Annexure - I

Pharmacy Council of India

New Delhi

“Syllabus framed under Regulation 7,

List of prescribed equipments and
apparatus under Appendix-A of
The Education Regulations, 2020
For Diploma Course in Pharmacy”
 COMMITTEE MEMBERS
S. No. Name Affiliation Role
1. Dr. B. Suresh President, Ex-Officio
Pharmacy Council of India, New Delhi
2. Dr. Shailendra Saraf Vice President, Ex-Officio
Pharmacy Council of India, New Delhi
3. Dr. V. Gopal Member, Pharmacy Council of India, Convener
(Puducherry)
4. Dr. B. Jayakar Member, Pharmacy Council of India, Member
(Tamil Nadu)
5. Sri Kumar Ajay Member, Pharmacy Council of India, Member
(Bihar)
6. Dr. H. Lalhlenmawia Member, Pharmacy Council of India, Member
(Mizoram)
7. Dr. R. Debnath Member, Pharmacy Council of India, Member
(West Bengal)
8. Shri Annada Sankar Member, Pharmacy Council of India, Member
Das (Orissa)
9. Dr. Priyashree Sunita Member, Pharmacy Council of India, Member
(Jharkhand)
10. Dr. Mannava Member, Pharmacy Council of India, Member
Radhakrishna Murthy (Andhra Pradesh)
11. Shri Prakash Member, Pharmacy Council of India, Member
Jeevandas Wanjari (Maharashtra)
12. Shri K.R. Dinesh Kumar Member, Pharmacy Council of India, Member
(Kerala)
13. Mrs. Manjiri Sandeep Principal I/c., Member
Gharat Prin. K.M. Kundnani Pharmacy
Polytechnic, Ulhasnagar, Maharashtra
14. Shri Raj Vaidya Community Pharmacist, Member
Hindu Pharmacy, Goa
15. Dr. R.N. Gupta Professor, Member
Birla Institute of Technology,
Ranchi, Jharkhand.
16. Dr. K.P. Arun Associate Professor, Member
JSS College of Pharmacy,
Ooty, Tamil Nadu
17. Dr. Neeraj Upmanyu Professor & Dean, Special
School of Pharmacy & Research, Invitee
People's University
Bhopal, Madhya Pradesh
 CONTENTS

S. No. Contents Page No.

1. Preamble 1-2

2. Competencies for the Indian 3-4

D.Pharm Holders
3. Competency Mapping with the 5
Courses (Part I, II & III) of Education
Regulations 2020
4. ER-2020 D.Pharm Syllabus – An 6-8
Overview
5. Guidelines for the conduct of theory 9
examinations
6. Guidelines for the conduct of 10-11
practical examinations
7. ER-2020 D.Pharm Syllabus – Part I 12-35

8. ER-2020 D.Pharm Syllabus – Part II 36-64

9. Appendices 65-77
 1. Preamble
“Revamping the curriculum, pedagogy, assessment, and student support” is one of
the vision statements and recommendations of the National Education Policy (NEP)
of Govt. of India for attaining enhanced learning experiences by the students. In light
of this, Pharmacy Council of India, the apex body regulating the pharmacy education
in the country, committed to revise the education regulations of Diploma in Pharmacy
(D.Pharm) program and thus, the ‘Education Regulations 2020’ (ER-2020) has been
notified in the Gazette of India in October 2020. This new regulation has given due
consideration for the fact that, universally the role of pharmacist has undergone
continuous evolution from ‘dispenser of medicines’ to ‘medicine expert’ in the
multidisciplinary health care team.

Accordingly, the courses (course means the subject) of the existing education
regulations (ER-91) have been revisited, compared with the present and future
needs of the society, expectations of the healthcare team and other stakeholders
from the pharmacists were assessed, feedback from the experts in the pharmacy
and other healthcare professions were sought. Thus, the course of study prescribed
in ER-2020 is an amalgamation of all such exercises to arrive at a curriculum
structure for D.Pharm that is more relevant to the current practice standards,
dynamic to accommodate and address the upcoming changes.

Though the total number of courses across the program remain 21 as that of ER-91,
the number of theory courses is reduced from 12 to 11 in the new regulation, while
the number of practical courses is increased from 9 to 10. Further, the theory
teaching hours across the program have been reduced from 850 to 825, while the
practical hours have been increased from 750 to 800 in the new regulation. Three
practical courses have been introduced for the first time in ER-2020. Further, about
275 hours have been assigned for the first time in D.Pharm curriculum for ‘Tutorial’
activities. All such changes explicitly reveal that the ER-2020 is intended to provide a
little edge to the experiential learning through the practical courses and encourages
the small group teaching-learning, self-directed learning, etc. in the tutorial hours.

Introduction of ‘Pharmacotherapeutics’ courses (theory and practical) is one of the

revolutionary changes in the new curriculum, that will help the students to hone their
knowledge and skills in the area of pharmaceutical care services which will certainly
redefine the roles of the D.Pharm qualified pharmacists in both community and
hospital settings. Also, the introduction of ‘Social Pharmacy’ courses (theory and
practical) will provide insights about the primary and preventive healthcare concepts
in the country and the potential roles of pharmacists in such healthcare segments.

In this backdrop, the Council has formulated a Committee which comprised of 16

Members who have rich experiences in various domains such as education, hospital

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pharmacy practice, community pharmacy practice, clinical pharmacy practice,
administrative and regulatory affairs to design the syllabus for the individual theory
and practical courses as per the curriculum framework defined in ER-2020. The
Committee with its clear understanding about the philosophy and objectives of the
ER-2020, drafted the syllabus for individual theory and practical courses with utmost
care to avoid repetitions, redundancy, over/under utilization of hours, etc. Every
course is defined with scope, set of course objectives and course outcomes which
will help to understand the significance and the expectations of the course from both
teachers and students. Lots of scope has been given in the syllabus for the active
learning by the students through the assignment topics and field visit activities which
will enhance their critical thinking, searching scientific literatures, interpretational
skills and communication skills.

According to the ER-2020 curriculum framework, the students do not earn any
credits based on the academic hours they spend. However, as per the conventional
methodology of credit calculations, the curriculum of ER-2020 shall be deemed
equivalent to 80 credits that shall be used for the administrative purposes, wherever
necessary.

Further, the ‘Competencies for the Indian D.Pharm Holders’ based on the
knowledge, skill, attitude and value that are essential for the successful practice of
the profession have been derived. These competencies have also been mapped with
the individual courses of the curriculum based on the expected outcomes of the
individual course. Thus, the courses and the competencies are interlaced in such a
way that multiple courses contribute to build one competency and one course
contributes to build more than one competency, which reveal the strength of the
competency mapping.

The Council strongly believes that the ER-2020 regulations, curriculum and syllabus
will uplift the knowledge and skills of the students on par with the contemporary and
future professional demands and enable them to be a successful practitioner in the
chosen field of pharmacy.

By considering the substantial changes and inclusion of advanced and current

subject matters in the new syllabus, the Council shall conduct series of meetings,
seminars, conferences, workshops, and webinars for the faculty members handling
D.Pharm courses and equip them to deliver such new courses / topics more
effectively and efficiently.

The Council appreciate all the efforts of the Members for successfully bringing out
the Education Regulations 2020, curriculum and syllabus. Also, profound gratitude to
all the stakeholders who contributed directly or indirectly in completing this task.

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 2. Competencies for the Indian D.Pharm Holders
Competency is defined as “A distinct composite of knowledge, skill, attitude and
value that is essential to the practice of the profession in real life contexts”.

The candidates who successfully complete the Diploma in Pharmacy (D.Pharm)

program of Education Regulations 2020 (ER-2020), from the institutions approved by
the Pharmacy Council of India are expected to attain the following professional
competencies.

