Evolution of Pharmacy and Pharmaceutical Literature
Syllabus:
History of Pharmacy, Historical background and importance of
various Pharmacopoeias with special reference to Indian Pharmacopoeia,
International Pharmacopoeia and Extra Pharmacopoeia.
Questions:
Q1. What do you know
about the IP. [4]
Q2. Short Note on
Pharmacopoeia [4]
Q3. Short note on
Indian Pharmacopoeial List [5]
Q4. What is meant by
National Pharmacopoeia? [8]
Q6. What are the
various official publications related to pharmacy profession of India.?[12]
Q7. Discuss briefly
the importance of pharmacopoeia to drug industry and administration.[12]
In ancient India the sources of drugs were of vegetable,
animal and mineral origin. They were prepared empirically by few experienced
persons. Knowledge of that medical system was usually kept secret within a
family.
There were no scientific methods of standardization of
drugs.
Muslim rule in India
The Indian system of medicine declined during the Muslim
rule while the Arabic or the Unani-Tibbi system flourished.
British rule in India
The western or the so-called Allopathic system came into
India with the British traders who later become the rulers. Under British rule
this system got state patronage. At that time it was meant for the ruling race
only. Later it descended to the people and become popular by the close of 19th
Century.
Before 1940
Initially all the drugs were imported from Europe. Later
some drugs of this system began to be manufactured in this country.
1901: Establishment of
the Bengal Chemical and Pharmaceutical Works, Calcutta by Acharya Prafulla
Chandra Ray.
1903: A small factory
at Parel (Bombay) by Prof. T.K. Gujjar.
1907: Alembic
Chemical Works at Baroda by Prof. T.K. Gujjar.
Drugs were mostly exported in crude form and imported in
finished form. During World War-I (1914 – 1920) the imports of drugs were
cut-off. Imports of drugs were resumed after the War. There was complete absence of any
restrictions on the quality of drugs imported, so manufacturer abroad took advantage
of the situation. The consequences were as follows:
Foreign manufacturers dumped inferior quality medicines and
adulterated drugs.
Markets were full of all sorts of useless and deleterious
drugs were sold by unqualified men.
Examples of maladies:
Poisoning due to quinine.
Putting of croton oil into eye instead of atropine solution.
Selling of chalk powder tablets in place of quinine.
Drug santonin was badly adulterated.
Potent drugs like compounds of antimony and arsenic and
preparations of digitalis were dispensed without any standard.
At that time few laws were there having indirect connection
to drugs, but they were insufficient.
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1878
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Opium Act
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Dealt with cultivation of poppy and the manufacture,
transport, export, import and sale of opium.
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1889
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Indian Merchandise Act
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Misbranding of goods in general
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1894
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Indian Tariff Act
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Levy of customs duty on goods including foods, drinks,
drugs, chemicals and medicines imported into India or exported there from.
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1898
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Sea Customs Act
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Goods with ‘false trade description’ were prevented from
importing under this act.
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1919
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Poisons Act
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Regulated the import, possession and sale of poisons.
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Indian Penal Code
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Some sections of IPC have mention of intentional
adulterations as punishable offence.
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Some state-level law had indirect references to drugs:
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1884
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Bengal Municipal Act
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1901
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City of Bombay District Municipal Act
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Concerned with food.
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1909
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Bengal Excise Act
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1911
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Punjab Municipal Act
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1912
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United Provinces (now Uttar Pradesh) Prevention of
Adulteration Act
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Refers to adulteration of foods and drugs.
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1914
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Pujab Excise Act
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1916
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United Provinces Municipalities Act
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Inspection of shops and seizure of adulterated substances.
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1919
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Bengal Food Adulteration Act
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1919
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Bihar and Orissa Prevention of Adulteration Act
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1919
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Madras Prevention of Adulteration Act
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Chiefly concerned with food adulteration
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1922
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Bihar and Orissa Municipal Act
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1922
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Central Provinces Municipalities Act
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1925
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Bombay Prevention of Adulteration Act
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1929
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Punjab Pure Food Act
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The laws were too superficial and had indirect link to
drugs.
Drug enquiry committee
Government of India on 11th
August 1930, appointed a committee under the chairmanship of Late Col.
