Indian Pharmacopoeia 2010, in three volumes, and with DVD followed by its addendum 2012;

   • Seventh edition: Indian Pharmacopoeia 2014, with DVD followed by its addendum 2015 and addendum 2016;

   • Eighth edition: Indian Pharmacopoeia 2018, with DVD

   • Ninth edition: Indian Pharmacopoeia 2022 - Ninth edition

Indian Pharmacopoeia (IP) is published by the Indian Pharmacopoeia Commission (IPC), Ghaziabad, on behalf of the Ministry of Health and Family Welfare, Government of India. It is published to fulfil the requirements of the Drugs and Cosmetics Act 1940 and Rules 1945. Indian Pharmacopoeia (IP) is a recognized official book of standards for the manufacturing and marketing of drugs in India. Indian Pharmacopoeia (IP) contains procedures for the analysis of their identity, purity and strength. Indian regulatory authorities enforce the standards of Indian Pharmacopoeia (IP) to ensure drug quality in India. Five countries recognize Indian Pharmacopoeia (IP) as an official book. These countries are Afghanistan, Ghana, Nepal, Mauritius and Suriname. Afghanistan was the first country to recognize Indian Pharmacopoeia (IP) as an official book.

British pharmacopoeia (BP)

The British Pharmacopoeia (BP) has been providing official standards of medicine since 1864. The British Pharmacopoeia (BP) is the national pharmacopoeia of the United Kingdom. It is published annually in August and becomes effective from 1st January of the following years. It is updated and published by the British Pharmacopoeia Commission (BPC). It is an official book in over 100 countries.

United States Pharmacopoeia (USP):

The first edition of United States Pharmacopoeia (USP) was published in 1820. National Formulary (NF) was also published in the USA In addition to United States Pharmacopoeia (USP). NF and USP were merged into a single publication in 1975. USP-NF is continuously revised. It is revised three times a year. In 2018 USP went electronics. Latest printed edition of USP was published in 2019. It is considered the most comprehensive source for medicine quality standards throughout the world. It revolves around four public health programs. These are Dietary supplements, verification programs, health care information and patient safety.

Extra Pharmacopoeia

Extra Pharmacopoeia is a supplementary reference source to complement official pharmacopoeia. Thus also called Supplementary pharmacopoeia. It contains information about pharmaceutical substances, formulations and standards that may not be included in the pharmacopoeia. They are relevant to the pharmacy and medical practice. They include updated and emerging technology, analytical methods, and regulatory changes. Extra Pharmacopoeia is a valuable reference book for pharmacists, researchers, and healthcare professionals.  Example of extra pharmac.opoeia is "Martindle: The Complete Drug Refrence"