1. Review Prescriptions
2. Dispense Prescription / Non-Prescription Medicines
3. Provide Patient Counselling / Education
4. Hospital and Community Pharmacy Management
5. Expertise on Medications
6. Proficiency on drugs / pharmaceuticals
7. Entrepreneurship and Leadership
8. Deliver Primary and Preventive Healthcare
9. Professional, Ethical and Legal Practice
10. Continuing Professional Development

1. Review Prescriptions: The student should receive and handle prescriptions in a

professional manner and be able to check for their completeness and correctness.
Also, the prescribers should be contacted for any clarifications and corrections in the
prescriptions with suggestions if any.

2. Dispense Prescription / Non-Prescription Medicines: The student should be

able to dispense the various scheduled drugs / medicines as per the implications of
the Drug & Cosmetics Act and Rules thereunder. Also, the non-prescription
medicines (over-the-counter drugs) should be dispensed judicially to the patients as
required.

3. Provide Patient Counselling / Education: The student should be able to

effectively counsel / educate the patients / caretakers about the prescription / non-
prescription medicines and other health related issues. Effective communication
includes using both oral and written communication skills and various communication
techniques.

4. Hospital and Community Pharmacy Management: The student should be able

to manage the drug distribution system as per the policies and guidelines of the
hospital pharmacy, good community pharmacy practice and the recommendations of
regulatory agencies. Also, be able to manage the procurement, inventory, and
distribution of medicines in hospital / community pharmacy settings.

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5. Expertise on Medications: The student should be able to provide an expert
opinion on medications to health care professionals on safe and effective
medication-use, relevant policies and procedures based on available evidences.

6. Proficiency on Pharmaceutical Formulations: The student should be able to

describe the chemistry, characteristics, types, merits and demerits of both drugs and
excipients used in pharmaceutical formulations based on her/his knowledge and
scientific resources.

7. Entrepreneurship and Leadership: The student should be able to acquire the

entrepreneurial skills in the dynamic professional environments. Also, be able to
achieve leadership skills through teamwork and sound decision- making skills.

8. Deliver Primary and Preventive Healthcare: The student should be able to

contribute to various healthcare programs of the nation including disease prevention
initiatives to improve public health. Also contribute to the promotion of national health
policies.

9. Professional, Ethical and Legal Practice: The student should be able to deliver
professional services in accordance with legal, ethical, and professional guidelines
with integrity.

10. Continuing Professional Development: The student should be able to

recognize the gaps in the knowledge and skills in the effective delivery of
professional services from time to time and be self-motivated to bridge such gaps by
attending continuing professional development programs.

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 3. Competency Mapping with the Courses (Part I, II & III) of
Education Regulations 2020

Biochemistry & Clinical

Pharmacotherapeutics
Community Pharmacy
Human Anatomy &

Hospital & Clinical

Practical Training
Social Pharmacy

Pharmacy Law &

Pharmacognosy
Pharmaceutical
Pharmaceutics

& Management
Pharmacology
Physiology
Chemistry

Pathology

Pharmacy

Ethics
Competencies

1. Review the Prescriptions √ √ √ √ √ √ √ √ √ √ √

2. Dispense Prescription / Non-Prescription √ √ √ √ √ √ √ √ √ √ √
Medicines
3. Provide Patient Counselling / Education √ √ √ √ √ √ √ √ √ √ √ √
4. Hospital and Community Pharmacy Management √ √ √ √ √
5. Expertise on Medications √ √ √ √ √ √ √ √ √ √ √ √
6. Proficiency on Pharmaceutical Formulations √ √ √ √ √ √
7. Entrepreneurship and Leadership √ √ √
8. Deliver Primary and Preventive Healthcare √ √ √ √ √ √ √ √ √
9. Professional, Ethical and Legal Practice √ √ √ √ √ √
10. Continuing Professional Development √ √ √ √ √ √ √ √ √ √

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 4. ER-2020 D.Pharm Syllabus – An Overview

The ER-2020 D.Pharm Syllabus has the following structure in every course. Though
the theory and practical courses are not mutually exclusive, as per the Regulations,
the theory and practical are to be considered as individual courses.

Scope: These are broader statements on the purpose of the course in the
curriculum, key contents of the course that will contribute to the specific knowledge
and or skill developments. The teacher is expected to orient the students about the
scope of the particular course at the beginning and intermittently.

Course Objectives: The course objectives describe the key topics that are
intended by the teacher to be covered in the course. In general, these are more
specific than the scope and broader than the course outcomes. The teacher is
expected to discuss the objectives of the course with the students and break-down
the course objectives into micro levels as objectives of a specific topic / objectives of
a specific lecture, etc. Such an exercise shall make the students to understand the
significance of the course / topic / lecture and enhance their attention on the course /
topic / lecture.

Course Outcomes: The course outcomes are more specific than the course
objectives describe that describe the abilities of the students to perform/act, upon
successful completion of the course. Hence, conventionally the course outcomes are
described with verbs that are measurable or observable actions. The teacher is
expected to describe the desired outcomes of the particular course, so that the
students shall understand the various assessment criteria, modalities, and
parameters. This also serves as a broader guideline for the teachers for preparing
the assessment plan. A well-structured assessment plan associated with the course
outcomes shall enable to mapping with the professional competencies and their
attainment levels that are attributed to the program outcomes.

Theory Courses: The theory courses basically provide concepts and explain the
relationships between the concepts. Understanding of the theoretical courses enable
the students to identify the problems in real life situation and make a plan for
addressing such problems. Also, the theory course helps to understand what is not
known and thus is the tool for accumulation of knowledge. The syllabus of the theory
courses has been systematically and logically described as different chapters and
the minimum number of hours to be spent on teaching are mentioned chapter wise
and course wise. The teachers shall further distribute the total hours of any given
chapter among the sub-topics as required by the subject matter.

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Practical Courses: The practical courses are designed for applying the theoretical
knowledge in the given experimental / simulated conditions. The practical courses
deepen the understanding of theories, develop the skills, hone professional
competencies, provide opportunities to observe, think and analyse problem solving
methods. Further, they help to gain experience with the real things in practice. The
teachers shall train the students in actual / simulated practical conditions.

Tutorials: The purpose of the tutorial hour is typically to engage the students in
smaller groups in order to pay a closer attention on their learning process. This is an
opportunity for the students to complete their assignments, develop specific skills,
discuss any problems in the study topics in a less formal way. During the tutorial
hour, the students shall exchange their ideas within the small group, and learn to
accept constructive criticism and listen to others. Also, the tutorial hour enables the
teachers to closely monitor the progress of the individual student and provide
additional academic support to individuals, if necessary.

Assignments: The purpose the assignments are to encourage the students for self-
directed learning. Further, the assignments will provoke critical thinking, enhance the
skills such as literature search, data mining, data interpretation, report formatting,
time-management, and written communication. This is also a mode of self-
assessment for the student about the level of understanding of the concepts of a
particular course. The teachers shall apply their knowledge and wisdom in choosing
the assignment topics at a micro level in alignment with the topics given in the
syllabus. The assignments shall be evaluated against a set of criteria. A typical
format for the assessment of an assignment is given in Appendix -1.

Field Visits: The purpose of field visits is to provide a real-world experience to the
students. The field visits will help them to realize that what they learn within the walls
of the classroom / laboratory can help them solve the problems they see in the world
around them. Also, this is helpful to the teachers to widen their horizons of
knowledge and broadening the scope of the syllabus. Every student shall submit a
report describing their objectives, experience, learning points, etc. pertaining to the
field trip, in the typical format given in Appendix-2.

