CHAPTER

Introduction to Pharmacopoeia
MULTIPLE CHOICE QUESTIONS
1. The full form of IP is :
(a) International Pharmacopoeia (b) International Pharmacognosy
(b) Indian Pharmacopoeia / (d) Indian Pharmacology
2. Who was the father of medicine?
(a) Luther (b) Hippocrates /
(c) Louis Pasteur (d) Bhaskar
3. The first edition of IP was published in:
(a) 1955 (b) 1965
(c) 1975 (d) 1985
4. Indian Pharmacy Act came into force in :
(a) 1947 (b) 1948
(c) 1949 (d) 195S0
5. The Pharmacy Council of India (PCI) was established in:
(a) 1947 (b) 1948
(c) 1949 / (d) 1950
6. What is USP?
(a) United States Pharmacology (b) United States Pharmacy
(c) United States Department of Pharmacy (d) United States Pharmacopoeia /
7. The British Pharmaceutical Codex (BPC) was published in :
(a) 1883 / (b) 1746
(c) 1904 (d) 1954
8. The second edition of NFI was published in :
(a) 1960 (b) 1966
(c) 1979 (d) 1984
9. The first Indian Pharmacopoeia was published in :
(a) 1952 (b) 1954
(c) 1955 / (d) 1956
10. The seventh edition of IP came into force in :
(a) 2014 (b) 2016
(c) 2015 (d) 2018
 6| GARTHAK Pharmaceutics
VERY SHORT ANSWER TYPE QUESTIONS
Q1. Write the pharmacopoeia of different countries.
Ans. Following ar the pharmacopocia of different countries:
British Phamacopoeia
The lntemational Pharmacopocia
The Eurvpean Pharmacopoeia
The British Pharmaceutical Codex
$. The Extra
6. The
Phamacopocia
United States of Pharmacopoeia & National
7 The Indian Phamacopoeia. Formulary
Q2. Comment briefly on British Pharmacopoela.
Ans. British Pharmacopoeia : The British
Pharmacopoeia provides references to pharmaceutical
researchers and manufacturers. pharmacists, chemists,
control inspectors. laboratory technicians and regulatorybiotechnologists, quality assurance and quality
The British bodies.
Pharmacopocia, UK is the official collection of standard substances for
pharmaceutical producers and pharmaceuticals. The Secretariat, part of the
products produced by the British medical and health
contribution to the regulatory agency. Phamacopocia Commission and the B.P. make a significant
From 1864 onwards it has been providing
Official Standards for pharmaceutical substances.
Q3. Explain International
Pharmacopoeia.
Ans. International Pharmacopeia : A
pharmacopocia selected by the World Hcalth Organization
as a recommendation; It aims to achieve broad
pharmaceutical drugs, excipients and global unifomity of quality specifications for
selected
dosage forms. Information published in the Intemational
Pharmacopoeia is provided through an advisory process.
Q4. Write the objectives of the PQM (Product Quality
Ans. The main objectives of PQM are: Management).
Strengthening of Quality Assurance (QA) and Quality Control (QC) systems.
* Enhancing the supply of quality assured medicines.
To check the availability of substandard and counterfeit
medicines.
Providing technical leadership and global advocacy.
USP-USAID collaborative efforts to help communities improve drug quality in more than 35
countries.
Q5. Write the various editions of Indian
Ans. Following are the versions of Indian Pharmacopoeia.
Pharmacopocia :
* Indian Pharmacopoeia 1955-First Edition, after
* Indian Pharmacopocia 1966-Second
supplementation in 1960;
Edition, after Supplementation in l1975;
3 Indian Pharmacopoeia 1985--Third Edition,
followed by appendices in l989 and 1991;
 Introduction to Pharmacopoeia I7
* Indian Phanacopocia 1996- Fouth Edition, its replacement 2000 for Supplemental
Veterinary Products, Appendix 2002 and Appendix 2005;
* Indian Pharmacopocia 2007-Fifh Edition, Appendix 2008 onwards;
* Indian Pharmacopoeia 2010-Sixth Edition, Appendix to 2012 onwards;
DVD of Indian Pharmacopocia 2010
Indian Pharmacopocia 2014-Seventh Edition with DVD.
* Indian Pharmacopoeia 2018-Eighth Edition with DVD.
SHORT ANSWER TYPE QUESTIONS
Q1. Define the word "Pharmacopoela" Enumerate few names of official
pharmacopoeia.
