SAVITRIBAI PHULE PUNE UNIVERSITY

FACULTY OF
SCIENCE AND TECHNOLOGY

COURSE STRUCTURE AND SYLLABUS

FINAL YEAR BACHELOR OF PHARMACY (B. Pharm.) 2019PATTERN

(EFFECTIVE FROM ACADEMIC YEAR 2022 – 2023)
 CHAPTER- I: REGULATIONS

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 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 of Indian 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
Pharmacy Council of India, New Delhi.
4. Medium of instruction and examinations
Medium of instruction and examination shall be in English.
5. Working days in each semester:
Each semestershall consist of not less than 90 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, 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 (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 semester carries a credit of 2.
7.2. Minimum credit requirements
The minimum credit points required for award of a B. Pharm. degree is 211.
These credits are divided into Theory courses, Tutorials, Practical, Practice
School and Projectover 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.
Table-I: Course of study for semester I

No.of
Course Credit
Name of the course Hours per week/Total Tutorial
code points
no of hours
Human Anatomy and
BP101T Physiology I– 3/45 1 4
Theory
Pharmaceutical Analysis I –
BP102T 3/45 1 4
Theory
BP103T Pharmaceutics I – Theory 3/45 1 4
Pharmaceutical Inorganic
BP104T 3/45 1 4
Chemistry – Theory
Communication skills –
BP105T 2/30 - 2
Theory *
Remedial Biology/
BP106RBT
Remedial Mathematics – 2/30 - D
BP106RMT
Theory*
Human Anatomy and
BP107P Physiology – 4/60 - 2
Practical
Pharmaceutical Analysis I –
BP108P 4/60 - 2
Practical
BP109P Pharmaceutics I – Practical 4/60 - 2
Pharmaceutical Inorganic
BP110P 4/60 - 2
Chemistry – Practical
Communication skills –
BP111P 2/30 - 1
Practical*
BP112RBP Remedial Biology – Practical* 2/30 - D

Total 32/34$/36#/480/510$/540# 4 27

# Applicable ONLY for the students who have studied Mathematics / Physics / Chemistry at HSC
and appearing for Remedial Biology (RB) course. However for Remedial biology and
Mathematics no credits to be allotted only 50 % passing i.e D grade will be prerequisite.

$ Applicable ONLY for the students who have studied Physics / Chemistry / Botany / Zoology at
HSC andappearing for Remedial Mathematics (RM) course.

* Non University Examination (NUE)

Table-II: Course of study for semester II

No. of
Course Hours per Credit
Name of the course week/Total Tutorial
Code points
no of
hours
Human Anatomy and Physiology II –
BP201T 3/45 1 4
Theory
Pharmaceutical Organic Chemistry I –
BP202T 3/45 1 4
Theory
BP203T Biochemistry – Theory 3/45 1 4

BP204T Pathophysiology – Theory 3/45 1 4

Computer Applications in Pharmacy –
BP205T 3/45 - 3
Theory *
BP206T Environmental sciences – Theory * 3/45 - 3
Human Anatomy and Physiology II –
BP207P 4/60 - 2
Practical
Pharmaceutical Organic Chemistry I–
BP208P 4/60 - 2
Practical
BP209P Biochemistry – Practical 4/60 - 2
Computer Applications in Pharmacy –
BP210P 4/60 - 1
Practical*
Total 32/480 4 29
* Non University Examination (NUE)

Table-III: Course of study for semester III

No. of
Course Hours per Credit
Name of the course Tutorial
code week/Total points
no of hours
Pharmaceutical Organic Chemistry II –
BP301T 3/45 1 4
Theory
BP302T Physical Pharmaceutics I – Theory 3/45 1 4
BP303T Pharmaceutical Microbiology – Theory 3/45 1 4
BP304T Pharmaceutical Engineering – Theory 3/45 1 4
Pharmaceutical Organic Chemistry II –
BP305P 4/60 - 2
Practical
BP306P Physical Pharmaceutics I – Practical 4/60 - 2
BP307P Pharmaceutical Microbiology – Practical 4/60 - 2
BP 308P Pharmaceutical Engineering –Practical 4/60 - 2
Total 28/420 4 24
Table-IV: Course of study for semester IV

No. of
Course Hours per Credit
Name of the course Tutorial
code week/Total points
no of hours
Pharmaceutical Organic Chemistry III–
BP401T 3/45 1 4
Theory
BP402T Medicinal Chemistry I – Theory 3/45 1 4
BP403T Physical Pharmaceutics II – Theory 3/45 1 4
BP404T Pharmacology I – Theory 3/45 1 4
Pharmacognosy and Phytochemistry I–
BP405T 3/45 1 4
Theory
BP406P Medicinal Chemistry I – Practical 4/60 - 2
BP407P Physical Pharmaceutics II – Practical 4/60 2
BP408P Pharmacology I – Practical 4/60 - 2
Pharmacognosy and Phytochemistry I –
BP409P 4/60 - 2
Practical
Total 31/465 5 28

Table-V: Course of study for semester V

No. of
Course Hours per Credit
Name of the course Tutorial
code week/Total points
no of hours
BP501T Medicinal Chemistry II – Theory 3/45 1 4

BP502T Industrial Pharmacy-I– Theory 3/45 1 4

BP503T Pharmacology II – Theory 3/45 1 4

Pharmacognosy and Phytochemistry II–
BP504T 3/45 1 4
Theory
BP505T Pharmaceutical Jurisprudence – Theory 3/45 1 4

BP506P Industrial Pharmacy-I - Practical 4/60 - 2

BP507P Pharmacology II – Practical 4/60 - 2

Pharmacognosy and Phytochemistry II –
BP508P 4/60 - 2
Practical
Total 27/405 5 26
Table-VI: Course of study for semester VI

No. of
Course Hours per Credit
code Name of the course week/Total Tutorial points
no of hours
BP601T Medicinal Chemistry III – Theory 3/45 1 4

BP602T Pharmacology III – Theory 3/45 1 4

BP603T Herbal Drug Technology – Theory 3/45 1 4

Biopharmaceutics and Pharmacokinetics –
BP604T Theory 3/45 1 4
BP605T Pharmaceutical Biotechnology – Theory 3/45 1 4

BP606T Quality Assurance –Theory 3/45 1 4

BP607P Medicinal chemistry III – Practical 4/60 - 2

BP608P Pharmacology III – Practical 4/60 - 2

BP609P Herbal Drug Technology – Practical 4/60 - 2

Total 30/450 6 30

Table – VII: Course of study for semester VII

No. of
Course Hours per Credit
code Name of the course week/Total Tutorial points
no of hours
Instrumental Methods of Analysis –
BP701T 3/45 1 4
Theory
BP702T Industrial Pharmacy-II – Theory 3/45 1 4
BP703T Pharmacy Practice – Theory 3/45 1 4
BP704T Novel Drug Delivery System – Theory 3/45 1 4
Instrumental Methods of Analysis –
BP705P 4/60 - 2
Practical
BP706PS Practice School* 12/180 - 6
Total 28/420 5 24

* Non University Examination (NUE)

Table – VIII:Course of study for semester VIII

No. of
Credi
Course Hours per
Name of the course Tutorial t
code week/Total
points
no of hours
BP801T Biostatistics and Research Methodology 3/45 1 4
BP802T Social and Preventive Pharmacy 3/45 1 4
BP803ET Pharma Marketing Management
BP804ET Pharmaceutical Regulatory Science
BP805ET Pharmacovigilance
Quality Control and Standardizations of
BP806ET Herbals
BP807ET Computer Aided Drug Design
BP808ET Cell and Molecular Biology 4+4
3+3=
1+1=2 =
BP809ET Cosmetic Science 6/90
8
BP810ET Experimental Pharmacology

BP811ET Advanced Instrumentation Techniques

BP812ET Dietary Suppliments and Nutraceuticals
BP813PW Project Work 12/180 - 6
Total 24/360 4 22

Table-IX: Semester wise credits distribution

Semester Credit Points

I 27
II 29
III 24
IV 28
V 26
VI 30
VII 24
VIII 22
Extracurricular/ Co curricular activities 01*
Total credit points for the program 211
* 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.

