MRA202021

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ANDHRA UNIVERSITY

MASTER OF PHARMACY
(2020)
Regulations and Syllabus
Four semester pattern
With effect from 2020-21
M.PHARM (2020) REGULATIONS AND SYLLABUS
INDEX:
1. Admission, instruction and attendance
2. Examinations - Sessional and Semester - end
3. Eligibility criteria for appointment as examiner for M.Pharm examination
4. Regulations for pursuing M.Pharm III and IV Semester project
5. Declaration of results and classification:
6. Grading system:
7. Guidelines for paper setting and model papers.
1. Admission, instruction and attendance
The degree of Master of Pharmacy of the Andhra University will be conferred on a
candidate who has satisfied the following conditions:
1.1. The candidate must have passed the B.Pharm. Degree examination of this University or
B.Pharm. Degree examinations of any other University recognized by the Academic
Council as equivalent thereto in First or Second class; and must have qualified in any
entrance examination, if prescribed.
1.2. Every student, selected for admission to PG Pharmacy program in any PCI approved
institution should have obtained registration with the State Pharmacy Council or should
obtain the same within one month from the date of his/her admission, failing which the
admission of the candidate shall be cancelled.
1.3. The candidate should have undergone a regular course of study as prescribed hereunder
extending over a period of four semesters, ordinarily consecutive, and satisfied the
academic requirements as prescribed hereinafter. The course of instruction and periods
of study shall be as given in the scheme of instruction and in the syllabus.
1.4. The subjects of specializations for Master of Pharmacy Course shall be as follows:
1. Pharmaceutical Analysis
2. Pharmaceutical Chemistry
3. Pharmaceutics
4. Pharmaceutical Biotechnology
5. Pharmacology
6. Pharmacognosy
7. Pharmaceutical Regulatory Affairs
8. Pharmaceutical Quality Assurance
9. Industrial Pharmacy
10. Pharmacy Practice
1.5. Instruction and examination in each academic year is spread over two semesters with a
minimum of 96 working days in each semester (192 in any given academic year). The
odd semesters shall be conducted from the month of July to November and the even
semesters shall be conducted from the month of December to April.
1.6. Each period of instruction is of 45 minutes duration. Eight periods of instruction are
provided on each day and there are six working days in a week (Monday to Saturday).
1.7. Attendance Requirements: A regular course of study during an academic semester
means a minimum of average attendance of 80% of all the courses of the semester
computed by totaling the number of periods of lectures and practicals, as the case may
be, held in every course. In special cases where sufficient causes were shown, the Vice-
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Chancellor may on the recommendation of the Principal concerned condone the
deficiency in the average attendance to an extent of 9% for reasons such as ill health, if
the application for condonation is submitted at the time of actual illness and is
supported by certificate of; authorized Medical officer approved by the Principal.
However, in the case of students, who participate in activities like N.S.S., N.C.C., Inter-
Collegiate tournaments conducted by Andhra University, Inter-University tournaments
conducted by Inter-university Board and any such other activities involving the
representation of the College/University with the prior approval of the principal, the
candidate may be deemed to have attended the college during the period solely for the
purpose of the examination.
1.7. A candidate who cannot satisfy the attendance requirements in clause 1.5 because of
late admission under special circumstances reasonable and acceptable to the University
on the basis of document, shall fulfill the following conditions; Average attendance: A
candidate shall have attended at least a total of 90% of the periods-lectures/practicals as
the case may be held from the date of admission and also shall attend at least 50% of
the total working days during that academic semester (Late admission means,
admissions made after 45 days from date of commencement of the academic semester
for the course).
1.8. If any candidate fails to satisfy the regulation under 1.5 or 1.6 she/he shall not be
allowed for the University Examinations at the end of the semester, and he/she shall not
be allowed for promotion to the next higher class of study. He/she shall be required to
repeat the regular course of study of that academic semester along with the next regular
batch.
1.9. A regular record of attendance 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.
2. Examinations – Internal assessment and Semester-end
2.1. Assessment for the award of degree shall consists of (a) internal assessment for 30
marks in each of the theory and practical courses separately. (b) Semester-end
examination as detailed in the scheme of examination for 70 marks in each of the theory
and practical separately.
2.2. Regulations concerning internal assessment: Internal assessment consist of continuous
mode (10 marks for theory and 15 marks for practical) and sessional examinations (20
marks for theory and 15 marks for practical)
2.2.1. Scheme for awarding continuous mode marks for theory and practical
Theory-Criteria Marks
Attendance 5
Student-Teacher Interaction 5
Theory sessional examination 20
Total theory internal assessment 30
Practical-Criteria
Attendance 5
Record + Viva-voce 10
Practical sessional examination 15
Total practical internal assessment 30

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2.2.1.1. Guidelines for the allotment of marks for attendance
Percentage of Attendance Theory/Practical
95 -100 5
90-94 4
85-89 3
80-84 2
Less than 80 0
2.2.1.2. Guidelines for allotment of marks for Student-Teacher interaction
The teacher shall create some interactive sessions for theory topics and every student
shall interact on the given topic relating to its application in pharmacy. The teacher
should assess the student capacity for understanding of the concept taught. It shall not
be like seminars.
2.2.1.3. Guidelines for allotment of marks Record + Viva-voce
The teacher should conduct viva-voce at the end of each practical and evaluate the
record on continuous mode and shall award these marks.
2.2.4. Guidelines for sessional examinations
Two sessional examinations shall be conducted for each theory/practical course. The
average marks of the two shall be computed.
The teacher who teaches the subject shall ordinarily to be the internal examiner.
There shall be no provision for the improvement of the sessional marks.
There is no minimum mark prescribed for sessional examination for pass in the end
semester examination.
If any student is absent for a single or both sessional examinations, the candidate will
be awarded “ZERO” in the respective examination.
The theory average sessional mark shall be finally computed for 20 marks and
average practical sessional mark shall be finally computed for 15 marks.
2.3. Regulations concerning M.Pharm I and II semester evaluation pattern:
2.3.1. There shall be one semester end examination in each theory course based on the
question paper set by an external paper setter and there shall be single valuation.
There shall be one semester end examination in each practical course as per the
scheme of examination and valuation shall be done by examiner. The duration of the
practical examination is of 6 hours as prescribed.
2.3.2. However the student may apply for revaluation of any subject in theory papers after
declaring the results as per University examination guide lines.
2.3.3. Seminar
A seminar at the end of first and second semesters is separately conducted keeping in
view of the enrichment of required communication, presentation and explanatory
skills. A minimum of four seminars shall be given during the semester before the
Program Committee and other students and documented separately for record in a
Semester Seminar Register.
2.3.4. Comprehensive viva
At the end of II Semester comprehensive viva will be conducted for all the subjects
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covering the theory subjects of I & II semesters by the external examiner and eligible
internal examiners (at least two from the college) who taught these subjects. The
candidate should obtain minimum of 50% marks for passing the examination.
2.3.4. Journal Club
In case of Journal Club, based on the research proposal, each student shall collect a
minimum of 5 research papers (published in a reputed journal with impact factor of
Thomson & Reuters of not less than 1.0) and should discuss in a Programme
Committee (consisting of Head of the Department, Research Supervisor and other
Senior faculty members) and documented separately for record in a Journal Club
Register.
2.3.5. A student shall be eligible to carry forward all the courses of I, II semesters.
However, he/she shall not be eligible to attend the courses of IV semester until the
candidate clears III semester Midterm Project Review.
2.4. Regulations concerning M. Pharm. III and IV Semester evaluation pattern:
2.4.1. Evaluation of the seminar on the objectives and work plan of the proposed project is
to be completed within one month from the commencement of the project date with
three examiners from the same college consisting of research guide, another teacher in
the concerned specialization and third teacher from different specialization. These
teachers must fulfill the eligibility criteria laid down in Section 3.
2.4.2. Evaluation of the M.Pharm III Semester Mid-term project review and seminar on
selected topic will be done by the research guide and external examiner. The seminar
on the selected topic shall not be the one connected with the topic of the thesis work
but should be related to concerned specialization.
2.4.3. A candidate shall submit four copies of his/her thesis either printed or typed,
embodying the results of research work done by him under direction of an approved
research director following the specific guidelines as stipulated under Section 5. All
the candidates must submit their thesis within the prescribed date as per the academic
calendar.
2.4.4. The thesis submitted by the candidate shall be examined by a Board of Examiners
consisting of an External Examiner and the research director and shall have to be
approved after holding a viva voce examination to test the knowledge of the candidate
in the subject. The thesis will be evaluated independently by the external examiner
and research director and in case the difference between examiners is more than 20%,
the thesis shall be sent to a second external examiner whose award shall be the final.
The viva-voce examination will be jointly conducted both by the external examiner
and research director. A candidate can re-submit the thesis in a revised form after
further work, if required to do so.
2.4.5. A candidate desires of improving his/her class shall take either or both of the first two
semesters as a whole.
2.5. Guidelines for writing the thesis
The thesis should have the following pages in order:
1. Title page highlighting the title, name of the candidate, reg. no., guide name, college
name and month and year of submission.
2. The inner title page containing the same details on white background.
3. Certificate from the Head of the institution
4. Certificate from the Research Director
5. Certificate from the ethical committees for approval of study, if any

