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,   prepare by   a   nationa or   regiona 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 consume in India. 

The   se of   standards   are   published   unde 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  HealtMinister 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.

Todays 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 priorityWork 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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