M.Pharm.(Pharmaceutics-Drug Regulatory Affairs)

ACADEMIC

REGULATIONS

&

SYLLABUS

Faculty of Pharmacy

Master of Pharmacy Programme [Pharmaceutics (Drug Regulatory Affairs)]

From Academic Year–2013-14

Page 2 of 47

CHAROTAR UNIVERSITY OF

SCIENCE & TECHNOLOGY

Education Campus – Changa, (ECC), hitherto a conglomerate of institutes of professional education

in Engineering, Pharmacy, Computer Applications, Management, Applied Sciences, Physiotherapy

and Nursing, is one of the choicest destinations by students. It has been transformed into Charotar

University of Science and Technology (CHARUSAT) through an Act by Government of Gujarat.

CHARUSAT is permitted to grant degrees under Section-22 of UGC- Govt. of India.

The journey of CHARUSAT started in the year 2000, with only 240 Students, 4 Programmes, one

Institute and an investment of about Rs. 3 Crores (INR 30 million). At present there are seven

different institutes falling under ambit of six different faculties. The programmes offered by these

faculties range from undergraduate (UG) to Ph.D degrees including M.Phil. These faculties, in all

offer 32 different programmes. A quick glimpse in as under:

Faculty Institute Programmes

Offered

Faculty of Technology & Engineering

Chandubhai S. Patel Institute of

Technology B.Tech

M.Tech

Ph.D Faculty of Pharmacy Ramanbhai Patel College of Pharmacy B.Pharm

M.Pharm

Ph.D Faculty of Management Studies Indukaka Ipcowala Institute of

Management M.B.A

PGDM

Ph.D Faculty of Computer Applications

Smt. Chandaben Mohanbhai Patel

Institute of Computer Applications M.C.A.

M.Sc.(IT)

Ph.D Faculty of Applied Sciences P. D. Patel Institute of Applied Sciences M.Sc

M.Phil

Ph.D Faculty of Medical Sciences Charotar Institute of Physiotherapy

Manikaka Topawala Institute of Nursing

B.PT

B.Sc (Nursing)

G.N.M.

Page 3 of 47

The development and growth of the institutes have already led to an investment of over Rs.80 crores

(INR 800 Million). The future outlay is planned with an estimate of Rs. 250 Crores (INR 2500

Million).

The University is characterized by state-of-the-art infrastructural facilities, innovative teaching

methods and highly learned faculty members. The University Campus sprawls over 105 acres of land

and is Wi-Fi enabled. It is also recognized as the Greenest Campus of Gujarat.

CHARUSAT is privileged to have 350 core faculty members, educated and trained in IITs, IIMs and

leading Indian Universities, and with long exposure to industry. It is also proud of its past students

who are employed in prestigious national and multinational corporations.

From one college to the level of a forward-looking University, CHARUSAT has the vision of entering

the club of premier Universities initially in the country and then globally. High Moral Values like

Honesty, Integrity and Transparency which have been the foundation of ECC continue to anchor

the functioning of CHARUSAT. Banking on the world class infrastructure and highly qualified and

competent faculty, the University is expected to be catapulted into top 20 Universities in the coming

five years. In order to align with the global requirements, the University has collaborated with

internationally reputed organizations like Pennsylvania State University – USA, University at

Alabama at Birmingham – USA, Northwick Park Institute –UK, ISRO, BARC, etc.

CHARUSAT has designed curricula for all its programmes in line with the current international

practices and emerging requirements. Industrial Visits, Study Tours, Expert Lectures and Interactive

IT enabled Teaching Practice form an integral part of the unique CHARUSAT pedagogy.

The programmes are credit-based and have continuous evaluation as an important feature. The

pedagogy is student-centred, augurs well for self-learning and motivation for enquiry and research,

and contains innumerable unique features like:

• Participatory and interactive discussion-based classes. • Sessions by visiting faculty members drawn from leading academic institutions and industry.

• Regular weekly seminars. • Distinguished lecture series.

• Practical, field-based projects and assignments. • Summer training in leading organizations under faculty supervision in relevant programmes.

• Industrial tours and visits.

• Extensive use of technology for learning. • Final Placement through campus interviews.

Exploration in the field of knowledge through research and development and comprehensive

industrial linkages will be a hallmark of the University, which will mould the students for global

assignments through technology-based knowledge and critical skills.

Page 4 of 47

The evaluation of the student is based on grading system. A student has to pursue his/her programme

with diligence for scoring a good Cumulative Grade Point Average (CGPA) and for succeeding in the

chosen profession and life.

CHARUSAT welcomes you for a Bright Future

Page 5 of 47

CHAROTAR UNIVERSITY OF SCIENCE AND TECHNOLOGY

Faculty of Pharmacy

ACADEMIC REGULATIONS

M. Pharm. [Pharmaceutics (Drug Regulatory Affairs)] Programme

Charotar University of Science and Technology (CHARUSAT)

CHARUSAT Campus, At Post: Changa – 388421, Taluka: Petlad, District: Anand

Phone: 02697-247500, Fax: 02697-247100, Email: [email protected]

www.charusat.ac.in

From Academic Year–2013-14

Page 6 of 47

CHARUSAT

FACULTY OF PHARMACY

ACADEMIC REGULATIONS


To ensure uniform system of education, duration of post graduate programmes, eligibility criteria

for and mode of admission, credit load requirement and its distribution between courses and

system of examination and other related aspects, following academic rules and regulations are

recommended.

1. System of Education

The Semester system of education should be followed across The Charotar University of Science

and Technology (CHARUSAT) at Master’s levels. Each semester will be at least of 90 working

days duration. Every enrolled student will be required to take a specified load of course work in

the chosen subject of specialization and also complete a project/dissertation if any.

2. Duration of Programme

Postgraduate programme (M.Pharm)

Minimum 4 semesters (2 academic years)

Maximum 6 semesters (3 academic years)

Maximum limit can be extended by one or two semesters subject to approval of University on

case to case basis.

3. Eligibility for admissions

As decided from time to time by the Government of Gujarat and CHARUSAT

4. Mode of admissions

As decided from time to time by the Government of Gujarat and CHARUSAT

5. Programme structure and Credits

A student admitted to a program should study the courses and earn credits specified in

the course structure. Please refer detailed syllabus.

