historical background and development of profession of pharmacy 5th sem notes pharmaceutical jurisprudence

1. CHAPTER 1
HISTORICAL BACKGROUND AND DEVELOPMENT OF PROFESSION
OF PHARMACY
1.1 INTRODUCTION
➢ Pharmacy has been defined as “the profession which is concerned with the art & science of
identification, selection, preparation, preservation and standardization of suitable drug
substances and their formulations and dispensing of these with the aim of achieving complete
pharmaceutical care.
➢ Pharmacy profession is mainly categorized as manufacturers and traders of medicinal
products. In recent years, pharmacy is considered as part of health policy framework, where
pharmacists provide pharmaceutical health care.
➢ In summary, Indian pharmacy profession is broadly classified as pharmaceutical technology
(Industrial oriented) and pharmacy practice (Patient oriented).
1.2 HISTORY OF PROFESSION OF PHARMACY IN INDIA
➢ For convenience of understanding the section is subdivided into development of pharmacy
profession, growth of pharmaceutical industry and pharmacy education.
LEARNING OBJECTIVES
On completion of this chapter students will come to know about the following aspects:
• History of profession of pharmacy includes current developments in pharmacy
Education, Industry and Organization.
• Pharmacy as a career or Role of pharmacist in Pharmaceutical industry and pharmacy
practice.
• Introduction to IP, BP, USP and Extra Pharmacopoeia with features.

2. 1.2.1 Development of Pharmacy Profession
➢ The word pharmacy is derived from the Greek word phrmakon, which means drug or
medicine. The evolution of the profession of pharmacy can be divided into five historical
periods.
a) Ancient era: From the beginning of time to AD 1600.
b) Emperic era: 1600-1940
c) Industrialization era: 1040-1970
d) Patient care era: 1970-present
e) Biotechnology and genetic engineering era: The new Horizon.
• Papyrus Ebers (1550 BC): Was the first to attempt in the systemic classification of
medicines. Forms document containing drug formulae and drugs mainly of vegetable origin.
Eg. Fennel, acacia, castor bean, sulphur etc.
• Hippocratus (400 BC): is referred to as FATHER OF MEDICINE who systemized the
knowledge available and linked it with ethics. His concepts were then accepted worldwide
and still utilized by health professionals.
• Diascorides (65 AD): A Greek physician linked botany to this field and wrote MATERIA
MEDICA , which included various drugs of vegetable origin.
• Galen (131-201 AD): The ancient Greek physician reported his medical literature carrying
description of number of drugs, their formulae and method of preparations called as
GALENICALS.
➢ In early days, the physician had to do both diagnosis and compounding and dispensing of
medicines. King Frederick in 1240 declared pharmacy as separate profession in Europe. The
job of compounding medicines was exclusively of the pharmacists who were then known by
the name ‘Apothecaries’.
➢ A pharmacy established in Germany in 1241 may be the first pharmacy. Thus, the
physicians, apothecaries (pharmaceutical chemists) and drug merchants (druggists) were
involved in the supply of medicament to the patient. The chemists were related to
compounding and druggists were referred to people who supplied and sold medicines.
➢ Pharmacy is an ancient profession dedicated to provide health care. Several developed and
developing countries have been recognizing pharmacists as members of health care team. In

3. India, also pharmacy is regarded as a prestigious profession; however, the recognition of the
profession is comparatively recent.
➢ The ‘compounder’ a person who was able to read a prescription and assist the physician in
compounding, was considered as pharmacy professional. It was only after 1st
September 1984
a diploma in pharmacy is considered a minimum qualification to register as a pharmacist.
➢ Therefore, pharmacists having a D. pharm degree are more in retail drug business. However,
due to lack of in-depth knowledge and skills of pharmacy practice, these retail pharmacies
remain mere centers of trading.
➢ With aim of strengthening pharmacy practice, post graduation in pharmacy practice
(M.Pharm.) was introduced in 1994 and the recent developments like Pham.D. Regulation
2008, Bachelor of pharmacy (practice) regulation 2014 and pharmacy practice regulation
2015 are milestone contributions for the development of pharmacy profession.
➢ Dr. B. Suresh, President of Pharmacy Council of India is the person behind these important
developments. The expertise of clinical pharmacists in hospitals, in clinical trials and in
Pharmacovigilance has started opening new doors for pharmacy professionals.
1.2.2 PHARMACEUTICAL INDUSTRY IN INDIA
➢ Before 1900, the Indian science of medicine, Ayurveda, was system of medicine; however
medicines were not produced on an industrial scale. India was largely dependent on the UK,
France and Germany for pharmaceutical products. In 1901, a small factory ‘Bengal
Chemicals and Pharmaceutical works’ was established in Calcutta by AcharyaPrafulla
Chandra Ray.
➢ In 190, Prof. T.K. Gujjar established a small factory in Mumbai, which has grown into the
Alembic Chemical Works Ltd. at Baroda (1907). After the first world war with the spirit of
‘Swadeshi’ to compete with inferior quality imported medicines, the Government of India
appointed the Drug Inquiry Committee,(1931). Lt. Col. R. N. Chopra headed the committee.
As per recommendation of this committee, Drug and Cosmetic Act 1940 and its Rules 1945
were enacted.
➢ Role of allopathic medicines, mainly antibiotics was well accepted, that lead to the
establishment of Hindustan Antibiotics Ltd. (HAL) at Pune in the early 1950’s and Indian
Drugs and Pharmaceutical Ltd.(IDPL) at Rishikesh and Hyderabad in the 1960’s which have

