Sanjay Ghodawat University

Kolhapur
Established under section 2(f) of UGC act 1956
Sanjay Ghodawat University Act XL of 2017of Govt. of Maharashtra
Approved by PCI, COA & AICTE

Empowering Lives Globally!

School of Pharmaceutical Science

Final Year B. Pharm.
Curriculum
Academic Year 2022-23

1
 Revised Ordinance Governing
Bachelor of Pharmacy (B. Pharm.)
Degree Course
Pharmacy Council of India.

Rules & Syllabus for the Bachelor of

Pharmacy
(Final Year B. Pharm) Course

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 1
 Index
SR.NO CONTENT PAGE NO.
I SANJAY GHODAWAT UNIVERSITY KOLHAPUR 3
VISION 4
MISSION 4
CORE VALUES 4
QUALITY POLICY 4
OUTCOME BASED EDUCATION (OBE) MODEL 5-7
II CHAPTER-I:REGULATIONS 8- 29
III CHAPTER-II:SYLLABUS 30
A Semester VII 31
BP701T: Instrumental Method Analysis(Theory) 32-33
BP702T: Industrial Pharmacy (Theory) 36- 37
BP703T: Pharmacy practice(Theory) 38- 40
BP704T: Novel Drug delivery system(Theory) 41- 42

BP705P: Instrumental Method Analysis (Practical) 34-35

BP706PS: Practice School* 43- 51

B Semester-VIII 52

BP801T :Biostatistics and Research Methodology 53- 54

BP802T : Social and Preventive Pharmacy 55- 56

BP803ET: Pharma Marketing Management 57- 58

BP804ET: Pharmaceutical Regulatory Science 59- 60

BP805ET: Pharmacovigilance 61- 63

BP806ET: Quality Control and Standardization of Herbals 64- 65

BP807ET: Computer Aided Drug Design 66- 67

BP808ET: Cell and Molecular Biology 68- 69

BP809ET: Cosmetic Science 70- 71

BP810ET: Pharmacology Screening Method 72- 73

BP811ET: Advanced Instrumentation Techniques 74- 75

BP812ET: Dietary Supplements and Nutraceuticals 76- 78

BP813ET: Pharmaceutical Product Development 79- 80

BP813PW:Project Work ----

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 2
 SANJAY GHODAWAT UNIVERSITY KOLHAPUR

Sanjay Ghodawat University (SGU) is established in the Academic Year 2017-18, as a State Private
University under Govt. of Maharashtra Act No. XL of 2017 dated 3rd May2017, with the approval
of the UGC and the State Government. "For the true measure of giving is giving without measure"
Spread across150Acres, Sou. Sushila Danchand Ghodawat Charitable Trust's Sanjay Ghodawat
University (SGU) is situated in a serene atmosphere amidstidyllic hills and lush green meadows to
study in harmony with Nature. The Institution aspires to run along the lines of best- in-the-world
education and become a world-class institution where the teaching-learning process gets a far
deeper meaning. SGU always stands as the guiding star of brilliance, quality, and deliverance
beyond expectations. Innovativeness and Creativity are the hallmarks of a genius enterprise and
SGU stands to be a stage where the equalities would be nurtured, encouraged, and blossomed. The
genius is incomplete without the sense of social responsibility and SGU's ultimate goal remains
the development of an attitude of gratitude that freely gives back without expectations. The Sanjay
Ghodawat University stands as a beacon of light to guide the younger generation of the day on the
right path to fulfillment in career and life. The USP of the University is its research-based
curriculum and academically-oriented teaching staff. The world-class ambiance and infrastructure
help the students to easily accommodate themselves in an environment that is conducive to the
teaching-learning process. Hands-on experience, challenge- based case studies, maximum
participation of students in the classroom, use of modern digital technology, smart classrooms,
solution-oriented thinking promotion, stress on research and innovation, international tie-ups,
choice-based credit system for flexibility in choosing areas of interest, etc. are some of the features
of the University. The university will help students develop as unique individual- to be educated as
a whole person, intellectually, emotionally, socially, ethically, and spiritually. The educational
program designs are worked out meticulously in line with best in class universities with a special
focus on:
 Flexible Choice Based Credit System
 OBE-Outcome Based Education System
 Experiential Learning
 Project-Based Learning
 Case-Based Learning
 Training need analysis based on Performance Appraisal System
 Active Learning tools for effective delivery
 Mentoring/Proctorship
 Online learning/Self-learning platforms
 Flipped Classroom concept
 Effective Student Feedback Mechanism

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 3
 VISION
Internationally recognized university of excellence in creating and disseminating knowledge
through value-based quality education leading to the betterment of mankind

MISSION

 To prepare students for life-long learning and leadership in a global academic culture
 To create intellectual manpower relevant to the industry and society at large
 To collaborate with institutions of international repute for academic excellence
 To promote research and development through a conducive environment
 To encourage entrepreneurship and skill development programs

COREVALUES
 Integrity
 Transparency
 Accountability
 Equality
 Empathy
 Stewardship

QUALITYPOLICY

Sanjay Ghodawat University is committed to establish high standards in value-based quality

education to enhance and nurture young minds to excel in their chosen profession and develop into
socially responsible citizens through resourceful collaboration, innovation and research

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 4
 OUTCOME BASED EDUCATION (OBE) MODEL

Sanjay Ghodawat University (SGU) has implemented the OBE model of education, which is a
learner cantered approach. SGU has witnessed a sea change in the entire academic system with the
implementation of all three components of OBE – Design, Delivery, and Assessment. The SGU
model of autonomy focuses on experiential learning which believes in learning by doing. This is
achieved through hands-on experience, industrial assignments, mini-projects, and live problem
solving and collaboration with industries. SGU is set into dynamics of transformation and
witnessing a shift in focus from teaching to learning and the entire academic system of SGUis
designed to provide multiple learning opportunities for students to acquire and demonstrate the
Knowledge, Skills, and Attitudes (KSA) for rewarding career. The Vision and Mission of the
Management, the contribution from eminent BOG members and knowledgeable members of
Academic Council and Board of Studies, the motivation and drive of the Director, the relentless
efforts of the fellow Deans and Head of Departments and all teaching and non-teaching staff
along with a commitment to the learning of students made it possible to successfully transform
the institute and stand out to carve a niche for itself as an Institute of repute. OBE is an approach to
curriculum design and teaching that focuses on what students should be able to do (attained) at the
end of the course/ program. Outcome-based education (OBE) is a student-centered instruction
model that focuses on measuring student performance through outcomes. Outcomes include
knowledge, skills, and attitudes (KSA). Its focus remains on the evaluation of outcomes of the
program by stating the knowledge, skill and behavior a graduate is expected to attain upon
completion of a program and after 4 – 5 years of graduation. In the OBE model, the required
knowledge and skill sets for a particular degree are predetermined and the students are evaluated
for all the required parameters (Outcomes) during the program.

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 5
 The OBE model measures the progress of the graduate in three parameters, which are
 Program Educational Objectives (PEO)
 Program Outcomes (PO)
 Course Outcomes (CO)

Program Educational Objectives (PEO) are broad statements that describe the career and
professional accomplishments that the program is preparing the graduates to achieve. PEO’s are
measured 4-5 years after graduation. Program outcomes are narrower statements that describe what
students are expected to know and be able to do by the time of graduation. They must reflect the
Graduate attributes. Course outcomes are the measurable parameters that evaluate each student's
performance for each course that the student undertakes every semester.

The various assessment tools for measuring Course Outcomes include Tests and End Semester
Examinations, Tutorials, Assignments, Project work, Labs, Presentations, Employer/Alumni
Feedback, etc, These course outcomes are mapped to Graduate attributes and Program outcomes
based on relevance. This evaluation pattern helps Institutions to measure the Program Outcome.
The Program Educational Objective is measure through Employer satisfaction survey (Yearly),
Alumni survey (Yearly), Placement records, and higher education records.

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 6
 Special Features of OBE
 OBE is an educational process that focuses on what students can do or the qualities they should
develop after they are taught.
 OBE involves the restructuring of curriculum, assessment, and reporting practices in education
to reflect the achievement of high order learning and mastery rather than accumulation of course
credits.
 Both structures and curricula are designed to achieve those capabilities or qualities.
 Discourages traditional education approaches based on direct instruction of facts and standard
methods.
 It requires that the students demonstrate that they have learned the required skills and content.

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 7
 CHAPTER-I:
REGULATIONS

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 8
 1. Short Title and Commencement
These regulations shall be called as “The Revised Regulations for the B. Pharm. Degree Program
(CBCS) of the Pharmacy Council of India, New Delhi”. They shall come into effect from the
Academic Year 2016-17. The regulations framed are subject to modifications from time to time
by the Pharmacy Council of India.
2. Minimum qualification for admission
2.1 First-year B. Pharm:
Candidate shall have passed 10+2 examination conducted by the respective state/central
government authorities recognized as equivalent to 10+2 examination by the Association ofIndian
Universities (AIU) with English as one of the subjects and Physics, Chemistry, Mathematics
(P.C.M) and or Biology (P.C.B / P.C.M.B.) as optional subjects individually. Any other
qualification approved by the Pharmacy Council of India as equivalent to any of the above
examinations.
2.2 B. Pharm lateral entry (to third semester):
A pass in D. Pharm. course from an institution approved by the Pharmacy Council of India under
section 12 of the Pharmacy Act.
3. Duration of the program
The course of study for B. Pharm shall extend over a period of eight semesters (four academic
years) and six semesters (three academic years) for lateral entry students. The curricula and syllabi
for the program shall be prescribed from time to time by the Pharmacy Council of India, New Delhi.
4. Medium of instruction and examinations
The medium of instruction and examination shall be in English.
5. Working days in each semester
Each semester shall consist of not less than 100 working days. The odd semesters shall be conducted
from the month of June/July to November/December and the even semesters shall be conducted
from December/January to May/June in every calendar year.
6. Attendance and progress
A candidate is required to put in at least 80% attendance in individual courses considering theory
and practical separately. The candidate shall complete the prescribed course satisfactorily to be
eligible to appear for the respective examinations.
7. Program/Course credit structure
As per the philosophy of Credit-Based Semester System, a certain quantum of academic work viz.
theory classes, tutorial hours, practical classes, etc. are measured in terms of credits. On satisfactory
completion of the courses, a candidate earns credits. The amount of credit associated with a course
is dependent upon the number of hours of instruction per week in that course. Similarly, the credit
associated with any of the other academic, co/extra-curricular activities is dependent upon the
quantum of work expected to be put in for each of these activities per week.
7.1 Credit assignment
7.1.1 Theory and Laboratory courses
Courses are broadly classified as Theory and Practical. Theory courses consist of lecture (L) and
/or tutorial (T) hours, and Practical (P) courses consist of hours spent in the laboratory. Credits

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 9
 (C) for a course is dependent on the number of hours of instruction per week in that course and is
obtained by using a multiplier of one (1) for lecture and tutorial hours, and a multiplier of half (1/2)
for practical (laboratory) hours. Thus, for example, a theory course having three lectures and one
tutorial per week throughout the semester carries a credit of 4. Similarly, a practical having four
laboratory hours per week throughout the semester carries a credit of 2.

Sr. Component Hours Credit

No
B. Pharm (Direct)
1 Theory 1hr 1
2 Tutorial 1hr 1
3 Practical Hr ½ per Hr
Lateral Entry
D. Pharm 52
Remedial Course Communication Skills (Theory and 7
Practical) and ‘Computer Applications in Pharmacy)

7.2 Minimum credit requirements

The minimum credit point required for award of B. Pharm. degree is 208. These credits are divided
into Theory courses, Tutorials, Practical, Practice School, and Projects over the duration of eight
semesters. The credits are distributed semester-wise as shown in Table IX. Courses generally
progress in sequences, building competencies and their positioning indicates certain academic
maturity on the part of the learners. Learners are expected to follow the semester-wise schedule of
courses given in the syllabus.
The lateral entry students shall get 52 credit points transferred from their D. Pharm program. Such
students shall take up additional remedial courses of ‘Communication Skills’ (Theory and Practical)
and ‘Computer Applications in Pharmacy’ (Theory and Practical) equivalent to 3 and 4 credit points
respectively, a total of 7 credit points to attain 59 credit points, the maximum of I and II semesters.
8. Academic work
A regular record of attendance both in Theory and Practical shall be maintained by the teaching
staff of respective courses.
9. Course of study
The course of study for B. Pharm shall include Semester Wise Theory & Practical as given in Table
– I to VIII. The number of hours to be devoted to each theory, tutorial and practical course in any
semester shall not be less than that shown in Table – I to VIII.

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 10
 Table I: Course of study for Semester-I
Course code Name of the course No. of Tutorial Credit
hours points
BP101T Human Anatomy and Physiology-I (Theory) 3 1 4
BP102T Pharmaceutical Analysis-I(Theory) 3 1 4
BP103T Pharmaceutics-I(Theory) 3 1 4
BP104T Pharmaceutical Inorganic Chemistry (Theory) 3 1 4
BP105T Communication skills (Theory)* 2 - 2
BP106RBT Remedial Biology/ 2 - 2
BP106RMT Remedial Mathematics (Theory)*
BP107P Human Anatomy and Physiology(Practical) 4 - 2
BP108P Pharmaceutical Analysis-I(Practical) 4 - 2
BP109P Pharmaceutics-I(Practical) 4 - 2
BP110P Pharmaceutical Inorganic Chemistry(Practical) 4 - 2
BP111P Communication skills(Practical)* 2 - 1
BP112RBP Remedial Biology(Practical)* 2 - 1
Total 32/34$/36# 4 27/29$/30#

*
Applicable ONLY for the students who have studied Mathematics/Physics/Chemistry at HSC
and appearing for Remedial Biology (RB) course.
*Applicable ONLY for the students who have studied Physics/Chemistry/Botany/Zoology at HSC
and appearing for Remedial Mathematics (RM) course.
*Non-University Examination (NUE)

Table II: Course of study for Semester-II

Course Name of the course No. of Tutorial Credit

Code hours points
BP201T Human Anatomy and Physiology-II (Theory) 3 1 4
BP202T Pharmaceutical Organic Chemistry-I(Theory) 3 1 4
BP203T Biochemistry (Theory) 3 1 4
BP204T Pathophysiology (Theory) 3 1 4
BP205T Computer Applications in Pharmacy (Theory)* 3 - 3
BP206T Environmental Sciences (Theory)* 3 - 3
BP207P Human Anatomy and Physiology-II (Practical) 4 - 2
BP208P Pharmaceutical Organic Chemistry-I (Practical) 4 - 2
BP209P Biochemistry (Practical) 4 - 2
BP210P Computer Applications in Pharmacy (Practical)* 2 - 1
Total 32 4 29
*Non-University Examination (NUE)

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 11
 Table III: Course of study for Semester-III
Course Name of the course No. of Tutorial Credit
code hours points
BP301T Pharmaceutical Organic Chemistry-II (Theory) 3 1 4
BP302T Physical Pharmaceutics-I (Theory) 3 1 4
BP303T Pharmaceutical Microbiology (Theory) 3 1 4
BP304T Pharmaceutical Engineering (Theory) 3 1 4
BP305P Pharmaceutical Organic Chemistry-II (Practical) 4 - 2
BP306P Physical Pharmaceutics-I(Practical) 4 - 2
BP307P Pharmaceutical Microbiology (Practical) 4 - 2
BP308P Pharmaceutical Engineering (Practical) 4 - 2
Total 28 4 24