Page 7 of 47

6. Attendance

All activities prescribed under these regulations and listed by the course faculty members in

their respective course outlines are compulsory for all students pursuing the M. Pharm.

programme. No exemption will be given to any student from attendance except on account of

serious personal illness or accident or family calamity that may genuinely prevent a student

from attending a particular session or a few sessions. However, such unexpected absence

from classes and other activities will be required to be condoned by the Principal.

Student attendance in a course should be 80%.

7. Course Evaluation

7.1 The performance of every student in each course will be evaluated as follows:

7.1.1. Internal evaluation by the course faculty member (s) based on continuous assessment,

for 30% of the marks for the course; and

7.1.2 Final examination by the University through written paper or practical test or oral test

or presentation by the student or a combination of any two or more of these, for 70%

of the marks for the course.

7.1.3 Theory and Practical component of the same course shall be considered as separate

courses.

7.2 Internal Evaluation (Theory)

The distribution of marks for calculating the internal marks in every course of theory shall be:

Test * 20 Marks

Seminar/quiz/viva 10 Marks

___________________________________________________________________________

Total 30 Marks

* One test (60 marks, 2.5 hours duration) shall be conducted as per the schedule to be

notified by the institute for every course in a semester.

7.3. Internal evaluation (Practicals)

The distribution of marks for calculating the internal marks in every course of practical shall

be:

Performance of the exercises * 15 Marks

Viva 10 Marks

Quiz 05 Marks

Total 30 Marks

Page 8 of 47

*One test (60 marks, 6 hours duration) shall be conducted as per the schedule to be notified

by the Institute for every course of practical in a semester.

7.4 University Examination

7.4.1 The final examination by the University for 70% of the evaluation for the course will

be through written paper or practical test or oral test or presentation by the student

or a combination of any two or more of these.

In order to earn the credit in a course a student has to obtain grade other than FF.

7.5 Performance at University Examination

7.5.1 Minimum performance with respect to university examination as well as overall

(university + internal) will be an important consideration for passing a course.

Details of minimum percentage of marks to be obtained in the examinations are as

follows:

Minimum marks in University

Examination for every course

Minimum marks Overall (internal +

university examination) for every

course

40% 50%

7.5.2 If a candidate obtains minimum required marks per course in university examination

but fails to obtain minimum required overall marks, he/she has to repeat the

university examination till the minimum required overall marks are obtained.(As per

the clause 7.5.1)

8. Grading

8.1 The total of the internal evaluation marks and final University examination marks in each

course will be converted to a letter grade as well as to a ten-point scale as per the following

scheme:

Grading Scheme:

Range of Marks (%) ≥80 <80

≥75

<75

≥70

<70

≥65

<65

≥60

<60

≥55

<55

≥50

<50

Letter Grade AA AB BB BC CC CD DD FF

Grade Point 10 9 8 7 6 5 4 0

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8.2 The student’s performance in any semester will be assessed by the Semester Grade Point

Average (SGPA). Similarly, his/her performance at the end of two or more consecutive

semesters will be denoted by the Cumulative Grade Point Average (CGPA). The SGPA and

CGPA are defined as follows:

(i) SGPA = ∑ Ci Gi / ∑ Ci where Ci is the number of credits of course i

Gi is the Grade Point for the course i

and i = 1 to n, n = number of courses in the semester

(ii) CGPA = ∑ Ci Gi / ∑ Ci where Ci is the number of credits of course i

Gi is the Grade Point for the course i

and i = 1 to n, n = number of courses of all semesters

up to which CGPA is computed.

No student will be allowed to move further if CGPA is less than 3 at the end of every

academic year.

9. Award of Degree

9.1 Every student of the programme who fulfils the following criteria will be eligible for the

award of the degree:

9.1.1 He/She should have earned at least minimum required credits as prescribed in course

structure; and

9.1.2 He/She should have cleared all external and overall evaluation components in every

course; and

He/She should have secured a minimum CGPA of 5.0 at the end of the programme;

In addition to above, the student has to complete the required formalities as per the

regulatory bodies, if any.

9.2 The student who fails to satisfy minimum requirement of CGPA will be allowed to improve

the grades so as to secure a minimum CGPA for award of degree. Only latest grade will be

considered.

10. Award of Class

The class awarded to a student in the programme is decided by the final CGPA as per the

following scheme:

Distinction: CGPA ≥ 7.5

First class: CGPA≥ 6.0 & <7.5

Second Class: CGPA≥ 5.0 & <6.0

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11. Transcript

The transcript issued to the student at the time of leaving the University will contain a

consolidated record of all the courses taken, credits earned, grades obtained, SGPA,CGPA,

class obtained, etc.

Page 11 of 47


M. PHARM [Pharmaceutics (Drug Regulatory Affairs)]

1st Semester Scheme of Teaching

Course Contact Hours/Week Credits

Sr. No.

Name

Theory

Seminar

Practical

Total

Theory+ Seminar

Practical

Total

PH819.01 Basic Analytical Techniques

4 -- -- 4 4 -- 4

PH819.02 Biopharmaceutics & Pharmacokinetics

4 -- -- 4 4 -- 4

PH820.01 Pharmaceutical Formulation Development

4 1 -- 5 5 -- 5

PH820.02 Drug Regulatory Affairs-I 4 1 -- 5 5 -- 5

PH820.03 Drug Regulatory Affairs Practical-I

-- -- 6 6 -- 3 3

PH820.04 Drug Regulatory Affairs Practical-II

-- -- 6 6 -- 3 3

PH824.01 Scientific Communication

-- -- 3 3 -- 1 1

PH824.02 Community services-I

-- -- 3 3 -- 1 1

Total 16 2 18 36 18 8 26

Total Credits of 1st

semester: 26

Scheme of Evaluation

Course Theory Practical

Sr. No.