4. been milestones in the history of pharmaceutical industry of India. At the time
ofindependence the production of drugs was worth only Rs. 10 crores, which has grown
significantly due to the implementation of the Process Protection Patent Act 1970.
➢ Manufacturing and export of drugs at great economy by modifying the process of
manufacturing accelerated the growth of industry and it was about 12000 crores in 1997.
➢ The pharmaceutical industry in India has attained remarkable growth during the last decade.
This rapid growth can be attributed to the technological advancement and increased export in
post GATT (General Agreement on Tariffs and Trade) era. GATT was signed by India on
5th
April 1994. Product Patent Act was accepted by India in 2005, when the Indian pharm.
Market was US $ 6 Billion.
➢ Then spender progress started as:
• 2015- US $ 30 billion
• 2016-US $ 36.7 billion
• 2020- US $ 55 billion
➢ The pharmaceutical industry is the world’s third largest in terms of volume and 14th
in terms
of value.
➢ India is the only country after America that has a large number of US FDA approved
pharmaceutical formulation units (more than 800 units) and due to which export contributes
for almost 50% of total Pharma business. Export of generic drug formulations is considered
as a major boost that account for 20% of global exports in terms of volume.
➢ The exports from India grew to US $ 14.6 billion in 2012-13 from US $ 6.23 billion in 2006-
07, where exports to USA accounts more than 30%. India has gained recognition as ‘Generic
Pharmacy of the world’.
1.2.3 PHARMACY EDUCATION IN INDIA
➢ During 13th
century AD, the Greek-Arab system of medicine named ‘Unani’ was introduced
in India. The beginning of Pharmacy education in India can be traced back to 1842, when the
Portugese started ‘Escola Medico de Goa’ at that time the pharmacists were recognized as
‘Farmaceuticos’. The same college is now called as Goa College of pharmacy.
➢ In 1870, Madras Medical College was given permission to conduct licentiate examination for
candidates, who wished to work as Chemists and Druggists. In 1894, a two year pharmacy

5. course after secondary school level was introduced and it was guided by Pharmaceutical
society of Great Britain. However, there was no uniformity in the syllabus and legislation to
control the pharmacy education. Professor R. N. Chopra committee recommended the need
of pharmacy qualified person to perform pharmacy related services and laid down
qualifications for diploma and degree pharmacy.
➢ As part of recommendations, the Pharmacy Act 1948 was passed with the objective to
regulate the profession of pharmacy in India and the Pharmacy Council of India (PCI) came
into existence in 1949; as part of which the first Educational Regulation (ER) was introduced
in 1953 by the PCI.
➢ The Birla Institute of Technology is the first approved institute by PCI to conduct the
Diploma in Pharmacy as per ER-53. As per ER-53, the minimum qualification for a
registered pharmacist was two year diploma followed by professional training or one year
condensed course for experienced persons. It is subsequently revised and updated in 1972,
1981 and 1991. To fulfill the needs of Pharma industry, the Chopra committee also
recommended a course in degree pharmacy.
➢ In 1932, Prof. M. L. Shroff ‘The Father of Pharmacy Education in India’ initiated
pharmaceutical education at the university level in the Banaras Hindu University. A regular
three-year B. pharm course made a beginning from July 1937 with beginning of other
universities like
• 1945- Bombay University
• 1947- LMCP Ahmedabad and Punjab University
• 1950- BITS Pillani
• 1951- Andhra University
• 1956- Sagar University
• 1956- Nagpur University
➢ Currently, pharmaceutical education in India is imparted as:
• Diploma in Pharmacy: Two year course after 12th
science
• Bachelor of Pharmacy: Four year course after 12th
science
• B. Pharm. (Practice) 3 years after B. Pharm.
• Master of Pharmacy: Two year course after B. Pharm and Pharm. D.

6. ➢ Master’s programme in pharmacy is available in various branches such as Pharmaceutics,
Industrial pharmacy, Pharmaceutical Technology, Pharmaceutical Chemistry, Pharmaceutical
Analysis, Pharmacology, Pharmacognosy, Pharmaceutical Quality Assurance,
Pharmaceutical Biotechnology, Phyto-pharmacy and Phyto-medicine, Regulatory Affairs and
Practice of Pharmacy.
➢ Students who qualify GPAT (Graduate Pharmacy Aptitude Test) examination and admitted
to M. Pharm. are entitled for scholarship sanctioned by AICTE. Since 1950s, Doctoral
research has been started in various institutes.
1.3 CARRIER IN PHARMACY/ SCOPE OF PHARMACY
➢ An individual who is trained and licensed to prepare, compound and dispense drugs upon
written order (prescription) from a licensed veterinary, medical or dental practitioner is called
pharmacist. The scope of pharmacy practice includes compounding and dispensing of
medications, and more modern services such as clinical services, reviewing medications or
safety and efficacy, and providing drug information.
➢ The pharmacist has job opportunities in industry, universities, teaching, hospitals,
investigation and research institutes, Government departments, etc. a wide range of
opportunities are available to pharmacists but if nothing, he can get going with his own
business.
➢ The professional role or career options are as follows:
1) As a pharmacist: The pharmacy course is considered as a paramedical program. The
pharmacist can therefore work in hospitals as hospital pharmacist, community pharmacist,
consultant pharmacist or industrial pharmacist.
a) Hospital Pharmacist: A registered pharmacist can work in hospitals drug stores as hospital
pharmacist who plays role in dispensing or compounding the prescription, maintaining
patient’s medical history and all patient profile.
b) Community Pharmacist: A registered pharmacist who works to ensure correct and safe
supply of medical products to the general public. He is a vital link between the patient and
physician. They are involved in maintaining and improving people’s health by providing
advice and information as well as supplying prescription medicines.