Ans. Pharmacopoeia
For preparation of medicines there is a requirement of specific directions, which is written in a
book called Pharmacopoeia. Usually this book is published by a concerned authority. Therefore,
Pharnacopoeia is a legislation of a country responsible for seting standards as well as parameters
related to quality and quantity of drugs, and raw materials required for the preparation of several
pharmaceutical formulations.
Pharmacopoeia can be defined as a book of standards applicable to drugs and their common
dosage forms and pharmaceutical aids published in a country under the authority of its own
Government. Many advanced countries publish their own Pharmacopoeias, eg, Indian
Pharmacopoeia (LP.), British Pharnacopocia (B.P.), etc. which are published by the authority or
commission of their respective countries.
The first edition of the British Pharmacopoeia was published in 1864 and was one of the first
attempts to harmonize pharmaceutical standards. A Commission was first appointed by the General
Medical Council (GMC) under the Medical Act 1858 for producing a British Pharmacopoeia on a
national basis.

List of Different Official Pharmacopoeia

1. Indian pharnacopoeia (I.P.) 7. Indian pharmaceutical codex (L.P.C.)
2. British pharmacopoeia (B.P.) 8. Merck index
3. United state pharmacopoeia (U.S.P.) 9. National formulary of India (N.F.I)
4. British Pharmaceutical codex (B.P.C.) 10. International pharmacopoeia
S. British national formulary (B.N.F.) 11. Pharmaceutical codex
6. National formulary (N.F.)
Q2. Write comment on Indian Formulary.
Ans. National Formulary of India or NFI
A formulary is a type of manual that contains a collection of summaries of drugs of medical
importance. It also contains statutory and administrative information so that doctors should take care
while prescribing medicines. Fornerly the British National Formulary was published in Britain under
the name of the National Formulary. On the same lines, NFI is published by the Ministry of Health and
Family Welfare, Government of India. NFI includes the list of operational drugs/prescriptions which
 81JARTHAK Pharmaceutics
are healthy and affordable for the patients. First, Second and Third
NFI were published
of Health, Government of India in 1960, 1966 and 1979 respectively. After this, iby the
due to theMinist
Dumber of medicines and new products coming, the Ministry of Health,
letter no. FNo. XI1035/2/06-DFÌC dated Sth May. 2008 this task has been Governmcnt
oflndia In i
Pharmacopocia Commission of India, Ghaziabad. Thercatter, NFI Is published by IPC asSigncd to
on behule th
Govermment of India.
The model of Indian formula is being preparcd and published on the
basiIS of the model muhli
by World Hcalth Organisation. NFI's latest publication is NFI 201|
Q3. Explain the United States Pharmacopoeia.
Ans. United States Pharmacopoeia
The United States Pharmacopoeia is a phamacopocia for the United States (collection of dnuc
infomation) published annually by the
United
called USP), a non-profit organization that ownsStates Pharmacopocia Convention
the trademarks and also owns the(commonly
ale
pharmacopoeia itself USP is published in joint volume with the national copvright Th
pharmaceutical ingredient or pharmaceutical product has an applicable USPformula as USP-NF. If
quality standard (in the
fom of a USP-NF monograph) it must confom to use
subiect to USP standards include both human the USP" or 'NF' designation. Medicines
medicines
and animal medicines. USP-NF standards also have a (prescription, over-the-counter, or otherwise
rolc in US federal law; Adrug or
ingredient with a name recognized in the USP-NF is considered pharmaceutica
mandatory standards for strength, quality or purity. The USP also setsadulterated if it does not meer
standards
supplements and food ingredients (as part of the Food Chemistry Codex). The USP has no dietaryfor
enforcing its standards: Enforcement is the responsibility of the US Food role in
(FDA) and other
govermment officials in the United States. and Drug Administration
Q4.Throw light on Indian Pharmacopoeia-2014.
Ans. Indian Pharmacopoeia-2014
The book Indian Pharmacopocia 2014 covers pharmaceutical standards from across the world. The
standards set out in this Pharmacopcia are official, legally enforceable and are intended to assist in the
inspection and licensing of manufacturing units and the distribution of drugs and pharmaceuticals.
The new edition includes advanced techniques and experimental methods widely adopted
in India
and abroad.
The Seventh Indian Pharmacopocia (P 2014) cdition is published by the Indian
Pharmacopocia
Commission (IPC) to meet the requirements of the Drugs and Cosmetics Act, 1940 and the regulations
thereunder.
It sets standards for drugs to be produccd and/or marketed in India and thus contributes to
quality control and assurance of medicines.
The Indian Pharmacopoeia 2014 is prescnted in four volumes.