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6. Declaration by the student
7. Acknowledgements
8. Index highlighting chapter titles and sections titles
9. Index for tables, figures and plates, if any
10. Abbreviations and symbols
11. Materials used in the investigation with their procurement details like name of the
company, batch number etc.
12. Equipment used in the study with the model number and other details
13. The thesis should contain the following chapters:
a) Aim and objectives of the investigation
b) Introduction and literature survey
c) Description: Methods and Materials, etc.
d) Experimental work
e) Results and discussion
f) Summary and conclusions
g) References (The references may be included at the end of each chapter or at the
end of the thesis according to the convenience)
2.5.1. The thesis should be typed in times new roman in 12 font size with 1.5 line spacing
from the beginning of the thesis including titles to the chapters and sections. Bold font
may be used wherever necessary. The students are expected to follow scientific
grammar for writing in vivo etc. which should be in italics.
2.5.2. The citation of references should be done carefully by citing the complete reference
i.e. name of all the authors. Usage of et al. is not allowed in the citation of reference.
The students are expected to give the primary references rather than secondary or
higher levels of references. The presentation of reference must be in Vancouver style.
2.5.3. No code names or numbers are allowed to be written in the thesis for the materials
used in the project.
2.5.4. The examiners of thesis evaluation are expected to verify all this and appropriate
corrections are to be made before conducting the viva-voce examination.
2.5.5 Project Work/IV Semester Assessment – Division of Marks:
Course 402 -Thesis Evaluation (Max. Marks – 150)
Criteria of Evaluation Marks
Seminar/Presentation of work 20
Objective(s) of the work done 20
Methodology adopted 40
Results and Discussion 40
Conclusions and Outcomes 30
Total 150
The division of marks shall be clearly indicated for every candidate in the marks
statement being sent to the University.
2.6. End Semester examinations
The End Semester examination for each theory, practical and other courses through

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semesters I to IV shall be conducted by the University except for the subject with
asterisk symbol (*) in the tables of the each specialization courses (Non University
Examinations) for which examinations shall be conducted by the subject experts at
college level and the marks/grades shall be submitted to the University. In case of
theory examinations, the question paper of the corresponding subject shall be mailed
(Official mail id) to the Controller of Examinations and Chairman, BOS with
signature of the Head of the Institute in PDF format within twenty four hours after
completion of the examination.
3. Eligibility criteria for appointment as examiner for M.Pharm examination
3.1. In order to eligible to be appointed as an internal examiner for the semester end
examination in the respective specialization, a teacher shall have M. Pharm. or Ph.D.
in the respective specialization with at least three years of M.Pharm teaching
experience for the course concerned.
3.2. The eligibility of a teacher for guiding the M.Pharm III and IV semester project is as
follows:
3.2.1. The teacher must have M.Pharm/Ph.D. in the respective specialization with an
experience of minimum 3 years of Post Graduate teaching in the respective
specialization.
3.2.2. The eligibility of such teachers qualified for guiding M.Pharm projects must be
ratified by the Board of Studies before commencement of M.Pharm guidance.
3.2.3. The recognized M.Pharm guides are not eligible to guide more than 6 students in one
academic year including joint guidance.
4. Regulations for pursuing M.Pharm III and IV Semester project
4.1. Students desirous of pursuing M.Pharm III and IV semester projects outside college are
required to get the approval from the college before one month from the
commencement of the project work. The research work can be carried out in a GMP
compliant industry (as approved by WHO, USFDA etc.) and Central research
laboratories like IICT, CDRI, NIH etc. or DSIR and Drug Control Administration
recognized laboratories. A certificate to that effect must be incorporated in the M.Pharm
thesis indicating the duration of stay. If the duration of stay is less than nine months the
remaining period of stay in the college should be certified by the research supervisor
and the Principal.
4.2. All the students should present a seminar on the objectives of their work, work plan,
etc. within one month from the commencement of the project. The students should
attend a mid-term review seminar in the presence of a committee consisting of one
external examiner, research director. The suggestions made by the committee are to be
taken into consideration for further work and should be presented in the thesis.
5. Declaration of results and classification:
5.1. A candidate shall be declared to have passed the examination held at the end of each
semester if obtains i) not less than 40% in the each theory and 50% in each practical,
seminar, comprehensive viva, thesis and thesis viva-voce at the end of each semester
end examination and ii) an aggregate of 50% of all examinations of that semester
including sessoinals. There are no minimum marks prescribed for sessional
examination.
5.2. A candidate who has successfully completed the examination in a course by securing
not less than 50% of marks shall not be permitted to retake the examination in that
course.
5.3. A candidate who fails to secure 50% of marks on the aggregate but secures 50% or
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more in some courses and between 40-49% in the other courses, he/she shall be
required to retake the semester and supplementary examination in one or more of the
courses in which he/she secures less than 50% of marks as per his/her choice to satisfy
the requirement of 50% aggregate.
5.4. Declaration of class
The classes shall be awarded on the basis of CGPA as follows
First Class with Distinction = CGPA of 7.50 and above
First Class = CGPA of 6.00 to 7.49
Second Class = CGPA of 5.00 to 5.99
6. Grading system:
6.1. Appropriate letter grades are awarded in each theory and practical subject to only such
candidates who have passed in the university examinations. Internal assessment marks
and university examination marks put together will be taken into account for the letter
grading system in each subject separately.
6.2. A candidate registered for the university examination but fails to appear or fails to score
the minimum required 40% marks in the university examination will get a grade ‘F’,
indicating failure or grade of incompletion.
6.3. A subject successfully completed cannot be repeated. Final evaluation of each subject
(theory and practical separately) will be carried out on a 10- point grading system
corresponding to the marks obtained in that subject. Each subject letter grade is
converted into a specific grade value associated with the letter grade as given below
(Table).
6.4. Grading of performances
Based on the performance, each student shall be awarded a final letter grade at the end
of the semester for each course. The letter grades and their corresponding grade points
are given below.
10-Point grading system
Percentage of marks Grade Grade
points
90.00 - 100 O 10.0
80.00 - 89.99 A 9.0
70.00 – 79.99 B 8.0
60.00 – 69.99 C 7.0
50.00 – 59.99 D 6.0
40.00 – 49.99 E 5.0
< 40.00 F (Fail) 0.0
The grade W represents failure due to insufficient W 0.0
attendance in the semester or year
Incomplete (subsequently to be changed into pass I 0.0
or E or O or F grade in the same semester)
6.5 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
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grade points obtained in all the courses by the student during the semester. For
example, if a student takes five courses (Theory/Practical) in a semester with
credits C1, C2, C3 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+𝐂𝟐𝐆𝟐+𝐂𝟑𝐆𝟑+𝐂𝟒𝐆𝟒
SGPA = 𝐂𝟏+𝐂𝟐+𝐂𝟑+𝐂𝟒
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 AB grade awarded in that
semester. For example if a learner has F or AB grade in course 4, the SGPA shall
then be computed as:
𝐂𝟏𝐆𝟏+𝐂𝟐𝐆𝟐+𝐂𝟑𝐆𝟑+𝐂𝟒∗𝐙𝐄𝐑𝐎
SGPA = 𝐂𝟏+𝐂𝟐+𝐂𝟑+𝐂𝟒
The credits allotted to each course are given in the respective specialization
Tables 1-10.
6.6. 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), till the course(s) is/are passed. When the course(s) is/ are passed by
obtaining a pass grade on subsequent examination(s) the CGPA shall only reflect the
new grade and not the fail grades earned earlier. The CGPA is calculated as:
𝐂𝟏𝐒𝟏+𝐂𝟐𝐒𝟐+𝐂𝟑𝐒𝟑+𝐂𝟒𝐒𝟒
CGPA = 𝐂𝟏+𝐂𝟐+𝐂𝟑+𝐂𝟒
Where C1,C2,C3, C4….is the total number of credits for semester I, II, III
and IV and S1, S2, S3 and S4 are the SGPA of semester I, II, III and IV.
7. Guidelines for paper setting and model papers.
7.1. Guidelines for theory paper setting for semester end examinations
7.1.1. The semester end question paper in each theory course is to be set for a total of 70
marks by an external paper setter as per the general model given below.
7.1.2. Question paper consists of 5 questions each carrying 5 marks out of which 4 questions
are to be answered by the candidate and 7 questions each carrying 10 marks out of
which 5 questions are to be answered by the candidate for a total of 70 marks. Each
main question may contain subsections like a, b, c etc.
7.1.3. The questions given should be spread over the entire syllabus in an even manner
covering all the units as per the pattern of the question paper given below.
7.1.4. Model question paper for theory course:
Course No.
Specialization Name:
Title of the course:
Time: 3 Hours Max. Marks: 70
Part A (Question Numbers 1-5)
Answer any four questions out of five questions 4X5=20
One question has to be set from each unit.
Part B
Answer any five questions out of seven questions (Question Numbers 6-12) 5X10=50