7. c) Industrial Pharmacist: They undertake research and the development, manufacture,
testing, analysis and marketing activities for pharmaceutical and medical products.
d) Consultant Pharmacist: They work as a part of healthcare team and are involved in
monitoring of medicine usage, counseling patients, providing drug information and advice to
health professionals and the community, conducting clinical trials and preparing products for
patient use.
2. Central and State Government: The Central and State Governments appoints Drug
Inspectors for controlling and regulating medicine related activities in definite areas. Drug
Inspectorsare public servants and are working under the control of Licensing Authority.
Pharmacist as a drug inspector or government analyst has to make sure that the drugs
manufactured and sold are of standard quality. A pharmacist has positions in the Regulatory
bodies like Food and Drug Administration (FDA) at state and central level. For these govt.
jobs the pharmacist needs to appear and pass the respective state service commission
examination. Pharmacist can even find jobs in various government sectors like Railways,
Hospitals, Navy and Military, and Food Inspector etc.
3) Pharmaceutical industry: Pharmacists can do marketing, research and product
development, quality control, sales, and administration.
a) Research and development: It includes R&D activities like finding new drug molecules or
to improve effectiveness of the existing drugs, clinical research, Formulation &
Developments(F&D), Novel Drug Delivery Systems etc.
b) Production and manufacturing: India has a vast and growing pharmaceutical industry. It
also has a vast market and many foreign pharmaceutical industries are opening their set-up in
India. In these industries a pharmacist can start his career as a trainee production or chemist
and grow up with becoming Production Executive, Production Officer, Production Manager,
Director, Vice-President, President etc .in the production of bulk drug and intermediates or
dosage forms. Production of Ayurvedic / Homeopathic / Unani medicines, blood and plasma
products, biological and biotechnological products, surgical dressings, medical devices and
equipments, perfumery, Nutraceuticals etc.
c) Quality Control and Quality Assurance: Identification and characterization of raw
materials are required during production, storage, and at handling of finished products. QC
chemists are responsible for the biological and chemical testing of products, raw and

8. intermediate materials, and facilities. Their duties include performing assays and establishing
and writing specifications and standard operating procedures. Quality assurance is one of the
areas that get a lot of attention in pharmaceutical industries. Quality experts ensure that
medicines are manufactured and tested in compliance with federal standards. QA personals
ensure that in-house testing, reporting, and manufacturing are in compliance with regulatory
requirements. QA personnel conduct site audits and review and analyze data and
documentation.
d) Regulatory affairs:A pharmacy graduate can work as Regulatory Manager (RM) in
industries and contract research organizations. He can handle the job of monitoring the
conduct of clinical trials that are conducted on human volunteers. He has to supervise
regulatory documents such as clinical trial approval permission, marketing approval
permission; etc. It is their responsibility to see that the clinical trials are carried out as per the
international guidelines.
e) Pharmacovigilance: Pharmacovigilance is pharmacological science relating to the
collection, detection, assessment, monitoring, and prevention of adverse effects with
pharmaceutical products. It is more concerned with identifying the hazards associated with
pharmaceutical products and with minimizing the risk of any harm that may come to patients.
It is an emerging field. Drug safety and adverse effect monitoring have now been made
compulsory by the Indian Government. Therefore a career into pharmacovigilance can be
fruitful on long run.
f) Marketing: All movements of drug products starting from dispatch section of a
manufacturing unit up to its retail sale covered under marketing activities. International
marketing and specialized marketing are newer specialties of the modern era.
4) Pharmaceutical marketing: Pharmaceutical marketing is challenging job in the field of
pharmacy because it is different than other businesses. The pharmaceutical marketing is a
highly technical field and offers excellent opportunities for pharmacy graduates. Ambitious
people with pleasant personality and good communication skills can think of making career
inpharmaceutical marketing. Pharmacy graduate with MBA degree enhances job
opportunities in this field. The industries preferpharmacy graduate for this job, as they have a
good knowledge about the drug molecules, their therapeutic effects, how drug products are
prepared, and stability of products as well as drug-excipient and drug-drug interactions.