Recommended Books: For each course, a list of recommended books is given in

the syllabus. The list shall be considered as an important and common resource for
the teaching-learning process, but not the complete list. It is always encouraged to
use the latest edition of the books specified. Further, the teachers and students are
encouraged to explore more primary, secondary, and tertiary resources as required.

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Practical Training: The goal of the practical training for the students is to provide a
real-time, supervised experience on the professional tasks emphasised in their
course of study. Further, it helps them to apply their acquired knowledge and skills in
the professional working environment. The practical training intensively prepares the
students with adequate competencies and qualifications required for the career
opportunity in the future.

Thus, the ER 2020 D.Pharm syllabus is designed to nurture the students in all the
three domains of Bloom’s Taxonomy viz. cognitive (knowledge), affective (attitude)
and psychomotor (skills). Further, it also provides ample of scope to the students for
different learning styles viz. visual, auditory and kinaesthetic, i.e., ‘see, hear and do’.

The summary of the curriculum, courses and other activities and their metrics across
the ER-2020 D.Pharm program (Part I, II & III) are given here.

Criteria Metrics
Number of subject areas (considering both theory & practical together) 11
Number of theory courses 11
Number of practical courses 10
Number of theory hours 825
Number of practical hours 600
Number of practical training hours 500
Number of tutorial hours 275
Number of course outcomes for theory courses 45
Number of course outcomes for practical courses 40
Number of courses which have given assignments 9
Number of assignment topics given 75
Number of assignments reports each student shall submit 27
Number of courses which have field visit 5
Number of field visit reports each student shall submit 9
Number of professional competencies 10

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5. Guidelines for the conduct of theory examinations

Sessional Examinations

There shall be two or more periodic sessional (internal assessment) examinations

during each academic year. The duration of the sessional exam shall be 90 minutes.
The highest aggregate of any two performances shall form the basis of calculating
the sessional marks. The scheme of the question paper for theory sessional
examinations shall be as given below.
I. Long Answers (Answer 3 out of 4) 3 x 5 = 15
II. Short Answers (Answer 5 out of 6) 5 x 3 = 15
III.Objective type Answers (Answer all 10 out of 10) 10 x 1 =10
(Multiple Choice Questions / Fill-in the Blanks /
One word OR one Sentence questions)
------------------
Total = 40 marks
------------------
Internal assessment: The marks secured by the students out of the total 40 shall be
reduced to 20 in each sessional, and then the internal assessment shall be
calculated based on the best two averages for 20 marks.

Final Board / University Examinations

The scheme of the question paper for the theory examinations conducted by the
examining authority (Board / University) shall be as given below. The duration of the
final examination shall be 3 hours.
I. Long Answers (Answer 6 out of 7) = 6 x 5 = 30
II. Short Answers (Answer 10 out of 11) = 10 x 3 = 30
III. Objective type Answers (Answer all 20) = 20 x 1 = 20
(Multiple Choice Questions / Fill-in the Blanks /
One word OR one Sentence questions)
------------------
Total = 80 marks
------------------

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6. Guidelines for the conduct of practical examinations

Sessional Examinations

There shall be two or more periodic sessional (internal assessment) practical

examinations during each academic year. The duration of the sessional exam shall
be three hours. The highest aggregate of any two performances shall form the basis
of calculating the sessional marks. The scheme of the question paper for practical
sessional examinations shall be as given below.
I. Synopsis = 10
II. Experiments = 50*
III. Viva voce = 10
IV. Practical Record Maintenance = 10
------------------
Total = 80 marks
------------------
* The marks for the experiments shall be divided into various categories, viz. major
experiment, minor experiment, spotters, etc. as per the requirement of the course.

Internal assessment: The marks secured by the students out of the total of 80 shall
be reduced to 10 in each sessional, and then the internal assessment shall be
calculated based on the best two averages for 10 marks from the sessional and
other 10 marks shall be awarded as per the details given below.

Actual performance in the sessional examination = 10 marks

Assignment marks (Average of three) = 5 marks*
Field Visit Report marks (Average for the reports) = 5 marks$
------------------
Total = 20 marks
------------------
$
*, Only for the courses given with both assignments and field visit/s

Note:
1. For the courses having either assignments or field visit/s, the assessments of
assignments or field visit/s shall be done directly for 10 marks and added to
the sessional marks.
2. For the courses not having both assignment and field visit, the whole 20
marks shall be calculated from the sessional marks.

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Final Board / University Examinations
The scheme of the question paper for the practical examinations conducted by the
examining authority (Board / University) shall be as given below. The duration of the
final examination shall be 3 hours.
I. Synopsis = 10
II. Experiments = 60*
III. Viva voce = 10
------------------
Total = 80 marks
------------------
* The marks for the experiments shall be divided into various categories, viz. major
experiment, minor experiment, spotters, etc. as per the requirement of the course.

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 8. ER-2020 D.Pharm Syllabus – Part II

S. Course Name of the Course Total Total Theory / Tutorial

No. Code Theory / Tutorial Practical Hours
Practical Hours Hours per
Hours per Week
Week
1. ER20-21T Pharmacology – 75 25 3 1
Theory
2. ER20-21P Pharmacology – 50 - 2 -
Practical
3. ER20-22T Community Pharmacy 75 25 3 1
& Management –
Theory
4. ER20-22P Community Pharmacy 75 - 3 -
& Management –
Practical
5. ER20-23T Biochemistry & Clinical 75 25 3 1
Pathology – Theory
6. ER20-23P Biochemistry & Clinical 50 - 2 -
Pathology – Practical
7. ER20-24T Pharmacotherapeutics 75 25 3 1
– Theory
8. ER20-24P Pharmacotherapeutics 25 - 1 -
– Practical
9. ER20-25T Hospital & Clinical 75 25 3 1
Pharmacy – Theory
10. ER20-25P Hospital & Clinical 25 - 1 -
Pharmacy – Practical
11. ER20-26T Pharmacy Law & 75 25 3 1
Ethics

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 PHARMACOLOGY – THEORY

Course Code: ER20-21T 75 Hours (3 Hours/week)

Scope: This course provides basic knowledge about different classes of drugs
available for the pharmacotherapy of common diseases. The indications for use,
dosage regimen, routes of administration, pharmacokinetics, pharmacodynamics,
and contraindications of the drugs discussed in this course are vital for successful
professional practice.

Course Objectives: This course will discuss the following:

1. General concepts of pharmacology including pharmacokinetics,
pharmacodynamics, routes of administration, etc.
2. Pharmacological classification and indications of drugs
3. Dosage regimen, mechanisms of action, contraindications of drugs
4. Common adverse effects of drugs

Course Outcomes: Upon successful completion of this course, the students will be
able to
1. Describe the basic concepts of pharmacokinetics and pharmacodynamics2.
Enlist the various classes and drugs of choices for any given disease condition
3. Advice the dosage regimen, route of administration and contraindications for a
given drug
4. Describe the common adverse drug reactions

Chapter Topic Hours

1 General Pharmacology 10
 Introduction and scope of Pharmacology
 Various routes of drug administration - advantages and
disadvantages
 Drug absorption - definition, types, factors affecting
drug absorption
 Bioavailability and the factors affecting bioavailability
 Drug distribution - definition, factors affecting drug
distribution
 Biotransformation of drugs - Definition, types of
biotransformation reactions, factors influencing drug
metabolisms
 Excretion of drugs - Definition, routes of drug excretion
 General mechanisms of drug action and factors
modifying drug action