Name

University

Institute

Total

University

Institute

Total Test Seminar

PH819.01 Basic Analytical Techniques 70 30 -

- 100 -- -- --

PH819.02 Biopharmaceutics &

Pharmacokinetics

70 30

--

100 -- -- --

PH820.01 Pharmaceutical Formulation Development

70

20

10

100 -- -- --

PH820.02 Drug Regulatory Affairs-I

70 20

10

100 -- -- --

PH820.03 Drug Regulatory Affairs

Practical-I --

-

- --

-

-

70

30

100

PH820.04 Drug Regulatory Affairs Practical-II

-- --

-- --

70

30

100

PH824.01 Scientific Communication

-- --

-- --

-- 50 50

PH824.02 Community services-I -- --

-- --

-- 50 50

Total 280

100 20

400 140 160 300

Total marks of 1st

semester: 700

Page 12 of 47



SEMESTER II

Scheme of Teaching


Sr. No. Name

Theory

Seminar

Practical

Project Total

Theory+ Seminar

Practical+ Project

Total

PH824.03 Research methodology& IPR 4 -- -- -- 4 4 -- 4

PH819.07 GMP,QA & Process Validation 4 -- -- -- 4 4 -- 4

PH820.05 Drug Regulatory Affairs-II 4 1

-

-- 5 5

--

5

PH820.06 Drug Regulatory Affairs-III 4 1 --

-- 5

5 -- 5

PH820.07 Drug Regulatory Affairs Practical-III

-- - 6 -- 6 -- 3 3

PH820.08 Drug Regulatory Affairs Practical-IV

-- -- 6 -- 6 -- 3 3

PH824.04 Community services-II -- -- 3 -- 3 -- 1 1

PH820.09 Dissertation part -I -- -- -- 3 3 -- 3 3

Total 16 2 15 3 36 18 10 28

Total Credits of 2nd semester: 28


Course Theory Practical

Sr. No.

Name

University Institute

Total

University

Institute

Total Test Seminar

PH824.03 Research methodology &IPR 70 30 -- 100 -- -- --

PH819.07 GMP,QA & Process Validation 70

30

--

100 -- -- --

PH820.05 Drug Regulatory Affairs-II 70

20

10

100 -- -- --

PH820.06 Drug Regulatory Affairs-III 70

20

10

100 -- -- --

PH820.07 Drug Regulatory Affairs Practical-III

-- ---

-- --

70

30 100

PH820.08 Drug Regulatory Affairs Practical-IV

-- -- -- --

70

30 100

PH824.04 Community services-II -- -- -- --

--

50

50

PH820.09 Dissertation part-I -- -- -- --

--

50

50

Total 280 100 20 400 140 160 300

Total marks of 2nd semester: 700

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SEMESTER III

Scheme of Teaching


Sr. No. Name Theory Practical Project Total Theory Practical Project Total

PH920.01 Dissertation Part-II -- -- 36 36 -- -- 25 25

Total -- -- 36 36 -- -- 25 25

Total credits: 25


Course

Theory Practical Project

University Institute Total University Institute Total University Institute Total

Sr. No. Name

PH920.01 Dissertation Part-II -- -- -- -- -- -- 150 100 250

Total -- -- -- -- -- -- 150 100 250

Total marks of 3rd semester : 250

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SEMESTER IV

Scheme of Teaching

Part I: 10 weeks


Sr. No. Name Theory Practical Project Total Theory Practical Project Total

PH920.02 Dissertation Part-III -- -- 36 36 -- -- 25 25

Part II: 5 Weeks

PH920.03 Industrial Training -- -- -- -- -- -- 2 2

Total -- -- -- -- -- -- 27 27

Total Credit :27


Course

Theory Practical Project

University Institute Total University Institute Total University Institute Total

Sr. No. Name

PH920.02 Dissertation

Part-III -- -- -- -- -- -- 150 100 250

PH920.03 Industrial

Training -- -- -- -- -- -- -- 50 50

Total -- -- -- -- -- -- 150 150 300

Total Marks of 4th Semester : 300

Page 15 of 47


SYLLABI (Semester – 1)


Page 16 of 47

SEMESTER-I BASIC ANALYTICAL TECHNIQUES (PH819.01)

Credits: 4 Theory Contact hrs per week: 4

Objective of the Course:

To make students familiar with the principles of basic analytical techniques and its application in pharmacy.

Student Learning Outcomes/Objectives:

At the end of the course, the student will be able to understand the fundamental concept of basic analytical

techniques, which is important for qualitative as well as quantitative analysis of drug substances and drug product.

Instructional Methods and Pedagogy:

Faculty member/s shall explain in a class room using black board and multimedia projector.

Outline of the Course:

No.

Minimum No.

of Contact Hours

Approx.

Weightage %

Unit I 30 50

1 Spectroscopic techniques 15 25

2 Chromatographic techniques 15 25

Unit II 30 50

4 Thermal Methods of Analysis 8 13

5 X-Ray Diffraction Methods 6 11

6 Miscellaneous Analytical Methods 4 6

7 Impurity profiling of pharmaceuticals 4 7

8 Analytical Method Validation 5 8

9 Reference standards 3 5

Total 60 100

Page 17 of 47

Detailed Syllabus (Theory):

No. Unit Details Hrs.

Unit I

1. Spectroscopic techniques: Introduction, basic principle, instrumentation (components and their

function), sampling techniques, interpretation of spectra and applications of following

Spectroscopic techniques; UV – Visible spectroscopy, Infrared spectroscopy, Nuclear Magnetic

Resonance Spectroscopy and Mass Spectroscopy.

15

2. Chromatographic techniques: Classification of chromatographic methods based on mechanism of

separation. Theories of chromatographic separation. Principles, elution techniques,

instrumentation, derivatization and application of GC, HPLC, HPTLC. Principles, elution

techniques, applications of ion exchange and ion pair chromatography, affinity chromatography,

Size exclusion chromatography, chiral chromatography, super fluid chromatography (SFC), GC-

MS, short column chromatography, flash chromatography, medium pressure LC and LC-MS.

15

Unit II

4. Thermal Methods of Analysis: Theory, instrumentation and application of thermogravimetric

analysis (TGA), Differential Thermal Analysis (DTA), Differential Scanning Calorimetry (DSC) and

Thermo Mechanical Analysis (TMA).

8

5. X-Ray Diffraction Methods: Introduction, generation of X-rays, X-ray diffraction, Bragg’s Law,

single crystal and powder X-ray diffraction, interpretation of diffraction pattern and applications. 6

6. Miscellaneous Analytical Methods

a) Electrophoresis: Theory and principles, classifications, instrumentation and

applications.

b) Microscopic techniques: Theory, principle and applications of following ; optical

microscopy, scanning electron microscopy, transmission electron microscopy, hot stage

microscopy, fluorescence microscopy, magnetic force microscopy, atomic force

microscopy.