9. Pharmacist can work as a medical representative, medical sales executive to the levels of
International Marketingand exports. Area sales manager, regional sales manager, division
manager are the various positions of job inpharmaceutical marketing.
5) Academics: Academic profession is associated with job satisfaction and social status as
teaching is considered to be a noble profession. Pharmacy graduate may take-up teaching as
a profession as assistant professor. Working in academia can allow the pharmacist to educate
and inspire the next generation of healthcare profession. Academic pharmacist can work on
post such as Assistant professor, Associate professor, Professor, Principal etc. They are
involved in teaching, research, public service, and patient care. Students graduate in
pharmacy with first class are eligible to teaching D. Pharm. programme. Post graduate
candidate with first class can work as an Assistant Professor in degree pharmacy colleges.
Candidate with Ph.D. degree in any of the pharmacy specialization with 5 years of teaching
experience can reach to the grade of Associate professor. He can be professor after 10 years
of experience and 13 years to become a principal of a college. Besides teaching, academics
related opportunities involve various positions on research posts and training programmes.
6) Clinical research: In clinical research, the phase of testing drug in human in product
development is called as the clinical trial. Pharmacy graduate have a good knowledge of
therapeutic effects of drugs as well as drug-drug interactions thus can opt for career in
clinical research. They are employed as clinical pharmacist or clinical research Associate
(CRA), clinical data manager (CDM), statistical analysis software (SAS) technician and can
reach to the position of project manager in a clinical research organization. The responsibility
of a clinical research associate is to help the doctors in monitoring the adverse effects of
drugs under trial.
7) Pharmaceutical Journalism: Pharmaceutical Journalism has great potential. His requires
specialist technical personnel to cover various aspects related to the field of pharmacy.
Pharmacist can provide reliable and authentic information on drug and diseases through
publishing articles in health and medical journals, scientific journals, magazines, newspapers,
internet websites etc.
8) Consultancy: Pharmacist may serve as consultants for local, state, national, and international
organizations. Most of experienced pharmacy professionals are providing consultancy to
industry and also earning a good salary and popularity. Services in pharmacy are offered in

10. various fields such as regulatory affairs, manufacturing, analytical services, documentation,
approvals, research, marketing policies etc.
9) Business: Pharmacists can establish their own pharmacy store like wholesale distribution and
recognized stockists, also can establish own manufacturing/ production plant and testing
laboratories.
10) Scientific service officer: Pharma companies regularly appoint a medical advisor/ scientific
service officer to support marketing team as well as to prepare technical notes, pamphlets,
brochures etc. These professionals take lead in organizing meeting with doctors and solve
medicine related queries raised by them.
11) Entrepreneur: Entrepreneurship can be developed in varied areas of core pharmacy like
manufacturing, marketing or sales or consultancy services like Pharma advertisements,
intellectual property rights, DRA, pharmacovigilance, pharmacoeconomics etc. Many
Pharma professionals have chosen allied fields like cosmetics, herbal and Ayurvedic
medicines, homeopathy medicines, Nutraceuticals and even food industry.
1.4 PHARMACOPOEIA
➢ The word “Pharmacopoeia” is derived from the Greek words ‘pharmakon’ meaning drug and
‘poieo’ means ‘make’. It is a legal and official book issued by recognized authorities
appointed by the government of each country that describes lists of pharmaceutical
substances, formulae together with standards, quality control tests in order to build quality
and maintain uniformity.Pharmacopoeias are developed to improve and maintain the
standards and quality of medicinal preparations. In the event of doubt or dispute, the
information given in them is considered authoritative and valid.
➢ These books are revised from time-to-time to introduce the latest information available as
early as possible. In order to keep the size of book within reasonable limit it becomes
necessary to omit certain less frequently used drug information and pharmaceutical
excipients from each new edition. In each new edition of these books certain monographs are
added, some are amended while older ones are deleted. These books are prepared by expert
amongst medical practitioners, teachers and pharmaceutical manufacturers.

11. ➢ Monograph: A monograph includes the name of the ingredients or preparations, the
definition, packaging, storage and labeling requirements, and the specification. The
specification includes test, procedures for the test and acceptance criteria.
➢ The books containing the standards for drugs and other related substances are known as
compendia. This book contain list of drugs and other related substances regarding their
source, descriptions, standards, tests, formulae for preparation, action and uses, doses,
storage conditions etc.
➢ The drug compendia are classified as:
1) Official compendia
2) Non-official compendia
1) Official compendia: Official compendia are the compilations of drugs and other related
substances are recognized as legal standards of purity, quality and strength by a government
agency of respective countries of their origin. Examples:
❖ British Pharmacopoeia
❖ Indian Pharmacopoeia
❖ United States Pharmacopoeia
❖ National Pharmacopoeia
2) Non-official compendia: The book other than official compendia which are used as
secondary reference sources for drugs and other relatedsubstances are known as non-official
compendia. Example:
❖ Merck Index
❖ Extra Pharmacopoeia etc.
➢ EXAMPLES OF VARIOUS PHARMACOPOEIAS
✓ Indian Pharmacopoeia
✓ British Pharmacopoeia
✓ United States Pharmacopoeia
✓ National Pharmacopoeia
✓ British Pharmaceutical Codex
✓ Japanese Pharmacopoeia
✓ European Pharmacopoeia
✓ International Pharmacopoeia