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Five questions are to be set from five units and the remaining two should cover
at least four out of five units. The main questions may contain sub question like
6(a), 6(b) etc.
7.2. Guidelines for practical paper setting for semester end examination
7.2.1. The question paper in each semester end practical examination is to be set jointly by
two examiners and evaluated, one external and one internal as per the general model
provided below.
7.2.2. Model question paper for practical course:
Course No.
Title of the course
Time: 6 hrs.
1. Synopsis 10 marks
2. Major experiment 30 marks
3. Minor experiment 20 marks
4. Viva voce 10 marks
Total: 70 marks
7.3. Guidelines for theory/practical sessional examination paper setting:
Question paper pattern for theory Sessional examinations
Max. Marks: 30
Time: 2 Hours
Part A
Answer any two questions out of three questions 2X5=10
Part B
Answer any two questions out of three questions 2X10=20
Each of the sessional examination question paper should cover at least half the
units of the syllabus.
Question paper pattern for practical sessional examinations
Max. Marks: 30
Time: 4 hours
1. Synopsis 5 Marks
2. Experiment 20 Marks
3. Viva 5 Marks
Total: 30 Marks

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Table 7: Pharmaceutical Regulatory Affairs (MRA)
Internal Assessment
Hours/ Semester
Code Course Credits Total
week Continuous Sessional Total End Exam
mode Exam
I Semester
MRA 101T Good Regulatory Practices 4 4 10 20 30 70 100
MRA 102T Documentation and Regulatory 4 4 10 20 30 70 100
Writing
MRA 103T Clinical Research Regulations 4 4 10 20 30 70 100
MRA 104T Regulations and Legislation for Drugs & Cosmetics, 4 4 10 20 30 70 100
Medical Devices, Biologicals, Herbals & Food and
Neutraceuticals in India & Intellectual Property Rights
MRA 105P Regulatory Affairs Practical - I 2 6 15 15 30 70 100
MRA 106P Regulatory Affairs Practical - II 2 6 15 15 30 70 100
MRA 107 Seminar* 2 4 50 --- --- --- 50
Total 22 32 --- --- --- --- 650

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Table 7: Pharmaceutical Regulatory Affairs (MRA) continued
II Semester
MRA 201T Regulatory Aspects of Drugs & Cosmetics 4 4 10 20 30 70 100
MRA 202T Regulatory Aspects of Herbal & Biologicals 4 4 10 20 30 70 100
MRA 203T Regulatory Aspects of Medical Devices 4 4 10 20 30 70 100
MRA 204T Regulatory Aspects of Food & Neutraceuticals 4 4 10 20 30 70 100
MRA 205P Regulatory Affairs Practical - III 2 6 15 15 30 70 100
MRA 206 Comprehensive Viva 2 --- --- --- --- --- 50
MRA 207 Seminar* 2 2 50 --- --- --- 50
Total 22 26 --- --- --- --- 600
III Semester
MRM 301T Research Methodology and Biostatistics* 2 4 10 20 30 70 100
MRA 302 Journal Club* 2 2 50 --- --- --- 50
MRA 303 Discussion /Presentation (Dissertation Title & 2 --- 50 --- --- --- 50
Project Proposal)*
MRA 304 Seminar on selected topic 4 4 --- --- --- 100 100
MRA 305 Research Work Progress (Mid Term Report) 10 20 --- 200 100
Total: 20 30 --- --- --- --- 400
IV Semester
MRA 401 Journal Club* 2 2 50 --- --- --- 50
MRA 402 Thesis evaluation 12 20 --- --- --- 150 150
MRA 403 Thesis viva 4 --- --- --- --- 50 50
Total: 20 22 --- --- --- --- 250
* Non-University Examination

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DRUG REGULATORY AFFAIRS

PROGRAM OUTCOMES

PO1: This program is designed to impart fundamental knowledge on various Good


Regulatory Practices
PO2: The student can prepare and implement the check lists and SOPs for various Good
Regulatory Practices
PO3: Student can understand the various documentation pertaining to drugs in
pharmaceutical industry.
PO4: Student can understand the basics of regulatory compilation
PO5: Student can understand the ethics of clinical and biomedical research and evaluation
PO6: This program is designed to impart fundamental knowledge on regulations and legislation
in India
PO7: Student will be able to know about the clinical trial protocol.
PO8: Student will have the knowledge on comparison between brand and generics, BA/BEstudies

