MPharm_1 Syllabus Mumbai University

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UNIVERSITY OF MUMBAI













Manual on
CHOICE BASED CREDIT SYSTEM
for
Postgraduate Program
(Master of Pharmacy, M. Pharm.)
in
PHARMACY
Revised Course (Revised 2019)
(from the academic year 2019 –2020)
1

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INTRODUCTION

RECOMMENDATIONS OF NATIONAL REGULATORY AUTHORITIES
The University Grants Commission (UGC), the National Assessment and Accreditation
Council (NAAC), the Distance Education Council (DEC) and the National Knowledge
Commission (NKC) have time and again come out with recommendations for improving the
quality and effectiveness of Higher education provisions in the country. The ministry of
Human Resource Develop ment at the Central level and the Ministry of Higher & Technical
Education, Govt. of Maharashtra have also repeatedly stressed on the need for universities to
pay prompt attention to improve the quality of education. The National Knowledge
Commission (NKC) , in its report to the Prime Minister on 29th November 2006) has also
reiterated the importance of higher education and the contribution it has made to economic
development, social progress and political democracy in independent India.
An important concern voiced more strongly in recent times, is the need to develop a Choice -
Based Credit System (CBCS) in tune with global trends and the adoption of a sound grading
system for reflecting learner performance. This is in line with the recomme ndation of the
UGC in its Action Plan for Academic and Administrative Reforms (Ref. UGC letters January
2008; March 2009) “……. Curricular flexibility and learners’ mobility are issue s that
warrant our urgent attention. These can be addressed by introducing credit based courses
and credit accumulation. In order to provide with some degree of flexibility to learners, we
need to provide flexibility in course selection and also a minimum as well as a maximum
permissible span of time in which a course can be com pleted by a learner… The Choice -
Based Credit System (CBCS) imminently fits into the emerging socioeconomic milieu, and
could effectively respond to the educational and occupational aspirations of the upcoming
generations. In view of this, institutions of h igher education in India would do well to invest
thought and resources into introducing CBCS. Aided by modern communication and
information technology, CBCS has a high probability to be operationali zed efficiently and
effectively — elevating learners, inst itutions and higher education system in the country to
newer heights…”.
RATIONALE FOR INTRODUCTION OF CREDIT AND GRADING SYSTEM
The UGC while outlining the several unique features of the Choice -Based Credit System
(CBCS) has, in fact, given in a nutshell, the rationale for its introduction. Among the features

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highlighted by the UGC are: Enhanced learning opportunities, ability to match learners’
scholastic needs and aspirations, inter -institution transferability of learners (following the
completion of a se mester), part -completion of an academic programme in the institution of
enrolment and part -completion in a specialized (and recognized) institution, improvement in
educational quality and excellence, flexibility for working learners to complete the
programme over an extended period of time, standardization and comparability of
educational programmes across the country, etc.
This Choice Based Credit Sy stem enables a much -required shift in focus from teacher -centric
to learner -centric education since the workload estimated is based on the investment of time
in learning, not in teaching. It also focuses on continuous evaluation which will enhance the
quality of education. It can be concluded from the above discussion that it is very much
essential to implement the Choice Based Credit System in higher education in India. Course
credit structure, examination/assessment and grading are mainly focused aspects of this
manual and discussed in subsequent chapters.
DIRECTIVES OF PHARMACY COUNCIL OF INDIA
The Pharmacy Council of India (PCI) in exercise of the powers conferred to it under the
sections 10 and 18 of the Pharmacy Act 1948 (8 of 1948), with the approval of the Central
Government, had made the Bachelor of Pharmacy (B. Pharm.) Course Regulations, 2014 and
Master of Pharmacy (M. Pharm.) Course regulations vide Gazette dated December 10, 2014.
Further as per regulations 6 and 8 of the above course regulations the PCI has also prescribed
the Rules and Syllabus for B. Pharm. course and Scheme and Syllabus for M. Pharm., its
letter Ref 14 -136/2016 -PCI and Ref 14 -154/2015 PCI dated December 21, 2016, with the
subject heading “Statutory Scheme/Rules and syllabus fo r B. Pharm and M. Pharm. courses”.
It is thus mandatory to implement the directives of PCI with regard to the
Rules/Regulations/Syllabus for recognition and extension of approval of B. Pharm. and M.
Pharm. programs of institutes/Universities by the PCI

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1. ADMISSION CRITERIA
Admission to the M. Pharm. program of University of Mumbai is governed by the rules and
regulations of University of Mumbai and as per norms of the Govt. of Maharashtra through
State CET Cell and the Directorate of Technical Education (DTE) and the All India Council
for Technical Education (AICTE, New Delhi) in force at the time of admission and as
amended from time to time.
In general, a learner who has passed the examination for the B. Pharm. Degree from All India
Council for Technical Education or Pharmacy Council of India or Central or State
Government approved institutions, with at least 55 % marks (at least 50% marks in case of
SC or ST category and persons with disability belonging to Maharashtra state only.) a nd
obtained Score in Graduate pharmacy Aptitude Test conducted by All India Council of
Technical Education may be admitted to the M. Pharm. Program (Partly by Papers and Partly
by Research). However, the rules/regulations a nd qualifications for admission be tho se in
effect at the day and time of admission.
2. COURSE STRUCTURE
2.1 Duration of the program
The program of study for M. Pharm. shall extend over a period of four semesters (two
academic years). The medium of instruction shall be English.

2.2 Working days in each semester
Each semester shall consist of not less than 100 working days. The odd semesters shall be
conducted from the month of July to November/December and the even semesters shall be
conducted from the month of December/January to Ma y/June in every calendar year.
As the requirements for a particular degree (undergraduate or postgraduate), a certain
quantum of academic work measured in terms of credits is laid down in general. Learner
earns credits every semester by satisfactorily clea ring courses/other academic activities. 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
activities is dependent upon the quan tum of work expected to be put in for each of the other
activity per week.

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2.3 Attendance and progress
According to ordinance O.6086 (repealing O.119, O.120 and O.125), it is mandatory for
every learner to have minimum 50% attendance for each cour se and average attendance of all
the courses together has to be 75% in each semester. The candidate shall complete the
prescribed course satisfactorily to be eligible to appear for the respective examinations.

2.4 Credit assignment
2.4.1 Theory and Laboratory courses
Courses are broadly classified as Theory and Practical. Theory courses consist of lecture
(L) 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 a multiplier of half (1/2) for
practical (laboratory) hours. Thus, for example, a theory course having four lectures per
week throughout the semester carries a credit of 4. Sim ilarly, a practical having four
laboratory hours per week throughout semester carries a credit of 2.
The contact hours of seminars, assignments and research work shall be treated as that of
practical courses for the purpose of calculating credits. i.e., th e contact hours shall be
multiplied by 1/2. Similarly, the contact hours of journal club, research work
presentations and discussions with the supervisor shall be considered as theory course
and multiplied by1.

2.5 Minimum credit requirements
The minimum credit points required for the award of M. Pharm. degree is 95. However ,
based on the credit points earned by the students under the head of co -curricular
activities, a student shall earn a maximum of 100 credit points. These credits are divide d
into Theory courses, Practical, Seminars, Assignments, Research work, Discussions
with the supervisor, Journal club and Co-Curricular activities over the duration of four
semesters. The credits are distributed semester -wise as shown in Table 1 3. Courses
generally progress in sequence, 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.

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3. ACADE MIC WORK
A regular record of attendance both in Theory, Practical, Seminar, Assignment, Journal
club, Discussion with the supervisor, Research work presentation and Dissertation shall
be maintained by the department / teaching staff of respective courses.

4. COURSE OF STUDY
The specializations in M. Pharm program is given in Table 1.

Table – 1: List of M. Pharm. Specializations and their Code
S. No. Specialization Code
1. Pharmaceutics MPH
2. Industrial Pharmacy MIP
3. Pharmaceutical Chemistry MPC
4. Pharmaceutical Analysis MPA
5. Pharmaceutical Quality Assurance (Quality Assurance) MQA
6. Pharmaceutical Regulatory Affairs MRA
7. Pharmaceutical Biotechnology MPB
8. Pharmacy Practice MPP
9. Pharmacology MPL
10. Pharmacognosy (Pharmacognosy and Phytochemistry) MPG

The course of study for M. Pharm . specializations shall include Semester wise Theory &
Practical as given in Table s – 2 to 11. The number of hours to be devoted to each theory
and practical course in any semester shall not be less than that shown in Table – 2 to 11.

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Table – 2: Course of study for M. Pharm. (Pharmaceutics)
Course
Code Course Credit
Hours Credit
Points Hrs./w
k Marks
Semester I
MPH101T Modern Pharmaceutical
Analytical Techniques 4 4 4 100
MPH102T Drug Delivery System 4 4 4 100
MPH103T Modern Pharmaceutics 4 4 4 100
MPH104T Regulatory Affair 4 4 4 100
MPH105P Pharmaceutics Practical I 12 6 12 150
- Seminar/Assignment 7 4 7 100
Total 35 26 35 650
Semester II

MPH201T Molecular Pharmaceutics
(Nano Tech and Targeted
DDS)
4
4
4
100

MPH202T Advanced
Biopharmaceutics&
Pharmacokinetics
4
4
4
100
MPH203T Computer Aided Drug
Delivery System 4 4 4 100
MPH204T Cosmetic and
Cosmeceuticals 4 4 4 100
MPH205P Pharmaceutics Practical II 12 6 12 150
- Seminar/Assignment 7 4 7 100
Total 35 26 35 650

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Table – 3: Course of study for M. Pharm. (Industrial Pharmacy)
Course
Code Course Credit
Hours Credit
Points Hrs./w
k Ma
rks
Semester I
MIP101T Modern Pharmaceutical
Analytical Techniques 4 4 4 100
MIP102T Pharmaceutical Formulation
Development 4 4 4 100
MIP103T Novel drug delivery systems 4 4 4 100
MIP104T Intellectual Property Rights 4 4 4 100
MIP105P Industrial Pharmacy Practical
I 12 6 12 150
- Seminar/Assignment 7 4 7 100
Total 35 26 35 650
Semester II
MIP201T Advanced Biopharmaceutics
and Pharmacokinetics 4 4 4 100
MIP202T Scale up and Technology
Transfer 4 4 4 100
MIP203T Pharmaceutical Production
Technology 4 4 4 100
MIP204T Entrepreneurship
Management 4 4 4 100
MIP205P Industrial Pharmacy Practical
II 12 6 12 150
- Seminar/Assignment 7 4 7 100
Total 35 26 35 650

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Table – 4: Course of study for M. Pharm. (Pharmaceutical Chemistry)
Course Code Course Credit
Hours Credit
Points Hrs./
w
k Marks
Semester I
MPC101T Modern Pharmaceutical
Analytical Techniques 4 4 4 100
MPC10 2T Advanced Organic
Chemistry -I 4 4 4 100
MPC103T Advanced Medicinal
chemistry 4 4 4 100
MPC104T Chemistry of Natural
Products 4 4 4 100
MPC105P Pharmaceutical
Chemistry Practical I 12 6 12 150
- Seminar/Assignment 7 4 7 100
Total 35 26 35 650
Semester II
MPC201T Advanced Spectral
Analysis 4 4 4 100
MPC202T Advanced Organic
Chemistry -II 4 4 4 100
MPC203T Computer Aided Drug
Design 4 4 4 100
MPC204T Pharmaceutical Process
Chemistry 4 4 4 100
MPC205P Pharmaceutical
Chemistry Practical II 12 6 12 150
- Seminar/Assignment 7 4 7 100
Total 35 26 35 650

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Table – 5: Course of study for M. Pharm. (Pharmaceutical Analysis)
Course
Code Course Credit
Hours Credit
Points Hrs./w
k Mark
s
Semester I
MPA101T Modern Pharmaceutical
Analytical Techniques 4 4 4 100
MPA102T Advanced Pharmaceutical
Analysis 4 4 4 100
MPA103T Pharmaceutical Validation 4 4 4 100
MPA104T Food Analysis 4 4 4 100
MPA105P Pharmaceutical Analysis
Practical I 12 6 12 150
- Seminar/Assignment 7 4 7 100
Total 35 26 35 650
Semester II
MPA201T Advanced Instrumental
Analysis 4 4 4 100
MPA202T Modern Bio-Analytical
Techniques 4 4 4 100
MPA203T Quality Control and Quality
Assurance 4 4 4 100
MPA204T Herbal and Cosmetic
Analysis 4 4 4 100
MPA205P Pharmaceutical Analysis
Practical II 12 6 12 150
- Seminar/Assignment 7 4 7 100
Total 35 26 35 650

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Table – 6: Course of study for M. Pharm. (Pharmaceutical Quality Assurance or
Quality Assurance )
Course
Code Cours e Credit
Hours Credit
Points Hrs./
w
k Mark
s
Semeste r I
MQA101T Modern Pharmaceutical
Analytical Techniques 4 4 4 100
MQA102T Quality Management
System 4 4 4 100
MQA103T Quality Control and
Quality
Assurance 4 4 4 100
MQA104T Product Development
and
Technology Transfer 4 4 4 100
MQA105P Pharmaceutical Quality
Assurance Practical I 12 6 12 150
- Seminar/Assignment 7 4 7 100
Total 35 26 35 650
Semester II
MQA201T Hazards and Safety
Management 4 4 4 100
MQA202T Pharmaceutical
Validation 4 4 4 100
MQA203T Audits and Regulatory
Compliance 4 4 4 100
MQA204T Pharmaceutical
Manufacturing
Technology 4 4 4 100
MQA205P Pharmaceutical Quality
Assurance Practical II 12 6 12 150
- Seminar/Assignment 7 4 7 100
Total 35 26 35 650

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Table – 7: Course of study for M. Pharm. (Regulatory Affairs)
Course
Code Course Credit
Hours Credi
t
Points Hrs./
wk Mar
ks
Semester I
MRA101T Good Regulatory Practices 4 4 4 100
MRA102T Documentation and
Regulatory Writing 4 4 4 100
MRA103T Clinical Research
Regulations 4 4 4 100
MRA 104T Regulations and Legislation
for Drugs & Cosmetics,
Medical Devices,
Biologicals& Herbals, and
Food &Nutraceuticals in India
and Intellectual Property
Rights

4

4

4

100
MRA105P Regulatory Affairs Practical I 12 6 12 150
Seminar/Assignment 7 4 7 100
Total 35 26 35 650
Semester II
MRA201T Regulatory Aspects of Drugs
& Cosmetics 4 4 4 100
MRA202T Regulatory Aspects of Herbal
&Biologicals 4 4 4 100
MRA203T Regulatory Aspects of
Medical Devices 4 4 4 100
MRA204T Regulatory Aspects of Food
&Nutraceuticals 4 4 4 100
MRA205P Regulatory Affairs Practical II 12 6 12 150
Seminar/Assignment 7 4 7 100
Total 35 26 35 650

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Table – 8: Course of study for M. Pharm. (Pharmaceutical Biotechnology)
Course
Code Course Credi
t
Hour
s Credi
t
Points Hrs./
w
k Mar
ks
Semester I
MPB101T Modern Pharmaceutical
Analytical Techniques 4 4 4 100
MPB102T Microbial And Cellular Biology 4 4 4 100
MPB103T Bioprocess Engineering and
Technology 4 4 4 100
MPB104T Advanced Pharmaceutical
Biotechnology 4 4 4 100
MPB105P Pharmaceutical Biotechnology
Practical I 12 6 12 150
- Seminar/Assignment 7 4 7 100
Total 35 26 35 650
Semester II
MPB201T Proteins and protein
Formulation 4 4 4 100
MPB202T Immunotechnology 4 4 4 100
MPB203T Bioinformatics and Computer
Technology 4 4 4 100
MPB204T Biological Evaluation of Drug
Therapy 4 4 4 100
MPB205P Pharmaceutical Biotechnology
Practical II 12 6 12 150
- Seminar/Assignment 7 4 7 100
Total 35 26 35 650

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Table – 9: Course of study for M. Pharm. (Pharmacy Practice)
Course
Code Course Credit
Hours Credit
Points Hrs./
wk Mar
ks
Semester I
MPP101T Clinical Pharmacy Practice 4 4 4 100
MPP102T Pharmacotherapeutics -I 4 4 4 100
MPP103T Hospital & Community
Pharmacy 4 4 4 100
MPP104T Clinical Research 4 4 4 100
MPP105P Pharmacy Practice Practical
I 12 6 12 150
- Seminar/Assignment 7 4 7 100
Total 35 26 35 650
Semester II
MPP201T Principles of Quality Use of
Medicines 4 4 4 100
MPP2 02T Pharmacotherapeutics II 4 4 4 100
MPP203T Clinical Pharmacokinetics
and Therapeutic Drug
Monitoring 4 4 4 100
MPP204T Pharmacoepidemiology&
Pharmacoeconomics 4 4 4 100
MPP205P Pharmacy Practice Practical
II 12 6 12 150
- Seminar/Assignment 7 4 7 100
Total 35 26 35 650

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Table – 10: Course of study for (Pharmacology)
Course
Code Course Credi
t
Hour
s Credit
Points Hrs./
wk Mar
ks
Semester I
MPL101T Modern Pharmaceutical Analytical
Techniques 4 4 4 100
MPL102T Advanced Pharmacology -I 4 4 4 100
MPL103T Pharmacological and
Toxicological Screening Methods -
I
4
4
4
100
MPL104T Cellular and Molecular
Pharmacology 4 4 4 100
MPL105P Pharmacology Practical I 12 6 12 150
- Seminar/Assignment 7 4 7 100
Total 35 26 35 650
Semester II
MPL201T Advanced Pharmacology II 4 4 4 100
MPL2 02T Pharmacological and
Toxicological Screening
Methods -II
4
4
4
100
MPL203T Principles of Drug Discovery 4 4 4 100
MPL204T Clinical Research and
Pharmacovigilance 4 4 4 100
MPL205P Pharmacology Practical II 12 6 12 150
- Seminar/Assignment 7 4 7 100
Total 35 26 35 650

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Table – 11: Course of study for M. Pharm. ( Pharmacognosy or
Pharmacognosy and Phytochemistry )
Course
Code Course Credit
Hours Credi
t
Point
s Hrs./
wk Mar
ks
Semester I
MPG101T Modern Pharmaceutical
Analytical Techniques 4 4 4 100
MPG102T Advanced
Pharmacognosy -1 4 4 4 100
MPG103T Phytochemistry 4 4 4 100
MPG104T Industrial
Pharmacognostical
Technology 4 4 4 100
MPG105P Pharmacognosy Practical I 12 6 12 150
- Seminar/Assignment 7 4 7 100
Total 35 26 35 650
Semester II
MPG201T Medicinal Plant
biotechnology 4 4 4 100
MPG2 02T Advanced
Pharmacognosy -II 4 4 4 100
MPG203T Indian system of medicine 4 4 4 100
MPG204T Herbal cosmetics 4 4 4 100
MPG205P Pharmacognosy Practical
II 12 6 12 150
- Seminar/Assignment 7 4 7 100
Total 35 26 35 650

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Table – 12: Course of study for M. Pharm. III and IV Semester s
(Common for All Specializations)
Course
Code Course Credit
Hours Credit
Points
MRM301T Research Methodology and
Biostatistics* 4 4
- Journal club 2 2
- Discussion / Presentation
(Proposal Presentation) 5 5
- Research Work 30 30
Total 41 41
* Non University Exam

Table – 13: Semester wise credits distribution
Semester Credit Points
I 26
II 26
III and IV 41

Co-curricular Activities
(Attending Conference, Scientific
Presentations and Other Scholarly Activities) Minimum=02
Maximum=07*
Total Credit Points Minimum=95
Maximum=100*
*Credit Points for Co -curricular Activities
Table – 14: Guidelines for Awarding Credit Points for Co -curricular Activities

Name of the Activity Maximum
Credit Points
Eligible /
Activity
Participation in National Level Seminar/Conference/Workshop/Symposium/
Training Programs (related to the specialization of the student)
01
Participation in international Level
Seminar/Conference/Workshop/Symposium/ Training Programs (related to
the specialization of the student)
02
Academic Award/Research Award from State Level/National Agencies 01
Academic Award/Research Award from International Agencies 02
Research / Review Publication in National Journals (Indexed in Scopus / Web
of Science) 01
Research / Review Publication in International Journals (Indexed in Scopus
/Web of Science) 02

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*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.

5. Program Committee
1. The M. Pharm. programme shall have a Programme Committee constituted by
the Hea d of the institution in consultation with all the Heads of the
departments.

2. The composition of the Programme Committee shall be as follows:
A teacher at the cadre of Professor shall be the Chairperson; One Teacher from
each M. Pharm specialization and fou r student representatives (two from each
academic year), nominated by the Head of the institution.

3. Duties of the Programme Committee:
i. Periodically reviewing the progress of the classes.
ii. Discussing the problems concerning curriculum, syllabus and the condu ct 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 Programme Committee shall meet at least twice in a semester preferably at
the end of each sessional exam and before the end semester exam.

6. Examinations/Assessments
The schemes for internal assessment and end semester e xaminations are given in
Table s – 15 to 25 .

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Tables – 15: Schemes for internal assessments and end semester examinations
(Pharmaceutics - MPH)


Course
Code


Course
Internal Assessment End
Semeste
r Exams
Tota l
Mar
ks Continuo
us Mode Sessional
Exams
To
t
al
Mar
ks
Dura
tion Mar
ks Dura
tion
SEMESTER I

MPH101T Modern Pharmaceutical
Analytical
Techniques
10
15
1 Hr
25
75
3 Hrs
100
MPH1 02T Drug Delivery System
10
15
1 Hr
25
75
3 Hrs
100
MPH 103T Modern
Pharmaceutics
10
15
1 Hr
25
75
3 Hrs
100
MPH104T Regulatory
Affair 10 15 1 Hr 25 75 3 Hrs 100
MPH105P Pharmaceutics Practical I 20 30 6 Hrs 50 100 6 Hrs 150
- Seminar
/Assignment - - - - - - 100
Total 650
SEMESTER II

MPH 201T Molecular Pharmaceutics
(Nano Tech and Targeted
DDS)

10

15

1 Hr

25

75

3 Hrs

100
MPH 202T Advanced
Biopharmaceutics &
Pharmacokinetics

10

15

1 Hr

25

75

3 Hrs

100
MPH 203T Computer Aided Drug
Delivery System
10
15
1 Hr
25
75
3 Hrs
100
MPH 204T Cosmetic and
Cosmeceutic als 10 15 1 Hr 25 75 3 Hrs 100
MPH205P Pharmaceutics Practica l I 20 30 6 Hrs 50 100 6 Hrs 150
- Seminar
/Assignment - - - - - - 100

TOTAL 650

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Tables – 16: Schemes for internal assessments and end semester examinations (Industrial Pharmacy -
MIP)


Course
Code


Course
Internal Assessment End
Semester
Exams

Tot
al
Mar
ks Con
ti
nuo
u s
Mod
e Sessional
Exams
To
t
al
Ma
r
ks
Dura
tion Mar
ks Dura
ti
on
SEMESTER I

MIP101T Modern Pharmaceutical
Analytical
Techniques
10
15
1 Hr
25
75
3
Hrs
10
0

MIP102T Pharmaceutical Formulation
Development
10
15
1 Hr
25
75 3
Hrs
10
0

MIP103T Novel drug
delivery systems
10
15
1 Hr
25
75 3
Hrs
10
0

MIP104T Intellectual
Property Rights
10
15
1 Hr
25
75 3
Hrs
10
0

MIP105P Industrial
Pharmacy Practical I
20
30
6 Hrs
50
100 6
Hrs
15
0
- Seminar
/Assignment - - - - - - 10
0
Total 65
0
SEMESTER II


MIP201T
Advanced Biopharmaceutics
and Pharmacokinetics

10

15

1 Hr

25

75
3
Hrs

10
0

MIP202T Scale up and
Technology Transfer
10
15
1 Hr
25
75 3
Hrs
10
0

MIP203T Pharmaceutical Production
Technology
10
15
1 Hr
25
75 3
Hrs
10
0

MIP204T Entrepreneurship
Management
10
15
1 Hr
25
75 3
Hrs
10
0

MIP205P Industrial
Pharmacy Practical II
20
30
6 Hrs
50
100 6
Hrs
15
0
- Seminar
/Assignment - - - - - - 10
0
Total 650

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Tables – 17: Schemes for internal assessments and end semester examinations (Pharmaceutical
Chemistry -MPC)



Course
Code


Course
Internal Assessment End
Semeste
r Exams


Tota
l
Mar
ks Con
tinu
o us
Mo
d
e Sessional
Exams
To
t
al
Ma
r
ks
D
u
ra
ti
on Ma
r
ks Dura
ti
on
SEMESTER I

MPC101T
Modern Pharmaceutical
Analytical Techniques
10
15
1 Hr
25
75
3
Hrs
100

MPC102T Advanced
Organic Chemistry -I
10
15
1 Hr
25
75 3
Hrs
100

MPC103T Advanced
Medicinal chemistry
10
15
1 Hr
25
75 3
Hrs
100

MPC104T Chemistry of
Natural Products
10
15
1 Hr
25
75 3
Hrs
100

MPC105P Pharmaceutic al Chemistry
Practical I
20
30
6
Hrs
50
100 6
Hrs
150
- Seminar
/Assignment - - - - - - 100
Total 650
SEMESTER II

MPC201T Advanced
Spectral Analysis
10
15
1 Hr
25
75 3
Hrs
100

MPC202T Advanced
Organic Chemistry -II
10
15
1 Hr
25
75 3
Hrs
100

MPC203T Computer
Aided Drug Design
10
15
1 Hr
25
75 3
Hrs
100

MPC204T Pharmaceutical Process
Chemistry
10
15
1 Hr
25
75 3
Hrs
100
MPC205P Pharmaceutic al Chemistry
Practical II 20 30 6
Hrs 50 100 6Hr
s 150
-- Seminar
/Assignment - - - - - - 100
Total 650

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Tables – 18: Schemes for internal assessments and end semester examinations (Pharmaceutical
Analysis -MPA)


Course
Code


Course
Internal Assessment End
Semeste
r Exams

Tota
l
Mar
ks
Continuo
us Mode Sessional
Exams
To
t
al
Mar
k s
Dur
a
tion
Mar
k
s Dura
ti
on
SEMESTER I

MPA101T Modern
Pharmaceutical
Analysis
10
15
1 Hr
25
75
3
Hrs
100

MPA102T Advanced
Pharmaceutical
Analysis
10
15
1 Hr
25
75
3
Hrs
100

MPA103T Pharmaceutical
Validation
10
15
1 Hr
25
75
3
Hrs
100
MPA104T Food
Analysis 10 15 1 Hr 25 75 3
Hrs 100

MPA105P Pharmaceutical
Analysis - I
20
30
6 Hrs
50
100
6
Hrs
150
- Seminar
/Assignment - - - - - - 100
Total 650
SEMESTER II

MPA201T Advanced Instrumental
Analysis
10
15
1 Hr
25
75
3
Hrs
100

MPA202T Modern Bio -
Analytical Techniques
10
15
1 Hr
25
75
3
Hrs
100

MPA203T Quality
Control and Quality
Assurance
10
15
1 Hr
25
75
3
Hrs
100


MPA204T Herbal and
Cosmetic analysis
10
15
1 Hr
25
75
3
Hrs
100

MPA205P Pharmaceutical
Analysis -II
20
30
6 Hrs
50
100
6
Hrs
150
- Seminar
/Assignment - - - - - - 100
Total 650

Page 25

20
Tables – 19: Schemes for internal assessments and end semester examinations (Pharmaceutical
Quality Assurance or Quality Assurance -MQA)


Cours e
Code


Course
Internal Assessment End
Semeste
r Exams

Tota
l
Mar
ks Cont
i
nuou
s
Mod
e Sessional
Exams T
ot
al
Ma
r
ks
Dur
a
tion Mar
ks Dura
ti
on
SEMESTER I

MQA1 01T Modern Pharmaceutical
Analytical
Techniques
10
15
1 Hr
25
75
3
Hrs
100
MQA102T Quality Management
System 10 15 1 Hr 25 75 3
Hrs 100
MQA103T Quality Control and
Quality Assurance 10 15 1 Hr 25 75 3
Hrs 100
MQA1 04T Product
Development and
Technology Transfer
10
15
1 Hr
25
75
3
Hrs
100
MQA1 05P Pharmaceutical
Quality Assurance Practical I
20
30
6 Hrs
50
100
6
Hrs
150
- Seminar
/Assignment - - - - - - 100
Total 650
SEMESTER II
MQA201T Hazards and Safety
Management 10 15 1 Hr 25 75 3
Hrs 100
MQA202T Pharmaceutical
Validation 10 15 1 Hr 25 75 3
Hrs 100
MQA2 03T Audits and
Regulatory
Compliance
10
15
1 Hr
25
75
3
Hrs
100
MQA2 04T Pharmaceutical
Manufacturing
Technology
10
15
1 Hr
25
75
3
Hrs
100
MQA2 05P Pharmaceutical
Quality Assurance Practical
II
20
30
6 Hrs
50
100
6
Hrs
150
- Seminar
/Assignment - - - - - - 100
Total 650

Page 26

21
Tables – 20: Schemes for internal assessments and end semester examinations (Pharmaceutical
Regulatory Affairs -MRA)



Course
Code
Internal Assessment End
Semester
Exams
Course Cont
inuo
us
Mod
e Sessional
Exams
To
t
al
Ma
r
ks
Dur
a
tion Total
Marks
Ma
r
ks Durat
i on
SEMESTER I
MRA10 1T Good Pharmaceutical
Practices
10
15
1 Hr
25
75
3
Hrs
100
MRA10 2T Documentation
and Regulatory Writing
10
15
1 Hr
25
75
3
Hrs
100
MRA10 3T Clinical
Research Regulations
10
15
1 Hr
25
75
3
Hrs
100





MRA10 4T Regulations and Legislation
for Drugs &Cosmetics,
Medical Devices,
Biologicals & Herbals, and
Food & Nutraceuticals In
India and
IntellectualProperty Rights





10





15





1 Hr





25





75





3
Hrs





100
MRA10 5T Pharmaceutical
Regulatory Affairs Practical
I
20
30
6
Hrs
50
100
6
Hrs
150
- Seminar/Assignment - - - - - - 100
Total 650
SEMESTER II

MRA20 1T
Regulatory Aspects of
Drugs &Cosmetics
10
15
1 Hr
25
75
3
Hrs
100

MRA20 2T
Regulatory Aspects of
Herbal &Biologicals
10
15
1 Hr
25
75
3
Hrs
100
MRA20 3T
Regulatory Aspects of
Medical Devices
10
15
1 Hr
25
75
3
Hrs
100
MRA20 4T
Regulatory Aspects of
Food & Nutraceuticals
10
15
1 Hr
25
75
3
Hrs
100

MRA20 5P Pharmaceutical
Regulatory Affairs
Practical II
20
30
6
Hrs
50
100
6
Hrs
150
- Seminar
/Assignment - - - - - - 100
Total 650

Page 27

22
Tables – 21: Schemes for internal assessments and end semester examinations (Pharmaceutical
Biotechnology -MPB)


Course Code Internal Assessment End Semester
Exams
Tota
Course Conti
nuous
Mode Sessional
Exams
To
t
al
Ma
r
ks
Durat
i on l
Ma
r
Ma
r
ks Durat
i on ks
SEMESTER I

MPB10 1T Modern Pharmaceutical
Analytical Techniques
10
15
1 Hr
25
75
3
Hrs
100
MPB10 2T Microbial And Cellular
Biology 10 15 1 Hr 25 75 3
Hrs 100
MPB103T
Bioprocess
Engineering and Technology
10
15
1 Hr
25
75
3
Hrs
100
MPB104T Advanced
Pharmaceutical
Biotechnology
10
15
1 Hr
25
75
3
Hrs
100
MPB105P Pharmaceutical
Biotechnology Practical
I
20
30
6
Hrs
50
100
6
Hrs
150
- Seminar
/Assignment - - - - - - 100
Total 650
SEMESTER II
MPB201T Proteins and
protein Formulation
10
15
1 Hr
25
75
3
Hrs
100
MPB202T Immunotechnology 10 15 1 Hr 25 75 3
Hrs 100
MPB203T Bioinformatics and
Computer Technology
10
15
1 Hr
25
75
3
Hrs
100
MPB204T Biological Evaluation of
Drug Therapy
10
15
1 Hr
25
75
3
Hrs
100
MPB205P Pharmaceutical
Biotechnology Practical
II
20
30
6
Hrs
50
100
6
Hrs
150
- Seminar
/Assignment - - - - - - 100
Total 650

Page 28

23
Tables – 22: Schemes for internal assessments and end semester examinations (Pharmacy Practice -
MPP)


Cours e
Code


Course
Internal Assessment End
Semester
Exams

Tot
al
Ma
r
ks
Conti
nuous
Mode Sessional
Exams
To
t
al
Ma
r
ks
Durat
i on Ma
r
ks Du
rati
o n
SEMESTER I
MPP101T Clinical Pharmacy Practice 10 15 1
Hr 25 75 3
Hrs 100
MPP102T Pharmacotherapeutic s-I 10 15 1
Hr 25 75 3
Hrs 100
MPP10 3T Hospital & Community
Pharmacy
10
15
1
Hr
25
75
3
Hrs
100
MPP104T Clinical Research 10 15 1
Hr 25 75 3
Hrs 100
MPP105P Pharmacy Practice Practical I 20 30 6
Hrs 50 100 6
Hrs 150
- Seminar /Assignment - - - - - - 100
Total 650
SEMESTER II
MPP201T Principles of Quality Use of
Medicines 10 15 1 Hr 25 75 3
Hrs 100
MPP102T Pharmacotherapeutics II 10 15 1 Hr 25 75 3
Hrs 100

MPP203T Clinical Pharmacokinetics
and Therapeutic Drug
Monitoring
10
15
1 Hr
25
75
3
Hrs
100
MPP204T Pharmacoepidemiology &
Pharmacoeconomics
10
15
1 Hr
25
75
3
Hrs
100
MPP205P Pharmacy Practice Practical II 20 30 6 Hrs 50 100 6
Hrs 150
- Seminar /Assignment - - - - - - 100
Total 650

Page 29

24
Tables – 23: Schemes for internal assessments and end semester examinations (Pharmacology -
MPL)


Course Code Internal Assessment End Semester
Exams
Tot
Course Conti
nuous
Mode Sessional
Exams
To
t
al
Ma
r
ks
Durat
i on al
Ma
r
Ma
r
ks Durat
i on ks
SEMESTER I

MPL10 1T Modern Pharmaceutical
Analytical Techniques
10
15
1 Hr
25
75
3
Hrs
100
MPL10 2T Advanced Pharmacology -
I 10 15 1 Hr 25 75 3
Hrs 100

MPL10 3T Pharmacological and
Toxicological
Screening Methods -I
10
15
1 Hr
25
75
3
Hrs
100
MPL10 4T Cellular and
Molecular Pharmacology
10
15
1 Hr
25
75
3
Hrs
100
MPL10 5P Experimental
Pharmacology - I 20 30 6 Hrs 50 100 6
Hrs 150
- Seminar
/Assignment - - - - - - 100
Total 650
SEMESTER II
MPL20 1T Advanced Pharmacology
II 10 15 1 Hr 25 75 3
Hrs 100

MPL2 0 2T Pharmacological and
Toxicological Screening
Methods -II
10
15
1 Hr
25
75
3
Hrs
100
MPL20 3T Principles of Drug
Discovery 10 15 1 Hr 25 75 3
Hrs 100

MPL20 4T Clinical research and
pharmacovigilance
10
15
1 Hr
25
75
3
Hrs
100
MPL20 5P Experimental
Pharmacology - II
20
30
6 Hrs
50
100
6
Hrs
150
- Seminar
/Assignment - - - - - - 100
Total 650

Page 30

25 Tables – 24: Schemes for internal assessments and end semester examinations (Pharmacognosy and
Phytochemistry -MPG)


Course Code Internal Assessment End Semester
Exams
Tota
Course Conti
nuous
Mode Sessional
Exams
To
t
al
Ma
r
ks
Durat
i on l
Ma
r
Ma
r
ks Durat
i on ks
SEMESTER I

MPG10 1T Modern
Pharmaceutical
Analytical Techniques
10
15
1 Hr
25
75
3 Hrs
100
MPG10 2T Advanced
Pharmacognosy -1
10
15
1 Hr
25
75
3 Hrs
100
MPG10 3T Phytochemistry 10 15 1 Hr 25 75 3 Hrs 100

MPG10 4T Industrial
Pharmacognostical
Technology
10
15
1 Hr
25
75
3 Hrs
100
MPG10 5P Pharmacognosy
Practical I 20 30 6 Hrs 50 100 6 Hrs 150
- Seminar
/Assignment - - - - - - 100
Total 650
SEMESTER II
MPG20 1T Medicinal
Plant biotechnology
10
15
1 Hr
25
75
3 Hrs
100
MPG2 0 2T Advanced
Pharmacognosy -II
10
15
1 Hr
25
75
3 Hrs
100
MPG20 3T Indian system of
medicine 10 15 1 Hr 25 75 3 Hrs 100
MPG20 4T Herbal
cosmetics 10 15 1 Hr 25 75 3 Hrs 100
MPG20 5P Pharmacognosy
Practical II 20 30 6 Hrs 50 100 6 Hrs 150
- Seminar
/Assignment - - - - - - 100
Total 650

Page 31

26 Tables – 25: Schemes for internal assessments and end semester examinations (Semester III&
IV)



Course
Code
Internal Assessment End Semester
Exams
Tota
Course Conti
nuou
s
Mod
e Sessional
Exams
To
t
al
Mar
k s
Durat
i on l
Mar
k
Mar
k s Durat
i on s
SEMESTER III

MRM
30
1T
Research Methodology
and Biostatistics*
10
15
1 Hr
25
75
3
Hrs
100
- Journal club - - - 25 - - 25

- Discussion /
Presentation
(Proposal Presentation)
-
-
-
50
-
-
50
- Research work and
colloqui um - - - - - - -
Total 175
SEMESTER IV
- Journal club - - - 25 - - 25

- Discussion /
Presentation
(Proposal Presentation)
-
-
-
75
-
-
75

- Research
work and
Colloquium
-
-
-
-
750
1 Hr
850
Total 102
5
*Non -University Examination

Page 32

27 6.1 Internal assessment: Continuous mode
The marks allocated for Continuous mode of Internal Assessment shall be awarded as
per the scheme given below.