4

7. Impurity profiling of pharmaceuticals : Introduction, methods for identification, application 4

8. Analytical Method Validation: Basis concepts for development and validation of analytical and bio

analytical method. 5

9. Reference standards source, preparation, characterization, usage, storage and records. 3

Recommended study materials: (Latest edition of the books should be referred)

1. Principles of Instrumental Analysis, Skoog, Hollar and Nieman, Saunders College Publishers, Philadelphia.

2. Instrumental Methods of Analysis, Willard, Merritt, Dean and Settle, CBS publishers and Distributers, Delhi.

3. Instrumental Methods of Chemical Analysis, G. W. Ewing, McGraw Hill Book Co, NY.

Page 18 of 47

4. Instrumental Methods of Chemical Analysis, B.K. Sharma, Goel Publication House, Meerut, India. 5. United States Pharmacopoeia-27(NF-22), 2004, United State of Pharmacoppeal convention,

INC,12601 Twinbrook Parkway, Rockville, MD 20852. 6. British Pharmacopoeia, 2004, The British Pharmacopoeia commission office, Market Tower, Nine Elms

Lane, London. 7. Indian Pharmacopoeia-2007, Indian pharmacopoeia commission, Sector-23, Raj Nagar, Ghaziabad. 8. Remington’s Pharmaceutical Sciences, J. P. Remington, Mack Pub. Co., Pennsylvania. 9. Statistics for Analytical Chemists, T Caulcutt and R. Boddy, Chapman & Hall, London. 10. Modern Methods of Pharmaceutical Analysis, Vol 1, 2, RE Schirmer, Franklin Book Co, PA. 11. Spectroscopic identification of organic compounds. R.M. Silverstein, G.C. Bassler, T.C. Morrill, Pub:

John Wiley and Sons, NY. 12. Spectroscopic identification of organic compounds. John Dyer, Willy, NY. 13. Organic Spectroscopy W. Kemp, NY. 14. NMR spectroscopy (Basic Principles, concepts and application in Chemistry) Herald Gunther,

(JohnWiley and Sons), NY. 15. Fundamentals of Mathematical Statistics, S.C. Gupta and V.K. Kapoor (Sulthyan Chand and Sons),

New Delhi. 16. Pharmaceutical Analysis – Modern Methods – Part A, Part B, J. W. Munson, Marcel Dekker, NY. 17. Practical Pharmaceutical Chemistry, Part two, edited by A. H. Beckett & J. B. Stenlake 18. Identification of Drugs and Pharmaceutical Formulations by Thin Layer Chromatography, 2nd

Edition, 19. P. D. Sethi, CBS Publishers and Distributers, New Delhi. 20. HPTLC – Quantitative Analysis of Pharmaceutical Formulations – P. D. Sethi, CBS Publishers and

Distributers, New Delhi. 21. Stereo Chemistry – Conformation and Mechanism by P. S. Kalsi, New Age International Publishers. 22. Chromatographic Analysis of Pharmaceuticals, A. John, Adamovics, Cytogan Corporation,

Princeton,NJ. 23. Clerk’s analysis of Drugs and Poisons, A.C. Moffet, M. D. Osselton, B. Widdop L. Y. Galichet,

Pharmaceutical Press. 24. Impurity Profiling of Drugs and Pharmaceuticals: New Analytical Methods- Development and

Validation by M V Narendra Kumar Talluri, Lambert Academic Publishing House. 25. Relevant articles from journals.

Page 19 of 47

SEMESTER-I

BIO-PHARMACEUTICS & PHARMACOKINETICS (PH819.02)

Credits: 4 Contact hrs per week: 4

Objectives of the course:

• To Study the absorption, distribution, metabolism and excretion of drugs.

• The primary goal of the course related to pharmacokinetics is to provide a conceptual and

quantitative background in pharmacokinetic theory and applications. This will be needed to

pursue studies in clinical pharmacokinetics.

• The overall study of biopharmaceutics and pharmacokinetics will help in design of drug delivery

system and development of pharmaceutical formulations.

Students learning outcomes/objectives:

• Students will be able to estimate pharmacokinetic parameters using plasma and urine drug level

data.

• Students will be able to predict the effects of various physicochemical, biochemical, physiological and

pathological processes on the kinetics and extent of drug absorption, distribution and elimination.


• Lectures will be taken in class room with the aid of multi-media presentations / black board or

mix of both.


No Unit Minimum No. of

Contact Hours

Approx.

Weightage %

1 ADME Characteristics of drug 20 33

2 Pharmacokinetics 25 42

3 Bioavailability & Bioequivalence 9 15

4 In-vitro In-vivo Correlation (IVIVC) 6 10

Total 60 100%

Page 20 of 47



1. ADME Characteristics of drug Drug Absorption: General consideration, absorption / drug transport mechanisms, role of sorption promoters, factors affecting absorption, absorption of drug through routes other then oral. Methods to determine absorption of drugs including in-vitro, in-situ, in-vivo and cell line (Caco – 2) study. Drug Distribution: Factors affecting drug distribution, protein & tissue binding, Apparent volume of drug distribution Drug Metabolism (Biotransformation): Biotransformation, factors affecting biotransformation, Phase I & Phase-II reactions. Drug Excretion: Glomerular filtration, tubular secretion, tubular reabsorption, Factors affecting drug excretion. BCS and BDDCS: Introduction, History, Classification, Significance, Biowaivers, Case studies and correlation with Regulatory bodies.

20

2. Pharmacokinetics One compartment open model

I.V. bolus administration I.V. infusion Extra vascular administration

Two compartment open model I.V. bolus administration I.V. infusion Extra vascular administration

Multi compartment model Application of Pharmacokinetics: new drug development, Design of dosage forms and novel drug delivery systems, Case studies based on pharmacokinetic principles Determination of various pharmacokinetic parameters Absorption rate constant, elimination rate constant, biological half life, % drug metabolized, apparent volume of distribution, excretion rate constant, Clearance (including the concept of renal & non-renal clearance), Kinetics of protein binding and other Pharmacokinetic parameters, Softwares used for determination of pharmacokinetic parameters Pharmacokinetics of Multiple Dosing: Adjustment of dosage in renal & hepatic impairment, individualization of therapy, therapeutic drug monitoring, Kinetics of sustained release Non-linear Pharmacokinetics: Causes of non-linearity, estimation of various parameters and bioavailability of drugs that follow non-linear kinetics.

