Pharmacopoeia and the drug standard

The word, pharmacopoeia, is derived from the Greek pharmakon, a drug or a medicine and poiein, to make. So literally, the pharmacopoeia means a book that treats with of making of drugs or medicines. In a modern sense, a pharmacopoeia is a compilation intended to secure uniformity in medicinal substances as to kind, quality, composition and therapeutic strength, whose specifications are legally obligatory within a country. Such a pharmacopoeia is complied by a recognized authority, usually appointed by government of a country. The pharmacopoeia issued for a country is the legal standard for drugs of that country.

Pharmacopoeias are not of recent innovation. They are found as far back in antiquity as King Hammurabi period in Babylon, in the region of today’s Iraq, perhaps about 4000 years ago. Whenever civilization arose, ancient men recognized the need for safeguards against error and/or abuse in the selection of and preparation of medicines even though the remedies were largely magical, empirical or ceremonial. This need for medicine standards led to the development of many countries’ own pharmaceutical and medical treatises.

World’s first pharmacopoeia: In the United States first pharmacopoeia 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. The first edition of the British Pharmacopoeia (published in the year 1864) was the world’s second national pharmacopoeia. International Pharmacopoeia 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.

History of Indian Pharmacopoeia: The allopathic drug was introduced in India by the British and was available toward the end of 19th century. The allopathic drug was not manufactured in India at that time and the requirement of the same was met from import. There was no control on manufactured or imported drugs, except perhaps the availability of London Pharmacopoeia that helped to detect and identify impurities in medicinal substances. After the enactment of Drugs Act in the year 1940, the restrictions on quality of drugs was partially met by the specifications of standards, mentioned in the second schedule to the Drugs Act, 1940. The British Pharmacopoeia was utilized as reference standard book from 1945 in the absence of the Indian Pharmacopoeia. However many indigenous drugs which were in use in India did not appear in the BP.  With an objective of standards for drugs in use in India a book of standards, Indian Pharmacopoeial List (IPL) was published in 1946. It served as a supplement to the BP. A full-fledged pharmacopoeial committee under the chairmanship of Dr. B.N. Ghosh was appointed by the Indian Government and the 1st edition of the Indian Pharmacopoeia was brought out in 1955.   A supplement to the IP 1955 was published in 1960. The IP 1955 listed monographs according to Latin nomenclature and it relied on the BP. After the reconstitution of pharmacopoeial committee, the second edition of the IP was published in 1966, followed by its supplement in 1975. The third edition of the IP was published in 1985 and it had standards pertaining to drugs and medicines manufactured in India. The fourth edition of the IP was published in 1996 and the fifth edition in 2007.The sixth edition of the IP was published in the year 2010 and an addendum was published in 2012.

The Indian Pharmacopoeia (IP) is the legal standard of drugs in the country. That means anyone who manufactures a drug should conform to the specifications in the current IP. The present (seventh) edition of the IP, 2014  was released on November 4, 2013 and official with effect from January 1, 2014.


About subalcbasak

I am an Associate Professor of pharmacy at Annamalai University, Annamalainagar, Chidambaram,Tamilnadu. I am a person who is interested in pharmaceutical sciences and its education in India. Originally from West Bengal, I am now living in CHIDAMBARAM, Tamilnadu. I just want to share some of my subject basics; and thoughts associated with travelling and living. I also enjoy clicking camera, eating bengali cuisine, listening Rabindra sangeet, reading, learning, and open source of literature/publications.
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