PO9: Student can gain professional knowledge on the regulatory requirements and management of

pharmaceuticals, cosmetics, and food products

PROGRAM SPECIFIC OUTCOMES

Upon completion of the program, the student will be able

PSO1: To prepare for the readiness and conduct of audits and inspections
PSO2: To implement the goals of laboratory quality audit
PSO3: To study USP, GDP(Supply chain integrity), relevant CDSCO guidance and ISO
standards
PSO4: To gain knowledge on various aspects of pharmaceutical regulatory affairs and
management
PROGRAM EDUCATIONAL OBJECTIVES
Upon completion of the program, the student will be able

1. To know the key regulatory and compliance elements with respect to Good Manufacturing
Practices, Good Laboratory Practices, Good Automated Laboratory Practices and Good
Documentation Practices
2. To study about ICH guidelines Q2,Q3,Q7,Q8,Q9,Q10&Q11
3. To assemble the regulatory submissions as per the regulatory agency requirements
4. To learn about guidance related to safety, efficacy, ethical conduct and regulatory approval of
clinical research
5. To impart knowledge on Code of Federal Regulations regarding clinical trials and application
processes.
DRA Course outcomes:

Class Course / Course Course objectives Course outcomes


code
M.Pharm GOOD This course is 1. Good Manufacturing
Semester -I REGULATOR designed to impart Practices, Good
Y PRACTICES fundamental Laboratory Practices,
(MRA 101T) knowledge on Good Automated
various Good Laboratory Practices and
Regulatory Good Documentation
Practices viz., Practices.
cGMP, GLP, 2. Prepare and implement
GALP and GDP for the check lists and SOPs
Pharmaceuticals, for various Good
Cosmetics, Food & Regulatory Practices
Nutraceuticals, 3. Implement Good
Medical devices, Regulatory Practices in
In-vitro Diagnostic the Healthcare and related
Medical Devices Industries
(IVDs) and 4. Prepare for the readiness
biological products and conduct of audits and
and understand the inspections.
rationale behind
these requirements
and will propose
ways and means of
complying with
them.
M.Pharm DOCUMENTATIO This course is 1. Various documents
Semester -I N AND designed to impart pertaining to drugs in
REGULATORY fundamental pharmaceutical industry.
WRITING knowledge on 2.understand the basics of
(MRA 102T) documentation and regulatory compilation
general principles 3.Create and assemble the
involved in regulation submission as
regulatory writing per the requirements of
and submission to agencies
agencies. 4.Follow up the
submissions and post
approval document
requirements
M.Pharm CLINICAL This course is 1. History, origin and ethics
Semester -I RESEARCH designed to impart of clinical and biomedical
REGULATION the fundamental research and evaluation.
S (MRA 103T) knowledge on the 2.Clinical drug, medical
clinical device development
development process and different
process of drugs, types and phases of
pharmaceuticals clinical trials
and Medical 3.Regulatory requirements
Devices, phases and guidance for conduct
and conduct of of clinical trials and
clinical trials and research
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.
M.Pharm REGULATIONS This course is 1. Acts and guidelines that
Semester -I AND designed to impart regulate Drugs &
LEGISLATION fundamental Cosmetics, Medical
FOR DRUGS & knowledge on Devices, Biologicals &
COSMETICS, regulations and Herbals, and Food &
MEDICAL legislation in India Nutraceuticals industry in
DEVICES, w.r.t. Drugs & India.
BIOLOGICALS Cosmetics, Medical 2. The approval process and
& HERBALS, Devices, regulatory requirements
AND FOOD & Biologicals & for Drugs & Cosmetics,
NUTRACEUTI Herbals, and Food Medical Devices,
CALS IN & Nutraceuticals. It Biologicals & Herbals,
INDIA AND prepares the and Food &
INTELLECTU students for basic Nutraceuticals
AL PROPERTY regulatory
RIGHTS requirements in
(MRA 104T) India of Drugs &
Cosmetics, Medical
Devices,
Biologicals &
Herbals, and Food
& Nutraceuticals.
For manufacture,
import &
registration, export,
sale, marketing
authorization,
clinical trials and
intellectual
property rights.

M.Pharm REGULATORY This course is 1 GPP,Analytical reports,


Semester -I AFFAIRS designed to impart clinicaltrialprotocol,
PRACTICAL-I the fundamental reports.
(MRA 105P) knowledge on the 2. Comparison between
good brand and generics,
manufacturing BA/BE
practices,quality studies,requirements of
control CTD, IND, ANDA and
tests,stability and NDA submissions.
validation. It 3. Regulatory approval of
prepares the drugs by CDSCO, Indian
student to learn in patent scenario.
detail on BA/BE
studies,CTD,
IND.NDA and
ANDA.
M.Pharm REGULATORY This course is 1.USFDA authorities,IMPD
Semester -I AFFAIRS designed to impart for EU
PRACTICAL-II the fundamental submissions,comparative
(MRA 106P) knowledge on study of regulatory
USFDA warning requirements.
letters,IMPD for 2.Regulatory requirements
EU submissions, for ECTD in EU, US and
Marketing India.
Authorization,DMF 3.Writing validation and
systems in EU, US stability protocols.
and JAPAN.It 4. Compiling of dossier and
prepares the site master file.
students to learn in
detail on CTA,
conduction of
clinical trials and
compiling dossier
and site master file.
M.Pharm REGULATORY This course is 1. The process of drug
Semester -II ASPECTS OF designed to impart discovery and
DRUGS & the fundamental development and generic
COSMETICS knowledge on the product development
(MRA 201T) drug development 2. Regulatory approval
process, regulatory process and registration
requirements for procedures for API and
approval of new drug products in US, EU
drugs, drug 3. Cosmetics regulations in
products and regulated and semi-
cosmetics in regulated countries
regulated and semi- 4. A comparative study of
regulated countries. India with other global
It prepares the regulated markets
students to learn in
detail on the
regulatory
requirements,
documentation
requirements, and
registration
procedures for
marketing the drug
products and
cosmetics in
regulated and semi-
regulated countries.
M.Pharm REGULATORY This course is 1. Regulatory Requirements
Semester -II ASPECTS OF designed to impart for Biologics and
HERBAL AND fundamental Vaccines
BIOLOGICALS knowledge on 2. Regulation for newly
(MRA 202T) Regulatory developed biologics and
Requirements, biosimilar
Licensing and 3. Pre-clinical and clinical
Registration, development
Regulation on considerations of
Labelling of biologics
Biologics in India, 4. Regulatory Requirements
USA and Europe It of Blood and/or Its
prepares the Components Including
students to learn in Blood Products and label
detail on requirements
Regulatory
Requirements for
biologics, Vaccines
and Blood Products
M.Pharm REGULATORY This course is 1.Basics of medical devices
Semester -II ASPECTS OF designed to impart and IVDs, process of
MEDICAL the fundamental development, ethical and
DEVICES knowledge on the quality considerations.
(MRA 203T) medical devices 2. Harmonization initiatives
and in vitro for approval and
diagnostics, basis marketing of medical
of classification devices and IVDs
and product life 3.Regulatory approval
cycle of medical process for medical
devices, regulatory devices and IVDs in
requirements for India, US, Canada, EU,
approval of Japan and ASEAN
medical devices in 4.Clinical evaluation and
regulated countries investigation of medical
like US, EU and devices and IVDs
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.
M.Pharm REGULATORY This course is 1. Regulatory Requirements
Semester -II ASPECTS OF designed to impart for Nutraceuticals.
FOOD & the fundamental 2. Regulation for
NUTRACEUTI knowledge on registration and labelling
CALS Regulatory of Nutraceuticals and
(MRA 204T) Requirements, food supplements in
Registration and India, USA and Europe.
Labelling
Regulations of
Nutraceuticals in
India, USA and
Europe. It prepares
the students to
learn in detail on
Regulatory Aspects
for Nutraceuticals
and food
supplements.