Table – 26: Scheme for awarding internal assessment: Continuous mode
Theory
Criteria Maximum
Marks
Attendance (Refer Table – 27) 8
Student – Teacher interaction 2
Total 10
Practical
Attendance (Refer Table – 27) 10
Based on Practical Records, Regular viva voce, etc. 10
Total 20

Table – 27: Guidelines for the allotment of marks for attendance
Percentage of Attendance Theory Practical
90 – 100 8 10
85 – 89 6 7.5
80 – 84 4 5
75– 79 2 2.5
Less than 75 0 0

6.2 Sessional Exams
Two sessional exams shall be conducted for each theory / practical course as per the
schedule fixed by the college(s). The average marks of two sessional exams shall be
computed for internal assessment as per the requirements given in the tables above .
6.3 End Semester Exam:
The End Semes ter Examinations in Semesters I and II (Theory Courses) of the M. Pharm.
degree, and the viva-voce examination of the thesis at the end of Semester IV for the M.
Pharm. Degree course will be conducted by the university.
A time -table and question papers for all the theory examinations of Semesters I and II will be
prepared/set by the university as per the procedure.

Page 33

28 The question papers for the Theory courses in Semesters I and II will be set by examiners and
paper -setters appoint ed by the University.
The assessment and moderation of the answer booklets for the examinations in Theory
courses in Semesters I and II will be carried out by examiners and moderators appointed by
the ad -hoc Board of Studies in Pharmacy and approved by the University.
The assessment and moderation of the answer booklets of the Theory courses in Semesters I
and II will be conducted by the University through Central Assessment Programme (CAP).
The evaluation of the End Semester Examination in the Practical subject s and
Seminar /assignment in Semester I and II will be conducted at the college/institutional level
by PG teachers recognized as research guides by the university
7. Promotion and award of grades
A student shall be declared PASS and eligible for getting grade in a course of M. Pharm.
programme if he/she secures at least 50% marks in that particular course including
internal assessment.

8. Carry forward of marks
In case a student fails to secure the minimum 50% in any Theory or Practical c ourse ,
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.
9. Improvement of internal assessment
A student sha ll have the opportunity to improve his/her performance only once in the
Sessional exam compo nent of the internal assessment. The re -conduct of the Sessional exam
shall be completed before the commencement of next en d semester theory examinations.
10. Reexamination of end semester examinations
Reexamination of end semester examination shall be conducted as pe r the schedule
given in table 28 . The exact dates of examinations shall be notified from time to time.
Table – 28: Tentative schedule of end semest er examinations
Semester For Regular Candidates For Failed Candidates
I and III November / December May / June
II and IV May / June November / December
11. Allowed to keep terms(ATKT):

Page 34

29 No student shall be admitted to any examination unless he/s he fulfills the norms of
attenda nce. ATKT rules are applicable as follows:
A student shall be eligible to carry f orward all the courses of I, II and III. The
submission of synopsis and the holding of the viva voce examination shall be
permitted only if the student has successfully cleared semester I , II and III.
A student shall be eligible to get his/her CGPA upon successful completion of the
courses of I to IV semesters within the stipulated time period as per the norms.
Note: Grade AB should be considered as failed and treated as one head for deciding
ATKT. Such rules are also applicable for those students who fail to register for
examination(s) of any course in any semester.

12. Grading of performances
a. 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 grad e
points are given in Table – 29.
Table – 29: Letter grades and grade points equivalent to
Percentage of marks and performances
Percentage of
Marks Obtained Letter Grade Grade Point Performan
ce
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.
13. 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

Page 35

30 C1, C2, C3 and C4 and the student’s grade points in these courses are G1, G2, G3
and G4, respectively, and then students’ SGPA is equal to:
C1G1 + C 2G2 + C 3G3 + C 4G4
SGPA = ------- --------------------------------------------------
C1 + C 2 + C 3 + C 4
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. F or example , if a learner has a F or ABS grade in course 4, the SGPA shall
then be computed as:
C1G1 + C2G2 +C3G3 + C4* 0
SGPA =------------------------------ --------------------------
C1 + C2 + C3 + C4

14. Cumulative Grade Point Average (CGPA)
The CGPA is calculated with the SGPA of all the IV semesters to two decimal points and is
indicated in final grade report card/final transcript showing the grades of all IV semesters
and their courses. The CGPA shall reflect the failed status in case of F grade(s), ti ll 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
CGPA = ---------------------------- ------------------------
C1 + C2 + C3 + C4

where C 1, C2, C3,…. is the total number of credits for semester I,II,III,…. and S 1,S2,
S3,….is the SGPA of semester I,II,III,…. .
15. Declaration of class
Although the GPA system is a stand -alone system of grading and not amenable to facile
conversion to percent marks, in general , the conversion of CGPA to percent marks is:
CGPA x 9. 5 = Percent marks.
The class shall be awarded on the basis of CGPA as follows:
 First Class with Distinction = CGPA of. 7.37 and above
 First Class = CGPA of 6.32 to 7.36
 Second Class = CGPA of 6.00 to 6.31

Page 36

31 16. Project work
All the students shall undertake a project under the supervision of a teacher in Semester III
to IV and submit a report. Four copies of the project report shall be submitted.
 Writing the thesis
The thesis will be typed using Times New Roman font, size 11, 1.5 line spacing, with all
headings/subheadings in bold.
The thesis will be of maximum 125 pages and composed in the following manner :
Chapter 1 – Introduction. This should be limited to about 30 pages and will describe all
background information of the research described in the thesis.
Chapter 2 – Aims and objectives, limited to 2 pages.
Chap ter 3 – Plan of Work, limited to 4 pages
Chapter 4 – Experimental. This section should preferably include only the optimized
experiments from which the inferences and conclusions were drawn.
Chapter 5 – Results and Discussion, this should constitute 40 to 50 pages of the thesis.
Chapter 6 – References. This should be in ACS format. Refer to Ch. 14 In The ACS Style
Guide ; Coghill, A., et al.; American Chemical Society: Washington, DC, 2006.

If any deviations are found in the style of writing the thesis, the thesis is liable to be
rejected by the University.
Scheme of assessment for Thesis
Assessment External
Examiner Internal (Guiding
Teacher) Total
50% of marks 50% of marks 100%

The assessment of the thesis submitted at the end of Semester IV will done by both the
internal (guiding) teacher and an external examiner chosen from the industry with established
competence in the field or may be any recognized research guide from another recognized
university. It is proposed that every learner will submi t a synopsis of the research work
carried out by him/her during Semesters III and IV which forms the content of the thesis . A
learner will be permitted to submit his/her synopsis no earlier than 20 months (after 20
months) from the beginning of the M. Phar m. program as instructed by the

Page 37

32 Government/Regulatory Authority for the respective year, BUT will have to submit the final
thesis by the end of 24 months from the beginning of the M. Pharm program as instructed by
the Government/Regulatory Authority. The t ime between submission of synopsis and thesis
should be at least one month. The learner must submit his thesis to the University in a format
as prescribed by the University. The university will take all steps to conduct the viva-voce
examination at the ea rliest after the submission of the thesis. It is expected that only the
synopsis of the thesis submitted by the learner will be forward by the university to the
external examiner at least one week before the conduct of the viva-voce examination. Only at
the time of the viva-voce examination, the external examiner will be presented the thesis
submitted by the candidate for the award of the degree.
The evaluation will be done by a pair of examiners (research guide and external examiner),
appointed by and at the University, based on the report and a viva -voce. Final Grade reports
are to be sent by the Institute to the respective section of university on completion of the
viva-voce. The criteria of eva luation of Dissertation are given in the curriculum manual.
Any late submission of synopsis or thesis will result in the learner requiring to keep
terms for the next semester and any subsequent semester/s till the learner finishes
his/her degree.
The inter nal and external examiner appointed by the Univer sity shall evaluate the project.
The projects shall be evaluated as per the criteria given below.
Evaluation of Dissertation Book:
Objective(s) of the work done
Methodology adopted
Results and Discussions
Conclusions andOutcomes 50
150
250
50
Total 500 Marks
Evaluation of Presentation:
Presentation of work
Communication skills
Question and answer s kills 100
50
100
Total 250 Marks
17. Award of degree
Candidates who fulfill the requirements mentioned above shall be eligible for award of

Page 38

33 degree during the ensuing convocation.
18. Duration for completion of the program of study
The duration for the completion of the program shall be fixed as per the norms of the
University of Mumbai

Page 39

1


UNIVERSITY OF MUMBAI













Scheme and Syllabus For
CHOICE BASED CREDIT SYSTEM
for
Postgraduate Program
(Master of Pharmacy, M. Pharm.)
in
PHARMACY
Revised Course (Revised 2019)
(from the academic year 2019 –2020)

Page 40

2
1. Course of study
The specializations in M.Pharm program is given in Table 1.


Table – 1: List of M.Pharm. Specializations and their Code
S. No. Specialization Code
1. Pharmaceutics MPH
2. Industrial Pharmacy MIP
3. Pharmaceutical Chemistry MPC
4. Pharmaceutical Analysis MPA
5. Pharmaceutical Quality Assurance MQA
6. Pharmaceutical Regulatory Affairs MRA
7. Pharmaceutical Biotechnology MPB
8. Pharmacy Practice MPP
9. Pharmacology MPL
10. Pharmacognosy MPG

The course of study for M.Pharm specializations shall include Semester wise
Theory & Practical as given in Table – 2 to 11. The number of hours to be
devoted to each theory and practical course in any semester shall not be less
than that shown in Table – 2 to 11.

Page 41

3 Table – 2: Course of study for M. Pharm. (Pharmaceutics)
Course
Code Course Credit
Hours Credit
Points Hrs./wk Marks
Semester I
MPH101T Modern Pharmaceutical
Analytical Techniques 4 4 4 100
MPH102T Drug Delivery System 4 4 4 100
MPH103T Modern Pharmaceutics 4 4 4 100
MPH104T Regulatory Affair 4 4 4 100
MPH105P Pharmaceutics Practical I 12 6 12 150
- Seminar/Assignment 7 4 7 100
Total 35 26 35 650
Semester II

MPH201T Molecular Pharmaceutics
(Nano Tech and Targeted
DDS)
4
4
4
100

MPH202T Advanced
Biopharmaceutics &
Pharmacokinetics
4
4
4
100
MPH203T Computer Aided Drug
Delivery System 4 4 4 100
MPH204T Cosmetic and
Cosmeceuticals 4 4 4 100
MPH205P Pharmaceutics Practical II 12 6 12 150
- Seminar/Assignment 7 4 7 100
Total 35 26 35 650

Page 42

4 Table – 3: Course of study for M. Pharm. (Industrial Pharmacy)
Course
Code Course Credit
Hours Credit
Points Hrs./w
k Marks
Semester I
MIP101T Modern Pharmaceutical
Analytical Techniques 4 4 4 100
MIP102T Pharmaceutical Formulation
Development 4 4 4 100
MIP103T Novel drug delivery systems 4 4 4 100
MIP104T Intellectual Property Rights 4 4 4 100
MIP105P Industrial Pharmacy Practical
I 12 6 12 150
- Seminar/Assignment 7 4 7 100
Total 35 26 35 650
Semester II
MIP201T Advanced Biopharmaceutics
and Pharmacokinetics 4 4 4 100
MIP202T Scale up and Technology
Transfer 4 4 4 100
MIP203T Pharmaceutical Production
Technology 4 4 4 100
MIP204T Entrepreneurship
Management 4 4 4 100
MIP205P Industrial Pharmacy Practical
II 12 6 12 150
- Seminar/Assignment 7 4 7 100
Total 35 26 35 650

Page 43

5 Table – 4: Course of study for M. Pharm. (Pharmaceutical Chemistry)
Course Code Course Credit
Hours Credit
Points Hrs./w
k Marks
Semester I
MPC101T Modern Pharmaceutical
Analytical Techniques 4 4 4 100
MPC10 2T Advanced Organic
Chemistry -I 4 4 4 100
MPC103T Advanced Medicinal
chemistry 4 4 4 100
MPC104T Chemistry of Natural
Products 4 4 4 100
MPC105P Pharmaceutical
Chemistry Practical I 12 6 12 150
- Seminar/Assignment 7 4 7 100
Total 35 26 35 650
Semester II
MPC201T Advanced Spectral
Analysis 4 4 4 100
MPC202T Advanced Organic
Chemistry -II 4 4 4 100
MPC203T Computer Aided Drug
Design 4 4 4 100
MPC204T Pharmaceutical Process
Chemistry 4 4 4 100
MPC205P Pharmaceutical
Chemistry Practical II 12 6 12 150
- Seminar/Assignment 7 4 7 100
Total 35 26 35 650

Page 44

6 Table – 5: Course of study for M. Pharm. (Pharmaceutical Analysis)
Course
Code Course Credit
Hours Credit
Points Hrs./wk Marks
Semester I
MPA101T Modern Pharmaceutical
Analytical Techniques 4 4 4 100
MPA102T Advanced Pharmaceutical
Analysis 4 4 4 100
MPA103T Pharmaceutical Validation 4 4 4 100
MPA104T Food Analysis 4 4 4 100
MPA105P Pharmaceutical Analysis
Practical I 12 6 12 150
- Seminar/Assignment 7 4 7 100
Total 35 26 35 650
Semester II
MPA201T Advanced Instrumental
Analysis 4 4 4 100
MPA202T Modern Bio-Analytical
Techniques 4 4 4 100
MPA203T Quality Control and Quality
Assurance 4 4 4 100
MPA204T Herbal and Cosmetic
Analysis 4 4 4 100
MPA205P Pharmaceutical Analysis
Practical II 12 6 12 150
- Seminar/Assignment 7 4 7 100
Total 35 26 35 650

Page 45

7 Table – 6: Course of study for M. Pharm. (Pharmaceutical Quality Assurance)
Course
Code Course Credit
Hours Credit
Points Hrs./w
k Marks
Semester I
MQA101T Modern Pharmaceutical
Analytical Techniques 4 4 4 100
MQA102T Quality Management
System 4 4 4 100
MQA103T Quality Control and Quality
Assurance 4 4 4 100
MQA104T Product Development and
Technology Transfer 4 4 4 100
MQA105P Pharmaceutical Quality
Assurance Practical I 12 6 12 150
- Seminar/Assignment 7 4 7 100
Total 35 26 35 650
Semester II
MQA201T Hazards and Safety
Management 4 4 4 100
MQA202T Pharmaceutical Validation 4 4 4 100
MQA203T Audits and Regulatory
Compliance 4 4 4 100
MQA204T Pharmaceutical
Manufacturing Technology 4 4 4 100
MQA205P Pharmaceutical Quality
Assurance Practical II 12 6 12 150
- Seminar/Assignment 7 4 7 100
Total 35 26 35 650

Page 46

8 Table – 7: Course of study for M. Pharm. (Regulatory Affairs)
Course
Code Course Credit
Hours Credit
Points Hrs./
wk Marks
Semester I
MRA
101T Good Regulatory Practices 4 4 4 100
MRA
102T Documentation and
Regulatory Writing 4 4 4 100
MRA
103T Clinical Research
Regulations 4 4 4 100


MRA
104T Regulations and Legislation
for Drugs & Cosmetics,
Medical Devices, Biologicals
& Herbals, and Food &
Nutraceuticals In India and
Intellectual Property Rights

4

4

4

100
MRA
105P Regulatory Affairs Practical I 12 6 12 150
Seminar/Assignment 7 4 7 100
Total 35 26 35 650
Semester II
MRA
201T Regulatory Aspects of Drugs
& Cosmetics 4 4 4 100
MRA
202T Regulatory Aspects of Herbal
& Biologicals 4 4 4 100
MRA
203T Regulatory Aspects of
Medical Devices 4 4 4 100
MRA
204T Regulatory Aspects of Food
& Nutraceuticals 4 4 4 100
MRA
205P Regulatory Affairs Practical II 12 6 12 150
Seminar/Assignment 7 4 7 100
Total 35 26 35 650

Page 47

10 Table – 8: Course of study for M. Pharm. (Pharmaceutical Biotechnology)
Course
Code Course Credit
Hours Credit
Points Hrs./w
k Marks
Semester I
MPB
101T Modern Pharmaceutical
Analytical Techniques 4 4 4 100
MPB
102T Microbial And Cellular Biology 4 4 4 100
MPB
103T Bioprocess Engineering and
Technology 4 4 4 100
MPB
104T Advanced Pharmaceutical
Biotechnology 4 4 4 100
MPB
105P Pharmaceutical Biotechnology
Practical I 12 6 12 150
- Seminar/Assignment 7 4 7 100
Total 35 26 35 650
Semester II
MPB
201T Proteins and protein
Formulation 4 4 4 100
MPB
202T Immunotechnology 4 4 4 100
MPB
203T Bioinformatics and Computer
Technology 4 4 4 100
MPB
204T Biological Evaluation of Drug
Therapy 4 4 4 100
MPB
205P Pharmaceutical Biotechnology
Practical II 12 6 12 150
- Seminar/Assignment 7 4 7 100
Total 35 26 35 650

Page 48

11
Table – 9: Course of study for M. Pharm. (Pharmacy Practice)
Course
Code Course Credit
Hours Credit
Points Hrs./wk Marks
Semester I
MPP
101T Clinical Pharmacy Practice 4 4 4 100
MPP
102T Pharmacotherapeutics -I 4 4 4 100
MPP
103T Hospital & Community
Pharmacy 4 4 4 100
MPP
104T Clinical Research 4 4 4 100
MPP
105P Pharmacy Practice Practical I 12 6 12 150
- Seminar/Assignment 7 4 7 100
Total 35 26 35 650
Semester II
MPP
201T Principles of Quality Use of
Medicines 4 4 4 100
MPP
202T Pharmacotherapeutics II 4 4 4 100
MPP
203T Clinical Pharmacokinetics and
Therapeutic Drug Monitoring 4 4 4 100
MPP
204T Pharmacoepidemiology &
Pharmacoeconomics 4 4 4 100
MPP
205P Pharmacy Practice Practical II 12 6 12 150
- Seminar/Assignment 7 4 7 100
Total 35 26 35 650

Page 49

12
Table – 10: Course of study for (Pharmacology)
Course
Code Course Credit
Hours Credit
Points Hrs./wk Marks
Semester I
MPL
101T Modern Pharmaceutical
Analytical Techniques 4 4 4 100
MPL
102T Advanced Pharmacology -I 4 4 4 100
MPL
103T Pharmacological and
Toxicological Screening
Methods -I
4
4
4
100
MPL
104T Cellular and Molecular
Pharmacology 4 4 4 100
MPL
105P Pharmacology Practical I 12 6 12 150
- Seminar/Assignment 7 4 7 100
Total 35 26 35 650
Semester II
MPL
201T Advanced Pharmacology II 4 4 4 100
MPL
202T Pharmacological and
Toxicological Screening
Methods -II
4
4
4
100
MPL
203T Principles of Drug Discovery 4 4 4 100
MPL
204T Clinical Research and
Pharmacovigilance 4 4 4 100
MPL
205P Pharmacology Practical II 12 6 12 150
- Seminar/Assignment 7 4 7 100
Total 35 26 35 650

Page 50

13
Table – 11: Course of study for M. Pharm. (Pharmacognosy)
Course
Code Course Credit
Hours Credit
Points Hrs./wk Marks
Semester I
MPG101T Modern Pharmaceutical
Analytical Techniques 4 4 4 100
MPG102T Advanced Pharmacognosy -1 4 4 4 100
MPG103T Phytochemistry 4 4 4 100
MPG104T Industrial Pharmacognostical
Technology 4 4 4 100
MPG105P Pharmacognosy Practical I 12 6 12 150
- Seminar/Assignment 7 4 7 100
Total 35 26 35 650
Semester II
MPG201T Medicinal Plant
biotechnology 4 4 4 100
MPG2 02T Advanced Pharmacognosy -II 4 4 4 100
MPG203T Indian system of medicine 4 4 4 100
MPG204T Herbal cosmetics 4 4 4 100
MPG205P Pharmacognosy Practical II 12 6 12 150
- Seminar/Assignment 7 4 7 100
Total 35 26 35 650

Page 51

34 Table – 12: Course of study for M. Pharm. III and IV Semesters
(Common for All Specializations)
Course
Code Course Credit
Hours Credit
Points
MRM301T Research Methodology and Biostatistics* 4 4
- Journal club 2 2
- Discussion / Presentation
(Proposal Presentation) 5 5
- Research Work 30 30
Total 41 41
* Non University Exam

Page 52

35 PHARMACEUTICS (MPH)

MODERN PHARMACEUTICAL ANALYTICAL TECHNIQUES
(MPH 101T)
Scope
This subject deals with various advanced analytical instrumental techniques for
identification, characterization and quantification of drugs. Instruments dealt are
NMR, Mass spectrometer, IR, HPLC, GC etc.

Objectives
After completion of course student is able to know,
 Chemicals and Excipients
 The analysis of various drugs in single and combination dosage forms
 Theoretical and practical skills of the instruments

THEORY 60 HOURS
1. a. UV-Visible spectroscopy : Introduction, Theory, Laws,
Instrumentation associated with UV -Visible spectroscopy,
Choice of solvents and solvent effect and Applications of UV -
Visible spectroscopy.

b. IR spectroscopy : Theory, Modes of Molecular vibrations,
Sample handling, Instrumentation of Dispersive and Fourier -
Transform IR Spectrometer, Factors affecting vibrational
frequencies and Applications of IR spec troscopy

c. Spectroflourimetry: Theory of Fluorescence, Factors
affecting fluorescence, Quenchers, Instrumentation and
Applications of fluorescence spectrophotometer.

d. Flame emission spectroscopy and Atomic absorption
spectroscopy : Principle, Instrumentation , Interferences and
Applications.
2 NMR spectroscopy : Quantum numbers and their role in NMR,
Principle, Instrumentation, Solvent requirement in NMR,
Relaxation process, NMR signals in various compounds,
Chemical shift, Factors influencing chemical shift, Spin-Spin
coupling, Coupling constant, Nuclear magnetic double resonance,
Brief outline of principles of FT -NMR and 13C NMR. Applications
of NMR spectroscopy. 11
Hrs















11
Hrs

Page 53

36 3 Mass Spectroscopy : Principle, Theory, Instrumentation of Mass
Spectroscopy, Different types of ionization like electron impact,
chemical, field, FAB and MALDI, APCI, ESI, APPI Analyzers of
Quadrupole and Time of Flight, Mass fragmentation and its rules,
Meta s table ions, Isotopic peaks and Applications of Mass
spectroscopy 11
Hrs

4 Chromatography : Principle, apparatus, instrumentation,
chromatographic parameters, factors affecting resolution and
applications of the following:
a) Paper chromatography b) Thin Layer chromatography
c) Ion exchange chromatography d) Column chromatography
e) Gas chromatography f) High Performance Liquid
chromatog raphy
g) Affinity chromatography 11
Hrs

5 a. Electrophoresis : Principle, Instrumentation, Working
conditions, factors affecting separation an d applications of the
following:
a) Paper electrophoresis b) Gel electrophoresis c) Capillary
electrophoresis d) Zone electrophoresis e) Moving boundary
electrophoresis f) Iso electric focusing
b. X ray Crystallography : Production of X rays, Different X ray
diffraction methods, Bragg‘s law, Rotating crystal technique, X
ray powder technique, Types of crystals and applications of X -
ray diffraction.
6 Immunological assays : RIA (Radio immuno assay), ELISA,
Bioluminescence assays.
REFERENCES 11
Hrs








5 Hrs
1. Spectrometric Identification of Organic compounds - Robert M Silverstein,
Sixth edition, John Wiley & Sons, 2004.
2. Principles of Instrumental Analysis - Doglas A Skoog, F. James Holler,
Timothy A. Nieman, 5th edition, Eastern press, Bangalore, 1998.
3. Instrumental methods of analysis – Willards, 7th edition, CBS publishers.
4. Practical Pharmaceutical Chemistry – Beckett and Stenlake, Vol II, 4th
edition, CBS Publishers, New Delhi, 1997.
5. Organic Spec troscopy - William Kemp, 3rd edition, ELBS, 1991.
6. Quantitative Analysis of Drugs in Pharmaceutical formulation - P D Sethi, 3rd
Edition, CBS Publishers, New Delhi, 1997.
7. Pharmaceutical Analysis - Modern methods – Part B - J W Munson, Volume
11, Marcel Dekke r Series

Page 54

37 DRUG DELIVERY SYSTEMS
(MPH 102T)
SCOPE
This course is designed to impart knowledge on the area of advances in novel
drug delivery systems.
OBJECTIVES
Upon completion of the course, student shall be able to understand
 The various approaches for development of novel drug delivery
systems.
 The criteria for selection of drugs and polymers for the development of
delivering system
 The formulation and evaluation of Novel drug delivery systems..

THEORY 60 Hrs

1. Sustained Release(SR) and Controlled Release (CR)
formulations: Introduction & basic concepts, advantages/
disadvantages, factors influencing, Physicochemical & biological
approaches for SR/CR formulation, Mechanism of Drug Delivery
from SR/CR formulation. Polymers: introduction, definition,
classification, properties and application Dosage Forms for
Personalized Medicine: Introduction, Definition,
Pharmacogenetics, Categories of Patients for P ersonalized
Medicines: Customized drug delivery systems, Bioelectronic
Medicines, 3D printing of pharmaceuticals, Telepharmacy. 10
Hrs

2 Rate Controlled Drug Delivery Systems: Principles &
Fundamentals, Types, Activation; Modulated Drug Delivery
Systems;Mechanically activated, pH activated, Enzyme activated,
and Osmotic activated Drug Delivery Systems Feedback
regulated Drug Delivery System s; Principles & Fundamentals. 10
Hrs

3 Gastro -Retentive Drug Delivery Systems : Principle, concepts
advantages and disadvantages, Modulation o f GI transit time
approaches to extend GI transit. Buccal Drug Delivery Systems:
Principle of muco adhesion, advantages and
disadvantages, Mechanism of drug permeation, Methods of
formulation and its evaluations.
4 Occular Drug Delivery Systems : Barriers of drug permeation,
Methods to overcome barriers. 10
Hrs




06
Hrs

Page 55

40 5 Transdermal Drug Delivery Systems: Structure of skin and
barriers, Penetration enhancers, Transdermal Drug Delivery
Systems, Formulation and evaluation.
6 Protein and Peptide Delivery: Barriers for protein delivery.
Formulation and Evaluation of delivery systems of proteins and
other macromolecules. 10
Hrs

08
Hrs

7 Vaccine delivery systems: Vaccines, uptake of antigens, single
shot vaccines, mucosal and transdermal delivery of vaccines. 06
Hrs


REFERENCES
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, Ma rcel
Dekker,Inc., New York, 1992.
3. Encyclopedia of controlled delivery, Editor - Edith Mathiowitz, Published by
WileyInterscience Publication, John Wiley and Sons, Inc, New York!
Chichester/Weinheim
4. N.K. Jain, Controlled and Novel Drug Delivery, CBS Publishers & Distributors,
New Delhi, First edition 1997 (reprint in 2001).
5. S.P.Vyas and R.K.Khar, Controlled Drug Delivery - concepts and advances,
Vallabh Prakashan, New Delhi, First edition 2002

JOURNALS
1. Indian Journal of Pharmaceutical Sciences (IPA)
2. Indian drugs (IDMA)
3. Journal of controlled release (Elsevier Sciences) desirable
4. Drug Development and Industrial Pharmacy (Marcel & Decker) desirable

Page 56

41 MODERN PHARMACEUTICS
(MPH 103T)
Scope
Course designed t o impart advanced knowledge and skills required to learn
various aspects and concepts at pharmaceutical industries

Objectives
Upon completion of the course, student shall be able to understand
 The elements of preformulation studies.
 The Active Pharmaceutical Ingredients and Generic drug Product
development
 Industrial Management and GMP Considerations.
 Optimization Techniques & Pilot Plant Scale Up Techniques
 Stability Testing, sterilization process & packaging of dosage forms.
THEORY 60 HRS
1. a. Preformation Concepts – Drug Excipient interactions -
different methods, kinetics of stability, Stability testing. Theories of
dispersion and pharmaceutical Dispersion (Emu lsion and
Suspension, SMEDDS) preparation and stability Large and small
volume parental – physiological and formulation consideration,
Manufacturing and evaluation.
b. Optimization techniques in Pharmaceutical Formulation :
Concept and parameters of optimiz ation, Optimization techniques
in pharmaceutical formulation and processing. Statistical design,
Response surface method, Contour designs, Factorial designs
and application in formulation
2 Validation : Introduction to Pharmaceutical Validation, Scope &
merits of Validation, Validation and calibration of Master plan,
ICH & WHO guidelines for calibration and validation of
equipments, Validation of specific dosage form, Types of
validation. Government regulation, Manufacturing Process Model,
URS, DQ, IQ, OQ & P.Q. of facilities.
3 cGMP & Industrial Management : Objectives and policies of
current good manufacturing practices, layout of buildings,
services, equipments and their maintenance Production
management: Production organization, , materials management,
handl ing and transportation, inventory management and control,
production and planning control, Sales forecasting, budget and
cost control, industrial and personal relationship. Concept of Total
Quality Management. 10
Hrs




10
Hrs



10
Hrs




10
Hrs

Page 57

42 4 Compression and compaction : Physics of tablet compression,
compression, consolidation, effect of friction, distribution of
forces, compaction profiles. Solubility.
5 Study of consolidation parameters ; Diffusion parameters,
Dissolution parameters and Pharmacokinetic parameters, Heckel
plots, Similarity factors – f2 and f1, Higuchi and Peppas plot,
Linearity Concept of significance, Standard deviation , Chi square
test, students T -test , ANOVA test. 10
Hrs

10
Hrs

REFERENCES
1. Theory and Practice of Industrial Pharmacy By Lachmann and Libermann
2. Pharmaceutical dosage forms: Tablets Vol. 1 -3 by Leon Lachmann.
3. Pharmaceutical Dosage f orms: Disperse systems, Vol, 1 -2; By Leon
Lachmann.
4. Pharmaceutical Dosage forms: Parenteral medications Vol. 1 -2; By Leon
Lachmann.
5. Modern Pharmaceutics; By Gillbert and S. Banker.
6. Remington’s Pharmaceutical Sciences.
7. Advances in Pharmaceutical Sciences Vol. 1 -5; By H.S. Bean & A.H.
Beckett.
8. Physical Pharmacy; By Alfred martin
9. Bentley’s Textbook of Pharmaceutics – by Rawlins.
10. Good manufacturing practices for Pharmaceuticals: A plan for total quality
control, Second edition; By Sidney H. Willig.
11. Quality As surance Guide; By Organization of Pharmaceutical producers of
India.
12. Drug formulation manual; By D.P.S. Kohli and D.H.Shah. Eastern
publishers, New Delhi.
13. How to practice GMPs; By P.P.Sharma. Vandhana Publications, Agra.
14. Pharmaceutical Process Validation; By Fra. R. Berry and Robert A. Nash.
15. Pharmaceutical Preformulations; By J.J. Wells.
16. Applied production and operations management; By Evans, Anderson,
Sweeney and Williams.
17. Encyclopaedia of Pharmaceutical technology, Vol I – III.

