history of pharmacydocshare01.docshare.tips/files/24131/241315297.pdf · 2016. 6. 2. · indian...

History of Pharmacy

Origin, history & development of pharmacy in India.

Pharmacy in relation to allied health profession.

Pharmacopoeias – I.P., B.P., U.S.P, and EP

Pharmacy – What it is ???

• Pharmacy is the health profession which links the health science with chemical science & is charged with ensuring the safe and effective use of pharmaceutical drugs.

• pharmacy is derived from pharma (since the 15th–17th

centuries).

• Original Greek roots from "Pharmakos" imply sorcery or

even poison.

• Pharmakon: Drug or medicine

Pharmacy – What it is ???

Pharmacy – Symbols

• The one snake on a staff symbol is called the

serpent of Epidaurus on the staff of Aesculapius, and can be

seen in the bottom left quarter of the shield on the crest of the

Royal Pharmaceutical Society of Great Britain.

• Aesculapius was one of the Greek Gods of medicine, and is usually

depicted carrying a staff with a snake coiled around it.

• The snake was a symbol of wisdom, immortality and healing in

Middle and far Eastern cultures

• This symbol is often considered particularly

suitable for pharmacy.

Origin, history & development of pharmacy

• Ayurveda – Ayu (Life)

– Veda (Knowledge)

• Charak-samhita is a continuation & renewal of ancient knowledge.

• Sushrutha-sanhita- encyclopedia of surgery


contd.

• Archaeological survey discovered the material

related to the historical part of drugs or

medicines, Papyrus-Ebers of 16th Century BC.

• It contains important information on vegetable

drugs & the formulations made from them.


contd.

• Then came the era of individuals by virtue of

their involvement in the profession, contributed

for development in science, which in turn has

affected pharmacy profession.

– Hippocrates

– Aristotle

– Dioscorides

– Galen etc

Hippocrates- Father of Medicine

(466-377 BC)

• Systematized the knowledge available and linked it with ethics

• His knowledge were then accepted worldwide & still utilized by health professionals.

• He developed an Oath of Medical Ethics for physicians to follow.

• Hippocrates is known as the "Father of Medicine".

Aristotle (384/3 B.C.-322/1 B.C.)

• He not only contributed enormously to medicine per se, but also to the natural sciences, for he was the first to classify animals

• It seems that he sustained the notion that certain "inferior" animals such as insects (whose name derived from the evident segmentation of the body into its components) came into the world spontaneously from decomposing material regenerating and so their growth could not be limited or restrained.

• Aristotle elaborated a physiological system centred on the heart, in which according to him, there burned a life-giving vital flame maintained by a spirit named pneuma or spirito vitale (vital spirit) that produced heat. He felt that the lungs and the brain had a primary function of cooling. The heart was the most important organ because when the heart stopped, the body died.

• Furthermore, he studied embryology.

Dioscorides - A Scientist Looks At Drugs

(040-80 BC)

• Greek physician linked botany to this field & wrote materia medica, which included various drugs of vegetable origin.

• He described various naturally occurring drugs & provided the basic information regarding its identification, cultivation, collection & storage.

Galen - Experimenter In Drug Compounding

(131-200 AD) Of the men of ancient times whose names are

known and revered among both the professions of Pharmacy and Medicine, Galen, undoubtedly, is the foremost.

Galen (130-200 A.D.) practiced and taught both Pharmacy and Medicine in Rome;

His principles of preparing and compounding medicines ruled in the Western world for 1,500 years; and his name still is associated with that class of pharmaceuticals compounded by mechanical means - galenicals.

He was the originator of the formula for a cold cream, essentially similar to that known today.

Many procedures Galen originated have their counterparts in today's modern compounding laboratories.

Paraselsus- Swiss physician (1493-1541)

• Responsible for developing the basic

thinking of using individual chemical

moiety for treatment of diseases.

Charak Samhita

• Charak Samhita is one of the structuring dynamics of Rk Veda.