The scope of the.Pharmacopocia has been cxpanded to include products from biotcchnology.
indigenous herbs and herbal products, veterináry vaccines and additional antiretroviral drugs and
formulations, including commonly used fixed-dose combinations.
Standards for new drugs and drugs used under national health programs have been added and
drugs as well as their formulations that are no longer in usc have been removed from this edition.
 Introduction to Pharmacopoeia | S
This includes 2548 monographs on medicines, including 577 ncw monographs on APIs,
excipients, dosage forms, antibiotic monographs, insulin products and hcrbal products.
19 new radio pharmaccutical monographs and a general chapter are included in this edition for
thc first time.
Q5. Explain career in pharmacy.
Ans. Career in Pharmacy
We all have scen the importance of the pharma sector in the last ycar. The pharma
inextricably linkcddwith sector is
w the health of the people. India is counted as onc of the leading countrics in this
field. There are also many plans to devclop it further in the future.
At present, the pharma sector is the leader in the rapidly growing healthcare sector. The need of
the phama sector is never cnding, be it the COVID-19 crisis or for extraordinary discases, calamities
or health care in normal times. The current situation is also being seen as the beginning ofa new era of
clinical trials and drug production. In the last year, India has also established itself as a pharmacy
hub
in the world by exporting medicines to many countries. India ranks third in the world in
pharmaccutical production and has 3.000 pharmaceutical companics and 10,500 pharmaceutical
manufacturing units. In such a situation, there is a need for skilled youth in this sector at every level.
According to the figures two years ago today. there were l million registered pharmacists in India then
and 40 lakh pharmacies. These figures have increased in the last one and a half years. According to a
2020 report., of all the pharma companies, there were more than 2,800 positions that needed to be filled
immediately.
Q 6. What is the educational qualification and course required in Pharmacy?
Ans Educational Qualification and Course
For admission to the undergraduate course in Pharma sector, it is necessary that the student has
passed class 10th from Biology, Physics, Chemistry or 12th from Maths, Physics, Chemistry group.
Most of the colleges either relcase the cut off list or conduct entrance exam before giving admission in
any pharma course. Some of the popular courses in this sector are as follows :
Diploma in Pharmacy (D.Pharm) : This course will give you the basic qualifications for this
sector. This is a two ycar course. For this, 12th (with chemistry, maths, biology or physics) is
necessary, after which hospital training is done.
Bachelor of Pharmacy (B.Pharm) : Instead of D.Pharm, you can also do a four-year (eight
semester ) undergraduate B.Pharm course. For this, students should have passed 12th in Science stream.
Students who have done 12th in Maths, Biology and Physics or PCM can take admission in this course.
There is no specialization in this.
Master in Pharmacy (M.Pharma) : After B.Pharm, two years postgraduate course can be done.
In this, students can do specialization of their choice. In M.Pharma, one can do specializations like
Pharmacogross, Pharmaceutical Engineering, Bio-Chemistry. GPAT is the national level entrance
exam for masters course. If the goal is to work in the field of research, then there is also an option to do
PhD.
There are also some other courses in Pharma, such as PG Diploma in Pharmaceutical and
Healthcare Marketing, Diploma in Pharma Marketing, Advance Diploma in Pharma Marketing and PG
Diplorma in Pharrna Marketing, whose duration is between six months to one year. The eligibility for
adnission in these is B.Sc., B.Pharma or D. Pharm (according to the course).
10 1 SARTHAK Pharmaceutics
Q7. Write the salient features of the sixth èdition of IP.
Ans. Following are the salient features of the sixth edition of IP:
1. It consists of 3parts, which are hard bound.
2. In this 1918 monographs have been included, out of which 287 monographs are ncw.
3. Drug classification, dosage and available potency dosages were also combined.
4. Conventional tests have been replaced by specialized tests. C.g., 1.R. (Infrared) and II w
(Ultraviolet spectrophotometry).
5. Cross-referencing has also been eliminated.
6. The topics are described in more detail.
7. The usefulness of chromatography is described in detail.
8. Pyrogen test has been removed fom the fixed threshold.
9. Monographs related to herbal medicines have also been included.
10. It includes many monographs that are not present in any other major pharrnacopoeia.
11. It also inchudes certificates to prove its authority.
12. Its form is more simple and easily understandable.
LONG ANSWERTYPE QUESTIONS
Q1. Describe in brief about the history of Pharmacopoeia of India.
Ans. Pharmacopoeia of India
Indian Pharmacopoeia (1.P.) is an official document meant for overall quality control and
assurance of pharmaceutical products marketed in India by way of contributing to their safety, efficacy
and affordability. L.P. contains a collection of authoritative procedures of analysis and specifications!
for drugs. The I.P. or any part of it has got legal status under the Second Schedule of the Drugs &
Cosmetics Act, 1940 and Rules 1945 thereunder.