Table IV: Course of study for Semester-IV

Course Name of the course No. of Tutorial Credit

code hours points
BP401T Pharmaceutical Organic Chemistry-III (Theory) 3 1 4
BP402T Medicinal Chemistry-I (Theory) 3 1 4
BP403T Physical Pharmaceutics-II (Theory) 3 1 4
BP404T Pharmacology-I(Theory) 3 1 4
BP405T Pharmacognosy and Phytochemistry-I (Theory) 3 1 4
BP406P Medicinal Chemistry-I (Practical) 4 - 2
BP407P Physical Pharmaceutics-II (Practical) 4 2
BP408P Pharmacology-I(Practical) 4 - 2
BP409P Pharmacognosy and Phytochemistry-I (Practical) 4 - 2
Total 31 5 28

Table V: Course of study for Semester-V

Course Name of the course No. of Tutorial Credit

code hours points
BP501T Medicinal Chemistry-II (Theory) 3 1 4
BP502T Industrial Pharmacy-I (Theory) 3 1 4
BP503T Pharmacology-II(Theory) 3 1 4
BP504T Pharmacognosy and Phytochemistry-II (Theory) 3 1 4
BP505T Pharmaceutical Jurisprudence (Theory) 3 1 4
BP506P Industrial Pharmacy-I (Practical) 4 - 2
BP507P Pharmacology-II (Practical) 4 - 2
BP508P Pharmacognosy and Phytochemistry-II (Practical) 4 - 2
Total 27 5 26

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 12
 Table VI: Course of study for Semester-VI

Course Name of the course No. of Tutorial Credit

code hours points
BP601T Medicinal Chemistry-III(Theory) 3 1 4
BP602T Pharmacology-III(Theory) 3 1 4
BP603T Herbal Drug Technology(Theory) 3 1 4
BP604T Biopharmaceutics and Pharmacokinetics(Theory) 3 1 4
BP605T Pharmaceutical Biotechnology(Theory) 3 1 4
BP606T Pharmaceutical Quality Assurance(Theory) 3 1 4
BP607P Medicinal Chemistry-III(Practical) 4 - 2
BP608P Pharmacology-III(Practical) 4 - 2
BP609P Herbal Drug Technology (Practical) 4 - 2
Total 30 6 30

Table VII: Course of study for Semester-VII

Course Name of the course No. of Tutorial Credit

Code hours points
BP701T Instrumental Methods of Analysis (Theory) 3 1 4
BP702T Industrial Pharmacy-II(Theory) 3 1 4
BP703T Pharmacy Practice(Theory) 3 1 4
BP704T Novel Drug Delivery System(Theory) 3 1 4
BP705P Instrumental Methods of Analysis(Practical) 4 - 2
BP706PS Practice School* 12 - 6
Total 28 4 24
*Non-University Examination (NUE)

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 13
 Table VIII: Course of study for semester VIII

Course Name of the course No. of Tutorial Credit

code hours points
BP801T Biostatistics and Research Methodology 3 1 4
BP802T Social and Preventive Pharmacy 3 1 4
BP803ET Pharma Marketing Management
BP804ET Pharmaceutical Regulatory Science
BP805ET Pharmacovigilance
BP806ET Quality Control and Standardization of Herbals
BP807ET Computer Aided Drug Design 3+3= 4+4=
BP808ET Cell and Molecular Biology 6 1+1=2 8
BP809ET Cosmetic Science
BP810ET Experimental Pharmacology
BP811ET Advanced Instrumentation Techniques
BP812ET Dietary Supplements and Nutraceuticals
BP813ET Pharmaceutical Product Development
BP813PW Project Work 12 - 6
Total 24 4 22

Table IX: Semester wise credits distribution

Semester Credit Points
I 27/29$/30#
II 29
III 24
IV 28
V 26
VI 30
VII 24
VIII 22
Extracurricular/Co-curricular 01*
activities
Total credit points for the program 210/212$/213#+(01*)

*The credit points assigned for extracurricular and/or co-curricular activities shall be given by the
Principals of the colleges and the same shall be submitted to the University. The criteria to acquire
this credit point shall be defined by the colleges from time to time.
*Applicable ONLY for the students studied Physics/ Chemistry/ Botany/ Zoology at HSC and
appearing for Remedial Mathematics course.
*Applicable ONLY for the students studied Mathematics/Physics/Chemistry at HSC and appearing
for Remedial Biology course.

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 14
 10. Program Committee

1. The B. Pharm program shall have a Program Committee constituted by the Head of the
institution in consultation with all the Heads of the departments.
2. The composition of the Program Committee shall be as follows:
A senior teacher shall be the Chairperson; One Teacher from each department handling B.
Pharm courses; and four student representatives of the program (one from each academic year),
nominated by the Head of the institution.
3. Duties of the program committee:
i. Periodically reviewing the progress of the classes.
ii. Discussing the problems concerning curriculum, syllabus, and the conduct of classes.
iii. Discussing with the course teachers on the nature and scope of assessment for the
course and the same shall be announced to the students at the beginning of respective
semesters.
iv. Communicating its recommendation to the Head of the institution on academicmatters.
v. The Program Committee shall meet at least thrice in a semester preferably at the end
of each Sessional exam (Internal Assessment) and before the end semester exam.

11. Examinations/Assessments

The scheme for internal assessment and end semester examinations is given in Table–X.
End semester examinations
The End Semester Examinations (ESE) for each theory and practical course through semesters I to
VIII shall be conducted by the university except for the subjects with a steric symbol (*) in Table I
and II for which examinations shall be conducted by the subject experts at the college level and the
marks / grades shall be submitted to the university.

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 15
 Table X:-SEMESTER–VII

Course Course Title L T P C Component Exam WT Passing

Code (Marks) Min.(%)
BP701T Instrumental 3 1 - 4 Theory CA 10 10
Methods of (100) Sessional- 15
Analysis – 1 15 50
(Theory) Sessional- 15
2
ESE 75
BP702T Industrial 3 1 - 4 Theory CA 10 10 50
Pharmacy-II (100) Sessional- 15
(Theory) 15
1
Sessional- 15
2
ESE 75
BP703T Pharmacy 3 1 - 4 Theory CA 10 10 50
Practice – (100) Sessional- 15
(Theory) 1 15
Sessional- 15
2
ESE 75
BP704T Novel Drug 3 1 - 4 Theory CA 10 10 50
Delivery System (100) Sessional- 15
(Theory) 1 15
Sessional- 15
2
ESE 75
BP705P Instrumental - - 4 2 Practical CA 5 5 50
Methods of (50) Sessional- 10
Analysis 10
1
(Practical) Sessional- 10
2
ESE 35
BP706PS Practice 12 - 5 6 Practical CA 25 25 50
School* (150) Sessional- -
1
Sessional- -
2
ESE 125
Total 28 4 12 24
600
32

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 16
 Table X: SEMESTER-VIII

Course Course Title L T P C Component Exam WT Passing

Code (Marks) Min
(%)
BP801T Biostatistics and 3 1 - 4 Theory CA 10 10
Research (100) Sessional-1 15
15 50
Methodology Sessional-2 15
(Theory) ESE 75
BP802T Social and Preventive 3 1 - 4 Theory CA 10 10 50
Pharmacy (Theory) (100) Sessional-I 15
15
Sessional-II 15
ESE 75
BP803ET Pharmaceutical 3 1 - 4 Theory CA 10 10 50
Marketing (100) Sessional-I 15
15
(Theory) Sessional-II 15
ESE 75
BP804ET Pharmaceutical 3 1 - 4 Theory CA 10 10 50
Regulatory (100) Sessional-I 15
15
Science(Theory) Sessional-II 15
ESE 75
BP805ET Pharmacovigilance 3 1 - 4 Theory CA 10 10 50
(Theory) (100) Sessional-I 15
15
Sessional-II 15
ESE 75
BP806ET Quality Control and 3 1 - 4 Theory CA 10 10 50
Standardization of (100) Sessional-I 15
15
Herbals (Theory) Sessional-II 15
ESE 75
BP807ET Computer Aided 3 1 - 4 Theory CA 10 10 50
Drug Design (100) Sessional-I 15
15
(Theory) Sessional-II 15
ESE 75
BP808ET Cell and Molecular 3 1 - 4 Theory CA 10 10 50
Biology (Theory) (100) Sessional-I 15
15
Sessional-II 15
ESE 75
BP809ET Cosmetic 3 1 - 4 Theory CA 10 10 50
Science (Theory) (100) Sessional-I 15
15
Sessional-II 15
ESE 75
BP810ET Experimental 3 1 - 4 Theory CA 10 10 50
Pharmacology (Theory) (100) Sessional-I 15
15
Sessional-II 15
ESE 75

BP811ET Advanced Instrumental 3 1 - 4 Theory CA 10 10 50

Techniques (Theory) (100) Sessional-I 15
15
Sessional-II 15
ESE 75

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 17
 50
550
BP812ET Dietary supplements and 3 1 - 4 Theory CA 10 10 50
Nutraceuticals (100)
Sessional-I 15
15
Sessional-II 15

ESE 75

BP813ET Pharmaceutical Product 3 1 - 4

Development
BP813 PW Project Work 12 - - 6 6 150 ESE 150

Total 24 4 - 22
550

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 18
 Internal assessment: Continuous mode
The marks allocated for the Continuous mode of Internal Assessment shall be awarded as per the
scheme given below.

Table XI: Scheme for awarding internal assessment: Continuous mode

Theory
Criteria Maximum
Marks
Attendance(Refer Table–XII) 4 2
Academic activities (Average of any 3 activities e.g. 3 1.5
quiz, assignment, openbook test, field work, group discussion and
seminar)
Student–Teacher interaction 3 1.5
Total 10 5
Practical
Attendance(Refer Table–XII) 2
Based on Practical Records, Regular viva voce, etc. 3
Total 5

Table XII: Guidelines for the allotment of marks for attendance

Percentage of Attendance Theory Practical

95– 100 4 2
90– 94 3 1.5
85– 89 2 1
80– 84 1 0.5
Less than 80 0 0

Table XIII: Assessment criteria and standards for Practice School

Assessment task Marks Rubrics

Assessment : 150 Internal Marks - 25
External Marks-125

Assessment task Marks Rubrics

Internal Assessment 25
Assessment 1: 15 1. Content: 4 marks
Mid- Seminar Presentation 2. Confidence: 4 marks
3. Presentation: 4 marks
4. Language command: 3 mark

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 19
 10 1. Activity-03
2. Attendance-04
3. Student teacher interaction-03
External Assessment 125
Assessment 2: Dissertation 75 1. Objectives of the work done- 15
marks
2. Methodology adopted- 10 marks
3. Skill assessment- 10 marks
4. Results and Discussion- 20 marks
5. Conclusion and outcomes- 20 marks
Assessment 3: Presentation 50 1. Presentation of work- 20 marks
2. Communication skills- 10 marks
3. Subject knowledge- 20 marks

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 20
 Sessional Exams
Two sessional exams shall be conducted for each theory/ practical course as per the schedule
fixed by the college(s). The scheme of the question paper for theory and practical sessional
examinations is given below. The average marks of two sessional exams shall be computed for
internal assessment as per the requirements given in tables–X.
A sessional exam shall be conducted for 30 marks for theory and shall be computed for 15marks.
Similarly, Sessional exam for practical shall be conducted for 40 marks and shall be computed
for10 marks.
Question paper pattern for theory Sessional examinations for subjects having University
examination

I Multiple Choice Questions (MCQs)(10x1) 10x1=10

OR
Objective Type Questions (5x2) 05x2=10
(Answer all questions)
II Long Answer Questions(Answer1outof2) 01x10=10

III Short Answers (Answer2outof3) 02x05 =10

Total 30marks

For subjects having Non University Examination

I Long Answers(Answer1outof2) 1x10=10

II Short Answers(Answer4outof6) 4x5=20

Total 30marks

Question paper pattern for practical sessional examinations

I Synopsis 10
II Experiments
Major experiment 15
Minor experiment 10
III Viva voce 05

Total 40 marks

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 21
 12. Promotion and award of grades
A student shall be declared PASS and eligible for getting a grade in a course of B. Pharm program
if he/she secures at least 50% marks in that particular course including internal assessment. For
example, to be declared as PASS and to get the grade, the student has to secure a minimum of 50
marks for the total of 100 including continuous mode of assessment and end semester theory
examination and has to secure a minimum of 25 marks for the total 50 including internal assessment
and end semester practical examination.

13. Carry forward of marks

In case a student fails to secure the minimum 50% in any Theory or Practical course as specified in
12, then he/she shall reappear for the end semester examination of that course. However, his/ her
marks of the Internal Assessment shall be carried over and he/ she shall be entitled to thegrade
obtained by him/ her on passing.
14. Improvement of internal assessment
A student shall have the opportunity to improve his/ her performance only once in the Sessional
exam component of the internal assessment. The re-conduct of the Sessional exam shall be
completed before the commencement of the next end semester theory examinations.
15. Re-examination of end semester examinations
Reexamination of the end semester examination shall be conducted as per the schedule given in
Table XIII. The exact dates of examinations shall be notified from time to time.
Table XIII: Tentative schedule of end semester examinations

Semester For Regular Candidates For Failed Candidates

I, III, V and VII November/December May/June
II, IV, VI and VIII May/June November/December

Question paper pattern for end semester theory examinations

For 75 marks paper

I Multiple Choice Questions (MCQs)OR 20x1=20OR
Objective Type Questions (10x2) 10x2=20
(Answer all the questions)
II Long Answers (Answer 2outof3) 2x10=20
III Short Answers (Answer7outof9) 7x5=35
Total 75marks
For 50 marks paper
I. Long Answers (Answer2outof3) 2x10=20
II. Short Answers (Answer6outof8) 6x05 =30
Total 50marks
For 35 marks paper
I. Long Answers (Answer1outof2) 1x10=10
II. Short Answers (Answer5outof7) 5x5 =25
Total 35marks
Question paper pattern for end semester practical examinations
I. Synopsis 5
Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 22
 Experiments 25
Viva voce 5
Total 35marks

16. Academic Progression:

No student shall be admitted to any examination unless he/she fulfills the norms given in
6.Academic progression rules are applicable as follows:
A student shall be eligible to carry forward all the courses of I, II, and III semesters till the IV
semester examinations. However, he/ she shall not be eligible to attend the courses of the V
semester until all the courses of I and II semesters are successfully completed.
A student shall be eligible to carry forward all the courses of III, IV, and V semesters till the VI
semester examinations. However, he/she shall not be eligible to attend the courses of VII semester
until all the courses of I, II, III, and IV semesters are successfully completed.
A student shall be eligible to carry forward all the courses of V, VI, and VII semesters till the VIII
semester examinations. However, he/she shall not be eligible to get the course completion
certificate until all the courses of I, II, III, IV, V, and VI semesters are successfully completed.
A student shall be eligible to get his/her CGPA upon successful completion of the courses of I to
VIII semesters with in the stipulated time period as per the norms specified in 26.
A lateral entry student shall be eligible to carry forward all the courses of III, IV, and V semesters
till the VI semester examinations. However, he/she shall not be eligible to attend the courses of VII
semester until all the courses of III and IV semesters are successfully completed.
A lateral entry student shall be eligible to carry forward all the courses of V, VI, and VII semesters
till the VIII semester examinations. However, he/she shall not be eligible to get the course
completion certificate until all the courses of III, IV, V, and VI semesters are successfully
completed.
A lateral entry student shall be eligible to get his/her CGPA upon successful completion of the
courses of III to VIII semesters within the stipulated time period as per the norms specified in 26.
Any student who has given more than 4 chances for successful completion of I/III semester courses
and more than 3 chances for successful completion of II/IV semester courses shall be permitted to
attend V/VII semester classes ONLY during the subsequent academic year as the case may be. In
simpler terms, there shall NOT be any ODD BATCH for any semester.
Note: Grade AB should be considered as failed and treated as one head for deciding academic
progression. Such rules are also applicable for those students who fail to register for examination(s)
of any course in any semester.
17. Grading of performances
17.1 Letter grades and grade points allocations:
Based on the performances, each student shall be awarded a final letter grade at the end of the
semester for each course. The letter grades and their corresponding grade points are given in Table–
XIV.