• It highlights the BALANCING — HOLDING TOGETHER, NOURISHING, and SUPPORTING — quality involved in structuring Rk Veda.

• With reference to consciousness, Charak Samhita comprises the specific sets of laws of Nature that are engaged in promoting the quality of Rishi — the observer, the witnessing quality — within the Samhita level of consciousness, providing a structure to the eternally silent, self-referral, self-sufficient, fully awake state of consciousness, which is intimately personal to everyone.


contd. • 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 Poisons Act Regulated the import, possession and sale of poisons.

• 1912 United Provinces (now Uttar Pradesh) Prevention of Adulteration Act Refers to adulteration of foods and drugs.

• 1919 Bengal Food Adulteration Act


contd.

• Each government made some rules & the standards to maintain the uniformity & to control the standards of drugs & devices available in market.

• Each country has its own book of standards which includes the list of the drugs along with related substances with their complete protocol.

• These books are known as Pharmacopoeia

PHARMACOPOEIA

• Pharmakon : a drug

• Poieo: I make

• Pharmacopoeia (literally, the art of the drug

compounder), in its modern technical sense, is a book

containing directions for the identification of samples and

the preparation of compound medicines, and published

by the authority of a government or a medical or

pharmaceutical society.

PHARMACOPOEIA

• Indian Pharmacopoeia is the official book of standards

for drugs included therein, in terms of the Second

Schedule to the Drugs and Cosmetics Act, 1940so as to

specify the:

• Standards of identity, purity and strength for the drugs

imported, manufactured for sale, stocked or exhibited for

sale or distributed in India.

PHARMACOPOEIA

• It is a reference document for various stakeholders like

enforcement agency, industry, lab, academic institutions

etc.

• Compliance with IP Standards by drug manufacturing

industry assures consumers, patients and healthcare

professionals of their quality.

Indian Pharmacopoeia (I. P.)

• Various editions of I.P.

Edition Year

1st Edition 1955

2nd Edition 1966

3rd Edition 1985

4th Edition 1996

5th Edition 2007

Indian Pharmacopoeia (I. P.) • The actual process of publishing the first Pharmacopoeia started in 1944 under

the chairmanship of Col. R. N. Chopra. The I. P. list was first published in 1946

and was put forth for approval. The titles are suffixed with the respective years of

publication, eg. IP 1996.

• 1st edition I. P. 1955 published in the official gazette. Dr. B. N. Ghosh, Chairman

– Supplement 1960

• 2nd edition I. P. 1966 Dr. B. Mukherji, Chairman

– Supplement 1975

• 3rd edition I. P. 1985 Dr. Nityanand, Chairman

– I Addendum/Supplement 1989

– II Addendum/Supplement 1991

• 4th edition I. P. 1996 Dr. Nityanand, Chairman

– Addendum/ Supplement 2000

– Addendum/ Supplement 2002

• 5th edition I. P. 2007 Dr. Nityanand, Chairman

• 6th edition I. P. 2010


• In 1944, Govt. of India asked the drugs Technical advisory Board to prepare the list of drugs in use in India, having sufficient medicinal value to justify their inclusion in official pharmacopoeia.

• Published by the Govt. of India under the name The Indian Pharmacopoeial List 1946

• The Committee constituted under the chaimanship of Lt. Col. Sir R.N. Chopra along with 9 members.


• Indian Pharmacopoeia Commission

• Formation: 1945

• Headquarters: Ghaziabad, Uttar Pradesh, India

• Chairman: P. K. Pradhan, Secretary (Health & Family

Welfare), Government of India.

• Website: ipc.nic.in

http://ipc.nic.in/

Indian Pharmacopoeia (I. P.) • Monograph:

• A Monograph is the documentation of the quality parameters for drugs.

• It comprises of the name and synonym of the drug;

-- where appropriate, the chemical, empirical and structural formulae of the

molecule –the base or its salt –involved,

-- its molecular weight, production, definition, category, dose, usual strength,

description, solubility, tests for identity, tests for impurities, tests for assay or

potency in general and

-- in the case of injectables, tests for pyrogen, sterility and

-- in the cases of certain biological products abnormal toxicity and storage.