12. ✓ Martindale Extra Pharmacopoeia
✓ Argentine Pharmacopoeia
1.4.1 INDIAN PHARMACOPOEIA
➢ Indian Pharmacopoeia Commission (IPC) is an autonomous institution of the welfare which
sets standards for all drugs that are manufactured, sold and consumed in India. A Drug
Enquiry Committee appointed in 1927 by the Britishgovernment recommended the
publication of an Indian National Pharmacopoeia.
➢ The set of standards are published under the title “Indian Pharmacopoeia” (IP) has been
molded over theBritish Pharmacopoeia. The IP is an official book meant for overall quality
control and assurance based on safety, efficacy and affordability of pharmaceutical products
marketed in India. It contains a collection of approved methods and procedures of analysis
and specifications for drugs and products.
➢ The IP prescribes standards for identity, purity, strength of drugs essentially required from
the health care perspective of human beings and animals. The standards given in IP are
authoritative in nature and are enforced by the Regulatory authorities for quality control of
medicines in India.
➢ The history of the IP began in the year 1833 when a committee of the East Indian Company’s
Dispensary recommended the Publication a Pharmacopoeia. The ‘Bengal Pharmacopoeia and
General Conspectus of Medicinal Plants’ were published in 1844.
➢ The author of this book was W.B.O’ Shaunhnessy and published by Calcutta, Bishop’s
College Press. This book listed the information about most commonly used
indigenousremedies.
➢ This was followed by IP 1868, written by Edward John Waring, which covered both the
drugs of British Pharmacopoeia (BP; 1867) and indigenous drugs used in India. The
supplement to IP was published in 1869 incorporating the vernacular names of indigenous
drugs and plants. But, from 1885 the BP was made official book of standards in India. The
colonial addendum of BP 1898 was published in 1900 appeared as Government of India
edition in 1901.
➢ A ‘Drug Enquiry Committee’ was appointed in 1927 by the government who recommended
of an Indian National Pharmacopoeia. Then Government of India on 11th
August 1930,

13. appointed an Indian Pharmacopoeial Commission under the chairmanship of Late Col. R. N.
Chopra to see into the issues of pharmacy in India and recommend the measure to be taken.
➢ This committee report got published in 1931 with remarks that there was no recognized
specialized profession of pharmacy.
➢ In 1940 Government of India brought ‘Import of Drugs Bill’ which was later withdrawn. In
the same year Government brought ‘Drugs Bill’ to regulate the import, manufacture, sale and
distribution of drugs in British India. This Bill was adopted as ‘Drugs And Cosmetics Act
1940. The first Technical Advisory Board (DTAB) under this Act was constituted in 1941.
➢ In 1946 the Central Drugs Laboratory (CDL) was established in Calcutta. In
1944Government of India asked the DTAB to prepare the list of drugs used.In India, having
sufficient medicinal value to justify their inclusion in official book Pharmacopoeia.
➢ The work of preparing lists of drugs in use in India at those times which were not included in
British Pharmacopoeia was given to late Col. R. N. Chopra along with other nine members,
by Department of Health, Government of India. This work was published as an Indian
Pharmacopoeial List (IPL)’. The IPL, published in 1946 formed the foundation for the true
first official Indian Pharmacopoeia.
➢ After independence, the Indian Pharmacopoeia Committee was constituted under the
chairmanship of late Dr. B. N. Ghosh in 1948 for publication of Indian Pharmacopoeia as its
main function. Tenure of this committee was five years. This committee was assigned the
task of preparing Indian Pharmacopoeia and to keep it up-to-date.
➢ 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 were also actively participated.
1. Salient features of first edition of IP: The first edition of IP was published in 1955, under
the chairmanship of Dr. B. N. Ghosh, by the controller of Publications, Delhi, on behalf
ofGovernment of India, Ministry of Health and Family Welfare. Cost was ₨ 5/- (Dollar-8).
• It covers 986 monographs.
• The titles of monographs have been given in Latin language. Abbreviated titles are also given.
• The weights and measures have been given in metric system.
• Doses are expressed both in metric as well as in the English system.

14. • A list of preparations has been given at the end of some monographs.
• The temperature has been expressed in Celsius thermometric scale.
• The descriptive terms (very soluble, sparingly soluble, slightly soluble, very slightly soluble,
and practically insoluble) have been used where the exact solubility of a pharmaceutical
substance is not known.
2. Salient features of second edition of IP: The second edition of IP was published in 1966
under chairmanship of Dr. B. Mukherji.
• In all 274 monographs from IP 1955 and their supplement were deleted, 93 new monographs
were added.
• The supplement to this edition was published in 1975. In this supplement 126 new
monographs were included and 250 monographs were amended. Most important cholera
vaccine was deleted.
• The titles of monographs have been changed from Latin to English.
• The title changed e.g. Injection of Aminophylline has been changed to Aminophylline
Injection.
• Doses are expressed in the metric system only.
• Solubility is expressed in parts of solvent per unit part of solute.
• The test for sterility has been modified to provide for detection of fungi in addition to aerobic
and anaerobic bacteria.
• New analytical techniques such as non-aqueous titrimetry, column chromatography have been
included.
• In the monograph of “Tablets” and “Injections”, a new sub-heading “Usual Strength” has
been given to represent the strength of the tablet or injection in which it should be generally
marketed.
3. Salient features of third edition of IP: The third edition of IP was published in 1985 was
presented in two volumes as I and II, and nine appendices.
• In all total 261 new monographs were added and 450 monographs were deleted.
• Addendum I to IP was published in 1989 was 46 new monographs added and 126 amended.
• Addendum II was published in 1991 was 62 new monographs added and 110 amended.