Page 58

43 REGULATORY AFFAIRS
(MPH 104T)
Scope
Course designed to impart advanced knowledge and skills required to learn the
concept of generic drug and their development, various regulatory filings in
different co untries, different phases of clinical trials and submitting regulatory
documents : filing process of IND, NDA and ANDA
 To know the approval process of
 To know the chemistry, manufacturing controls and their regulatory
importance
 To learn the documentation requirements for
 To learn the importance and
Objectives:
Upon completion of the course, it is expected that the students will be able to
understand

 The Concepts of innovator and generic drugs, drug development
process
 The Regulatory guidance’s and guidelines for filing and approval
process
 Preparation of Dossiers and their submission to regulatory agencies in
different countries
 Post approval regulatory requirements for actives and drug products
 Submission of global documents in CTD/ eCTD formats
 Clinical trials requirements for approvals for conducting clinical trials
 Pharmacovigilence and process of monitoring in clinical trials.

THEORY 60 Hrs
1. a. Documentation in Pharmaceutical industry : Master
formula record, DMF (Drug Master File), distribution records.
Generic drugs product development Introduction , Hatch -
Waxman act and amendments, CFR (CODE OF FEDERAL
REGULATION) ,drug product performance, in -vitro, ANDA
regulatory approval process, NDA approval process, BE and drug
product assessment, in –vivo, scale up process approval
changes, post marketing surveillance, outsourcing BA and BE to
CRO.
b. Regulatory requirement for product approval : API,
biologics, novel, therapies obtaining NDA, A NDA for generic
drugs ways and means of US registration for foreign drugs 12
Hrs

Page 59

44 2 CMC, post approval regulatory affairs. Regulation for combination
products and medical devices.CTD and ECTD for mat, industry
and FDA liaison. ICH - Guidelines of ICH -Q, S E, M. Regulatory
requirements of EU, MHRA, TGA and ROW countries.
3 Non clinical drug development: Global submission of IND,
NDA, ANDA. Investigation of medicinal products dossier, dossier
(IMPD) an d investigator brochure (IB).
4 Clinical trials: Developing clinical trial protocols. Institutional
review board/ independent ethics committee Formulation and
working procedures informed Consent process and procedures.
HIPAA - new, requirement to clinical stu dy process,
pharmacovigilance safety monitoring in clinical trials. 12
Hrs


12
Hrs

12
Hrs

REFERENCES
1. Generic Drug Product Development, Solid Oral Dosage forms, Leon Shargel
and IsaderKaufer,Marcel Dekker series, Vol.143
2. The Pharmaceutical Regulatory Process, Second Edition Edited by Ira R.
Berry and Robert P.Martin, Drugs and the Pharmaceutical Sciences,Vol.185,
Informa Health care Publishers.
3. New Drug Approval Process: Accelerating Global Registrations By Richard A
Guarino, MD,5th edition, Drugs and the Pharmaceutical Sciences,Vol.190.
4. Guidebook for drug regulatory submissions / Sandy Weinberg. By John Wiley
& Sons.Inc.
5. FDA regulatory affairs: a guide for prescription drugs, medical devices, and
biologics/edited By Douglas J. Pisano, David Mantus.
6. Clinical Trials and Human Research: A Practical Guide to Regulatory
Compliance By Fay A.Rozovsky and Rodney K. Adams
7. www.ich.org/
8. www.fda.gov/
9. europa.eu/index_en.htm
10. https:/ /www.tga.gov.au/tga -basics

Page 60

45 PHARMACEUTICS PRACTICALS - I
(MPH 105P)
1. Analysis of pharmacopoeial compounds and their formulations by UV Vis
spectrophotometer
2. Simultaneous estimation of multi component containing formulations by UV
spectrophotometry
3. Experiments based on HPLC
4. Experiments based on Gas Chromatography
5. Estimation of riboflavin/quinine sulphate by fluorimetry
6. Estimation of sodium/potassium by flame photometry
7. To perform In-vitro dissolution profile of CR/ SR marketed formulation
8. Formulation and evaluation of sustained release matrix tablets
9. Formulation and evaluation osmotically controlled DDS
10. Preparation and evaluation of Floating DDS - hydro dynamically balanced
DDS
11. Formulation and evaluation of Muco adhesive tablets.
12. Formulation and evaluation of trans dermal patches.
13. To carry out preformulation studies of tablets.
14. To study the effect of compressional force on tablets disintegration time.
15. To study Micromeritic properties of powders and granulation.
16. To study the effect of particle size on dissolution of a tablet.
17. To study the effect of binders on dissolution of a tablet.
18. To plot Heckal plot, Higuchi and peppas plot and determine similarity factors.

Page 61

46 MOLECULAR PHARMACEUTICS (NANO TECHNOLOGY &
TARGETED DDS) (NTDS)
(MPH 201T)
Scope
This course is designed to impart knowledge on the area of advances in novel
drug delivery systems.

Objectives
Upon completion of the course student shall be able to understand
 The various approaches for development of novel drug delivery
systems.
 The criteria for selection of drugs and polymers for the development of
NTDS
 The formulation and evaluation of novel drug delivery systems.

THEORY 60 Hrs
1. Targeted Drug Delivery Systems: C oncepts, Events and
biological process involved in drug targeting. Tumor targeting and
Brain specific delivery.
2 Targeting Methods : introduction preparation and evaluation.
Nano Particles & Liposomes: Types, preparation and evaluation. 12
Hrs

12
Hrs

3 Micro Capsules / Micro Spheres: Types, preparation and
evaluation , Monoclonal Antibodies ; preparation and application,
preparation and application of Niosomes, Aquasomes,
Phytosomes, Electrosomes.
4 Pulmonary Drug Delivery Systems : Aerosols, propellents,
ContainersTypes, preparation and evaluation, Intra Nasal Route
Delivery systems; Types, preparation and evaluation.
5 Nucleic acid based therapeutic delivery system : Gene therapy,
introduction (ex -vivo & in -vivo gene therapy). Potential target
diseases for gene therapy (inherited disorder and cancer). Gene
expression syste ms (viral and nonviral gene transfer). Liposomal
gene delivery systems.
Biodistribution and Pharmacokinetics. knowledge of therapeutic
antisense molecules and aptamers as drugs of future.
REFERENCES 12
Hrs


12
Hrs

12
Hrs
1. Y W. Chien, Novel Drug Delivery Systems, 2nd edition, revised and
expanded,Marcel Dekker, Inc., New York, 1992.
2. S.P.Vyas and R.K.Khar, Controlled Drug Delivery - concepts and
advances, VallabhPrakashan, New Delhi, First edition 2002.
3. N.K. Jain, Controlled and Novel Drug Delivery, CBS Publishers &
Distributors, NewDelhi, First edition 1997 (reprint in 2001).

Page 62

47 ADVANCED BIOPHARMACEUTICS & P HARMACOKINETICS
(MPH 202T)
Scope
This course is designed to impart knowledge and skills necessary for dose
calculations, dose adjustments and to apply biopharmaceutics theories in
practical problem solving. Basic theoretical discussions of the principles o f
biopharmaceutics and pharmacokinetics are provided to help the students’ to
clarify the concepts.

Objectives
Upon completion of this course it is expected that students will be able
understand,
 The basic concepts in biopharmaceutics and pharmacokinetics .
 The use raw data and derive the pharmacokinetic models and
parameters the best describe the process of drug absorption,
distribution, metabolism and elimination.
 The critical evaluation of biopharmaceutic studies involving drug
product equivalency.
 The design and evaluation of dosage regimens of the drugs using
pharmacokinetic and biopharmaceutic parameters.
 The potential clinical pharmacokinetic problems and application of
basics of pharmacokinetic

THEORY 60 Hrs
1. Drug Absorption from the Gastrointestinal Tract :
Gastrointestinal tract, Mechanism of drug absorption, Factors
affecting drug absorption, pH –partition theory of drug absorption.
Formuulation and p hysicochemical factors: Dissolution rate,
Dissolution process, Noyes –Whitney equation and drug
dissolution, Factors affecting the dissolution rate. Gastrointestinal
absorption: role of the dosage form: Solution (elixir, syrup and
solution) as a dosage form ,Suspension as a dosage form,
Capsule as a dosage form, Tablet as a dosage form ,Dissolution
methods ,Formulation and processing factors, Correlation of in
vivo data with in vitro dissolution data.Transport model:
Permeability -Solubility -Charge State and the pH Partition
Hypothesis, Properties of the Gastrointestinal Tract (GIT), pH
Microclimate Intracellular pH Environment, Tight -Junction
Complex. 12
Hrs

Page 63

48 2 Biopharmaceutic considerations in drug product design
and In Vitro Drug Product Performance: Introduction,
biopharmaceutic factors affecting drug bioavailability, rate -limiting
steps in drug absorption, physicochemical nature of the drug
formulation factors affecting drug product performance , in vitro :
dissolution and drug release testing, compendial methods of
dissolution, alternative methods of dissolution testing,meeting
dissolution requirements,problems of variable control in
dissolution testingperformance of drug products. In vitro –in vivo
correlation, dissolution profile comparisons, drug product
stability,considerations in the design of a drug product.
3 Pharmacokinetics: Basic considerations, pharmacokinetic
models, compartment modeling: one compartment model - IV
bolus, IV infusion, extra -vascular. Multi compartment model:two
compartment - model in brief, non -linear pharmacokinetics: cause
of non -linearity, Michaelis – Menten equation, estimation of k max
and v max. Drug interactions: introduction, the effect of protein -
binding intera ctions,the effect of tissue -binding
interactions,cytochrome p450 -based drug interactions,drug
interactions linked to transporters.
4 Drug Product Performance, In Vivo: Bioavailability and
Bioequivalence : drug product performance, purpose of
bioavailability s tudies, relative and absolute availability. methods
for assessing bioavailability, bioequivalence studies, design and
evaluation of bioequivalence studies, study designs, crossover
study designs, evaluation of the data, bioequivalence example,
study submis sion and drug review process. biopharmaceutics
classification system, methods. Permeability: In -vitro, in -situ and
In-vivo methods.generic biologics (biosimilar drug
products),clinical significance of bioequivalence studies, special
concerns in bioavailabi lity and bioequivalence studies, generic
substitution.
5 Application of Pharmacokinetics: Modified -Release Drug
Products, Targeted Drug Delivery Systems and Biotechnological
Products. Introduction to Pharmacokinetics and
pharmacodynamic, drug interactions. P harmacokinetics and
pharmacodynamics of biotechnology drugs. Introduction, Proteins
and peptides, Monoclonal antibodies, Oligonucleotides, Vaccines
(immunotherapy), Gene therapies. 12
Hrs









12
Hrs







12
Hrs










12
Hrs

Page 64

49 REFERENCES
1. Biopharmaceutics and Clinical Pharmacokinetics by Milo Gibaldi, 4th
edition,Philadelphia, Lea and Febiger, 1991
2. Biopharmaceutics and Pharmacokinetics, A. Treatise, D .M. Brahmankar
and Sunil B. Jaiswal., VallabPrakashan, Pitampura, Delhi
3. Applied Biopharmaceutics and Pharmacokinetics by Shargel. Land
YuABC, 2ndedition, Connecticut Appleton Century Crofts, 1985
4. Textbook of Biopharmaceutics and Pharmacokinetics, Dr. Shobha Rani R.
Hiremath,Prism Book
5. Pharmacokinetics by Milo Gibaldi and D. Perrier, 2nd edition, Marcel
Dekker Inc.,New York, 1982
6. Current Concepts in Pharmaceutical Sciences: Biopharmaceutics,
Swarbrick. J, Leaand Febiger, Philadelphia, 1970
7. Clinical Pharmacokin etics, Concepts and Applications 3rd edition by
MalcolmRowland and Thom~ N. Tozer, Lea and Febiger, Philadelphia,
1995
8. Dissolution, Bioavailability and Bioequivalence, Abdou. H.M, Mack
PublishingCompany, Pennsylvania 1989
9. Biopharmaceutics and Clinical Phar macokinetics, An Introduction, 4th
edition,revised and expande by Robert. E. Notari, Marcel Dekker Inc, New
York and Basel,1987.
10 . Biopharmaceutics and Relevant Pharmacokinetics by John. G Wagner and
M.Pemarowski, 1st edition, Drug Intelligence Publications, Hamilton,
Illinois, 1971.
11 . Encyclopedia of Pharmaceutical Technology, Vol 13, James Swarbrick,
James. G.Boylan, Marcel Dekker Inc, New York, 1996.
12 . Basic Pharmacokinetics,1 st edition,Sunil S JambhekarandPhilip J
Breen,pharmaceutical press, RPS Publishing,2 009.
13 . Absorption and Drug Development - Solubility, Permeability, and Charge
State, Alex Avdeef, John Wiley & Sons, Inc,2003.

Page 65

50 COMPUTER AIDED DRUG DEVELOPMENT
(MPH 203T)
Scope
This course is designed to impart knowledge and skills necessary for computer
Applications in pharmaceutical research and development who want to
understand the application of computers across the entire drug research and
development process. Basic theoretical discussions of the pri nciples of more
integrated and coherent use of computerized information (informatics) in the
drug development process are provided to help the students to clarify the
concepts.

Objectives
Upon completion of this course it is expected that students will be able to
understand,
 History of Computers in Pharmaceutical Research and Development
 Computational Modeling of Drug Disposition
 Computers in Preclinical Development
 Optimization Techniques in Pharmaceutical Formulation
 Computers in Market Analysis
 Computers in Clinical Development
 Artificial Intelligence (AI) and Robotics
 Computational fluid dynamics(CFD)

THEORY 60 Hrs
1. a. Computers in Pharmaceutical Research and
Development : A General Overview: History of Computers in
Pharmaceutical Research and Development. Statistical modeling
in Pharmaceutical research and development: Descriptive versus
Mechanistic Modeling, Statistical Parameters, Estimation,
Confidence Regions, Nonlinearit y at the Optimum, Sensitivity
Analysis, Optimal Design, Population Modeling
b. Quality -by-Design In Pharmaceutical Development:
Introduction, ICH Q8 guideline, Regulatory and industry views on
QbD, Scientifically based QbD - examples of application.
2 Computational Modeling Of Drug Disposition: Introduction
,Modeling Techniques: Drug Absorption, Solubility, Intestinal
Permeation, Drug Distribution ,Drug Excretion, Active Transport;
P-gp, BCRP, Nucleoside Transporters, hPEPT1, ASBT, OCT,
OATP, BBB -Cholin e Transporter. 12
Hrs








12
Hrs

Page 66

51 3 Computer -aided formulation development :: Concept of
optimization, Optimization parameters, Factorial design,
Optimization technology & Screening design. Computers in
Pharmaceutical Formulation: Development of pharmaceutical
emulsions, microemulsion drug carriers Legal Protection of
Innovative Uses of Computers in R&D, The Ethics of Computing
in Pharmaceutical Research, Computers in Market analysis
4 a. Compu ter-aided biopharmaceutical characterization :
Gastrointestinal absorption simulation. Introduction, Theoretical
background, Model construction, Parameter sensitivity analysis,
Virtual trial, Fed vs. fasted state, In vitro dissolution and in vitro -
in vivo correlation, Biowaiver considerations
b. Computer Simulations in Pharmacokinetics and
Pharmacodynamics: Introduction, Computer Simulation: Whole
Organism, Isolated Tissues, Organs, Cell, Proteins and Genes.
c. Computers in Clinical Development : Clinical Data Col lection
and Management, Regulation of Computer Systems
5 Artificial Intelligence (AI), Robotics and Computational fluid
dynamics: General overview, Pharmaceutical Automation,
Pharmaceutical applications, Advantages and Disadvantages.
Current Challenges and F uture Directions. 12
Hrs





12
Hrs








12
Hrs

REFERENCES
1. Computer Applications in Pharmaceutical Research and Development,
Sean Ekins, 2006, John Wiley & Sons.
2. Computer -Aided Applications in Pharmaceutical Technology, 1st Edition,
Jelena Djuris, Woodhead Publishing
3. Encyclopedia of Pharmaceutical Technology, Vol 13, James Swarbrick,
James. G.Boylan, Marcel Dekker Inc, New York, 1996.

Page 67

52 COSMETICS AND COSMECEUTICALS
(MPH 204T)
Scope
This course is designed to impart knowledge and skills necessary
forthefundamental need for cosmetic and cosmeceutical products.

Objectives
Upon completion of the course, the students shall be able to understand
 Key ingredients used in cosmetics and cosmeceuticals.
 Key building blocks for various formulations.
 Current technologies in the market
 Various key ingredients and basic science to develop cosmetics an d
cosmeceuticals
 Scientific knowledge to develop cosmetics and cosmeceuticals with
desired Safety, stability, and efficacy.

THEORY 60 Hrs
1. Cosmetics – Regulatory : Definition of cosmetic products as per
Indian regulation. Indian regulatory requirements for labeling of
cosmetics Regulatory provisions relating to import of cosmetics.,
Misbranded and spurious cosmetics. Regulatory provisions
relating to manufacture of c osmetics – Conditions for obtaining
license, prohibition of manufacture and sale of certain cosmetics,
loan license, offences and penalties.
2 Cosmetics - Biological aspects : Structure of skin relating to
problems like dry skin, acne, pigmentation, prickly heat, wrinkles
and body odor. Structure of hair and hair growth cycle. Common
problems associated with oral cavity. Cleansing and care needs
for face, eye lids, lips, hands, feet, nail, scalp, neck, body and
under -arm.
3 Formulation Building blocks: Building blocks for different
product formulations of cosmetics/cosmeceuticals. Surfactants –
Classification and application. Emollients, rheological additives:
classification and application. Antimicrobial used as preservatives,
their merits and demerits. Factors affecting microbial preservative
efficacy. Building blocks for formulation of a moisturizing cream,
vanishing cream, cold cream, shampoo and toothpaste. Soaps
and syndetbars.
Perfumes ; Classification of perfumes. Perfume ingredients listed
as allergens in EU regulation. 12
Hrs





12
Hrs




12
Hrs

Page 68

53 Controversial ingredients: Parabens, formaldehyde liberators,
dioxane.
4 Design of cosmeceutical products: Sun protection, sunscreens
classification and regulatory aspects. Addressing dry skin, acne,
sun-protection, pigmentation, prickly heat, wrinkles, body odor.,
dandruff, dental cavities, bleeding gums, mouth odor and
sensitive teeth through cosmeceutical formulations.
5 Herbal Cosmetics : Herbal ingredients used in Hair care, skin
care and oral care. Review of guidelines for herbal cosmetics by
private bodies like cosmos with respect to preservatives,
emollients, foaming agents, emulsifiers and rheology modifi ers.
Challenges in formulating herbal cosmetics.

12
Hrs



12
Hrs

REFERENCES
1. Harry’s Cosmeticology. 8th edition.
2. Poucher’sperfumecosmeticsandSoaps,10th edition.
3. Cosmetics - Formulation, Manufacture and quality control, PP.Sharma,4th
edition
4. Handbook of cosmetic science and Technology A.O.Barel, M.Paye and
H.I. Maibach. 3 rd edition
5. Cosmetic and Toiletries recent suppliers catalogue.
6. CTFA directory.

Page 69

54 PHARMACEUTICS PRACTICALS - II
(MPH 205P)
1. To study the effect of temperature change , non solvent addition,
incompatible polymer addition in microcapsules preparation
2. Preparation and evaluation of Alginate beads
3. Formulation and evaluation of gelatin /albumin microspheres
4. Formulation and evaluation of liposomes/niosomes
5. Formulation and evaluation of spherules
6. Improvement of dissolution characteristics of slightly soluble drug by Solid
dispersion technique.
7. Comparison of dissolution of two different marketed products /brands
8. Protein binding studies of a highly protein bound drug & poorly protein
bound drug
9. Bioavailability studies of Paracetamol in animals.
10. Pharmacokinetic and IVIVC data analysis by Win nolineR software
11. In vitro cell studies for permeability and metabolism
12. DoE Using Design Expert® Software
13. Formulation data analysis Using Design Expert® Software
14. Quality -by-Design in Pharmaceutical Development
15. Computer Simulations in Pharmacokinetics and Pharmacodynamics
16. Computational Modeling Of Drug Disposition
17. To develop Clinical Data Collection manual
18. To carry out Sensitivity Analysis, and Population Modeling.
19. Development and evaluation of Creams
20. Development and evaluation of Shampoo and Toothpaste base
21. To incorporate herbal and chemical actives to develop products
22. To address Dry skin, acne, blemish, Wrinkles, bleeding gums and
dandruff

Page 70

55 INDUSTRIAL PHARMACY (MIP)
MODERN PHARMACEUTICAL ANALYTICAL TECHNIQUES
(MIP 101T)

Scope
This subject deals with various advanced analytical instrumental techniques for
identification, characterization and quantification of drugs. Instruments dealt are
NMR, Mass spectrometer, IR, HPLC, GC etc.

Objectives
After completion of course student is able to know,
 The analysis of various drugs in single and combination dosage forms
 Theoretical and practical skills of the instruments

THEORY 60 HOURS
1. UV-Visible spec troscopy: Introduction, Theory, Laws,
Instrumentation associated with UV -Visible spectroscopy, Choice
of solvents and solvent effect and Applications of UV -Visible
spectroscopy.

IR spectroscopy : Theory, Modes of Molecular vibrations, Sample
handling, Inst rumentation of Dispersive and Fourier - Transform
IR Spectrometer, Factors affecting vibrational frequencies and
Applications of IR spectroscopy

Spectroflourimetry: Theory of Fluorescence, Factors affecting
fluorescence, Quenchers, Instrumentation and App lications of
fluorescence spectrophotometer.

Flame emission spectroscopy and Atomic absorption
spectroscopy: Principle, Instrumentation, Interferences and
Applications. 11
Hrs

2 NMR spectroscopy: Quantum numbers and their role in NMR,
Principle, Instrumentation, Solvent requirement in NMR,
Relaxation process, NMR signals in various compounds,
Chemical shift, Factors influencing chemical shift, Spin -Spin
coupling, Coupling constant, Nuclear magnetic double resonance,
Brief outline of principles of FT -NMR and 13C NMR. Applications
of NMR spectroscopy. 11
Hrs

Page 71

56 3 Mass Spectroscopy: Principle, Theory, Instrumentation of Mass
Spectroscopy, Different types of ionization like electron impact,
chemical, field, FAB and MALDI, APCI, ESI, APPI Analyzers of
Quadrupole and Time of Flight, Mass fragmentation and its rules,
Meta stable ions, Isotopic peaks and Applications of Mass
spectroscopy 11
Hrs

4 Chromatography: Principle, apparatus, instrumentation,
chromatographic parameters, factors affecting resolution and
applications of the following:
a) Paper chromatography b) Thin Layer chromatography
c) Ion exchange chromatography d) Column chromatography
e) Gas chromatography f) High Performance Liquid
chromatog raphy
g) Affinity chromatography 11
Hrs

5 Electrophoresis: Principle, Instrumentation, Working conditions,
factors affecting separation and a pplications of the following:
a) Paper electrophoresis b) Gel electrophoresis c) Capillary
electrophoresis d) Zone electrophoresis e) Moving boundary
electrophoresis f) Iso electric focusing

X ray Crystallography: Production of X rays, Different X ray
methods, Bragg‘s law, Rotating crystal technique, X ray powder
technique, Types of crystals and applications of X -ray diffraction. 11
Hrs

6. Immunological Assays: Radioimmunology assay (RIA), ELISA
(Theory & practical) and knowledge on Bioluminescence assays. 5 Hrs

REFERENCES
1. Spectrometric Identification of Organic compounds - Robert M Silverstein,
6th edition, John Wiley & Sons, 2004.
2. Principles of Instrumental Analysis - Doglas A Skoog, F. James Holler,
Timothy A. Nieman, 5th edition, Eastern press, Bangalore, 1998.
3. Instrumental methods of analysis – Willards, 7th edition, CBS publishers.
4. Practical Pharmaceutical Chemistry – Beckett and Stenlake, Vol II, 4th
edition, CBS Publishers, New Delhi, 1997.
5. Organic Spectroscopy - William Kemp, 3rd edition, ELBS, 1991.
6. Quantitative Analysis of Drugs in Pharmaceutical formulation - P D Sethi,
3rd Edition, CBS Publishers, New Delhi, 1997.
7. Pharmaceutical Analysis - Modern methods – Part B - J W Munson,
Volume 11, Marcel Dekker Series

Page 72

57 PHARMACEUTICAL FORMULATION DEVELOPMENT
(MIP 102T)

Scop e
This course is designed to impart knowledge and skills necessary to train the
students on par with the routine of Industrial activities in R&D and F&D.

Objectives
On completion of this course it is expected that students will be able to
understand -
 The scheduled activities in a Pharmaceutical firm.
 The pre formulation studies of pilot batches of pharmaceutical industry.
 The significance of dissolution and product stability

THEORY 60 Hrs
1. Preformulation Studies: Molecular optimization of APIs (drug
substances), crystal morphology and variations, powder flow,
structure modification, drug -excipient compatibility studies,
methods of determination. 12
Hrs

2 Formulation Additives : Study of different formulation additives,
factors influencing their incorporation, role of formulation
development a nd processing, new developments in excipient
science. Design of experiments – factorial design for product and
process development. 12
Hrs

3 Solubility: Importance, experimental determination, phase -
solubility analysis, pH -solubility profile, solubility techniques to
improve solubility and utilization of analytical methods –
cosolvency, salt formation, complexation, solid dispersion,
micellar solubilization and hydrotropy. 12
Hrs

4 Dissolution: Theories, mechanisms of dissolution, in-vitro
dissolution testing models – sink and non -sink. Factors
influencing dissolution and intrinsic dissolution studies.
Dissolution test apparatus – designs, dissolution testing for
conventional and controlled release products. Data handling and
correction fact or. Biorelevent media, in-vitro and in-vivo
correlations, levels of correlations. 12
Hrs

Page 73

58 5 Product Stability: Degradation kinetics, mechanisms, stability
testing of drugs and pharmaceuticals, fa ctors influencing -media
effects and pH effects, accelerated stability studies, interpretation
of kinetic data (API & tablets). Solid state stability and shelf life
assignment. Stability protocols, reports and ICH guidelines. 12
Hrs

REFERENCES
1. Lachman L, Lieberman HA, Kanig JL. The Theory and Practice Of
rd
Industrial Pharmacy, 3 ed., Varghese Publishers, Mumbai 1991.
th
2. Sinko PJ. Martin's physical pharmacy and pharmaceutical sciences, 5
ed., B.I. Publications Pvt. Ltd, Noida, 2006.
3. Lieberman HA, Lachman L, Schwartz JB. Pharmaceutical dosage forms:
nd
tablets Vol. I -III, 2 ed., CBS Publishers & distributors, New Delhi, 2005.
4. Conners KA. A Text book of pharmaceutical analysi Wells JI.
Pharmaceutical preformulation: The physicochemical properties of drug
substances. Ellis Horwood Ltd., England, 1998.
5. Yalkowsky SH. Techniques of solubilization of drugs. Vol -12.
Marcel Dekker Inc., New York, 1981
6. Dressman J, Kramer J. Pharmaceutical dissolution testing. Saurah printer
pvt. Ltd., New Delhi,2005.
rd
7. Sethi PD. Quantitative analysis of drugs in pharmaceutical formulations, 3
ed., CBS publications, New Delhi, 2008.
rd
8. Carstensen JT, Rhodes CT. Drug stability principles and practices, 3
CBS Publishers & distributors, New Delhi, 2005. ed.,
9. Yoshioka S, Stella VJ. Stability of drugs and dosage forms, Springer
(India) Pvt. Ltd., New Delhi, 2006.
th
10. Banker GS, Rhodes CT. Modern Pharmaceutics, 4
Inc, New York, 2005.
11. W. Grimm - Stability testing of drug products. ed., Marcel Dekker
12. Mazzo DJ. International stability testing. Eastern Press Pvt. Ltd.,
Bangalore, 1999. 13. Beckett AH, Stenlake JB. Practical pharmaceutical
th
chemistry, Part I & II., 4
2004. ed., CBS Publishers & distributors, New Delhi,
14. Indian Pharmacopoeia. Controller of Publication. Delhi, 1996.
15. British Pharmacopoeia. British Pharmacopoeia Commission Office,
London, 2008.
16. United States Pharmacopoeia. United States Pharmacopeial Convention,
Inc, USA, 2003.
17. Encyclopaedia of Pharm. Technology, Vol I – III.
18. Wells J. I. Pharmaceutical Preformulation : The physicochemical properties
of drug substances, Ellis Horwood Ltd. England, 1988.

Page 74

59 NOVEL DRUG DELIVERY SYSTEMS
(MIP 103T)
Scope
This course is de signed to impart knowledge and skills necessary to train the
students in the area of novel drug delivery systems.

Objective
On completion of this course it is expected that students will be able to
understand,
 The need, concept, design and evaluation of various customized,
sustained and controlled release dosage forms.
 To formulate and evaluate various novel drug delivery systems

THEORY 60 Hrs
1. Concept & Models for NDDS: Classification of rate con trolled
drug delivery systems (DDS), rate programmed release,
activation modulated & feedback regulated DDS, effect of system
parameters in controlled drug delivery, computation of desired
release rate and dose for controlled release DDS,
pharmacokinetic design for DDS – intermittent, zero order & first
order release.

Carriers for Drug Delivery: Polymers / co -polymers -
introduction, classification, characterization, polymerization
techniques, application in CDDS / NDDS, biodegradable & natural
polymers. 12
Hrs

2 Study of Various DDS: Concepts, design, formulation &
evaluation of controlled release oral DDS, Mucoadhesive DDS
(buccal, nasal, pul monary) Pulsatile, colon specific, liquid
sustained release systems, Ocular delivery systems 12
Hrs

3 Transdermal Drug Delivery Systems: Theory, design,
formulation & evaluation including iontophoresis and other latest
developments in skin delivery systems. 08
Hrs

4 Sub Micron Cosmeceuticals: Biology, formulation science and
evaluation of various cosmetics for skin, hair, nail, eye etc and it’s
regulatory aspects. 04
Hrs

Page 75

60 5 Targeted Drug Delivery Systems: Importance, concept,
biological process and events involved in drug targeting, design,
formulation & evaluation, methods in drug targeting –
nanoparticles, liposomes, niosomes, pharmacosomes, resealed
erythrocytes, microspheres, magnetic microspheres. Specia lized
pharmaceutical emulsions – multiple emulsions, micro -emulsions. 12
Hrs

6 Protein / Peptide Drug Delivery Systems: Concepts, delivery
techniques, formulation, stability testing, causes of protein
destabilization, stabilization methods.

7 Biotechnology in Drug Delivery Systems: Brief review of
major areas -recombinant DNA technology, monoclonal
antibodies, gene therapy. 06
Hrs

8 New trends for Personalized Medicine: I ntroduction, Definition,
Pharmacogenetics, Categories of Patients for Personalized
Medicines: Custom ized drug delivery systems, Bioelectronic
Medicines, 3D printing of pharmaceuticals, Telepharmacy. 06
Hrs

REFERENCES
1. Novel Drug Delivery System, Y.W. Chein, Vol 50, Marcel Dekker, NY.
2. Controlled Drug Delivery Systems, Robinson, Vol 29, Marcel Dekker, NY.
3. Transdermal Controlled Systemic Medications, YW Chein, Vol 31, Marcel
Dekker, NY.
4. Bioadhesive DDS, E. Mathiowitz, Vol 98, Marcel Dekker, NY.
5. Nasal System Drug Delivery, K.S.E. Su, Vol 3 9, Marcel Dekker, NY.
6. Drug Delivery Devices, Vol 32, P Tyle Marcel Dekker, NY.
7. Polymers for Controlled Drug Delivery, P.J. Tarcha, CRC Press.
8. Pharmaceutical Biotechnology, Vyas, CBS, Delhi.
9. Biotechnology of Industrial Antibiotics, E.J. Vandamme, Marcel Dek ker,
NY.
10. Protein Formulation & Delivery, E.J. McNally, Vol 99, Marcel Dekker, NY.
11. Drug Targeting, M.H. Rubinstein, John Wiley, NY.