25

3. Bioavailability & Bioequivalence: Objectives of bio-availability & bioequivalence studies, Measurements of bio-availability, Concept of Bioequivalence, Experimental Designs in Bioequivalence study (Cross over, Latin Square, Balance incomplete block design). Numericals and case studies. Regulatory aspects of bio-availability and bioequivalence studies for conventional dosage forms and controlled drug delivery systems.

9

4. In-vitro In-vivo Correlation (IVIVC) Concept, Methods of establishing IVIVC, Factors affecting IVIVC. Numericals and Case studies. Application of IVIVC for biowaivers of immediate release dosage forms. IVIVC for Sustained Release and controlled release dosage forms. Regulatory aspects of IVIVC.

6

Page 21 of 47


1. Pharmacokinetics, M Gibaldi, Marcel Dekker, Inc., New York.

2. Remington’s Pharmaceutical Sciences, Mack publishing company, Pennsylvania.

3. Clinical Pharmacokinetics, Concepts and Applications, M. Rowland and T. N. Tozer, Lippincott

Williams & Wilkins, Philadelphia

4. Biopharmaceutics and Clinical Pharmacokinetics- An introduction; Robert. E. Notari, Marcel

Dekker Inc, New York

5. Encyclopedia of Pharmaceutical Technology, James Swarbrick and C.Boylan, Marcel Dekker Inc,

New York,

6. Pharmaceutical dissolution testing, U.V. Banaker, Marcel Dekker, Inc., New York.

7. The United States Pharmacopoeia-35 (NF-30), 2012, United State of Pharmacoppeal convention,

INC, 12601 Twinbrook Parkway, Rockville, MD 20852.

8. Applied Biopharmaceutics and pharmacokinetics, Leon Shargel, Mc Graw Hill.

9. Pharmacokinetics, Welling and Tse, Marcel Dekker, Inc., New York.

10. Biopharmaceutics and Clinical Pharmacokinetics, Niazi, Prentice Hall, London

11. Dose finding in Drug Development, N. Ting, Springer, U.K.

12. Drug disposition & Pharmacokinetics, S.H. Curry, Pharma Med Press , Hyderabad

13. Introduction of Biopharmaceutics & Pharmacokinetics, H. P. Tipnis and M. S. Nagarsenkar, Nirali

Prakashan, Pune.

14. Textbook of Biopharmaceutics & Pharmacokinetics, Javed Ali, R. K. Khar and Alka Ahuja, Birla

Publication, Delhi.

15. Biopharmaceutics & Pharmacokinetics, Venkateshwarlu, India

16. Drug discovery and evaluation: Pharmacological assays, H. Gerhard Vogel, 2nd edition, 2002.

17. Screening methods in pharmacology Vol-1 & 2, Robert Arnold Turner, 1971, Academic Press.

18. Fundamental of experimental pharmacology, M.N. Ghosh, 971, Scientific Book Agency.

19. Quality control of herbal drugs: an approach to evaluation of botanicals, Pulok K. Mukherjee, 2002,

Business horizons.

20. Relevant articles from journals.

21. Drug bioscreening: drug evaluation techniques in pharmacology, Emmanuel B. Thompson, 1990,

VCH publisher.

22. Drug absorption studies: in situ, in vitro and in silico models, By Carsten Ehrhardt, Kwang-Jin Kim,

Page 22 of 47

2008.

23. Biopharmaceutics and Pharmacokinetics- A Treatise, D.M. Brahmankar and Sunil B. Jaiswal,

Vallabh Prakashan Pitampura, Delhi.

24. www.oecd.org

25. http://www.ich.org

Page 23 of 47

SEMESTER-I PHARMACEUTICAL FORMULATION DEVELOPMENT (PH820.01)



• To integrate aspects of physical pharmacy, stability requirements and drug delivery for the development of Pharmaceutical Dosage Forms. Students learning outcomes/objectives:

• To develop the ability to effectively apply knowledge of excipients, preformulation studies, stability, evaluation in the formulation of pharmaceutical products and drug delivery systems. Instructional Methods and Pedagogy:

• Through discussion in a class-room, and performing experiments related to Product development studies.

Outline of the course:

No.

Unit Minimum no. of

Contact Hour

Approx.

Weightage %

1 Preformulation 8 13

2 Solubilization and solubilized system 4 7

3 Excipients for Pharmaceutical formulations 6 10

4 Stability of drug & dosage forms 6 9

5 Drug Diffusion & Dissolution 8 13

6 Drug Carrier Delivery Systems 10 17

7 Fundamental of controlled release drug

delivery

10 17

8 Immediate Release Novel Dosage Forms 4 7

9 Novel Emulsion systems 4 7

Total 60 100

Page 24 of 47



1. Preformulation

• Physical, Chemical and Pharmaceutical factors influencing formulation of drugs

• Solid-state characterization: Crystallinity, hygroscopicity, Particle size and particle size

distribution, compression and compaction properties, surface area

• Crystalline and polymorphism and its evaluation. Rationale for selecting the preferred

polymorph/crystalline form

• Applications of various characterization techniques viz: Differential thermal analysis

Differential scanning calorimeter, X-Ray diffraction, FTIR in Preformulation study

• Traces of organic volatile impurities (OVIs) and their regulatory limits (residual

solvents)

8

2. Solubilization and solubilized system

• Theoretical aspects and applications.

• Techniques for improvement in drug Solubilization for development of various dosage

forms

4

3. Excipients for Pharmaceutical formulations Factors affecting the selection (including safety considerations), drug-excipient and excipient- package interactions, Study of newer excipients like cyclodextrin, ion exchange resins, film coating materials, superdisintegrants, directly compressible vehicles, surfactants, thickeners. Co-processed excipients. · Guidelines for excipients: IIG, GRAS, NICNAS.