15. • In the IP 1985 and its Addendums, traditional drugs were not included as publication of a
Pharmacopoeia. Traditional system drugs were taken up separately and only those herbal
drugs were included which had supporting definitive quality control standards.
4. Salient features of fourth edition of IP: The fourth edition of IP was published in 1996
under the chairmanship of Dr. Nityan and made effective from 1st
December 1996.
• It was presented in two volumes.
• It covered 1149 monographs and 123 appendices.
• It includes 294 new monographs and 110 monographs have been deleted.
• Addendum I has been made effective from 31st
December 2000 were 42 new monographs
have been added.
• Addendum II has been made effective from 31st
June 2003 were 19 new monographs have
been added.
• The veterinary supplement to IP 1996 contains 208 monographs and 4 appendices.
5. Salient features of fifth edition of IP: The fifth edition of IP was published in 2007 and
addendum to this edition was published in 2008 containing 72 monographs.
• IP 2007 presented in three volumes.
• Volume I contains general notices and general chapters.
• Volume II and III contains general monographs on drug substances, dosage forms and
pharmaceutical aids.
6. Salient features of sixth edition of IP: The sixth edition of IP was published in 2010 by the
IPC Ghaziabad.
• This edition was effective from 1st
September 2010.
• It is presented in three volumes.
• Volume I contains the Notices, Preface, the Structure of the IPC, Acknowledgements,
Introduction, and the General Chapters.
• Volume II contains the General Notice, General Monographs on Dosage Forms and
Monographs on drug substances, dosage forms and pharmaceutical aids (A to M).
• Volume III contains Monographs on drug substances, dosage forms and pharmaceutical aids
(N to Z).

16. • Monographs on Vaccines and Immuno-sera for Human use, Herbs and Herbal products,
Blood and Blood-related products, Biotechnology products and Veterinary products.
• The number of monographs of excipients, Anti-cancer drugs, Herbal products and Anti-
retroviral drugs has been increased in this edition.
• A chapter on NMR and chapter on microbial contamination also updated.
7. Salient features of seventh edition of IP: The seventh edition of IP was published in 2014
by the Indian Pharmacopoeia Commission (IPC) on behalf of theGovernment of India,
Ministry of Health and Family Welfare by Ghulam Nabi Azad.
• This edition was made effective from 1st
January 2014.
• It is presented in four volumes with DVD-ROM.
• The scope of this has been extended to include additional anticancer drugs and antiretroviral
drugs and formulations, products of biotechnology, indigenous herbs and herbal products,
veterinary vaccines.
• The IP 2014 incorporates 2550 monographs of drugs out of which 577 are new monographs
consisting of APIs, excipients, dosage forms and herbal products etc.
1.4.2 NATIONAL FORMULARY OF INDIA
➢ For the easy selection of suitable formulation, the pocket-sized National formulary of India
(NFI) was published in 1960, followed by 1966 and 1979. It is not a mandatory document but
its aim is to promote rational drug use and as guidelines for a physician and a pharmacist.
➢ The latest 4th
edition is published in a new format in 2011. A section ‘General Advice for
Prescribers’ elaborate principles of prescription writing, drug selection, drug interactions,
dose, adverse drug reactions, patient compliance etc.
➢ It includes monographs of 377 drugs and 22 fixed dose combinations explaining their
indications, contraindications, precautions, adverse effects and storage. The drugs and
formulations included in these are classified on the basis of pharmacological actions.
1.4.3 BRITISH PHARMACOPOEIA
➢ The British Pharmacopoeia is the national pharmacopoeia of the United Kingdom. The first
edition of BP was published in 1864 which consists of two sections Materia Medica and
Preparation and Compounding.

17. ➢ It is an annual published collection of quality standards for UK medicinal substances. The BP
is used by all those who were involved in pharmaceutical research, development, and
manufacture and testing.
➢ BP is an important statutory part in the control of drugs and medicines which complements
and assists the licensing and inspection processes of the medicines and Healthcare Products
Regulatory Agency (MHRA) of the UK.
➢ The BP includes general notices, general monographs, and specific monographs providing
mandatory standards for active pharmaceutical ingredients, excipients, formulated
preparations, herbal drugs, herbal drug products and herbal medicinal products, materials for
use in the manufacture of homeopathic preparations, infrared reference spectra, appendices,
supplementary chapters and comprehensive index. The BP (veterinary) is published as a
companion volume to the British Pharmacopoeia.
➢ It contains standards for substances and products used solely in the practice of veterinary
medicine in the UK.
➢ The British Pharmacopoeia editions are as follows:
✓ 1st
edition-1864
✓ 2nd
Edition-1867
✓ 3rd
Edition-1885
✓ 4th
Edition-1898
✓ 5th
Edition-1914
✓ 6th
Edition-1932
✓ 7th
Edition-1948
✓ 8th
Edition-1953
✓ 9th
Edition-1958
✓ 13th
Edition-1980
✓ 14th
Edition -1988
✓ 15th
Edition-1993
➢ British Pharmacopoeia 2000 edition has an additional companion edition, theBritish
Pharmacopoeia (veterinary) 2000. Since 2007, the British Pharmacopoeia comprises of six
volumes as viz. volumes I and II contain medicinal substances, volume III contains
formulated preparations, surgical materials and homeopathic preparations, volume IV