Page 76

61 INTELLECTUAL PROPERTY RIGHTS
(MIP 104T)

Scope
This course is designed to impart knowledge and skills necessary to train the
students to be on par with the routine of Industrial activities in drug regulatory
affairs

Objectives
On completion of this course it is expected that students will be able to
understand,
 Assist in Regul atory Audit process.
 Establish regulatory guidelines for drug and drug products
 The Regulatory requirements for contract research organization

THEORY 60 Hrs
1. Definition, Need for patenting, Types of Patents, Conditions to
be satisfied by an invention to be patentable, Introduction to
patent search. Parts of patents. Filling of patents. The
essential elements of patent; Guidelines for preparation of
laboratory note book, Non -obviousness in Patent. 12 Hrs

2 Role of GATT, TRIPS, and WIPO 12 Hrs
3 Brief introduction to Trademark protection and WHO Patents.
IPR’s and its types, Major bodies regulating Indian
Pharmaceutical sector.
4 Brief introduction to CDSCO. WHO, USFDA, EMEA, TGA,
MHRA, MCC, ANVISA
5 Regulatory requirements for contract research organization.
Regulations for Biosimilars. 12 Hrs


12 Hrs

12 Hrs

REFERENCES :
1. Pharmaceutical Process Validation: By Fra R. Berry and Robert A. Nash, Vol
57, 2nd Edition
2. Applied Production and Operation Management By Evans, Anderson and
Williams
3. GMP for pha rmaceuticals Material Management by K.K. Ahuja Published by
CBS publishers
4. ISO 9000 -Norms and explanations
5. GMP for pharmaceuticals - Willing S.H. Marcel and Dekker

Page 77

62 INDUSTRIAL PHARMACY PRACTICAL - I
(MIP 105P)
1. Analysis of pharmacopoeial compounds and their formulations by UV Vis
spectrophotometer
2. Simultaneous estimation of multi component containing formulations by UV
spectrophotometry
3. Experiments based on HPLC / GC
4. Estimation of riboflavin/quinine sulphat e by fluorimetry
5. Estimation of sodium/potassium by flame photometry
6. Effect of surfactants on the solubility of drugs.
7. Effect of pH on the solubility of drugs.
8. Stability testing of solution and solid dosage forms for photo degradation..
9. Stability studies of drugs in dosage forms at 25
RH. o
C, 60% RH and 40 o
C, 75%
10. Compatibility evaluation of drugs and excipients ( DSC & FTIR).
11. Preparation and evaluation of different polymeric membranes.
12. Formulation and evaluation of sustained release oral matrix tablet/ oral
reservoir system.
13. Formulation and evaluation of microspheres / microcapsules.
14. Formulation and evaluation of transdermal drug delivery systems.
15. Design and evaluation of face wash, body - wash, creams, lotions, shampoo,
toothpaste, lipstick.
16. Electrophoresis of protein solution.
17. Preparation and evaluation of Liposome delivery system.

Page 78

63 ADVANCED BIOPHARMACEUTICS & PHARMACOKINETICS
(MIP 201T)
Scope
This course is designed to impart knowledge and skills necessary for dose
calculations, dose adjustments and to apply Biopharmaceutics theori es in
practical problem solving.

Objectives
On completion of this course it is expected that students will be able to
understand,
 The basic concepts in Biopharmaceutics and pharmacokinetics.
 The use of raw data and derive the pharmacokinetic models and
parameters the best describe the process of drug absorption,
distribution, metabolism and elimination.
 To critically evaluate Biopharmaceutics studies involving drug product
equivalency.
 To design and evaluate dosage regimens of the drugs using
pharmacokin etic and biopharmaceutic parameters.

THEORY 60 Hrs
1. Drug Absorption From The Gastrointestinal Tract :
Gastrointestinal tract, Mechanism of drug absorption, Factors
affecting, pH –partition theory, Form ulation and physicochemical
factors: Dissolution rate, Dissolution process, Noyes –Whitney
equation and drug dissolution, Factors affecting the dissolution
rate. Gastrointestinal absorption: role of the dosage form: Solution
(elixir, syrup and solution) as a dosage form ,Suspension as a
dosage form, Capsule as a dosage form, Tablet as a dosage form
,Dissolution methods ,Formulation and processing factors,
Correlation of in vivo data with in vitro dissolution data. Transport
model: Permeability -Solubility -Charge State and the pH Partition
Hypothesis, Properties of the Gastrointestinal Tract (GIT), pH
Microclimate Intracellular pH Environment, Tight -Junction
Complex. Solubility: Experimental methods. Permeability: In -vitro,
in-situ and In -vivo methods. 12
Hrs

2 Biopharmaceutic Considerations in Drug Product Design
and In Vitro Drug Product Performance : Introduction,
Biopharmaceutic Factors Affecting Drug Bioavailability, Rate -
Limiting Steps in Drug Absorption, Physicochemical Nature of the 12
Hrs

Page 79

64 Drug Formulation Factors Affecting Drug Product Performance, In
Vitro: Dissolution and Drug Release Testing, Compendial
Methods of Dissolution, Alternative Methods of Dissolution
Testing, Meeting Dissolution Requirements, Problems of Variable
Control in Dissolution Testing Performance of Drug Products: In
Vitro–In Vivo Correlation, Dissolution Profile Comparisons, Drug
Product Stability, Considerations in the Design of a Drug Product.

3 Pharmacokinetics : Basic considerations, Pharmacokinetic
models, Compartment modeling: O ne compartment model - IV
bolus, IV infusion, Extra -vascular; Multi Compartment model: Two
compartment - model in brief, Non -Linear Pharmacokinetics:
Cause of non -linearity, Michaelis – Menten equation, Estimation
Kmax and Vmax. Drug interactions: Introduct ion, The effect of
protein -binding interactions, The effect of tissue -binding
interactions, Cytochrome P450 -based drug interactions, Drug
interactions linked to transporters. 12
Hrs

4 Drug Product Performance, In Vivo: Bioavailability and
Bioequivalence : Drug Product Performance, Purpose of
Bioavailability Studies, Relative and Absolute Availability, ,
Methods for Assessing Bioavailab ility, Bioequivalence Studies,
Design and Evaluation of Bioequivalence Studies, Study Designs,
Crossover Study Designs, Evaluation of the Data, Bioequivalence
Example, Study Submission and Drug Review Process, The
Biopharmaceutics Classification System, Ge neric Biologics
(Biosimilar Drug Products),Clinical Significance of Bioequivalence
Studies, Special Concerns in Bioavailability and Bioequivalence
Studies, Generic Substitution. 12
Hrs

5 Application of Pharmacokinetics: Modified -Release Drug
Products, Targeted Drug Delivery Systems and Biotechnological
Products. Relationship between Pharmacokinetics including
Pharmacodynamics: Generation of a pharmacokinetic –
pharmacodynamic (PKPD) equation, Pharmacokinetic and
pharmacodynamic, interactions. Pharmacokinetics and
pharmacodynamics of biotechnology drugs: Introduction, Proteins
and peptides, Monoclonal antibodies, Oligonucleotides, Vaccines
(immunotherapy),Gene therapies. 12
Hrs

Page 80

65 REFERENCES
1. Biopharmaceutics and Clinical Pharmacokinetics by Milo Gibaldi, 4th
edition,Philadelphia, Lea and Febiger, 1991
2. Biopharmaceutics and Pharmacok inetics, A. Treatise, D .M. Brahmankar
and Sunil B.J aiswal., Vallab Prakashan, Pitampura, Delhi
3. Applied Biopharmaceutics and Pharmacokinetics by Shargel. Land
YuABC, 2nd edition, Connecticut Appleton Century Crofts, 1985
4. Textbook of Biopharmaceutics and Pharmacokinetics, Dr. Shobha Rani R.
Hiremath,Prism Book
5. Pharmacokinetics by Milo Gibaldi and D. Perrier, 2nd edition, Marcel
Dekker Inc.,New York, 1982
6. Current Concepts in Pharmaceutical Sciences: Biopharmaceutics,
Swarbrick. J, Lea and Febiger, Philadelp hia, 1970
7. Clinical Pharmacokinetics, Concepts and Applications 3rd edition by
Malcolm Rowland and Thom~ N. Tozer, Lea and Febiger, Philadelphia,
1995
8. Dissolution, Bioavailability and Bioequivalence, Abdou. H.M, Mack
Publishing Company, Pennsylvania 1989
9. Biopharmaceutics and Clinical Pharmacokinetics, An Introduction, 4th
edition, revised and expande by Robert. E. Notari, Marcel Dekker Inc, New
York and Basel,1987.
10. Biopharmaceutics and Relevant Pharmacokinetics by John. G Wagner and
M.Pemarowski, 1st editi on, Drug Intelligence Publications, Hamilton,
Illinois, 1971.
11. Encyclopedia of Pharmaceutical Technology, Vol 13, James Swarbrick,
James. G.Boylan, Marcel Dekker Inc, New York, 1996.
12. Basic Pharmacokinetics,1 st edition, Sunil S Jambhekar and Philip J
Breen, pharmaceutical press, RPS Publishing,2009.
13. Absorption and Drug Development - Solubility, Permeability, and Charge
State, Alex Avdeef, John Wiley & Sons, Inc,2003.

Page 81

66 SCALE UP AND TECHNOLOGY TRANSFER
(MIP 20 2T)

Scope
This course is designed to impart knowledge and skills necessary to train the
students to be on scale up, technology transfer process and industrial safety
issues.

Objectives:
On completion of this course it is expected that students will be ab le to
understand,
 Manage the scale up process in pharmaceutical industry.
 Assist in technology transfer.
 To establish safety guidelines, which prevent industrial hazards.


THEORY 60 Hrs
1. Pilot plant design: Basic requirements for design, facility,
equipment selection, for tablets, capsules, liquid orals, parentral
and semisolid preparations.

Scale up: Importance, Technology transfer from R & D to pilot
plant to plant scale, process scale up for tablets, capsules, liquid
orals, semisolids, parentral, NDDS products – stress on formula,
equipments, product uniformity, stability, raw materials, physical
layout, input, in -process and finished product specifications,
problems encountered during transfer of technology 12
Hrs

2 Validation: General concepts, types, procedures & protocols,
documentation, VMF. Analytical method validation , cleaning
validation and vender qualification.
3 Equipment Qualification: Importance, IQ, OQ, PQ for
equipments – autoclave, DHS, membrane filter, rapid mixer
granulator, cone blender, FBD, tablet compression machine,
liquid filling and sealing machine. Aseptic room validation. 12
Hrs

12
Hrs

4 Process validation: Importance, validation of mixing,
granulation, drying, compression, tablet coat ing, liquid filling and
sealing, sterilization, water process systems, environmental
control. 12
Hrs

Page 82

67 5 Industrial safety: Hazards – fire, mechanical, electrical,
chemical and pharmaceutical, Monitoring & prevention systems,
industrial effluent testing & treatment. Control of environmental
pollution. 12
Hrs

REFERENCES
1. Pharmaceutical process validation, JR Berry, Nash, Vol 57, Marcel Dekker,
NY.
2. Pharmaceutical Production facilities, design and applications, by GC Cole,
Taylor and Francis.
3. Pharmaceutical project management, T.Kennedy, Vol 86, Marcel Dekker,
NY.
4. The theory & Practice of Industrial Pharmacy, L.Lachman, H.A.Lieberma n,
Varghese Publ. Bombay.
5. Tablet machine instruments in pharmaceuticals, PR Watt, John Wiloy.
6. Pharmaceutical dosage forms, Tablets, Vol 1, 2, 3 by Lachman,
Lieberman, Marcel Dekker, NY.
7. Pharmaceutical dosage forms, Parentral medications, Vol 1, 2 by K.E.
Avis, Marcel Dekker, NY.
8. Dispersed system Vol 1, 2, 3 by Lachman, Lieberman, Marcel Dekker,
NY.
9. Subrahmanyam, CVS, Pharmaceutical production and Management, 2007,
Vallabh Prakashan,Dehli.

Page 83

68 PHARMACEUTICAL PRODUCTION TECHNOLOGY
(MIP 203T)

Scope
This course is designed to impart knowledge and skills necessary to train the
students to be on par with the routine of Industrial activities in Production

Objectives
On completion of this course it is expected that students will be able to
understand,
 Handle the scheduled activities in a Pharmaceutical firm.
 Manage the production of large batches of pharmaceutical
formulations.

THEORY 60 Hrs
Improved Tablet Production: Tablet production process, unit
1. operation improvements, granulation and pelletization
equipments, continuous and batch mixing, rapid mixing
granulators, rota granulators, spheronizers and marumerisers,
and other specialized granulation and drying equipments.
Problems encountered.

Coating Technology: Process, equipments, particle coating,
fluidized bed coating, application techniques. Problems
encountered. 12
Hrs

2 Parenteral Production: Area planning & environmental control,
wall and floor treatment, fixtures and machineries, change rooms,
personnel flow, utilities & utilities equipment location, engineering
and maintenance. 12
Hrs

3 Lyophilization & Spray drying Technology: Principles,
process, freeze -drying and spray drying equipments. 12
Hrs

4 Capsule Production: Production process, improved capsule
manufacturing and filling machines for hard and soft gelatin
capsules. Layout and problems encountered.
Disperse Systems Production: Production pr ocesses,
applications of mixers, mills, disperse equipments including fine
solids dispersion, problems encountered. 12
Hrs

Page 84

69 Packaging Technology: Types of packaging materials,
machinery, label ing, package printing for different dosage forms.

5 Air Handling Systems: Study of AHUs, humidity & temperature
control, air filtration systems, dust collectors. Water Treatment
Process: Techniques and maintenance – RO, DM, ultra –
filtration, WFI. 12
Hrs


REFERENCES
1. The Theory & Practice of Industrial Pharmacy, L. Lachman, Varghese
Publ, Bombay.
2. Modern Pharmaceutics by Banker, Vol 72, Marcel Dekker, NY.
3. Pharmaceutical Dosage Forms, Vol 1, 2, 3 by Lachman, Lieberman,
Marcel Dekker, NY.
4. Pharmaceutical Dosage Forms, Parentral medications, Vol 1, 2 by K.E.
Avis, Marcel Dekker, NY.
5. Pharmaceutical Production Facilities, design and application s, by G.C.
Cole, Taylor and Francis.
6. Dispersed System Vol 1, 2, 3 by Lachman, Lieberman, Marcel Dekker, NY.
7. Product design and testing of polymeric materials by N.P. Chezerisionoff.
8. Pharmaceutical Project Management, T.Kennedy, Vol 86, Marcel Dekker,
NY.
9. Packaging Pharmaceutical and Health Care, H.Lockhard.
10. Quality Control of Packaging Materials in Pharmaceutical Industy,
.Kharburn, Marcel Dekker, NY.
11. Freeze drying / Lyophilization of Pharmaceuticals & Biological Products, L.
Ray, Vol 96, Marcel Dekker, NY.
12. Tablet Machine Instrumentation In Pharmaceuticals, PR Watt, Ellis
Horwoods, UK.

Page 85

70 ENTREPRENEURSHIP MANAGEMENT
(MIP 204T)
Scope
This course is designed to impart knowledge and skills necessary to train t he
students on entrepreneurship management.

Objectives:
On completion of this course it is expected that students will be able to
understand,
 The Role of enterprise in national and global economy
 Dynamics of motivation and concepts of entrepreneurship
 Demands and challenges of Growth Strategies And Networking

THEORY 60 Hrs
1. Conceptual Frame Work: Concept need and process in
entrepreneurship development. Role of enterprise in national and
global economy. Types of enterprise – Merits and Demerits.
Government policies and schemes for enterprise development.
Institutional support in enterprise development and management. 12
Hrs

2 Entrepreneur: Entrepreneurial motivation – dynamics of
motivation. Entrepreneurial competency –Concepts. Developing
Entrepreneurial competencies - requirements and understanding
the process of entrepreneurship development, self -awareness,
interpersonal skills, creativity, assertiveness, achievement, factors
affecting entrepreneur role. 12
Hrs

3 Launching And Organising An Enterprise: Environment
scanning – Information, sources, schemes of assistance,
problems. Enterprise selection, market assessment, enterprise
feasibility study, SWOT Analysis. Resource mobilisation -
finance, technology, raw material, site and manpower. Costing
and marketing management and quality control. Feedback,
monitoring and evaluation.
4 Growth Strategies And Networking: Performance appraisal and
assessment. Profitability and control measures, demands and
challenges. Need for diversification. Future Growth – Techniques
of expansion and diversification, vision strategies. Concept and
dynamics. Methods, Joint venture, co -ordination and feasibility
study. 12
Hrs





12
Hrs

Page 86

71 5 Preparing Project Proposal To Start On New Enterprise
Project work – Feasibility report; Planning, resource mobilisation
and implementation. 12
Hrs

REFERENCES
1. Akhauri, M.M.P.(1990): Entrepreneurship for Women in India, NIESBUD,
New Delhi.
2. Hisrich, R.D & Brush, C.G.(1996) The Women Entrepreneurs, D.C. Health
& Co., Toranto.
3. Hisrich, R.D. and Peters, M.P. (1995): Entrepreneurship – Starting,
Developing and Managing a New Enterprise, Richard D., Inwin, INC, USA.
4. Meredith, G.G. etal (1982): Practice of Entrepreneurship, ILO, Geneva.
5. Patel, V.C. (1987): Women Entrepreneurship – Developing New
Entrepreneurs, Ahmedabad EDII.

Page 87

72 INDUSTRIAL PHARMACY PRACTICAL - II
(MIP 205P)
1. Improvement of dissolution characteristics of slightly soluble drug by Solid
dispersion technique.
2. Comparison of dissolution of two different marketed products /brands
3. Protein binding studies of a highly protein bound drug & poorly protein bound
drug
4. Bioavailability studies of Paracetamol (Animal).
5. Pharmacokinetic and IVIVC data analysis by WinnolineR software
6. In vitro cell studies for permeability and metabolism
7. Formulation and evaluation of tablets
8. Formulation and evaluation of capsules
9. Formulation and evaluation of injections
10. Formulation and evaluation of emulsion
11. Formulation and evaluation of suspension.
12. Formulation and evaluation of enteric coating tablets.
13. Preparation and evaluation of a freeze dried formulation.
14. Preparation and evaluation of a spray dried formulation.

Page 88

73 PHARMACEUTICAL CHEMISTRY (MPC)

MODERN PHARMACEUTICAL ANALYTICAL TECHNIQUES
(MPC 101T)

Scope
This subject deals with various advanced analytical instrumental techniques for
identification, characterization and quantification of drugs. Instruments dealt are
NMR, Mass spectrometer, IR, HP LC, GC etc.

Objectives
After completion of course student is able to know about chemicals and
excipients
 The analysis of various drugs in single and combination dosage forms
 Theoretical and practical skills of the instruments

THEORY 60 Hrs
1. a. UV-Visible spectroscopy : Introduction, Theory, Laws,
Instrumentation associated with UV -Visible spectroscopy, Choice
of solvents and solvent effect and Applications of UV -Visible
spectroscopy, Di fference/ Derivative spectroscopy.
b. IR spectroscopy : Theory, Modes of Molecular vibrations,
Sample handling, Instrumentation of Dispersive and Fourier -
Transform IR Spectrometer, Factors affecting vibrational
frequencies and Applications of IR spectroscopy , Data
Interpretation.
c. Spectroflourimetry: Theory of Fluorescence, Factors affecting
fluorescence (Characterestics of drugs that can be analysed by
flourimetry), Quenchers, Instrumentation and Applications of
fluorescence spectrophotometer.
d. Flame emission spectroscopy and Atomic absorption
spectroscopy : Principle, Instrumentation, Interferences and
Applications.
2 NMR spectroscopy : Quantum numbers and their role in NMR,
Principle, Instrumentation, Solvent requirement in NMR,
Relaxation process, NMR signals in various compounds,
Chemical shift, Factors influencing chemical shift, Spin -Spin
coupling, Coupling constant, Nuclear magnetic double resonance,
Brief outline of principles of FT -NMR and 13C NMR. Applications
of NMR spectroscopy. 10
Hrs














10
Hrs

Page 89

74 3 Mass Spectroscopy : Principle, Theory, Instrumentation of Mass
Spectroscopy, Different types of ionization like electron impact,
chemical, field, FAB and MALDI, APCI, ESI, APPI Analyzers of
Quadrupole and Time of Flight, Mass fragmentation and its rules,
Meta stable ions, Isotopic peaks and Applications of Mass
spectroscopy. 10
Hrs

4 Chromatography : Principle, apparatus, instrumentation,
chromatographic parameters, factors affecting resolution, isolation
of drug from excipients, data interpretation and applications of the
following:
a) Thin Layer chromatography
b) High Performance Thin Layer Chromatography
c) Ion exchange chromatography
d) Column chromatography
e) Gas chromatography
f) High Performance Liquid chromatography
g) Ultra High Performance Liquid chromatography
h) Affinity chromatography
i) Gel Chromatography 10
Hrs

5 a. Electrophoresis : Principle, Instrumentation, Working
conditions, factors affecting separation and applications of the
following:
a) Paper electrophoresis b) Gel electrophoresis c) Capillary
electrophoresis d) Zone electrophoresis e) Moving boundary
electrophoresis f) Iso electric focusing
b. X ray Crystallography : Production of X rays, Different X ray
methods, Bragg‘s la w, Rotating crystal technique, X ray powder
technique, Types of crystals and applications of X -ray diffraction. 10
Hrs

6 a. Potentiometry: Principle, working, Ion selective Electrodes
and Application of potentiometry.

b. Thermal Techniques : Principle, thermal transitions and
Instrumentation (Heat flux and power -compensation and designs),
Modulated DSC, Hyper DSC, experimental parameters (sample
preparation, experimental conditions, calibration, heating and
cooling rates, resolution, source of errors) and their influence,
advantage and disadvantages, pharmaceutical applications.
Differential Thermal Analysis (DTA): Principle, instrumentati on 10
Hrs

Page 90

75 and advantage and disadvantages, pharmaceutical applications,
derivative differential thermal analysis (DDTA). TGA: Principle,
instrumentation, factors affecting results, advantage and
disadvantages, pharmaceutical applications.

REFERENCES
1. Spectrometric Iden tification of Organic compounds - Robert M Silverstein,
Sixth edition, John Wiley & Sons, 2004.
2. Principles of Instrumental Analysis - Doglas A Skoog, F. James Holler,
Timothy A. Nieman, 5th edition, Eastern press, Bangalore, 1998.
3. Instrumental methods of a nalysis – Willards, 7th edition, CBS publishers.
4. Practical Pharmaceutical Chemistry – Beckett and Stenlake, Vol II, 4th
edition, CBS Publishers, New Delhi, 1997.
5. Organic Spectroscopy - William Kemp, 3rd edition, ELBS, 1991.
6. Quantitative Analysis of Drugs i n Pharmaceutical formulation - P D Sethi,
3rd Edition, CBS Publishers, New Delhi, 1997.
7. Pharmaceutical Analysis - Modern Methods – Part B - J W Munson, Vol
11, Marcel. Dekker Series
8. Spectroscopy of Organic Compounds, 2nd edn., P.S/Kalsi, Wiley estern
Ltd., Delhi.
9. Textbook of Pharmaceutical Analysis, KA.Connors, 3rd Edition, John Wiley
& Sons, 1982.

Page 91

76 ADVANCED ORGANIC CHEMISTRY - I
(MPC 102T)
Scope
The subject is designed to pr ovide in -depth knowledge about advances in
organic chemistry, different techniques of organic synthesis and their
applications to process chemistry as well as drug discovery.

Objectives
Upon completion of course, the student shall be to understand

 The pr inciples and applications of reterosynthesis
 The mechanism & applications of various named reactions
 The concept of disconnection to develop synthetic routes for small
target molecule.
 The various catalysts used in organic reactions
 The chemistry of heterocyclic compounds

THEORY 60 Hrs
1. Basic Aspects of Organic Chemistry:
1. Organic intermediates: Carbocations, carbanions, free
radicals, carbenes and nitrenes. Their method of
formation, stability and synthetic applications.
2. Types of reaction mechanisms and methods of
determining them,
3. Detailed knowledge regarding the reactions,
mechanisms and their relative reactivity and orientations.
Addition reactions
a) Nucleophilic uni - and bimolecular reactions (SN1 and
SN2)
b) Elimination reactions (E1 & E2; Hoffman & Saytzeff’s
rule)
c) Rearrangement reaction
2 Study of mechanism and synthetic applications of following
named Reactions:
Ugi reaction, Brook rearrangement, Ullmann coupling reactions,
Dieckmann Reaction, Doebn er-Miller Reaction, Sandmeyer
Reaction, Mitsunobu reaction, Mannich reaction, Vilsmeyer -Haack
Reaction, Sharpless asymmetric epoxidation, Baeyer -Villiger
oxidation, Shapiro & Suzuki reaction, Ozonolysis and Michael
addition reaction 12
Hrs












12
Hrs

Page 92

77 3 Synthetic Reagents & Applications :
Aluminiumisopropoxide, N -bromosuccinamide, diazomethane,
dicyclohexylcarbodimide, Wilkinson reagent, Witting reagent.
Osmium tetroxide, titanium chloride, diazopropane, diethyl
azodicarboxylate, Triphenylphosphine, Benzotriazol -1-yloxy) tris
(dimethylamino) phosphonium hexafluoro -phosphate (BOP).

Protecting groups
a. Role of protection in organic synthesis
b. Protection for the hydroxyl group, including 1,2 -and1 ,3-diols:
ethers, esters, carbonates, cyclic acetals & ketals
c. Protection for the Carbonyl Group: Acetals and Ketals
d. Protection for the Carboxyl Group: amides and hydrazides,
esters
e. Protection for the Amino Group and Amino acids: carbamates
and amides
4 Heterocyclic Chemistry:
Organic Name reactions with their respective mechanism and
application involved in synthesis of drugs containing five, six
membered and fused hetrocyclics such as Debus -Radziszewski
imidazole synthesis, Knorr Pyrazole Synthesis Pinn er Pyrimidine
Synthesis, Combes Quinoline Synthesis, Bernthsen Acridine
Synthesis, Smiles rearrangement and Traube purine synthesis.

Synthesis of few representative drugs containing these
hetrocyclic nucleus such as Ketoconazole, Metronidazole,
Miconazol e, celecoxib, antipyrin, Metamizole sodium,
Terconazole, Alprazolam, Triamterene, Sulfamerazine,
Trimethoprim, Hydroxychloroquine, Quinine, Chloroquine,
Quinacrine, Amsacrine, Prochlorpherazine, Promazine,
Chlorpromazine,Theophylline , Mercaptopurine and Thioguanine. 12
Hrs














12
Hrs

5 Synthon approach and retrosynthesis applications
i. Basic principles, terminologies and advantages of
retrosynthesis; guidelines for dissection of molecules.
Functional group interconvertion and addition (FGI and FGA)
ii. C‐X disconnections; C ‐C disconnections – alcohols and
carbonyl compounds; 1,2 ‐, 1,3‐,1,4‐, 1,5‐, 1,6‐difunctionalized
compounds
iii. Strategies for synthesis of three, four, five and six ‐membered
ring. 12
Hrs

Page 93

78 REFERENCES
1. “Advanced Organic chemistry, Reaction, Mechanisms and Structure”, J
March, John Wiley and Sons, New York.
2. “Mechanism and Structure in Organic Chemistry”, ES Gould, Hold Rinchart
and Winston, New York.
3. “Organic Chemistry” Clayden, Greeves, Warren and Woihers., Oxford
University Press 2001.
4. “Organic Chemistry” Vol I and II. I.L. Finar. ELBS, Pearson Education Lts,
Dorling Kindersley 9India) Pvt. Ltd.,.
5. A guide to mechanisms in Organic Chemistry, Peter Skyes (Orient
Longman, New Delhi).
6. Reactive Intermediates in Organic Chemistry, Tandom and Gowel, Oxford
& IBH Publishers.
7. Combinational Chemistry – Synthesis and applications – Stephen R
Wilson & Anthony W Czarnik, Wiley – Blackwell.
8. Carey, Organic Chemistry, 5th Edition (Viva Books Pvt. Ltd.)
9. Organic Synthesis - The Disconnection Approach, S. Warren, Wily India
10. Principles of Organic Synthesis, ROC Norman and JM Coxan, Nelson
Thorns.
11. Organic Synthesis - Special Techniques. VK Ahluwalia and R Agarwal,
Narosa Publishers.
12. Organic Reaction Mechanisms IVth Edtn, VK Ahluwalia and RK Parashar,
Narosa Publishers.

Page 94

79 ADVANCED MEDICINAL CHEMISTRY
(MPC 103T)
Scope
The subject is designed to impart knowledge about recent advances in the field
of medicinal chemistry at the molecular level including different techniques for
the rational drug design.

Objectives
At completio n of this course it is expected that students will be able to
understand
 Different stages of drug discovery
 Role of medicinal chemistry in drug research
 Different techniques for drug discovery
 Various strategies to design and develop new drug like molecule s for
biological targets
 Peptidomimetics

THEORY 60 Hrs
1. Drug discovery: Stages of drug discovery, lead discovery;
identification, validation and diversity of drug targets.

Biological drug targets: Receptors, types, binding and
activation, theories of drug receptor interaction, drug receptor
interactions, agonists vs antagonists, artificial enzymes. 12
Hrs

2 Prodrug Design and Analog design:
a) Prodrug design : Basic concept, Carrier linked prodrugs/
Bioprecursors, Prodrugs of functional group, Prodrugs to
improve patient acceptability, Drug solubility, Drug
absorption and distribution, site specific drug delivery
and sustained drug action. Rationale of prodrug design
and practical consideration of prodrug design.

b) Combating drug resistance: Causes for drug
resistance, strategies to combat drug resistance in
antibiotics and anticancer therapy, Genetic principles of
drug resistance.

c) Analog Design: Introduction, Classical & Non classical,
Bioisosteric replacement strategies, rigid analogs, 12
Hrs

Page 95

80 alteration of chain branching, changes in ring size, ring
position isomers, design of stereo isomers and
geometric isomers, fragments of a lead molecule,
variation in inter atomic distance.

3 a) Medicinal chemistry aspects of the following class of drugs

Systematic study, SAR, Mechanism of action and synthesis of
new generation molecules of following class of drugs:
a) Anti-hypertensive drugs, Psychoactive drugs, Anticonvulsant
drugs, H1 & H2 receptor antagonist, COX1 & COX2 inhibitors,
Adrenergic & Cholinergic agents, Antineoplastic and Antiviral
agents.

b) Stereochemistry and Drug action: Realization that stereo
selectivity is a pre -requisite for evolution. Role of chirality in
selective an d specific therapeutic agents. Case studies,
Enantio selectivity in drug adsorption, metabolism, distribution
and elimination. 12
Hrs

4 Ratio nal Design of Enzyme Inhibitors
Enzyme kinetics & Principles of Enzyme inhibitors, Enzyme
inhibitors in medicine, Enzyme inhibitors in basic research,
rational design of non -covalently and covalently binding enzyme
inhibitors. 12
Hrs

5 Peptidomimetics
Therapeutic values of Peptidomimetics, design of
peptidomimetics by manipulation of the amino acids, modification
of the peptide backbone, incorporating conformational constraints
locally or globally. Chemistry of prostaglandins, leukotrienes and
thromboxones. 12
Hrs

REFERENCES
1. Medicinal Chemistry by Burger, Vol I –VI.
2. Wilson and Gisvold’s Text book of Organic Medicinal and Pharmaceutical
Chemistry, 12th Edition, Lppincott Williams & Wilkins, Woltess Kluw er
(India) Pvt.Ltd, New Delhi.
3. Comprehensive Medicinal Chemistry – Corwin and Hansch.
4. Computational and structural approaches to drug design edited by Robert
M Stroud and Janet. F Moore

Page 96

81 5. Introduction to Quantitative Drug Design by Y.C. Martin.
6. Principles of Medicinal Chemistry by William Foye, 7th Edition, Ippincott
Williams & Wilkins, Woltess Kluwer (India) Pvt.Ltd, New Delhi.
7. Drug Design Volumes by Arienes, Academic Press, Elsevier Publishers,
Noida, Uttar Pradesh..
8. Principles of Drug Design by Smith.
9. The Organic Chemistry of the Drug Design and Drug action by Richard
B.Silverman, II Edition, Elsevier Publishers, New Delhi.
10. An Introduction to Medicinal Chemistry, Graham L.Patrick, III Edition,
Oxford U niversity Press, USA.
11. Biopharmaceutics and pharmacokinetics, DM.Brahmankar, Sunil B.
Jaiswal II Edition, 2014, Vallabh Prakashan, New Delhi.
12. Peptidomimetics in Organic and Medicinal Chemistry by Antonio Guarna
and Andrea Trabocchi, First edition, Wiley pub lishers.

Page 97

82 CHEMISTRY OF NATURAL PRODUCTS
(MPC 104T)
Scope
The subject is designed to provide detail knowledge about chemistry of
medicinal compounds from natural origin and general methods of structural
elucidation of such compounds. It also emphasizes on isolation, purification and
characterization of medicinal compounds from natural origin.

