Pharmacopoeia

Pharmacopoeia


Pharmacopoeia the word derives from the ancient Greek pharmakopoiia from (pharmako″drug″, followed by the verbstem (poi) make and finally the abstract noun ending ια (-
ia). 

These three
elements together can be
rendered as ″drugmaking or
to
make 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
and
purity of the product, ascertain the
strength (or amount) of the active substance and, when needed, its performance characteristics. 

Reference substances, i.e. highlycharacterized, physical specimens, are used
in testing to help ensure the quality, such as identity, strength and purity, of medicines. 

The
texts
cover 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 ind
ividual pharmaceutical preparations in their final form.

According to the information available to
the 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
ph
armacopoeias, The International Pharmacopoeia (Ph. Int.) is issued by
WHO
as a recommendation with the aim to provide international
s
tandards 

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  Healt
Minister on 4 November 2013.

I.P.,
the abbreviation
of 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 nonproprietary
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 the
first 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
suf
fixed with the respective years of publication, e.g. IP 1996. The following table describes the publication history of
the
Indian
Pha
rmacopoeia.

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
qu
ality specifications  for selected pharmaceutical  products,  excipients  and  dosage forms
came with increased globalization and reciprocal collaboration. 

History
of these approaches
goes back to 1902–1925
when 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
medi
cines 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
WHA
re
named it the Expert
Co
mmittee on International
Pharmacopoeia.

 

Current Issues

 

Amendments to IP 2007 have been published in IP Addendum 2008. Further amendments

are
to 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
Comm
ission

 

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 and
others 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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