Evolution of Pharmacy and Pharmaceutical Literature
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.
| 1878 | Opium Act | Dealt with cultivation of poppy and the manufacture, transport, export, import and sale of opium. |
| 1889 | Indian Merchandise Act | Misbranding of goods in general |
| 1894 | Indian Tariff Act | Levy of customs duty on goods including foods, drinks, drugs, chemicals and medicines imported into India or exported there from. |
| 1898 | Sea Customs Act | Goods with ‘false trade description’ were prevented from importing under this act. |
| 1919 | Poisons Act | Regulated the import, possession and sale of poisons. |
| | Indian Penal Code | Some sections of IPC have mention of intentional adulterations as punishable offence. |
Some state-level law had indirect references to drugs:
| 1884 | Bengal Municipal Act | |
| 1901 | City of Bombay District Municipal Act | Concerned with food. |
| 1909 | Bengal Excise Act | |
| 1911 | Punjab Municipal Act | |
| 1912 | United Provinces (now Uttar Pradesh) Prevention of Adulteration Act | Refers to adulteration of foods and drugs. |
| 1914 | Pujab Excise Act | |
| 1916 | United Provinces Municipalities Act | Inspection of shops and seizure of adulterated substances. |
| 1919 | Bengal Food Adulteration Act | |
| 1919 | Bihar and Orissa Prevention of Adulteration Act | |
| 1919 | Madras Prevention of Adulteration Act | Chiefly concerned with food adulteration |
| 1922 | Bihar and Orissa Municipal Act | |
| 1922 | Central Provinces Municipalities Act | |
| 1925 | Bombay Prevention of Adulteration Act | |
| 1929 | Punjab Pure Food Act | |
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.
| 1937: | Government of India brought ‘Import of Drugs Bill’; later it was withdrawn. |
| 1940: | 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’. |
| 1941: | The first Drugs Technical Advisory Board (D.T.A.B.) under this act was constituted. Central Drugs Laboratory was established in Calcutta |
| 1945: | ‘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. |
| 1945: | Govt. brought the Pharmacy Bill to standardize the Pharmacy Education in India |
| 1946: | 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. |
| 1948: | Pharmacy Act 1948 published. |
| 1948: | Indian Pharmacopoeial Committee was constituted under the chairmanship of late Dr. B.N. Ghosh. |
| 1949: | Pharmacy Council of India (P.C.I.) was established under Pharmacy Act 1948. |
| 1954: | Education Regulation have come in force in some states but other states lagged behind. |
| 1954: | |
| 1955: | Medicinal and Toilet Prepartions (Excise Duties) Act 1955 was introduced to enforce uniform duty for all states for alcohol products. |
| 1955: | First Edition of Indian Pharmacopoeia was published. |
| 1985: | Narcotic and Psychotropic Substances Act has been enacted to protect society from the dangers of addictive drugs. |
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:
| Year | Events |
| 1946 | |
| 1948 | |
| 1955 | |
| 1960* | 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. |
| 1966* | The second edition of IP was published. |
| 1975 | A supplement of IP 1966 was published. |
| 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. |
| 1985 | 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. |
| 1989 1991 | Addendum (I) to IP 1985 was published. Addendum (II) to IP 1985 was published. |
| 1996* | 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 |
| 1967 | Second Edition of The International Pharmacopoeia was published as Specification for the Quality Control of Pharmaceutical Preparations. |
| 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.
Angle of repose