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2 Drugs Acting on the Peripheral Nervous System 11
 Steps involved in neurohumoral transmission
 Definition, classification, pharmacological actions, dose,
indications, and contraindications of
a) Cholinergic drugs
b) Anti-Cholinergic drugs
c) Adrenergic drugs
d) Anti-adrenergic drugs
e) Neuromuscular blocking agents
f) Drugs used in Myasthenia gravis
g) Local anaesthetic agents
h) Non-Steroidal Anti-Inflammatory drugs
(NSAIDs)
3 Drugs Acting on the Eye 2
Definition, classification, pharmacological actions, dose,
indications and contraindications of
 Miotics
 Mydriatics
 Drugs used in Glaucoma
4 Drugs Acting on the Central Nervous System 8
Definition, classification, pharmacological actions, dose,
indications, and contraindications of
 General anaesthetics
 Hypnotics and sedatives
 Anti-Convulsant drugs
 Anti-anxiety drugs
 Anti-depressant drugs
 Anti-psychotics
 Nootropic agents
 Centrally acting muscle relaxants
 Opioid analgesics
5 Drugs Acting on the Cardiovascular System 6
Definition, classification, pharmacological actions, dose,
indications, and contraindications of
 Anti-hypertensive drugs
 Anti-anginal drugs
 Anti-arrhythmic drugs
 Drugs used in atherosclerosis and
 Congestive heart failure
 Drug therapy for shock

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6 Drugs Acting on Blood and Blood Forming Organs 4
Definition, classification, pharmacological actions, dose,
indications, and contraindications of
 Hematinic agents
 Anti-coagulants
 Anti-platelet agents
 Thrombolytic drugs
7 Definition, classification, pharmacological actions, dose, 2
indications, and contraindications of
 Bronchodilators
 Expectorants
 Anti-tussive agents
 Mucolytic agents
8 Drugs Acting on the Gastro Intestinal Tract 5
Definition, classification, pharmacological actions, dose,
indications, and contraindications of
 Anti-ulcer drugs
 Anti-emetics
 Laxatives and purgatives
 Anti-diarrheal drugs
9 Drugs Acting on the Kidney 2
Definition, classification, pharmacological actions, dose,
indications, and contraindications of
 Diuretics
 Anti-Diuretics
10 Hormones and Hormone Antagonists 8
Physiological and pathological role and clinical uses of
 Thyroid hormones
 Anti-thyroid drugs
 Parathormone
 Calcitonin
 Vitamin D
 Insulin
 Oral hypoglycemic agents
 Estrogen
 Progesterone
 Oxytocin
 Corticosteroids

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 11 Autocoids 3
 Physiological role of Histamine, 5 HT and
Prostaglandins
 Classification, clinical uses, and adverse effects of
antihistamines and 5 HT antagonists
12 Chemotherapeutic Agents: Introduction, basic principles 12
of chemotherapy of infections, infestations and neoplastic
diseases, Classification, dose, indication and
contraindications of drugs belonging to following classes:
 Penicillins
 Cephalosporins
 Aminoglycosides
 Fluoroquinolones
 Macrolides
 Tetracyclines
 Sulphonamides
 Anti-tubercular drugs
 Anti-fungal drugs
 Anti-viral drugs
 Anti-amoebic agents
 Anthelmintics
 Anti-malarial agents
 Anti-neoplastic agents
13 Biologicals 2
Definition, types, and indications of biological agents with
examples

PHARMACOLOGY – PRACTICAL

Course Code: ER20-21P 50 Hours (2 Hours/week)

Scope: This course provides the basic understanding about the uses, mechanisms
of actions, dose dependent responses of drugs in simulated virtual animal models
and experimental conditions.

Course Objectives: This course will demonstrate / provide hands-on experience in

the virtual platform using appropriate software on the following
1. Study of pharmacological effects of drugs like local anaesthetics, mydriatic
and mitotic on rabbit eye
2. Screening the effects of various drugs acting in the central nervous system
3. Study of drug effects on isolated organs / tissues
4. Study of pyrogen testing on rabbit

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Course Outcomes: Upon successful completion of this course, the students will be
able to
1. Study and report the local anaesthetic, mydriatic and mitotic effects of the
given drug on the rabbit eye
2. Choose appropriate animal experiment model to study the effects of the given
drugs acting on the central nervous system and submit the report
3. Perform the effects of given tissues (simulated) on isolated organs / tissues
and interpret the results
4. Interpret the dose dependent responses of drugs in various animal experiment
models

Practicals

Introduction to the following topics pertaining to the experimental

pharmacology have to be discussed and documented in the practical manuals.

1. Introduction to experimental pharmacology

2. Study of laboratory animals
(a) Mice; (b) Rats; (c) Guinea pigs; (d) Rabbits
3. Commonly used instruments in experimental pharmacology
4. Different routes of administration of drugs in animals
5. Types of pre-clinical experiments: In-Vivo, In-Vitro, Ex-Vivo, etc.
6. Techniques of blood collection from animals

Experiments

Note: Animals shall not be used for doing / demonstrating any of the experiments
given. The given experiments shall be carried- out / demonstrated as the case may
be, ONLY with the use of software program(s) such as ‘Ex Pharm’ or any other
suitable software

1. Study of local anaesthetics on rabbit eye

2. Study of Mydriatic effect on rabbit eye
3. Study of Miotic effect on rabbit eye
4. Effect of analgesics using Analgesiometer
5. Study of analgesic activity by writhing test
6. Screening of anti-convulsant using Electro Convulsiometer
7. Screening of Muscle relaxants using Rota-Rod apparatus
8. Screening of CNS stimulants and depressants using Actophotometer
9. Study of anxiolytic activity using elevated plus maze method
10. Study of effect of drugs (any 2) on isolated heart
11. Effect of drugs on ciliary motility on frog’s buccal cavity
12. Pyrogen testing by rabbit method

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Assignments

The students shall be asked to submit written assignments on the following topics
(One assignment per student per sessional period. i.e., a minimum of THREE
assignments per student)
1. Introduction to Allergy Testing
2. Introduction to Toxicity Studies
3. Drug Facts Labels of US FDA
4. Pre-clinical studies in new drug development
5. Medicines and meals: Before or After food
6. Pre-clinical studies in new drug development
7. Drugs available as paediatric formulations
8. Drug information apps

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 COMMUNITY PHARMACY AND MANAGEMENT – THEORY

Course Code: ER20-22T 75 Hours (3 Hours/week)

Scope: The course is designed to impart basic knowledge and skills to provide
various pharmaceutical care services to patients and general practitioners in the
community setup.

Course Objectives: This course will discuss the following:

1. Establishing and running a community pharmacy and its legal requirements
2. Professional aspects of handling and filling prescriptions
3. Patient counselling on diseases, prescription and or non-prescription
medicines
4. Scope for performing basic health screening in community pharmacy settings

Course Outcomes: Upon successful completion of this course, the students will be
able to
1. Describe the establishment, legal requirements, and effective administration
of a community pharmacy
2. Professionally handle prescriptions and dispense medications
3. Counsel patients about the disease, prescription and or non-prescription
medicines
4. Perform basic health screening on patients and interpret the reports in the
community pharmacy settings

Chapter Topic Hours

1 Community Pharmacy Practice – Definition, history and 2
development of community pharmacy - International and Indian
scenarios
2 Professional responsibilities of community pharmacists 3

Introduction to the concept of Good Pharmacy Practice and

SOPs.
3 Prescription and prescription handling 7
 Definition, parts of prescriptions, legality of prescriptions,
prescription handling, labelling of dispensed medications
(Main label, ancillary label, pictograms), brief instructions
on medication usage
 Dispensing process, Good Dispensing Practices,
dispensing errors and strategies to minimize them