6

4. Stability of drug & dosage forms Basic concept and objectives of stability study, Importance of accelerated stability study,

Degradation of drug in solid state & liquid state, stabilization methods, importance of

stability indicating assay in stability evaluation, stability evaluation of disperse systems.

6

5. Drug Diffusion & Dissolution

• Drug diffusion: steady state diffusion, diffusion principles in biological systems, thermodynamics of diffusion, Fick’s Law of diffusion.

• Theory of dissolution, factors influencing dissolution, interpretation of dissolution rate data, Comparison of dissolution profile by model independent (similarity and dissimilarity factor) and dependent methods.

• Biopharmaceutical classification system (BCS), its significance in context of dissolution

8

Page 25 of 47

study and dosage form development.

• Selection of dissolution media.

• Pharmacopoeial & Non-Pharmacopoeial dissolution testing devices, Automation in dissolution testing

• Dissolution of immediate release and modified release dosage forms 6. Drug Carrier Delivery Systems

Structure, stability, composition, methods of preparation, applications in drug delivery,

drug targeting and commercial aspects of following: Particulate Carriers, Vesicular carriers,

Cellular carriers, Monoclonal antibodies and other Carriers.

10

7. Fundamental of controlled release drug delivery Influence of drug properties and pharmacokinetic principles involved in the design and fabrication of controlled release system, introduction to oral, parenteral, transdermal and mucosal controlled drug delivery systems.

10

8. Immediate Release Novel Dosage Forms: Fast dissolving tablets including Effervescent Tablets, Oral Films.

4

9. Novel Emulsion systems: Microemulsion & Nanoemulsion, Self emulsifying drug delivery system (SEDDS), Self microemulsifying drug delivery system(SM EDDS)

4


1. Drug Stability, J. T. Carstensen, Marcel Dekker, New York. 2. Theory & Practice of Industrial Pharmacy, L. Lachman, Varghese Publication, Bombay. 3. Modern Pharmaceutics, G.S. Banker and C.T. Rhodes, Marcel Dekker, NY. 4. Physical Characterization of Pharmaceutical Solids, H. G. Brittain, Marcel Dekker,NY. 5. Physical Pharmacy, A. Martin, Lea and Febiger, Philadelphia. 6. Pharmaceutical dissolution testing, U.V. Banaker, Marcel Dekker, Inc., New York. 7. Pharmaceutical Dosage Forms : Parenteral Medications, Avis K. E., Leon Lachmanand H. Lieberman,

Marcel Dekker, New York 8. Pharmaceutical Dosage Forms : tablets, Lierberman H. A. and Leon Lachman, Marcel Dekker, New

York 9. Oral lipid based formulations; D.J. Hauss, Informa Healthcare, New York 10. Polymorphism in Pharmacetucial solids: H.G. Brittain, Marcel Dekker, New York 11. Biodegradable polymers as drug delivery systems, edited by M.Chasin, R.langer, Marcel Dekker, New

York. 12. Handbook of Preformulations, S. K. Niazi, Informa Healthcare, New York. 13. Pharmaceutical Preformulations & Formulation, edited by Marks Gibson, Interpharm/CRC, Boca

Raton, Florida, USA. 14. Novel Drug Delivery Systems, Y.W. Chien, Marcel Dekker, Inc., New York. 15. Progress in Controlled and Novel Delivery Systems, edited by N.K. Jain, CBS Publishers &

Distributors, New Delhi. 16. Targeted & Controlled Drug Delivery, S. P. Vyas and R. K. Khar, CBS Publishers & Distributors, New

Delhi. 17. Advances in Controlled and Novel Drug Delivery, Edited by N.K. Jain, CBS Publishers & Distributors,

New Delhi

Page 26 of 47

SEMESTER-I

DRUG REGULATORY AFFAIRS-I (PH820.02)


Objectives of the Course:

• To study the basics of the regulations of drugs, cosmetics, medical devices and biologics as per the Indian legislation. The primary goal of the course related to introduce the basic concepts of drug regulatory affairs with special emphasis on the Indian pharmaceutical legislations. Students learning outcomes/objectives:

• Students will be aware of the drug regulatory affairs.

• Students will be able to understand the pharmaceutical legislations of India. Instructional Methods and Pedagogy:

• Through discussion in a class room, performing practicals, preparing assignments and case studies. Outline of the Course: Sr.No. Unit

Minimum No. of Contact Hours

Approx. Weightage %

1 Pharmaceutical legislations in India 25 42

2 Pharmaceutical Regulatory Process in India 30 50

3 Legal Environment of Business 05 8

60 100



1. Pharmaceutical legislations in India I. Origin, development, scope, objectives and nature of Pharmaceutical legislation in India. II. A detailed study of the Drugs and Cosmetics Act, 1940 and Rules 1945(with including latest amendments) III. An introductory study of following acts/ laws of that affect drug product design, manufacture and distribution in India (with latest amendments):

• The Narcotics Drugs and Psychotropic Substances Act

• Medicinal and Toilet Preparations (Excise Duties) Act, 1955

• Drugs (Price Control) Order in force

25

Page 27 of 47

• Laws on Trade Marks and Copy Rights

• The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1955

• Prevention of Cruelty to Animals Act

• Factory’s Act

• The Environmental Protection Act

• Consumer Protection Act

• Law of Torts

• Monopolistic & Restrictive Trade Practices Act

• Food, safety and standards act

2. Pharmaceutical Regulatory Process in India I. Drug regulatory authorities in India-- Introduction, Organization and General

Guidelines. II. Regulation and registration of followings in India;

• Drugs

• Medical devices

• Cosmetics

• Biologics & Biotechnological products

III. Regulatory consideration for pre-clinical testing and clinical testing in India IV. Regulation of generic pharmaceutical and bio similar products

Introduction to regulation of OTC drugs, Orphan drugs, herbal drugs,

neutraceuticals and Fast Track Products. Case study

30

3. Legal Environment of Business Need for government regulations; financial regulations, SEBI, BIFR, FEMA & CSR, Contract Act and Sale of Goods Act, Corporate tax laws, Regulatory affairs in an entrepreneurial environment.