18. comprises supplementary chapters, volume V is veterinary edition and volume VI is CD-
ROM version.
➢ The British Pharmacopoeia (BP) 2017 supersedes the BP 2016 and becomes legally effective
on 1st
January 2017.
➢ Features of BP 2017
✓ 29 new BP monographs total making it about 40000monographs.
✓ 234 amended monographs.
✓ 4 new formulated preparation monographs for biological medicines.
✓ 2 new monographs for unlicensed formulations.
✓ A new Supplementary Chapter on DNA bar coding.
✓ A new Supplementary Chapter on the Aseptic Preparation of Unlicensed medicines.
✓ All European Pharmacopoeia monographs integrated (8th
Edition as amended by Supplements
8.1 to 8.8)
➢ Website and offline download updates to harmonize with the European Pharmacopoeia 9th
Edition (9.0) and supplements 9.1 and 9.2.
1.4.4 UNITED STATES PHARMACOPOEIA
➢ The United States Pharmacopoeia and National Formulary (USP-NF) is an official public
standards-setting authority for all prescription and over-the-counter medicines and other
health care products manufactured or sold in the United States. USP also sets recognized
standards for food ingredients and dietary supplements.
➢ These standards help to ensure the quality, purity, strength, and consistency of products made
for public consumption. USP’s standards are recognized and used in more than 130 countries
around the globe.
➢ The first edition of United States Pharmacopoeia (USP) was published on December 15, 1820
in both Latin and English. From year 1920 to 1942 it was published at ten year intervals, then
up to year 2000 it was at an interval of five years and from 2002 it has been published
annually. The first National Formulary of the United States was published in 1888. In 1975,
unification of the USP and NF was announced.
➢ The USP22-NF17, 1990 is the third revision that consolidates USP and NF into a single
volume. An electronic version of the USP NF on floppy disks was introduced in 1992. The

19. USP23-NF18 was published in Mumbai in 1994 as an Asian edition in response to increase
recognition and use of the USP-NF standards by the government and pharmaceutical
manufacturers in India and other Asian nations.
➢ From 2006 the USP began to publish the Spanish edition also. A new edition with 2017
standards USP40-NF35, published in November 2016, and becomes official on May 1, 2017.
That contains more than 4900 monographs with specifications for identity, strength, quality,
purity, packaging, and labeling for substances and dosage forms. More than 300 General
chapters providing clear, step-by-step guidance for assays, tests and procedures.
➢ USP’s standards for food ingredients can be found in its Food Chemicals Codex (FCC). The
FCC is a compendium of standards used internationally for the quality and purity of food
ingredients like preservatives, flavorings, colorings and nutrients.
➢ While the FCC is recognized in law in countries like Australia, Canada, and New Zealand, it
currently does not have statutory recognition in the United States, although FCC standards are
incorporated by reference in over 200 FDA food regulations. USP also conducts verification
programs for dietary supplement products and ingredients. These are testing and audit
programs. Products that meet the requirements of the program can display the USP Verified
Dietary Supplement Mark on their labels.
➢ USP works internationally, largely through agreements with otherPharmacopoeias, as well as
regulatory bodies, manufacturer associations and others. In recent years, USP signed a series
of Memoranda of Understanding (MOU) with groups including the Chinese Pharmacopoeia
Commission, nine countries belonging to the Association of Southeast Asian Nations
(ASEAN), and the Federal Service on Surveillance in Healthcare and Social Development of
the Russian Federation (Roszdravnadzor). USP also operates an international office in
Switzerland and offices and laboratories in Brazil, India and China.
1.4.5 EXTRAPHARMACOPOEIA
➢ This book is a little piece of history now. “The extra pharmacopoeia of unofficial drugs and
chemical and pharmaceutical preparations” written by William Martindale. Martindale aims to
cover drugs and related substances reported to be of clinical interest anywhere in the world.

20. ➢ It provides a useful source of information for patients arriving from abroad to identify their
existing medication. This may reveal that a currently taken proprietary preparation is available
under another brand name.
➢ Alternatively, if the drug is not available, the class of agent can be determined allowing a
pharmacist or doctor to determine which alternative equivalent drugs can be substituted.Extra
Pharmacopoeiawas first published in 1883 under the title “Martindale: The Extra
Pharmacopoeia”.
➢ Martindale contains information on drugs in clinical use worldwide, as well as selected
investigational and veterinary drugs, herbal and complementary medicines, pharmaceutical
excipients, radiopharmaceuticals, vitamins and nutritional agents, vaccines, contrast media
and diagnostic agents, medicinal gases, drugs of abuse and recreational drugs, toxic
substances, disinfectants and pesticides. ‘Martindale: The Complete Drug Reference’ is a
reference book published by Pharmaceutical Press.
➢ Feature of Martindale: The Extra Pharmacopoeia
✓ List some 6000 drugs and medicines used throughout the world.
✓ Includes details of over 180000 proprietary preparations.
✓ It also includes almost 700 disease treatment reviews.
✓ Monographs of some toxic substances are also included.
✓ Lists nearly 5600 pharmaceutical terms and routes of administration.
✓ Information to enable identification of medicines, the local equivalent and the manufacturer.
✓ Monographs include Chemical Abstracts Service (CAS), Anatomical Therapeutic Chemical
Classification System (ATC) numbers and FDA Unique Ingredient Identifier (UNII) codes to
help readers refer to other information systems.
✓ Recognized and adopted worldwide.