R.N.Chopra to see into the problems of Pharmacy in India and recommend the
measures to be taken. This committee published its report in 1931. It was
reported that there was no recognized specialized profession of Pharmacy. A set
of people known as compounders were filling the gap.
Just after the publication of the
report Prof. M.L.Schroff (Prof. Mahadeva Lal Schroff) initiated pharmaceutical
education at the university level in the Banaras Hindu University.
In 1935 United Province
Pharmaceutical Association was established which later converted into Indian
Pharmaceutical Association.
The Indian Journal of Pharmacy was
started by Prof. M.L.Schroff in 1939. All India Pharmaceutical Congress
Association was established in 1940. The Pharmaceutical Conference held its
sessions at different places to publicize Pharmacy as a whole.
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1937:
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Government of India brought ‘Import of Drugs Bill’; later
it was withdrawn.
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1940:
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Govt. brought ‘Drugs Bill’ to regulate the import,
manufacture, sale and distribution of drugs in British India. This Bill was
finally adopted as ‘Drugs Act of 1940’.
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1941:
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The first Drugs Technical Advisory Board (D.T.A.B.) under
this act was constituted. Central Drugs Laboratory was established in
Calcutta
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1945:
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‘Drugs Rule under the Drugs Act of 1940’ was established.
The Drugs Act has been modified from time to time and at present the
provisions of the Act cover Cosmetics and Ayurvedic, Unani and Homeopathic
medicines in some respects.
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1945:
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Govt. brought the Pharmacy Bill to standardize the
Pharmacy Education in India
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1946:
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The Indian Pharmacopoeial List was published under the
chairmanship of late Col.R.N. Chopra. It contains lists of drugs in use in
India at that time which were not included in British Pharmacopoeia.
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1948:
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Pharmacy Act 1948 published.
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1948:
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Indian Pharmacopoeial Committee was constituted under the
chairmanship of late Dr. B.N. Ghosh.
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1949:
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Pharmacy Council of India (P.C.I.) was established under
Pharmacy Act 1948.
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1954:
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Education Regulation have come in force in some states but
other states lagged behind.
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1954:
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Drugs and Magic Remedies (Objectionable
Advertisements) Act 1954 was passed to stop misleading advertisements (e.g.
Cure all pills)
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1955:
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Medicinal and Toilet Prepartions (Excise Duties) Act 1955
was introduced to enforce uniform duty for all states for alcohol products.
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1955:
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First Edition of Indian Pharmacopoeia was published.
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1985:
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Narcotic and Psychotropic Substances Act has been enacted
to protect society from the dangers of addictive drugs.
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Govt. of India controls the price of drugs in India by Drugs
Price Order changed from time to time.
PHARMACOPOEIA / FORMULARIES / COMPENDIA
The books
containing the standards for drugs and other related substances are known as pharmacopoeia
and formularies - collectively these books are known as the drug
compendia.
The pharmacopoeias or formularies contain a list of
drugs and other related substances regarding their source, descriptions,
standards, tests, formulae for preparing the same, action and uses, doses,
storage conditions etc.
These books are
prepared under the authority of the Government of the respective countries. The
word “pharmacopoeia” is derived from the Greek words ‘pharmacon’ meaning ‘drug’ and ‘poieo’
means ‘make’. Literally it means that it is a list of medicinal substances,
crude drugs and formulae for making preparations from them.
These books are
revised from time to time so as to introduce the latest information available
as early as possible after they become established. In order to keep the size
of book within reasonable limit it becomes necessary to omit certain less frequently
used drugs and pharmaceutical adjuvants from each new edition of the book.
Therefore, in each new edition of these books certain new monographs are added
while the older ones are deleted.
For the
preparation of these books the expert opinion of medical practitioners,
teachers and pharmaceutical manufacturers are obtained.
CLASSIFICATION
The
drug-compendia are classified as:
(i)
Official compendia
(ii)
Non-official compendia
A. Official
compendia
Official compendia are the compilations of drugs
and other related substances which are recognized as legal standards of purity,
quality and strength by a government agency of respective countries of their
origin.
e.g. British Pharmacopoeia (BP)
British Pharmaceutical Codex (BPC)
Indian Pharmacopoeia (IP)
United States Pharmacopoeia (USP)
National Formulary (NF)
The
State Pharmacopoeia of USSR and
Pharmacopoeias
of other countries
B. Non-official
compendia
The book other
than official drug compendia which are used as secondary reference sources for
drugs and other related substances are known as non-official drug compendia.
e.g. Merck Index
Extra
Pharmacopoeia (Martindale)
United States
Dispensatory etc.