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 23
 Table XIV: Letter grades and grade points equivalent to Percentage of marks and performances.

Percentage of Letter Grade Grade Point Performance

Marks Obtained
90.00–100 O 10 Outstanding
80.00–89.99 A 9 Excellent
70.00–79.99 B 8 Good
60.00–69.99 C 7 Fair
50.00–59.99 D 6 Average
Lessthan50 F 0 Fail
Absent AB 0 Fail
Table XV: Letter grades and grade points equivalent to percentage of marks and performance
Practice School (BP706PS)

Grading of course : Practice School (BP706P)

Range of Marks Percentage of Letter Grade point Performance
obtained out of marks obtained Grade
150
135-150 90.00-100 O 10 Outstanding
120-134 80.00-89.99 A 9 Excellent
105-119 70.00-79.99 B 8 Good
90-104 60.00-69.99 C 7 Fair
75-89 50.00-59.99 D 6 Average
Less than 75 Less than 50 F 0 Fail
Absent Absent AB 0 Fail
A learner who remains absent for any end-semester examination shall be assigned a letter grade
of AB and a corresponding grade point of zero. He/she should reappear for the said evaluation/
examination in due course.
18. The Semester grade point average (SGPA)
The performance of a student in a semester is indicated by a number called ‘Semester Grade Point
Average’ (SGPA). The SGPA is the weighted average of the grade points obtained in all the courses
by the student during the semester. For example, if a student takes five courses (Theory/Practical)
in a semester with credits C1, C2, C3,C4, and C5 and the student’s grade points in these courses
are G1, G2, G3, G4, and G5, respectively, and then students’ SGPA is equal to:
C1G1 +C2G2+C3G3+C4G4+C5G5
SGPA=
C1 +C2 +C3+C4+C5

The SGPA is calculated to two decimal points. It should be noted that the SGPA for any semester
shall take into consideration the F and ABS grade awarded in that semester. For example, if a learner
has For ABS grade in course 4, the GPA shall then be computed as:

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 24
 C1G1 +C2G2+C3G3+C4*ZERO +C5G5
SGPA=
C1 +C2 +C3+C4+C5

19. Cumulative Grade Point Average (CGPA)

The CGPA is calculated with the SGPA of all the VIII semesters to two decimal points and
is indicated in the final grade report card/final transcript showing the grades of all VIII
semesters and their courses. The CGPA shall reflect the failed status in case of F grade(s),
till the course(s) is/are passed. When the course(s) is/are passed by obtaining a passing grade
on subsequent examination(s) the GPA shall only reflect the new grade and not the fail
grades earned earlier. The CGPA is calculated as:
C1S1+C2S2+C3S3+C4S4+C5S5+C6S6+C7S7+C8S8
CGPA= C1 +C2+C3+C4+C5+C6+C7+C8

Where C1,C2,C3,….is the total number of credits for the semester I, II, III,….and S1, S2, S3,
….is the SGPA of the semester I, II, III,…..

20. Declaration of class

The class shall be awarded on the basis of CGPA as follows:

First Class with = CGPA of.7.50 and above

Distinction
First Class = CGPA of 6.00 to7.49

Second Class = CGPA of 5.00 to 5.99

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 25
 21. Project work
All the students shall undertake a project under the supervision of a teacher and submit a report.
The area of the project shall directly relate to any one of the elective subjects opted by the student
in Semester-VIII. The project shall be carried out in a group not exceeding 5in number. The project
report shall be submitted in triplicate (typed & bound copy not lessthan25pages).
The internal and external examiner appointed by the University shall evaluate the project at the time
of the Practical examinations of other semester(s). Students shall be evaluated in groups for four
hours (i.e., about half an hour for a group of five students).The projects shall be evaluated as per
the criteria given below.

Evaluation of Dissertation Book:

Objective(s)of the work done 15Marks
Methodology adopted 20Marks
Results and Discussions 20Marks
Conclusions and Outcomes 20Marks
Total 75Marks

Evaluation of Presentation:
Presentation of work 25Marks
Communication skills 20Marks
Question and answers skills 30Marks
Total 75Marks

Explanation: The 75 marks assigned to the dissertation book shall be the same for all the students
in a group. However, the 75 marks assigned for the presentation shall be awarded based on the
performance of individual students in the given criteria.

22. Industrial training (Desirable)

Every candidate shall be required to work for at least 150 hours spread over four weeks in a
Pharmaceutical Industry/Hospital. It includes the production unit, Quality Control department,
Quality Assurance department, Analytical laboratory, Chemical manufacturing it, Pharmaceutical
R&D, Hospital (Clinical Pharmacy), Clinical Research Organization, Community Pharmacy, etc.
After the Semester–VI and before the commencement of Semester–VII, and shall submit the
satisfactory report of such work and certificate duly

Signed by the authority of training organization to the head of the institute.

23. Practice School
In the semester-VII, every candidate shall undergo practice school for a period of 150hours evenly
distributed throughout the semester. The student shall opt for any one of the domainsfor
practice school declared by the program committee from time to time.
At the end of the practice school, every student shall submit a printed report (in triplicate) on the
practice school he/she attended (not more than 25 pages). Along with the exams of Semester-VII,
the report submitted by the student, knowledge, and skills acquired by the student throughpractice
school shall be evaluated by the subject experts at the college level and grade point shall be awarded.

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 26
 24. Award of Ranks
Ranks and Medals shall be awarded on the basis of the final CGPA. However, candidates who fail
in one or more courses during the B. Pharm program shall not be eligible for the award of ranks.
Moreover, the candidates should have completed the B. Pharm program in the minimum prescribed
number of years, (four years) for the award of ranks.
25. Award of degree
Candidates who fulfill the requirements mentioned above shall be eligible for the award of degree
during the ensuing convocation.
26. Duration for completion of the program of study
The duration for the completion of the program shall be fixed as double the actual duration of
the program and the students have to pass within the said period, otherwise, they have to get fresh
registration.
27. Re-admission after a break of study
The candidate who seeks re-admission to the program after a break of study has to get approval
from the university by paying a condonation fee.
No condonation is allowed for the candidate who has more than 2 years of break up period and
he/she has to rejoin the program by paying the required fees.
28. Audit Course:
A student may have to register for an audit course in a D. Pharm Part-I or Part-II which could be
an institute requirement or department requirement.
An audit course may include either a regular course required to be done as per structure or required
as a pre-requisite of any higher-level course or b) the programs like practical training, industry
visits, societal activities, etc.
Audit course shall not carry any credits but shall be reflected in Grade Card as "PP”/"NP" depending
upon the satisfactory performance in the semester evaluation as per the course curriculum structure.

29. Facilitation to Students:

29.1 Faculty Advisor:
On joining the institute, a student or a group of students shall be assigned to a faculty advisor who
shall be a mentor for a student throughout his/her tenure in the institute. A student shall be expected
to consult the faculty advisor on any matter relating to his/her academic performance and the
courses he/she may take in various semesters/summer terms. A faculty advisor shall be the person
to whom the parents/guardians should contact for performance- related issues of their ward.
The role of the Faculty Adviser is outlined below:
a) Guide the students about the rules and regulations governing the courses of study for a
particular degree.
b) Advise the students for registering courses as per the curriculum given. For this purpose,
the Faculty Adviser has to discuss with the student his/ her academic performance during the
previous semester and then decide the number and nature of the courses for which He/

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 27
 She can register during the semester as per the curriculum.
c) Approve the registration of the students.
d) Advice students to overload/drop one or more courses/activities based on her/ his academic
performance as per the prescribed rules.
e) At the end of the first semester/year, the Faculty Adviser may even advise a reduced load
program for a poorly performing student.
f) Pay special attention to weak students and carefully monitor the performance of students
recommended for the slow track option.
g) Advice students for Course Adjustment/Dropping of courses during the Semester within the
stipulated time frame given in the Academic calendar.
h) Advice students seeking semester drop either during the ongoing semester or before the
commencement of the semester. FA has to ensure strict compliance of rules and regulations
laid down for this purpose. Recommend the cases to the appropriate authorities for
consideration.
i) Make a revised plan of study for weak/bright students based on their semester-wise
performance.
j) Suggest modalities for course/credit requirements for the students recommended for the
exchange program.
k) Guidance and liaison with parents of students for their performance.
l) To ensure that students are not permitted to reregister for courses, which they have already
passed.
m) Inform students that any academic activity (course/Lab/seminar/project/non-credit
requirement etc.) undergone without proper registration will not be counted towards the
requirements of his/ her degree.

n) Strictly warn students that if she/he fails to register during any semester without prior
approval, his/ her studentship is liable to be canceled.
o) Keep the students updated about the Academic Administration of the University.
29. 2. Helping Weaker Students:
A student with backlog/s should continuously seek help from his/her faculty advisor, Head of the
Department and the Dean of respective schools. Additionally, he/she must also be in constant touch
with his/ her parents/ local guardians for keeping them informed about academic performance. The
university also shall communicate to the parents/ guardians of such students at least once during
each semester regarding his/ her performance in various tests and examinations and also about
his/her attendance. It shall be expected that the parents/guardians to keep constant touch with the
concerned faculty advisor or Head of the Department, and if necessary- the Deanof the respective
school.
30. Discipline and Conduct:
 Every student shall be required to observe discipline and decorous behavior both inside and
outside the campus and not to indulge in any activity, which shall tend to bring down the
prestige of the university.

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 28
  Any act of indiscipline of a student reported to the Dean, Student Development, shall be
discussed in a Disciplinary Action Committee of the institute. The Committee shall enquire
into the charges and recommend suitable punishment if the charges are substantiated.
 If a student while studying in the university is found indulging in anti-national activities
contrary to the provisions of acts and laws enforced by the Government, he/ she shall be liable
to be expelled from the institute without any notice.
 If a student is involved in any kind of ragging, the student shall be liable for strict action as
per provisions in the Maharashtra anti-ragging act.
 If any statement/information supplied by the student in connection with his/ her admission is
found to be false/ incorrect at any time, his/ her admission shall be cancelled and he/she shall
be expelled from the university, and fees paid shall be forfeited.
 If a student is found guilty of malpractice in examinations, then he/she shall be punished as
per the recommendations of the Grievance Redressal Committee (CRC) constituted by the
Board of Examinations.
 Every admitted student shall be issued a photo identification (ID) card which must be retained
by the student while he/she is registered at Sanjay Ghodawat University Kolhapur. The student
must have a valid ID card with him/ her while in the University Campus.
 Any student who alters or intentionally mutilates an ID card or who uses the ID card of another
student or allows his/her ID card to be used by another, a student shall be subjected to
disciplinary action.
 The valid ID card must be presented for identification purposes as and when demanded by
authorities. Any student refusing to provide an ID card shall be Subjected to disciplinary action.
 Students should switch off the Mobiles during the Instructional hours and in the academic
areas of the university Building, Library, Reading room etc. Strict action will be taken if
students do not adhere to this.
 During the conduct of any Tests and Examinations, students must not bring their mobiles. A
student in possession of the mobile whether in use or switched off condition will face
disciplinary action and will be debarred from appearing for the Test/ Examination.
31. Academic Calendar
The academic activities of the institute are regulated by Academic Calendar and are madeavailable
to the student’s/ faculty members and all other concerned in electronic form or hardcopy. It shall
be mandatory for students/faculty to strictly adhere to the academic calendar for the completion of
academic activities.

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 29
 CHAPTER-II:
SYLLABUS

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 30
 Semester VII
Course Name of the course No. of Tutorial Credit Internal ESE
code Hr/wk points CA SE
BP701T Instrumental Methods of Analysis (T) 3 1 4 10 15 75
BP702T Industrial Pharmacy-II(T) 3 1 4 10 15 75
BP703T Pharmacy Practice (T) 3 1 4 10 15 75
BP704T Novel Drug Delivery System (T) 3 1 4 10 15 75
BP705P Instrumental Methods of Analysis(P) 4 2 5 10 35
BP706PS Practice School* 12 6 25 - 125
Total 28 4 24 70 70 460
= 600

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 31
 BP701T. Instrumental Methods of Analysis (Theory)
45 Hours
Course Course Title L T P C Component Exam WT Passing
Code Min. (%)
BP701T Instrumental 3 1 - 4 Theory CA 10 10
Methods of (100 marks) Sessional-1 15
15 50
Analysis – Sessional-2 15
(Theory) ESE 75

Scope:
This subject deals with the application of instrumental methods in qualitative and quantitative analysis of
drugs. This subject is designed to impart a fundamental knowledge on the principles and instrumentation
of spectroscopic and chromatographic technique. This also emphasizes on theoretical and practical
knowledge on modern analytical instruments that are used for drug testing.

Objectives:
Upon completion of this course, the student should be able to
CLO1. State1 the definition and meaning and classes of different terminologies used in different
instrumental method of analysis.
CLO2. Illustrate4 the principle, theory and methodology employed for the characterization and analysis of
drugs.
CLO3. Illustrate 4the principle, procedure, applications used in various spectroscopic methods
CLO4. Evaluate5 the drugs by quantitative & qualitative analysis using various analytical techniques.
CLO5. Interpret5 merit demerit and differences in the selected instrumental method of analysis.

Course Content
UNIT Description Hours
I UV Visible spectroscopy 10
Electronic transitions, chromophores, auxochromes, spectral shifts,
solvent effect on absorption spectra, Beer and Lambert’s law,
Derivation and deviations.
Instrumentation - Sources of radiation, wavelength selectors, sample
cells, detectors- Photo tube, Photomultiplier tube, Photo voltaic cell,
Silicon Photodiode.
Applications - Spectrophotometric titrations, Single component and
multi component analysis
Fluorimetry
Theory, Concepts of singlet, doublet and triplet electronic states, internal
and external Conversions, factors affecting fluorescence, quenching,
instrumentation and applications.

II IR spectroscopy 10
Introduction, fundamental modes of vibrations in poly atomic

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 32
 molecules, sample handling, factors affecting vibrations.
Instrumentation - Sources of radiation, wavelength selectors, detectors
Golay cell, Bolometer, Thermocouple, Thermister, Pyroelectric detector
and applications
Flame Photometry- Principle, interferences, instrumentation and
applications.
Atomic absorption spectroscopy-Principle, interferences,
instrumentation and applications
Nepheloturbidometry- Principle, instrumentation and applications.

III Introduction to chromatography 10

Adsorption and partition column chromatography- Methodology,
advantages, disadvantages and applications.
Thin layer chromatography- Introduction, Principle, Methodology, Rf
values, advantages, disadvantages and applications.
Paper chromatography-Introduction, methodology, development
techniques, advantages, disadvantages and applications
Electrophoresis– Introduction, factors affecting electrophoretic
mobility, Techniques of paper, gel, capillary electrophoresis,
applications.

IV Gas chromatography 08
Introduction, theory, instrumentation, derivatization, temperature
programming, Advantages, disadvantages and applications.
High performance liquid chromatography (HPLC)-Introduction,
theory, Instrumentation, advantages and applications.
V Ion exchange chromatography 07
Introduction, classification, ion exchange resins, properties, mechanism
of ion exchange process, factors affecting ion exchange, methodology
and applications
Gel chromatography- Introduction, theory, instrumentation and
applications Affinity chromatography- Introduction, theory,
instrumentation and applications.