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
academic matters.
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.
11.1 End semester examinations
The End Semester Examinations for each theory and practical course
through semesters I to VIII shall be conducted by the university except for
the subjects with asterix symbol (*) in table I and II for which examinations
shall be conducted by the subject experts at college level and the
marks/grades shall be submitted to the university.
Tables-X: Schemes for internal assessments and end sem exam semester wiseSem I

End Semester
Internal Assessment
Exams
Course Total
Name of the Contin Sessional Exams
code Marks
course uousM Total Marks Duration
ode Marks Duration
Human Anatomy
BP101T and Physiology 10 15 1 Hr 25 75 3 Hrs 100
I– Theory
Pharmaceutical
BP102T Analysis I – 10 15 1 Hr 25 75 3 Hrs 100
Theory
Pharmaceutics I
BP103T 10 15 1 Hr 25 75 3 Hrs 100
– Theory
Pharmaceutical
Inorganic
BP104T 10 15 1 Hr 25 75 3 Hrs 100
Chemistry –
Theory
Communication
BP105T 5 10 1 Hr 15 35 1.5 Hrs 50
skills – Theory *
BP106R Remedial
BT Biology/
5 10 1 Hr 15 35 1.5 Hrs 50
BP106R Mathematics –
MT Theory*
Human Anatomy
BP107P and Physiology – 5 10 4 Hrs 15 35 4 Hrs 50
Practical
Pharmaceutical
BP108P Analysis I – 5 10 4 Hrs 15 35 4 Hrs 50
Practical
Pharmaceutics I
BP109P 5 10 4 Hrs 15 35 4 Hrs 50
– Practical
Pharmaceutical
Inorganic
BP110P 5 10 4 Hrs 15 35 4 Hrs 50
Chemistry –
Practical
Communication
BP111P 5 5 2 Hrs 10 15 2 Hrs 25
skills – Practical*
Remedial
BP112R
Biology – 5 5 2 Hrs 10 15 2 Hrs 25
BP
Practical*
490/525 675/72
70/75$/8 115/125$/ 23/24$/26 185/200 $ 31.5/33$/
Total / 5$/
0# 130# #
Hrs $
/210# 35#Hrs
540# 750#

#
Applicable ONLY for the students studied Mathematics / Physics / Chemistry at HSC and appearing for
Remedial Biology (RB)course.
$
Applicable ONLY for the students studied Physics / Chemistry / Botany / Zoology at HSC and appearing
for Remedial Mathematics (RM)course.

* Non University Examination(NUE)

Semester II

End Semester
Internal Assessment
Exams
Course Name of the Total
code course Continu Sessional Exams Marks
ous Total Marks Duration
Mode Marks Duration

Human Anatomy
BP201T and Physiology 10 15 1 Hr 25 75 3 Hrs 100
II – Theory

PharmaceuticalOr
ganic
BP202T 10 15 1 Hr 25 75 3 Hrs 100
Chemistry I –
Theory

Biochemistry –
BP203T 10 15 1 Hr 25 75 3 Hrs 100
Theory

Pathophysiology
BP204T 10 15 1 Hr 25 75 3 Hrs 100
– Theory

Computer
Applications in
BP205T 10 15 1 Hr 25 50 2 Hrs 75
Pharmacy –
Theory*

Environmental
BP206T sciences – 10 15 1 Hr 25 50 2 Hrs 75
Theory*

Human Anatomy
BP207P and Physiology 5 10 4 Hrs 15 35 4 Hrs 50
II –Practical

Pharmaceutical
Organic
BP208P 5 10 4 Hrs 15 35 4 Hrs 50
Chemistry I–
Practical

Biochemistry –
BP209P 5 10 4 Hrs 15 35 4 Hrs 50
Practical
Computer
Applications in
BP210P 5 5 2 Hrs 10 15 2 Hrs 25
Pharmacy –
Practical*
Total 80 125 20 Hrs 205 520 30 Hrs 725

* The subject experts at college level shall conductexaminations.

Semester III

End Semester
Internal Assessment
Exams
Course Total
Name of the course Sessional Exams
code Continuous Marks
Total Marks Duration
Mode Marks Duration
PharmaceuticalOrganic
BP301T 10 15 1 Hr 25 75 3 Hrs 100
Chemistry II – Theory
PhysicalPharmaceuticsI
BP302T 10 15 1 Hr 25 75 3 Hrs 100
–Theory
Pharmaceutical
BP303T Microbiology – 10 15 1 Hr 25 75 3 Hrs 100
Theory
Pharmaceutical
BP304T Engineering – 10 15 1 Hr 25 75 3 Hrs 100
Theory
PharmaceuticalOrganic
BP305P 5 10 4 Hr 15 35 4 Hrs 50
Chemistry II – Practical
Physical
BP306P Pharmaceutics I – 5 10 4 Hr 15 35 4 Hrs 50
Practical
Pharmaceutical
BP307P Microbiology – 5 10 4 Hr 15 35 4 Hrs 50
Practical
Pharmaceutical
BP308P Engineering – 5 10 4 Hr 15 35 4 Hrs 50
Practical
Total 60 100 20 160 440 28Hrs 600

Semester IV

End Semester
Internal Assessment
Exams
Course Total
Sessional Exams
code Name of the course Continuous Marks
Total Marks Duration
Mode
Marks Duration

Pharmaceutical Organic
BP401T 10 15 1 Hr 25 75 3 Hrs 100
Chemistry III– Theory

Medicinal Chemistry I
BP402T 10 15 1 Hr 25 75 3 Hrs 100
– Theory
Physical Pharmaceutics
BP403T II – 10 15 1 Hr 25 75 3 Hrs 100
Theory
Pharmacology I –
BP404T 10 15 1 Hr 25 75 3 Hrs 100
Theory

Pharmacognosy I –
BP405T 10 15 1 Hr 25 75 3 Hrs 100
Theory
 Medicinal Chemistry I
BP406P 5 10 4 Hr 15 35 4 Hrs 50
– Practical
Physical Pharmaceutics
BP407P II – 5 10 4 Hrs 15 35 4 Hrs 50
Practical
Pharmacology I –
BP408P 5 10 4 Hrs 15 35 4 Hrs 50
Practical

Pharmacognosy I –
BP409P 5 10 4 Hrs 15 35 4 Hrs 50
Practical

Total 70 115 21 Hrs 185 515 31 Hrs 700

Semester V

End Semester
Internal Assessment
Exams
Course Total
code Name of the course Sessional Exams Marks
Continuous
Total Marks Duration
Mode
Marks Duration

Medicinal Chemistry II
BP501T 10 15 1 Hr 25 75 3 Hrs 100
– Theory

Industrial Pharmacy–I-
BP502T 10 15 1 Hr 25 75 3 Hrs 100
Theory

Pharmacology II –
BP503T 10 15 1 Hr 25 75 3 Hrs 100
Theory

Pharmacognosy II –
BP504T 10 15 1 Hr 25 75 3 Hrs 100
Theory
Pharmaceutical
BP505T Jurisprudence– 10 15 1 Hr 25 75 3 Hrs 100
Theory
Industrial Pharmacy–I
BP506P 5 10 4 Hr 15 35 4 Hrs 50
– Practical

Pharmacology II –
BP507P 5 10 4 Hr 15 35 4 Hrs 50
Practical

Pharmacognosy II –
BP508P 5 10 4 Hr 15 35 4 Hrs 50
Practical

Total 65 105 17 Hr 170 480 27 Hrs 650

Semester VI

End Semester
Internal Assessment
Exams
Course Total
Name of the course Sessional Exams
code Continuous Marks
Total Marks Duration
Mode
Marks Duration
Medicinal Chemistry
BP601T 10 15 1 Hr 25 75 3 Hrs 100
III – Theory
Pharmacology III –
BP602T 10 15 1 Hr 25 75 3 Hrs 100
Theory
Herbal Drug
BP603T Technology – 10 15 1 Hr 25 75 3 Hrs 100
Theory
Biopharmaceutics and
BP604T Pharmacokinetics – 10 15 1 Hr 25 75 3 Hrs 100
Theory
Pharmaceutical
BP605T Biotechnology– 10 15 1 Hr 25 75 3 Hrs 100
Theory
Quality Assurance–
BP606T 10 15 1 Hr 25 75 3 Hrs 100
Theory
Medicinal chemistry III
BP607P – 5 10 4 Hrs 15 35 4 Hrs 50
Practical
Pharmacology III –
BP608P 5 10 4 Hrs 15 35 4 Hrs 50
Practical
Herbal Drug
BP609P Technology – 5 10 4 Hrs 15 35 4 Hrs 50
Practical
Total 75 120 18 Hrs 195 555 30 Hrs 750
Semester VII

End Semester
Internal Assessment
Exams

Course Sessional Exams Total

Name of the course
code Continuous Marks
Total Marks Duration
Mode
Marks Duration

Instrumental Methods of
BP701T Analysis 10 15 1 Hr 25 75 3 Hrs 100
– Theory
Industrial Pharmacy -II–
BP702T 10 15 1 Hr 25 75 3 Hrs 100
Theory

Pharmacy Practice –
BP703T 10 15 1 Hr 25 75 3 Hrs 100
Theory
Novel Drug Delivery
BP704T System – 10 15 1 Hr 25 75 3 Hrs 100
Theory
Instrumental Methods of
BP705 P Analysis 5 10 4 Hrs 15 35 4 Hrs 50
– Practical

BP706 PS Practice School* 25 - - 25 125 5 Hrs 150

Total 70 70 8Hrs 140 460 21 Hrs 600

* The subject experts at college level shall conduct examinations

 Semester VIII

End Semester
Internal Assessment
Exams
Course Total
Name of the course Sessional Exams
code Marks
Continuous
Total Marks Duration
Mode
Marks Duration