NATIONAL PHARMACOPOEIAS
Pharmacopoeias are generally
prepared under the authority of the government of the respective countries -
these pharmacopoeias are known as national pharmacopoeias.
Example of some national
pharmacopoeias are as follows:-
Indian Pharmacopoeia, British
Pharmacopoeia, united States Pharmacopoeia etc.
The drugs used may vary from
nation to nation so, the respective pharmacopoeia includes those drugs or
dosage forms which are frequently used in that very country at that time.
The national pharmacopoeia is recognized as the reference
book by the legislative authority (by law) of the respective country, Whenever
a conflict arises regarding drugs these books will be referred.
INDIAN PHARMACOPOEIA
History
The historical developments of
Pharmacopoeia in India traces back to 1563 and the credit goes to Garcia da
Orta a Portugese physician-cum-teacher.
The idea of indigeneous Indian
Pharmacopoeia was conceived in 1837 which bore fruits in 1841 in the shape of Bengal Pharmacopoeia and Conspectus of Drugs.
The Bengali and Hindi version of London Pharmacopoeia was made available
in India from 1901 onwards.
The Indian Pharmacopoeial List, published in 1946 formed the seeding
for the true Official Indian
Pharmacopoeia published in 1955.
The first edition of Indian
Pharmacopoeia was published in 1955, but actually the process was started as
early as 1944. In 1944 Government of India asked the Drugs Technical Advisory
Board to prepare the list of drugs used, in India, having sufficient medicinal
value to justify their inclusion in official pharmacopoeia.
The Indian Pharmacopoeial List, 1946.
The list of drugs both included
and not included in the British Pharmacopoeia along with standards to secure
their usefulness, tests for identity and purity was prepared by the committee
and was published by the Government of India under the name ‘The Indian Pharmacopoeial List 1946’.
The committee constituted under
the ch airmanship of Col. Sir R.N.Chopra along with other nine members,
prepared the list of drugs with the following details:
Substances included in the British Pharmacopoeia
for crude drugs, chemicals and their preparations.
Substances not included in the British
pharmacopoeia
a)
Drugs of plant origin
b)
Drugs of animal origin
c)
Biological products
d)
Insecticides
e)
Colouring agents
f)
Synthetics
g)
Miscellaneous
h)
Drugs for veterinary use.
The Indian Pharmacopoeial List 1946
was prepared by Department of Health, Govt. of India in 1946.
The history of development of Indian Pharmacopoeia:
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Year
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Events
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1946
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The Govt. of India published the Indian Pharmacopoeial List.
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1948
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The Govt. of India constituted a
permanent Indian Pharmacopoeia Committee. This committee was assigned the
task of preparing Indian Pharmacopoeia and to keep it up-to-date.
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1955
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The first edition of Indian
Pharmacopoeia (IP) was published.
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1960*
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Supplement of IP 1955 was
published.
N.B. The work of revision of the Indian Pharmacopoeia
as well as compilation of new edition was taken up simultaneously under the
chairmanship of Dr. B.N.Ghosh, who died in 1958. After Dr. B.N.Ghosh, Dr.
B.Mukherjee, the Director of Central Drug Research Institute was appointed as
the chairman of Indian Pharmacopoeia committee.
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1966*
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The second edition of IP was published.
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1975
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A supplement of IP 1966 was
published.
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1978
|
The Indian Pharmacopoeia
Committee was reconstituted by the Govt. of India, Ministry of Health and
Family Welfare, under the chairmanship of Dr. Nitya Nand, Director, Central
Drug Research Institute, Lucknow.
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1985
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The third edition of IP was published in two volumes, Volume-I and
Volume-II by the Controller of Publications, on behalf of Govt. of India,
Ministry of Health and Family Welfare.
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1989
1991
|
Addendum (I) to IP 1985 was
published.
Addendum (II) to IP 1985 was
published.
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1996*
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The fourth edition of IP was published.
Volume-I contains:
Legal Notices, Preface,
Acknowledgments, Introduction, General Notices, and Monographs from A to O.