• All the parameters of quality set out in a monograph are designed to determine

the quality of a drug

Indian Pharmacopoeia (I. P.) • IP General Chapters:

• It provides the information about the common analytical procedures applicable to

IP monographs and information pertaining to the quality requirements of

pharmaceutical products.

• The interpretation of a monograph must be in accordance with all the general

requirements, testing methods, texts and notices pertaining to it, in the IP.

• A product is not of standard quality unless it complies with all the requirements

of the monograph.


• The Indian Pharmacopoeial List 1946 Details

1. Substances included in the British Pharmacopoeia, 48 monographs for crude drugs, chemicals & their preparations

2. Substances not included in British Pharmacopoeia: (a) Drugs of Plant origin 90

(b) Drugs of animal origin 10

(c) Biological Products 05

(d) Insecticides 07

(e) Colouring agents 03

(f) Synthetics 05

(g) Miscellaneous 15

(h) Drugs for veterinary use 02

Indian Pharmacopoeia (I. P.) 1955

(1st edition) • First edition published in 1955

• Written in English

• The official Title of the monographs are given in Latin

• Total 986 Monographs (includes crude-drugs, chemicals, biologicals & several formulae derived from them)

• Supplements to first edition in 1960


(2nd edition) • 274 monographs from IP 55 & its supplement of

1960 were deleted

• 93 new monographs were added

• New analytical techniques were adapted

• Usual strength for the preparations like tablets &

injection was given.


(3rd edition) • Published in two Volumes

• Nine appendices

• 261 new monographs

• 450 monographs included in 2nd Edition were deleted

• IUPAC nomenclature has been used

• New analytical Techniques

• Dissolution test

• Limit test for microbial contamination


(4th edition) • Made effective from 1st Dec 1996

• 1149 monographs

• 123 appendices

• 294 new monographs

• 110 included in 3rd edition were deleted

• General monographs of formulations

• Addendums of I.P. 1996

– Addendums 2000

– Addendums 2002


(5th edition) • prepared by the Indian Pharmacopoeia Commission

(IPC) in accordance with a plan and completed through the untiring efforts of its members and its Secretariat over a period of about two years.

• This is the fifth edition of the Indian Pharmacopoeia after Independence.

• It supersedes the 1996 edition but any monograph of the earlier edition that does not figure in this edition continues to be official as stipulated in the Second Schedule of the Drugs and Cosmetics Act, 1940.


(5th edition) • The Indian Pharmacopoeia 2007 is presented in

three volumes. – Volume 1 contains the Notice, Preface, the structure

of the IPC, Acknowledgements, Introduction, and the General Chapters.

– Volume 2 deals with the General Monographs on Drug Substances, Dosage Forms and Pharmaceutical Aids (A to M).

– Volume 3 contains Monographs on Drug Substances, Dosage Forms and Pharmaceutical Aids (N to Z) followed by Monographs on Vaccines and Immunosera for Human use, Herbs and Herbal products, Blood and blood-related products, Biotechnology products and Veterinary products.


(5th edition) • The scope of the Pharmacopoeia has been extended to

include products of biotechnology, indigenous herbs and herbal products, viral vaccines and additional antiretroviral drugs and formulations, inclusive of commonly used fixed-dose combinations.

• Standards for veterinary drugs and products that were published as a Supplement to the previous edition of the Indian Pharmacopoeia now form an integral part of this compendium.


(6th edition) • Released on 4th August 2012.

• A list of 287 new monographs items not included in the 2007 edition of the

Indian Pharmacopoeia and its addendum 2008 added in this edition


(6th edition) Addendum 2012 • Addendum 2012 to IP 2010 is released by Shri. P. K. Pradhan, Secretary

(Health & Family Welfare), Government of India and Chairman, IPC on

27th December, 2011. It came in to effect from 1st January, 2012.