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4 Communication skills 6
 Definition, types of communication skills
 Interactions with professionals and patients
 Verbal communication skills (one-to-one, over the
telephone)
 Written communication skills
 Body language
 Patient interview techniques
5 Patient counselling 10
 Definition and benefits of patient counselling
 Stages of patient counselling - Introduction, counselling
content, counselling process, and closing the counselling
session
 Barriers to effective counseling - Types and strategies
to overcome the barriers
 Patient counselling points for chronic
diseases/disorders - Hypertension, Diabetes, Asthma,
Tuberculosis, Chronic obstructive pulmonary disease, and
AIDS
 Patient Package Inserts - Definition, i mportance and
benefits, Scenarios of PPI use in India and other countries
 Patient Information leaflets - Definition and uses
6 Medication Adherence 2
Definition, factors influencing non- adherence, strategies to
overcome non-adherence
7 Health Screening Services in Community Pharmacy 5
Introduction, scope, and importance of various health screening
services - for routine monitoring of patients, early detection, and
referral of undiagnosed cases
9 Over The Counter (OTC) Medications 15
 Definition, need and role of Pharmacists in OTC medication
dispensing
 OTC medications in India, counseling for OTC products
 Self-medication and role of pharmacists in promoting the
safe practices during self-medication
 Responding to symptoms, minor ailments, and advice for
self-care in conditions such as - Pain management,
Cough, Cold, Diarrhea, Constipation, Vomiting, Fever,
Sore throat, Skin disorders, Oral health (mouth ulcers,
dental pain, gum swelling)

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 10 Community Pharmacy Management
 Legal requirements to set up a community pharmacy 25
 Site selection requirements
 Pharmacy designs and interiors
 Vendor selection and ordering
 Procurement, inventory control methods, and inventory
management
 Financial planning and management
 Accountancy in community pharmacy – Day book, Cash
book
 Introduction to pharmacy operation softwares – usefulness
and availability
 Customer Relation Management (CRM)
 Audits in Pharmacies
 SOP of Pharmacy Management
 Introduction to Digital Health, mHealth and Online
pharmacies

COMMUNITY PHARMACY AND MANAGEMENT – PRACTICAL

Course Code: ER20-22P 75 Hours (3 Hours/week)

Scope: The course is designed to train the students and improve professional skills
to provide various pharmaceutical care services in community pharmacy.

Course Objectives: This course will train the students in the following
1. Professional handling and filling prescriptions
2. Patient counselling on diseases and minor ailments
3. Patient counselling on prescription and / or non-prescription medicines
4. Preparation of counselling materials such as patient information leaflets
5. Performing basic health screening tests

Course Outcomes: Upon successful completion of this course, the students will be
able to
1. Handle and fill prescriptions in a professional manner
2. Counsel patients on various diseases and minor ailments
3. Counsel patients on prescription and or non-prescription medicines
4. Design and prepare patient information leaflets
5. Perform basic health screening tests

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Practicals

Note: The following practicals shall be carried out in the model community pharmacy
with appropriate simulated scenarios and materials. Students shall be trained
through role plays wherever necessary. The activities of the students shall be
assessed / evaluated using a structured objective assessment form.

1. Handling of prescriptions with professional standards, reviewing prescriptions,

checking for legal compliance and completeness (minimum 5)
2. Identification of drug-drug interactions in the prescription and follow-up actions
(minimum 2)
3. Preparation of dispensing labels and auxiliary labels for the prescribed
medications (minimum 5)
4. Providing the following health screening services for monitoring patients /
detecting new patients (one experiment for each activity)
Blood Pressure Recording, Capillary Blood Glucose Monitoring, Lung
function assessment using Peak Flow Meter and incentive spirometer,
recording capillary oxygen level using Pulse Oximeter, BMI
measurement
5. Providing counselling to simulated patients for the following chronic diseases /
disorders including education on the use of devices such as insulin pen,
inhalers, spacers, nebulizers, etc. where appropriate (one experiment for each
disease)
Type 2 Diabetes Mellitus, Primary Hypertension, Asthma,
Hyperlipidaemia, Rheumatoid Arthritis
6. Providing counselling to simulated patients for the following minor ailments
(any three)
Headache, GI disturbances (Nausea, Vomiting, Dyspepsia, diarrhoea,
constipation), Worm infestations, Pyrexia, Upper Respiratory Tract
infections, Skin infections, Oral and dental disorders.
7 Appropriate handling of dummy dosage forms with correct administration
techniques - oral liquids with measuring cup/cap/dropper, Eye Drops, Inhalers,
Nasal drops, Insulin pen, nebulizers, different types of tablets, patches,
enemas, suppositories
8 Use of Community Pharmacy Software and digital health tools

Assignments

The students shall be asked to submit written assignments on the following topics
(One assignment per student per sessional period. i.e., a minimum of THREE
assignments per student)

1. SOPs for various activities in Community Pharmacy (as discussed in Theory

and Practical)

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 2. List out the various abbreviations, short forms used in prescriptions and their
interpretation
3. Patient Information Leaflet for a given chronic disease / disorder
4. Patient Information Leaflet for prescription / non-prescription medicines
5. Preparation of window / shelf display materials for the model community
pharmacy
6. Overview of Software available for retail pharmacy management including
billing, inventory, etc.
7. Dosage / Medication Reminder Aids
8. Overview on the operations and marketing strategies of various online
pharmacies
9. Overview on the common fixed dose combinations
10. Overview on the medications requiring special storage conditions
11. Role of Community Pharmacists in preventing Antimicrobial Resistance
12. Jan Aushadhi and other Generic Medicine initiatives in India
13. Global Overview of Online Pharmacies
14. Community Pharmacy Practice Standards: Global Vs. Indian Scenario
15. Overview of pharmacy associations in India

Field Visit

The students shall be taken in groups to visit community pharmacies and medicine
distributors to understand and witness the professional activities of the community
pharmacists, and supply chain logistics. Individual reports from each student on their
learning experience from the field visit shall be submitted.

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 BIOCHEMISTRY & CLINICAL PATHOLOGY – THEORY

Course Code: ER20-23T 75 Hours (3 Hours/week)

Scope: This course is designed to impart basic knowledge on the study of structure
and functions of biomolecules and the chemical processes associated with living
cells in normal and abnormal states. The course also emphasizes on the clinical
pathology of blood and urine.

Course Objectives: This course will discuss the following at the fundamental level
1. Structure and functions of biomolecules
2. Catalytic activity, diagnostic and therapeutic importance of enzymes
3. Metabolic pathways of biomolecules in health and illness (metabolic
disorders)
4. Biochemical principles of organ function tests and their clinical significance
5. Qualitative and quantitative determination of biomolecules / metabolites in the
biological sample
6. Clinical pathology of blood and urine

Course Outcomes: Upon successful completion of this course, the students will be
able to
1. Describe the functions of biomolecules
2. Discuss the various functions of enzymes in the human system
3. Explain the metabolic pathways of biomolecules in both physiological and
pathological conditions
4. Describe the principles of organ function tests and their clinical significances
5. Determine the biomolecules / metabolites in the given biological samples,
both qualitatively and quantitatively
6. Describe the clinical pathology of blood and urine

Chapter Topic Hours

1 Introduction to biochemistry: Scope of biochemistry in 2
pharmacy; Cell and its biochemical organization.
2 Carbohydrates 5
 Definition, classification with examples, chemical
properties
 Monosaccharides - Structure of glucose, fructose, and
galactose
 Disaccharides - structure of maltose, lactose, and
sucrose
 Polysaccharides - chemical nature of starch and
glycogen
 Qualitative tests and biological role of carbohydrates