Volume-II contains:
Monographs from P to Z,
Appendices, Contents of Appendices and Index.
The Appendices includes the
(i)
Infra Red Spectra of drugs,
(ii)
Apparatus for tests and assays
(iii)
biological tests and determinations,
(iv)
chemical tests and assays,
(v)
chromatography and electrophoresis
(vi)
Spectrophotometry
(vii)
Clarity and color of solutions
(viii) Disintegration
and dissolution tests
(ix)
Physical tests and determinations
(x)
microbiological assays and tests,
(xi)
limit tests of particulate matter
(xii)
other tests and determinations
(xiii) general
information
(xiv) reagents
and solutions
(xv) reference
substances
(xvi) tables
Index
Under each monograph chemical
structures, molecular weight, physical description, solubility,
identification tests, standards, assay method, storage etc. are given.
|
Published by: The Controller of Publications, Delhi, on behalf of
Govt. of India, Ministry of Health and Family Welfare.
Ø
For the preparation of Pharmacopoeia of India,
the pharmacopoeias of other countries, like British, Europe, United States,
USSR, Japan, the National Formulary (USA) and Merck Index were consulted. The
persons working in pharmaceutical industry, drug control laboratories, research
and teaching institutions also actively participated.
Ø
Under the Drugs and Cosmetics Act 1940, the
Indian Pharmacopoeia is an official book that contains the standards for drugs
and other related substances included in the pharmacopoeia. The drugs and other
related substances prepared by pharmaceutical manufacturers must comply with
these standards.
EXAMPLE OF A MONOGRAPH OF AN OFFICIAL DRUG
The word ‘Monograph’ means the written study of a subject. The pharmacopoeial
monographs (for example in IP) give the following information about the drugs
and pharmaceutical aids:-
1.
Main title: The mai100n name of the substance.
2.
Synonym: The common name(s), if any, of
the substance.
3.
Chemical formula and Molecular Weight of
the substance: If necessary, its I.U.P.A.C.
chemical name and/or its chemical structure is also given.
4.
Category: Indicates the use of the drug
in medicine and pharmaceutical practices. e.g.
Antibacterial, antimalarial, diuretic, emetic, expectorant etc.
5.
Doses: Represents the average range of
quantities suitable for adults.
6.
Description: This includes the general
physical properties, i.e. whether the substance
is a solid or liquid, colourless or coloured, crystalline or amorphous, its taste etc.
7.
Solubility: According to IP the
solubilities of the substances are mentioned in terms of descriptive phrases as
follows:
|
Descriptive
phrase
|
Volume of
solvent for dissolving 1 part of solute.
|
|
Very soluble
Freely soluble
Soluble
Sparingly
soluble
Slightly
soluble
Very slightly
soluble
Practically
insoluble / insoluble
|
Less than 1
part
1 to 10parts
10 to 30 parts
30 to 100 parts
100 to 1000
parts
1000 to 10,000
parts
more than
10,000 parts
|
8. Standards: Prescribes the standards of purity and strength
e.g. Sodium bicarbonate IP contains not less than 99.0 % and not more than
100.5 % of NaHCO3.
9. Identification: This includes some specific and some
non-specific tests for identity of substance.
10.Tests of purity: These tests include melting point, boiling
point, weight per ml, limit tests for chloride, sulfates, iron, heavy metals,
lead and arsenic, specific optical rotation, sulfated ash, loss on drying, pH
of solution, etc. as may be applicable for the substance.
11.Method of Assay: The term ‘Assay’ is used in pharmacopoeias
for quantitative determination of principal ingredients of the official
substances and of their preparations.
12.Storage: Prescribes some conditions for the storage of some
official substances which are likely to deteriorate if not properly stored.
THE INTERNATIONAL
PHARMACOPOEIA
The
International Pharmacopoeia is published by the World Health Organization and
is particularly used in developing countries. The object of this was to provide
a uniform list which would avoid the confusion caused by different national
standards, strengths and names.
Published by: World Health Organization
Prepared
by: WHO Expert Advisory Panel on the International Pharmacopoeia and
Pharmaceutical Preparations.
|
1951
1952
1959
|
Volume-1 of First Edition of The International
Pharmacopoeia was published.