21. REVIEW QUESTIONS
SHORT/ LONG ANSWER QUESTION
1) Define the term Pharmacopoeia.
Ans: Pharmacopoeia is a legal and official book issued by recognized authorities appointed by
the government of each country that describes lists of pharmaceutical substances, formulae
together with standards, quality control tests in order to build quality and maintain
uniformity.Pharmacopoeias are developed to improve and maintain the standards and quality of
medicinal preparations.
2) Mention the different editions of IP.
Ans:
✓ First edition-1955
✓ Second edition-1966
✓ Third edition-1985
✓ Fourth edition-1996
✓ Fifth edition-2007
✓ Sixth edition-2010
✓ Seventh edition-2014
3) List out various roles of pharmacist in health care system.
Ans:
✓ As a pharmacist
✓ Hospital pharmacist
✓ Community pharmacist
✓ Industrial pharmacist
✓ Consultant pharmacist
4) Explain briefly history and development of pharmacy profession in India.
Ans: Refer point 1.2.1.
5) Explain history of Indian Pharmacopoeia.
Ans: Refer point 1.4.1.
6) Explain various carrier options after pharmacy.
Ans: Refer point 1.3.
7) Describe history of pharmaceutical education in India.

22. Ans: Refer point 1.2.3.
8) Define the terms Pharmacy, Pharmacopoeia and Pharmacovigilance.
Ans:
a) Pharmacy: Pharmacy is defined as “the profession which is concerned with the art &
science of identification, selection, preparation, preservation and standardization of suitable
drug substances and their formulations and dispensing of these with the aim of achieving
complete pharmaceutical care.”
b) Pharmacopoeia: Refer answer of question no. 1.
c) Pharmacovigilance: Pharmacovigilance is pharmacological science relating to the
collection, detection, assessment, monitoring, and prevention of adverse effects with
pharmaceutical products.
9) Write short note on following:
Ans:
a) Pharmacy education programs in India: Refer Point 1.2.3.
b) British Pharmacopoeia: Refer point 1.4.3
c) National formulary of India: Refer point 1.4.2.
d) Indian Pharmaceutical Industry: Refer point 1.2.2.
e) Role of pharmacist in academics: Refer 1.3.
10) Write features of BP 2017.
Ans: Refer point 1.4.3.
MULTIPLE CHOICE QUESTIONS
1) Which of the following Pharmacopoeia is published every year?
a) I.P.
b) B.P.
c) U.S.P.
d) B.P. and U.S.P. both.
2) Extra Pharmacopoeia is also called as……….
a) European Pharmacopoeia
b) Martindale
c) Merk Index

23. d) Additional Pharmacopoeia
3) Which was the first official Pharmacopoeia of India?
a) 1945
b) 1955
c) 1948
d) 1966
4) The B. Pharm course was first started in India in 1937 at
a) Madras Medical College
b) Banaras Hindu University
c) Punjab University
d) Bombay University
5) The architect of Indian pharmaceutical industry Acharya P. C. Ray founded
a) Maharashtra Antibiotic Corporations Ltd.
b) Bengal Chemicals and Pharmaceuticals work Ltd.
c) Hindustan Antibiotics Ltd.
d) None of the above
6) The first edition of Indian Pharmacopoeia was published in
a) 1950
b) 1948
c) 1996
d) 1955
7) USP first edition was published in
a) Latin
b) English
c) English and Latin
d) French
8) …………… is the father of medicine.
a) Hippocrates
b) Ebers
c) Discorides
d) Papyrus

24. 9) The first edition of British Pharmacopoeia was published in
a) 1867
b) 1948
c) 1885
d) 1864
10) First edition of USP was published in
a) 1834
b) 1820
c) 1848
d) 1914
11) Registered pharmacist is the person who is
a) Having the knowledge of compounding and dispensing of drug
b) Qualified in pharmacy courses
c) Also taken training in any registered medical dispensing
d) All of above
12) The earliest pharmacies were known as………….
a) Apothecary shop
b) Medical shop
c) Medical stores
d) None
13) The Indian Journal of Pharmacy was started by…………..
a) Prof. M. L. Schroff
b) Acharya P. C. Ray
c) Dr. Mukharji
d) None
14) The Pharmacopoeias contain
a) Monograph of drug/ substance
b) Standard test
c) Description, formulae
d) All of above
15) ……………… was the Chairman of the committee of IP-1955.

25. a) Dr. B. Mukharji
b) Dr. B. N. Ghosh
c) Sir R. N. Chopra
d) Dr. Nityanand
ANSWERS
1) B.P. and U.S.P. both 2) Martindale3)1955 4) Banaras Hindu University 5) Bengal Chemicals
and Pharmaceuticals work Ltd. 6)19557) English and Latin 8) Hippocrates 9) 1864 10) 1820 11)
All of the above 12) Apothecary shop13) Prof. M. L. Schroff14) All of the above 15) Sir R. N.
Chopra