• Addendum 2012 to IP 2010 incorporates 52 new monographs consisting of

APIs, dosage forms, herbal and blood products etc.


(7th edition)

• Four volumes.

• The scope extended to includes additional anticancer drugs & antiretroviral

drugs and formulations, products of biotechnology, indigenous herbs and

herbal products, veterinary vaccines.

• Standards for new drugs and drugs used under National Health

Programmes are added and the drugs as well as their formulations not in

use now a days are omitted from this edition.

• 2550 monographs of drugs out of which 577 are new monographs

consisting of APIs, excipients, dosage forms and herbal products etc.


(7th edition)

• A list of 577 New Monographs not included in IP-2010 and its Addendum-

2012 but added in this edition containing

– 313 New Monographs on drug substances, Dosage forms &

Pharmaceutical aids (A to Z),

– 43 New Drugs Substances Monographs, 10 Antibiotic Monographs, 31

Herbal Monographs, 05 Vaccines & immunosera for human use, 06

Insulin Products, 07 Biotechnology Products etc. along with

– the 19 new General Chapters.

•

• 19 New Radiopharmaceutical Monographs & 1 General chapter is first time

being included in this edition.

•

• This edition of Indian Pharmacopoeia-2014 is now under printing and will be

available to stakeholders probably in Sept.2013, before three months of its

effective date, i.e. 1st Jan. 2014.

British Pharmacopoeia

• London Pharmacopoeia first published in 1618

• British Pharmacopoeia published in 1864 through the merger of the London, Edinburgh and Dublin Pharmacopoeias

• Legally enforced in UK through Medicines Act 1968

• National pharmacopoeias in EU enforced by Annex 1 of

• Directive 2001/83/EC, the Community Code relating to medicinal products for human use

• Published in UK by the British Pharmacopoeia Commission on behalf of UK Health Ministers

• Legal Status in Australia and Canada


• Monographs for Chemical and

pharmaceutical substances

• General monographs for dosage

forms

• Monographs for finished dosage

forms

• One of only two English texts for

monographs for finished dosage

forms


• Published annually

• Incorporate all the monographs of the current European Pharmacopoeia including its supplements – Provides the user with one comprehensively indexed

compendium of all current UK pharmacopoeial standards

– Links standards for pharmaceutical substances and formulated preparations

– Includes reference infra-red spectra

– Ph Eur monographs identified by a European chaplet of stores

United State Pharmacopoeia (USP)

• The United States Pharmacopeia (USP) is the official public standards-setting authority for all prescription and over-the-counter medicines, dietary supplements, and other healthcare products manufactured and sold in the United States.

• USP sets standards for the quality of these products and works with healthcare providers to help them reach the standards.

• USP's standards are also recognized and used in more than 130 countries.

• These standards have been helping to ensure good pharmaceutical care for people throughout the world for more than 185 years.

United State Pharmacopoeia (USP) • 1820

U.S. Pharmacopeia founded; all state societies of medicine invited to send delegates; 11 attended. USP created a system of standards, a system of quality control (formulae), and a national formulary. Only 217 drugs that met the criteria of "most fully established and best understood" were admitted.

• 1830 Committee of Revision created (seven members); first revision of the USP published; revisions continue at 10-year intervals. Surgeons General of U.S. Army and Navy became first federal agencies to participate in USP revision.

• 1848 Drug Import Act–Federal legislation recognizes the USP as an official compendium.

• 1850 Colleges of pharmacy invited to participate in revision of the USP.

• 1880s–1890s State Boards of Pharmacy formed; USP becomes a state board requirement.

• 1900 USP incorporated in D.C. as not-for-profit corporation. U.S. Pharmacopeial Convention and Board of Trustees created.

• 1906 Federal Food & Drugs Act: USP and NF strength, quality, and purity recognized as official standards.


