Pharmacopoeia

 Chapter 3

Pharmacopoeia

Introduction

The word Pharmacopoeia derives from the ancient Greek word pharmacopoeia. Pharmakoi

denotes "drug": whereas the word (poi-) denotes "make", thus the term collectively denotes "drug-make-Ing" or "to make a drug". A pharmacopoeia, pharmacopeia, or pharmacopoeia is a legally binding collection of standards and quality specifications for medicines used in a country or region. It is prepared by a national or regional authority in that country or region. A quality specification is a compilation of a set of appropriate tests that ascertain the amount of the active substance in the product and confirm the identity, purity and performance characteristics of the product. Reference standards are employed in such testing to ensure the quality of medicines. The compilation covers starting materials, excipients, intermediates and finished pharmaceutical products (FPPs). It also covers the General requirements related to quality of medicines such as analytical methods, microbiological purity, dissolution testing, stability, etc. International standards are provided in the International Pharmacopoeia (Ph. Int.) issued by WHO.

Indian Pharmacopoeia

Indian Pharmacopoeia is published by the Indian Pharmacopoeia Commission (IPC), Government of India, Ministry of Health & Family Welfare. The Indian Pharmacopoeia (IP) is published according to the requirements of the Drugs and Cosmetics Act, 1940. It prescribes the standards and ensures the quality control and assurance of the drugs produced and marketed in India. The standards of this pharmacopoeia are authoritativorceabl and intend to help in the licensing of manufacturing, inspect medicines. IP is published to contribute to the mint of public health. 33/211 n gt quality, safety and efficacy of medicines. It is published at regular and shorter intervals.

IPC Commission

The Indian Pharmacopoeia Commission (IPC) has been formed under the Ministry of Health and Family Welfare's Resolution in the year 2008. It is comprising of the General Body of 25 members, Governing Body of 13 members and scientific body of 15-23 members from different related scientific fields. The Secretary, Ministry of Health and Family Welfare, is the Chairman and the Chairman-Scientific Body is the Co-Chairman of the Commission. 

Mission: The mission of the IPC is to promote public health in India by bringing out authoritative and officially accepted standard for quality of drugs including active pharmaceutical ingredients, excipients and dosage forms, used by health professionals, patients and consumers.

 Vision: The vision of the IPC is to promote the highest standards of drugs for use in human and animals within practical limits of the technologies available for manufacture and analysis.

Objectives:

Objectives of IPC are summarized as below.

1. To develop comprehensive monographs for drugs to be included in the Indian Pharmacopoeia, including active pharmaceutical ingredients, pharmaceutical aids and dosage forms as well as medical devices, and to keep them updated by revision regularly.

 2. To develop monographs for herbal drugs, both raw drugs and extracts/formulations from that place.

History of Indian Pharmacopoeia

In 1833, East India Company's Dispensary committee recommended the publication of a Pharmacopoeia. Thus, Bengal Pharmacopoeia (Bengal Pharmacopoeia and General Conspectus of Medicinal Plants) was published in 1844. It included the commonly used indigenous drugs. The first IP published in 1868 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. In 1927, Government formed a Drugs Enquiry Committee that recommended the publication of a National Pharmacopoeia. Later, The Indian Pharmacopoeia Committee was constituted in 1948, which published the IP in 1955, followed by a Supplement in 1960.

General Chapters of Indian Pharmacopoeia

1. General Notices, which includes General Statements,

Name

Official and Official Articles

Official Standards

Added Substances

Alternative Methods

Meanings of Terms

Provisions Applicable to Monographs and Test Methods

Expression of Contents

Expression of Concentrations

Abbreviated Statements

Weights and Measures 

2. Test Methods, which includes

Apparatus

Biological Methods

Chemical Methods

Physical and Physicochemical Methods

Pharmaceutical Methods

Tests on Herbal Products

Tests on Vaccines

Tests on Blood and Blood-related Products

 Reference Data

Reagents and Solutions

General Tests

Containers

Tables

Monographs

General Monographs

Individual Monographs