Biostatistics and Research

BP801T 10 15 1 Hr 25 75 3 Hrs 100
Methodology – Theory
Social and Preventive
BP802T Pharmacy 10 15 1 Hr 25 75 3 Hrs 100
– Theory
Pharma. Marketing
BP803ET
Management–Theory
Pharmaceutical Regulatory
BP804ET
Science – Theory
Pharmacovigilance –
BP805ET
Theory
Quality Control and
Standardizations of Herbals
BP806ET
–Theory
Computer Aided Drug
BP807ET
Design –Theory
Cell and Molecular Biology
BP808ET
–Theory
100 +
10 + 10 15 + 15 = 1 + 1 = 25 + 25 = 75 + 75 3 + 3 = 6
100 =
BP809ET Cosmetic Science – Theory = 20 30 2 Hrs 50 = 150 Hrs
200
Experimental
BP810ET
Pharmacology
Advanced Instrumentation
BP811ET
Techniques – Theory
Dietary Suppliments and
BP812ET
Nutraceuticals

BP813PW Project Work - - - - 150 4 Hrs 150

Total 40 60 4 Hrs 100 450 16 Hrs 550

11.2 Internal assessment: Continuous mode
The marks allocated for 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 2 activities e.g. quiz,
assignment, 4
open book test, field work, group discussion and seminar) 03
Student – Teacher interaction 2
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
Theory Practical
Attendance
95 – 100 4 2

90 – 94 3 1.5

85 – 89 2 1

80 – 84 1 0.5

Less than 80 0 0

11.2.1. 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 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.
Sessional exam shall be conducted for 30 marks for theory and shall be computed for
15 marks. Similarly Sessional exam for practical shall be conducted for 40 marks and
shall be computed for 10 marks. The duration for the conduct of the exam is as below

Exam Type Marks allotted Duration

Theory 30 1.5 Hr

Practical 40 04 Hr

Question paper pattern for theory Sessional

For subjects having University exams

I. Objective Type Questions (Answer 05 out of 7) =5 x 2 = 10

II. Long Answers (Answer 1 out of 2) =1 x 10 = 10
III. Short Answers (Answer 2 out of 3) =2 x 5 = 10
Total 30 marks

For subjects having Non University Examination

I. Long Answers (Answer 1 outof2) =1 x 10 = 10

II.Short Answers (Answer 4 outof 6) =4 x 5 = 20
Total 30 marks

Question paper pattern for practical sessional examinations

I. Synopsis = 10
II. Experiments = 25
III. Viva voce = 05
Total 40 marks

12 . Promotion and award of grades

A student shall be declared PASS and eligible for getting gradein 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 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 for grade obtained by him/her on passing.
14. Improvement of internal assessment
A student shall have the opportunity to improve his/her performance only oncein the
Sessional exam component of the internal assessment. The re-conduct of the Sessional
exam shall be completed before the commencement of next end semester theory
examinations.
15. Re-examination of end semester examinations
Reexamination of 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

For Regular For Failed

Semester
Candidates Candidates

I, III, V and VII November / December May / June

II, IV, VI and

May / June November / December
VIII

Question paper pattern for end semester theory examinations

For 75 marks paper

I. Objective Type Questions (Answer 5 out of 7) =5x 3= 15

II. Long Answers (Answer 2 out of 4) = 2 x 10 = 20
III. Short Answers (Answer 8 out of 10) = 8 x 5 = 40
Total = 75marks

For 50 marks paper

 I. Long Answers (Answer 2 out of 3) = 2 x 10 = 20
II. Short Answers (Answer 6 out of 8) = 6 x 5 = 30
Total = 50 marks

For 35 marks paper

I. Long Answers (Answer 1out of 2 ) = 1 x 10 = 10

II. Short Answers (Answer 5 out of 7) = 5 x 5 = 25
Total = 25marks

Question paper pattern for end semester practical examinations

I. Synopsis =5
II. Experiments = 25
III. Viva voce = 05
Total = 35marks

16. Academic Progression:

No student shall be admitted to any examination unless he/she fulfills the norms
givenin6. 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 V semester until all the courses of I and II semesters are
successfullycompleted.
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 within 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
successfullycompleted.
 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 successfullycompleted.
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 anysemester.
Note: Grade ABshould 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 anysemester.
Rules for Carry Forward:
The curriculum (including regulations, structure and syllabi) is in force from
academic year 2018-19 and onwards for First Year B. Pharm, for academic
year 2019- 20 onwards for Second Year B. Pharm., for academic year 2020-21 and
onwards for Third Year B. Pharm., and for academic year 2021-22 and onwards for
Final Year B. Pharm.
The learners who were admitted to First Year B. Pharm. of 2015 pattern during the
academic year 2017-18 or before & failed in the First Year B.Pharm. of 2015 pattern
examination will have to take admission to Semester-III of Second Year B. Pharm. of
2018 pattern in academic year 2019-20 or onwards, provided that
a. Their result of F. Y. B. Pharm of 2015 pattern is either pass or fails with A. T.
K. T.
The said students will have to take up additional remedial courses as follows.
b. The learners who were admitted to S.Y B. Pharm. of 2015 pattern during the
academic year 2018-19 or before and fail in the S.Y B.Pharm. of 2015 pattern
examination will have to take admission to Semester-V of Third Year B.
Pharm. of 2018 pattern in academic year 2020-21 or onwards, provided
thatTheir result of S. Y. B. Pharm of 2015 pattern is either pass or fails with A.
T. K. T. The said students will have to take up additional remedial course as
follows.

17. Grading of performances:

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 –XII.
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

Less than 50 F 0 Fail

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 equalto:

C 1G1 + 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 a F or ABS grade in
course 4, the SGPA shall then be computed as:

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 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 pass grade on subsequent examination(s) the CGPA 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 semester I,II,III,….
and S1,S2, S3,….is the SGPA of semester I,II,III,…. .

20. Declaration ofclass

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

First Class with Distinction = CGPA of. 7.50 and above

First Class = CGPA of. 6.00 to7.49
Second Class = CGPA of. 5.00 to5.99

21. Project work

A] Selection of the Project Topic
All the students shall undertake a projectunder the supervision of a teacher and
submit a report.The project can be based on Lab oriented( small part of
original research work) Study /Survey oriented or Computational studies
or oriented. / Review topic/ Extension of Practice school work etc., based
on Current Trends in Pharmaceutical science. The project shall be carried
out in group not exceeding 5 in number. The project report shall be submitted
in triplicate (typed &hard bound copy not less than 25 pages).
The internal and external examiner appointed for evaluation of the project
shall be approved teachers of SPPU /Industrial Experts appointed by Principal
of the respective institute. 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
Communications kills 20Marks
Question and answers kills 30Marks

Total 75Marks

Explanation: All the students should be evaluated thoroughly based on their

performance in the Laboratory /Literature work and presentation done as
individual student under given criteria.
B] Practice School /Project Coordinator:
One of the Staff members shall be assigned as the Project coordinator for a
given Academic Year.
Duties of the Coordinator:
a. Overall co-ordination
b. Facilitator in Guide-Student allotment.
c. Preparation of schedules and Time – tables.
d. All relevant documentation and filing
e. Submission of marks to and communication with College and
University exam sections.
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 Production unit, Quality
Control department, Quality Assurance department, Analytical laboratory, Chemical
manufacturing unit, 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 satisfactory report of
such work and certificate duly signed by the authority of training organization to the
head of the institute.
AND/OR
Every candidate shall be required to undergo any one of the Skill development
modules mentioned below (Duration – Min. 04 weeks)
a) Hands on Training (Central instrumentation lab/Machine room etc)
b) UGC/AICTE recognized online courses (SWAYAM/NPTEL etc)
After the successful completion of the module the candidate shall submit satisfactory
report and certificate duly signed by the authority of training organization/Head of the
institute
23. Practice School
In the VII semester, every candidate shall undergo practice school for a period of 150
hours evenly distributed throughout the semester. The student shall opt any one of the
domains for 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 through practice school shall be evaluated by the subject
experts at college level and grade point shall be awarded.