Objectives
At completion of this course it is expected that students will be able to
under stand -
 Different types of natural compounds and their chemistry and
medicinal importance
 The importance of natural compounds as lead molecules for new drug
discovery
 The concept of rDNA technology tool for new drug discovery
 General methods of structural elucidation of compounds of natural
origin
 Isolation, purification and characterization of simple chemical
constituents from natural source

THEORY 60 Hrs
1. Study of Natural products as leads for new pharmaceuticals
for the following class of drugs
a) Drugs Affecting the Central Nervous System: Morphine
Alkaloids
b) Anticancer Drugs: Paclitaxel and Docetaxel, Etoposide, and
Teniposide
c) Cardiovascular Drugs: Lovastatin, Teprotide and Dicoumarol
d) Neuromuscul ar Blocking Drugs: Curare alkaloids
e) Anti-malarial drugs and Analogues
f) Chemistry of macrolid antibiotics (Erythromycin, Azithromycin,
Roxithromycin, and Clarithromycin) and β - Lactam antibiotics
(Cephalosporins and Carbapenem)
2 a) Alkaloids
General introduction, classification, isolation, purification,
molecular modification and biological activity of alkaloids, general
methods of structural determination of alkaloids, structural
elucidation and stereochemistry of ephedrine, morphine, ergot,
emetine and reserpine. 12
Hrs










12
Hrs

Page 98

83 b) Flavonoids
Introduction, isolation and purification of flavonoids, General
methods of structural determination of flavonoids; Structural
elucidation of quercetin.

c) Steroids
General introduction, chemistry of sterols, sapogenin and cardiac
glycosides. Stereochemistry and nomenclature of steroids,
chemistry of contraceptive agents male & female sex hormo nes
(Testosterone, Estradiol, Progesterone), adrenocorticoids
(Cortisone), contraceptive agents and steroids (Vit – D).
3 a) Terpenoids

Classification, isolation, isoprene rule and general methods of
structural elucidation of Terpenoids; Structural elucidat ion of
drugs belonging to mono (citral, menthol, camphor), di(retinol,
Phytol, taxol) and tri terpenoids (Squalene,Ginsenoside)
carotinoids (β carotene).

b) Vitamins
Chemistry and Physiological significance of Vitamin A, B1, B2,
B12, C, E, Folic acid and Niacin.





12
Hrs

4 a). Recombinant DNA technology and drug discovery
rDNA technology, hybridoma technology, New pharmaceuticals
derived from biotechnology; Oligonucleotide therapy. Gene
therapy: Introduction, Clinical application and recent advances in
gene therapy, principles of RNA & DNA estimation

b). Active constituent of certain crude drugs used in
Indigenous system Diabetic therapy – Gymnema sylvestre,
Salacia reticulate, Pterocarpus marsupiam, Swertia chirata,
Trigonella foenum graccum; Liver dysfunction – Phyllanthus niruri;
Antitumor – Curcuma longa Linn. 12
Hrs

5 Structural Characterization of natural compounds
Structural characterization of natural compounds using IR,
1HNMR, 13CNMR and MS Spectroscopy of specific drugs e.g.,
Penicillin, Morphine, Camphor, Vit -D, Quercetin and Digitalis
glycosides. 12
Hrs

Page 99

84 REFERENCES
1. Modern Methods of Plant Analysis, Peech and M.V.Tracey, Springer –
Verlag, Berlin, Heidelberg.
2. Phytochemistry Vol. I and II by Miller, Jan Nostrant Rein Hld.
3. Recent advances in Phytochemistry Vol. I to IV – Scikel Runeckles,
Springer Science & Business Media.
4. Chemistry of natural products Vol I onwards IWPAC.
5. Natural Product Chemistry Nakanishi Gggolo, University Science Books,
California.
6. Natural Product Chemistry “A laboratory guide” – Rapheal Khan.
7. The Alkaloid Chemistry and Physiology by RHF Manske, Academic Press.
8. Introduction to molecular Phytochemistry – CHJ Wells, Chapmannstall.
9. Organic Chemistry of Natural Products Vol I and II by Gurdeep and
Chatwall, Himalaya Publishing House.
10. Organic Chemistry of Natural Products Vol I and II by O.P. Agarwal,
Krishan Prakashan.
11. Organic Chemistry Vol I and II by I.L. F inar, Pearson education.
12. Elements of Biotechnology by P.K. Gupta, Rastogi Publishers.
13. Pharmaceutical Biotechnology by S.P.Vyas and V.K.Dixit, CBS Publishers.
14. Biotechnology by Purohit and Mathur, Agro -Bios, 13th edition.
15. Phytochemical methods of Harborne, S pringer, Netherlands.
16. Burger’s Medicinal Chemistry.

Page 100

85 PHARMACEUTICAL CHEMISTRY PRACTICAL - I
(MPC 105P)
1. Analysis of Pharmacopoeial compounds and their formulations by UV Vis
spectrophotometer, RNA & DNA estimation
2. Simultaneous estimation of multi component containing formulations by UV
spectrophotometry
3. Experiments based on Column chromatography
4. Experiments based on HPLC
5. Experiments based on Gas Chromatography
6. Estimation of riboflavin/quinine sulphate by fluorimetry
7. Estimation of sodium/potassium by flame photometry

To perform the following reactions of synthetic importance
1. Purification of organic solvents, column chromatography
2. Claisen -schimidt reaction.
3. Benzyllic acid rearrangement.
4. Beckmann rearrangement.
5. Hoffmann rearrangement
6. Mannich reaction
7. Synthesis of medicinally important compounds involving more than one
step along with purification and Characterization using TLC, melting point
and IR spectroscopy (4 experiments)
8. Estimation of elemen ts and functional groups in organic natural compounds
9. Isolation, characterization like melting point, mixed melting point, molecular
weight determination, functional group analysis, co -chromatographic
technique for identification of isolated compounds and interpretation of UV
and IR data.
10. Some typical degradation reactions to be carried on selected plant
constituents

Page 101

86 ADVANCED SPECTRAL ANALYSIS
(MPC 201T)
Scope
This subject deals with various hyphenated analytical instrumental techniques
for identification, characterization and quantification of drugs. Instruments dealt
are LC -MS, GC -MS, ATR -IR, DSC etc.

Objectives
At completion of this course it is expected that students will be able to
understand -
 Interpretation of the NMR, Mass and IR spectra of various organic
compounds
 Theoretical and practical skills of the hyphenated instruments
 Identification of organic compounds

THEORY 60Hrs
1. UV and IR spec troscopy:
Wood ward – Fieser rule for 1,3 - butadienes, cyclic dienes and α,
β-carbonyl compounds and interpretation compounds of enones.
ATR-IR, IR Interpretation of organic compounds. 12
Hrs

2 NMR spectroscopy:
1-D and 2 -D NMR, NOESY and COSY, HECTOR, INADEQUATE
techniques, Interpretation of organic compounds. 12
Hrs

3 Mass Spectroscopy

Mass fragmentation and its rules, Fragmentation of important
functional groups like alcohols, amines, carbonyl groups and
alkanes, Meta stable ions, Mc Lafferty rearrangement, Ring rule,
Isotopic peaks, Interpretation of organic compounds. 12
Hrs

4 Chromatography:
Principle, Instrumentation and Applications of the following :
a) GC-MS b) GC -AAS c) LC -MS d) LC -FTIR e) LC -NMR f) CE -
MS g) High Performance Thin Layer chromatography h) Super
critical fluid chromatography i) Ion Chromatography j) I -EC (Ion -
Exclusion Chromatography) k) Flash chromatography 12
Hrs

Page 102

87 5 a). Thermal methods of analysis
Introduction, principle, instrumentation and application of DSC,
DTA and TGA.

b). Raman Spectroscopy
Introduction, Principle, Instrumentation and Applications.

c). Radio immuno assay
Biological standardization , bioassay, ELISA, Radioimmuno
assay of digitalis and insulin. 12
Hrs

REFERENCES
1. Spectrometric Identification of Organic compounds - Robert M S ilverstein,
Sixth edition, John Wiley & Sons, 2004.
2. Principles of Instrumental Analysis - Doglas A Skoog, F. James Holler,
Timothy A. Nieman, 5th edition, Eastern press, Bangalore, 1998.
3. Instrumental methods of analysis – Willards, 7th edition, CBS publishers.
4. Organic Spectroscopy - William Kemp, 3rd edition, ELBS, 1991.
5. Quantitative analysis of Pharmaceutical formulations by HPTLC - P D
Sethi, CBS Publishers, New Delhi.
6. Quantitative Analysis of Drugs in Pharmaceutical formulation - P D Sethi,
3rd Edition, CBS Publishers, New Delhi, 1997.
7. Pharmaceutical Analysis - Modern methods – Part B - J W Munson,
Volume 11, Marcel Dekker Series

Page 103

88 ADVANCED ORGANIC CHEMISTRY - II
(MPC 202T)

Scope
The subject i s designed to provide in -depth knowledge about advances in
organic chemistry, different techniques of organic synthesis and their
applications to process chemistry as well as drug discovery.

Objectives
Upon completion of course, the student shall able to understand
 The principles and applications of Green chemistry
 The concept of peptide chemistry.
 The various catalysts used in organic reactions
 The concept of stereochemistry and asymmetric synthesis.

THEORY 60 Hrs
1. Green Chemistry:
a. Introduction, principles of green chemistry
b. Microwave assisted reactions: Merit and demerits of its use,
increased reaction rates, mechanism, superheating effects of
microwave, effects of solvents in microwave assisted
synthesis, microwave technology in process optimization, its
applications in various organic reactions and heterocycles
synthesis
c. Ultrasound assisted reactions: Types of sonochemical
reactions, homogenous, heterogeneous l iquid -liquid and
liquid -solid reactions, synthetic applications
d. Continuous flow reactors: Working principle, advantages and
synthetic applications.
2 Chemistry of peptides
a. Coupling reactions in peptide synthesis
b. Principles of solid phase peptide synthesis, t-BOC and FMOC
protocols, various solid supports and linkers: Activation
procedures, peptide bond formation, deprotection and
cleavage from resin, low and high HF cleavage protocols,
formation of free peptides and peptide amides, purification and
case stud ies, site -specific chemical modifications of peptides
c. Segment and sequential strategies for solution phase peptide
synthesis with any two case studies
d. Side reactions in peptide synthesis: Deletion peptides, side 12
Hrs











12
Hrs

Page 104

89 reactions initiated by proton abstraction, protonation, over -
activation and side reactions of individual amino acids.

3 Photochemical Reac tions
Basic principles of photochemical reactions. Photo -oxidation,
photo -addition and photo -fragmentation.

Pericyclic reactions
Mechanism, Types of pericyclic reactions such as cyclo addition,
electrocyclic reaction and sigmatrophic rearrangement reactions
with examples 12
Hrs

4 Catalysis:
a. Types of catalysis, heterogeneous and homogenous catalysis,
advantages and disadvantages
b. Heterogeneous catalysis – preparation, characterization,
kinetics, supported catalysts, catalyst deactivation and
regeneration, some examples of heterogeneous catalysis
used in synthesis of drugs.
c. Homogenous catalysis, hydrogenation, hydroformylation,
hydrocyanation, Wilkinson catalysts, chiral ligands and chiral
induction, Ziegler ‐Natta catalysts, some examples of
homogenous catalysis used in synthesis of drugs
d. Transition -metal and Organo -catalysis in organic synthesis:
Metal -catalyzed reactions
e. Biocatalys is: Use of enzymes in organic synthesis,
immobilized enzymes/cells in organic reaction.
f. Phase transfer catalysis ‐ theory and applications 12
Hrs

5 Stereochemistry & Asymmetric Synthesis
a. Basic concepts in stereochemistry – optical activity, specific
rotation, racemates and resolution of racemates, the Cahn,
Ingold, Prelog (CIP) sequence rule, meso c ompounds, pseudo
asymmetric centres, axes of symmetry, Fischers D and L
notation, cis -trans isomerism, E and Z notation.
b. Methods of asymmetric synthesis using chiral pool, chiral
auxiliaries and catalytic asymmetric synthesis, enantiopure
separation and Stereo selective synthesis with examples. 12
Hrs

Page 105

90 REFERENCES
1. “Advanced Organic chemistry, Reaction, mechanisms and structure”, J
March, John Wiley and sons, New York.
2. “Mechanism and structure in organic chemistry”, ES Gould, Hold Rinchart
and Winston,NewYork.
3. “Organic Chemistry” Clayden, Greeves, Warren and Woihers., Oxford
University Press 2001.
4. “Organic Chemistry” Vol I and II. I.L. Finar. ELBS, Sixth ed., 1995.
5. Carey, Organic chemistry, 5th edition (Viva Books Pvt. Ltd.)
6. Organic synthesis -the disconnection approach, S. Warren, Wily India
7. Principles of organic synthesis, ROCNorman and JMCoxan, Nelson thorns
8. Organic synthesis - Special techniques VK Ahluwalia and R Aggarwal,
Narosa Publishers.
9. Organic reaction mechanisms IV edtn, VK Ahluwalia and RK Parashar,
Narosa Publishers.

Page 106

91 COMPUTER AIDED DRUG DESIGN
(MPC 203T)
Scope
The subject is designed to impart knowledge on the current state of the art
techniques involved in computer assisted drug design.

Objectives
At completion of this course it is expected that students will be able to
understand
 Role of CADD in drug discovery
 Different CADD techniques and their applications
 Various strate gies to design and develop new drug like molecules.
 Working with molecular modeling softwares to design new drug
molecules
 The in silico virtual screening protocols

Theory 60 Hrs
1. Introduction to Computer Aided Drug Design (CADD)

History, different techniques and applications.
Quantitative Structure Activity Relationships: Basics
History and development of QSAR: Physicochemical parameters
and methods to calculate physicochemical parameters: Hammett
equation and electronic parameters (sigma), lipophilicity effects
and parameters (log P, pi -substituent constant), steric effects
(Taft steric and MR parameters) Experimental and theoretical
approaches for the determination of these physicochemical
parameters. 12
Hrs

2 Quanti tative Structure Activity Relationships: Applications
Hansch analysis, Free Wilson analysis and relationship between
them, Advantages and disadvantages; Deriving 2D -QSAR
equations.
3D-QSAR approaches and contour map analysis.
Statistical methods used in QSAR analysis and importance of
statistical parameters. 12
Hrs

3 Molecular Modeling and Docking
a) Molecular and Quantum Mechanics in drug desig n.
b) Energy Minimization Methods: comparison between global 12
Hrs

Page 107

92 minimum conformation and bioactive conformation
c) Molecular docking and drug receptor interactions: Rigid
docking, flexible docki ng and extra -precision docking.
Agents acting on enzymes such as DHFR, HMG -CoA
reductase and HIV protease, choline esterase ( AchE &
BchE)

4 Molecular Properties and Drug Design
a) Prediction and analysis of ADMET properties of new
molecules and its importance in drug design.
b) De novo drug design: Receptor/enzyme -interaction and its
analysis, Receptor/enzyme cavity size prediction, predicting
the functional components of cavities, Fragment based drug
design.
c) Homology modeling and generation of 3D -structure of
protein. 12
Hrs

5 Pharmacophore Mapping and Virtual Screening
Concept of pharmacophore, pharmacophore mapping,
identification of Pharmacophore features and Pharmacophore
modeling; Conformational search used in pharmacophore
mapping.

In Silico Drug Design and Virtual Screening Techniques
Similarity based methods and Pharmacophore based screening,
structure based In-silico virtual screening protocols. 12
Hrs


REFERENCES
1. Computational and structural approaches to drug discovery , Robert M
Stroud and Janet. F Moore, RCS Publishers.
2. Introduction to Quantitative Drug Design by Y.C. Martin, CRC Press,
Taylor & Francis group..
3. Drug Design by Ariens Volume 1 to 10, Academic Press, 1975, Elsevier
Publishers.
4. Principles of Drug Design b y Smith and Williams, CRC Press, Taylor &
Francis.
5. The Organic Chemistry of the Drug Design and Drug action by Richard B.
Silverman, Elsevier Publishers.
6. Medicinal Chemistry by Burger, Wiley Publishing Co.

Page 108

93 7. An Introduction to Medicinal Chemistry –Graham L. Patrick, Oxford
University Press.
8. Wilson and Gisvold’s Text book of Organic Medicinal and Pharmaceutical
Chemistry, Ippincott Williams & Wilkins.
9. Comprehensive Medicinal Chemistry – Corwin and Hansch, Pergamon
Publishers.
10. Computational and structural approaches to drug design edited by Robert
M Stroud and Janet. F Moore

Page 109

94 PHARMACEUTICAL PROCESS CHEMISTRY
(MPC 204T)
Scope
Process chemistry is often described as scale up reactions, taking them from
small quantities created in the research lab to the larger quantities that are
needed for further testing and then to even larger quantities required for
commercial production. The goal of a process chemist is to develop synthetic
routes that are safe, cost -effective, environmentally friendly, and efficient. The
subject is designed to impart knowledge on the development and optimization of
a synthetic route/s and the pilot plant procedure for the manufacture of Active
Pharmaceutical Ingredients (APIs) and new chemical entities (NCEs) for the
drug development phase.

Objectives
At completion of this course it is expected that students will be able to
understand
 The strategies of scale up process of apis and intermediates
 The various unit operations and various reactions in process chemistry

THEO RY 60 Hrs
1. Process chemistry
Introduction, Synthetic strategy
Stages of scale up process: Bench, pilot and large scale process.
In-process control and validation of large scale process.
Case studies of some scale up process of APIs.
Impurities in API, types and their sources including genotoxic
impurities 12
Hrs

2 Unit operations
a) Extraction: Liquid equilibria, extraction with reflux,
extraction with agitation, counter current extraction.
b) Filtration : Theory of filtration, pressure and vacuum
filtration, centrifugal filtration,
c) Distillation : azeotropic and steam distillation
d) Evaporation : Types of evaporators, factors affecting
evaporation.
e) Crystallization : Crystallization from aqueous, non -
aqueous solu tions factors affecting crystallization,
nucleation. Principle and general methods of Preparation
of polymorphs, hydrates, solvates and amorphous APIs. 12
Hrs

Page 110

95 3 Unit Processes - I
a) Nitration: Nitrating agents, Aromatic nitration, kinetics
and mechanism of aromatic nitration, process equipment
for technical nitration, mixed acid for nitration,
b) Halogenation: Kinetics of halogenations, types of
halogenations, catalytic halogenations. Case study on
industrial halogenation process.
c) Oxidation : Introduction, types of oxidative reactions,
Liquid phase oxidation with oxidizing agents. Nonmetallic
Oxidizing agents such as H 2O2, sodium hypochlorite,
Oxygen gas, ozonolysis. 12
Hrs

4 Unit Processes - II
a) Reduction: Catalytic hydrogenation, Heterogeneous
and homogeneous catalyst; Hydrogen transfer reactions,
Metal hydrid es. Case study on industrial reduction
process.
b) Fermentation : Aerobic and anaerobic fermentation.
Production of
i. Antibiotics; Penicillin and Streptomycin,
ii. Vitamins: B2 and B12
iii. Statins: Lovastatin, Simvastatin
c) Reaction progress kinetic analysis
i. Streamlining reaction steps, route selection,
ii. Characteristics of expedient routes, characteristics of
cost-effective routes, reagent selection, families of
reagents useful for scale -up. 12
Hrs

5 Industrial Safety
a) MSDS (Material Safety Data Sheet), hazard labels of
chemicals and Personal Protection Equipment (PPE)
b) Fire hazards, types of fire & fire extinguishers
c) Occupational Health & Safety Assessment Series 1800
(OHSAS -1800) and ISO -14001(Environmental
Management System), Effluents and its management 12
Hrs

Page 111

96 REFERENCES
1. Process Chemistry in the Pharmaceutical Industry: Challenges in an Ever -
Changing Climate -An Overview; K. Gadamasetti, CRC Press.
2. Pharmaceutical Manufacturing Encyclopedia, 3rd edition, Volume 2.
3. Medicinal Chemistry by Burger, 6th edition, Volume 1-8.
4. W.L. McCabe, J.C Smith, Peter Harriott. Unit operations of chemic al
engineering, 7th edition, McGraw Hill
5. Polymorphism in Pharmaceutical Solids .Dekker Series Volume 95 Ed: H
G Brittain (1999)
6. Regina M. Murphy: Introduction to Chemical Processes: Principles,
Analysis, Synthesis
7. Peter J. Harrington: Pharmaceutical Proce ss Chemistry for Synthesis:
Rethinking the Routes to Scale -Up
8. P.H.Groggins: Unit processes in organic synthesis (MGH)
9. F.A.Henglein: Chemical Technology (Pergamon)
10. M.Gopal: Dryden’s Outlines of Chemical Technology, WEP East -West
Press
11. Clausen,Mattson: Principle of Industrial Chemistry, Wiley Publishing Co.,
12. Lowenheim & M.K. Moran: Industrial Chemicals
13. S.D. Shukla & G.N. Pandey: A text book of Chemical Technology Vol. II,
Vikas Publishing House
14. J.K. Stille: Industrial Organic Chemistry (PH)
15. Shreve: Chemi cal Process, Mc Grawhill.
16. B.K.Sharma: Industrial Chemistry, Goel Publishing House
17. ICH Guidelines
18. United States Food and Drug Administration official website www.fda.gov

Page 112

97 PHARMACEUTICAL CHEMISTRY PRACTICALS – II
(MPC 205P)
1. Synthesis of organic compounds by adapting different approaches
involving (3 experiments)
a) Oxidation
b) Reduction/hydrogenation
c) Nitration
2. Comparative study of synthesis of APIs/intermediates by different synthetic
routes (2 experiments)
3. Assignments on regulatory requirements in API (2 experiments)
4. Comparison of absorption spectra by UV and Wood ward – Fieser rule
5. Interpretation of organic compounds by FT-IR
6. Interpretation of organic compounds by NMR
7. Interpretation of organic compounds by MS
8. Determination of purity by DSC in pharmaceuticals
9. Identification of organic compounds using FT -IR, NMR, CNMR and Mass
spectra
10. To carry out the preparation of following organic compounds
11. Preparation of 4 -chlorobenzhydrylpiperazine. (an intermediate for cetirizine
HCl).
12. Preparation of 4 -iodotolene from p-toluidine.
13. NaBH 4 reduction of vanillin to vanillyl alcohol
14. Preparation of umbelliferone by Pechhman reaction
15. Preparation of triphenyl imidazole
16. To perform the Microwave irradiated reactions of synthetic importance
(Any two)
17. Determination of log P, MR, hydrogen bond donors and acceptors of
selected drugs using softwares
18. Calculation of ADMET properties of drug molecules and its analysis using
softwares
Pharmacophore modeling
19. 2D-QSAR based experiments
20. 3D-QSAR based experiments
21. Docking study based experiment
22. Virtual screening based experiment

Page 113

98 PHARMACEUTICAL ANA LYSIS (MPA)

MODERN PHARMACEUTICAL ANALYTICAL TECHNIQUES
(MPA 101T)
Scope
This subject deals with various advanced analytical instrumental techniques for
identification, characterization and quantification of drugs. Instruments dealt are
NMR, Mass spectrom eter, IR, HPLC, GC etc.

Objectives
After completion of course student is able to know about chemicals and
excipients
 The analysis of various drugs in single and combination dosage forms
 Theoretical and practical skills of the instruments

THEORY 60 Hrs
1. a. UV-Visible spectroscopy : Introduction, Theory, Laws,
Instrumentation associated with UV -Visible spectroscopy, Choice
of solvents and solvent effect and Applications of UV -Visible
spectroscopy, Di fference/ Derivative spectroscopy.
b. IR spectroscopy : Theory, Modes of Molecular vibrations,
Sample handling, Instrumentation of Dispersive and Fourier -
Transform IR Spectrometer, Factors affecting vibrational
frequencies and Applications of IR spectroscopy , Data
Interpretation.
c. Spectroflourimetry: Theory of Fluorescence, Factors affecting
fluorescence (Characterestics of drugs that can be analysed by
flourimetry), Quenchers, Instrumentation and Applications of
fluorescence spectrophotometer.
d. Flame emission spectroscopy and Atomic absorption
spectroscopy : Principle, Instrumentation, Interferences and
Applications.
2 NMR spectroscopy : Quantum numbers and their role in NMR,
Principle, Instrumentation, Solvent requirement in NMR,
Relaxation process, NMR signals in various compounds,
Chemical shift, Factors influencing chemical shift, Spin -Spin
coupling, Coupling constant, Nuclear magnetic double resonance,
Brief outline of principles of FT -NMR and 13C NMR. Applications
of NMR spectroscopy. 10
Hrs














10
Hrs
3 Mass Spectroscopy : Principle, Theory, Instrumentation of Mass 10

Page 114

99 Spectroscopy, Different types of ionization like electron impact,
chemi cal, field, FAB and MALDI, APCI, ESI, APPI Analyzers of
Quadrupole and Time of Flight, Mass fragmentation and its rules,
Meta stable ions, Isotopic peaks and Applications of Mass
spectroscopy. Hrs

4 Chromatography : Principle, apparatus, instrumentation,
chromatographic parameters, factors affecting resolution, isolation
of drug from e xcipients, data interpretation and applications of the
following:
a. Thin Layer chromatography
b. High Performance Thin Layer Chromatography
c. Ion exchange chromatography
d. Column chromatography
e. Gas chromatography
f. High Performance Liquid chromatography
g. Ultra High Performance Liquid chromatography
h. Affinity chromatography
i. Gel Chromatography 10
Hrs

5 a. Electrophoresis : Principle, Instrumentation, Working
conditions, factors affecting separation and applications of the
following:
a) Paper electrophoresis b) Gel electrophoresis c) Capillary
electrophoresis d) Zone electrophoresis e) Moving boundary
electrophoresis f) Iso electric focusing

b. X ray Crystall ography : Production of X rays, Different X ray
methods, Bragg‘s law, Rotating crystal technique, X ray powder
technique, Types of crystals and applications of X -ray diffraction 10
Hrs

6 Potentiometry: Principle, working, Ion selective Electrodes and
Application of potentiometry.

Thermal Techniques : Principle, thermal transitions and
Instrumentation (Heat flux and power -compensation and designs),
Modulated DSC, Hyper DSC, experimental parameters (sample
preparation, experimental conditions, calibration, heating and
cooling rates, resolution, source of errors) and their influence,
advantage and disadvantages, pharmaceutical applications.
Differential Thermal Analysis (DTA): Principle, instrumentation 10
Hrs

Page 115

100 and advantage and disadvantages, pharmaceutical applications,
derivative differential thermal analysis (DDTA). TGA: Principle,
instrumentation, factors affecting results, advantage and
disadvantages, pharmaceutical applications.


REFERENCES
1. Spectrometric Ide ntification of Organic compounds - Robert M Silverstein,
Sixth edition, John Wiley & Sons, 2004.
2. Principles of Instrumental Analysis - Doglas A Skoog, F. James Holler,
Timothy A. Nieman, 5th edition, Eastern press, Bangalore, 1998.
3. Instrumental methods of analysis – Willards, 7th edition, CBS publishers.
4. Practical Pharmaceutical Chemistry – Beckett and Stenlake, Vol II, 4th
edition, CBS Publishers, New Delhi, 1997.
5. Organic Spectroscopy - William Kemp, 3rd edition, ELBS, 1991.
6. Quantitative Analysis of Drugs in Pharmaceutical formulation - P D Sethi,
3rd Edition, CBS Publishers, New Delhi, 1997.
7. Pharmaceutical Analysis - Modern Methods – Part B - J W Munson, Vol
11, Marcel. Dekker Series
8. Spectroscopy of Organic Compounds, 2nd edn., P.S/Kalsi, Wiley estern
Ltd., Delhi.
9. Textbook of Pharmaceutical Analysis, KA.Connors, 3rd Edition, John Wiley
& Sons, 1982.

Page 116

101 ADVANCED PHARMACEUTICAL ANALYSIS
(MPA 102T)

Scope
This subject deals with the various aspects o f Impurity, Impurities in new drug
products, in residual solvents, Elemental impurities, Impurity profiling and
characterization of degradents, Stability testing of phytopharmaceuticals and
their protocol preparation. It also covers the biological testing of various
vaccines and their principle and procedure.

Objective
After completion of the course students shall able to know,
 Appropriate analytical skills required for the analytical method
development.
 Principles of various reagents used in functional group analysis that
renders necessary support in research methodology and
demonstrates its application in the practical related problems.
 Analysis of impurities in drugs, residual solvents and stability studies of
drugs and biological products

THEORY 60 Hrs
1. Impurity and stability studies: 10
Definition, classification of impurities in drug Substance or Active Hrs
Pharmaceutical Ingredients and quantification of impurities as per
ICH guidelines
Impurities in new drug products:
Rationale for the reporting and control of degradation products,
reporting degradation products content of batches, listing of
degradation products in specifications, qualification of degradation
products
Impurities in residual solvents:
General principles, classification of residual solvents, Analytical
procedures, limits of residual solvents, reporting levels of residual
solvents
2 Elemental impurities: 10
Element classification, control of elemental impurities, Potential Hrs
Sources of elemental Impurities, Identification of Potential
Elemental Impurities, analytical procedures, instrumentation & C,
H, N and S analysis

Page 117

102 Stability testing protocols:
Selection of batches, container orientation, test parameters,
sampling frequency, specification, storage conditions, recording of
results, concept of stability, commitment etc. Important
mechanistic and stability related information provided by results of
study of factors like temperature, pH, buffering species ionic
strength and dielectric constant etc. on the reaction rates. With
practical considerations.

3 Impurity profiling and degradent characterizat ion: Method
development, Stability studies and concepts of validation
accelerated stability testing & shelf life calculation, WHO and ICH
stability testing guidelines, Stability zones, steps in development,
practical considerations. Basics of impurity profiling and
degradent characterization with special emphasis. Photostability
testing guidelines, ICH stability guidelines for biological products 10
Hrs

4 Stability testing of phytopharmaceuticals:
Regulatory requirements, protocols, HPTLC/HPLC finger printing,
interactions and complexity. 10
Hrs

5 Biological tests and assays of the following:
a. Adsorbed Tetanus vaccine b. Adsorbed Diphtheria vaccine
c. Human anti haemophilic vaccine d. Rabies vaccine e.
Tetanus Anti toxin f. Tetanus Anti serum g. Oxytocin h.
Heparin sodium IP i. Antivenom. PCR, PCR studies for gene
regulation, instrumentation (Principle and Procedures) 10
Hrs

6 Immunoassays (IA)
Basic principles, Production of antibodies, Separation of bound
and unbound drug, Radioimmunoassay, Optical IA, Enzyme IA ,
Fluoro IA, Luminiscence IA, Quantification and applications of IA. 10
Hrs


REFERENCES
1. Vogel‘s textbook of quantitative chemical analysis - Jeffery J Bassett, J.
Mendham, R. C. Denney, 5th edition, ELBS, 1991.
2. Practical Pharmaceutical Chemistry - Beckett and Stenlake, Vol II, 4th
Edition, CBS publishers, New Delhi, 1997.
3. Textbook of Pharmaceutical Analysis - K A Connors, 3rd Edition, John
Wiley & Sons, 1982.

Page 118

103 4. Pharmaceutical Analysis - Higuchi, Brochmman and Hassen, 2nd Edition,
Wiley – Inter science Publication, 1961.
5. Quantitative Analysis of Drugs in Pharmaceutical formulation – P D Sethi,
3rd Edition, CBS P ublishers New Delhi, 1997.
6. Pharmaceutical Analysis - Modern methods - J W Munson – Part B,
Volume 11, Marcel Dekker Series.
7. The Quantitative analysis of Drugs - D C Carratt, 3rd edition, CBS
Publishers, NewDelhi, 1964.
8. Indian Pharmacopoeia Vol I , II & III 2007, 2010, 2014.
9. Methods of sampling and microbiological examination of water, first
revision, BIS
10 . Practical HPLC method development – Snyder, Kirkland, Glajch, 2nd
edition, John Wiley & Sons.
11 . Analytical Profiles of drug substances – Klaus Florey, Volume 1 – 20,
Elsevier, 2005
12 . Analytical Profiles of drug substances and Excipients – Harry G Brittan,
Volume 21 – 30, Elsevier, 2005.
13 . The analysis of drugs in biological fluids - Joseph Chamberlain, 2nd
edition, CRC press, London.
14 . ICH Guidelines for impurity pr ofiles and stability studies.

Page 119

104 PHARMACEUTICAL VALIDATION
(MPA 103T)
Scope
The main purpose of the subject is to understand about validation and how it
can be applied to industry and thus to improve the quality of the products. The
subject covers the complete information about validation, types, methodology
and application.