Recommended Books (Latest Editions)

1. Instrumental Methods of Chemical Analysis by B.K Sharma
2. Organic spectroscopy by Y.R Sharma
3. Text book of Pharmaceutical Analysis by Kenneth A. Connors
4. Vogel’s Text book of Quantitative Chemical Analysis by A.I. Vogel
5. Practical Pharmaceutical Chemistry by A.H. Beckett and J.B. Stenlake
6. Organic Chemistry by I. L. Finar
7. Organic spectroscopy by William Kemp
8. Quantitative Analysis of Drugs by D. C. Garrett
9. Quantitative Analysis of Drugs in Pharmaceutical Formulations by P. D. Sethi
10. Spectrophotometric identification of Organic Compounds by Silverstein R.

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 33
 BP705P. Instrumental Methods of Analysis (Practical)
4 Hours/Week
Course Course Title L T P C Component Exam WT Passing
Code Min. (%)
BP705P Instrumental - - 4 2 Practical CA 05 05
Methods of (50 marks) Sessional-1 10
10 50
Analysis Sessional-2 10
ESE 35

Scope:
This course includes quantitative and qualitative analysis of drugs using various analytical techniques.
This also understand the chromatographic separation and analysis of drug. This course include interaction
of matter with electromagnetic radiations and its applications in drug analysis.

Objectives:
Upon completion of the course students shall be able to
CLO1.State1 the principles involved in various analytical techniques and instruments.
CLO2.Determine5 of drugs/ions by using UV, Visible spectroscopy, fluorimetry, and flame photometry
CLO3.Estimate5 the organic compounds/amino acids/plant pigments by using various chromatographic,
electrophoretic and spectroscopic techniques.
CLO4.Analyze4 the various organic compounds using nephelo turbidometry.
CLO5.Demonstrate3instrumentation, working and application of HPLC and Gas chromatography.

No Description
1 Determination of absorption maxima and effect of solvents on absorption maxima of
organic compounds
2 Estimation of dextrose by colorimetry
3 Estimation of sulfanilamide by colorimetry
4 Simultaneous estimation of ibuprofen and paracetamol by UV spectroscopy
5 Assay of paracetamol by UV- Spectrophotometry
6 Estimation of quinine sulfate by fluorimetry
7 Study of quenching of fluorescence
8 Determination of sodium by flame photometry
9 Determination of potassium by flame photometry
10 Determination of chlorides and sulphates by nephelo turbidometry
11 Separation of amino acids by paper chromatography
12 Separation of sugars by thin layer chromatography
13 Separation of plant pigments by column chromatography
14 Demonstration experiment on HPLC
15 Demonstration experiment on Gas Chromatography

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 34
 Recommended Books: (Latest Editions)
1. Instrumental Methods of Chemical Analysis by B.K Sharma
2. Organic spectroscopy by Y.R Sharma
3. Text book of Pharmaceutical Analysis by Kenneth A. Connors
4. Vogel’s Text book of Quantitative Chemical Analysis by A.I. Vogel
5. Practical Pharmaceutical Chemistry by A.H. Beckett and J.B. Stenlake
6. Organic Chemistry by I. L. Finar
7. Organic spectroscopy by William Kemp
8. Quantitative Analysis of Drugs by D. C. Garrett
9. Quantitative Analysis of Drugs in Pharmaceutical Formulations by P. D. Sethi
10. Spectrophotometric identification of Organic Compounds by Silverstein

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 35
 BP702T. INDUSTRIAL PHARMACY-II (Theory)
45 Hours
Course Course Title L T P C Component Exam WT Passing
Code Min. (%)
BP702T Industrial 3 1 - 4 Theory CA 10 10
Pharmacy-II (100 Marks) Sessional-1 15
15 50
(Theory) Sessional-2 15
ESE 75

Scope:
This course is designed to impart fundamental knowledge on pharmaceutical product development and
translation from laboratory to market.

Objectives:
Upon completion of this course the student should be able to:
CLO1. State1 the meaning of various terminologies involved in pilot plant scale up, technology transfer,
regulatory affairs and quality management.
CLO2. Illustrate4 pilot plant scale up techniques, SUPAC guidelines and various quality management
systems in pharmacy
CLO3. Outline3 various aspects of drug approvals and technology transfer involved from R & D to
production.
CLO4. Describe2 the history, constitution, roles, responsibilities, and requirements for drug approval of
regulatory affairs department
CLO5.Illustrate4 the regulatory requirement, approval procedures and accreditations for pharmaceuticals.

Course Content:
UNIT Description Hours
I Pilot plant scale up techniques: 10
General considerations - including significance of personnel requirements, space
requirements, raw materials, Pilot plant scale up considerations for solids, liquid orals,
semi solids and relevant documentation, SUPAC guidelines, Introduction to platform
technology.

II Technology development and transfer 10

WHO guidelines for Technology Transfer (TT):
Terminology, Technology transfer protocol, Quality risk management, Transfer from
R& D to production (Process, packaging and cleaning), Granularity of TT Process
(API, excipients, finished products, packaging materials) Documentation, Premises
and equipments, qualification and validation, quality control, analytical method
transfer, Approved regulatory bodies and agencies, Commercialization - practical
aspects and problems (case studies), TT agencies in India - APCTD, NRDC, TIFAC,
BCIL, TBSE / SIDBI; TT related documentation - confidentiality agreement, licensing,
MoUs, legal issues.

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 36
 III Regulatory affairs 10
Introduction, Historical overview of Regulatory Affairs, Regulatory authorities, Role
of Regulatory affairs department, Responsibility of Regulatory Affairs Professionals.
Regulatory requirements for drug approval
Drug Development Teams, Non-Clinical Drug Development, Pharmacology, Drug
Metabolism and Toxicology, General considerations of Investigational New Drug
(IND) Application, Investigator’s Brochure (IB) and New Drug Application (NDA),
Clinical research / BE studies, Clinical Research Protocols, Biostatistics in
Pharmaceutical Product Development, Data Presentation for FDA Submissions,
Management of Clinical Studies.

IV Quality management systems 08

Quality management & Certifications: Concept of Quality, Total Quality Management,
Quality by Design (QbD), Six Sigma concept, Out of Specifications (OOS), Change
control, Introduction to ICH guidelines for QbD (Q8 to Q12) Introduction to ISO 9000
series of quality systems standards, ISO 14000, NABL, GLP.

V Indian Regulatory Requirements 07

Central Drug Standard Control Organization (CDSCO) and State LicensingAuthority:
Organization, Responsibilities, Certificate of Pharmaceutical Product (COPP),
Regulatory requirements and approval procedures for New Drugs.

Recommended Books: (Latest Editions)

1. Regulatory Affairs from Wikipedia, the free encyclopedia modified on 7th April available
at http,//en.wikipedia.org/wiki/Regulatory_ Affairs.
2. International Regulatory Affairs Updates, 2005. available at http://www.iraup.com/about.php
3. Douglas J Pisano and David S. Mantus. Text book of FDA Regulatory Affairs A Guide for
Prescription Drugs, Medical Devices, and Biologics’ Second Edition.
4. Regulatory Affairs brought by learning plus, inc. available at http.//www.cgmp.com/ra.htm.

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 37
 BP 703T. PHARMACY PRACTICE (Theory)
45Hours
Course Course Title L T P C Component Exam WT Passing
Code Min. (%)
BP703T Pharmacy Practice 3 1 - 4 Theory CA 10 10
(Theory) (100marks) Sessional-1 15
15 50
Sessional-2 15
ESE 75

Scope:
In the changing scenario of pharmacy practice in India, for successful practice of Hospital Pharmacy, the
students are required to learn various skills like drug distribution, drug information, and therapeutic drug
monitoring for improved patient care. In community pharmacy, students will be learning various skills such
as dispensing of drugs, responding to minor ailments by providing suitable safe medication, patient
counseling for improved patient care in the community set up.

Objectives:
Upon completion of the course, students shall be able to
CLO1.State1 the meaning of various terminologies of pharmacy practice
CLO2.Illustrate4 the organizational structure, classification, functions and policies (including
formularies) of hospitals and pharmacy organizations.
CLO3.Describe2 the personnel and their responsibilities in hospital and pharmacy organizations.
CLO4.Illustrate4 the distribution, use and monitoring of drug, clinical interpretations, Patient counseling
and pharmacy management.
CLO5.Explain2 the importance of drug information services, education and training programmes in
hospitals and the role of pharmacist therein.
Course Content:
UNIT Description Hours
I a) Hospital and it’s organization 10
Definition, Classification of hospital- Primary, Secondary and Tertiary hospitals,
Classification based on clinical and non- clinical basis, Organization Structure of a
Hospital and Medical staffs involved in the hospital and their functions.
b) Hospital pharmacy and its organization
Definition, functions of hospital pharmacy, Organization structure, Location, Layout
and staff requirements, and Responsibilities and functions of hospital pharmacists.
c) Adverse drug reaction
Classifications - Excessive pharmacological effects, secondary pharmacological
effects, idiosyncrasy, allergic drug reactions, genetically determined toxicity, toxicity
following sudden withdrawal of drugs, Drug interaction- beneficial interactions,
adverse interactions, and pharmacokinetic drug interactions, Methods for detecting
drug interactions, spontaneous case reports and record linkage studies, and Adverse
drug reaction reporting and management.
d) Community Pharmacy
Organization and structure of retail and wholesale drug store, types and design, Legal
requirements for establishment and maintenance of a drug store, Dispensing of
proprietary products, maintenance of records of retail and Wholesale drug store.

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 38
 II a) Drug distribution system in a hospitals 10
Dispensing of drugs to inpatients, types of drug distribution systems, charging policy
and labelling, Dispensing of drugs to ambulatory patients, and Dispensing of
controlled drugs
b) Hospital formulary
Definition, contents of hospital formulary, Differentiation of hospital formulary and
Drug list, preparation and revision, and addition and deletion of drug from Hospital
formulary
c) Therapeutic drug monitoring
Need for Therapeutic Drug Monitoring, Factors to be considered during the
Therapeutic Drug Monitoring, and Indian scenario for Therapeutic Drug Monitoring.
d) Medication adherence
Causes of medication non-adherence, pharmacist role in the medication adherence,
and monitoring of patient medication adherence.
e) Patient medication history interview
Need for the patient medication history interview, medication interview forms.
f) Community pharmacy management
Financial, materials, staff, and infrastructure requirements.

III a) Pharmacy and therapeutic committee 10

Organization, functions, Policies of the pharmacy and therapeutic committee in
including drugs into formulary, inpatient and outpatient prescription, automatic stop
order, and emergency drug list preparation.
b) Drug information services
Drug and Poison information Centre, Sources of drug information, computerized
services, and storage and retrieval of information.
c) Patient counseling
Definition of patient counseling; steps involved in patient counseling, and Special
cases that require the pharmacist.
d) Education and training program in the hospital
Role of pharmacist in the education and training program, Internal and external training
program, Services to the nursing homes/clinics, Code of ethics for community
pharmacy, and Role of pharmacist in the interdepartmental communication and
community health education.
e) Prescribed medication order and communication skills
Prescribed medication order- interpretation and legal requirements, and
Communication skills- communication with prescribers and patients.

IV a) Budget preparation and implementation 08

Budget preparation and implementation
b) Clinical Pharmacy
Introduction to Clinical Pharmacy, Concept of clinical pharmacy, functions and
responsibilities of clinical pharmacist, Drug therapy monitoring - medication chart
review, clinical review, pharmacist intervention, Ward round participation,
Medication history and Pharmaceutical care. Dosing pattern and drug therapy based
on Pharmacokinetic & disease pattern.
c) Over the counter (OTC) sales

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 39
 Introduction and sale of over the counter, and rational use of common over the counter
medications.

V a) Drug store management and inventory control 07

Organisation of drug store, types of materials stocked and storage conditions,
Purchase and inventory control: principles, purchase procedure, purchase order,
procurement and stocking, Economic order quantity, Reorder quantity level, and
Methods used for the analysis of the drug expenditure.
b) Investigational use of drugs
Description, principles involved, classification, control, identification, role of
hospital pharmacist, advisory committee.
c) Interpretation of Clinical Laboratory Tests
Blood chemistry, hematology, and urinalysis

Recommended Books (Latest Edition):

1. Merchant S.H. and Dr. J.S.Quadry. A textbook of hospital pharmacy, 4th ed. Ahmadabad: B.S.
Shah Prakakshan; 2001.
2. Parthasarathi G, Karin Nyfort-Hansen, Milap C Nahata. A textbook of Clinical Pharmacy
Practice- essential concepts and skills, 1st ed. Chennai: Orient Longman Private Limited; 2004.
3. William E. Hassan. Hospital pharmacy, 5th ed. Philadelphia: Lea & Febiger;1986.
4. Tipnis Bajaj. Hospital Pharmacy, 1st ed. Maharashtra: Career Publications; 2008.
5. Scott LT. Basic skills in interpreting laboratory data, 4thed. American Society of Health System
Pharmacists Inc; 2009.
6. Parmar N.S. Health Education and Community Pharmacy, 18th ed. India: CBS Publishers &
Distributers; 2008.

Journals:
1. Therapeutic drug monitoring. ISSN: 0163-4356
2. Journal of pharmacy practice. ISSN : 0974-8326
3. American journal of health system pharmacy. ISSN: 1535-2900 (online)
4. Pharmacy times (Monthly magazine)

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 40
 BP704T. Novel Drug Delivery system (Theory)
45 Hours
Course Course Title L T P C Component Exam WT Passing
Code Min. (%)
BP704T Novel Drug 3 - 1 4 Theory CA 10 10
Delivery (100 Marks)
system 50
Sessional-1 15
15
Sessional-2 15
(Theory)
ESE 75

Scope:
This subject is designed to impart basic knowledge on the area of novel drug delivery.

Objectives:
Upon completion of the course, the student shall be able to
CLO1. State1the meaning of various NDDS.
CLO2. Discuss2 the fundamentals, polymers and its applications used in the design of controlled drug
delivery systems.
CLO3. Classify3the polymers and different drug delivery systems
CLO4. Summarize5the formulation, evaluation, advantages, disadvantages and applications of various
DDS.
CLO5. Illustrate4the principles and fundamentals of drug targeting, ocular drug delivery and IUDDS.

Course content:

UNIT Description Hours

I. Controlled drug delivery systems: 10
Introduction, terminology/definitions and rationale, advantages, disadvantages,
selection of drug candidates. Approaches to design controlled release formulations
based on diffusion, dissolution and ion exchange principles. Physicochemical and
biological properties of drugs relevant to controlled release formulations Polymers:
Introduction, classification, properties, advantages and application of polymers in
formulation of controlled release drug delivery system. Introduction to large scale
manufacturing of CDDS with example.

II. Microencapsulation: 10
Definition, advantages and disadvantages, microspheres/microcapsules,
microparticles, methods of microencapsulation, applications.
Mucosal Drug Delivery system: Introduction, Principles of bioadhesion/
mucoadhesion, concepts, advantages and disadvantages, transmucosal permeability
and formulation considerations of buccal delivery systems
Implantable Drug Delivery Systems: Introduction, advantages and disadvantages,
concept of implants and osmotic pump.
Introduction to large scale manufacturing of IDDS with example.