24. Award of Ranks

Ranks and Medals shall be awarded on the basis of final CGPA. However, candidates
who fail in one or more courses during the B.Pharm program shall not be eligible for
award of ranks. Moreover, the candidates should have completed the B. Pharm
program in 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 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 staid period,
otherwise they have to get fresh Registration.
27. Re-admission after break of study
Candidate who seeks re-admission to the program after break of study has to get the
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 requiredfees.
 FINAL YEAR B. PHARM SEMESTER – VII

INSTRUMENTAL METHODS OF ANALYSIS 45

BP701T
(Theory) Hours
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 the course the student shall be able to:
1. Upon completion of the course the student shall be ableto
2. Illustrate the interaction of matter with electromagnetic radiations and justify its
applications in drug analysis
3. Classifythechromatographicseparationmethodsandchooseappropriatetechniquefor
analysis of drugs.
4. Design methods for performing quantitative & qualitative analysis of drugs using
various analytical instruments.
Course Content:
UNIT - I
UV Visible spectroscopy
Introduction to spectroscopy, 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 10
Photodiode. Hours
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
UNIT –II
FTIR spectroscopy
Introduction, fundamental modes of vibrations in poly atomic molecules,
sample handling, factors affecting vibrations
10
Instrumentation - Sources of radiation, wavelength selectors, detectors - Hours
Golay cell, Bolometer, Thermocouple, Thermister, Pyroelectric detector,
FTIR instrument, sample handling attachments –DRS and ATR and
applications
Flame Photometry
Principle, interferences, instrumentation and applications
Atomic absorption spectroscopy
Principle, interferences, instrumentation and Applications
Nepheloturbidimetry
Introduction
UNIT –III
Introduction to chromatography -
Adsorption and partition column chromatography:
Methodology, advantages, disadvantages and applications.
Paper chromatography:
Introduction, methodology, development techniques, advantages, 10
disadvantages and applications Hours
Thin layer chromatography:
Introduction, Principle, Methodology, Rf values, advantages, disadvantages
and applications.
HPTLC:
Introduction, Instrumentation and applications

UNIT –IV
Theory of Chromatography
Plate theory, Rate theory, System suitability parameters
Gas chromatography 08
Introduction, theory, instrumentation, temperatureprogramming,advantages, Hours
disadvantages andapplications
High performance liquid chromatography (HPLC)
Introduction, theory, instrumentation, advantages and applications.
UNIT –V
Ion exchange chromatography-
Introduction, classification, ion exchange resins, properties, mechanism of
ion exchange process, factors affecting ion exchange, methodology and 07
applications Hours
Gel chromatography-
Introduction, theory, instrumentation and applications Affinity
chromatography- Introduction

Recommended Books (Latest Editions):

1. Instrumental Methods of Chemical Analysis by B.K Sharma
2. Organic spectroscopy by Y.RSharma
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 WilliamKemp
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 bySilverstein.
 45
BP702T INDUSTRIAL PHARMACY -II (Theory)
Hours
Scope:
This course is designed to impart fundamental knowledge on pharmaceutical product
development and translation from laboratory to market.
Objectives: Upon completion of the course, the student shall be able to:
1. Know the process of pilot plant and scale up of pharmaceutical dosage forms
2. Understand the process of technology transfer from lab scale to commercial batch
3. Know different Laws and Acts that regulate pharmaceutical industry
4. Understand the approval process and regulatory requirements for drug products
Course Content:

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

UNIT-II
Technology development and transfer:
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, 10
finished products, packaging materials) Documentation, Premises and Hours
equipments, qualification and validation, quality control, analytical method
transfer, Approved regulatory bodies and agencies,Commercialization-
practicalaspectsandproblems(casestudies),TTagencies in India - APCTD,
NRDC, TIFAC, BCIL, TBSE / SIDBI; TT related documentation -
confidentiality agreement, licensing, MoU’s, legal issues
UNIT-III
Regulatory affairs: 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, 10
Drug Hours
MetabolismandToxicology,GeneralconsiderationsofInvestigationalNewDrug(IN
D)
Application,Investigator’sBrochure(IB)andNewDrugApplication(NDA),Clinical
research / BE studies, Clinical Research Protocols, Biostatistics in
Pharmaceutical

Product Development, Data Presentation for FDA Submissions, Management of

Clinical Studies.

UNIT-IV
Indian Regulatory Requirements:
Central Drug Standard Control Organization (CDSCO) and State Licensing
07
Authority: Organization, Responsibilities, Certificate of Pharmaceutical Hours
Product (COPP), Regulatory requirements and approval procedures for New
Drugs.

UNIT-V
Quality management systems:
Quality management & Certifications: Concept of Quality, Total Quality 08
Management, Quality by Design (QbD), Six Sigma concept, Out of Hours
Specifications (OOS), Change control, Introduction to ISO 9000 series of
quality systems standards, ISO 14000, NABL, GLP

Recommended Books: (Latest Editions)

1. Regulatory Affairs from Wikipedia, the free encyclopedia modified on 7thApril
available at http,//en.wikipedia.org/wiki/Regulatory_Affairs.
2. International Regulatory Affairs Updates, 2005.available
athttp://www.iraup.com/about.php
3. Douglas J Pisano and David S. Mantus. Text book of FDA Regulatory Affairsa
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.
 45
BP703T PHARMACY PRACTICE (Theory) Hour
s
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 and dispensing of drugs, responding to
minor ailments by providing suitable safe medication, patient counseling for improved patient
care in the community setup.
Objectives:
Upon completion of the course, the student shall be able to:
1. Know various drug distribution methods in a hospital
2. Appreciate the pharmacy stores management and inventory control
3. Monitor drug therapy of patient through medication chart review and clinical review.
4. Obtain medication history interview and counsel the patients
5. Identify drug related problems
6. Detect and assess adverse drug reactions
7. Interpret selected laboratory results (as monitoring parameters in therapeutics) of
specific disease states
8. Know pharmaceutical care services
9. Do patient counseling in community pharmacy;
10. Appreciate the concept of rational drug therapy.
Course Content:
UNIT-I
Hospital and it’s organization
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.
Hospital pharmacy and its organization
10
Definition, functions of hospital pharmacy, Organization structure, Location, Hours
Layout and staff requirements, and Responsibilities and functions of hospital
pharmacists.
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.
Community Pharmacy
Organization and structure of retail and wholesale drug store, types and design,
Legal
requirementsforestablishmentandmaintenanceofadrugstore,Dispensingofpropriet
ary products, maintenance of records of retail and wholesale drugstore.

UNIT-II 10
Drug distribution system in a hospital Hours
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. 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. Therapeutic drug monitoring
Need for Therapeutic Drug Monitoring, Factors to be considered during the
Therapeutic Drug Monitoring, and Indian scenario for Therapeutic Drug
Monitoring. Medication adherence
Causes of medication non-adherence, pharmacist role in the medication
adherence, and monitoring of patient medication adherence.
Patient medication history interview
Need for the patient medication history interview, medication interview forms.
Community pharmacy management
Financial, materials, staff, and infrastructure requirements.

UNIT-III
Pharmacy and therapeutic committee
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.
Drug information services
Drug and Poison information centre, Sources ofdrug information,
Computerized services, and storage and retrieval of information.
Patient counseling 10
Definition of patient counseling; steps involved in patient counseling, and Hour
Special cases that require the pharmacist s
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.
Prescribed medication order and communication skills
Prescribed medication order- interpretation and legal requirements, and
Communication skills- communication with prescribers and patients.
UNIT-IV
Budget preparation and implementation Budget preparation and
implementation 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,
08
Medication history and Pharmaceutical care.
Hour
Dosing pattern and drug therapy based on Pharmacokinetic & disease pattern. s
Over the counter (OTC) sales
Introduction and sale of over the counter, and Rational use of common
over the counter medications.

UNIT-V
Drug store management and inventory control
Organization 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 07
expenditure. Hour
s
Investigational use of drugs
Description,principals involved, classification, control, identification, role
of hospital pharmacist, advisory committee.
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)
 45
NOVEL DRUG DELIVERY SYSTEM (Theory)
BP704T Hours
Scope:
This subject is designed to impart basic knowledge on the area of novel drug delivery
systems.
Objectives:
Upon completion of the course student shall be able
1. To understand various approaches for development of novel drug delivery systems.
2. To understand the criteria for selection of drugs and polymers for the development
of novel drug delivery systems, their formulation and evaluation.
Course Content:

UNIT-I
Controlled drug delivery systems:
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 10 Hours
drugs relevant to controlled release formulations
Polymers:
Introduction, classification, properties, advantages and application of
polymers in formulation of controlled release drug delivery systems.

UNIT-II
Microencapsulation:
Definition, advantages and disadvantages, microspheres
/microcapsules, microparticles, methods of microencapsulation,
applications
Mucosal Drug Delivery system:
10 Hours
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.
UNIT-III
Transdermal Drug Delivery Systems:
Introduction, Permeation through skin, factors affecting permeation,
permeation enhancers, basic components of TDDS, formulation
approaches.
Gastroretentive drug delivery systems:
Introduction, advantages, disadvantages, approaches for GRDDS – 10 Hours
Floating, high density systems, inflatable and gastro adhesive systems
and their applications
Nasopulmonary drug delivery system:
Introduction to Nasal and Pulmonary routes of drug delivery
,Formulation of Inhalers(dry powder and metered dose), nasal
sprays,nebulizers.
UNIT-IV
Targeted drug Delivery:
Concepts and approaches advantages and disadvantages, introduction to 08 Hours
liposomes, niosomes, nanoparticles, monoclonal antibodies and their
applications.