M.Pharm REGULATORY This course is 1. The change controls,


Semester -II AFFAIRS designed to impart deviations,submission to
PRACTICAL- the fundamental EMA, MHRA,and FDA.
III knowledge on 2. Vaccine product
(MRA 205T) Deviations, CAPA, approvals,clinical trial
and submission of applications and
FDA,MHRA,and registration of blood and
EMA.It prepares blood products.
the registration of 3. Comparative study on
blood product and emerging markets of
BLA,comparison WHO and BRICS.
study on emerging
markets and
medical devices
facility.

Class / course Learning Learning outcome


code
LMRA U.S and E.U GMP, GMAP-5,GHTF
GOOD 101T-1 documents
REGULATORY LMRA USFDA regulation process, audits,
PRACTICES 101T-2 documentation, and inspection process.
(MRA 101T) LMRA Principles, documentation, requirements and
101T-3 SOPs of GALP and relevant standards of
M.Pharm ISO.
Semester -I LMRA WHO and US GDP, CDSCO guidance and
101T-4 ISO standards.
LMRA QMS, OOS, validation, HVAC and ICH
101T-5 guidelines
LMRA EPDB, PDP, PDR, records, CoA, DMF and
102T-1 master file.
DOCUMENTATION LMRA CTD, ECTD, NEES, ACTD, SUGAM system
AND 102T-2 of CDSCO.
REGULATORY LMRA Audits its types, preparation, submissions,
WRITING 102T-3 strategies, and timelines of audits.
(MRA 102T) LMRA inspections, drug distribution channels, good
102T-4 manufacturing practices, route cause
M.PharmSemester -I analysis and CAPA
LMRA ICH Q12, life cycle management, FDA
102T-5 inspection and enforcement, warning letters,
recalls, and ISO risk manufacture standards
LMRA Types of clinical studies, phases of studies,
103T-1 clinical evaluation and clinical investigation
CLINICAL LMRA Ethics in clinical research, ICH-GCP, CRO
RESEARCH 103T-2 roles and responsibilities.
REGULATIONS LMRA Clinical research regulations in INDIA, U.S
(MRA 103T) 103T-3 and EUROPE.
LMRA ICH GCP guidelines, CDSCO guidelines
M.Pharm Semester -I 103T-4 ,ICH-E7,E8,E4,E10,E11,ICMR Ethical
Guidelines for Biomedical Research
LMRA USFDA CFR parts and EMA guidance
103T-5 documents of clinical research. FDA Safety
Reporting Requirements for INDs and
BA/BE Studies, FDA Med Watch ,Good
Pharmacovigilance Practices and Pharmaco-
epidemiologic Assessment
LMRA Drug and cosmetic act and rules, schedule M,
REGULATIONS AND 104T-1 NPPA and DPCO. Narcotics act ,magic
LEGISLATION FOR remedies act , Pharmacy act
DRUGS & LMRA regulatory requirements and regulatory
COSMETICS, 104T-2 approval of drugs and cosmetics, herbals
MEDICAL and biologicals, food and Nutraceuticals as
DEVICES, per CDSCO and state licensing authority
BIOLOGICALS & LMRA ISO, Indian pharmacopeia, and BIS standards.
HERBALS, AND 104T-3 Packaging regulations and requirements.
FOOD LMRA BA&BE studies, ICH and WHO guidelines for
&NUTRACEUTICA 104T-4 drug testing.CPCSEA and ICMR guidelines
LS IN INDIA AND for stem cell research.
INTELLECTUAL LMRA Patent, trade mark, copyright, industrial
PROPERTY 104T-5 designs and difference between IPR and
RIGHTS regulatory affairs.
(MRA 104T)
M.Pharm Semester -I
LMRA FDA, CFR, Food Drug and Cosmetic Act,
REGULATORY 201T-1 Hatch Waxman Act, Orange book, Purple
ASPECTS OF book, ANDA, NDA, SNDA, IND, Drug
DRUGS & Master File, Regulatory requirements for
COSMETICS Orphan drugs, Regulations for Import,
(MRA 201T) Manufacture, distribution of sale and
cosmetic in USA and Canada.
M.Pharm Semester -II LMRA Organization and Structure of EMA and
201T-2 EDQM, ASMF system in EU, IMPD,
Marketing Authorization Procedure in EU,
Regulatory consideration for Manufacturing,
labelling and packaging in EU, Compliance
of Human Pharmacopeia/Certificate of
suitability, Legislation and regulations for
Import, Manufacture in EU, Australia
LMRA Emerging Market(Countries Covered, Study
201T-3 of various committees among the world,
Regulatory requirements for registration of
drugs and post approval requirements,
Certificate of Pharmaceutical Product
LMRA Brazil, ASEAN, CIS and CGS Countries
201T-4 (Introduction to ACTD, Regulatory
requirements for drugs and post approval
changes in China, South Korea, and
Association of Southeast Asian Nations i.e.;
Vietnam, Malaysia, Philippines, Singapore,
and Thailand.
LMRA Regulatory Prerequisites related to marketing
201T-5 authorization requirements for drugs and
post approval changes in CIS countries and
GCC countries
LMRA In India , Applicable regulations and
REGULATORY 202T-1 Guidelines, Principles and Post marketing
ASPECTS OF surveillance for development of similar
HERBAL AND biologics, Data requirements for Preclinical
BIOLOGICALS studies, Clinical Trail application, and
(MRA 202T) Market authorization application.
M.Pharm Semester -II LMRA In USA and EU, biological and biosimilar
202T-2 products, difference between generic and
biosimilar, development and approval of
biologics [NDA, IND, PMA, BLA,],
preclinical and clinical considerations.
LMRA Clinical evaluation, market authorization,
202T-3 registration/licensing, quality assessment,
pharmacovigilance, blood and blood product
regulation in India, US and EU
LMRA Regulatory requirements for blood/ its
202T-4 components, label requirements, ISBT, IHN.