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3 Proteins 5
 Definition, classification of proteins based on
composition and solubility with examples
 Definition, classification of amino acids based on
chemical nature and nutritional requirements with
examples
 Structure of proteins (four levels of organization of
protein structure)
 Qualitative tests and biological role of proteins and
amino acids
 Diseases related to malnutrition of proteins.
4 Lipids 5
 Definition, classification with examples
 Structure and properties of triglycerides (oils and fats)
 Fatty acid classification - Based on
chemical and nutritional requirements with
examples
 Structure and functions of cholesterol in the body
 Lipoproteins - types, composition and functions in the
body
 Qualitative tests and functions of lipids
5 Nucleic acids 4
 Definition, purine and pyrimidine bases
 Components of nucleosides and nucleotides with
examples
 Structure of DNA (Watson and Crick model), RNA and
their functions
6 Enzymes 5
 Definition, properties and IUB and MB classification
 Factors affecting enzyme activity
 Mechanism of action of enzymes, Enzyme inhibitors
 Therapeutic and pharmaceutical importance of
enzymes
7 Vitamins 6
 Definition and classification with examples
 Sources, chemical nature, functions, coenzyme form,
recommended dietary requirements, deficiency
diseases of fat-and water-soluble vitamins
8 Metabolism (Study of cycle/pathways without chemical 20
structures)
 Metabolism of Carbohydrates: Glycolysis, TCA cycle
and glycogen metabolism, regulation of blood glucose

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 level. Diseases related to abnormal metabolism of
Carbohydrates
 Metabolism of lipids: Lipolysis, β-oxidation of Fatty acid
(Palmitic acid) ketogenesis and ketolysis. Diseases
related to abnormal metabolism of lipids such as
Ketoacidosis, Fatty liver, Hypercholesterolemia
 Metabolism of Amino acids (Proteins): General
reactions of amino acids and its significance–
Transamination, deamination, Urea cycle and
decarboxylation. Diseases related to abnormal
metabolism of amino acids, Disorders of ammonia
metabolism, phenylketonuria, alkaptonuria and
Jaundice.
 Biological oxidation: Electron transport chain
and Oxidative phosphorylation
9 Minerals: Types, Functions, Deficiency diseases, 05
recommended dietary requirements
10 Water and Electrolytes 05
 Distribution, functions of water in the body
 Water turnover and balance
 Electrolyte composition of the body fluids, Dietary
intake of electrolyte and Electrolyte balance
 Dehydration, causes of dehydration and oral
rehydration therapy
11 Introduction to Biotechnology 01
12 Organ function tests 06
 Functions of kidney and routinely performed tests to
assess the functions of kidney and their clinical
significances
 Functions of liver and routinely performed tests to
assess the functions of liver and their clinical
significances
 Lipid profile tests and its clinical significances
13 Introduction to Pathology of Blood and Urine 06
 Lymphocytes and Platelets, their role in health and
disease
 Erythrocytes - Abnormal cells and their significance
 Normal and Abnormal constituents of Urine and their
significance

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 BIOCHEMISTRY & CLINICAL PATHOLOGY – PRACTICAL

Course Code: ER20-23P 50 Hours (2 Hours/week)

Scope: This course is designed to train the students in the qualitative testing of
various biomolecules and testing of biological samples for determination of normal
and abnormal constituents

Course Objectives: This course will train and provide hands-on experiences on the
following
1. Qualitative determination of biomolecules / metabolites in simulated biological
samples
2. Determination of normal and abnormal constituents of simulated blood and
urine samples

Course Outcomes: Upon successful completion of this course, the students will be
able to
1. Qualitatively determine the biomolecules / metabolites in the given biological
samples
2. Determine the normal and abnormal constituents in blood and urine samples
and interpret the results of such testing

Practicals

1. Qualitative analysis of carbohydrates (4 experiments)

2. Qualitative analysis of Proteins and amino acids (4 experiments)
3. Qualitative analysis of lipids (2 experiments)
4. Qualitative analysis of urine for normal and abnormal constituents
(4 experiments)
5. Determination of constituents of urine (glucose, creatinine, chlorides)
(2 experiments)

6. Determination of constituents of blood/serum (simulated) (Creatine, glucose,

cholesterol, Calcium, Urea, SGOT/SGPT) (5 experiments)
7. Study the hydrolysis of starch from acid and salivary amylase enzyme
(1 experiment)

Assignments
The students shall be asked to submit written assignments on Various Pathology
Lab Reports (One assignment per student per sessional period. i.e., a minimum of
THREE assignments per student)

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 PHARMACOTHERAPEUTICS - THEORY

Course Code: ER20-24T 75 Hours (3 Hours/week)

Scope: This course is designed to impart basic knowledge on etiopathogenesis of

common diseases and their management along with quality use of medicines.

Course Objectives: This course will discuss about

1. Etiopathogenesis of selected common diseases and evidence-based
medicine therapy
2. Importance of individualized therapeutic plans based on diagnosis
3. Basic methods for assessing the clinical outcomes of drug therapy

Course Outcomes: Upon successful completion of this course, the students will be
able to
1. Help assessing the subjective and objective parameters of patients in
common disease conditions
2. Assist other healthcare providers to analyse drug related problems and
provide therapeutic interventions
3. Participate in planning the rational medicine therapy for common diseases
4. Design and deliver discharge counselling for patients

Chapter Topic Hours

1 Pharmacotherapeutics – Introduction, scope, and objectives. 8
Rational use of Medicines, Evidence Based Medicine,
Essential Medicines List, Standard Treatment Guidelines
(STGs)
2 Definition, etiopathogenesis, clinical manifestations, non-
pharmacological and pharmacological management of the
diseases associated with
(a) Cardiovascular System
 Hypertension 8
 Angina and Myocardial infarction
 Hyperlipidaemia
 Congestive Heart Failure
(b) Respiratory System 4
 Asthma
 COPD
(c) Endocrine System 5
 Diabetes
 Thyroid disorders - Hypo and Hyperthyroidism
(d) Central Nervous System 8
 Epilepsy

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  Parkinson’s disease
 Alzheimer’s disease
 Stroke
 Migraine
(e) Gastro Intestinal Disorders 8
 Gastro oesophageal reflux disease
 Peptic Ulcer Disease
 Alcoholic liver disease
 Inflammatory Bowel Diseases (Crohn’s Disease and
Ulcerative Colitis)
(f) Haematological disorders 4
 Iron deficiency anaemia
 Megaloblastic anaemia
(g) Infectious diseases 12
 Tuberculosis
 Pneumonia
 Urinary tract infections
 Hepatitis
 Gonorrhoea and Syphilis
 Malaria
 HIV and Opportunistic infections
 Viral Infections (SARS, CoV2)
(h) Musculoskeletal disorders 3
 Rheumatoid arthritis
 Osteoarthritis
(i) Dermatology 3
 Psoriasis
 Scabies
 Eczema
(j) Psychiatric Disorders 4
 Depression
 Anxiety
 Psychosis
(k) Ophthalmology 2
 Conjunctivitis (bacterial and viral)
 Glaucoma
(l) Anti-microbial Resistance 2
(m) Women’s Health 4
 Polycystic Ovary Syndrome
 Dysmenorrhea
 Premenstrual Syndrome

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 PHARMACOTHERAPEUTICS – PRACTICAL

Course Code: ER20-24P 25 Hours (1 Hour/week)

Scope: This course is designed to train the students in the basic skills required to
support the pharmaceutical care services for selected common disease conditions.

Course Objectives: This course will train the students on

1. How to prepare a SOAP (Subjective, Objective, Assessment and Plan) note
for clinical cases of selected common diseases
2. Patient counselling techniques/methods for common disease conditions

Course Outcomes: Upon successful completion of this course, the students will be
able to
1. Write SOAP (Subjective, Objective, Assessment and Plan) notes for the
given clinical cases of selected common diseases
2. Counsel the patients about the disease conditions, uses of drugs, methods of
handling and administration of drugs, life-style modifications, and monitoring
parameters.