UNIT-V
Ocular Drug Delivery Systems:
Introduction, intra ocular barriers and methods to overcome –Preliminary
study, ocular formulations and ocuserts
07 Hours
Intrauterine Drug Delivery Systems:
Introduction, advantages and disadvantages, development of intra uterine
devices (IUDs) and applications

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,VallabhPrakashan, New Delhi, First edition2002.
 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)
International Journal of Pharmaceutics (Elsevier Sciences)

04 Hours/
BP705P INSTRUMENTAL METHODS OF ANALYSIS (Practical)
Week
1. Weights and measures and pharmacopoeia inanalysis
2. Determination of absorption maxima and effect of solvent on absorption maxima of
organiccompounds
3. Assay of Drug product as per IP (Assay of Paracetamol tablet by UV-
Spectrophotometry)
4. Assay of Drug product by Calibration curvemethod
5. Assay of any drug/drug product bycolorimetry.
6. Simultaneous estimation of multicomponent formulation by UV spectroscopy(SE/Q
analysis)
7. Estimation of drug by fluorimetry
8. Study of quenching of fluorescence
9. Determination of sodium and potassium by flame photometry
10. Separation of amino acids by paper chromatography
11. Separation of sugars by thin layer chromatography
12. Separation of plant pigments by columnchromatography
13. Demonstration of HPLC instrument
14. Demonstration of FTIRinstrument
15. Interpretation of spectra of organic compounds by IR spectroscopy asper
pharmacopoeia
Recommended Books (Latest Editions)
1. Instrumental Methods of Chemical Analysis by B.KSharma
2. Organic spectroscopy by Y.RSharma
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 WilliamKemp
8. Quantitative Analysis of Drugs by D. C. Garrett
9. Quantitative Analysis of Drugs in Pharmaceutical Formulations by P. D. Sethi
10. HPLC by P.D.Sethi
11. HPTLC by P.D. Sethi
12. Spectrophotometric identification of Organic Compounds bySilverstein

BP706PS PRACTICE SCHOOL* 150 Hours

In the VII semester, every candidate shall undergo practice school for a period of 150 hours
evenly distributed throughout the semester. The student shall opt any one of the domains for
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 through practice school shall be evaluated by the subject experts at college level and
grade point shall be awarded.
 SEMESTER – VIII

BIOSTATISTICS AND RESEARCH METHODOLOGY 45

BP801T
(Theory) Hours
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
1. Know the operation of M.S. Excel, SPSS, R and MINITAB®, DoE (Design of
Experiment)
2. Know the various statistical techniques to solve statistical problems
3. Appreciate statistical techniques in solving the problems.

Course content:

UNIT-I
Introduction:
Statistics, Biostatistics, Frequency distribution
Measures of central tendency:
Mean, Median, Mode- Pharmaceutical examples 10
Measures of dispersion: Hours
Dispersion, Range, standard deviation, Pharmaceutical problems
Correlation:
Definition,KarlPearson’scoefficientofcorrelation,Multiplecorrelation-
Pharmaceuticals examples

UNIT-II
Regression:
Curve fitting by the method of least squares, fitting the lines y= a + bx and x = a
+ by, Multiple regression, standard error of regression– Pharmaceutical Examples
Probability:
Definition of probability, Binomial distribution, Normal distribution, Poisson’s
distribution,properties– 10
problems,Sample,Population,largesample,smallsample,Null Hours
hypothesis,alternativehypothesis,sampling,essenceofsampling,typesofsampling,
Error-I type, Error-II type, Standard error of mean (SEM) - Pharmaceutical
examples
Parametric test:
t-test(Sample, Pooled or Unpaired and Paired),ANOVA,(Oneway and Two
way),Least Significance difference
UNIT-III
Non Parametric tests:
Wilcoxon Rank Sum Test, Mann-Whitney U test, Kruskal-Wallis test, Friedman
Test
Introduction to Research:
Need for research, Need for design of Experiments, Experiential Design
10
Technique, plagiarism
Hours
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
ofdata, Protocol,Cohortsstudies, Observational studies,Experimental
studies,Designingclinical trial, various phases.
UNIT-IV
Blocking and confounding system for Two-level factorials
Regression modeling:
Hypothesis testing in Simple and Multiple regression nmodels 08
Introduction to Practical components of Industrial and Clinical Trials Hours
Problems: Statistical Analysis Using Excel, SPSS, MINITAB®, DESIGN OF
EXPERIMENTS, R - Online Statistical Software’s to Industrial and Clinical trial
approach
UNIT-V
Design and Analysis of experiments:
Factorial Design: 07
Definition, 22, 23 design. Advantage of factorial design Hours
Response Surface methodology:
Central composite design, Historical design, Optimization Techniques
Recommended Books (Latest edition):
1. Pharmaceutical statistics- Practical and clinical applications, Sanford Bolton,
publisher Marcel Dekker Inc. NewYork.
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
andC.Montgomery
 45
BP802T SOCIAL AND PREVENTIVE PHARMACY (Theory)
Hours
Scope:
The purpose of this course is to introduce to students a number of health issues and their
challenges. This course also introduced a number of national health programmes. The roles of
the pharmacist in these contexts are also discussed.
Objectives:
After the successful completion of this course, the student shall be able to:
1. Acquire high consciousness/realization of current issues related to health and
pharmaceutical problems within the country andworldwide.
2. Develop a critical way of thinking based on current health care development.
3. Evaluate alternative ways of solving problems related to health and pharmaceutical
issues.
Course Content:
UNIT-I
Concept of health and 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. 10
Sociology and health Hours
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.

UNIT-II
Preventive medicine
General principles of prevention and control of diseases such as cholera, SARS, 10
Ebola virus, influenza, acute respiratory infections, malaria, chicken guinea, Hours
dengue, lymphatic filariasis, pneumonia, hypertension, diabetes mellitus, cancer,
drug addiction-drug substance abuse

UNIT-III
National health programs, its objectives, functioning and outcome of the
following: HIV AND AIDS control programme, TB, Integrated disease
10
surveillance program (IDSP), National leprosy control programme, National
Hours
mental health program, National programme for prevention and control of
deafness, Universal immunization programme,National programme for control of
blindness, Pulse polio programme.

UNIT-IV
National health intervention programme for mother and child, National family
08
welfare programme, National tobacco control programme, National Malaria
Hours
PreventionProgram, National programme for the health care for the elderly, Social
health programme; role of WHO in Indian national program
UNIT-V
Community services in rural, urban and school health: Functions of PHC, 07
Improvement in rural sanitation, national urban health mission, Health promotion Hours
and education in school.
Recommended Books (Latest edition):
1. ShortTextbookofPreventiveandSocialMedicine,PrabhakaraGN,2ndEdition,2010,
ISBN: 9789380704104, JAYPEE Publications
2. Textbook of Preventive and Social Medicine (Mahajan and Gupta), Edited by
Roy RabindraNath, Saha Indranil, 4th Edition, 2013, ISBN: 9789350901878,
JAYPEE Publications
3. Review of Preventive and Social Medicine (Including Biostatistics), Jain
Vivek, 6thEdition, 2014, ISBN: 9789351522331, JAYPEEPublications
4. Essentials of Community Medicine: A Practical Approach, Hiremath Lalita D,
HiremathDhananjaya A, 2nd Edition, 2012, ISBN: 9789350250440, JAYPEE
Publications
5. Park Textbook of Preventive and Social Medicine, K Park, 21st Edition, 2011,
ISBN- 14: 9788190128285, BANARSIDAS BHANOTPUBLISHERS.
6. Community Pharmacy Practice, Ramesh Adepu, BSP publishers,Hyderabad

Recommended Journals:
1. Research in Social and Administrative Pharmacy, Elsevier, Ireland
 45
BP803ET PHARMACEUTICAL MARKETING (Theory)
Hours
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.
Objective:
The course aims to provide an understanding of marketing concepts and techniques and their
applications in the pharmaceutical industry.
Course Content:

UNIT-I
Marketing:
Definition, general concepts and scope of marketing; Distinction between
marketing & selling; Marketing environment; Industry and competitive analysis;
Analyzing consumer buying behavior; industrial buying behavior.
Pharmaceutical market: 10 Hours
Quantitative and qualitative aspects; size and composition of the market;
demographic descriptions and socio-psychological characteristics of the
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.

UNIT-II
Product decision:
Classification, product line and product mix decisions, product life
10 Hours
cycle, product portfolio analysis; product positioning; New product decisions;
Product branding, packaging and labelling decisions, Product management in
pharmaceutical industry.

UNIT-III
Promotion:
Methods, determinants of promotional mix, promotional budget; An overview of 10 Hours
personal selling, advertising, direct mail, journals, sampling, retailing, medical
exhibition, public relations, online promotional techniques for OTC Products.
UNIT-IV
Pharmaceutical marketing channels:
Designing channel, channel members, selecting the appropriate channel, conflict
in channels, physical distribution management: Strategic importance, tasks
inphysical distributionmanagement. 08
Hours
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.