LMRA Legislation of Herbal Products in India, US


202T-5 and EU
LMRA Risk based classification and principals of
203T-1 medical devices, IVD’s and combination
REGULATORY products, History of medical device
ASPECTS OF regulation, Product life cycle and
MEDICAL classification of medical devices,
DEVICES IMDRF/GHTF.
(MRA 203T) LMRA Clinical investigation and plan for medical
M.Pharm Semester -II 203T-2 devices, Good clinical practices, ISO
14155:2011, ISO 13485, validation,
verification and adverse reporting of
medical devices.
LMRA Regulatory approval process, 510k, post
203T-3 market approval, IDE and in-vitro
diagnostics, CFR part 820, 801, post
marketing surveillance and unique device
identification in US.
LMRA Regulatory approval process, in-vitro
203T-4 diagnostics, CE certification in EU

LMRA Regulatory registration process, Quality


203T-5 system requirements and clinical evaluation
and investigation, IMDRF and guidance
documents, medical device 2017 regulation
in ASEAN, China and Japan.
LMRA History of Food and Nutraceuticals
REGULATORY 204T-1 regulations, scope and opportunities in
ASPECTS OF FOOD Nutraceuticals market.
AND LMRA WHO guidelines on nutrition, NSF, HACCP.
NUTRACEUTICAL 204T-2
S (MRA 204T) LMRA Food safety and Standards act, Authority,
204T-3 Recommended dietary allowances in India.
M.Pharm Semester -II
LMRA US food safety modernization act, Dietary
204T-4 supplement Health and Education act,
Regulations, Recommended dietary
allowance in US.
LMRA European Food Safety Authority, EU
204T-5 directives and regulations for
manufacturing, sale of Nutraceuticals, EU
regulations on novel foods and food
ingredients, Recommended dietary
allowances in EU.
PHARMACEUTICAL REGULATORY AFFAIRS (MRA)
First Semester
GOOD REGULATORY PRACTICES (MRA 101T)
Unit 1:
Current Good Manufacturing Practices (cGMP): Introduction, US cGMP Part 210 and
Part 211. EC principles of GMP (Directive 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. 12 Hours
Unit 2:
Good Laboratory Practices (GLP): Introduction, USFDA GLP Regulations (Subpart A to
Subpart K). Controlling the GLP inspection process, documentation, audit, goals of
Laboratory Quality Audit, Audit tools. Future of GLP regulations, relevant ISO and Quality
Council of India (QCI) Standards. 12 Hours
Unit 3:
Good Automated Laboratory Practices (GALP): Introduction to GALP, principles of
GALP, GALP requirements, SOPs of GALP, Training Documentation, 21 CFR Part 11,
General check list of 21 CFR Part 11, Software Evaluation checklist, relevant ISO and QCI
Standards. 12 Hours
Unit 4:
Principles, personnel, documentation, premises and equipment, deliveries to customers,
returns, self-inspection, provision of information, stability testing principles, WHO Good
Distribution Practices. USP GDP (Supply chain integrity), relevant CDSCO guidance and
ISO standards. 6 Hours
Unit 5:
Quality management systems: Concept of quality, Total Quality Management, quality by
design, six sigma concept, Out of Specifications (OOS), change controls.
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
Council for Harmonization (ICH) process, ICH guidelines to establish quality, safety and
efficacy of drug substances and products, ISO 13485, Schedule M-III and other relevant
CDSCO regulatory guidance documents.
ICH Guidelines: Emphasis on Q2, Q3, Q7, Q8, Q9, Q10 & Q11 (draft Form) 18 Hours
REFERENCES
1. Good Laboratory Practice Regulations - Sandy Weinberg, 4th ed. Drugs and The
Pharmaceutical Sciences, Vol.168.
2. How to Practice GLP – P.P. Sharma. Vandana Publications.
3. Laboratory Auditing for Quality and Regulatory Compliance - Donald C Singer. Drugs
and The Pharmaceutical Sciences, Vol. 150.
4. Drugs & Cosmetics Act, Rules & Amendments, Government of India.
5. Good Pharmaceutical Manufacturing Practice, Rationale and Compliance - John Sharp.
CRC Press.
6. Establishing a cGMP Laboratory Audit System, A Practical Guide - David M Bleisner.
Wiley.

91
DOCUMENTATION AND REGULATORY WRITING (MRA 102T)
Unit 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 packaging records, print pack specifications,
distribution records, Certificate of Analysis (CoA), site master file and Drug Master Files
(DMF). 12 Hours
Unit 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 modules 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. Pharmaceutical
Inspection & Convention Scheme and Pharmaceutical Inspection & Cooperation Scheme
(PIC/S), ASEAN Pharmaceutical harmonization on initiative. 12 Hours
Unit 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
strategies, preparation and conducting audit, 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 Hours
Unit 4:
Inspections: Pre-approval inspections, inspection of pharmaceutical manufacturers,
inspection of drug distribution channels, 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 Hours
Unit 5:
Product life cycle management: ICH life cycle management (Q12), post approval labeling
changes, lifecycle management, FDA inspection and enforcement, Establishment Inspection
Report (EIR), warning letters, recalls, seizure and injunctions. ISO risk management
standard. 12 Hours
REFERENCES
1. Laboratory Auditing for Quality and Regulatory Compliance - Donald C Singer, Raluca-
loana Stefan & Jacobus F Van Staden. Taylor and Francis, 2005.
2. Handbook of Microbiological Quality Control - Rosamund M Baird, Norman A Hodges
& Stephen P Denyar. CRC Press, 2000.
3. Juran's Quality Handbook - Joseph M Juran & Joseph A De Feo. 6th ed. ASQ
Publications.
4. Compliance Auditing for Pharmaceutical Manufacturers - Karen Ginsbury & Gil
Bismuth. Interpharm/CRC, Boca Raton, London New York, Washington D.C.
5. Pharmaceutical Manufacturing Handbook: Regulations and Quality - Shayne Cox Gad.
Wiley-Interscience, A John Wiley and Sons, Inc., Publications.

92
6. Implementing Juran's Road Map for Quality Leadership: Benchmarks and Results - Al
Endres. Wiley, 2000.
7. Understanding, Managing and Implementing Quality: Frameworks, Techniques and Cases
- Jiju Antony. David Preece, Routledge, 2002.
8. Organizing for High Performance: Employee Involvement, TQM, Reengineering, and
Knowledge Management in the Fortune 1000: The CEO Report - Edward E Lawler III,
Susan Albers Mohrman & George Benson. Jossey-Bass, 2001.
9. Corporate Culture and the Quality Organization - James W Fairfield-Sonn. Quorum
Books, 2000.
10. The Quality Management Sourcebook: An International Guide to Materials and
Resources By Christine Avery & Diane Zabel. Routledge, 1997.
11. The Quality Toolbox - Nancy R Tague. 2nd ed. ASQ Publications.
12. Root Cause Analysis, The Core of Problem Solving and Corrective Action - Duke Okes.
ASQ Publications.
13. International Medical Device Regulators Forum (IMDRF) Medical Device Single Audit
Program (MDSAP).
CLINICAL RESEARCH REGULATIONS (MRA 103T)
Unit 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
endpoints. 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 - PMS), 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 Hours
Unit 2:
Ethics in clinical research: Historical perspectives: 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 ongoing 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 Hours
Unit 3:
Regulations governing clinical trials in India: Clinical research regulations in India –
Schedule Y & Medical Device Guidance USA: Regulations to conduct drug studies in USA
(FDA). NDA505(b)(1) of the FD&C Act (Application for approval of a new drug)
NDA505(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 Hours