Volume-2 of First Edition of The International
Pharmacopoeia was published.
Supplement to First Edition was published
First Edition includes
344
monographs on drug substances
183
monographs on dosage forms (capsules, injections, tablets and
tinctures)
84 tests, methods and general
requirements.
|
|
1967
|
Second Edition
of The International Pharmacopoeia was published as Specification for the Quality Control of Pharmaceutical Preparations.
Second Edition includes
New
analytical techniques involving infrared spectroscopy, chromatography
(column, paper and thin-layer), non-aqueous titration, and radioactivity.
162
new pharmaceutical preparations were added.
114
monographs present in the first edition were deleted.
|
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1975
|
Volume-1 of Third Edition of
The International Pharmacopoeia was published.
|
|
1981
1982
1988
2003
|
Volume-2 of Third Edition of The International
Pharmacopoeia was published.
Volume-3 of Third Edition of The International
Pharmacopoeia was published.
Volume-4 of Third Edition of The International
Pharmacopoeia was published.
Volume-5 of Third Edition of The International
Pharmacopoeia was published.
|
|
|
Salient features of Third edition
Emphasis on
classical chemical techniques available in the developing world.
Drugs those
are used all over the world by various WHO programs.
Drugs those
degrade or are difficult to manufacture.
Drugs from WHO Model List of Essential Drugs, and their updates.
Volume-1: General
methods of analysis
Volume-2 & 3:Quality specifications of essential drug
substances in the WHO
Model List of Essential Drugs.
Volume-4:
Tests, methods, and general requirements. Quality specifications for
pharmaceutical substances, excipients, and dosage forms.
Volume-5: Contains tests and
general requirements for dosage forms and quality specifications for
pharmaceutical substances and tablets, an a section on antimalarial drugs and
their most widely used dosage forms.
|
EXTRA PHARMACOPOEIA (MARTINDALE)
|
History:
|
The Extra Pharmacopoeia was
first produced in 1883 by William Martindale and is still known as ‘Martindale’.
|
|
Produced by:
|
The Royal Pharmaceutical
Society of Great Britain
|
|
Meant for:
|
Medical Practitioners and
Pharmacists all over the world.
|
|
Sources of
information:
|
Journals and periodicals, licensed product literature, WHO
publications, government reports and legislation and other official and
standard publications.
|
|
Contains information
of:
|
Drugs and medicines, selected
investigational and veterinary drugs, herbal medicines, pharmaceutical
excipients, vitamins and nutritional agents, vaccines, radiopharmaceuticals,
contrast media and diagnostic agents, medicinal gases, drugs of abuse and recreational
drugs, toxic substances, disinfectants, and pesticides .
|
|
Monograph headings:
|
Definitions and descriptions, pharmacokinetics, adverse
effects and treatments, uses, precautions, administration, interactions,
tradenames of preparations.
|
|
Additional
information
|
·
Disease treatment reviews that provide
overviews of diseases and the choice of
treatments available.
·
Details of commercial preparations from a wide
range of countries.
·
Directory of drug-manufacturers and their
addresses worldwide.
|
THE BRITISH PHARMACOPOEIA (BP)
|
History
|
1964: First edition of BP
1968: British Pharmacopoeia Committee was constituted.
1980: 13th Edition of BP was published
1988: 14th Edition of BP was published. Contains two volumes with
2100 monographs.
1993: 15th Edition of BP was published
1998: A consolidated edition as published.
|
Salient features of BP 1998
·
Three volumes.
·
All monographs of the European Pharmacopoeia
(third edition) included
·
Includes British Pharmacopoeia (Veterinary)
·
CD-ROM included in the package for easy search.
·
Annual publication from 1998 onwards. In every
year a new edition is published.
·
Free access to Pharmacopoeia website
|
Meant for
|
The pharmaceutical and chemical industries, quality
control personnel, analysts, government regulators, academics and students of
pharmacy.
|
|
Published by
|
The British Pharmacopoeia Commission The Stationary Office
|
NATIONAL FORMULARY OF INDIA
For the guidance of medical
practitioners, medical students and pharmacists in hospitals and in sales
departments National Formulary of India has been formulated.
1960 First edition was published by Govt. of India, Ministry of
Health.
1966 Second edition was published.
1979 Third edition was published.
It contains information about drug interaction,
resistance, cumulative effects, drug dependence, prescription writing etc.