UNIT-V
Pricing:
Meaning, importance, objectives, determinants of price; pricing methods and
strategies, issues in price management in pharmaceutical industry. An overview
of DPCO
07
(Drug Price Control Order) and NPPA (National Pharmaceutical Pricing Hours
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
ofIndia, NewDelhi
2. Walker, Boyd and Larreche : Marketing Strategy- Planning and
Implementation, Tata MC GrawHill, New Delhi.
3. Dhruv Grewal and Michael Levy: Marketing, Tata MC GrawHill
4. Arun Kumar and N Menakshi: Marketing Management, Vikas
Publishing,India
5. RajanSaxena: Marketing Management; Tata MC Graw-Hill (IndiaEdition)
6. Ramaswamy,U.S&Nanakamari,S:MarketingManagemnt:GlobalPerspective,I
ndian Context, Macmilan India, NewDelhi.
7. Shanker, Ravi: Service Marketing, Excell Books, NewDelhi
8. Subba Rao Changanti, Pharmaceutical Marketing in India (GIFT – Excel
series)Excel Publications.
BP804ET PHARMACEUTICAL REGULATORY SCIENCE (Theory) 45 Hours

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 subject student shall be able to;
1. Know about the process of drug discovery and development
2. Know the regulatory authorities and agencies governing the manufacture andsale of
pharmaceuticals
3. Know the regulatory approval process and their registration in Indian andinternational markets.
Course content:

UNIT-I
New Drug Discovery and development
Stages of drug discovery, Drug development process, pre-clinical studies, non-clinical 10 Hours
activities, clinical studies, Innovator and generics, Concept of generics, Generic drug
product development.

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

UNIT-III
Registration of Indian drug product in overseas market
Procedure for export of pharmaceutical products, Technical documentation, Drug Master 10 Hours
Files (DMF), Common Technical Document (CTD), electronic Common Technical
Document (eCTD), ASEAN Common Technical Document (ACTD) research.
UNIT-IV
Clinical trials
Developing clinical trial protocols, Institutional Review Board / Independent Ethics 08 Hours
committee - formation and working procedures, Informed consent process and
procedures, GCP obligations of Investigators, sponsors & Monitors, Managing and
Monitoring clinical trials, Pharmacovigilance -safety monitoring in clinical trials

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

Recommended books (Latest edition):

• Drug Regulatory Affairs by SachinItkar, Dr. N.S. Vyawahare, NiraliPrakashan.
• The Pharmaceutical Regulatory Process, Second Edition Edited by Ira R. Berry
and Robert P. Martin, Drugs and the Pharmaceutical Sciences, Vol.185.
InformaHealth carepublishers.
• New Drug Approval Process: Accelerating Global Registrations By Richard A
Guarino,MD,5thedition, Drugsand the Pharmaceutical Sciences, Vol.190.
• Guidebook for drug regulatory submissions / Sandy Weinberg. By John Wiley
&Sons. Inc.
• FDA Regulatory Affairs: a guide for prescription drugs, medical devices,
andbiologics
• /edited by Douglas J. Pisano, David Mantus.
• Generic Drug Product Development, Solid Oral Dosage forms, Leon Shargeland
IsaderKaufer, Marcel Dekker series,Vol.143
• Clinical Trials and Human Research: A Practical Guide to RegulatoryCompliance
By Fay A. Rozovsky and Rodney K.Adams
• Principles and Practices of Clinical Research, Second Edition Edited by JohnI.
Gallin and Frederick P.Ognibene
• Drugs: From Discovery to Approval, Second Edition By RickNg
BP805ET PHARMACOVIGILANCE (Theory) 45 Hours

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
andsignaldetection.Thispaperalsodevelopstheskillsofclassifyingdrugs,diseasesand adverse
drugreactions
Objectives:
• At completion of this paper it is expected that students will be able to (know, do, and appreciate):
• Understand importance of drug safetymonitoring.
• Explain History, development, National and international scenario of pharmacovigilance &
comprehend dictionaries, coding and terminologies used in pharmacovigilance
• Understand detection and assessment of new adverse drug reactions, Adverse drug reaction
reporting systems and communication in pharmacovigilance, Pharmacovigilance Program of
India (PvPI) requirement for ADR reporting in India ICH guidelines for ICSR, PSUR, expedited
reporting, pharmacovigilance planning. CIOMS requirements for ADRreporting
• Comprehend methods of safety data during pre-clinical, clinical andpost approval phases of
drugs’ lifecycle.
• Write case narratives of adverse events and their quality.
Course Content:

UNIT-I
Introduction to Pharmacovigilance
History and development of Pharmacovigilance, Importance of safety monitoring of
Medicine, WHO international drug monitoring programme, Pharmacovigilance Program
of India (PvPI)
Introduction to adverse drug reactions 10 Hours
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
Basic terminologies used in pharmacovigilance
Terminologies of adverse medication related events, Regulatory terminologies
UNIT-II
Drug and disease classification
Anatomical, therapeutic and chemical classification of drugs, International
classification of diseases, Daily defined doses, International Nonproprietary
Names for drugs
Drug dictionaries and coding in pharmacovigilance
WHO adverse reaction terminologies, MedDRA and Standardized MedDRA 10
queries, WHO drug dictionary, Eudravigilance medicinal product dictionary Hours
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.

UNIT-III
Vaccine safety surveillance
Vaccine Pharmacovigilance, Vaccination failure, Adverse events following
immunization
Pharmacovigilance methods
Passive surveillance – Spontaneous reports and case series, Stimulated reporting,
10
Active surveillance – Sentinel sites, drug event monitoring and registries, Hours
Comparative observational studies – Cross sectional study, case control study and
cohort study, Targeted clinical investigations
Communication in pharmacovigilance
Effective communication in Pharmacovigilance, Communication in Drug Safety
Crisis management, Communicating with Regulatory Agencies, Business
Partners, Healthcare facilities & Media

UNIT-IV
Safety data generation
Pre-clinical phase, Clinical phase, Post approval phase (PMS)
08
ICH Guidelines for Pharmacovigilance Hours
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
UNIT-V
Pharmacogenomics of adverse drug reaction
Genetics related ADR with example focusing PK parameters.
07
CIOMS
Hours
CIOMSWorking Groups, CIOMS Form CDSCO (India) and Pharmaco -
vigilance D&C Act and Schedule Y
Differences in Indian and global pharmacovigilance requirements
Recommended Books (Latest edition):
1. Textbook of Pharmacovigilance: S K Gupta, Jaypee Brothers, MedicalPublishers.
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, WileyPublishers.
4. Stephens' Detection of New Adverse Drug Reactions: John Talbot, PatrickWalle,
WileyPublishers.
5. An Introduction to Pharmacovigilance: Patrick Waller,Wiley Publishers.
6. Cobert's Manual of Drug Safety and Pharmacovigilance: Barton Cobert,Jones&
BartlettPublishers.
7. Textbook of Pharmacoepidemiolog edited by Brian L. Strom, Stephen E Kimmel, Sean
Hennessy, WileyPublishers.
8. A Textbook of Clinical Pharmacy Practice -Essential Concepts and Skills:G.
Parthasarathi, Karin NyfortHansen, Milap C.Nahata
9. National Formulary ofIndia
10. Text Book of Medicine by YashpalMunjal
11. Text book of Pharmacovigilance: concept and practice by GP Mohanta and PK Manna
12. http://www.whoumc.org/DynPage.aspx?id=105825&mn1=7347&mn2=7259&mn
3=7297
13. http://www.ich.org/
14. http://www.cioms.ch/
15. http://cdsco.nic.in/
16. http://www.who.int/vaccine_safety/en/
17. http://www.ipc.gov.in/PvPI/pv_home.html
 QUALITY CONTROL AND STANDARDIZATION OF
BP806ET 45 Hours
HERBALS(Theory)

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 subject student shall be able to;
1. Know WHO guidelines for quality control of herbal drugs
2. Know Quality assurance in herbal drug industry
3. Know the regulatory approval process and their registration in Indian and international
markets
4. Appreciate EU and ICH guidelines for quality control of herbal drugs
Course Content

UNIT-I
Basic tests for drugs – Pharmaceutical substances, Medicinal plants materialsand 10 Hours
dosage forms, WHO guidelines for quality control of herbal drugs, Evaluation of
commercial crude drugs intended foruse

UNIT-II
• Quality assurance in herbal drug industry of cGMP, GAP, GMP and
GLP in traditional system of medicine 10 Hours
• WHO guidelines on current Good Manufacturing Practices (cGMP) for
Herbal Medicines, WHO guidelines on GACP for Medicinal Plants.