93
Unit 4:
Clinical research related guidelines: Good Clinical Practice Guidelines (ICHGCP 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 biostatistics principle applied in
clinical research. 12 Hours
Unit 5:
USA & EU Guidance: FDA Guidance. CFR 21 Part 50: Protection of human subjects. CFR
21 Part 54: Financial disclosure by clinical investigators. CFR 21 Part 312: IND Application.
CFR 21 Part 314: Application for FDA Approval to market a new drug. CFR 21 Part 320:
Bioavailability and bioequivalence requirements. CFR 21 Part 812: Investigational device
exemptions. CFR 21 Part 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 Hours
REFERENCES
1. Clinical Trials and Human Research: A Practical Guide to Regulatory Compliance - Fay A
Rozovsky & Rodney K Adams.
2. FDA Regulatory Affairs: a Guide for Prescription Drugs, Medical Devices, and Biologics
- Douglas J Pisano & David Mantus. CRC Press, USA.
3. New Drug Approval Process: The Global Challenge – Guarino & A. Richard. Marcel
Dekker Inc.
4. HIPAA and Human Subjects Research: A Question and Answer Reference Guide - J.D.
Mark Barnes & J.D. Jennifer Kulynych.
5. Principles and Practices of Clinical Research, John I Gallin & Frederick P Ognibene. 2nd
ed.
6. Reviewing Clinical Trials: A Guide for the Ethics Committee - Johan P E Karlberg &
Marjorie A Speers. Hong Kong.
7. International Pharmaceutical Product Registration: Aspects of Quality, Safety and
Efficacy - Anthony C Cartwright. Taylor & Francis Inc., USA.
REGULATIONS AND LEGISLATION FOR DRUGS & COSMETICS, MEDICAL
DEVICES, BIOLOGICALS, HERBALS, FOOD & NUTRACEUTICALS IN INDIA
AND INTELLECTUAL PROPERTY RIGHTS (MRA 104T)
Unit 1:
Drugs Biologicals & Herbals, and Food & Nutraceuticals Acts and Rules (with latest
amendments): 1) Drugs and Cosmetics Act 1940 and Rules 1945: Schedule M, DPCO &
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: Narcotic Drugs and Psychotropic Substances Act; Pharmacy Act, 1948;
Drugs and Magic Remedies (Objectionable Advertisements) Act, 1955; Prevention of Cruelty
to Animals Act. 12 Hours

94
Unit 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 Hours
Unit 3:
Indian Pharmacopoeial Standards, BIS standards and ISO and other relevant standards.
Regulations for packaging material, packaging requirements & labeling requirements as per
Rules 94, 95, 96, 97 & 105 D& C Rules 1945. 12 Hours
Unit 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 Hours
Unit 5:
Intellectual property rights: Patent, trademark, copyright, industrial designs and
geographical indications, Indian patent scenario, IPR vs regulatory affairs. 12 Hours
REFERENCES
1. Manual of Patent Practice & Procedure - The Patent Office of India. 3rd ed.
2. Patent Failure How Judges, Bureaucrats, and Lawyers put Innovators at Risk - James
Bessen & Michael J Meurer.
3. Principles and Practice of Clinical Trial Medicine - Richard Chin & Bruce Y. Lee.
4. Ethical Guidelines for Biomedical Research on Human Participants - Indian Council of
Medical Research, New Delhi, 2006.
5. CPCSEA Guidelines for Laboratory Animal Facility by Committee for the Purpose of
Control and Supervision on Experiments on Animals (CPCSEA).
6. ICH E6 Guidelines ― Good Clinical Practice - 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).
9. Guidance for Industry on Requirement of Chemical & Pharmaceutical Information
including Stability Study Data before approval of clinical trials / BE studies by CDSCO.
10. Guidelines for Import and Manufacture of Medical Devices – CDSCO.
11. Guidelines from official website of CDSCO.
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

95
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 as per ICH CTD format
REGULATORY AFFAIRS PRACTICAL – II (MRA 106P)
1. Case studies on response with scientific rationale to USFDA Warning Letter
2. Preparation of submission check list of IMPD for EU submission
3. Comparison study of marketing authorization procedures in EU
4. Comparative study of DMF system in US, EU and Japan
5. Preparation of regulatory submission using eCTD software
6. Preparation of Clinical Trial Application (CTA) for US submission
7. Preparation of Clinical Trial Application (CTA) for EU submission
8. Comparison of Clinical Trial Application requirements of US, EU and Japan of a dosage
form
9. Regulatory requirements check list for conducting clinical trials in India
10. Regulatory requirements check list for conducting clinical trials in Europe
11. Regulatory requirements check list for conducting clinical trials in USA
12. Writing Stability Protocols as per ICH
13. Writing Validation Protocol of Water & AHU Systems
14. Writing & Compiling a Dossier
15. Writing & Compiling Site Master File
Second Semester
REGULATORY ASPECTS OF DRUGS & COSMETICS (MRA 201T)
Unit 1:
USA & Canada: Organization and functions of FDA. Federal register and Code of 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 for 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. Regulatory
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 Hours
Unit 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,
decentralized procedure, mutual recognition procedure and national procedure). Regulatory
considerations for manufacturing, packaging and labeling of pharmaceuticals in EU, Eudralex
directives for human medicines, variations & extensions, compliance of European
96
Pharmacopoeia (CEP)/Certificate of Suitability (CoS), Marketing Authorization (MA)
transfers, Qualified Person (QP) in EU. Legislation and regulations for import, manufacture,
distribution and sale of cosmetics in European Union & Australia. 12 Hours
Unit 3:
Emerging market: Introduction, countries covered, study of the world map, study of various
committees across the globe (ASEAN, APEC, EAC, GCC, PANDRH, SADC). 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 (India, South Africa, Egypt, Algeria and Morocco, Nigeria, Kenya and
Botswana. 12 Hours
Unit 4:
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. 12 Hours
Unit 5:
CIS (Commonwealth Independent States): Regulatory prerequisites related to marketing
authorization requirements for drugs and post approval requirements in CIS countries i.e.
Russia, Kazakhstan and Ukraine and sale of cosmetics in Brazil, ASEAN, CIS and GCC
Countries. 12 Hours
REFERENCES
1. Generic Drug Product Development: Solid Oral Dosage Forms - Leon Shargel. Marcel
Dekker Series, Vol. 143.
2. The Pharmaceutical Regulatory Process - Ira R Berry. Marcel Dekker Series, Vol.144.
3. Guidebook for Drug Regulatory Submissions - Sandy Weinberg. John Wiley & Sons. Inc.
4. New Drug Approval Process: Accelerating Global Registrations - Richard A Guarino,
Vol 190. 5th ed. Drugs and the Pharmaceutical Sciences.
5. Drugs and the Pharmaceutical Sciences. Vol.185. Informa Health Care Publishers.
6. Drugs: From Discovery to Approval – N.G. Rick. 2nd ed.
7. New Drug Development: A Regulatory Overview - Mark Mathieu. 8th ed.
8. Pharmaceutical Risk Management - Jeffrey E Fetterman, Wayne L Pines & Gary H
Slatko.
9. Preparation and Maintenance of the IND Application in eCTD Format - William K
Sietsema.
10. http://www.who.int/medicines/areas/quality_safety/regulation_legislation/List
MRAWebsites
11. Roadmap to an ASEAN economic community - Denis Hew. ISEAS Publications.
Singapore, 2005.
12. ASEAN - Rodolfo C. Severino. ISEAS Publications, Singapore.
13. Building a Future with Brics: The Next Decade for Offshoring - Mark Kobayashi-Hillary.
14. Outsourcing to India: The Offshore Advantage - Mark Kobayashi-Hillary. Springer Trade
Performance and Regional Integration of the CIS Countries - Lev Freinkman.
15. The World Bank, Washington DC.
16. Global Pharmaceutical Policy: Ensuring Medicines for Tomorrow's World - Frederick M
Abbott & Graham Dukes. Edward Elgar Publishing Inc.
17. The Gulf Cooperation Council: A Rising Power and Lessons for ASEAN by Linda Low
97
& Lorraine Carlos Salazar. ISEAS Publishing.
18. Doing Business in the Asean Countries - Balbir Bhasin. Business Expert Press.
19. Realizing the ASEAN Economic Community: A Comprehensive Assessment - Michael G
Plummer & Chia Siow Yue. Published by Institute of Southeast Asian studies, Singapore.
20. Country Specific Guidelines from official websites.
REGULATORY ASPECTS OF HERBAL AND BIOLOGICS (MRA 202T)
Unit 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 Hours
Unit 2:
USA & European Union: Introduction to biologics; biologics, biological and biosimilar,
different biological products, difference between generic drug and biosimilars, laws,
regulations and guidance on biologics/biosimilars, development and approval of biologics
and biosimilars (IND, PMA, BLA, NDA, 510(k), pre-clinical and clinical development
considerations, advertising, labeling and packing of biologics in USA and EU. 12 Hours
Unit 3:
Vaccine regulations in India, US and European Union: Clinical evaluation, marketing
authorization, registration or licensing, quality assessment, pharmacovigilance, additional
requirements. Blood and blood products regulations in India, US and European Union.
12 Hours
Unit 4:
Regulatory Requirements of Blood and/or its components including blood products, label
requirements, ISBT (International Society of Blood Transfusion) and IHN (International
Haemo vigilance Network). 12 Hours
Unit 5:
Herbal Products: Quality, safety and legislation for herbal products in India, USA and
European Union. 12 Hours
REFERENCES
1. FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and
Biologics - Douglas J. Pisano & David S Mantus. Taylor and Francis, 2008.
2. Biological Drug Products: Development and Strategies - Wei Wang. Wiley, 2013.
3. Development of Vaccines: From Discovery to Clinical Testing - Manmohan Singh.
Wiley, 2011.
4. www.who.int/biologicals/en
5. www.fda.gov/Biologics Blood Vaccines/Guidance Compliance Regulatory Information/
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