BRITISH PHARMACEUTICAL CODEX (BPC)
It was in 1903 that the
council of Pharmaceutical Society of Great Britain decided to prepare a
reference book for the use of medical practitioners and dispensing pharmacists.
The first edition of BPC was published in 1907.
On the request of British
Pharmacopoeia Commission, the Council of the Pharmaceutical Society agreed in
1959 for the publication of Codex to coincide with that of the BP, so that BP
and BPC should come into effect on the same date.
The BPC differs from BP in that:
a)
It contains many more drugs and preparations some may be included in
advance to the pharmacopoeia while other drugs may have been included in the
former editions of pharmacopoeia but now they are retained in the Codex because
they are still commonly used.
b)
It provides information on the actions and uses of drugs, their
undesirable effects, precautions and the treatment of poisoning.
c)
It contains formulae, method of preparation, container and storage
conditions of most of the preparations that are still extemporaneously prepared
in the pharmacy.
THE UNITED STATES PHARMACOPOEIA (USP)
The USP was originally published in 1820 under the
authority of United States Pharmacopoeial Convention. The National Formulary
(NF) was published in 1888 under the guidance of American Pharmaceutical
Association.
In 1974 the NF was purchased by the United States
Pharmacopoeial Convention and from 1980 onwards only one official book of drug
standards was published under the heading The United States Pharmacopoeia and
The National Formulary (USP-NF).
THE MERCK INDEX
It is an encyclopaedia of
chemicals, drugs and biologicals. The first edition was published in 1889 and
the eleventh edition was published in 1989 by Merck & Co., Inc. Rahway, New
Jersy, USA.
IMPORTANCE OF
PHARMACOPOEIA
The importance of
Pharmacopoeia can be discussed from the following three angles:
(i)
Drug industry
(ii) Administration
(iii) Academic
From the point
of view of drug industries
To market a new drug molecule stupendous amount
of money is required for the research and development. Very few companies can
bear this cost, especially the drug industries in developing countries (like
India) are unable to bear the expenditure. In that case the drugs of products
mentioned in the pharmacopoeias can be marketed without any further research on
it, because only the tested, safe and efficacious drugs and pharmaceuticals are
included in the pharmacopoeias.
Drugs and pharmaceuticals products are prepared
from some raw materials, the standards of which should rigorously be met with
that of pharmacopoeia. Though there are several other sources of information
about the standard of drugs and pharmaceuticals, the pharmacopoeia is the most
reliable one.
Assay methods and identifications of drug of
pharmaceuticals are given very clearly in the pharmacopoeias so it becomes easy
for the drug industry to design the tests and follow the methods confidently
because the assay and identification methods are tested and approved by the
authority.
2. From the
point of view of drug-administration
In every country there are drug industries with
varied intentions - among which the major one is ‘to make profit’. While making
the profit some industries ignore the quality of the drugs and pharmaceuticals.
Since drugs are related to the health of human beings and animals, this
negligence is unpardonable. So every nation made their own Drugs and Acts and
Rules. Whenever a conflict surfaces between a drug industry and Government the
first reference book that is consulted, regarding the quality if the product,
is the pharmacopoeia.
3. From the
stand point of academic
The
pharmacopoeias are mines of information regarding drugs and pharmaceuticals.
The researchers always consult it in first hand for developing an assay method
of certain drug, for testing the quality of a dosage form. The microbiological
and bioassays are given in details in the appendices with statistical quality
controls. The usage of the drug, the adverse reaction, if any, and many more
information are provided in the pharmacopoeias. The reason for the popularity
of pharmacopoeias among the students, researchers, teachers is for the
reliability of the information provided in it.
Questions for Test-I
Q1. Write a short note on The Indian Pharmacopoeial List
1946. [4]
Q2. Write the salient features of Indian Pharmacopoeia 1996. [4]
Q3. Write the salient features of International
Pharmacopoeia. [4]
Q4. Write the importance of pharmacopoeias in drug
industries. [4]
Q5. Write the importance of pharmacopoeias to drug
administration. [4]
Q6. Write the importance of pharmacopoeias to academic
community. [4]
N.B To answer the salient features write in chart form and
preferably in the form given under Extra Pharmacopoeia.