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 41
 III. Transdermal drug delivery systems. 10
Concepts and approaches advantages and disadvantages, introduction to liposomes,
niosomes, nanoparticles, monoclonal antibodies and their applications
Gastroretentive drug delivery systems: Introduction, advantages, disadvantages,
approaches for GRDDS – Floating, high density systems, inflatable and
gastroadhesive systems and their applications Introduction to large scale
manufacturing of GRDDS with example.
Nasopulmonary drug delivery system: Introduction to Nasal and Pulmonary routes
of drug delivery, Formulation of Inhalers (dry powder and metered dose), nasal sprays,
nebulizers

IV. Target drug delivery system 08

Concepts and approaches advantages and disadvantages, introduction to liposomes,
niosomes, nanoparticles, monoclonal antibodies and their applications. Introduction to
large scale manufacturing of TDDS with example.

V. Ocular Drug Delivery Systems: 07

Introduction, intra ocular barriers and methods to overcome –Preliminary study,
ocular formulations and ocuserts.
Intrauterine Drug Delivery Systems:
Introduction, advantages and disadvantages, development of intra uterine devices
(IUDs) and applications. Introduction to large scale manufacturing of ODDS with
example.

Recommended Books: (Latest Editions)

1. Y W. Chien, Novel Drug Delivery Systems, 2nd edition, revised and expanded, Marcel Dekker, Inc.,
New York, 1992.
2. Robinson, J. R., Lee V. H. L, Controlled Drug Delivery Systems, Marcel Dekker, Inc., New York,
1992.
3. Encyclopedia of Controlled Delivery. Edith Mathiowitz, Published by Wiley Interscience Publication,
John Wiley and Sons, Inc, New York. Chichester/Weinheim
4. N.K. Jain, Controlled and Novel Drug Delivery, CBS Publishers &Distributors, New Delhi, First
edition 1997 (reprint in 2001).
5. S.P. Vyas and R.K. Khar, Controlled Drug Delivery -concepts and advances, Vallabh Prakashan, New
Delhi, First edition 2002.
Journals
1. Indian Journal of Pharmaceutical Sciences (IPA)
2. Indian Drugs (IDMA)
3. Journal of Controlled Release (Elsevier Sciences)
4. Drug Development and Industrial Pharmacy (Marcel & Decker)
5. International Journal of Pharmaceutics (Elsevier Sciences)

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 42
 BP706PS. PRACTICE SCHOOL
Course Objectives
Each student is trained to develop their:
1. Problem solving, critical thinking and innovation abilities
2. Curiosity to learn
3. Teamwork and Responsibility
4. Professional and Ethical behavior
5. Attitude and Discipline

Course structure

Every candidate shall undergo practice school for a period of 150 hours evenly distributed throughout the
semester. The student shall come in any one of the domains enclosed in this course structure. At the end
of the practice school, every student shall submit a printed report (in triplicate) on the practice school he/she
attended (not more than 25 pages). Along with the exams of semester VII, the report submitted by the student,
knowledge and skills acquired by the student through practice school shall be evaluated by the subject
experts at college level and grade point shall be awarded. There are total 6 credit points for this course.

Examination Pattern

The total marks allotted for the course of Practice School is 150 Marks. Out of this 25 marks are for internal
assessment based on the Continues mode. The remaining 125 Marks is for End Semester examination.

Domains

Sr. Practice School (Domain) Department

No
1. Practice School 1: Formulation Development (product Pharmaceutics
manufacturing and evaluation)
2. Practice school 2 – Quality control and Quality assurance of Quality Assurance
Pharmaceuticals
3. Practice School 3 – Herbal Technology Pharmacognosy
4. Practice School 4 – Drug design and Process chemistry Pharmaceutical Chemistry
5. Practice School 5 – Pharmacovigilance Pharmacology

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 43
 Practice School 1: Formulation Development (product manufacturing and evaluation)

Course Learning Outcomes:

CLO 1: Discuss2 about the basic and advanced literature review amalgated with SOP and GMP guidelines

CLO 2: Select5 the modern tools, sophisticated instruments for drug testing, discovery & development
process.

CLO 3:Develop6 the skills that would inculcate entrepreneurship and industrial orientation.

CLO 4: Evaluate5 assigned modules individually as a team to create an innovative ideas related to health
care system.

CLO 5: Appraise5 a sense of understanding to undertake a project, its financial implication and necessity
for continuous learning.

CLO 6:Design6 and evaluate NDDS

CLO 7:Create6 preformulation, validation of product with the view of tech transfer.

Course Contents

Module –I Introduction (25Hrs)

• Pharma industry

• General aspects to be considered on formulation selection

• SOP handling

• Steps in Pharmaceutical Manufacturing

• GMP

Module –II Industrial Aspects of Tablet Technology (25Hrs)

• Literature review for tablet manufacturing

• Preformulation

• Providing Control number and documentation

• Trial batch and optimization

• Lab Validation

• Scale up validation

• Tech transfer

• Regulatory clearance in detail

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 44
 Module –III Instruments handling (50Hrs)

• Tablet compression, coating

• Dissolution and disintegration apparatus

• Orbitary shaker

• High speed homogenizer

• Stability chamber

Module –IV Novel Drug Delivery systems (50Hrs)

• Control/sustain drug delivery system

• Liposomes

• Fast dissolving/disintegrating drug delivery

• Nano-emulsions

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 45
 Practice school 2 – Quality control and Quality assurance of Pharmaceuticals
Course Learning Outcomes:

CLO 1: Discuss2 about the basic and advanced literature review amalgated with SOP and GMP guidelines

CLO 2: Select5 the modern tools, sophisticated instruments for drug testing, discovery & development
process.

CLO 3:Develop6 the skills that would inculcate entrepreneurship and industrial orientation.

CLO 4: Evaluate5 assigned modules individually as a team to create an innovative ideas related to health
care system.

CLO 5: Appraise5 a sense of understanding to undertake a project, its financial implication and necessity
for continuous learning.

CLO 6: Understand2 significance and concept of advanced instrumentation & become proficient in
advanced instruments.

CLO7: Interpret2 the quality assurance processes in pharma industry and documentation process.

Course Contents

Module – I Introduction (25 Hrs)

• Introduction to analytical techniques

• Importance and preparation of SOPs

• Guidelines for GLP as per the regulatory aspects

• Introduction to GC/MS and LC/MS

Module – II Industrial Aspects of QA & QC (25 Hrs)

• Calibration of glasswares

• Calibration of analytical instruments

• Preparation of analytical reagents and working standards

• Monograph analysis of Pharmaceuticals

• Analytical method developments and validation

Module – III Instruments handling (75 Hrs)

• Digital balance

• UV Spectrophotometer

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 46
 • HPLC

• FTIR

• Dissolution and disintegration apparatus

• Friability and hardness tester

Module – IV Documentation (25 Hrs)

• Preparation of Reports

• GLP, GDP

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 47
 Practice School 3 – Herbal Technology
Course Learning Outcomes:

CLO 1: Discuss2 about the basic and advanced literature review amalgated with SOP and GMP guidelines

CLO 2: Select5 the modern tools, sophisticated instruments for drug testing, discovery & development
process.

CLO 3:Develop6 the skills that would inculcate entrepreneurship and industrial orientation.

CLO 4: Evaluate5 assigned modules individually as a team to create an innovative ideas related to health
care system.

CLO 5: Appraise5 a sense of understanding to undertake a project, its financial implication and necessity
for continuous learning.

CLO 6: Develop6 advance extraction, isolation and identification techniques for herbal drugs by using
standard guidelines of WHO

CLO7: Formulate6 and evaluate herbal products by using AYUSH guidelines

Course Contents

Module – I Identification and Extraction of Herbs (15 Hrs)

 WHO guidelines for standardization of plant material

 AYUSH guidelines for herbal products

 Advanced extraction techniques

 Introduction to phytochemical markers

Module – II Isolation techniques (60 Hrs)

 General and advanced Isolation techniques

 Chromatographic techniques

 Column chromatography, HPTLC, HPLC.

 Rotary evaporator

 Preparative chromatography

Module – III Quantitative evaluation of Phytoconstituents (10 Hrs)

 Assay for phenols, alkaloids, glycosides and tannins.

Module – IV Formulation and evaluation of herbal product (65 Hrs)

 Preparation and evaluation of herbal formulations Tablet, Syrup, Asava, Granules etc.,

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 48
 Practice School 4 – Drug design and Process chemistry
Course Learning Outcomes:

CLO 1: Discuss2 about the basic and advanced literature review amalgated with SOP and GMP guidelines

CLO 2: Select5 the modern tools, sophisticated instruments for drug testing, discovery & development
process.

CLO 3:Develop6 the skills that would inculcate entrepreneurship and industrial orientation.

CLO 4: Evaluate5 assigned modules individually as a team to create an innovative ideas related to health
care system.

CLO 5: Appraise5 a sense of understanding to undertake a project, its financial implication and necessity
for continuous learning.

CLO 6: Discuss2 various tools available for in-silico studies

CLO7:Design6and Development of medicinal agents possessing specific pharmacological action

Course Contents

Module – I Basic Experimental Techniques in chemistry (30 Hrs)

 Introduction to hazardous chemicals and MSD

 Handling of hazardous chemicals and safety requirements

 Purification of organic solvents

 Crystallization techniques for purification of chemical compounds

Module – II Synthetic Chemistry (70 Hrs)

 Microwave assisted organic Synthesis

 Development of thin layer chromatography using silica gel

 Column chromatographic techniques

Module – III In-silico techniques (10 Hrs)

 Protein crystallographic data and protein data bank

 Protein modelling techniques

Module – IV New drug design techniques (40 Hrs)

 Introduction to software’s

 Docking study, QSAR and ADMET prediction and interpretation

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 49
 Practice School 5 – Pharmacovigilance
Course Learning Outcomes:

CLO 1: Discuss2 about the basic and advanced literature review amalgated with SOP and GMP guidelines

CLO 2: Select5 the modern tools, sophisticated instruments for drug testing, discovery & development
process.

CLO 3:Develop6 the skills that would inculcate entrepreneurship and industrial orientation.

CLO 4: Evaluate5 assigned modules individually as a team to create an innovative ideas related to health
care system.

CLO 5: Appraise5 a sense of understanding to undertake a project, its financial implication and necessity
for continuous learning.

CLO 6: Create6 questionnaires in relation to case studies of diseases.

CLO7: To understand2 adverse events reporting system in pharmacovigilance.

Course Contents

Module –I Introduction of Pharmacovigilance (25Hrs)

 Overview of Pharmacovigilance

 Standard Terms and Terminology in Pharmacovigilance

 Vaccine safety

Module –II Medical Evaluation of Adverse Events in Pharmacovigilance (50Hrs)

 Adverse Event Reporting System and Form

 Diagnosis and Managements of ADRs

 Medical Evaluation of AE

Module –III Case Processing (25Hrs)

 Global Perspective of Pharmacovigilance

 Single Case Processing

 Case Narrative Writing

Module –IV Pharmacovigilance Reporting and Risk assessment & Evaluation (50Hrs)

 Quality System in PV

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 50
  Expedited Reporting Criteria

 PSUR & PBRER

 PV Database and Signal detection

 Risk Assessment & Managements

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 51
 Semester VIII
Course Name of the course No. Tutorial Credit Internal ESE
Code of points CA SE
hour
s
BP801T Biostatistics and Research Methodology 3 1 4 10 15 75
BP802T Social and Preventive Pharmacy 3 1 4 10 15 75
BP803ET Pharma Marketing Management
BP804ET Pharmaceutical Regulatory Science
BP805ET Pharmacovigilance
BP806ET Quality Control and Standardization of
Herbals 3+3 4+4= 20 30 150
BP807ET Computer Aided Drug Design = 1+1= 8
BP808ET Cell and Molecular Biology 6 2
BP809ET Cosmetic Science
BP810ET Experimental Pharmacology
BP811ET Advanced Instrumentation Techniques
BP812ET Dietary Supplements and Nutraceuticals
BP813ET Pharmaceutical Product Development
BP813PW Project Work 12 - 6 - - 150
Total 24 4 22 40 60 450
550

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 52
 BP801T.Biostatistics and Research Methodology (Theory)

45Hours
Course Course Title L T P C Component Exam WT Passing
Code Min. (%)
BP801T Biostatistics 3 1 - 4 Theory(1 CA 10 10
and Research 00Marks) Sessional-1 15
Methodology 15 50
Sessional-2 15
(Theory) ESE 75

Scope:
To understand the applications of Biostatics in Pharmacy. This subject deals with descriptive statistics,
Graphics, Correlation, Regression, logistic regression Probability theory, Sampling technique, Parametric
tests, Non Parametric tests, ANOVA, Introduction to Design of Experiments, Phases of Clinical trials and
Observational and Experimental studies, SPSS, R and MINITAB statistical software’s, analyzing the
statistical data using Excel.
Objectives:
Upon completion of the course, the student shall be able to
CLO1.State1 the meaning of different statistical terms.
CLO2.Discuss2 the fundamentals of statistical techniques
CLO3.Evaluate5 experimental data using various statistical techniques.
CLO4.Illustrate4 the research, graphical presentation, research methodology and experimental designs in
pharmacy.
CLO5.Employ3 statistical software’s in industrial and clinical trial problems.
Course Content:
UNIT Description Hours
I Introduction: Statistics, Biostatistics, Frequency distribution 10
Measures of central tendency: Mean, Median, Mode- Pharmaceutical examples
Measures of dispersion: Dispersion, Range, standard deviation,
Pharmaceutical problems
Correlation: Definition, Karl Pearson’s coefficient of correlation,
Multiple correlation - Pharmaceuticals examples

II Regression: Curve fitting by the method of least squares, fitting the lines 10
y= a + bx and x = a + by, Multiple regression, standard error of regression, Logistical
regression, Pharmaceutical Examples
Probability: Definition of probability, Binomial distribution, Normal distribution,
Poisson’s distribution, properties - problems Sample, Population, large sample, small
sample, Null hypothesis, alternative hypothesis, sampling, essence of sampling, types
of sampling, Error-I type, Error-II type, Standard error of mean (SEM) -
Pharmaceutical examples
Parametric test: t-test (Sample, Pooled or Unpaired and Paired), ANOVA, (One way
and Two way), Least Significance difference. Applications of statistical tests in
pharmacy.

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 53
 III Non Parametric tests: Wilcoxon Rank Sum Test, Mann-Whitney U test, 10
Kruskal-Wallis test, Friedman Test
Introduction to Research: Need for research, Need for design of Experiments,
Experiential Design Technique, plagiarism
Graphs: Histogram, Pie Chart, Cubic Graph, response surface plot,
Counter Plot graph
Designing the methodology: Sample size determination and Power of a study,
Report writing and presentation of data, Protocol, Cohorts studies, Observational
studies, Experimental studies, Designing clinical trial, various phases.

IV Blocking and confounding system for Two-level factorials 8

Regression modeling: Hypothesis testing in Simple and Multiple regression
models
Introduction to Practical components of Industrial and Clinical Trials
Problems: Statistical Analysis Using Excel, SPSS, MINITAB ®, DESIGN OF
EXPERIMENTS, R - Online Statistical Software’s with its applications to
Industrial and Clinical trial approach.

