Pharmacopoeia
Pharmacopoeia the word derives from the ancient Greek pharmakopoiia from (pharmako-) ″drug″, followed by the verb-stem (poi-) ″make″ and finally the abstract noun ending -ια (- ia).
These three elements together can be rendered as ″drug-mak-ing″ or ″tomake a drug″.
A pharmacopoeia, pharmacopeia, or pharmacopoeia, in its modern sense, is a legally binding collection, prepared by a national or regional authority, of standards and quality specifications for medicines used in that country or region.
A quality specification is composed of a set of appropriate tests that will confirm the identity andpurity of the product, ascertain the strength (or amount) of the active substance and, when needed, its performance characteristics.
Reference substances, i.e. highly-characterized, physical specimens, are used in testing to help ensure the quality, such as identity, strength and purity, of medicines.
The textscover pharmaceutical starting materials, excipients, intermediates and finished pharmaceutical products (FPPs).
General requirements may also be given in the pharmacopoeia on important subjects related to medicines quality, such as analytical methods, microbiological purity, dissolution testing, stability, etc.
The role of a modern pharmacopoeia is to furnish quality specifications for active pharmaceutical ingredients (APIs), FPPs and general requirements,e.g. for dosage forms.
The existence of such specifications and requirements is necessary for the proper functioning or regulatory control of medicines.
Pharmacopoeial requirements form a base for establishing quality requirements for individual pharmaceutical preparations in their final form.
According to the information available tothe World Health Organization (WHO), 140 independent countries are at present employing some 30 national as well as the African, European and International Pharmacopoeias.
Compared to national and regional pharmacopoeias, The International Pharmacopoeia (Ph. Int.) is issued by WHOas a recommendation with the aim to provide international standards
Indian Pharmacopoeia Commission (IPC) is an autonomous institution of the Ministry of health and family welfare. which sets standards for all drugs that are manufactured, sold and consumed in India.
The set of standards are published under the title Indian Pharmacopoeia (IP) which has been modelled over and historically follows from the British Pharmacopoeia.
The standards that are in effect since 1 December 2010 is the Indian Pharmacopoeia 2010 (IP 2010).
The Pharmacopoeia 2014 was released by Health Minister on 4 November 2013.
I.P.,the abbreviationof 'Indian Pharmacopoeia' is familiar to the consumers in the Indian sub-continent as a mandatory drug name suffix.
Drugs manufactured in India have to be labelled with the mandatory non-proprietary drug name with the suffix I.P.
This is similar to the B.P. suffix for British Pharmacopoeia (BP) the U.S.P. suffix for the United State Pharmacopoeia (USP).
The IPC was formed according to the Indian Drugs and Cosmetics Act of 1940 and established by executive orders of the Government of India in 1945.
History of Pharmacopoeia
The actual process of publishing thefirst Pharmacopoeia started in the year 1944 under the chairmanship of Col.the I. P. list was first published in the year 1946 and was put forth for approval.
The titles are suffixed with the respective years of publication, e.g. IP 1996. The following table describes the publication history of the Indian Pharmacopoeia.
The term Pharmacopoeia first appears as a distinct title in a work published in Basel, Switzerland in 1561 by Dr A. Foes,
Not appear to have come into general use until the beginning of the 17th century.
Today’s pharmacopoeias focus mainly on assurance of quality of products by various tools of analytical sciences.
The aim to achieve a wide global harmonization of quality specifications for selected pharmaceutical products, excipients and dosage forms came with increased globalization and reciprocal collaboration.
History of these approaches goes back to 1902–1925when agreements established a ″Unified″ Pharmacopoeia.
In 1929 the "Brussels Agreement"stipulated the League of Nations to carry out related administrative functions. Eight years later, in 1937, the first meeting of the ″Technical Commission of Pharmaceutical Experts″ was held.
An important date in the history of quality assurance of medicines is 1948, when the First World Health Assembly (WHA) approved the Expert Committee on Unification of Pharmacopoeias to continue this work. One year later, the WHArenamed it the Expert Committee on International Pharmacopoeia.
Current Issues
Amendments to IP 2007 have been published in IP Addendum 2008. Further amendments
areto be taken care of in IP 2009 edition Publication of IP 2009 by Dec. 2009 is the
immediate priority. Work is in full swing.
159 Drug molecules have been short listed for the IP 2009. The APIs and their
formulations monographs are being prepared at the IPC.
Monograph inclusion/deletion criteria and the Monograph Inclusion Form have been
uploaded on the website of the Commission
Indian National Formulary
1st Edition 1960
2nd Edition 1966
3rd Edition 1979
4th Edition 2011
5th Edition 2016
It is a reliable reference book on drugs formulations for the practicing physicians/ clinicians, pharmacists, clinical pharmacists,nurses andothers engaged in healthcare profession
PHAMACOPOEIA OFFICIAL DRUGS
PHARM.CODEX OFFICIAL+UNOFFICIAL DRUGS
EXTRAPHARACOPOEIADETAILED INFORMATION OF OFFICIAL+UNOFFICIAL DRUGS
FORMULARYREGISTERED DRUGS FOR MARKETING
Table: 2 TYPES OF PHARMACOPOEIAS
| Edition | Year | Addendum/Supplement |
| 1st Edition | 1955 | Supplement 1960 |
| 2nd Edition | 1966 | Supplement 1975 |
| 3rd Edition | 1985 | Addendum 1989 |
| Addendum 1991 | ||
| 4th | 1996 | Addendum 2000 |
| Edition | | Vet Supplement 2000 |
| Addendum 2002 | ||
| Addendum 2005 | ||
| 5th Edition | 2007 | Addendum 2008 |
| 6th Edition | 2010 | Addendum 2012 |
| 7th Edition | 2014 | Addendum 2015 |
| Addendum 2016 | ||
| 8th Edition | 2018 | Addendum 2019 |
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