5

Recommended books: (Latest edition of the books should be referred) 1. Drugs and Cosmetics Act, 1940 and its rules, published by Ministry of health and family welfare,

Government of India. 2. Pharmaceutical Jurisprudence, G.K. Jani. 3. The Pharmaceutical Regulatory Process, 2nd ed. – Ira R. Berry, Robert P. Martin 4. Medical Product Regulatory Affairs: Pharmaceutical, Diagnostics, Medical Devices – John J. Tobin

and Gary Walsh. 5. FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices and Biologics, 2nd ed. –

Douglas J. Pisano and David S. Mantus 6. Good Drug Regulatory Practices: a Regulatory Affairs Quality Manual (Good Drug Development

Series) – Helene I. Dumitriu. 7. Pharmaceutical Patent Law – John R. Thomas. 8. http://cdsco.nic.in 9. Original laws published by Govt. of India.

Page 28 of 47

10. Text Book of Forensic Pharmacy by Mithal B. M.; Vallabh Prakashan, New Delhi. 11. Laws of Drugs in India by Hussain. 12. Text Book of Forensic Pharmacy by Jain N. K.; Vallabh Prakashan, New Delhi.

Page 29 of 47

SEMESTER-I DRUG REGULATORY AFFAIRS PRACTICAL I (PH820.03)


Detailed syllabus (Practical)

1. To illustrate the topics included under theory of Basic analytical techniques.

2. To illustrate the topics included under theory of Pharmaceutical Formulation Development.

SEMESTER-I DRUG REGULATORY AFFAIRS PRACTICAL II (PH820.04)



1. To illustrate the topics included under theory of Drug Regulatory Affairs-I.

2. To illustrate the topics included under theory of Biopharmaceutics & Pharmacokinetics.

Page 30 of 47

SEMESTER-I Scientific Communication (PH824.01)

(Practical) Credits: 1 (Practical) Contact Hours per week: 3 (Practical)


To enhance the scientific communication skills of students

Student Learning Outcomes / Objectives:

The students are expected to strengthen their communication skills in scientific writing as well

presentations.


The faculty shall stress on the importance of the concept of the specific type of module of communication

and explain using examples. The students may be assigned individual exercise and they will be counseled

personally, keeping in mind the aspects of plagiarism.

Outline of the Course (Practical):

No. Unit Practical hours per

week 1. Development of Scientific Writing Skills

3 .00 2. Development of Presentation Skills

Total 45 hours/

semester

Page 31 of 47

Detailed syllabus (Practical):

No. Unit Scientific Writing Skills

1 Review of Instruction for Authors of a Journal / Periodical - I

2 Report writing for publication in various formats

3 Preparation of Manuscript for publication to a Journal / Periodical - I

4 Writing in Laboratory Notebook on Experiment Carried Out

5 So P Preparation

Comprehension of Scientific writing

6 Review and Analysis of Review / Research Article - I

7 Review and Analysis of Review / Research Article - II

Presentation of Scientific Matter

8 Poster Presentation

9 Oral (Podium) Presentation - I

10 Oral (Podium) Presentation - II

11 Verification of plagiarism using softwares

Page 32 of 47

SEMESTER-I

COMMUNITY SERVICES-I (PH824.02)

(PRACTICAL)


Course Description

• Students are undertaking a group research project. Students of each group choosing community service projects must commit at least 3 hours/week to their projects.

• Students in this course will have an opportunity to work collaboratively with community partners to identify needs in communities.

• Students will investigate, discuss, and plan methods of addressing identified needs within the community.

• Under the guidance of the instructor or an advisor, students will be actively involved in implementing a self-designed community service project.

Course Goals

• Promote active learning and responsible citizenship.

• Identify personal values, beliefs, attitudes, and philosophies.

• Promote collaborative learning.

• Strengthen ties between student and community; and community and college.

• Foster a commitment of service to others. Course Objectives

• Develop interpersonal skills necessary for being an active participant in a community

• Develop a learning community

• Investigate and identify needs within a community

• Develop a plan of action for responding to an identified need of the community Course Evaluation

Students choosing to do projects are expected to demonstrate that they have expended at 45 hours on

their projects.

The performance of every student will be evaluated as follows: Approx. Weightage (%) Project Proposal 50 Midterm & Final report (assignment) 50

Page 33 of 47


SYLLABI (Semester – 2)


Page 34 of 47

SEMESTER-II RESEARCH METHODOLOGY & IPR (PH824.03)



• To make students familiar with various established methods used in pharmaceutical research.

• To explore practical aspects related to patenting.

Student Learning Outcomes/Objectives:

• At the end of the course, the student will be able to understand the hierarchy of continue research by proper fundamental methodology.

• The students will get familiar with IPR and Patents.


• Faculty member/s shall explain and discuss the case studies in a class room using black board and

multimedia projector.


Sr. No.

Unit Minimum No.

of Contact Hours

Approx. Weightage %

1 Research 4 7

2 Research problem formulation 5 8

3 Methods and tools used in research 5 8

4 Documentation 4 7

5 The Research Report writing, Paper writing/ thesis writing

10 16

6 Presentation 5 8

7 Cost analysis of the project 3 4

8 Sources for procurement of research grants 4 7

Page 35 of 47

Part – II : Intellectual Property Rights (IPR)

1 Intellectual Property Concepts 5 9

2 IPR and Pharmaceutical Research 3 4

3 Practical aspect of patenting 7 13

4 IPR related treaties 2 4

5 Case Study 3 5

Total 60 100%

Detailed Syllabus:

Part-I Research Methodology (40 hours)

1 Research:

Meaning, purpose, Types, (Educational, Clinical, Experimental, historical descriptive, Basic

applied and Patent oriented Research) objective of research.

2 Research Problem Formulation: Literature Survey: purpose and use of literature review, locating relevant information, use of library and electronic databases. Preparation and presentation of literature review, research and review articles, theoretical models and framework, selecting problem and preparing research proposal.

3 Methods and tools used in research:

• Qualitative studies, quantitative studies

• Simple data organization, descriptive data analysis

• Limitation & sources of Error

• Inquiries in form of Questionnaire, etc. 4 Documentation:

“How” of documentation Techniques of documentation Importance of documentation Use of computer packages in documentation. 5 The Research Report writing, Paper writing/ thesis writing:

Different parts of the Research paper

• Title , Authors Name & contact details

• Abstract- statement of the problem, background and purpose and scope of research.