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REGULATORY ASPECTS OF MEDICAL DEVICES (MRA 203T)
Unit 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 Life cycle of
medical devices and classification of medical devices.
IMDRF/GHTF: Introduction, organizational structure, purpose and functions, regulatory
guidelines, working groups, Summary Technical Document (STED), Global Medical Device
Nomenclature (GMDN). 12 Hours
Unit 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 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 Hours
Unit 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). Post marketing surveillance of MD and Unique Device
Identification (UDI). Basics of in vitro diagnostics, classification and approval process.
12 Hours
Unit 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 Hours
Unit 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. Medical Devices Act, 2017 Regulations. 12 Hours
REFERENCES
1. Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices -
John J Tobin & Gary Walsh.
2. Medical Device Development: A Regulatory Overview - Jonathan S Kahan.
3. Compliance Handbook for Pharmaceuticals, Medical Devices and Biologics - Carmen
Medina.
4. Country Specific Guidelines from official websites.
REGULATORY ASPECTS OF FOOD AND NUTRACEUTICALS (MRA 204T)
Unit 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 Hours
Unit 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

99
dietary supplements. Good Manufacturing Practices for nutraceuticals, Hazard Analysis &
Critical Control Point (HACCP). 12 Hours
Unit 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 Hours
Unit 4:
USA: US FDA Food Safety Modernization Act, Dietary Supplement Health and Education
Act. U.S. regulations for manufacture and sale of nutraceuticals and dietary supplements.
Labeling requirements and label claims for dietary supplements, Recommended dietary
allowances (RDA) in the U.S. 12 Hours
Unit 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 labeling. European regulation on novel foods and novel food ingredients.
Recommended dietary allowances (RDA) in Europe. 12 Hours
REFERENCES
1. Regulation of Functional Foods and Nutraceuticals: A Global Perspective - Clare M
Hasler. Wiley Online Library.
2. Nutraceutical and Functional Food Regulations in the United States and Around the
World - 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/IPOLSTU
(2015)536324_EN.pdf
5. Handbook of Nutraceuticals - Yashwant Pathak. CRC Press.
6. Food Regulation: Law, Science, Policy and Practice - Neal D Fortin. Wiley.
7. Country Specific Guidelines from official websites.
REGULATORY AFFAIRS PRACTICAL – III (MRA 205P)
Case studies on:
1. Change Management/ Change control. Deviations
2. Corrective & Preventive Actions (CAPA)
3. Documentation of raw materials analysis as per official monographs
4. Preparation of audit checklist for various agencies
5. Preparation of submission to FDA using eCTD software
8. Preparation of submission to EMA using eCTD software
9. Preparation of submission to MHRA using eCTD software
10. Preparation of Biologics License Applications (BLA)
11. Preparation of documents required for Vaccine Product Approval
12. Comparison of clinical trial application requirements of US, EU and India of Biologics.
13. Preparation of Check list for Registration of Blood and Blood Products
14. Registration requirement comparison study in 5 emerging markets (WHO) and preparing
check list for market authorization
15. Registration requirement comparison study in emerging markets (BRICS) and preparing
check list for market authorization

100
16. STED Application for Class III Devices
17. Audit Check list for Medical Device Facility
18. Clinical Investigation Plan for Medical Devices.

101
Third Semester
RESEARCH METHODOLOGY & BIOSTATISTICS (MRM 301T)
(Note: Common Paper for all specializations)
Unit 1:
General research methodology: Research, objective, requirements, practical difficulties,
review of literature, study design, types of studies, strategies to eliminate errors/bias,
controls, randomization, crossover design, placebo, blinding techniques. 12 Hours
Unit 2:
Biostatistics: Definition, application, sample size, importance of sample size, factors
influencing sample size, dropouts, statistical tests of significance, type of significance tests,
parametric tests (students “t” test, ANOVA, Correlation coefficient, regression), non-
parametric tests (Wilcoxan rank tests, analysis of variance, correlation, Chi-square test), null
hypothesis, P values, degree of freedom, interpretation of P values. 12 Hours
Unit 3:
Medical Research: History, values in medical ethics, autonomy, beneficence, non-
maleficence, double effect, conflicts between autonomy and beneficence/non-malfeasance,
euthanasia, informed consent, confidentiality, criticisms of orthodox medical ethics,
importance of communication, control resolution, guidelines, ethics committees, cultural
concerns, truth telling, online business practices, conflicts of interest, referral, vendor
relationships, treatment of family members, sexual relationships, fatality. 12 Hours
Unit 4:
CPCSEA guidelines for laboratory animal facility: Goals, veterinary care, quarantine,
surveillance, diagnosis, treatment and control of disease, personal hygiene, location of animal
facilities to laboratories, anesthesia, euthanasia, physical facilities, environment, animal
husbandry, record keeping, SOPs, personnel and training, transport of lab animals. 12 Hours
Unit 5:
Declaration of Helsinki: History, introduction, basic principles for all medical research, and
additional principles for medical research combined with medical care. 12 Hours
REFERENCES
1. Pharmaceutical Statistics: Practical and Clinical Applications - Stanford Bolton & Charles
Bon. 5th ed. CRC Press.
2. Biostatistics: A Foundation for Analysis in the Health Sciences - Wayne W Daniel. 10th
ed. John Wiley & Sons.
3. Introduction to Research in the Health Sciences - Stephen Polgar & Shane Thomas. 7th ed.
Elsevier.
4. www.cpcsea.nic.in
5. www.wma.net

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