UNIT-III
• EU and ICH guidelines for quality control of herbal drugs.
10 Hours
• Research Guidelines for Evaluating the Safety and Efficacy of Herbal
Medicines

UNIT-IV
• Stability testing of herbal medicines. Application of various
chromatographic techniques in standardization of herbal products. 08 Hours
• Preparation of documents for new drug application and export registration
• GMP requirements and Drugs & Cosmetics Act provisions.
UNIT-V
Regulatory requirements for herbal medicines.
07
WHO guidelines on safety monitoring of herbal medicines in pharmacovigilance Hours
systems.
Comparison of various Herbal Pharmacopoeias.
Recommended Books (Latest Editions)
• Role Pharmacognosy by Trease and Evans
• Pharmacognosy by Kokate, Purohit andGokhale
• Rangari, V.D., Text book of Pharmacognosy and Phytochemistry Vol.
I,Carrier Pub., 2006.
• Aggrawal, S.S., Herbal Drug Technology. Universities Press,2002.
• EMEA. Guidelines on Quality of Herbal Medicinal Products/Traditional
Medicinal Products,
• Mukherjee, P.W. Quality Control of Herbal Drugs: An Approach to
Evaluation of Botanicals. Business Horizons Publishers, New Delhi,
India,2002.
• 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.
• WHO. The International Pharmacopeia, Vol. 2: Quality Specifications,
3rdedn. World Health Organization, Geneva,1981.
• WHO. Quality Control Methods for Medicinal Plant Materials. World Health
Organization, Geneva,1999.
• 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.
• WHO. Guidelines on Good Agricultural and Collection Practices (GACP)for
Medicinal Plants. World Health Organization, Geneva, 2004.
BP807ET COMPUTER AIDED DRUG DESIGN (Theory) 45 Hours

Scope:
This subject is designed to provide detailed knowledge of rational drug design process and various
techniques used in rational drug design process.
Objectives:
Upon completion of the course, the student shall be able to understand
1. Understand the design and discovery of leadmolecules
2. Classify the role of drug design tools for drug discoveryprocess
3. Understand and analyse concepts of QSAR anddocking
4. Analyse and apply various strategies to develop new drug likemolecules.
5. Use various molecular modeling software to design new drugmolecule
Course Content
UNIT-I
Introduction to Drug Discovery and Development -
Stages of drug discovery and development,
Lead discovery approaches - 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.
14 Hours
Introduction to Ligand based and Structure Based DD
Analog Based Drug Design - Bioisosterism, Bioisosteric replacement
Case studies -
Ligand based (Design of inhibitors of tubulin polymerization eg. Colchicine), Structure
based (Design of HMG-CoA reductase inhibitors. eg. Statins) and Analog based DD
(Design of H2 histamine antagonist eg. Cimetidine)
UNIT- II
Introduction to Computational tools Molecular Modeling -
Introduction to molecular mechanics and quantum mechanics.
Energy Minimization methods and Conformational Analysis, global conformational 10 Hours
minima determination.
Molecular docking -
Rigid docking, flexible docking, manual docking, Docking based screening.
UNIT- III
Quantitative Structure Activity Relationship (QSAR) and Pharmacophore modeling
Introduction -
SAR versus QSAR, History and development of QSAR, Types of
physicochemicalparameters
2D QSAR -
Experimental and theoretical approaches for the determination of physicochemical
14 Hours
parameters such as Partition coefficient, Hammet’s substituent constant and Tafts steric
constant. Hansch’s analysis, Free Wilson analysis
3D-QSAR approaches -
COMFA and COMSIA.
Pharmacophore modeling -
Drug likeness screening, Concept of Pharmacophore mapping and Pharmacophore based
screening
UNIT- IV
Informatics & Methods in drug design Introduction to Bioinformatics, chemo
informatics Databases - 07 Hours
Chemical database, Natural compound database, Drug like compound database ,
Drug bank

Recommended Books (Latest Editions)

1. Robert GCK, ed., “Drug Action at the Molecular Level” University
PrakPress Baltimore.
2. Martin YC. “Quantitative Drug Design” Dekker,NewYork.
3. Delgado JN, Remers WA eds “Wilson &Gisvolds’s Text Book of
OrganicMedicinal & Pharmaceutical Chemistry” Lippincott,NewYork.
4. Foye WO “Principles of Medicinal chemistry ‘Lea&Febiger.
5. Korolkovas A, BurckhalterJH. “Essentials of Medicinal Chemistry” Wiley
Interscience.
6. WolfME,ed“TheBasisofMedicinalChemistry,Burger’sMedicinalChemistry”
John Wiley & Sons,NewYork.
7. PatrickGraham,L.,AnIntroductiontoMedicinalChemistry,OxfordUniversityP
ress.
8. Smith HJ, Williams H, eds, “Introduction to the principles of Drug Design”
WrightBoston.
9. Silverman R.B. “The organic Chemistry of Drug Design and Drug
Action”Academic Press NewYork.
10. D. J. Triggle, John Bodenhan Taylor, Peter Kennewell, Comprehensive
Medicinal Chemistry, Volume I-VIII : Germany: Elsevier Science.
BP808ET CELL AND MOLECULAR BIOLOGY (Theory) 45 Hours

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 lifecycle,
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.
Objectives:
Upon completion of the subject student shall be able to:
1. Summarize cell and molecular biology history, cellular functioning and Composition &
describe the chemical foundations of cell biology.
2. Describe cellular membrane structure and function properties and functionsof DNA,
CellCycle.
3. Describe basic molecular genetics mechanisms.
4. Understand the cell signaling pathways with their regulations and role indisease process.
Course contents

UNIT-I
Cell and Molecular Biology: Definitions theory and basics and Applications.
Cell and Molecular Biology: History and Summation. Properties of cells and 10 Hours
cell membrane, Prokaryotic versus Eukaryotic, Cellular Reproduction,
Chemical Foundations – an Introduction and Reactions (Types)

UNIT-II
DNA and the Flow of Molecular Information, DNA Functioning, DNA and 10 Hours
RNA, Types of RNA, Transcription and Translation

UNIT-III
Proteins: Defined and Amino Acids, Protein Structure, Regularities in Protein 10 Hours
Pathways, Cellular Processes, Positive Control and significance of Protein
Synthesis

UNIT-IV
Science of Genetics, Transgenics and Genomic Analysis, Cell Cycle analysis,
08 Hours
Mitosis and Meiosis, Cellular Activities and Checkpoints Clinical phase, Post
approval phase (PMS)
UNIT-V
Cell Signals: Introduction, Receptors for Cell Signals, Signaling Pathways: 07 Hours
Overview, Misregulation of Signaling Pathways, Protein-Kinases: Functioning
Recommended Books (latest edition):
1. W.B. Hugo and A.D. Russel: Pharmaceutical Microbiology,Blackwell
Scientific publications, OxfordLondon.
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:
PharmaceuticalMicrobiology. Rose: IndustrialMicrobiology.
5. Probisher, Hinsdill et al: Fundamentals of Microbiology, 9th ed.Japan
6. Cooper and Gunn’s: Tutorial Pharmacy, CBS Publisher and Distribution.
Peppler: MicrobialTechnology.
7. Edward: Fundamentals ofMicrobiology.
8. N.K.Jain: Pharmaceutical Microbiology, VallabhPrakashan,Delhi
9. Bergeys manual of systematic bacteriology, Williams and Wilkins- A
WaverlyCompany
10. B.R. Glick and J.J. Pasternak: Molecular Biotechnology: Principlesand
11. Applications of Recombinant DNA: ASM Press Washington D.C. RA
Goldshyet. al., :KubyImmunology.
BP809ET COSMETIC SCIENCE (Theory) 45 Hours

Scope:
Thiscourseisdesignedtoimpartfundamentalknowledgeofcosmeticandcosmeceutical products
&their formulationstudies.
Objectives:
Upon completion of the course, the student shall be able to:
1. Understand the concepts of cosmetics; anatomy of skin v/s hair, general excipients used
incosmetics.
2. Explain the concept of cosmeceuticals, history, difference between cosmetics &
cosmeceuticals & cosmeceuticals agents
3. Know different Laws and Acts that regulate pharmaceutical industry
4. Understand the approval process and regulatory requirements for drug products
Course contents
UNIT-I
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:
10 Hours
Surfactants, rheology modifiers, humectants, emollients, preservatives.
Classification and application
Skin: Basic structure and function of skin.
Hair: Basic structure of hair. Hair growth cycle.
Oral Cavity: Common problem associated with teeth and gums.

UNIT-II
Principles of formulation and building blocks of skin care products:
Face wash, Moisturizing cream, Cold Cream, Vanishing cream and their
advantages and disadvantages. Application of these products in formulation of
cosmeceuticals.
Antiperspants & deodorants- Actives & mechanism of action. Principles of 10 Hours
formulation and building blocks of Hair care products: Conditioning
shampoo, Hair conditioner, anti-dandruff shampoo. Hair oils, Chemistry and
formulation of Para-phylene diamine based hairdye.
Principles of formulation and building blocks of oral care products:
Toothpaste for bleeding gums, sensitive teeth. Teeth whitening, Mouthwash.
UNIT-III
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 10 Hours
clove Analytical cosmetics:
BIS specification and analytical methods for shampoo, skin cream and
toothpaste.

UNIT-IV
Principles of Cosmetic Evaluation: Principles of sebumeter, corneometer.
Measurement 08 Hours
of TEWL, Skin Color, Hair tensile strength, Hair combing properties, Soaps
and syndet bars. Evolution and skin benfits.

