Wherever civilization arose, ancient men recognized the need for safeguards against error and/or abuse in the selection of and preparation of medicines even though remedies were largely magical, empirical or ceremonial. Efforts to bring uniformity into medicaments and unifying drug standards designed to provide safe and effective drugs comprises one of man's basic needs in every principal civilization. This need for uniform standards led to the development of many countries' own pharmaceutical and medical treatises which became the model for all later books for drug standards and for centuries was the indispensable pharmacopoeia.

The word, pharmacopoeia, is derived from the Greek pharmakon, a drug and poiein, to make. Literally, the combination is a formula for making a drug. In a modern technical sense, a pharmacopoeia is a book containing compilation, intended to secure uniformity, of medicinal substances with specifications as to kind, quality, composition and therapeutic strength and legally obligatory within a country. Such a list is complied by a recognized authority, usually appointed by government of a country. There are various spelling of the term 'pharmacopoeia': "pharmacopoeia (English-British), pharmacopeia (English-American), pharmacopée (French), arzneibuch (German), farmacopea (Italian), farmacopéia (Portuguese), farmacopea (Spanish), farmakopé (Swedish)."

A formulary in 1499 (titled Nuovo receptario) published by the Florentine (Italy) guild of physicians and pharmacists, often is considered the first European pharmacopoeia. The first official pharmacopoeia in Germany was the Dispensatorium published by a physician Valerius Cordus in 1546 and made official for the city of Nuremburg. Many consider it to be first time pharmacopoeia anywhere in the world, since it was legally obligatory in Nuremburg. On the contrary the famous earlier book in Florentine was not enacted by civil authorities (Source: Kremers and Urdang's History of Pharmacy, 1976). From early sixteenth century, countless city, state and national pharmacopoeias were published in Europe. And in 18th and 19th centuries compendia were evolved in many countries to ensure uniform quality of medicines and to enforce standard in their preparation.

In the United States first pharmacopoeia (world's first also) on a national basis was released on December 15, 1820. It became the first major step in the creation of authoritative national literature of drug standards. There were three official city pharmacopoeias in the United Kingdom (Viz. London, Edinburgh and Dublin) until 1864, when they were replaced by the British Pharmacopoeia (first edition). The middle of 20th century witnessed a blossoming of pharmaceutical inventions with breakthroughs in the developments of vitamins, sulfonamides, antibiotics, hormones, psychotropics, antihistamines and new vaccines. Pharmaceutical industries in the US, Europe and Japan expanded internationally after WWII and there was an obvious need to control the standards of quality of medicines at international level. International Pharmacopoeia (Int. P) under the auspices of WHO was developed during 1951 to 1959, the first edition of which was published in two volumes: the volume 1 in 1951 and the volume 2 in 1955 and a supplement in 1959.

Rapid changes in leading pharmacopoeias

Before 1940, The USP was revised every 10 years. After 1940, new revisions appeared every 5 years. To cope with the explosive growth of pharmaceuticals and their new standardization techniques, the USP/NF has been publishing annually from 2002 (Table1). The BP 2005, legally enforceable on 1st December 2005, is scheduled to be released in September 2005. The fifth edition of European Pharmacopoeia (EP 2005), came into force on 1st June 2005, is available with future supplements on regular basis (3 per year). The International Pharmacopoeia, does not carry any legal status, has been revising periodically. The major change took place in 1979, when drugs appearing in International pharmacopoeia were restricted to the substances of the WHO EDL. The USP pharmacists' pharmacopoeia, the first edition of which has been published in 2005, is the only pharmacopoeia dedicated on multiple aspects of pharmacy practice.

Table 1: IP and leading pharmacopoeias

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Indian pharmacopoeia and present scenario

The Indian Pharmacopoeia (IP) is the legal standard of drugs in our country. That means anyone who manufactures a drug should conform to the specifications in current IP. The present edition of IP was published in 1996 and two addenda were published in 2000, and one list of 19 antiretroviral drugs as addendum in 2002. It is a necessity today to revise IP regularly in view of not only rapid developments in pharmaceuticals but also to compete with other pharmacopoeias with largest international use viz. USP/NF, BP and EP. Pharmacopoeias of the past contained therapeutic uses of drugs, but today they provide official standards for purity, strength and quality, and provide rapidly changing analytical methods of drugs. The IP should include monographs on drugs against tropical diseases and diseases prevalent in India irrespective of their status in other pharmacopoeias. It also should consider approving FDC drugs and provide guidelines of storage and distribution in extremes of temperatures. Harmonization of standards will be beneficial to manufacturers who distribute their products to multinational locations. Today pharmacopoeia has become a part in the evolving picture of chemotherapy. Failing to adjust to needs of modern health demands, IP may also fail to gain intended importance.

-- The author is with Department in Pharmacy, Annamalai University, Annmalainagar 608 002 TN. Email: cdl_scbasak@sancharnet.in