Objectives
Upon completion of the subject student shall be able to
 Explain the aspect of validation
 Carryout validation of manufacturing processes
 Apply the knowledge of validation to instruments and equipments
 Validate the manufacturing facilities

THEORY 60 Hrs
1. Introduction : Definition of Qualification and Validati on,
Advantage of Validation, Streamlining of Qualification & Validation
process and Validation Master Plan.
Qualification: User Requirement Specification, Design
Qualification, Factory Acceptance Test (FAT)/ Site Acceptance
Test (SAT), Installation Qualification, Operational Qualification,
Performance Qualification, Re - Qualification (Maintaining status -
Calibration Preventive Maintenance, Change management),
Qualification of Manufacturing Equipments, Qualification of
Analytical Instruments and Labor atory equipments. 12
Hrs

2 Qualification of analytical instruments: Electronic balance, pH
meter, UV -Visible spectrophotometer, FTIR, GC, HPL C, HPTLC
Qualification of Glassware: Volumetric flask, pipette, Measuring
cylinder, beakers and burette. 12
Hrs

3 Validation of Utility syste ms: Pharmaceutical Water System &
pure steam, HVAC system, Compressed air and nitrogen.
Cleaning Validation: Cleaning Validation - Cleaning Method
development, Validation and validation of analytical method used
in cleaning. Cleaning of Equipment, Cleaning of Facilities.
Cleaning in place (CIP).
4 Analytical method validation: General principles, Validation of
analytical method as per ICH guidelines and USP. 12
Hrs




12
Hrs

Page 120

105 Computerized system validation : Electronic records and digital
significance -21 CFR part 11 and GAMP 5.
5 General Principles of Intellectual Property: Concepts of
Intellectual Property (IP), Intellectual Property Protection (IPP),
Intellectual Property Rights (IPR); Economic imp ortance,
mechanism for protection of Intellectual Property –patents,
Copyright, Trademark; Factors affecting choice of IP protection;
Penalties for violation; Role of IP in pharmaceutical industry;
Global ramification and financial implications. Filing a p atent
applications; patent application forms and guidelines. Types
patent applications -provisional and non -provisional, PCT and
convention patent applications; International patenting
requirement procedures and costs; Rights and responsibilities of
a paten tee; Practical aspects regarding maintaining of a Patent
file; Patent infringement meaning and scope. Significance of
transfer technology (TOT), IP and ethics -positive and negative
aspects of IPP; Societal responsibility, avoiding unethical
practices.


12
Hrs

REFERENCES
1. B. T. Loftus & R. A. Nash, "Pharmaceutical Process Validation", Drugs and
Pharm Sci. Series, Vol. 129, 3rd Ed., Marcel Dekker Inc., N.Y.
2. The Theory & Practice of Industrial Pharmacy, 3rd edition, Leon Lachman,
Herbert A. Lieberman, Joseph. L. Karig, Varghese Publishing House,
Bombay.
3. Validation Master plan by Terveeks or Deeks, Davis Harwood International
publishing.
4. Validation of Aseptic Pharmaceutical Processes, 2nd Editio n, by Carleton
& Agalloco, (Marcel Dekker).
5. Michael Levin, Pharmaceutical Process Scale -Up‖, Drugs and Pharm. Sci.
Series, Vol. 157,2nd Ed., Marcel Dekker Inc., N.Y.
6. Validation Standard Operating Procedures: A Step by Step Guide for
Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech
Industries, Syed Imtiaz Haider
7. Pharmaceutical Equipment Validation: The Ultimate Qualification
Handbook, Phillip A. Cloud, Interpharm Press
8. Validation of Pharmaceutical Processes: Sterile Products, Frederick J.
Carlton (Ed.) and James Agalloco (Ed.), Marcel Dekker, 2nd Ed.
9. Analytical Method validation and Instrument Performance Verification by
Churg Chan, Heiman Lam, Y.C. Lee, Yue. Zhang, Wiley Inter Science.

Page 121

106 FOOD ANALYSIS
(MPA 104T)
Scope
This course is designed to impart knowledge on analysis of food constituents
and finished food products. The course includes application of instrumental
analysis in the determination of pesticides in variety of food product s.

Objectives
At completion of this course student shall be able to understand various
analytical techniques in the determination of
 Food constituents
 Food additives
 Finished food products
 Pesticides in food
 And also student shall have the knowledge on food regulations and
legislations

THEORY 60 Hrs
1. Carbohydrates : classification and properties of food
carbohydrates, General methods of analysis of food
carbohydrates, Changes in food carbohydrates during processing,
Digestion, absorption and metabolism of carbohydrates, Dietary
fibre, Crude fibre and application of food carbohydrates
Proteins : Chemistry and classification of amino acids and
proteins, Physico -Chemical properties of protein and their
structure, general methods of analysis of proteins and amino
acids, Digestion, absorption and metabolism of proteins. 12
Hrs

2 Lipids : Class ification, general methods of analysis, refining of fats
and oils; hydrogenation of vegetable oils, Determination of
adulteration in fats and oils, Various methods used for
measurement of spoilage of fats and fatty foods.
Vitamins : classification of vitami ns, methods of analysis of
vitamins, Principles of microbial assay of vitamins of B -series. 12
Hrs

3 Food additives : Introduction, analysis o f Preservatives,
antioxidants, artificial sweeteners, flavors, flavor enhancers,
stabilizers, thickening and jelling agents.
Pigments and synthetic dyes : Natural pigments, their
occurrence and characteristic properties, permitted synthetic 12
Hrs

Page 122

107 dyes, Non -permitted synthetic dyes used by industries, Method of
detection of natural, permitted and non -permitted dyes.

4 General Analytical methods for milk, milk constituents and milk
products like ice cream, milk powder, butter, margarine, cheese
including adulterants and contaminants of milk.
Analysis of fermentation products like wine, spirits, beer and
vinegar. 12
Hrs

5 Pesticide analysis : Effects of pest and insects on various food,
use of pesticides in agriculture, pesticide cycle,
organophosphorus and or ganochlorine pesticides analysis,
determination of pesticide residues in grain, fruits, vegetables,
milk and milk products.
Legislation regulations of food products with special emphasis
on BIS, Agmark, FDA and US -FDA. 12
Hrs


REFERENCES
1. The chemical analysis of foods – David Pearson, Seventh edition,
Churchill Livingstone, Edinburgh London, 1976
2. Introduction to the Chemical analysis of foods – S. Nielsen, Jones &
Bartlett publishers, Boston London, 1994.
3. Official methods of analysis of AOAC International, sixth edition, Volume I
& II, 1997.
4. Analysis of Food constituents – Multon, Wiley VCH.
5. Dr. William Horwitz, Official methods of analysis of AOAC International,
18th edition, 2005.

Page 123

108 PHARMACEUTICAL ANALYSIS PRACTICALS - II
(MPA 105P)

1. Analysis of Pharmacopoeial compounds and their formulations by UV Vis
spectrophotometer
2. Simultaneous estimation of multi component containing formulations by UV
spectrophotometry
3. Experiments based on HPLC
4. Experiments based on Gas Chromatography
5. Estimation of riboflavin/quinine sulphate by fluorimetry
6. Estimation of sodium/potassium by flame photometry
7. Assay of official compounds by dif ferent titrations
8. Assay of official compounds by instrumental techniques.
9. Quantitative determination of hydroxyl group.
10 . Quantitative determination of amino group
11 . Colorimetric determination of drugs by using different reagents
12 . Imupurity profiling of drugs
13 . Calibration of glasswares
14 . Calibration of pH meter
15 . Calibration of UV -Visible spectrophotometer
16 . Calibration of FTIR spectrophotometer
17 . Calibration of GC instrument
18 . Calibration of HPLC instrument
19 . Cleaning validation of any one equipment
20 . Determination of total reducing sugar
21 . Determination of proteins
22 . Determination of saponification value, Iodine value, Peroxide value, Acid
value in food products
23 . Determination of fat content and rancidity in food products
24 . Analysis of natural and synthetic colors in food
25 . Determina tion of preservatives in food
26 . Determination of pesticide residue in food products
27 . Analysis of vitamin content in food products
28 . Determination of density and specific gravity of foods
29 . Determination of food additives

Page 124

109 ADVANCED INSTRUMENTAL ANALYSIS
(MPA 201T)
Scope
This subject deals with various hyphenated analytical instrumental techniques
for identification, characterization and quantification of drugs. Instrumen ts dealt
are LC -MS, GC -MS, and hyphenated techniques.

Objectives
After completion of course student is able to know,
 interpretation of the NMR, Mass and IR spectra of various organic
compounds
 theoretical and practical skills of the hyphenated instruments
 identification of organic compounds

THEORY 60 Hrs
1. HPLC : Principle, instrumentation, pharmaceutical applications,
peak shapes, capacity factor, selectivity, plate number, plate
height, resolution, band broadening, pumps, injector, detectors,
columns, column problems, gradient HPLC, HPLC solvents,
trouble shooting, sample preparation, method development, New
developments in HPLC -role and principles of ultra, nano liquid
chromatography in pharmaceuti cal analysis. Immobilized
polysaccharide CSP’s: Advancement in enantiomeric separations,
revised phase Chiral method development and HILIC
approaches. HPLC in Chiral analysis of pharmaceuticals.
Preparative HPLC, practical aspects of preparative HPLC. 12
Hrs

2 Biochromatography : Size exclusion chromatography, ion
exchange chromatography, ion pair chromatography, affinity
chromatography general principles, stationary phases and mobile
phases.
Gas chromatography : Principles, instrumentation, derivatization,
head space sampling, columns for GC, detectors, quantification.
High performance Thin Layer chromatography : Principles,
instrumentation, pharm aceutical applications.
3 Super critical fluid chromatography: Principles,
instrumentation, pharmaceutical applications.
Capillary electrophoresis: Overview of CE in pharmaceutical
analysis, basic configuration, CE characteristics, principles of CE,
methods and modes of CE. General considerations and method 12
Hrs






12
Hrs

Page 125

110 development in CE, Crown ethers as buffer additives in capillary
electrophoresis. CE -MS hyphenation.
4 Mass spectrometry: Principle, theory, instrumentation of mass
spectrometry, different types of ionization like electron impact,
chemical, field, FAB and MALD, APCI, ESI, APPI mass
fragmentation and its rules, meta stable ions, isotopic peaks and
applications of mass spectrom etry. LC -MS hyphenation and
DART MS analysis. Mass analysers (Quadrpole, Time of flight,
FT-ICR, ion trap and Orbitrap) instruments. MS/MS systems
(Tandem: QqQ, TOF -TOF;Q -IT, Q -TOF, LTQ -FT, LTQ-Orbitrap.

12
Hrs

5 NMR spectroscopy: Quantum numbers and their role in NMR,
Principle, Instrumentation, Solvent requirement in NMR,
Relaxation process, NMR signals in various compounds,
Chemical shift, Factors influencing chemical shift, Spin -Spin
coupling, Coupling constant, Nuclear magnetic double resonance,
Brief outline of principles of FT -NMR with reference to 13CNMR:
Spin spin and spin lattice relaxatio n phenomenon. 13C NMR, 1 -D
and 2 -D NMR, NOESY and COSY techniques, Interpretation and
Applications of NMR spectroscopy. LC -NMR hyphenations. 12
Hrs

REFERENCES
1. Spectrometric Identification of Organic compounds - Robert M Silverstein,
Sixth edition, John Wiley & Sons, 2004.
2. Principles of Instrumental Analysis - Doglas A Skoog, F. James Holler,
Timothy A. Nieman, 5th edition, Eastern press, Bangalore, 1998.
3. Instrumental methods of analysis – Willards, 7th edition, CBS publishers.
4. Organic Spectroscopy - William Kemp, 3rd edition, ELBS, 1991.
5. Quantitative analysis of Pharmaceutical formulations by HPTLC - P D
Sethi, CBS Publishers, New Delhi.
6. Quantitative Analysis of Drugs in Pharmaceutical formulation - P D Sethi,
3rd Edition, CBS Publishers, New Delhi, 1997.
7. Pharmaceutical Analysis - Modern methods – Part B - J W Munson,
Volume 11, Marcel Dekker Series.
8. Organic Spectroscopy by Donald L. Paviya, 5th Edition.

Page 126

111 MODERN BIO -ANALYTICAL TECHNIQUES
(MPA 202T)
Scope
This subject is designed to provide detailed knowledge about the importance of
analysis of drugs in biological matrices.

Objectives
Upon completion of the course, the student shall be able to understand
 Extraction of drugs from biological samples
 Separation of drugs from biological samples using different techniques
 Guidelines for BA/BE studies.

THEORY 60 Hrs
1. Extraction of drugs and metabolites from biological matrices:
General need, principle and procedure involved in the
Bioanalytical methods such as Protein precipitation, Liquid -
Liquid extrac tion and Solid phase extraction and other novel
sample preparation approach.
Bioanalytical method validation: USFDA and EMEA guidelines. 12
Hrs

2 Biopharmaceutical Consideration:
Introduction, Biopharmaceutical Factors Affecting Drug
Bioavailability, In Vitro: Dissolution and Drug Release Testing,
Alternative Methods of Dissolution Testing Transpo rt models,
Biopharmaceutics Classification System. Solubility: Experimental
methods. Permeability: In-vitro, in -situ and In-vivo methods. 12
Hrs

3 Pharmacokinetics and Toxicokinetics:
Basic consideration, Drug interaction (PK -PD interactions), The
effect of protein -binding interactions, The effect of tissue -binding
interactions, Cytochrome P450 -based drug interactions, Drug
interactions linked to transporters. Microsomal assays
Toxicokinetics -Toxicokinetic evaluation in preclinical studies,
Importa nce and applications of toxicokinetic studies. LC -MS in
bioactivity screening and proteomics. 12
Hrs

4 Cell culture techniques
Basic equipments used in cell culture lab. Cell culture media,
various types of cell culture, general procedure for cell cultures;
isolation of cells, subculture, cryopreservation, characterization of 12
Hrs

Page 127

112 cells and their applications. Principles and applications of cell
viability assays (MTT assays), Principles and applications of flow
cytometry.

5 Metabolite identification:
In-vitro / in -vivo approaches, protocols and sample preparation.
Microsomal approaches (Rat liver microsomes (RLM) and Human
liver microsomes (HLM) in Met –ID. Regulatory per spectives.
In-vitro assay of drug metabolites & drug metabolizing enzymes.

Drug Product Performance, In Vivo: Bioavailability and
Bioequivalence:
Drug Product Performance, Purpose of Bioavailability Studies,
Relative and Absolute Availability. Methods for Assessing
Bioavailability, Bioequivalence Studies, Design and Evaluation of
Bioequivalence Studies, Study Designs, Crossover Study
Designs, Generic Biologics (Biosimilar Drug Products), Clinical
Significance of Bioequivalence Studies. 12
Hrs

REFERENCES
1. Analysis of drugs in Biological fluids - Joseph Chamberlain, 2nd Edition.
CRC Press, Newyork. 1995.
2. Principles of Instrumental Analysis - Doglas A Skoog, F. James Holler,
Timothy A . Nieman, 5th edition, Eastern press, Bangalore, 1998.
3. Pharmaceutical Analysis - Higuchi, Brochmman and Hassen, 2nd Edition,
Wiley – Interscience Publications, 1961.
4. Pharmaceutical Analysis - Modern methods – Part B - J W Munson,
Volume 11, Marcel Dekker Series
5. Practical HPLC method Development – Snyder, Kirkland, Glaich, 2nd
Edition, John Wiley & Sons, New Jercy. USA.
6. Chromatographic Analysis of Pharmaceuticals – John A Adamovics, 2nd
Edition, Marcel Dekker, Newyork, USA. 1997.
7. Chromatographic methods in clinical chemistry & Toxicology – Roger L
Bertholf, Ruth E Winecker, John Wiley & Sons, New Jercy, USA. 2007.
8. Good Laboratory Practice Regulations, 2nd Edition, Sandy Weinberg Vol.
69, Marcel Dekker Series, 1995.
9. Good laboratory Practice Regulations – Allen F. Hirsch, Volume 38,
Marcel Dekker Series, 1989.
10. ICH, USFDA & CDSCO Guidelines.
11. Palmer

Page 128

113 QUALITY CONTROL AND QUALITY ASSURANCE
(MPA 203T)

Scope
This course deals with the various aspects of quality control and quality
assurance aspects of pharmaceutical industries. It covers the important aspects
like cGMP, QC tests, documentation, quality certifications, GLP and regulatory
affairs.

Objectives
At the completion of this subject it is expected that th e student shall be able to
know
 the cGMP aspects in a pharmaceutical industry
 to appreciate the importance of documentation
 to understand the scope of quality certifications applicable to
Pharmaceutical industries
 to understand the responsibilities of QA & QC departments

THEORY 60 hrs
1. Concept and Evolution of Quality Control and Quality
Assurance
Good Laboratory Practice, GMP, Overview of ICH Guidelines -
QSEM, with special emphasis on Q -series guidelin es.
Good Laboratory Practices: Scope of GLP, Definitions, Quality
assurance unit, protocol for conduct of non clinical testing, control
on animal house, report preparation and documentation. 12
Hrs

2. cGMP guidelines according to schedule M, USFDA (inclusive
of CDER and CBER) Pharmaceutical Inspection Convention
(PIC), WHO and EMEA covering: Organization and personnel
responsibilities, training, hygiene and personal records, drug
industry location, design, construction and plant lay out,
maintenance, sanitation, environmental control, utilities and
main tenance of sterile areas, control of contamination and Good
Warehousing Practice. CPCSEA guidelines. 12
Hrs

3. Analysis of raw materials, fini shed products, packaging
materials, in process quality control (IPQC), Developing
specification (ICH Q6 and Q3) 12
Hrs

Page 129

114 Purchase specifications and maintenance of stores for raw
materials. In p rocess quality control and finished products quality
control for following formulation in Pharma industry according to
Indian, US and British pharmacopoeias: tablets, capsules,
ointments, suppositories, creams, parenterals, ophthalmic and
surgical products (How to refer pharmacopoeias), Quality control
test for containers, closures and secondary packing materials.

4. Documentation in pharmaceutical industry: Three tier
documentation, Policy, Procedures and Work instructions, and
records (Formats), Basic principles - How to maintain, retention and
retrieval etc. Standard operating procedures (How to write), Master
Formula Record, Batch Formula Record, Quality audit plan and
reports. Specification and test pro cedures, Protocols and reports.
Distribution records. Electronic data. 12
Hrs

5. Manufacturing operations and controls: Sanitation of
manufacturing premises, mix -ups and cross contamination,
processing of intermediates and bulk products, packaging
operations, IPQC, release of finished product, process deviations,
charge -in of components, time limitations on production, drug
product inspe ction, expiry date calculation, calculation of yields,
production record review, change control, sterile products, aseptic
process control, packaging. 12
Hrs

REFERENCES
1. Quality Assurance Guid e by organization of Pharmaceutical Procedures of
India, 3rd revised edition, Volume I & II, Mumbai, 1996.
2. Good Laboratory Practice Regulations, 2nd Edition, Sandy Weinberg Vol.
69, Marcel Dekker Series, 1995.
3. Quality Assurance of Pharmaceuticals - A comped ium of Guide lines and
Related materials Vol I & II, 2nd edition, WHO Publications, 1999.
4. How to Practice GMP’s – P P Sharma, Vandana Publications, Agra, 1991.
5. The International Pharmacopoeia – vol I, II, III, IV & V - General Methods
of Analysis and Qual ity specification for Pharmaceutical Substances,
Excepients and Dosage forms, 3rd edition, WHO, Geneva, 2005.
6. Good laboratory Practice Regulations – Allen F. Hirsch, Volume 38, Marcel
Dekker Series, 1989.
7. ICH guidelines
8. ISO 9000 and total quality management

Page 130

115 9. The drugs and cosmetics act 1940 – Deshpande, Nilesh Gandhi, 4th
edition, Susmit Publishers, 2006.
10. QA Manual – D.H. Shah, 1st edition, Business Horizons, 2000.
11. Good Manufacturing Practices for Pharmaceuticals a plan for total quality
control – Sidney H. Willig, Vol. 52, 3rd edition, Marcel Dekker Series.
12. Steinborn L. GMP/ISO Quality Audit Manual for Healthcare Manufacturers
and Their Suppliers, Sixth Edition, (Volume 1 - With Checklists and
Software Package). Taylor & Francis; 2003.
13. Sarker DK. Quality Systems and Controls for Pharmaceuticals. John Wiley
& Sons; 2008.

Page 131

116 HERBAL AND COSMETIC ANALYSIS
(MPA 204T)
Scope
This course is designed to impart knowledge on analysis of herbal products.
Regulatory requirements, herbal drug interaction with monographs.
Performance evaluation of cosmetic products is included for the better
understanding of the equipments used in cosmetic industries for the purpose.

Objectives
At completion of this course student shall be able to understand
 Determination of herbal remedies and regulations
 Analysis of natural products and monographs
 Determination of Herbal drug -drug interaction
 Principles of performance evalua tion of cosmetic products.

THEORY 60 Hrs
1. Herbal remedies - Toxicity and Regulations: Herbals vs
Conventional drugs, Efficacy of herbal medicine products,
Validation of Herbal Therapies, Pharmacodynamic and
Pharmacokinetic issues. Herbal drug standardization : WHO and
AYUSH guidelines. 12
Hrs

2 Adulteration and Deterioration: Introduction, types of
adulteration/substitution of herbal drugs, Causes and Measure of
adulteration, Sampling Procedures, Determination of Foreign
Matter, DNA Finger printing techniques in identification of drugs of
natural origin, heavy metals, pesticide residues, phototoxin and
microbial contamination in herbal formulations.
Regulatory requirements for setting herbal drug industry:
Global marketing management, Indian and international patent
law as applicable herbal drugs and natural products and its
protocol. 12
Hrs

3 Testing of natural products and drugs: Effect of herbal
medicine on clinical laboratory testing, Adulterant Screening using
modern analytical instruments, Regulation and dispensing of
herbal drugs, Stability testing of natural products, protocol.

Monographs of Herbal drugs: Study of monographs of herbal
drugs and comparative study in IP, USP, Ayurvedic 12
Hrs

Page 132

117 Pharmacopoeia, American herbal Pharmacopoeia, British herbal
Pharmacopoeia, Siddha and Unani Pharmacopoeia, WHO
guidelines in quality assessment of herbal drugs.

4 Herbal drug -drug interaction: WHO and AYUSH guidelines for
safety monitoring of natural medicine, Spontaneous reporting
schemes for bio drug adverse reactions, bio drug -drug and bio
drug-food interacti ons with suitable examples. Challenges in
monitoring the safety of herbal medicines. 12
Hrs

5 Evaluation of cosmetic products : Determination of acid value,
ester value, saponification value, iodine value, peroxide value,
rancidity, moisture, ash, volatile matter, heavy metals, fineness of
powder, density, viscosity of cosmetic raw materials and finished
products. Study of quality of raw materia ls and general methods
of analysis of raw material used in cosmetic manufacture as per
BIS.
Indian Standard specification laid down for sampling and testing
of various cosmetics in finished forms such as baby care
products, skin care products, dental products, personal hygiene
preparations, lips sticks. Hair products and skin creams by the
Bureau Indian Standards. 12
Hrs

REFERENCES
1. Pharmacognosy by Trease and Evans
2. Pharmacognosy by Kokate, Purohit and Gokhale
3. Quality Control Methods for Medicinal Plant, WHO, Geneva
4. Pharmacognosy & Pharmacobiotechnology by Ashutosh Kar
5. Essential of Pharmacognosy by Dr.S.H.Ansari
6. Cosmetics – Formulation, Manufacturing and Quality Control, P.P.
Sharma, 4th edition, Vandana Publications Pvt. Ltd., Delhi
7. Indian Standard specification, for raw materials, BIS, New Delhi.
8. Indian Standard specification for 28 finished cosmetics BIS, New Delhi
9. Harry’s Cosmeticology 8th edition
10. Suppliers catalogue on specialize d cosmetic excipients
11. Wilkinson, Moore, seventh edition, George Godwin. Poucher’s Perfumes,
Cosmetics and Soaps
12. Hilda Butler, 10th Edition, Kluwer Academic Publishers. Handbook of
Cosmetic Science and Technology, 3rd Edition,

Page 133

118 PHARMACEUTICAL ANALYSIS PRACTICALS - I
(MPA 205P)
1. Comparison of absorption spectra by UV and Wood ward – Fiesure rule
2. Interpretation of organic compounds by FT-IR
3. Interpretation of organic compounds by NMR
4. Interpretation of organic compounds by MS
5. Determination of purity by DSC in pharmaceuticals
6. Identification of organic compounds using FT -IR, NMR, CNMR and Mass
spectra
7. Bio molecules separation utilizing various sample preparation techniques
and Quantit ative analysis of components by gel electrophoresis.
8. Bio molecules separation utilizing various sample preparation techniques
and Quantitative analysis of components by HPLC techniques.
9. Isolation of analgesics from biological fluids (Blood serum and urine) .
10. Protocol preparation and performance of analytical/Bioanalytical method
validation.
11. Protocol preparation for the conduct of BA/BE studies according to
guidelines.
12. In process and finished product quality control tests for tablets, capsules,
parenterals and creams
13. Quality control tests for Primary and secondary packing materials
14. Assay of raw materials as per official monographs
15. Testing of related and foreign substances in drugs and raw materials
16. Preparation of Master Formula Record.
17. Preparation of Batch Manufacturing Record.
18. Quantitative analysis of rancidity in lipsticks and hair oil
19. Determination of aryl amine content and Developer in hair dye
20. Determination of foam height and SLS content of Shampoo.
21. Determination of total fatty matter in creams (Soap, s kin and hair creams)
22. Determination of acid value and saponification value.
23. Determination of calcium thioglycolate in depilatories

Page 134

119 PHARMACEUTICAL QUALITY ASSURANCE (MQA)

MODERN PHARMACEUTICAL ANALYTICAL TECHNIQUES
(MQA 101T)
Scope
This subject deals with various advanced analytical instrumental techniques for
identification, characterization and quantification of drugs. Instruments dealt are
NMR, Mass spectrometer, IR, HPLC, GC etc.

Objectives
After com pletion of course student is able to know about chemicals and
excipients
 The analysis of various drugs in single and combination dosage forms
 Theoretical and practical skills of the instruments

THEORY 60 Hrs
1. a. UV-Visible spectroscopy : Introduction, Theory, Laws,
Instrumentation associated with UV -Visible spectroscopy, Choice
of solvents and solvent effect and Applications of UV -Visible
spectroscopy, Difference/ Derivative spectroscopy.
b. IR spectroscopy : Theory, Modes of Molecular vibrations,
Sample handling, Instrumentation of Dispersive and Fourier -
Transform IR Spectrometer, Factors affecting vibrational
frequencies and Applications of IR spectrosco py, Data
Interpretation.
c. Spectroflourimetry: Theory of Fluorescence, Factors
affecting fluorescence (Characterestics of drugs that can be
analysed by flourimetry), Quenchers, Instrumentation and
Applications of fluorescence spectrophotometer.
d. Flame emissio n spectroscopy and Atomic absorption
spectroscopy : Principle, Instrumentation, Interferences and
Applications.
2 NMR spectroscopy : Quantum numbers and their role in NMR,
Principle, Instrumentation, Solvent requirement in NMR,
Relaxation process, NMR signals in various compounds,
Chemical shift, Factors influencing chemical shift, Spin -Spin
coupling, Coupling constant, Nuclear magnetic double resonance,
Brief outline of principles of FT -NMR and 13C NMR. Applications
of NMR spectroscopy. 12
Hrs














12
Hrs

Page 135

120 3 Mass Spectroscopy : Principle, Theory, Instrumentation of Mass
Spectroscopy, Different types of ionization like electron impact,
chemical, field, FAB and MALDI, APCI, ESI, APPI Analyzers of
Quadrupole and Time of Flight, Mass fragmentation and its rules,
Meta stable ions, Isotopic peaks and Applications of Mass
spectroscopy. 12
Hrs

4 Chromatography : Principle, apparatus, instrumentation,
chromatographic parameters, factors affecting resolution, isolation
of drug from excipients, data interpretation and applications of the
following:
 Thin Layer chromatography
 High Performance Thin Layer Chromatography
 Ion exchange chromatography
 Column chromatography
 Gas chromatography
 High Performance Liquid chromatography
 Ultra High Performance Liquid chromatography
 Affinity chromatography
 Gel Chromatography 12
Hrs

5 a. Electrophoresis : Principle, Instrumentation, Working
conditions, factors affecting separation and applications of the
following:
a) Paper electrophoresis b) Gel electrophoresis c) Capillary
electrophoresis d) Zone electrophoresis e) Moving boundary
electrophoresis f) Iso electric focusing
b. X ray Crystallography : Production of X rays, Different X ray
methods, Bragg‘s law, Rotating crystal technique, X ray powder
technique, Types of crystals and applications of X -ray diffraction. 12
Hrs

6 a. Potentiometry: Principle, working, Ion selective Electrodes
and Application of potentiometry.
b. Thermal Techniques : Principle, thermal transitions and
Instrumentation (Heat flux and power -compensation and designs),
Modulated DSC, Hyper DSC, experimental parameters (sam ple
preparation, experimental conditions, calibration, heating and
cooling rates, resolution, source of errors) and their influence,
advantage and disadvantages, pharmaceutical applications.
Differential Thermal Analysis (DTA): Principle, instrumentation 12
Hrs

Page 136

121 and advantage and disadvantages, pharmaceutical applications,
derivative differential thermal analysis (DDTA). TGA: Principle,
instrumentation, factors affecting results, advantage and
disadvantages, pharmaceutical applications.

REFERENCES
1. Spectrometric Identification of Organic compounds - Robert M Silverstein,
Sixth edition, John Wiley & Sons, 2004.
2. Principles of Instrumental Analysis - Doglas A Skoog, F. James Holler,
Timothy A. Nieman, 5th edition, Eastern press, Bangalore, 1998.
3. Instrumental methods of analysis – Willards, 7th edition, CBS publishers.
4. Practical Pharmaceutical Chemistry – Beckett and Stenlake, Vol II, 4th
edition, CBS Publishers, New Delhi, 1997.
5. Organic Spectros copy - William Kemp, 3rd edition, ELBS, 1991.
6. Quantitative Analysis of Drugs in Pharmaceutical formulation - P D Sethi,
3rd Edition, CBS Publishers, New Delhi, 1997.
7. Pharmaceutical Analysis - Modern Methods – Part B - J W Munson, Vol
11, Marcel. Dekker Series
8. Spectroscopy of Organic Compounds, 2nd edn., P.S/Kalsi, Wiley estern
Ltd., Delhi.
9. Textbook of Pharmaceutical Analysis, KA.Connors, 3rd Edition, John Wiley
& Sons, 1982.
10. Textbook of Pharmaceutical Analysis, KA.Connors, 3rd Edition, John Wiley
& Sons, 1982.

Page 137

122 QUALITY MANAGEMENT SYSTEMS
(MQA 102T)
Scope
This course is designed to impart fundamental knowledge and concepts about
various quality management principles and systems utilized in the
manufacturing industry. It also aids in understanding the quality evaluation in the
pharmaceutical industries.

Objectives
At completion of this course it is expected that students will be able to
understand -
 The importance of quality
 ISO management systems
 Tools for quality improvement
 Analysis of issues in quality
 Quality evaluation of pharmaceuticals
 Stability test ing of drug and drug substances
 Statistical approaches for quality


THEORY 60 Hrs
1. Introduction to Quality: Evolution of Quality, Definition of
Quality, Dimensions of Quality
Quality as a Strategic Decision: Meaning of strategy and
strategic quality management, mission and vision statements,
quality policy, Quality objectives, strategic planning and
implementation, McKinsey 7s model, Competitive analysis,
Management commitment to quality
Customer Focus: Meaning of customer and customer focus,
Classification of customers, Customer focus, Customer
perception of quality, Factors affecting customer perception,
Customer requirements, Meeting customer needs and
expectations, Customer satisfaction and Customer delight,
Handling customer complaints, Understanding customer behavior,
concept of internal and external customers. Case studies.
Cost of Quality: Cost of quality, Categories of cost of Quality,
Models of cost of quality, Optimisi ng costs, Preventing cost of
quality. 12
Hrs

Page 138

123 2 Pharmaceutical quality Management: Basics of Quality
Management, Total Quality Management (TQM), Principles of Six
sigma, ISO 9001:2008, 9001:2015, ISO 14001:2004,
Pharmaceutical Quality Management – ICH Q10, Knowledge
management, Quality Metrics, Operational Excellence and Quality
Management Review. OSHAS guidelines, NABL certification and
accreditation, CFR -21 part 11, WHO -GMP requirements. 12
Hrs

3 Six System Inspection model: Quality Management system,
Production system, Facility and Equipment system, Laboratory
control system, Materials system, Packaging and labeling system.
Concept of self inspection.
Quality systems: Change Management/ Change control.
Deviations, Out of Specifications (OOS), Out of Trend (OOT),
Complaints - evaluation and handling, Investigation and
determinat ion of root cause, Corrective & Preventive Actions
(CAPA), Returns and Recalls, Vendor Qualification, Annual
Product Reviews, Batch Review and Batch Release. Concept of
IPQC, area clearance/ Line clearance. 12
Hrs

4 Drug Stability: ICH guidelines for stability testing of drug
substances and drug products.
Study of ICH Q8, Quality by Design and Process
development report
Quality risk management: Introduction, risk assessment, risk
control, risk review, risk management tools, HACCP, risk ranking
and filtering according to ICH Q9 guidelines . 12
Hrs

5 Statistical Process control (SPC): Definition and Importance of
SPC, Quality measurement in manufacturing, Statistical control
charts - concepts and general aspects, Advantages of statistical
control, Process capability, Estimating Inherent or potential
capability from a control chart analysis, Measuring process control
and quality improvement, Pursuit of decreased process variability. 8 Hrs

6 Regulatory Compliance through Quality Management and
development of Quality Culture
Benchmarking: Definition of benchmarking, Reasons for
benchmarking, Types of Benchmarking, Benchmarking process,
Advantages of benchmarking, Limitations of benchmarking. 4 Hrs

Page 139

124 REFERENCES
1. Implementing Juran's Road Map for Quality Leadership: Benc hmarks and
Results, By Al Endres, Wiley, 2000
2. Understanding, Managing and Implementing Quality: Frameworks,
Techniques and Cases, By Jiju Antony; David Preece, Routledge, 2002
3. Organizing for High Performance: Employee Involvement, TQM,
Reengineering, and K nowledge Management in the Fortune 1000: The
CEO Report By Edward E. Lawler; Susan Albers Mohrman; George
Benson, Jossey -Bass, 2001
4. Corporate Culture and the Quality Organization By James W. Fairfield -
Sonn, Quorum Books, 2001
5. The Quality Management Sourcebook: An International Guide to Materials
and Resources By Christine Avery; Diane Zabel, Routledge, 1997
6. The Quality Toolbox, Second Edition, Nancy R. Tague, ASQ Publications
7. Juran's Quality Handbook, Sixth Edition, Joseph M. Juran and Joseph A.
De F eo, ASQ Publications
8. Root Cause Analysis, The Core of Problem Solving and Corrective Action,
Duke Okes, 2009, ASQ Publications.