V Design and Analysis of experiments: 7

Factorial Design: Definition, 2 2, 2 3 design. Advantage of factorial design
Response Surface methodology: Central composite design, Historical design,
Screening and Optimization Techniques

Recommended Books (Latest Editions)

1. Pharmaceutical statistics- Practical and clinical applications, Sanford Bolton, publisher Marcel
Dekker Inc. New York.
2. Fundamental of Statistics – Himalaya Publishing House- S.C.Guptha
3. Design and Analysis of Experiments –PHI Learning Private Limited, R. Pannerselvam,
4. Design and Analysis of Experiments Wiley Students Edition, Douglas and C.Montgomery

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 54
 BP802T.Social and Preventive Pharmacy (Theory)
45 Hours
Course Course Title L T P C Component Exam WT Passing
Code Min. (%)
BP802T Social and 3 1 - 4 Theory CA 10 10
Preventive (100Marks) Sessional-1 15
Pharmacy 15 50
Sessional-2 15
(Theory) ESE 75
Scope:
The purpose of this course is to introduce to students a number of health issues and their
challenges.
Objectives:
Upon completion of the course, the student shall be able to
CLO1.State1 the meaning of various terminologies involved in social and Preventive pharmacy.
CLO2.Explain2 the concept of health education, nutrition and disease along with factors
affecting them.
CLO3.Illustrate4 the measures of prevention and control for communicable and non-
communicable diseases.
CLO4.Describe2 the aspects of various national and WHO health and welfare Programme.
CLO5. Illustrate5 the impact of socio-cultural factors and urbanization on health.

Course Content
UNIT Description Hrs
I Concept of health and disease: Terminologies used related to health and 10
disease. Definition, concepts and evaluation of Public health. Understanding the
concept of prevention and control of disease, social causes of diseases and social
problems of the sick.
Social and health education: Food in relation to nutrition and health, Balanced diet,
Nutritional deficiencies, Vitamin deficiencies, Malnutrition and its prevention.
Sociology and health: Socio cultural factors related to health and disease, Impact of
urbanization on health and disease, Poverty and health
Hygiene and health: personal hygiene and health care; avoidable habits

II Preventive medicine: General principles of prevention and control of diseases 10

such as cholera, SARS, Ebola virus, influenza, acute respiratory infections, malaria,
chicken, guinea, dengue, lymphatic filariasis, pneumonia, hypertension, diabetes
mellitus, cancer, metabolic syndrome drug addiction-drug substance abuse.

III National health programs, its objectives, functioning and outcome of the
following: 10

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 55
 HIV AND AIDS control Programme, TB, Integrated disease surveillance program
(IDSP), National leprosy control programme, National mental health program, National
programme for prevention and control of deafness, Universal Immunization
programme, National programme for control of blindness, Pulse polio programme.

IV National health intervention programme for mother and child, National 08

family welfare programme, National tobacco control programme, National Malaria
Prevention Program, National programme for the health care for the elderly, Social
health programme; role of WHO in Indian national program

V Community services in rural, urban and school health: 07

Functions of PHC, Improvement in rural sanitation, national urban health mission,
Health promotion and education in school.

Recommended Books (Latest edition):

1. Short Textbook of Preventive and Social Medicine, Prabhakara GN, 2 nd Edition, 2010, ISBN:
9789380704104, JAYPEE Publications
2. Textbook of Preventive and Social Medicine (Mahajan and Gupta),Edited by Roy RabindraNath,
SahaIndranil, 4 th Edition, 2013,ISBN: 9789350901878, JAYPEE Publications
3. Review of Preventive and Social Medicine (Including Biostatistics), Jain Vivek, 6 th Edition, 2014,
ISBN: 9789351522331, JAYPEE Publications
4. Essentials of Community Medicine—A Practical Approach, HiremathLalita D, HiremathDhananjaya
A, 2 nd Edition, 2012, ISBN: 9789350250440, JAYPEE Publications
5. Park Textbook of Preventive and Social Medicine, K Park, 21 st Edition, 2011, ISBN-14:
9788190128285, BANARSIDAS BHANOT PUBLISHERS.
6. Community Pharmacy Practice, Ramesh Adepu, BSP publishers, Hyderabad

Recommended Journals:
Research in Social and Administrative Pharmacy, Elsevier, Ireland

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 56
 BP803ET. Pharma Marketing Management (Theory)
45Hours
Course Course Title L T P C Component Exam WT Passing
Code Min. (%)
BP803ET Pharma 3 1 - 4 Theory CA 10 10
Marketing (100Marks) Sessional-1 15
15 50
Management Sessional-2 15
(Theory) ESE 75
Scope:
The pharmaceutical industry not only needs highly qualified researchers, chemists and, technical people, but
also requires skilled managers who can take the industry forward by managing and taking the complex
decisions which are imperative for the growth of the industry. The Knowledge and Know-how of marketing
management groom the people for taking a challenging role in Sales and Product management.
Objectives:
Upon completion of the course student shall able to
CLO1. State1 the types and meaning of various terminologies in pharmaceutical marketing management.
CLO2. Describe2market and its emerging concepts, characteristics, strategies, analysis and research in
pharmaceutical market.
CLO3. Explain2 the product design and promotional activities in pharmaceutical industry.
CLO4 Illustrate4 the channels, its importance and personnel involved in pharmaceutical marketing.
CLO5. Illustrate4 the price control of pharmaceutical products.
Course Content
UNIT Description Hours
I Marketing: Definition, general concepts and scope of marketing; Distinction 10
between marketing & selling; Marketing environment; Industry and competitive
analysis; Analyzing consumer buying behavior; industrial buying behavior.
Pharmaceutical market: Quantitative and qualitative aspects; size and composition of
the market; demographic descriptions and socio- psychological characteristics ofthe
consumer; market segmentation& targeting. Consumer profile; Motivation and
prescribing habits of the physician; patients' choice of physician and retail pharmacist.
Analyzing the Market; Role of market research. Preparation of questionnaire, design
survey, building business plan and introduction to data analytics software

II Product decision: Classification, product line and product mix decisions, 10

product life cycle, product portfolio analysis; product positioning; New product
decisions; Product branding, packaging and labeling decisions, Product management
in pharmaceutical industry.

III Promotion: Methods, determinants of promotional mix, promotional budget; 10

An overview of personal selling, advertising, direct mail, journals, sampling, retailing,
medical exhibition, public relations, online promotional techniques for OTCProducts.

IV Pharmaceutical marketing channels: Designing channel, channel members, 10

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 57
 selecting the appropriate channel, conflict in channels, physical distribution
management: Strategic importance, tasks in physical distribution management.
Professional sales representative (PSR): Duties of PSR, purpose of detailing,
selection and training, supervising, norms for customer calls, motivating, evaluating,
compensation and future prospects of the PSR.

V Pricing: Meaning, importance, objectives, determinants of price; 10

pricing methods and strategies, issues in price management in pharmaceutical industry.
An overview of DPCO (Drug Price Control Order) and NPPA (National Pharmaceutical
Pricing Authority).
Emerging concepts in marketing: Vertical & Horizontal Marketing; Rural Marketing;
Consumerism; Industrial Marketing; Global Marketing.

Recommended Books (Latest Editions)

1. Philip Kotler and Kevin Lane Keller: Marketing Management, Prentice Hall of India, New Delhi
2. Walker, Boyd and Larreche : Marketing Strategy- Planning and Implementation, Tata MC Graw
Hill, New Delhi.
3. Dhruv Grewal and Michael Levy: Marketing, Tata MC Graw Hill
4. Arun Kumar and N Menakshi: Marketing Management, Vikas Publishing, India
5. Rajan Saxena: Marketing Management; Tata MC Graw-Hill (India Edition)
6. Ramaswamy, U.S &Nanakamari, S: Marketing Managemnt:Global Perspective, Indian Context,
Macmilan India, New Delhi.
7. Shanker, Ravi: Service Marketing, Excell Books, New Delhi
8. Subba Rao Changanti, Pharmaceutical Marketing in India (GIFT – Excel series) Excel
Publications.

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 58
 BP804 ET: PHARMACEUTICAL REGULATORY SCIENCE (Theory)
45Hours
Course Course Title L T P C Component Exam WT Passing
Code Min.
(%)
BP804ET PHARMACEUTICAL 3 1 - 4 Theory(1 CA 10 10
REGULATORY 00Marks) Sessional-1 15
15 100
SCIENCE Sessional-2 15
ESE 75
Scope:
This course is designed to impart the fundamental knowledge on the regulatory requirements for approval
of new drugs, and drug products in regulated markets of India & other countries like US, EU, Japan,
Australia, UK etc. It prepares the students to learn in detail on the regulatory requirements, documentation
requirements, and registration procedures for marketing the drug products.
Objectives:
Upon completion of the course, student shall able to
CLO1. State1 the meaning of various terminologies of Regulatory Science.
CLO2. Illustrate4the regulatory authorities, agencies and approval processes.
CLO3. Describe2 new drug discoveries and development process and its registration.
CLO4. Explain2 clinical trials, initiation, conduction, monitoring and evaluation.
CLO5. Describe2 the concepts of Regulatory science in pharmaceutical industry.
Course content
UNIT Description Hours
I New Drug Discovery and Development 10
Stages of drug discovery, Drug development process, pre-clinical studies, non-clinical
activities, clinical studies, Innovator and generics, Concept of generics, Generic drug
product development.

II Regulatory Approval Process 10

Approval processes and timelines involved in Investigational New Drug
(IND), New Drug Application (NDA), and Abbreviated New Drug Application
(ANDA). Changes to an approved NDA / ANDA.
Regulatory authorities and agencies
Overview of regulatory authorities of India, United States, European Union,
Australia, Japan, Canada, Brazil, South Africa and Russia (Organization
structure and types of applications)

III Registration of Indian drug product in overseas market 10

Procedure for export of pharmaceutical products, Technical documentation, Drug
Master Files (DMF), Common Technical Document (CTD), electronic Common
Technical Document (eCTD), ASEAN Common Technical Document (ACTD)
research

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 59
 IV Clinical trials 08
Developing clinical trial protocols, Institutional Review Board / Independent Ethics
committee - formation and working procedures, Informed consent process and
procedures, ICH- GCP obligations of Investigators, sponsors & Monitors, Managing
and Monitoring clinical trials, Pharmacovigilance - safety monitoring in clinicaltrials,
data analytics

V Regulatory Concepts 07
Basic terminology, guidance, guidelines, regulations, Laws and Acts, Orange book,
Federal Register, Code of Federal Regulatory, Purple book

Recommended books (Latest edition):

1. Drug Regulatory Affairs by SachinItkar, Dr. N.S. Vyawahare, Nirali Prakashan.

2. The Pharmaceutical Regulatory Process, Second Edition Edited by Ira R. Berry and Robert P. Martin,
Drugs and the Pharmaceutical Sciences,Vol.185. Informa Health care Publishers
3. New Drug Approval Process: Accelerating Global Registrations By Richard A Guarino, MD, 5th
edition, Drugs and the Pharmaceutical Sciences,Vol.190
4. Guidebook for drug regulatory submissions / Sandy Weinberg. By John Wiley & Sons. Inc
5. FDA Regulatory Affairs: a guide for prescription drugs, medical devices, and biologics /edited by
Douglas J. Pisano, David Mantus
6. Generic Drug Product Development, Solid Oral Dosage forms, Leon Shargel and IsaderKaufer,
Marcel Dekker series, Vol.143
7. Clinical Trials and Human Research: A Practical Guide to Regulatory Compliance By Fay A.
Rozovsky and Rodney K. Adams
8. Principles and Practices of Clinical Research, Second Edition Edited by John I. Gallin and Frederick
P. Ognibene
9. Drugs: From Discovery to Approval, Second Edition By Rick Ng

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 60
 BP805ET. PHARMACOVIGILANCE (Theory)
45Hours
Course Course Title L T P C Component Exam WT Min.
Code Passing (%)
BP805ET Pharmacovigilance 3 1 - 4 Theory CA 10 10
(Theory) (100Marks) Sessional-1 15
15 50
Sessional-2 15
ESE 75

Scope:
This paper will provide an opportunity for the student to learn about development of pharmacovigilance as
a science, basic terminologies used in pharmacovigilance, global scenario of Pharmacovigilance, train
students on establishing pharmacovigilance programme in an organization, various methods that can be used
to generate safety data and signal detection. This paper also develops the skills of classifying drugs, diseases
and adverse drug reactions.
Objectives
CLO1. State1 history, terminologies, basic concept of pharmacovigilance, adverse drug reactions and
pharmacogenomics.
CLO2. Describe2 drug & disease classification, drug dictionaries, coding, information resources, and
establishing programs in pharmacovigilance as per regulatory guidelines.
CLO3. Illustrate3 vaccine safety surveillance, methods and communication in pharmacovigilance and
ADR.
CLO4. Summarise5 drug safety data generation and its evaluation.
CLO5. Explain4 guidelines and requirements of pharmacovigilance as per CDSCO, ICH, and CIOMs.

Course content
UNIT Description Hours

I Introduction to Pharmacovigilance 10
 History and development of Pharmacovigilance
 Importance of safety monitoring of Medicine
 WHO international drug monitoring programme
 Pharmacovigilance Program of India (PvPI)
 Roles and responsibilities of clinical pharmacist
Introduction to adverse drug reactions
 Definitions and classification of ADRs
 Detection and reporting
 Methods in Causality assessment
 Severity and seriousness assessment
 Predictability and preventability assessment
 Management of adverse drug reactions

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 61
 Basic terminologies used in pharmacovigilance
 Terminologies of adverse medication related events
 Regulatory terminologies
XX

II Drug and disease classification 10

 Anatomical, therapeutic and chemical classification of drugs
 International classification of diseases
 Daily defined doses
 International Non-proprietary Names for drugs
Drug dictionaries and coding in pharmacovigilance
 WHO adverse reaction terminologies
 MedDRA and Standardised MedDRA queries
 WHO drug dictionary
 Eudra vigilance medicinal product dictionary
Information resources in pharmacovigilance
 Basic drug information resources
 Specialized resources for ADRs
Establishing pharmacovigilance programme
 Establishing in a hospital
 Establishment & operation of drug safety department in industry
 Contract Research Organizations (CROs)
 Establishing a national programme
Software resources
 Micromedex software

III Vaccine safety surveillance 10

 Vaccine Pharmacovigilance
 Vaccination failure
 Adverse events following immunization
Pharmacovigilance methods
 Passive surveillance – Spontaneous reports and case series
 Stimulated reporting
 Active surveillance – Sentinel sites, drug event monitoring and registries
 Comparative observational studies – Cross sectional study, case control
study and cohort study
 Targeted clinical investigations
Poison information surveillance Communication in Pharmacovigilance
 Effective communication in Pharmacovigilance
 Communication in Drug Safety Crisis management
 Communicating with Regulatory Agencies, Business Partners,
Healthcare facilities & Media
IV Safety data generation 08

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 62
  Pre- clinical phase
 Clinical phase
 Post approval phase (PMS)
ICH Guidelines for Pharmacovigilance
 Organization and objectives of ICH
 Expedited reporting
 Individual case safety reports
 Periodic safety update reports
 Post approval expedited reporting
 Pharmacovigilance planning
 Good clinical practice in Pharmacovigilance studies

V. Pharmacogenomics of adverse drug reactions 07

 Genetics related ADR with example focusing PK parameters
Drug safety evaluation in special population
 Pediatrics
 Pregnancy and lactation
 Geriatrics
CIOMS
 CIOMS Working Groups
 CIOMS Form
CDSCO (India) and Pharmacovigilance
 D&C Act and Schedule Y
 Differences in Indian and global pharmacovigilance requirements
Chronic diseases
 HIV and multiple organ failure

Recommended books (Latest edition):
1. Textbook of Pharmacovigilance: S K Gupta, Jaypee Brothers, Medical Publishers.
2. Practical Drug Safety from A to Z By Barton Cobert, Pierre Biron, Jones and Bartlett Publishers.
3. Mann's Pharmacovigilance: Elizabeth B. Andrews, Nicholas, Wiley Publishers.
4. Stephens' Detection of New Adverse Drug Reactions: John Talbot, Patrick Walle, Wiley
Publishers.
5. An Introduction to Pharmacovigilance: Patrick Waller, Wiley Publishers.
6. Cobert's Manual of Drug Safety and Pharmacovigilance: Barton Cobert, Jones& Bartlett
Publishers.
7. Textbook of Pharmacoepidemiolog edited by Brian L. Strom, Stephen E Kimmel, Sean Hennessy,
Wiley Publishers.
8. A Textbook of Clinical Pharmacy Practice -Essential Concepts and Skills:G. Parthasarathi, Karin
Nyfort Hansen, Milap C. Nahata

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 63
 BP806ET. QUALITY CONTROL AND STANDARDIZATION OF HERBALS (Theory)
45 Hours
Course Course Title L T P C Compone Exam WT Passing
Code nt Min. (%)
Quality 3 1 - 4 CA 10 10
50
BP806ET Control &
Theory
Standardizati (100Marks) Sessional-1 15
on of 15
Sessional-2 15
Herbals
ESE 75
Scope:
In this subject the student learns about the various methods and guidelines for evaluation and standardization
of herbs and herbal drugs. The subject also provides an opportunity for the student to learn cGMP, GAP and
GLP in traditional system of medicines.
Objectives:
Upon completion of the course, student shall be able to

CLO1. State1 the types and meaning of various terminologies related to quality control and
standardization of herbal drugs.
CLO2. Describe2 WHO, ICH, TCM and EU Guidelines for quality control of herbal drugs.
CO3. Illustrate4 the development, standardization, evaluation and clinical monitoring of herbal drugs and
cosmetics.
CO4. Summarize5 the herbal research guidelines and pharmacopoeias.
CO5. Explain2 the regulatory requirements for approval of herbal medicine in national and international
markets.