Practicals

I. Preparation and discussion of SOAP (Subjective, Objective, Assessment and

Plan) notes for at least SIX clinical cases (real / hypothetical) of the following
disease conditions.
1. Hypertension
2. Angina Pectoris
3. Myocardial Infarction
4. Hyperlipidaemia
5. Rheumatoid arthritis
6. Asthma
7. COPD
8. Diabetes
9. Epilepsy
10. Stroke
11. Depression
12. Tuberculosis
13. Anaemia (any one type as covered in theory)
14. Viral infection (any one type as covered in theory)
15. Dermatological conditions (any one condition as covered in theory)

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II. Patient counselling exercises using role plays based on the real / hypothetical
clinical case scenarios. The students are expected to provide counselling on
disease condition, medications, life-style modifications, monitoring parameters,
etc. and the same shall be documented. (Minimum 5 cases)

III. Simulated cases to enable dose calculation of selected drugs in paediatrics, and
geriatrics under various pathological conditions. (Minimum 4 cases)

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 HOSPITAL AND CLINICAL PHARMACY – THEORY

Course Code: ER20-25T 75 Hours (3 Hours/week)

Scope: This course is designed to impart fundamental knowledge and professional

skills required for facilitating various hospital and clinical pharmacy services.

Course Objectives: This course will discuss and train the students in the following
1. Hospital and Hospital Pharmacy organization and set-ups
2. Basics of hospital pharmacy services including the procurement, supply chain,
storage of medicines and medical supplies
3. Basics of clinical pharmacy including introduction to comprehensive
pharmaceutical care services
4. Basic interpretations of common laboratory results used in clinical diagnosis
towards optimizing the drug therapy

Course Outcomes: Upon successful completion of this course, the students will be
able to
1. Explain about the basic concepts of hospital pharmacy administration
2. Manage the supply chain and distribution of medicines within the hospital
settings
3. Assist the other healthcare providers in monitoring drug therapy and address
drug related problems
4. Interpret common lab investigation reports for optimizing drug therapy

S. No. Topic Hours

1 Hospital Pharmacy
 Definition, scope, national and international scenario 6
 Organisational structure
 Professional responsibilities, Qualification and experience
requirements, job specifications, work load requirements
and inter professional relationships
 Good Pharmacy Practice (GPP) in hospital
 Hospital Pharmacy Standards (FIP Basel Statements,
AHSP)
 Introduction to NAQS guidelines and NABH Accreditation
and Role of Pharmacists
2 Different Committees in the Hospital 4
 Pharmacy and Therapeutics Committee - Objectives,
Composition, and functions
 Hospital Formulary - Definition, procedure for
development and use of hospital formulary

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  Infection Control Committee – Role of Pharmacist in
preventing Antimicrobial Resistance

4 Supply Chain and Inventory Control 14

 Preparation of Drug lists - High Risk drugs, Emergency
drugs, Schedule H1 drugs, NDPS drugs, reserved
antibiotics
 Procedures of Drug Purchases – Drug selection, short
term, long term, and tender/e-tender process, quotations,
etc.
 Inventory control techniques: Economic Order Quantity,
Reorder Quantity Level, Inventory Turnover etc.
 Inventory Management of Central Drug Store – Storage
conditions, Methods of storage, Distribution, Maintaining
Cold Chain, Devices used for cold storage (Refrigerator,
ILR, Walk-in-Cold rooms)
 FEFO, FIFO methods
 Expiry drug removal and handling, and disposal. Disposal
of Narcotics, cytotoxic drugs
 Documentation - purchase and inventory
5 Drug distribution 7
 Drug distribution (in- patients and out - patients) –
Definition, advantages and disadvantages of individual
prescription order method, Floor Stock Method, Unit Dose
Drug Distribution Method, Drug Basket Method.
 Distribution of drugs to ICCU/ICU/NICU/Emergency
wards.
 Automated drug dispensing systems and devices
 Distribution of Narcotic and Psychotropic substances and
their storage
6 Compounding in Hospitals. Bulk compounding, IV admixture 4
services and incompatibilities, Total parenteral nutrition
7 Radio Pharmaceuticals - Storage, dispensing and disposal of 2
radiopharmaceuticals
8 Application of computers in Hospital Pharmacy Practice, 2
Electronic health records, Softwares used in hospital pharmacy
9 Clinical Pharmacy: Definition, scope, and development - in 12
India and other countries

Technical definitions, common terminologies used in clinical

settings and their significance such as Paediatrics, Geriatric,
Anti-natal Care, Post-natal Care, etc.

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 Daily activities of clinical pharmacists: Definition, goal, and
procedure of
 Ward round participation
 Treatment Chart Review
 Adverse drug reaction monitoring
 Drug information and poisons information
 Medication history
 Patient counselling
 Interprofessional collaboration

Pharmaceutical care: Definition, classification of drug related

problems. Principles and procedure to provide pharmaceutical
care

Medication Therapy Management, Home Medication Review

10 Clinical laboratory tests used in the evaluation of disease 10
states - significance and interpretation of test results
 Haematological, Liver function, Renal function, thyroid
function tests
 Tests associated with cardiac disorders
 Fluid and electrolyte balance
 Pulmonary Function Tests
11 Poisoning: Types of poisoning: Clinical manifestations and 6
Antidotes
Drugs and Poison Information Centre and their services –
Definition, Requirements, Information resources with examples,
and their advantages and disadvantages
12 Pharmacovigilance 2
 Definition, aim and scope
 Overview of Pharmacovigilance
13 Medication errors: Definition, types, consequences, and 6
strategies to minimize medication errors, LASA drugs and
Tallman lettering as per ISMP

Drug Interactions: Definition, types, clinical significance of drug

interactions

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 HOSPITAL AND CLINICAL PHARMACY – PRACTICAL

Course Code: ER20-25P 25 Hours (1 Hour / Week)

Scope: This course is designed to train the students to assist other healthcare
providers in the basic services of hospital and clinical pharmacy.

Course Objectives: This course will train the students with hands-on experiences,
simulated clinical case studies in the following:
1. Methods to systematically approach and respond to drug information queries
2. How to interpret common laboratory reports to understand the need for
optimizing dosage regimens
3. How to report suspected adverse drug reactions to the concerned authorities
4. Uses and methods of handling various medical/surgical aids and devices
5. How to interpret drug-drug interactions in the treatment of common diseases.

Course Outcomes: Upon completion of the course, the students will be able to
1. Professionally handle and answer the drug information queries
2. Interpret the common laboratory reports
3. Report suspected adverse drug reactions using standard procedures
4. Understand the uses and methods of handling various medical/surgical aids
and devices
5. Interpret and report the drug-drug interactions in common diseases for
optimizing the drug therapy

Note: Few of the experiments of Hospital and Clinical Pharmacy practical course
listed here require adequate numbers of desktop computers with internet
connectivity, adequate drug information resources including reference books,
different types of surgical dressings and other medical devices and accessories.
Various charts, models, exhibits pertaining to the experiments shall also be
displayed in the laboratory.

Practicals

1. Systematic approach to drug information queries using primary / secondary /

tertiary resources of information (2 cases)
2. Interpretation of laboratory reports to optimize the drug therapy in a given clinical
case (2 cases)
3. Filling up IPC’s ADR Reporting Form and perform causality assessments using
various scales (2 cases)
4. Demonstration / simulated / hands-on experience on the identification, types, use /
application /administration of
 Orthopaedic and Surgical Aids such as knee cap, LS belts, abdominal belt,
walker, walking sticks, etc.