Page 140

125 QUALITY CONTROL AND QUALITY ASSURANCE
(MQA 103T)

Scope
This course deals with the various aspects of quality control and quality
assurance aspects of pharmaceutical industries. It covers the important aspects
like cGMP, QC tests, documentation, quality certifications, GLP and regulatory
affairs .

Objectives
Upon completion of t his course the student should be able to
 Understand the cGMP aspects in a pharmaceutical industry
 To appreciate the importance of documentation
 To understand the scope of quality certifications applicable to
Pharmaceutical industries
 To understand the responsibilities of QA & QC departments.

THEORY 60 Hrs
1. Introduction: Concept and evolution and scopes of Quality
Control and Quality Assurance, Good Laboratory Practice, GMP,
Overview of ICH Gui delines - QSEM, with special emphasis on Q -
series guidelines.
Good Laboratory Practices: Scope of GLP, Definitions, Quality
assurance unit, protocol for conduct of non clinical testing, control
on animal house, report preparation and documentation.
CPCSEA guidelines. 12
Hrs

2 cGMP guidelines according to schedule M, USFDA (inclusive of
CDER and CBER) Pharmaceutical Inspection Convention(PIC),
WHO and EMEA covering: Organization and personnel
responsibilities, training, hygiene and personal records, drug
industry location, design, construction and plant lay out,
maintenance, sanitation, environmental control, utilities and
maintenance of sterile areas, control of contamination and Good
Warehousing Practice. 12
Hrs

3 Analysis of raw materials, finished products, packaging materials,
in process quality control (IPQC), Developing specification (ICH
Q6 and Q3), purchase specifications and maintenance of stores
for raw materials. 12
Hrs

Page 141

126 In process quality control and finished products quality control for
following dosage forms in Pharma industry according to Indian,
US and British pharmacopoeias: tablets, capsules, ointments,
suppositories, creams, parenterals, ophthalmic and surgical
products (How to refer pharmacopoeias).

4 Documentation in pharmaceutical industry: Three tier
documentation, Policy, Procedures and Work instructions, and
records (Formats), Basic principles - How to maintain, retention
and retrieval etc. Stan dard operating procedures (How to write),
Master Batch Record, Batch Manufacturing Record, Quality audit
plan and reports. Specification and test procedures, Protocols and
reports. Distribution records. Electronic data handling. Concepts
of controlled and uncontrolled documents.
Submission documents for regulators DMFs, as Common
Technical Document and Electronic Common Technical
Documentation (CTD, eCTD). Concept of regulated and non
regulated markets. 12
Hrs

5 Manufacturing operations and controls: Sanitation of
manufacturing premises, mix -ups and cross contamination,
processing of intermediates a nd bulk products, packaging
operations, IPQC, release of finished product, process deviations,
charge -in of components, time limitations on production, drug
product inspection, expiry date calculation, calculation of yields,
production record review, chang e control, sterile products, aseptic
process control, packaging, reprocessing, salvaging, handling of
waste and scrap disposal.
Introduction, scope and importance of intellectual property rights.
Concept of trade mark, copyright and patents. 12
Hrs

REFERENCES
1. Quality Assurance Guide by organization of Pharmaceutical Procedures of
India, 3rd revised edition, Volume I & II, Mumbai, 1996.
2. Good Laboratory Practice Regulations, 2nd Edition, Sandy Weinberg Vol.
69, Marcel Dekker Series, 1995.
3. Quality Assurance of Pharmaceuticals - A compedium of Guide lines and
Related materials Vol I & II, 2nd edition, WHO Publications, 1999.
4. How to Practice GMP’s – P P Sharma, Vandana Publications, Agra, 1991.

Page 142

127 5. The International Pharmacopoeia – vol I, II, III, IV & V - General Methods
of Analysis and Quality specification for Pharmaceutical Substances,
Excepients and Dosage forms, 3rd edition, WHO, Geneva , 2005.
6. Good laboratory Practice Regulations – Allen F. Hirsch, Volume 38, Marcel
Dekker Series, 1989.
7. ICH guidelines
8. ISO 9000 and total quality management
9. The drugs and cosmetics act 1940 – Deshpande, Nilesh Gandhi, 4th
edition, Susmit Publishers, 2006.
10. QA Manual – D.H. Shah, 1st edition, Business Horizons, 2000.
11. Good Manufacturing Practices for Pharmaceuticals a plan for total quality
control – Sidney H. Willig, Vol. 52, 3rd edition, Marcel Dekker Series.
12. Steinborn L. GMP/ISO Quality Audit Manual for Healthcare Manufacturers
and Their Suppliers, Sixth Edition, (Volume 1 - With Checklists and
Software Package). Taylor & Francis; 2003.
13. Sarker DK. Quality Systems and Controls for Pharmaceuticals. John Wiley
& Sons; 2008.
14. Packaging of Pharmaceuticals.
15. Sche dule M and Schedule N.

Page 143

128
PRODUCT DEVELOPMENT AND TECHNOLOGY TRANSFER
(MQA 104T)
Scope
This deal with technology transfer covers the activities associated with Drug
Substance, Drug Product and analytical tests and methods, required following
candidate drug selection to completion of technology transfer from R&D to the
first receiving site and technology transfer related to post -marketing changes in
manufacturing places.

Objectives
Upon completion of this course the student should be able to
 To understand the new product development process
 To understand the necessary information to transfer technology from
R&D to actual manufacturing by sorting out various information
obtained during R&D
 To elucidate necessary information to transfer technology of existing
products between various manufacturing places

THEORY 60 Hrs
1. Principles of Drug discovery and development: Introduction,
Clinical research pro cess. Development and informational content
for Investigational New Drugs Application (IND), New Drug
Application (NDA), Abbreviated New Drug Application (ANDA),
Supplemental New Drug Application (SNDA), Scale Up Post
Approval Changes (SUPAC) and Bulk acti ve chemical Post
approval changes (BACPAC), Post marketing surveillance,
Product registration guidelines – CDSCO, USFDA.
2 Pre-formulation studies: Introduction/concept, organoleptic
properties, purity, impurity profiles, particle size, shape and
surface are a. Solubility, Methods to improve solubility of Drugs:
Surfactants & its importance, co -solvency. Techniques for the
study of Crystal properties and polymorphism. Pre -formulation
protocol, Stability testing during product development.
3 Pilot plant scale up: Concept, Significance, design, layout of
pilot plant scale up study, operations, large scale manufacturing
techniques (formula, equipment, process, stability and quality
control) of solids, liquids, semisolid and parenteral dosage forms.
New era of drug p roducts: opportunities and challenges. 12
Hrs






12
Hrs




12
Hrs

Page 144

129 4 Pharmaceutical packaging: Pharmaceutical dosage form and
their packaging requirments, Pharmaceutical packaging materials,
Medical device packaging, Enteral Packaging, Aseptic packaging
systems, Container closure systems, Issues facing modern drug
packaging, Selection and evaluation of Pharmaceutical packaging
materials.
Quality control test : Containers, closures and secondary
packing materials.
5 Technology transfer: Development of technology by R & D,
Technology transfer from R & D to production, Optimization and
Production, Qualitative and quantitative technology models.
Documentation in technology transfer: Development repor t,
technology transfer plan and Exhibit. 12
Hrs






12
Hrs

REFERENCES
1. The process of new drug discovery and development. I and II Edition
(2006) by Charles G. Smith, James T and O. Donnell. CRC Press, Group
of Taylor and Francis.
2. Leon Lac Lachman, Herbert A. Liberman, Theory and Practice of Industrial
Pharmacy. Marcel Dekker Inc. New York.
3. Sidney H Willing, Murray M, Tuckerman. Williams Hitchings IV, Good
manufacturing of pharmaceuti cals (A Plan for total quality control) 3rd
Edition. Bhalani publishing house Mumbai.
4. Tablets Vol. I, II, III by Leon Lachman, Herbert A. Liberman, Joseph B.
Schwartz, 2nd Edn. (1989) Marcel Dekker Inc. New York.
5. Text book of Bio - Pharmaceutics and clinica l Pharmacokinetics by Milo
Gibaldi, 3rd Edn, Lea & Febriger, Philadelphia.
6. Pharmaceutical product development. Vandana V. Patrevale. John I.
Disouza. Maharukh T.Rustomji. CRC Press, Group of Taylor and Francis.
7. Dissolution, Bioavailability and Bio -Equivalence by Abdou H.M, Mack
Publishing company, Eastern Pennsylvania.
8. Remingtons Pharmaceutical Sciences, by Alfonso & Gennaro, 19th
Edn.(1995)OO2C Lippincott; Williams and Wilkins A Wolters Kluwer
Company, Philadelp hia.
9. The Pharmaceutical Sciences; the Pharma Path way ‘Pure and applied
Pharmacy’ by D. A Sawant, Pragathi Books Pvt. Ltd.
10. Pharmaceutical Packaging technology by D.A. Dean. E.R. Evans, I.H. Hall.
1st Edition(Reprint 2006). Taylor and Francis. London and New York.

Page 145

130 QUALITY ASSURANCE PRACTICAL - I
(MQA 105P)

PRACTICALS
1. Analysis of Pharmacopoeial compounds in bulk and in their formulations
(tablet/ capsules/ semisolids) by UV Vis spectrophotometer
2. Simultane ous estimation of multi -drug component containing formulations
by UV spectrophotometry
3. Experiments based on HPLC
4. Experiments based on Gas Chromatography
5. Estimation of riboflavin/quinine sulphate by fluorimetry
6. Estimation of sodium/potassium by flame photometry or AAS
7. Case studies on
 Total Quality Management
 Six Sigma
 Change Management/ Change control. Deviations,
 Out of Specifications (OOS)
 Out of Trend (OOT)
 Corrective & Preventive Actions (CAPA)
 Deviations
8. Development of Stability study protocol
9. Estimation of process capability
10. In process and finished product quality control tests for tablets, capsules,
parenterals and semisolid dosage forms.
11. Assay of raw materials as per official monographs
12. Testing of related and foreign substances in drugs and raw materials
13. To carry out pre formulation study for tablets, parenterals (2 experiment).
14. To study the effect of pH on the solubility of drugs, (1 experiment)
15. Quality control tests for Primary and secondary packaging materials
16. Accelerated stability studies (1 experiment)
17. Improved solubility of drugs using surfactant systems (1 experiment)
18. Improved solubility of drugs using co -solvency method (1 experiment)
19. Determination of Pka and Log p of drugs.

Page 146

131 HAZARDS AND SAFETY MANAGEMENT
(MQA 201T)
Scope
This course is designed to convey the knowledge necessary to understand
issues related to different kinds of hazard and their management. Basic
theoretical and practical discussions integrate the proficiency to handle the
emergency situation in the pharmaceutical product development process and
provides the principle based approach to solve the complex tribulations.

Objectives
At completion of this course it is expected that students will be able to
 Understand about environmental problems among learners.
 Impart basic knowledge about the environment and its allied problems.
 Develop an attitude of concern for the industry environment.
 Ensure safety standards in pharmaceutical industry
 Provide comprehens ive knowledge on the safety management
 Empower an ideas to clear mechanism and management in different
kinds of hazard management system
 Teach the method of Hazard assessment, procedure, methodology for
provide safe industrial atmosphere.

THEORY 60Hrs
1. Multidisciplinary nature of environmental studies: Natural
Resources, Renewable and non -renewable resources, Natural
resources and associated problems,
a) Forest resources; b) Water resources; c) Mineral resources; d)
Energy resources; e) Land resources
Ecosystems: Concept of an ecosystem and Structure and
function of an ecosystem. Environmental hazards: Hazards
based on Air, Water, Soil and Radioisotopes. 12
Hrs

2 Air based hazards: Sources, Types of Hazards, Air circulation
maintenance industry for sterile area and non sterile area,
Preliminary Hazar d Analysis (PHA) Fire protection system: Fire
prevention, types of fire extinguishers and critical Hazard
management system. 12
Hrs

3 Chemical based hazards: Sources of chemical hazards,
Hazards of Organic synthesis, sulphonating hazard, Organic
solvent hazard, Control measures for chemical hazards, 12
Hrs

Page 147

132 Management of comb ustible gases, Toxic gases and Oxygen
displacing gases management, Regulations for chemical hazard,
Management of over -Exposure to chemicals and TLV concept.

4 Fire and Explosion : Introduction, Industria l processes and
hazards potential, mechanical electrical, thermal and process
hazards. Safety and hazards regulations, Fire protection system:
Fire prevention, types of fire extinguishers and critical Hazard
management system mechanical and chemical explos ion,
multiphase reactions, transport effects and global rates.
Preventive and protective management from fires and explosion -
electricity passivation, ventilation, and sprinkling, proofing, relief
systems -relief valves, flares, scrubbers. 12
Hrs

5 Hazard and risk management: Self-protective measures against
workplace hazards. Critical training for risk management, Process
of hazard ma nagement, ICH guidelines on risk assessment and
Risk management methods and Tools
Factory act and rules, fundamentals of accident prevention,
elements of safety programme and safety management,
Physicochemical measurements of effluents, BOD, COD,
Determina tion of some contaminants, Effluent treatment
procedure, Role of emergency services. 12
Hrs


REFERENCES
1. Y.K. Sing, Environmental Science, New Age International Pvt, Publishers,
Bangalore
2. “Quantitative Risk Assessment in Chemical Process Industries” American
Institute of Chemical Industries, Centre for Chemical Process safety.
3. Bharucha Erach, The Biodiversity of India, Mapin Pu blishing Pvt. Ltd.,
Ahmedabad – 380 013, India,
4. Hazardous Chemi cals: Safety Management and Global Regulations,
T.S.S. Dikshith, CRC press

Page 148

133 PHARMACEUTICAL VALIDATION
(MQA 202T)
Scope
The main purpose of the subject is to understand about validation and how it
can be ap plied to industry and thus improve the quality of the products. The
subject covers the complete information about validation, types, methodology
and application.

Objectives
At completion of this course, it is expected that students will be able to
understand
 The concepts of calibration, qualification and validation
 The qualification of various equipments and instruments
 Process validation of different dosage forms
 Validation of analytical method for estimation of drugs
 Cleaning validation of equipme nts employed in the manufacture of
pharmaceuticals

THEORY 60 Hrs
1. Introduction to validation: Definition of Calibration, Qualification
and Validation, Scope, frequency and importance. Difference
betw een calibration and validation. Calibration of weights and
measures. Advantages of Validation, scope of Validation,
Organization for Validation, Validation Master plan, Types of
Validation, Streamlining of qualification & Validation process and
Validation Master Plan.
Qualification: User requirement specification, Design
qualification, Factory Acceptance Test (FAT)/Site Acceptance
Test (SAT), Installation qualification, Operational qualification,
Performance qualification, Re -Qualification (Maintaining stat us-
Calibration Preventive Maintenance, Change management). 10
Hrs

2 Qualification of manufacturing equipment: Dry Powder
Mixers, Fluid Bed and Tray dryers, Tablet Compression
(Machine), Dry heat sterilization/Tunnels, Autoclaves, Membrane
filtration, Capsule filling machine.
Qualification of analytical instruments: UV-Visible
spectrophotometer, FTIR, DSC, GC, HPLC, HPTLC, L C-MS. 10
Hrs

Page 149

134 3 Qualification of laboratory equipments: Hardness tester,
Friability test apparatus, tap density tester, Disintegration tester,
Dissolution test apparatus
Validation of Utility sys tems: Pharmaceutical water system &
pure steam, HVAC system, Compressed air and nitrogen. 10
Hrs

4 Process Validation: Concept, Process and documentation of
Process Validation. Prospective, Concurrent & Retrospective
Validation, Re validation criteria, Process Validation of various
formulations (Coated tablets, Capsules, Ointment/Creams, Liquid
Orals and aerosols.), Aseptic filling: Media fil l validation, USFDA
guidelines on Process Validation - A life cycle approach.
Analytical method validation: General principles, Validation of
analytical method as per ICH guidelines and USP. 10
Hrs

5 Cleaning Validation: Cleaning Method development, Validation
of analytical method used in cleaning, Cleaning of Equipment,
Cleaning of Faci lities. Cleaning in place (CIP).
Validation of facilities in sterile and non -sterile plant.
Computerized system validation: Electronic records and digital
signature - 21 CFR Part 11 and GAMP 10
Hrs

6 General Principles of Intellectual Property: Concepts of
Intellectual Property (IP), Intellectual Property Protection (IPP),
Intellectual P roperty Rights (IPR); Economic importance,
mechanism for protection of Intellectual Property –patents,
Copyright, Trademark; Factors affecting choice of IP protection;
Penalties for violation; Role of IP in pharmaceutical industry;
Global ramification and financial implications. Filing a patent
applications; patent application forms and guidelines. Types
patent applications -provisional and non provisional, PCT and
convention patent applications; International patenting
requirement procedures and costs; Righ ts and responsibilities of
a patentee; Practical aspects regarding maintaining of a Patent
file; Patent infringement meaning and scope. Significance of
transfer technology (TOT), IP and ethics -positive and negative
aspects of IPP; Societal responsibility, avoiding unethical
practices. 10
Hrs

Page 150

135 REFERENCES
1. B. T. Loftus & R. A. Nash, "Pharmaceutical Process Validation", Drugs and
Pharm Sci. Series, Vol. 129, 3rd Ed., Marcel Dekker Inc., N.Y.
2. The Theory & Practice of Industrial Pharmacy, 3rd edition, Leon Lachman,
Herbert A. Lieberman, Joseph. L. Karig, Varghese Publishing House,
Bombay.
3. Validation Master plan by Terveeks or Deeks, Davis Harwood International
publishing.
4. Validation of Aseptic Pharm aceutical Processes, 2nd Edition, by Carleton
& Agalloco,
5. (Marcel Dekker).
6. Michael Levin, Pharmaceutical Process Scale -Up”, Drugs and Pharm. Sci.
Series, Vol. 157,2nd Ed., Marcel Dekker Inc., N.Y.
7. Validation Standard Operating Procedures: A Step by Step Gu ide for
Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech
Industries, Syed Imtiaz Haider
8. Pharmaceutical Equipment Validation: The Ultimate Qualification
Handbook, Phillip A. Cloud, Interpharm Press
9. Validation of Pharmaceutical Process es: Sterile Products, Frederick J.
Carlton (Ed.) and James Agalloco (Ed.), Marcel Dekker
10. Analytical Method validation and Instrument Performance Verification by
Churg Chan, Heiman Lam, Y.C. Lee, Yue. Zhang, Wiley Interscience.
11. Huber L. Validation and Quali fication in Analytical Laboratories. Informa
Healthcare
12. Wingate G. Validating Corporate Computer Systems: Good IT Practice for
Pharmaceutical Manufacturers. Interpharm Press
13. LeBlanc DA. Validated Cleaning Technologies for Pharmaceutical
Manufacturing. Inte rpharm Press

Page 151

136 AUDITS AND REGULATORY COMPLIANCE
(MPA 203T)

Scope
This course deals with the understanding and process for auditing in
pharmaceutical industries. This subject covers the methodology involved in the
auditing process of different in pharmaceutical industries.

Objectives
Upon completion of this course the student should be able to
 To understand the importance of auditing
 To understand the methodology of auditing
 To carry out the audit process
 To prepare the auditing report
 To prepare the check list for auditing

THEORY 60 Hrs
1. Introduction: Objectives, Management of audit , Responsibilities,
Planning process, information gathering, administration,
Classifications of deficiencies 12
Hrs

2 Role of quality systems and audits in pharmaceutical
manufacturing environment: cGMP Regulations, Quality
assurance functions, Quality systems approach, Management
responsibilities, Resource , Manufacturing operations, Evaluation
activities, Transitioning to quality system approach, Audit checklist
for drug industries. 12
Hrs

3 Auditing of vendors and production department : Bulk
Pharmaceutical Chemicals and packaging material Vendor audit,
Warehouse and weighing, D ry Production: Granulation, tableting,
coating, capsules, sterile production and packaging. 12
Hrs

4 Auditing of Microbiological laboratory: Auditing the
manufacturing process, Product and process information, General
areas of interest in the building raw materials, Water, Packaging
materials. 12
Hrs

Page 152

137 5 Auditing of Quality Assurance and engineering department:
Quality Assurance Maintenance, Critical systems: HVAC, Water,
Water for Injection systems, ETP. 12
Hrs

REFERENCES
1. Compliance auditing for Pharmaceutical Manufacturers. Karen Ginsbury
and Gil Bismuth, Interpharm/CRC, Boca Raton, London New York,
Washington D.C.
2. Pharmaceutical Manufacturing Handbook, Regulations and Quality by
Shayne Cox Gad. Wiley -Interscience, A John Wiley and s ons, Inc.,
Publications.
3. Handbook of microbiological Quality control. Rosamund M. Baird, Norman
A. Hodges, Stephen P. Denyar. CRC Press. 2000.
4. Laboratory auditing for quality and regulatory compliance. Donald C.
Singer, Raluca -loana Stefan, Jacobus F. Van Staden. Taylor and Francis
(2005).

Page 153

138 PHARMACEUTICAL MANUFACTURING TECHNOLOGY
(MQA 204T)
Scope
This course is designed to impart knowledge and skills necessary to train the
students with the industrial activities during Pharmaceutical Manufacturing.

Objectives
At completion of this course it is expected that students will be able to
understand,
 The common practice in the pharmaceutical industry developments,
plant layout and production planning
 Will be familiar with the principles and practices of aseptic process
technology, non sterile manufacturing technology and packaging
technology.
 Have a better understanding of principles and implementation of
Quality by design (QbD) and process analytical technolo gy (PAT) in
pharmaceutical manufacturing

THEORY 60 Hrs
1. Pharmaceutical industry developments: Legal requirements
and Licenses for API and formulation industry, Plant location -
Factors influencing.
Plant layout: Factors influencing, Special provisions, Storage
space requirements, sterile and aseptic area layout.
Production planning: General principles, production systems,
calculation of standard cost, process planning, routing, loading,
scheduling, dispatching of records, production control. 12
Hrs

2 Aseptic process technology: Manufacturing, manufacturing
flowcharts, in proc ess-quality control tests for following sterile
dosage forms: Ointment, Suspension and Emulsion, Dry powder,
Solution (Small Volume & large Volume ).
Advanced sterile product manufacturing technology : Area
planning & environmental control, wall and floor t reatment,
fixtures and machineries, change rooms, personnel flow, utilities
& utilities equipment location, engineering and maintenance .
Process Automation in Pharmaceutical Industry: With specific
reference to manufacturing of sterile semisolids, Small Vo lume
Parenterals & Large Volume Parenterals (SVP & LVP), Monitoring
of Parenteral manufacturing facility, Cleaning in Place (CIP), 12
Hrs

Page 154

139 Sterilization in Place (SIP), Prefilled Syringe, Powdered Jet,
Needle Free Injections, and Form Fill Seal Technology (FFS).
Lyophilization technology : Principles, process, equipment.

3 Non sterile manufacturing process technology:
Manufacturing, manufa cturing flowcharts, in process -quality
control tests for following Non -Sterile solid dosage forms: Tablets
(compressed & coated), Capsules (Hard & Soft).
Advance non -sterile solid product manufacturing
technology : Process Automation in Pharmaceutical Indus try with
specific reference to manufacturing of tablets and coated
products, Improved Tablet Production: Tablet production process,
granulation and pelletization equipments, continuous and batch
mixing, rapid mixing granulators, rota granulators, spheroniz ers
and marumerisers, and other specialized granulation and drying
equipments. Problems encountered.
Coating technology : Process, equipments, particle coating,
fluidized bed coating, application techniques. Problems
encountered. 12
Hrs

4 Containers and closures for pharmaceuticals: Types,
performance, assuring quality of glass; types of plastics used,
Drug plastic interactio ns, biological tests, modification of plastics
by drugs; different types of closures and closure liners; film
wrapper; blister packs; bubble packs; shrink packaging; foil /
plastic pouches, bottle seals, tape seals, breakable seals and
sealed tubes; qualit y control of packaging material and filling
equipment, flexible packaging, product package compatibility,
transit worthiness of package, Stability aspects of packaging.
Evaluation of stability of packaging material. 12
Hrs

5 Quality by design (QbD) and process analytical technology
(PAT): Current approach and its limitations. Why QbD is required,
Advantages, Elements of QbD, Terminology: QTPP. CMA, CQA,
CPP, RLD, Design space, Design of Experiments, Risk
Assessment and mitigation/minimization. Quality by Design,
Formulations by Design, QbD for drug products, QbD for Drug
Substances, QbD for Excipients, Analytical QbD. FDA initiative on
process analytical technology. PAT as a driver for improving
quality and reducing costs: quality by design (QbD), QA, QC and
GAMP. PAT guidance, standards and regulatory requirements. 12
Hrs

Page 155

140 REFERENCES
1. Lachman L, Lieberman HA, Kanig JL. The theory and practice of industrial
rd
pharmacy, 3 ed., Varghese Publishers, Mumbai 1991.
th
2. Sinko PJ. Martin's physical pharmacy and pharmaceutical sciences, 5
ed., B.I. Publications Pvt. Ltd, Noida, 2006.
3. Lieberman HA, Lachman L, Schwartz JB. Pharmaceutical dosage forms:
nd
tablets Vol. I -III, 2 ed., CBS Publishers & distributors, New Delhi, 2005.
th
4. Banker GS, Rhodes CT. Modern Pharmaceutics, 4
Inc, New York, 2005. ed., Marcel Dekker
5. Sidney H Willing, Murray M, Tuckerman. Williams Hitchings IV, Good
manufacturing of pharmaceuticals (A Plan for total quality control) 3rd
Edition. Bhalani publishing house Mumbai.
6. Indian Pharmacopoeia. Controller of Publication. Delhi, 1996.
7. British Pharmacopoeia. British Pharmacopoeia Commission Office,
London, 2008.
8. United States Pharmacopoeia. United States Pharmacope ial Convention,
Inc, USA, 2003.
9. Dean D A, Evans E R and Hall I H. Pharmaceutical Packaging
Technology. London, Taylor & Francis, 1st Edition. UK.
10. Edward J Bauer. Pharmaceutical Packaging Handbook. 2009. Informa
Health care USA Inc. New york.
11. Shaybe Cox Ga d. Pharmaceutical Manufacturing Handbook. John Willey
and Sons, New Jersey, 2008.

Page 156

141 QUALITY ASSURANCE PRACTICAL – II PRACTICALS
(MQA 205P)

1. Organic contaminants residue analysis by HPLC
2. Estimation of Metall ic contaminants by Flame photometer
3. Identification of antibiotic residue by TLC
4. Estimation of Hydrogen Sulphide in Air.
5. Estimation of Chlorine in Work Environment.
6. Sampling and analysis of SO 2 using Colorimetric method
7. Qualification of following Pharma equipment
a.Autoclave
b.Hot air oven
c.Powder Mixer (Dry)
d.Tablet Compression Machine
8. Validation of an analytical method for a drug
9. Validation of a processing area
10. Qualification of at least two analytical instruments
11. Cleaning validation of one equipment
12. Qualification of Pharmaceutical Testing Equipment (Dissolution testing
apparatus, Friability Apparatus, Disintegration Tester)
13. Check list for Bulk Pharmaceutical Chemicals vendors
14. Check list for tableting production.
15. Check list for sterile production area
16. Check list for Water for injection.
17. Design of plant layout: Sterile and non-sterile
18. Case study on application of QbD
19. Case study on application of PAT

Page 157

142 PHARMACEUTICAL REGULATORY AFFAIRS (MRA)


Scope GOOD REGULATORY PRACTICES (MRA 101T)
This course is designed to impart fundamental knowledge on various Good
Regulatory Practices viz., cGMP, GLP, GALP and GDP for Pharmaceuticals,
Cosmetics, Food & Nutraceuticals, Medical devices, In-vitro Diagnostic Medical
Devices (IVDs) and biological pro ducts and understand the rationale behind
these requirements and will propose ways and means of complying with them.

Objectives
At completion of this course it is expected that students will be able to
understand,
 The key regulatory and compliance elements with respect to Good
Manufacturing Practices, Good Laboratory Practices, Good Automated
Laboratory Practices and Good Documentation Practices.
 Prepare and implement the check lists and SOPs for various Good
Regulatory Practices
 Implement Good Regu latory Practices in the Healthcare and related
Industries
 Prepare for the readiness and conduct of audits and inspections.

THEORY 60 Hrs
1. Current Good Manufacturing Practices: Introduction, US cGMP
Part 210 and Part 211.EC Principles of GMP (Directive 12
Hrs
91/356/EEC) Article 6 to Article 14 and WHO cGMP guidelines
GAMP -5; Medical device and IVDs Global Harmonization Task
Force(GHTF) Guidance docs.
2 Good Laboratory Practices: Introduction, USFDA GLP 12
Regulations (Subpart A to Subpart K), Controlling the GLP Hrs
inspection process, Documentation, Audit, goals of Laboratory
Quality Audit, Audit tools, Future of GLP regulations, relevant ISO
and Quality Council of India(QCI) Standards
3 Good Automated Laboratory Practices: Introduction to GALP, 12
Principles of GALP, GALP Requirements, SOPs of GALP, Hrs
Training Documentation,21 CFR Part 11, General check list of
21CFR Part 11, Software Evaluation checklist, relevant ISO and
QCI Standards .

Page 158

143 4 Good Distribution Practices : Introduction to GDP, Legal GDP
requirements put worldwide, Principles, Personnel,
Documentation, Premises and Equipment, Deliveries to
Customers, Returns, Self -Inspection, Provision of information,
Stability testing principles, WHO GDP, USP GDP (Supply chain
integrity), relevant CDSCO guidance and ISO standards 12
Hrs

5 Quality management systems: Concept of Quality, Total Quality
Management, Quality by design, Six Sigma concept, Out of
Specifications (OOS), Change control. Validation: Types of
Validation, Types of Qualification, Validation master plan (VMP),
Analytical Method Validation. Validation of utilities, [Compressed
air, steam, water systems, Heat Ventilation and Air conditioning
(HVAC)]and Cleaning Validation. The International Conference on
Harmonization ( ICH) process, ICH guidelines to establish quality,
safety and efficacy of drug substances and products, ISO 13485,
Sch MIII and other relevant CDSCO regulatory guidance
documents. 12
Hrs


REFERENCES
1. Good Laboratory Practice Regulations, by Sandy Weinberg, Fourth Edition
Drugs and the Pharmaceutical Sciences, Vol.168
2. Good Pharmaceutical Manufacturing practice, Rational and compliance by
John Sharp, CRC Press
3. Establishing a cGMP Laboratory Au dit System, A practical Guide by David
M.Bleisner, Wiley Publication.
4. How to practice GLP by PP Sharma, Vandana Publications.
5. Laboratory Auditing for Quality and Regulatory compliance bu Donald
C.Singer, Drugs and the Pharmaceutical Sciences, Vol.150.
6. Drug s & Cosmetics Act, Rules & Amendments

Page 159

144 DOCUMENTATION AND REGULATORY WRITING
(MRA 102T)

Scope
This course is designed to impart fundamental knowledge on documentation
and general principles involved in regulatory writing and submission to agencies.