• 1938 Federal Food & Cosmetic Act: USP, NF, and Homeopathic Pharmacopeia standards of strength, quality, purity, packaging, and labeling recognized as official and enforced by FDA. "New Drug" concept established. FDA approves drugs for safety before marketing.

• 1942 USP revision cycle changed; USP published every 5 years.

• 1950 USP establishes its first permanent office in New York City. Lloyd C. Miller, Ph.D., becomes first employed director of revision.

• 1963 United States Adopted Names Council formed. Representatives from American Medical Association (AMA), American Pharmacists Association (APhA), USP, and FDA establish drug nomenclature.

• 1968 USP moves its headquarters from New York City, eventually locating in Rockville, Maryland, USA.

• 1970 USP adopts resolution calling for information to be provided to dispensers of drugs in United States. Position of executive director created, filled by William M. Heller, Ph.D.

United State Pharmacopoeia (USP) • 1975

USP acquires National Formulary and Drug Standards Laboratory from APhA.

• 1977 USP and NF scope redefined: USP standards for drug substances and dosage forms; NF standards for excipients.

• 1980 USP XX and the NF XV published under same cover; USP Dispensing Information, 1st Edition.

• 1990 Jerome A. Halperin becomes USP executive director (title later changed to executive vice president and CEO) at the 1990 USP Convention. USP members adopt a resolution to explore establishing standards for vitamins and minerals.

• 1990, 1993 Federal Omnibus Budget Reconciliation Acts (OBRA '90 and '93) name the USP Drug Information as a source of information that state Medicaid agencies could use for drug utilization review, patient counseling, and medically accepted off-label uses of medicines.

• 1994 USP signs an agreement with the American Medical Association to combine the information in AMA's Drug Evaluations database with the USP DI database to develop a single product that contains drug and therapeutic information.


• 1995 USP members adopt a resolution to explore establishing standards for botanical dietary supplements.

• 1997 The management consulting firm, McKinsey & Company, recommended new USP focus, including divestiture of print and electronic drug information products.

• 1998 USP sells USP DI and associated products to The Thomson Company and USP DI is published by their MICROMEDEX subsidiary. The new Reference Standard Center opens. MEDMARX®, an Internet-accessible medication errors reporting program for hospitals, is launched.

• 1999 USP publishes final USP DI in three-volume format; publishes USP 24–NF 19; initiated modernization project for developing e-commerce capabilities and establishing electronic communications with constituents.

• 2000 At the USP Convention in April 2000, Roger L. Williams, M.D., becomes USP executive vice president and CEO; members vote to change name of Committee of Revision to Council of Experts and elect chairpersons for 62 Expert Committees.

• 2002 USP–NF published annually.

European Pharmacopoeia

• The European Pharmacopoeia of the Council of Europe is a listing of a wide range of active substances and excipients used to prepare pharmaceutical products in Europe.

• The European Pharmacopoeia is developed by the European Directorate for the Quality of Medicines (EDQM) and is a part of the Council of Europe, Strasbourg, France.

• It bases on the Convention on the elaboration of a European Pharmacopoeia from 1964.

• The 2005 edition includes 1800 specific and general monographs, including various chemical substances, antibiotics, biological substances; Vaccines for human or veterinary use; Immunosera; Radiopharmaceutical preparations; Herbal drugs; Homoeopathic preparations and homoeopathic stocks.

• It also contains Dosage forms, General monographs, Materials and Containers, Sutures; 268 General methods with figures or chromatograms and 2210 reagents are described.

• The monographs give quality standards for all the main medicines used in Europe.

European Pharmacopoeia

• 1st edition - published 1967

• 2nd edition - published 1980

• 3rd edition - published 1997

• 4th edition - published 2001, valid from 1.1.2002

• 5th edition - published 15.6.2004, valid from 1.1.2005

• 6th edition - published 16 July 2007, valid from 1.1.2008

• It is published by EDQM in English and French, official national translations are available in German and Spanish (Spanish version only online)

history of pharmacydocshare01.docshare.tips/files/24131/241315297.pdf · 2016. 6. 2. · indian...

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