Course content
UNIT Description Hours
I Basic tests for drugs – Pharmaceutical substances, Medicinal plants materials 10
and dosage Forms WHO guidelines for quality control of herbal drugs. Evaluation of
commercial crude drugs intened for use, Adulteration and methods to evaluate
adulteration

II Quality assurance in herbal drug industry 10

cGMP, GAP, GMP and GLP in traditional system of medicine. WHO Guidelines on
current good manufacturing Practices (cGMP) for Herbal Medicines. WHO
Guidelines on GACP for Medicinal Plants.

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 64
 III 10
EU and ICH guidelines for quality control of herbal drugs. Research Guidelines for
Evaluating the Safety and Efficacy of Herbal Medicines. Guidelines regarding
traditional Chinese medicines (TCM)

IV 08
Stability testing of herbal medicines. Application of various chromatographic
techniques in standardization of herbal products. Preparation of documents for new
drug application and export registration GMP requirements and Drugs & Cosmetics
Act provisions.
V 07
Regulatory requirements for herbal medicines. WHO guidelines on safety monitoring
of herbal medicines in pharmacovigilance systems Comparison of various Herbal
Pharmacopoeias. Role of chemical and biological markers in standardization of herbal
products

Recommended Books: (Latest Editions)

1. Pharmacognosy by Trease and Evans
2. Pharmacognosy by Kokate, Purohit and Gokhale
3. Rangari, V.D., Text book of Pharmacognosy and Phytochemistry Vol. I , Carrier
4. Aggrawal, S.S., Herbal Drug Technology. Universities Press, 2002.
5. EMEA. Guidelines on Quality of Herbal Medicinal Products/Traditional Medicinal
6. Mukherjee, P.W. Quality Control of Herbal Drugs: An Approach to Evaluation of Botanicals. Business
Horizons Publishers, New Delhi, India, 2002.
7. Shinde M.V., Dhalwal K., Potdar K., Mahadik K. Application of quality control principles to herbal
drugs. International Journal of Phytomedicine 1(2009); p. 4-
8. WHO. Quality Control Methods for Medicinal Plant Materials,World Health Organization, Geneva,
1998. WHO. Guidelines for the Appropriate Use of Herbal Medicines. WHO Regional Publications,
Western Pacific Series No 3, WHO Regional office for the Western Pacific, Manila, 1998.
9. WHO. The International Pharmacopeia, Vol. 2: Quality Specifications, 3rd edn.
10. World Health Organization, Geneva, 1981.
11. WHO. Quality Control Methods for Medicinal Plant Materials. World Health Organization, Geneva,
1999.
12. WHO. WHO Global Atlas of Traditional, Complementary and Alternative Medicine. 2 vol. set. Vol. 1
contains text and Vol. 2, maps. World Health Organization, Geneva, 2005.
13. WHO. Guidelines on Good Agricultural and Collection Practices (GACP) for Medicinal Plants. World
Health Organization, Geneva, 2004.

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 65
 BP 807 ET. COMPUTER AIDED DRUG DESIGN (Theory)
45Hours
Course Course Title L T P C Component Exam WT Min.
Code Passing (%)
BP807ET Computer aided 3 1 - 4 Theory CA 10 10
drug design (100Mar Sessional-1 15
ks) 15 50
(Theory) Sessional-2 15
ESE 75
Scope:
This subject is designed to provide detailed knowledge of rational drug design process and various
techniques used in rational drug design process.
Objectives:

CLO1.State1the definition and meaning and classes of different terminologies used in CADD.
CLO2.Determine5the physiochemical parameters of drugs using molecular modeling, QSAR and virtual
screening techniques.
CLO3.Illustrate4the stages in drug discovery, drug development and drug design.
CLO4. Illustrate4 the role and applications and methods of Informatics and molecular modelling in drug
design.
CLO5.Compare4 between various methods used in drug discovery, drug development and drug design.

Course content
UNIT Description Hours
I 10
Introduction to Drug Discovery and Development: Stages of drug discovery and
development
Lead discovery and Analog Based Drug Design: Rational approaches to lead
discovery based on traditional medicine, Random screening, Non-random screening,
serendipitous drug discovery, lead discovery based on drug metabolism, lead discovery
based on clinical observation.
Analog Based Drug Design: Bioisosterism, Classification, Bioisosterice placement.
Any three case studies
II 10
Quantitative Structure Activity Relationship (QSAR): SAR versus QSAR, History
and development of QSAR, Types of physicochemical parameters, experimental and
theoretical approaches for the determination of physicochemical parameters such as
Partition coefficient, Hammet’s substituent constant and Tafts steric constant. Hansch
analysis, Free Wilson analysis, 3D-QSAR approaches like COMFA and COMSIA.

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 66
 III 10
Molecular Modeling and virtual screening techniques
Virtual Screening techniques: Drug likeness screening, Concept of pharmacophore
mapping and pharmacophore based Screening
Molecular docking: Rigid docking, flexible docking, manual docking, Docking
based screening. De novo drug design.

IV 08
Informatics & Methods in drug design: Introduction to Bioinformatics,
chemoinformatics. ADME databases, chemical, biochemical and pharmaceutical
databases.

V 07
Molecular Modeling: Introduction to molecular mechanics and quantum mechanics.
Energy Minimization methods and Conformational Analysis, global conformational
minima determination.

Recommended books (Latest edition):

1. Robert GCK, ed., “Drug Action at the Molecular Level” University Prak Press Baltimore.
2. Martin YC. “Quantitative Drug Design” Dekker, New York.
3. Delgado JN, Remers WA eds “Wilson &Gisvolds’s Text Book of Organic Medicinal &
Pharmaceutical Chemistry” Lippincott, New York.
4. Foye WO “Principles of Medicinal chemistry ‘Lea &Febiger.
5. Koro lkovas A, Burckhalter JH. “Essentials of Medicinal Chemistry” Wiley Interscience.
6. Wolf ME, ed “The Basis of Medicinal Chemistry, Burger’s Medicinal Chemistry” JohnWiley&
Sons, New York.
7. Patrick Graham, L., An Introduction to Medicinal Chemistry, Oxford University Press.
8. Smith HJ, Williams H, eds, “Introduction to the principles of Drug Design” Wright Boston.
9. Silverman R.B. “The organic Chemistry of Drug Design and Drug Action” Academic Press New
York.

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 67
 BP808ET: CELL AND MOLECULAR BIOLOGY (Elective subject)
45Hours
Course Course Title L T P C Component Exam WT Min.
Code Passing (%)
BP808ET Cell and molecular 3 1 - 4 Theory(1 CA 10 10
biology (Elective 00Marks) Sessional-1 15
15 50
subject) Sessional-2 15
ESE 75
Scope:

Cell biology is a branch of biology that studies cells – their physiological properties, their structure, the
organelles they contain, interactions with their environment, their life cycle, division, death and cell function.
This is done both on a microscopic and molecular level. Cell biology research encompasses both the great
diversity of single-celled organisms like bacteria and protozoa, as well as the many specialized cells in multi-
cellular organisms such as humans, plants, and sponges.

Objective:

CLO1. Summarize5history, basic concepts of cell and molecular biology with its applications.
CLO2.Explain2concept of DNA and RNA its functioning, transcription and translation.
CLO3. Illustrate3amino acids and proteins structure, synthesis, cellular processes, regulations and
significance.
CLO4. Illustrate3concept of genetics, cellular activities, division, checkpoints and analysis of cell cycle
CLO5. Illustrate3cell signaling, receptors, pathways and controlling mechanisms.

Course content
UNIT Description Hours
I 10
a) Cell and Molecular Biology: Definitions theory and basics and
Applications.
b) Cell and Molecular Biology: History and Summation.
c) Properties of cells and cell membrane
d) Prokaryotic versus Eukaryotic
e) Cellular Reproduction
f) Chemical Foundations – an Introduction and Reactions (Types)

II 10
a) DNA and the Flow of Molecular Information
b) DNA Functioning
c) DNA and RNA
d) Types of RNA
e) Transcription and Translation

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 68
 III 10
a) Proteins: Defined and Amino Acids pool and its significance
b) Protein Structure
c) Regularities in Protein Pathways
d) Cellular Processes
e) Positive Control and significance of Protein Synthesis
f) Introduction to proteomics

IV 08
a) Science of Genetics
b) Transgenic and Genomic Analysis with its application
c) Cell Cycle analysis
d) Mitosis and Meiosis
e) Cellular Activities and Checkpoints

V 07
a) Cell Signals: Introduction
b) Receptors for Cell Signals
c) Signaling Pathways: Overview
d) Regulation and misregulation of Signaling Pathways
e) Protein-Kinases: Functioning

Recommended books (Latest edition):

1. W.B. Hugo and A.D. Russel: Pharmaceutical Microbiology, Blackwell Scientific publications,
Oxford London.
2. Prescott and Dunn., Industrial Microbiology, 4th edition, CBS Publishers & Distributors, Delhi.
3. Pelczar, Chan Kreig, Microbiology, Tata McGraw Hill edn.
4. Malcolm Harris, Balliere Tindall and Cox: Pharmaceutical Microbiology.
5. Rose: Industrial Microbiology.
6. Probisher, Hinsdill et al: Fundamentals of Microbiology, 9th ed. Japan
7. Cooper and Gunn’s: Tutorial Pharmacy, CBS Publisher and Distribution.
8. Peppler: Microbial Technology.
9. Edward: Fundamentals of Microbiology.
10. N.K.Jain: Pharmaceutical Microbiology, Vallabh Prakashan, Delhi
11. Bergeys manual of systematic bacteriology, Williams and Wilkins- A Waverly company
12. B.R. Glick and J.J. Pasternak: Molecular Biotechnology: Principles and Applications of
RecombinantDNA: ASM Press Washington D.C.
13. RA Goldshyet. al., Kuby Immunology.

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 69
 BP809ET. COSMETIC SCIENCE (Theory)
45Hours
Course Course Title L T P C Component Exam WT Min.
Code Passing (%)
BP809ET Cosmetic 3 1 - 4 Theory CA 10 10
science(theory) (100Marks) Sessional-1 15
15 50
Sessional-2 15
ESE 75
Scope:
The purpose of this course is to introduce to students with number of materials and ingredient research
related to cosmetics, therapeutic options for skin, hair and body care, product formulations and ingredients,
cosmetic olfactory research developments, technologies in cosmetic product development, testing of skin
and hair products.

Objective:

CLO1. State1the types and meaning of various terminologies related to cosmetic science.
CLO2. Explain2the anatomy and associated problems of skin, hair and oral cavity.
CLO3. Illustrate4the categories, applications of cosmetic excipients, products and their formulations.
CLO4. Describe2the formulation, merits, demerits, mechanisms of cosmetics and oral care products.
CLO5. Illustrate4the principles, methods and techniques of cosmetics evaluation.

Course content
UNIT Description Hours
I 10
Classification of cosmetic and cosmeceutical products
Definition of cosmetics as per Indian and EU regulations, Evolution of
cosmeceuticals from cosmetics, cosmetics as quasi and OTC drugs
Cosmetic excipients: Surfactants, rheology modifiers, humectants, emollients,
preservatives. Classification and application
Skin: Basic structure and function of skin.
Hair: Basic structure of hair. Hair growth cycle.
Nail: Basic structure and function of nail.
Oral Cavity: Common problem associated with teeth and gums.

II 10
Principles of formulation and building blocks of skin care products: Face wash,
Moisturizing cream, Cold Cream, Vanishing cream, Anti-ageing creams and their
advantages and disadvantages. Application of these products in formulation of
cosmecuticals.
Antiperspants & deodorants- Actives & mechanism of action.
Principles of formulation and building blocks of Hair care products: Conditioning
shampoo, Hair conditioner, anti-dandruff shampoo, Hair oils, Hair strengthening and
waving products
Principles of formulation and building blocks of oral care products: Toothpaste
for bleeding gums, sensitive teeth. Teeth whitening, Mouthwash, Denture cleaners

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 70
 Principles of formulation and building blocks of Eye care products: Eye drops, eye
lotions, ointments, contact lens solutions and mascara, eyeliners, eye makeup remover
and eye shadow
Principles of formulation and building blocks of Nail care products: Nail lacquer,
Enamel remover, nail cream, nail bleach, cuticle remover, cuticle softener.
Introduction, formulation and evaluation of Lipsticks: Raw material,
Manufacturing process, defects and evaluation parameters
Introduction, formulation and evaluation of Rouge: Raw material, Manufacturing
process, defects and evaluation parameters

III 10
Sun protection, Classification of Sunscreens and SPF.
Role of herbs in cosmetics
Skin Care: Aloe and turmeric
Hair care: Henna and amla.
Oral care: Neem and clove
Analytical cosmetics: BIS specification and analytical methods for shampoo, skin
cream and toothpaste.
IV 08
Principles of Cosmetic Evaluation: Principles of sebumeter, corneometer.
Measurement of TEWL, Skin Color, Hair tensile strength, Hair combing properties
Soaps, and syndet bars. Evolution and skin benefits.

V 07
Oily and dry skin, causes leading to dry skin, skin moisturisation. Basic understanding
of the terms Comedogenic, dermatitis. Cosmetic problems associated with Hair and
scalp: Dandruff, Hair fall causes.
Cosmetic problems associated with skin: blemishes, wrinkles, acne, prickly heat and
body odor.
Antiperspirants and Deodorants- Actives and mechanism of action

Recommended books (Latest edition):

1) Harry’s Cosmeticology, Wilkinson, Moore, Seventh Edition, George Godwin.

2) Cosmetics – Formulations, Manufacturing and Quality Control, P.P. Sharma, 4th Edition,
Vandana Publications Pvt. Ltd., Delhi.
3) Text book of cosmelicology by Sanju Nanda &Roop K. Khar, Tata Publishers.