Objectives
Upon completion of the course the student shall be able to,
 Know the various documents pertaining to drugs in pharmaceutical
industry
 Understand the basics of regulatory compilation
 Create and asse mble the regulation submission as per the
requirements of agencies
 Follow up the submissions and post approval document requirements

THEORY 60 Hrs
1. Documentation in pharmaceutical industry : Exploratory
Product Development Brief (EPDB) for Drug substance and Drug
product, Product Development Plan (PDP), Product Development
Report (PDR), Master Formula Record, Batch Manufacturing
Record and its calculations, Batch Reconciliation, Batch
Packagin g Records, Print pack specifications, Distribution
records, Certificate of Analysis (CoA), Site Master File and Drug
Master Files (DMF). 12
Hrs

2 Dossier preparation and submission: Introduction and
overview of dossiers, contents and organization of dossier,
binders and sections, compilation and review of dossier. Paper
submissions, overview and m odules of CTD, electronic CTD
submissions; Electronic submission: Planning electronic
submission, requirements for submission, regulatory bindings and
requirements, Tool and Technologies, electronic dossier
submission process and validating the submission, Electronic
Submission Gateway (ESG). Non eCTD electronic submissions
(NeeS), Asian CTD formats (ACTD) submission. Organizing,
process and validation of submission. Submission in Sugam
system of CDSCO. 12
Hrs

Page 160

145 3 Audits: Introduction, Definition, Summary, Types of audits, GMP
compliance audit, Audit policy, Internal and External Audits,
Second Party Audits, External third party audits, Auditing
strateg ies, Preparation and conducting audit, Auditing strategies,
audit analysis, audit report, audit follow up. Auditing/inspection of
manufacturing facilities by regulatory agencies. Timelines for
audits/inspection. GHTF study group 4 guidance document.
ISO 13485. 12
Hrs

4 Inspections: Pre-approval inspections, Inspection of
pharmaceutical manufacturers, Inspection of drug distribution
channe ls, Quality systems requirements for national good
manufacturing practice inspectorates, inspection report, model
certificate of good manufacturing practices, Root cause analysis,
Corrective and Preventive action (CAPA). 12
Hrs

5 Product life cycle management: Prior Approval Supplement
(PAS), Post Approval Changes [SUPAC], Changes Being
Effected in 30 Days (CBE -30), Annual Report, Post marketing
Reporting Requirements, Post approval Labeling Changes,
Lifecycle Management, FDA Inspection and Enforcement,
Establishment Inspection Report (EIR), Warning Letters, Recalls,
Seizure and Injunctions. ISO Risk Management Stand ard 12
Hrs

REFERENCES
1. Compliance auditing for Pharmaceutical Manufacturers. Karen
Ginsbury and Gil Bismuth, Interpharm/CRC, Boca Raton, London New
York, Washington D.C.
2. Pharmaceutical Manufacturing Handbook, Regulations and Quality by
Shayne Cox Gad. Wiley -Interscience, A John Wiley and sons, Inc.,
Publications.
3. Handbook of microbiological Quality control. Rosamund M. Baird,
Norman A. Hodges, Stephen P. Denyar. CRC Press. 2000.
4. Laborato ry auditing for quality and regulatory compliance. Donald C.
Singer, Raluca -loana Stefan, Jacobus F. Van Staden. Taylor and
Francis (2005).
5. Implementing Juran's Road Map for Quality Leadership: Benchmarks
and Results, By Al Endres, Wiley, 2000
6. Understanding, Managing and Implementing Quality: Frameworks,
Techniques and Cases, By Jiju Antony; David Preece, Routledge, 2002

Page 161

146 7. Organizing for High Performance: Employee Involvement, TQM,
Reengineering, and Knowledge Management in the Fortune 1000: The
CEO Report By Edward E. Lawler; Susan Albers Mohrman; George
Benson, Jossey -Bass, 2001
8. Corporate Culture and the Quality Organization By James W. Fairfield -
Sonn, Quorum Books, 2001
9. The Quality Management Sourcebook: An International Guide to
Materials and Resources By Christine Avery; Diane Zabel, Routledge,
1997
10. The Quality Toolbox, Second Edition, Nancy R. Tague, ASQ
Publications
11. Juran's Quality Handbook, Sixth Edition, Joseph M. Juran and Joseph
A. De F eo, ASQ Publications
12. Root Cause Analysis, The Core of Problem Solving and Corrective
Action, Duke Okes, 2009, ASQ Publications
13. International Medical Device Regulators Forum (IMDRF) Medical
Device Single Audit Program (MDSAP)

Page 162

147 CLINICAL RESEARCH REGULATIONS
(MRA 103T)
Scope
This course is designed to impart the fundamental knowledge on the clinical
development process of drugs, pharmaceuticals and Medical Devices, phases
and conduct of clinical trials and research, regulations and guidance governing
the conduct of clinical research in India, USA and EU. It prepares the students
to learn in detail on various laws, legislations and guidance related to safety,
efficacy, ethical conduct and regulatory approval of clinical research.

Objectives
Upon completion of the course, the student shall be able to (know, do and
appreciate)
 History, origin and ethics of clinical and biomedical research and
evaluation
 Clinical drug, medical dev ice development process and different types
and phases of clinical trials
 Regulatory requirements and guidance for conduct of clinical trials and
research

Theory 60 Hrs
1. Clinical Drug Development Process
 Different types of Clinical Studies
 Phases of clinical trials, Clinical Trial protocol
 Phase 0 studies
 Phase I and subtype studies (single ascending, multiple
ascending, dose escalation, methods, food effect studies,
drug – drug interaction, PK end points
 Phase II studies (proof of concept or principle studies to
establish efficacy)
 Phase III studies (Multi ethnicity, global clinical trial,
registration studies)
 Phase IV studies (Post Marketing Studies; PSUR)
Clinical Investigation and Evaluation of Medical Devices &
IVDs
Different Types of Studies
Key Concepts of Medical Device Clinical Evaluation
Key concepts of Clinical Investigation 12
Hrs

Page 163

148 2 Ethics in Clinical Research:
 Historical Pers pectives: Nuremberg Code, Thalidomide study
, Nazis Trials, Tuskegee Syphilis Study, The Belmont Report,
The declaration of Helsinki
 Origin of International Conference on Harmonization - Good
Clinical Practice (ICH -GCP) guidelines.
 The ethics of randomized clinical trials
 The role of placebo in clinical trials
 Ethics of clinical research in special population
 Institutional Review Board/Independent Ethics
Committee/Ethics Committee – composition, roles,
responsibilities, review and approval process and ongoi ng
monitoring of safety data
 Data safety monitoring boards.
 Responsibilities of sponsor, CRO, and investigator in ethical
conduct of clinical research
 Ethical principles governing informed consent process
 Patient Information Sheet and Informed Consent Form
 The informed consent process and documentation 12
Hrs

3 Regulations governing Clinical Trials
India: Clinical Research regulations in India – Schedule Y &
Medical Device Guidance
USA: Regulations to conduct drug studies in USA (FDA)
 NDA 505(b)(1) of the FD&C Act (Application for approval of a
new drug)
 NDA 505(b)(2) of the FD&C Act (Application for approval of a
new drug that relies, at least in part, on data not developed
by the applicant)
 ANDA 505(j) of the FD&C Act (Application for approval of a
generic drug product)
 FDA Guidance for Industry - Acceptance of Foreign Clinical
Studies
 FDA Clinical Trials Guidance Document: Good Clinical
Practice
EU: Clinical Research regulations in European Union (EMA) 12
Hrs

Page 164

149 4 Clinical Research Related Guidelines
 Good Clinical Practice Guidelines (ICH GCP E6)
 Indian GCP Guidelines
 ICMR Ethical Guidelines for Biomedical Research
 CDSCO guidelines
GHTF study group 5 guidance documents
Regulatory Guidance on Efficacy and Safety ICH Guidance’s
 E4 – Dose Response Information to support Drug
Registration
 E7 – Studies in support of General Population: Geriatrics
 E8 – General Considerations of Clinical Trials
 E10 – Choice of Control Groups and Related Issues in
Clinical Trials,
 E 11 – Clinical Investigation of Medicinal Products in the
Pediatric Population
 General biostatics principle applied in clinical research
5 USA & EU Guidance
USA: FDA Guidance
 CFR 21Part 50: Protection of Human Subjects
 CFR 21Part 54: Financial Disclosure by Clinical Investigators
 CFR 21Part 312: IND Application
 CFR 21Part 314: Application for FDA Approval to Market a
New Drug
 CFR 21Part 320: Bioavailability and bioequivalence
requirements
 CFR 21Part 812: Investigational Device Exemptions
 CFR 21Part 822: Post -market surveillance
 FDA Safety Reporting Requirements for INDs and BA/BE
Studies
 FDA Med Watch
 Guidance for Industry: Good Pharmacovigilance Practices
and Pharmacoepidemiologic Assessment
European Union: EMA Guidance
 EU Directives 2001
 EudraLex (EMEA) Volume 3 – Scientific guidelines for
medicinal products for human use
 EU Annual Safety Report (ASR)
 Volume 9A – Pharmacovigilance for Medicinal Products for
Human Use
 EU MDD with respect to clinical research
 ISO 14155 12
Hrs















12
Hrs

Page 165

150 REFERENCES
1. Clinical Trials and Human Research: A Practical Guide to Regulatory
Compliance By Fay A. Rozovsky and Rodney K. Adams
2. HIPAA and Human Subjects Research: A Question and Answer
Reference Guide By Mark Barnes, JD, LLM and Jennifer Kulynych, JD,
PhD
3. Principles and Practices of Clinical Research, Second Edition Edited by
John I. Gallin and Frederick P. Ognibene
4. Reviewing Clinical Trials: A Guide for the Ethics Committee; Johan PE
Karlberg and Marjorie A Speers; Karlberg, Johan Petter Einar, Hong
Kong.
5. International Pharmaceutical Product Registrati on: Aspects of Quality,
Safety and Efficacy; Anthony C. Cartwright; Taylor & Francis Inc., USA.
6. New Drug Approval Process: The Global Challenge; Guarino, Richard
A; Marcel Dekker Inc., NY.
7. FDA regulatory affairs: a guide for prescription drugs, medical dev ices,
and biologics; Douglas J. Pisano, David Mantus; CRC Press, USA
8. Country Specific Guidelines from official websites.
9. Drugs & Cosmetics Act & Rules and Amendments

RECOMMENDED WEBSITES:
1. EU Clinical Research Directive 2001: http://www.eortc.be/services/doc
/clinical -eudirective -04-april-01.pdf
2. Code of Federal Regulations, FDA:
http://www.a ccessdata.fda.gov/scripts /cdrh /cfdocs/cfcfr/cfrsearch.cfm
3. Guidelines of International Conference on Harmonization: http://www .
ich.org /products/guidelines.html
4. Eudralex Guidelines: http://www.gmpcompliance.info/euguide.htm
5. FDA New Drug Application:
6. http://www.fda.gov/regulatoryinformation /legislation/FederalFoodDruga
ndCosmetic
ActFDCAct/FDCActChapterVDrugsandDevices/ucm108125.htm
7. Medicines and Healthcare products Regulatory Agency: http://www
.mhra.gov.uk
8. Central Drugs Standard Control Organization Guidance for Industry:
http://cdsco.nic.in/CDSCO -GuidanceForIndustry.pdf
9. ICMR Ethical Guidelines for Biomedical Research: http://icmr.nic.in
/ethical_guideli nes.pdf

Page 166

151 REGULATIONS AND LEGISLATION FOR DRUGS & COSMETICS,
MEDICAL DEVICES, BIOLOGICALS & HERBALS, AND FOOD &
NUTRACEUTICALS IN INDIA AND INTELLECTUAL PROPERTY
RIGHTS
(MRA 104T)
Scope
This course is designed to impart fundamental knowledge on regulations and
legislation in India w.r.t. Drugs & Cosmetics, Medical Devices, Biologicals &
Herbals, and Food & Nutraceuticals. It prepares the students for basic
regulatory requirements in Indi a of Drugs & Cosmetics, Medical Devices,
Biologicals & Herbals, and Food & Nutraceuticals. for manufacture, import &
registration, export, sale, marketing authorization, clinical trials and intellectual
property rights.

Objectives
Upon the completion of t he course the student shall be able to:
 Know different Acts and guidelines that regulate Drugs & Cosmetics,
Medical Devices, Biologicals & Herbals, and Food & Nutraceuticals
industry in India.
 Understand the approval process and regulatory requirements for
Drugs & Cosmetics, Medical Devices, Biologicals & Herbals, and Food
& Nutraceuticals

THEORY 60 Hrs
1. Biologicals & Herbals, and Food & Nutraceuticals
Acts and Rules (with latest amendments):
1. Drugs and Cosmetics Act 1940 and Rules 1945: DPCO
and NPPA
2. Other relevant provisions (rules schedules and
guidelines for approval of Drugs & Cosmetics, Medical
Devices, Biologicals & Herbals, and Food &
Nutraceuticals in India
Other relevant Acts: Narcotics Drugs and Psychotropic
Substances Act; Medicinal and Toilet Preparations (Excise
Duties) Act, 1955; Pharmacy Act, 1948; Drugs and Magic
Remedies (Objectionable Advertisements) Act, 1955; Prevention
of Cruelty to Animals Act. 12
Hrs

Page 167

152 2 Regulatory requirements and approval procedures for Drugs
& Cosmetics Medical Devices, Biologicals & Herbals, and
Food & Nutraceuticals
CDSCO (Central Drug Standard Control Organization) and State
Licensing Authority: Organization, Responsibilities
 Rules, regulations, guidelines and standards for
regulatory filing of Drugs & Cosmetics, Medical Devices,
Biologicals & Herbals, and Food & Nutraceuticals
 Format and contents of Regulatory dossier filing
Clinical trial/ investigations 12
Hrs

3 Indian Pharmacopoeial Standards, BIS standards and ISO and
other relevant standards 12
Hrs

4 Bioavailability and Bioequivalence data (BA &BE), BCS
Classification of Drugs, Regulatory Requirements for
Bioequivalence study
Stability requirements: ICH and WHO

Guidelines for Drug testing in animals/ Preclinical Studies

Animal testing: Rationale for conducting studies, CPCSEA
Guidelines
Ethical guidelines for human participants
ICMR -DBT Guidelines for Stem Cell Research 12
Hrs

5 Intellectual Property Rights : Patent, Trademark, Copyright,
Industrial Designs and Geographical Indications, Indian Patent
Scenario. IPR v s Regulatory Affairs 12
Hrs

REFERENCES
1. Manual of Patent Practice & Procedure, 3rd Edition, by The Patent Office
of India
2. Patent Failure How Judges, Bureaucrats, and Lawyers put innovators at
risk by James Bessen and Michael J. Meurer
3. Principles and Practice of Clinical Trial Medicine by Richard Chin and
Bruce Y. Lee
4. Ethical Guidelines for Biomedical Research on Human Participants by
Indian Council of Medical Research New delhi 2006.
5. CPCSEA Gui delines for Laboratory Animal Facility by Committee for the
purpose of control and supervision on experiments on animals (CPCSEA)

Page 168

153 6. ICH E6 Guideline ― Good Clinical Practice‖ by ICH Harmonised Tripartite
7. Guidance for Industry on Submission of Clinical Trial Application for
Evaluating Safety and Efficacy by CDSCO (Central Drug Standard Control
Organisation)
8. Guidance for Industry on Requirement of Chemical & Pharmaceutical
Information including Stability Study Data before approval of clinical trials /
BE studies by CDSCO
9. Guidelines for Import and Manufacture of Medical Devices by CDSCO
10. Guidelines from official website of CDSCO

Page 169

154 REGULATORY AFFAIRS PRACTICAL - I
(MRA 105P)
1. Case studies (4 Nos.) of each of Good Pharmaceutical Practices.
2. Documentation for in process and finished products Quality control tests for
Solid, liquid, Semisolid and Sterile preparations.
3. Preparation of SOPs, Analytical reports (Stability and validation)
4. Protocol preparation for documentation of various types of records (BMR,
MFR, DR)
5. Labeling comparison between brand & generics.
6. Preparation of clinical trial protocol for registering trial in India
7. Registration for conducting BA/ BE studies in India
8. Import of drugs for research and developmental activities
9. Preparation of regulatory dossier as per Indian CTD format and submission
in SUGAM
10. Registering for different Intellectual Property Rights in India
11. GMP Audit Requirements as per CDSCO
12. Preparation and documentation for Indian Patent application.
13. Preparation of checklist for registration of IND as per ICH CTD format.
14. Preparation of checklist for registration of NDA as per ICH CTD format.
15. Preparation of checklist for registration of ANDA a s per ICH CTD format.
16. Case studies on response with scientific rationale to USFDA Warning Letter
17. Preparation of submission checklist of IMPD for EU submission.
18. Comparison study of marketing authorization procedures in EU.
19. Comparative study of DMF system in US, EU and Japan
20. Preparation of regulatory submission using eCTD software
21. Preparation of Clinical Trial Application (CTA) for US submission
22. Preparation of Clinical Trial Application (CTA) for EU submission
23. Comparison of Clinical Trial Application requirem ents of US, EU and Japan
of a dosage form.
24. Regulatory requirements checklist for conducting clinical trials in India.
25. Regulatory requirements checklist for conducting clinical trials in Europe.
26. Regulatory requirements checklist for conducting clinical trials in USA

Page 170

155 SEMESTER II
REGULATORY ASPECTS OF DRUGS & COSMETICS
(MRA 201T)

Scope
This course is designed to impart the fundamental knowledge on the drug
development process, regulatory requirements f or approval of new drugs, drug
products and cosmetics in regulated and semi -regulated countriesIt prepares
the students to learn in detail on the regulatory requirements, documentation
requirements, and registration procedures for marketing the drug produ cts and
cosmetics in regulated and semi -regulated countries.

Objectives
Upon completion of the course, the student shall be able to know
 process of drug discovery and development and generic product
development
 regulatory approval process and registration procedures for API and
drug products in US, EU
 Cosmetics regulations in regulated and semi -regulated countries
 A comparative study of India with other global regulated markets

Theory 60 Hrs
1. USA & CANADA: Organization structure and functions of FDA.
Federal register and Code of Federal Regulations (CFR), History
and evolution of United States Federal, Food, Drug and Cosmetic
Act (FFDCA), Hatch Waxman act and Orange book, Purple book,
Drug Master Files (DMF) system in US, Regulatory Approval
Process fo r Investigational New Drug (IND), New Drug
Application (NDA), Abbreviated New Drug Application (ANDA),
Supplemental New Drug Application (SNDA); Regulatory
requirements for Orphan drugs and Combination Products,
Changes to an approved NDA / ANDA. Regulato ry considerations
for manufacturing, packaging and labeling of pharmaceuticals in
USA. Legislation and regulations for import, manufacture,
distribution and sale of cosmetics in USA and Canada. 12
Hrs
2 European Union & Australia: Organization and structure of EMA
& EDQM, General guidelines, Active Substance Master Files
(ASMF) system in EU, Content and approval process of IMPD,
Marketing Authorization procedures in EU (Centralized procedure, 12
Hrs

Page 171

156 Decentralized procedure, Mutual recognition procedure and
National Procedure). Regulatory considerations for
manufacturing, packaging and labeling of pharmaceuticals in EU,
Eudralex directives for huma n medicines, Variations &
extensions, Compliance of European Pharmacopoeia (CEP)/
Certificate of Suitability (CoS), Marketing Authorization (MA)
transfers, Qualified Person (QP) in EU. Legislation and
regulations for import, manufacture, distribution and s ale of
cosmetics in European Union & Australia.
3 Japan: Organization of the PMDA, Pharmaceutical Laws and
regulations, types of registration applications, DMF system in
Japan, drug regulatory approval process, Regulatory
considerations for manufacturing, pa ckaging and labeling of
pharmaceuticals in Japan, Post marketing surveillance in Japan.
Legislation and regulations for import, manufacture, distribution
and sale of cosmetics in Japan








12
Hrs

4 Emerging Market: Introduction, Countries covered, Study of the
world map,study of various committees across the globe (ASEAN,
APEC, EAC, GCC, PANDRH, SADC)
WHO: WHO, GMP, Regulatory Requirements for registration of
drugs and post approval requirements in WHO through
prequalification programme, Certificate of Pharmaceutical Product
(CoPP) - General and Country Specific (South Africa, Egypt,
Algeria and Morocco, Nigeria, Kenya and Botswana) 12
Hrs

5 Brazil, ASEAN, CIS and GCC Countries:
ASIAN Countries: Introduction to ACTD, Regulatory
Requirements for registration of drugs and post approval
requirements in China and South Korea & Association of
Southeast Asian Nations (ASEAN) Region i.e. Vietnam, Malaysia,
Philippines, Singapore and Thailand.
CIS (Commonwealth Independent Sta tes): Regulatory pre -
requisites related to Marketing authorization requirements for
drugs and post approval requirements in CIS countries i.e.
Russia, Kazakhstan and Ukraine GCC (Gulf Cooperation Council)
for Arab states: Regulatory pre -requisites related to Marketing
authorization requirements for drugs and post approval
requirements in Saudi Arabia and UAE
Legislation and regulations for import, manufacture, distribution
and sale of cosmetics in Brazil, ASEAN, CIS and GCC Countries. 12
Hrs

Page 172

157 REFERENCES :
1. Generic Drug Product Development, Solid Oral Dosage forms, Leon
Shargel and Isader Kaufer, Marcel Dekker series, Vol.143
2. The Pharmaceutical Regulatory Process, Edited by Ira R. Be rry Marcel
Dekker Series, Vol.144
3. The Pharmaceutical Regulatory Process, Second Edition Edited by Ira R.
Berry and Robert P. Martin, Drugs and the Pharmaceutical Sciences,
Vol.185 Informa Health care Publishers.
4. New Drug Approval Process: Accelerating Glob al Registrations By
Richard A Guarino, MD, 5th edition, Drugs and the Pharmaceutical
Sciences, Vol.190.
5. Guidebook for drug regulatory submissions / Sandy Weinberg. By John
Wiley & Sons. Inc.
6. Drugs: From Discovery to Approval, Second Edition By Rick Ng
7. New Drug Development: A Regulatory Overview, Eighth Edition By Mark
Mathieu
8. Pharmaceutical Risk Management By Jeffrey E. Fetterman, Wayne L.
Pines and Gary H. Slatko
9. Preparation and Maintenance of the IND Application in eCTD Format By
William K. Sietsema
10. Count ry Specific Guidelines from official websites.
11. http://www.who.int/medicines/areas/quality_safety/regulation_legislation/
ListMRAWebsites.pdf
12. Roadmap to an ASEAN ec onomic community Edited by Denis Hew.
ISEAS Publications, Singapore 2005, ISBN981 -230-347-2
13. ASEAN, Rodolfo C. Severino, ISEAS Publications, Singapore 2005,
ISBN 978-981-230-750-7
14. Building a Future with Brics: The Next Decade for Offshoring, Mark
Kobayashi -Hillary, Springer
15. Outsourcing to India: The Offshore Advantage, Mark Kobayashi -Hillary,
Springer Trade performance and Regional Integration of the CIS
Countries, Lev Freinkman,
16. The world Bank, Washington, DC, ISBN: 0-8212 -5896 -0
17. Global Pharmaceutical Policy: Ensuring Medicines for Tomorrow's World
ByFrederick M. Abbott, Graham Dukes, Maurice Nelson Graham Dukes
139
18. The Gulf Cooperation Council: A Rising Power and Lessons for ASEAN
by Linda Low and Lorraine Carlos Salazar (Nov 22, 2010)
19. Doing Business in the Asean Countries, Balbir Bhasin, Business Expert
Press ISBN:13:978 -1-60649 -108-9
20. Realizing the ASEAN Economic Community: A Comprehensive
Assessment, Michael G Plummer (Editor), Chia Siow Yue (Editor),
Instute of South east asian studies, Singapore

Page 173

158 REGULATORY ASPECTS OF HERBAL AND BIOLOGICALS
(MRA 202T)
Scope
This course is designed to impart fundamental knowledge on Regulatory
Requirements, Licensing and Registration, Regulation on Labelling of Biologics
in India, USA and Europe
It prepares the students to learn in detail on Regulatory Requirements for
biologics, Vaccines and Blood Products

Objectives
Upon the completion of the course the student shall be able to :
 Know the regulatory Requiremen ts for Biologics and Vaccines
 Understand the regulation for newly developed biologics and
biosimilars
 Know the pre -clinical and clinical development considerations of
biologics
 Understand the Regulatory Requirements of Blood and/or Its
Components Including Blood Products and label requirements

Theory 60 Hrs
1. India : Introduction, Applicable Regulations and Guidelines ,
Principles for Development of Similar Biologics, Data
Requirements for Preclinical Studies, Data Requirements for
Clinical Trial Application, Data Requirements for Market
Authorization Application, Post -Market Data for Similar Biologics,
Pharmacovigilance. GMP and GDP. 12
Hrs

2 USA: Introduction to Biologics; biologics, biological and
biosimilars, different biological products, difference between
generic drug and biosimilars, laws, regulations and guidance on
biologics/ biosi milars, development and approval of biologics and
biosimilars (IND, PMA, BLA, NDA, 510(k), pre -clinical and clinical
development considerations, advertising, labelling and packing of
biologics 12
Hrs

3 European Union: Introduction to Biologics; directives, scientific
guidelines and guidance related to biologics in EU, comparability/
biosimilarity assessment, Plasma master file, TSE/ BSE
evaluation, development and regulatory approval of biologics
(Investigational medicinal products and biosimilars), pre-clinical 12
Hrs

Page 174

159 and clinical development considerations; stability, safety,
advertising, labelling and packing of biologics in EU

4 Vaccine regulations in India, US and European Union: Clinical
evaluation, Marketing authorisation, Registration or licensing,
Quality assessment, Pharmacovigilance, Additional requirements
Blood and Blood Products Regulations in India, US and European
Union: Regulatory Requirements of Blood and/or Its Components
Including Blood Products, Label Requirements, ISBT
(International Society of Blood Transfusion) and IHN (International
Haemovigilence Network) 12
Hrs

5 Herbal Products: Quality, safety and legislation for herbal
products in India, USA and European Union. 12
Hrs


REFERENCES
1. FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devic es,
and Biologics, Douglas J. Pisano , David S. Mantus ; Informa ,2008
2. Biological Drug Products: Development and Strategies; Wei
Wang , Manmohan Singh ; wiley ,2013
3. Development of Vaccines: From Discovery to Clinical Testing; Manmohan
Singh , Indresh K. Srivastava ;Wiley, 2011
4. www.who.int/biologicals/en
5. www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegul atoryInfo
rmation/
6. www.ihn -org.com
7. www.isbtweb.org
8. Guidelines on Similar Biologics: Regulatory Requirements for Marketing
Authorization in India
9. www.cdsco.nic.in
10. www.ema.europa.eu › scientific guidelines › Biologicals
11. www.fda.gov/biol ogicsbloodVaccines/GuidanceCompliance Regulatory
Information (Biologics)

Page 175

160 REGULATORY ASPECTS OF MEDICAL DEVICES
(MRA 203T)

Scope
This course is designed to impart the fundamental knowledge on the medical
devices and in vitro diagnostics, basis of classification and product life cycle of
medical devices, regulatory requirements for approval of medical devices in
regulated countries like US, EU and Asian countries along with WHO
regulations. It prepares the students to learn in detail on the harmonization
initiatives, quality and ethical considerations, regulatory and documentation
requirements for marketing medical devices and IVDs in regulated countries.

Objectives
Upon completion of the course, the student shall be able to know
 basics of medical devices and IVDs, process of development, ethical
and quality considerations
 harmonization initiatives for approval and marketing of medical devices
and IVDs
 regulatory approval process for medical devices and IVDs in India, US,
Canada, EU, Japan and ASEAN
 clinical evaluation and investigation of medical devices and IVDs

Theory 60 Hrs
1. Medical Devices: Introduction, Definition, Risk based
classification and Essential Principles of Medical Devices and
IVDs. Differentiating medical devices IVDs and Combination
Products from that of pharmaceuticals, History of Medical Device
Regulation, Product Lifecycle of Medical Devices and
Classification o f Medical Devices.
IMDRF/GHTF: Introduction, Organizational Structure, Purpose
and Functions, Regulatory Guidelines, Working Groups,
Summary Technical Document (STED), Global Medical Device
Nomenclature (GMDN).
2 Ethics: Clinical Investigation of Medical Devices, Clinical
Investigation Plan for Medical Devices, Good Clinical Practice for
Clinical Investigation of medical devices (ISO 14155:2011)
Quality: Quality System Regulations of Medical Devices: ISO
13485, Quality Risk Management of Medical Devices: ISO
14971, Validation and Verification of Medical device, Adverse
Event Reporting of Medical device 12
Hrs








12
Hrs

Page 176

161 3 USA: Introduction, Classification, Regulatory approval process for
Medical Devices (510k) Premarket Notification, Pre -Market
Approval (PMA), Investigational Device Exemption (IDE) and In
vitro Diagnostics, Quality System Requirements 21 CFR Part 820,
Labeling requirements 21 CFR Part 801, P ost marketing
surveillance of MD and Unique Device Identification (UDI). Basics
of In vitro diagnostics, classification and approval process. 12
Hrs

4 European Union: Introduction, Classification, Regulatory
approval process for Medical Devices
(Medical Device Directive, Active Implantable Medical Device
Directive) and In vitro Diagnostics ( In Vitro Diagnostics Directive),
CE certification process.
Basics of In vitro diagnostics, classification and approval process. 12
Hrs

5 ASEAN, China & Japan: Medical Devices and IVDs, Regulatory
registration procedures, Quality System requirements and clinical
evaluation and investigation.
IMDRF study groups and guidance documents. 12
Hrs


REFERENCES
1. FDA regulatory affairs: a guide for prescription drugs, medical devices, and
biologics by Douglas J. Pisano, David Mantus.
2. Medical Device Development: A Regulatory Overview by Jonathan S.
Kahan
3. Medical Product Regulatory Affairs: Pharmaceuticals , Diagnostics, Medical
Devices by John J. Tobin and Gary Walsh
4. Compliance Handbook for Pharmaceuticals, Medical Devices and
Biologics by Carmen Medina
5. Country Specific Guidelines from official websites.

Page 177

162 REGULATORY ASPECTS OF FOOD & NUTRACEUTICALS
(MRA 204T)
Scope
This course is designed to impart the fundamental knowledge on Regulatory
Requirements, Registration and Labeling Regulations of Nutraceuticals in India,
USA and Europe.
It prepares the students to learn in detail on Regulatory Aspects for
nutraceuticals and food supplements.

Objectives
Upon completion of the course, the student shall be able to
 Know the regulatory Requirements for nutraceuticals
 Understand the regulation for registration and lab eling of nutraceuticals
and food supplements in India, USA and Europe.

Theory 60 Hrs
1. Nutraceuticals: Introduction, History of Food and Nutraceutical
Regulations, Meaning of Nutraceuticals, Dietary Supplements,
Functional Foods, Medical Foods, Scope and Opportunities in
Nutraceutical Market. 12
Hrs
2 Global Aspects: WHO guidelines on nutrition. NSF International:
Its Role in the Dietary Supplements and Nutraceuticals Industries,
NSF Certification, NSF Standards for Food And Dietary
Supplements. Good Manufacturing Practices for Nutraceuticals. 12
Hrs
3 India : Food Safety and Standards Act, Food Safety and
Standards Authority of India: Organization and Functions,
Regulations for import, manufacture and sale of nutraceutical
products in India, Recommended Dietary Allowances (RDA) in
India. 12
Hrs
4 USA: US FDA Food Safety Modernization Act, Dietary
Supplement Health a nd Education Act. U.S. regulations for
manufacture and sale of nutraceuticals and dietary supplements,
Labelling Requirements and Label Claims for Dietary
Supplements, Recommended Dietary Allowances (RDA) in the
U.S 12
Hrs

Page 178

163 5 European Union: European Food Safety Authority (EFSA):
Organization and Functions. EU Directives and regulations for
manufacture and sale of nutraceuticals and dietary supplements.
Nutrition labellin g. European Regulation on Novel Foods and
Novel Food Ingredients. Recommended Dietary Allowances
(RDA) in Europe. 12
Hrs


REFERENCES
1. Regulation of Functional Foods and Nutraceuticals: A Global Perspective
by Clare M. Hasler (Wiley Online Library)
2. Nutraceutical and Functional Food Regulations in the United States and
Around the World by Debasis Bagchi (Academic Press, Elsevier)
3. http://www.who.int/publications/guidelines/nutrition/en/
4. http://www.europarl.europa.eu/RegData/ etudes/STUD/2015/536324/IPOL_
STU(2015)536324_EN.pdf
5. Handbook of Nutraceuticals by Yashwant Pathak (CRC Press)
6. Food Regulation: Law, Science, Policy and Practice by Neal D. Fortin
(Wiley)
7. Country Specific Guidelines from official websites.

Page 179

164 REGULATORY AFFAIRS PRACTICAL - II
(MRA 205P)

1. Case studies on
2. Change Management/ Change control. Deviations
3. Corrective & Preventive Actions (CAPA)
4. Documentation of raw materials analysis as per official monographs
5. Preparation of audit checklist for various agencies
6. Preparation of submission to FDA using eCTD software
7. Preparation of submission to EMA using eCTD software
8. Preparation of submission to MHRA using eCTD software
9. Preparation of Biologics License Applications (BLA)
10. Preparation of documents required for Vaccine Product Approval
11. Comparison of clinical trial application requirements of US, EU and
India of Biologics
12. Preparation of Checklist for Registration of Blood and Blood Products
13. Registration requ irement comparison study in 5 emerging markets
(WHO) and preparing check list for market authorization
14. Registration requirement comparison study in emerging markets
(BRICS) and preparing check list for market authorization
15. Registration requirement comparis on study in emerging markets
(China and South Korea) and preparing check list for market
authorization
16. Registration requirement comparison study in emerging markets
(ASEAN) and preparing check list for market authorization
17. Registration requirement comparison study in emerging markets (GCC)
and preparing check list for market authorization
18. Checklists for 510k and PMA for US market
19. Checklist for CE marking for various classes of devices for EU
20. STED Application for Class III Devices
21. Audit Checklist for Medical Device Facility
22. Clinical Investigation Plan for Medical Devices

Page 180

165 PHARMACEUTICAL BIOTECHNOLOGY (MPB)

MODERN PHARMACEUTICAL ANALYTICAL TECHNIQUES
(MPB 101T)
Scope
This subject deals with various advanced analytical instrumental techniques for
identification, characterization and quantification of drugs. Instruments dealt are
NMR, Mass spectrometer, IR, HPLC, GC etc.

Objectives
After completion of course student is able to know,
 The analysis of various drugs in single and combination dosage forms
 Theoretical and practical skills of the instruments

THEORY 60 Hrs
1. a. UV-Visible spectroscopy : Introduction, Theory, Laws,
Instrumentation associa ted with UV -Visible spectroscopy, Choice
of solvents and solvent effect and Applications of UV -Visible
spectroscopy.
IR spectroscopy : Theory, Modes of Molecular vibrations,
Sample handling, Instrumentation of Dispersive and Fourier -
Transform IR Spectrome ter, Factors affecting vibrational
frequencies and Applications of IR spectroscopy
b. Spectroflourimetry: Theory of Fluorescence, Factors
affecting fluorescence, Quenchers, Instrumentation and
Applications of fluorescence spectrophotometer.
c. Flame emission spectroscopy and Atomic absorption
spectroscopy : Principle, Instrumentation, Interferences and
Applications. 12
Hrs

2 NMR spectroscopy : Quantum numbers and their role in NMR,
Principle, Instrumentation, Solvent requirement in NMR,
Relaxation process, NMR signals in various compounds,
Chemical shift, Factors influencing chemical shift, Spin -Spin
coupling, Coupling constant, Nuclear magnetic double resonance,
Brief outline of principles of FT -NMR and 13C NMR. Applications
of NMR spectroscopy. 12
Hrs