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  Different types of bandages such as sterile gauze, cotton, crepe bandages,
etc.
 Needles, syringes, catheters, IV set, urine bag, RYLE’s tube, urine pots,
colostomy bags, oxygen masks, etc.
5. Case studies on drug-drug interactions (any 2 cases)
6. Wound dressing (simulated cases and role play –minimum 2 cases)
7. Vaccination and injection techniques (IV, IM, SC) using mannequins (5 activities)
8. Use of Hospital Pharmacy Software and various digital health tools

Assignments

The students shall be asked to submit written assignments on the following topics
(One assignment per student per sessional period. i.e., a minimum of THREE
assignments per student)

1. Typical profile of a drug to be included in the hospital formulary

2. Brief layout and various services of the Central Sterile Supplies Department
(CSSD)
3. Various types of sterilizers and sterilization techniques used in hospitals
4. Fumigation and pesticide control in hospitals
5. Role of Pharmacists in Transition of Care: Discharge cards, post hospitalization
care, medicine reconciliation activities in developed countries
6. Total parenteral nutrition and IV admixtures and their compatibility issues
7. Concept of electronic health records
8. Invasive and Non-invasive diagnostic tests - HRCT, MRI, Sonography, 2D
ECHO, X-rays, Mammography, ECG, EMG, EEG
9. Home Diagnostic Kits - Pregnancy Test, COVID testing etc
10. Measures to be taken in hospitals to minimize Antimicrobial Resistance
11. Role and responsibilities of a pharmacist in public hospital in rural parts of the
country
12. Safe waste disposal of hospital waste

Field Visit

The students shall be taken in groups to visit a Government / private healthcare

facility to understand and witness the various hospital and clinical pharmacy services
provided. Individual reports from each student on their learning experience from the
field visit shall be submitted.

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 PHARMACY LAW AND ETHICS – THEORY

Course Code: ER20-26T 75 Hours (3 Hours/week)

Scope: This course is designed to impart basic knowledge on several important

legislations related to the profession of pharmacy in India

Course Objectives: This course will discuss the following

1. General perspectives, history, evolution of pharmacy law in India
2. Act and Rules regulating the profession and practice of pharmacy in India
3. Important code of ethical guidelines pertaining to various practice standards
4. Brief introduction to the patent laws and their applications in pharmacy

Course Outcomes: Upon successful completion of this course, the students will be
able to
1. Describe the history and evolution of pharmacy law in India
2. Interpret the act and rules regulating the profession and practice of pharmacy in
India
3. Discuss the various codes of ethics related to practice standards in pharmacy
4. Interpret the fundamentals of patent laws from the perspectives of pharmacy

Chapter Topics Hours

1 General Principles of Law, History and various Acts related 2
to Drugs and Pharmacy profession
2 Pharmacy Act-1948 and Rules: Objectives, Definitions, 5
Pharmacy Council of India; its constitution and functions,
Education Regulations, State and Joint state pharmacy
councils, Registration of Pharmacists, Offences and
Penalties.

Pharmacy Practice Regulations 2015

3 Drugs and Cosmetics Act 1940 and Rules 1945 and 23

New Amendments
Objectives, Definitions, Legal definitions of schedules to
the Act and Rules Import of drugs – Classes of drugs and
cosmetics prohibited from import, Import under license or
permit.

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 Manufacture of drugs – Prohibition of manufacture and
sale of certain drugs, Conditions for grant of license and
conditions of license for manufacture of drugs,
Manufacture of drugs for test, examination and analysis,
manufacture of new drug, loan license and repacking
license.

Study of schedule C and C1, G, H, H1, K, P, M, N, and X.

Sale of Drugs – Wholesale, Retail sale and Restricted

license, Records to be kept in a pharmacy
Drugs Prohibited for manufacture and sale in India

Administration of the Act and Rules – Drugs Technical

Advisory Board, Central Drugs Laboratory, Drugs
Consultative Committee, Government analysts, licensing
authorities, controlling authorities, Drug Inspectors.
4 Narcotic Drugs and Psychotropic Substances Act 1985 2
and Rules Objectives, Definitions, Authorities and Officers,
Prohibition, Control and Regulation, Offences and
Penalties.
5 Drugs and Magic Remedies (Objectionable 2
Advertisements) Act 1954
Objectives, Definitions, Prohibition of certain
advertisements, Classes of Exempted advertisements,
Offences and Penalties.
6 Prevention of Cruelty to Animals Act-1960: Objectives, 2
Definitions, CPCSEA - brief overview, Institutional Animal
Ethics Committee, Breeding and Stocking of Animals,
Performance of Experiments, Transfer and Acquisition of
animals for experiment, Records, Power to suspend or
revoke registration, Offences and Penalties.
7 Poisons Act-1919: Introduction, objective, definition, 2
possession, possession for sales and sale of any poison,
import of poisons
8 FSSAI (Food Safety and Standards Authority of India) 2
Act and Rules: brief overview and aspects related to
manufacture, storage, sale, and labelling of Food
Supplements

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9 National Pharmaceutical Pricing Authority: Drugs Price 5
Control Order (DPCO) - 2013. Objectives, Definitions, Sale
prices of bulk drugs, Retail price of formulations, Retail
price and ceiling price of scheduled formulations,
Pharmaceutical Policy 2002, National List of Essential
Medicines (NLEM)

10 Code of Pharmaceutical Ethics: Definition, ethical 5

principles, ethical problem solving, registration, code of
ethics for Pharmacist in relation to his job, trade, medical
profession and his profession, Pharmacist’s oath.
11 Medical Termination of Pregnancy Act and Rules – basic 2
understanding, salient features, and Amendments

12 Role of all the government pharma regulator bodies – 1

Central Drugs Standards Control Organization (CDSCO),
Indian Pharmacopoeia Commission (IPC)
13 Good Regulatory practices (documentation, licenses, 3
renewals, e-governance) in Community Pharmacy, Hospital
pharmacy, Pharma Manufacturing, Wholesale business,
inspections, import, export of drugs and medical devices
14 Introduction to BCS system of classification, Basic concepts 7
of Clinical Trials, ANDA, NDA, New Drug development,
New Drugs and Clinical Trials Rules, 2019. Brand v/s
Generic, Trade name concept, Introduction to Patent Law
and Intellectual Property Rights, Emergency Use
Authorization
15 Blood bank – basic requirements and functions 2
16 Clinical Establishment Act and Rules – Aspects related to 2
Pharmacy
17 Biomedical Waste Management Rules 2016 – Basic 2
aspects, and aspects related to pharma manufacture to
disposal of pharma / medical waste at homes, pharmacies,
and hospitals
18 Bioethics - Basic concepts, history and principles. Brief 2
overview of ICMR’s National Ethical Guidelines for
Biomedical and Health Research involving human
participants
19 Introduction to the Consumer Protection Act 1
20 Introduction to the Disaster Management Act 1
21 Medical Devices – Categorization, basic aspects related to 2
manufacture and sale

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Assignments

The students shall be asked to submit written assignments on the following topics
(One assignment per student per sessional period. i.e., a minimum of THREE
assignments per student)

1. Requirements for Ayurvedic, Homeopathic manufacturing, sale, and licensing

requirements
2. Layout and contents of official websites of various agencies regulating the
profession of pharmacy in India: e.g., CDSCO, SUGAM portal, PCI, etc.
3. Licenses required, application processes (online/offline), drug regulatory office
website of the respective state
4. Case studies – actions taken on violation of any act / rule related to pharmacy
5. Schedule H1 drugs and its implementation in India
6. Counterfeit / Spurious medicines
7. Drug Testing Labs in India
8. Overview of Pharma marketing practices
9. Generic Medicines

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