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 71
 BP810 ET. PHARMACOLOGICAL SCREENING METHODS
45Hours
Course Course Title L T P C Component Exam WT Min.
Code Passing(%)
BP810ET Pharmacological 3 1 - 4 Theory CA 10 10
screening methods (100Marks) Sessional-1 15
15 50
Sessional-2 15
ESE 75
Scope:
This subject is designed to impart the basic knowledge of preclinical studies in experimental animals
including design, conduct and interpretations of results.

Objectives:

CLO1. Explain2 breeding, pharmacological aspects and guidelines for experiments on laboratory animals.
CLO2.Summarise5 basic concept of preclinical screening and methods.
CLO3.Describe2 preclinical screening of bioactive of various pharmacological classes.
CLO4.Analyze4 dose of drug and experimental data.
CLO5.Explain2 fundamentals of bio-statistics and research methodology.

Course content
UNIT Description Hours
I 08
Laboratory Animals:
Study of CPCSEA and OECD guidelines for maintenance, breeding and conduct of
experiments on laboratory animals, Common lab animals: Description and applications
of different species and strains of animals. Popular transgenic and mutant animals.
Techniques for collection of blood and common routes of drug administration in
laboratory animals, Techniques of blood collection and euthanasia. An introduction to
virtual In-vitro and Ex-vivo alternatives for animal experiments(In silico methods)

II 10
Preclinical screening models
Introduction: Dose selection, calculation and conversions, preparation of drug
solution/suspensions, grouping of animals and importance of sham negative and
positive control groups. Rationale for selection of animal species and sex for the study.
Study of screening animal models for
Diuretics, nootropics, anti-Parkinson’s, antiasthmatics,
Preclinical screening models: for CNS activity- analgesic, antipyretic, anti-
inflammatory, general anesthetics, sedative and hypnotics, antipsychotic,
antidepressant, antiepileptic, antiparkinsonism, Alzheimer’s disease

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 72
 III 10
Preclinical screening models: for ANS activity, sympathomimetics, sympatholytics,
parasympathomimetics, parasympatholytics, skeletal muscle relaxants, drugs acting
on eye, local anesthetic
I

IV 12
Preclinical screening models: for CVS activity- antihypertensives, diuretics,
antiarrhythmic, antidyslepidemic, anti aggregatory, coagulants, and anticoagulants
Preclinical screening models for other important drugs like antiulcer, antidiabetic,
anticancer and antiasthmatics.

V 05
Research methodology and Bio-statistics
Selection of research topic, review of literature, research hypothesis and study design
Pre-clinical data analysis and interpretation using Students‘t’ test and One-way ANOVA.
Graphical representation of data

Recommended books (Latest edition):

1. Fundamentals of experimental Pharmacology-by M.N.Ghosh

2. Hand book of Experimental Pharmacology-S.K.Kulakarni
3. CPCSEA guidelines for laboratory animal facility.
4. Drug discovery and Evaluation by Vogel H.G.
5. Drug Screening Methods by Suresh Kumar Gupta and S. K. Gupta
6. Introduction to biostatistics and research methods by PSS Sundar Rao and
JRichard

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 73
 BP 811 ET. ADVANCED INSTRUMENTATION TECHNIQUES
45Hours
Course Course Title L T P C Component Exam WT Min.
Code Passing (%)
BP811ET Advanced 3 1 - 4 Theory CA 10 10
instrumentation (100Marks) Sessional-1 15
15 50
techniques Sessional-2 15
ESE 75

Scope:
This subject deals with the application of instrumental methods in qualitative and quantitative analysis of
drugs. This subject is designed to impart advanced knowledge on the principles and instrumentation of
spectroscopic and chromatographic hyphenated techniques. This also emphasizes on theoretical and
practical knowledge on modern analytical instruments that are used for drug testing.

Objectives:

CLO1. State1 the definition, different classes, terminologies, principle, procedure and applications used in
different instrumentation techniques.
CLO2.Explain2 the principle and sample preparation techniques involved in the radio-immuno assay.
CLO3. Evaluate5 the drugs by spectroscopic and thermal techniques and their characterization.
2
CLO4. Discuss the importance of calibration and validation process of analytical instruments as per ICH
and USFDA guidelines.
5
CLO5.Compare merit, demerit and differences in the selected instrumental analytical techniques

Course content
UNIT Description Hours
I 10
Nuclear Magnetic Resonance spectroscopy
Principles of H-NMR and C-NMR, chemical shift, factors affecting chemical shift,
coupling constant, Spin - spin coupling, relaxation, instrumentation and applications.
Mass Spectrometry Principles, Fragmentation, Ionization techniques – Electron
impact, chemical ionization, MALDI, FAB, Analyzers-Time of flight and
Quadrupole, instrumentation, applications

II 10
Thermal Methods of Analysis: Principles, instrumentation and applications of
Thermogravimetric Analysis (TGA), Differential Thermal Analysis (DTA),
Differential Scanning Calorimetry (DSC)
X-Ray Diffraction Methods: Origin of X-rays, basic aspects of crystals, X ray
Crystallography, rotating crystal technique, single crystal diffraction, powder
diffraction, structural elucidation and applications.

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 74
 III 10
Calibration and validation-as per ICH and USFDA guidelines
Calibration of following Instruments Electronic balance, UV-Visible
spectrophotometer, IR spectrophotometer, Fluorimeter, Flame Photometer, HPLCand
GC

IV 08
Radio immune assay: Importance, various components, Principle, different methods,
Limitation and Applications of Radio immuno assay
Extraction techniques: General principle and procedure involved in the solid phase
extraction and liquid-liquid extraction

V 07
Hyphenated techniques -LC-MS/MS, GC-MS/MS, HPTLC-MS.

Recommended books (Latest edition):

1. Instrumental Methods of Chemical Analysis by B.K Sharma

2. Organic spectroscopy by Y.R Sharma
3. Text book of Pharmaceutical Analysis by Kenneth A. Connors
4. Vogel’s Text book of Quantitative Chemical Analysis by A.I. Vogel
5. Practical Pharmaceutical Chemistry by A.H. Beckett and J.B. Stenlake
6. Organic Chemistry by I. L. Finar
7. Organic spectroscopy by William Kemp
8. Quantitative Analysis of Drugs by D. C. Garrett
9. Quantitative Analysis of Drugs in Pharmaceutical Formulations by P. D. Sethi
10. Spectrophotometric identification of Organic Compounds by Silverstein

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 75
 BP 812 ET. DIETARY SUPPLEMENTS AND NUTRACEUTICALS
45 Hours
Course Course Title L T P C Component Exam WT Min.
Code Passing (%)
BP812ET Dietary 3 1 - 4 Theory CA 10 10
Supplements and (100Marks) Sessional-1 15
15 50
Nutraceuticals Sessional-2 15
ESE 75

Scope:
This subject covers foundational topic that are important for understanding the need and requirements of
dietary supplements among different groups in the population.

Objectives:
CLO1. State1 the types and meaning of various terminologies related to dietary Supplements,
nutraceuticals and phytopharmaceuticals.
CLO2. Explain2 the nutraceuticals, dietary supplements, functional foods, antioxidants, their
pharmacology and role in public health.
CLO3. Describe2 the phytochemicals as nutraceuticals including occurrence and characteristics.
CLO4. Summarize5 the free radicals and their role in various disease conditions.
CLO5. Discuss2 regulatory aspects of dietary supplements and phytopharmaceuticals.

Course content

UNIT Description Hours

I 07
a. Definitions of Functional foods, Nutraceuticals and Dietary supplements.
Classification of Nutraceuticals, Health problems and diseases that can be
prevented or cured by Nutraceuticals i.e. weight control, diabetes, cancer, heart
disease, stress, osteoarthritis, hypertension etc.
b. Public health nutrition, maternal and child nutrition, nutrition and ageing,
nutrition education in community.
c. Source, Name of marker compounds and their chemical nature, Medicinal uses
and health benefits of following used as Nutraceuticals /functional foods:
Spirulina, Soyabean, Ginseng, Garlic, Broccoli, Gingko, Flaxseeds.

II 15
Phytochemicals as nutraceuticals: Occurrence and characteristic features (chemical
nature medicinal benefits) of following
a) Carotenoids- α and β-Carotene, Lycopene, Xanthophylls, leutin
b) Sulfides: Diallyl sulfides, Allyl trisulfide. c) Polyphenolics: Reservetrol
d) Flavonoids- Rutin , Naringin, Quercitin, Anthocyanidins, catechins, Flavones
e) Prebiotics / Probiotics.:Fructo oligosaccharides, Lacto bacillum

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 76
 f) Phyto estrogens: Isoflavones, daidzein, Geebustin, lignans
g) Tocopherols
h) Proteins, vitamins, minerals, cereal, vegetables and beverages as functional
foods: oats, wheat bran, rice bran, sea foods, coffee, tea and the like.

III 07
A) Introduction to free radicals: Free radicals, reactive oxygen species, production
of free radicals in cells, damaging reactions of free radicals on lipids, proteins,
Carbohydrates, nucleic acids.
B) Dietary fibers and complex carbohydrates as functional food ingredients.

IV 10
A) Free radicals in Diabetes mellitus, Inflammation, Ischemic reperfusion injury,
Cancer, Atherosclerosis, Free radicals in brain metabolism and pathology,
kidney damage, muscle damage. Free radicals involvement in other disorders.
Free radicals theory of ageing.
B) Antioxidants: Endogenous antioxidants – enzymatic and non-enzymatic
Antioxidant defence, Superoxide dismutase, catalase, Glutathione peroxidase,
Glutathione, Vitamin C, Vitamin E, α- Lipoic acid, melatonin Synthetic
antioxidants: Butylated hydroxy Toluene, Butylated hydroxy Anisole.
C) Functional foods for chronic disease prevention.

V 06
A) Effect of processing, storage and interactions of various environmental
factors on the potential of nutraceuticals.
B) Regulatory Aspects; FSSAI, FDA, FPO, MPO, AGMARK. HACCP and
GMPs on Food Safety. Adulteration of foods.
C) Pharmacopoeial Specifications for dietary supplements and nutraceuticals.

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 77
 Recommended books (Latest edition):
1. Dietetics by Sri Lakshmi
2. Role of dietary fibres and neutraceuticals in preventing diseases by K.T Agusti and P.Faizal: BS
Punblication.
3. Advanced Nutritional Therapies by Cooper. K.A., (1996).
4. The Food Pharmacy by Jean Carper, Simon & Schuster, UK Ltd., (1988).
5. Prescription for Nutritional Healing by James F.Balch and Phyllis A.Balch 2nd Edn., Avery
Publishing Group, NY (1997).
6. G. Gibson and C.williams Editors 2000 Functional foods Woodhead Publ. Co. London.
7. Goldberg, I. Functional Foods. 1994. Chapman and Hall, New York.
8. Labuza, T.P. 2000 Functional Foods and Dietary Supplements: Safety, Good
9. Manufacturing Practice (GMPs) and Shelf Life Testing in Essentials of Functional Foods M.K.
Sachmidl and T.P. Labuza eds. Aspen Press.
10. Handbook of Nutraceuticals and Functional Foods, Third Edition (Modern Nutrition)
11. Shils, ME, Olson, JA, Shike, M. 1994 Modern Nutrition in Health and Disease. Eighth edition.
Lea andF ebiger

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 78
 BP 813 ET. PHARMACEUTICAL PRODUCT DEVELOPMENT
45 Hours
Course Course Title L T P C Component Exam WT Min.
Code Passing(%)
BP813ET Pharmaceutical 3 1 - 4 Theory CA 10 10
product (100Marks) Sessional-1 15
15 50
development Sessional-2 15
ESE 75

Scope:
This course includes the formulation of product and selected for further development is fully optimized
and complies with the design specification and critical quality parameters.

Objectives:
CLO1. State1 the definition, objectives, regulations related to preformulation, development and stability.
Quality control testing of different dosage forms.
CLO2. Explain2 the pharmaceutical excipients used in pharmaceutical product development.
CLO3. Discuss2 the pharmaceutical excipients used in tablet, capsules, parenteral, aerosols product,
formulation of NDDS, Coating material and compressible vehicles with industrial applications.
CLO4. Discribe2 the optimization techniques used in pharmaceutical product development with
applications.
CLO5. Illustrate5 the Selection and quality control testing of packaging materials and regulatory
consideration for pharmaceutical Product development.

Course content
UNIT Description Hours
I 10
Introduction to pharmaceutical product development, objectives, and regulations
related to preformulation, formulation development, stability assessment,
manufacturing and quality control testing of different types of dosage forms

II 10
An advanced study of Pharmaceutical Excipients in pharmaceutical product
Development with a special reference to the following categories
i. Solvents and solubilizers
ii. Cyclodextrins and their applications
iii. Non - ionic surfactants and their applications
iv. Polyethylene glycols and sorbitols
v. Suspending and emulsifying agents
vi. Semi solid excipients

III 10
An advanced study of Pharmaceutical Excipients in pharmaceutical product
Development with a special reference to the following categories
i. Tablet and capsule excipients
ii. Directly compressible vehicles
iii. Coat materials
iv. Excipients in parenteral and aerosols products

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 79
 v. Excipients for formulation of NDDS
Selection and application of excipients in pharmaceutical formulations with
Specific industrial applications

IV 08
Optimization techniques in pharmaceutical product development. A study of various
optimization techniques for pharmaceutical product development with Specific
examples. Optimization by factorial designs and their applications. A study of QbD
and its application in pharmaceutical product development

V 07
Selection and quality control testing of packaging materials for pharmaceutical
Product development- regulatory considerations.

Recommended Books (Latest editions)

1. Pharmaceutical Statistics Practical and Clinical Applications by Stanford Bolton, Charles Bon; Marcel
Dekker Inc.
2. Encyclopedia of Pharmaceutical Technology, edited by James swarbrick, Third Edition,Informa
Healthcare publishers.
3. Pharmaceutical Dosage Forms, Tablets, Volume II, edited by Herbert A. Lieberman and Leon Lachman;
Marcel Dekker, Inc.
4. The Theory and Practice of Industrial Pharmacy, Fourth Edition, edited by Roop k Khar, S P Vyas,
Farhan J Ahmad, Gaurav K Jain; CBS Publishers and Distributors Pvt.Ltd. 2013.
5. Martin’s Physical Pharmacy and Pharmaceutical Sciences, Fifth Edition, edited by Patrick J. Sinko, BI
Publications Pvt. Ltd.
6. Targeted and Controlled Drug Delivery, Novel Carrier Systems by S. P. Vyas and R. K.Khar, CBS
Publishers and Distributors Pvt. Ltd, First Edition 2012.
7. Pharmaceutical Dosage Forms and Drug Delivery Systems, Loyd V. Allen Jr., Nicholas B.Popovich,
Howard C. Ansel, 9th Ed. 40
8. Aulton’s Pharmaceutics – The Design and Manufacture of Medicines, Michael E. Aulton, 3rd Ed.
9. Remington – The Science and Practice of Pharmacy, 20th Ed.
10. Pharmaceutical Dosage Forms – Tablets Vol 1 to 3, A. Liberman, Leon Lachman and Joseph B.
Schwartz
11. Pharmaceutical Dosage Forms – Disperse Systems Vol 1 to 3, H.A. Liberman, Martin, M.R and Gilbert
S. Banker.
12. Pharmaceutical Dosage Forms – Parenteral Medication Vol 1 & 2, Kenneth E. Avis and H.A.
Libermann.
13. Advanced Review Articles related to the topics.

Rules and Syllabus for Final. Year .B. Pharm course 2022-23 Page 80