UNIT-V
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 07 Hours
Cosmetic problems associated with skin: blemishes, wrinkles, acne, prickly heat
and body odor.
Antiperspirants and Deodorants- Actives and mechanism of action

References
1) Harry’s Cosmeticology, Wilkinson, Moore, Seventh Edition,
GeorgeGodwin.
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,
TataPublishers.
BP810ET EXPERIMENTAL PHARMACOLOGY (Theory) 45 Hours

Scope:
This subject is designed to impart the basic knowledge of preclinical studies in experimental
animals including design, conduct and interpretations of results.
Objectives
Upon completion of the course the student shall be able to,
1. Understand the applications of various commonly used laboratory animals.
2. Demonstrate the various screening methods used in preclinical research.
3. Comprehend and demonstrate the importance of biostatistics and research methodology.
4. Design and execute a research hypothesis independently.
Course contents
UNIT-I
Laboratory Animals:
Study of CPCSEA and OECD guidelines for maintenance, breeding and
conduct of experiments on laboratory animals, Common lab animals: 10 Hours
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.
UNIT-II
Preclinical screening models
a. Introduction: Dose selection, calculation and conversions, preparation of
drug solution/suspensions, grouping of animals and importance of sham
negative and
positivecontrolgroups.Rationaleforselectionofanimalspeciesandsexforthest 10 Hours
udy.
b. Study of screening animal models for Diuretics, nootropics, anti-
Parkinson’s, antiasthmatics, Preclinical screening models: for CNS
activity- analgesic, antipyretic, anti-inflammatory, general anaesthetics,
sedative and hypnotics, antipsychotic, antidepressant, antiepileptic,
antiparkinsonism, alzheimer’s disease.

UNIT-III
Preclinical screening models:
10 Hours
ForANSactivity,sympathomimetics,sympatholytics,parasympathomimetics,para
sympatholytics, skeletal muscle relaxants, drugs acting on eye, local anaethetics
UNIT-IV
Preclinical screening models:
for CVS activity- antihypertensives, diuretics, antiarrhythmic, antidyslepidemic, 08 Hours
anti aggregatory, coagulants, and anticoagulants
Preclinical screening models for other important drugs like antiulcer,
antidiabetic, anticancer and antiasthmatics

UNIT-V
Research methodology and Bio-statistics.
Selection of research topic, review of literature, research hypothesis and study 07 Hours
design Pre- clinical data analysis and interpretation using Students‘t’ test and
One-way ANOVA. Graphical representation ofdata

Recommended Books (latest edition):

1. Fundamentals of experimental Pharmacology-byM. N.Ghosh
2. Hand book of Experimental Pharmacology-S.K. Kulkarni
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 J
Richard
BP811ET ADVANCED INSTRUMENTATION TECHNIQUES (Theory) 45 Hours

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 drugtesting.
Objectives:
Upon completion of the course the student shall be able to
1. Express the principle of the advanced instruments used and justify its applications in
drug analysis
2. Understand the principles of analytical techniques and its application in analysis of
drugs
3. Explain the importance and methods for the calibration of various analytical
instruments
4. Formulate and justify techniques for the analysis of drugs using various analytical
instruments.
Course contents

UNIT-I
Nuclear Magnetic Resonance spectroscopy
Principles of 1H-NMR, chemical shift, factors affecting chemical shift, coupling
constant, Spin - spin coupling, relaxation, instrumentation and applications
13C-NMR- Introduction to 13C-NMR spectroscopy 14 Hours
Mass Spectrometry
Principles, , Ionization techniques –Electron impact, chemical ionization,
MALDI, FAB, Analyzers-Time of flight and Quadrupole, instrumentation,
Fragmentation, applications Simple structural elucidation problems

UNIT-II
Thermal Methods of Analysis
Principles, instrumentation and applications of Thermogravimetric Analysis 07 Hours
(TGA), Differential Thermal Analysis (DTA), Differential Scanning
Calorimetry (DSC)

UNIT-III
Electrophoresis
10 Hours
Introduction, factors affecting electrophoretic mobility, Techniques of paper,
gel,capillary electrophoresis, applications
X-Ray Diffraction Methods
 Origin of X-rays, basic aspects of crystals, Xray Crystallography, rotating
crystal technique, single crystal diffraction,powder diffraction, and
applications.
Calibration of following Instruments
Electronic balance, UV-Visible spectrophotometer, IR spectrophotometer,
Fluorimeter, HPLC.

UNIT-IV
Radio immuno assay
Principle, different methods, Importance, various components, Limitation and
Applications of Radioimmunoassay 06 Hours
Extraction techniques
General principle and procedure involved in the solid phase extraction and
liquid-liquid extraction.

UNIT-V
Hyphenated techniques
08 Hours
Introduction to hyphenated techniques and types of techniques Details of LC-
MS, GC-MS, HPTLC-MS, MS/MS.
Recommended Books (Latest Editions)
1. Instrumental Methods of Chemical Analysis by B.KSharma
2. Organic spectroscopy by Y.RSharma
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 spectroscopy by WilliamKemp
7. Quantitative Analysis of Drugs by D. C. Garrett
8. Spectrophotometric identification of Organic Compounds by Silverstein
9. Introduction to Spectroscopy by Donald Pavia
10. Spectroscopy of Organic compounds by P.S.Kalsi
11. Introduction to Spectroscopy by Donald Pavia
12. Spectroscopy of Organic compounds by P.S.Kalsi

DIETARY SUPPLEMENTS AND NUTRACEUTICALS

BP812ET 45 Hours
(Theory)
Scope:
This subject covers foundational topic that are important for understanding the need and
requirements of dietary supplements among different groups in the population.
Objective:
This module aims to provide an understanding of the concepts behind the theoretical
applications of dietary supplements. By the end of the course, students should be able to:
1. Understand the need of supplements by the different group of people to maintain
healthy life.
2. Understand the outcome of deficiencies in dietary supplements.
3. Recognize the components in dietary supplements and the application.
4. Acquaint with the regulatory and commercial aspects of dietary supplements including
healthclaims.
Course content:
UNIT-I
Definitions of Functional foods, Nutraceuticals and Dietary supplements. 07 Hours
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.
Public health nutrition, maternal and child nutrition, nutrition and ageing,
nutrition education in community.
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
UNIT-II
Phytochemicals as nutraceuticals: Occurrence and characteristic features
(chemical nature medicinal benefits) of following
Carotenoids- α and β-Carotene, Lycopene, Xanthophylls, leutin
Sulfides: Diallyl sulfides, Allyl trisulfide.
Polyphenolics: Reservetrol 15 Hours
Flavonoids- Rutin , Naringin, Quercitin, Anthocyanidins, catechins, Flavones
Prebiotics / Probiotics.: Fructo oligosaccharides, Lacto bacillum Phyto
estrogens : Isoflavones, daidzein, Geebustin, lignans Tocopherols
Proteins, vitamins, minerals, cereal, vegetables and beverages as functional
foods: oats,Wheat bran, rice bran, sea foods, coffee, tea and the like.

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

UNIT-IV
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.
10 Hours
Antioxidants: Endogenous antioxidants – enzymatic and nonenzymatic
antioxidant defense, Superoxide dismutase, catalase, Glutathione peroxidase,
Glutathione Vitamin C, Vitamin E, α- Lipoic acid, melatonin Synthetic
antioxidants: Butylated hydroxy Toluene, Butylated hydroxy Anisole.
Functional foods for chronic disease prevention.
UNIT-V
Effect of processing, storage and interactions of various environmental factors
on the potential of nutraceuticals.
06 Hours
Regulatory Aspects; FSSAI,FDA, FPO,MPO, AGMARK. HACCP and GMPs
on Food Safety. Adulteration of foods.
Pharmacopoeial Specifications for dietary supplements and nutraceuticals.

References:
1. Dietetics by SriLakshmi
2. Role of dietary fibres and neutraceuticals in preventing diseases by K.T
Agusti and P.Faizal: BSPublication.
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.Balchand Phyllis
A.Balch2ndEdn., 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, NewYork.
8. Labuza, T.P. 2000 Functional Foods and Dietary Supplements: Safety,
Good Manufacturing Practice (GMPs) and Shelf Life Testing in Essentials
of Functional Foods M.K. Sachmidl and T.P. Labuza eds. AspenPress.
9. Handbook of Nutraceuticals and Functional Foods, Third Edition (Modern
Nutrition)
10. Shils, ME, Olson, JA, Shike, M. 1994 Modern Nutrition in Health and
Disease. Eighth edition. Lea andFebiger

BP 813 PW PROJECT WORK 150 Hours

A] Selection of the Project Topic

All the students shall undertake a project under the supervision of a teacher and
submit a report. The project can be based on Lab oriented (small part of original
research work) Study / Survey oriented or Computational studies or oriented. /
Review topic/ Extension of Practice school work etc., based on Current Trends in
Pharmaceutical science. The project shall be carried out in group not exceeding 5 in
number. The project report shall be submitted in triplicate (typed & hard bound copy
not less than 25 pages).
The internal and external examiner appointed for evaluation of the project shall be
approved teachers of SPPU /Industrial Experts appointed by Principal of the
respective institute. 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
B] Evaluation of Dissertation Book:
Objective(s) of the work done 15Marks
Methodology adopted 20Marks
Results and Discussions 20Marks
Conclusions and Outcomes 20Marks

Total 75Marks
C] Evaluation of Presentation:
Presentation of work 25Marks
Communication skills 20Marks
Question and answer skills 30Marks

Total 75Marks

Explanation: All the students should be evaluated thoroughly based on their performance in
the Laboratory /Literature work and presentation done as individual student under given
criteria.