L.P. prescribes standards for identity, purity and strength of drugs essentially required from
healthcare perspective of human beings and animals. I.P. standards are authoritative in nature. They
are enforced by the Regulatory authorities for quality control of medicines in India. During quality!
assurance and at the time of dispute in the court of law, the I.P. standards are legally acceptable.
The Indian Pharmacopoeia is published by the Indian Pharmacopoeia Commission (IPC) ong
behalf of the Ministry of Health and Family Welfare, Government of India. The India,
Pha
rnamacopoeia is being produced to fulfl the requirement in the Drugs and Cosmetics Rules, 1945 o
standards of drugs d in India and in the belief that it contributes significantly in controlling the
quality of medicinal products. The standards of this Pharmacopoeia are legally enforceable and are
intended to heip in the licensing and inspection processes.
History 'of Indian Pharmacopoeia
The history of the IP began in the year 1833 when a committee of the East Indian Company'
Dispensary recommended the Publication ofa Pharmacopoeia and Bengal Phamacopoeia and Genera
Conspectus of Medicinal Plants was published in 1844, which mainly listed most of the commonl
used indigenous remedies. This was followed by IP 1868, which covered both the drugs of Britis
Pharmacopoeia (BP) 1867 and indigenous drugs used in India, with a supplement published in 186
incorporating the vernacular names of indigenous drugs and plants. However, from 1885 the BP wa
 Introduction to Pharmacopoeia l11
recommended
made official in India. A drug Enguiry Committee appointed in 1927 by the government
the publication of a National Pharmacopoeia.
After independence, the Indian Pharmacopoeia Committee was constituted in :1945, Tor
publication of I.P. as its main function. The Indian Pharmacopoeia editions are as follows
* Indian Pharmacopoeia 1955 - First edition, followed by supplement in 1960;
* Indian Pharmacopoeia 1966 -Second edition, followed by supplement in 1975;
* Indian Pharmacopoeia 1985 -Third edition, followed by its addendum in 1989 and 1991;
* Indian Pharmacopoeia 1996 -Fourth edition, followed by its addendum 2000, supplement
2000 for Veterinary Products, addendum 2002 and addendum 2005;
Indian Pharmacopoeia 2007 - Fifth edition, followed by addendum 2008;
Indian Pharmacopoeia 2010 - Six edition, followed by its addendum 2012; and
DVD of Indian Pharmacopoeia 2010
* Indian Pharmacopoeia 2014 with DVD- Seventh edition, followed by its addendum in 2015.
Q2. Explain the importance of pharmacy in different fields.
Ans. Pharmacy in Education
Phamacy education in India has traditionally been industry and product oriented. Unlike the
situation in developed countries, graduate pharmacists prefer placement in the pharmaceutical
industry. To practise as a pharnacist in India, one needs at least a Diploma in Pharmacy, which is
awarded only after 2years and 3months of phar1macy study. These diploma-trained pharmacists are the
i mainstay of pharmacy practice. The curriculum in pharmacy practice has not received much attention.
In India, there has been an increase in the number of institutes offering pharmacy degrees at various
levels and in 2008 a practice-based Doctor of Pharmacy (Pharma-D) degree program was introduced in
some private institutions.

Pharmacy in Industries
The pharmaceutical industry detects, develops, produces, and markets drugs or pharmaceutical
y drugs intended to be used as drugs to be administered (or self-administered) to patients, intended to
cure them, vaccinate them or reduce symptoms. Pharmacutical companies may trade generic or
branded drugs and medical devices. They 'are subject to various laws and regulations that govern the
n patent, testing, safety, efficacy and marketing of drugs.

f
Pharmacy inPractice
Pharmacy practice is the discipline of pharmacy that involves developing the professional roles of
e pharmacists. Pharmacy practice offers pharmacists in-depth useful reviews and research trials and
e
surveys of new drugs and innovative therapeutic approaches.
Journal of Pharmacy Practice
Pharmaceutical Regulatory Affairs; Open Access, Advances in Pharmacoepidemiology and Drug
Safety, Journal of Applied Pharmacy, Research and Reviews; Journal of Hospital and Clinical
Pharmacy, Research and Reviews; Journal of Pharmacy and Phamaceutical Sciences; Journal of
Research in Pharmacy Practice; International Journal Pharmacy Practice; Journal of Pharmacy Practice
and Research.
9