• Key Words

• Subject Area

• Methodology: apparatus, instrumentation & procedure.

• Results- tables, graphs, figures & statistical presentation

• Discussion : support or non support of hypothesis, practical & theoretical Implications

• Conclusion

Page 36 of 47

• Acknowledgements.

• References

• Errata

• Importance of Spell check for entire research paper

• Uses of footnotes 6 Presentation (especially for oral presentation):

Importance, types different skills, content, format of model, gestures, eye contact, facial

expressions, stage-fright, volume- pitch, speed, pause & language, Visual aids & Questionnaire.

7 Cost analysis of the project: Cost incurred on raw materials, different testing procedures for the same parameter, cost of instrument utilization & cost of the clinical trials.

8 Sources for procurement of research grants: International agencies, Government and private bodies, Industrial projects and their feasibility reports

Part-II IPR (20 Hours)

1. Intellectual Property Concepts:

• Concept of property, conventional property Vs Intellectual Property

• Basic aspect of the 8 different IPR mechanism Viz. Patents, Copyright, trademark, industrial design, layout design of integrated circuits, geographical indicators, plant varieties & trade secrets.

2. IPR and Pharmaceutical Research:

• Benefits of IPRs to improve the quality of research work

• Strategies for avoiding research duplications, infringements 3. Practical aspect of patenting:

• Indian patent act and its recent amendment with respect to following aspect o Patentable and non-patentable inventions. o Essential criteria for filing a patent. o Filling a patent in India and abroad o Drafting of patent application

• Patenting: Regional routes & national routes.

• Introduction to World Intellectual Property Organization. (WIPO)

• Commercialization of patent: Need for Commercialization of research and role of IPRs in research Commercialization.

• Benefit/Disadvantages of patenting to the society 4. IPR related treaties:

1. Patent co-operative treaty 2. Budapest treaty

5. Case Study

Recommended Study materials:

1. Research In Education- John V. Best, John V. Kahn 7th edition, Published by: Phi Learning Pvt. Ltd

Page 37 of 47

2. Presentation skills - Michael Hallon- Indian Society for Institute education

3. Practical Introduction to copyright.- Gavin McFarlane, Published By: Mcgraw-Hill Inc, USA.

4. Thesis projects in Science & Engineering – Richard M. Davis. New York: St. Martin’s Press, 1980.

5. A review of “Scientist in legal Systems”, Journal of Forensic Sciences (JOFS),21(2),1976.

6. Thesis & Assignment – Jonathan Anderson by John Wiley & Sons Inc. USA (1998).

7. Donald Menzel, Jones, Howard Mumford; Boyd, Lyle G., Writing a technical paper, J. Chem. Edu.,

1962, 39 (6), p A500

8. Effective Business Report Writing –Leland Brown, 2nd Edition, Prentice-Hall, Englewood Cliffs,

New Jersey, 1963.

9. Protection of industrial Property rights- P. Das & Gokul Das.

10. Preparing for publication: A Style Book for Authors, Editors, Compilers and Typists – King

Edward Hospital Fund for London.

11. The Hindu speaks on Information Technology (Special Publication by The Hindu)

12. Manual for evaluation of industrial projects-(Prepared Jointly by United Nations Industrial

Development Organization and the Industrial Development Center for Arab States).

13. Manual for the preparation of industrial feasibility studies (Newly rev. and expanded ed. W.

Behrens, P.M. Hawranek, Published by United Nations Industrial Development Organization in

Vienna .1991.

14. Stanford Bolton, Charles Bon (2004), Pharmaceutical Statistics, Practical and Clinical

Applications (Fourth rev. ed) Marcel Dekker, Inc

15. Relevant articles from journals

16. IPR Handbook for Pharma Students and Researchers, Parikshit Bansal, Pharma Book Syndicate,

Hyderabad.

17. Patents, N. R. Subbaram, Pharma Book Syndicate, Hyderabad.

18. Relevant articles from journals.

19. www.pat2pdf.org

20. www.patentstorm.us

21. www.freepatentsonline.com

22. http://www.wipo.int/pctdb/en/

23. www.espacenet.com

Page 38 of 47

SEMESTER-II GMP, QA & PROCESS VALIDATION (PH819.07)

(THEORY) Credits: 4 Contact hrs per week: 4


• To provide the student with understanding of various facets of Quality Assurance System, Good Manufacturing Practices and Process Validation

Students learning outcomes/objectives

• The basic understanding acquired by the student at the end of the course shall help him/her to appreciate the Quality Assurance System of a Pharmaceutical Industry during his/her training.


• The course employs lectures and class discussions. It also includes presentation by a students on a specific topic assigned to them by the faculty

• Presentation on a case related to the course

• Visit to Pharmaceutical Industry

Outline of the course:

No. Unit Minimum no. of Aprrox.

Contact Hour Weightage % 1 Good Manufacturing Practices (GMP) 30 50

2 Quality Assurance 10 15

3 Process Validation 20 35

Total 60 100%

Page 39 of 47

Detailed Syllabus:

1. Good Manufacturing Practices (GMP)

a. Introduction to Current Good Manufacturing Practices

b. The History of GMP's

c. GMP Definitions

d. Provisions of GMP with respect to followings

• Building & facilities

• Personnel & Sanitation

• Equipment

• Raw Material Testing

• Manufacturing Control

• Packaging and labeling control

• Quality Control

• Finished Product Testing

• Warehousing & Distribution

• Records & Reports

• Complaints and recalls

• Waste disposal, scrap disposal procedures

2. Quality Assurance:

• Role of raw material testing, finished product testing, in process quality control in assuring quality of drug products to consumers

• Role of quality audit & quality circle in quality assurance

• Application of Process Analytical Technology (PAT) in quality assurance

3. Process Validation

• Regulatory basis, Terminology: validation, qualification, calibration

• Prospective process validation

• Retrospective validation

• Validation of sterilization processes (Heat & Filtration)

• Validation of tablets & capsules manufacturing processes

• Qualification of water systems

• Qualification of Air-Handling systems

Page 40 of 47

• Qualification of Equipments

• Qualification of Facility

• Validation & verification of cleaning process

• Computer system validation

Recommended Study materials:

1. How to practice GMPs; P.P.Sharma, 5th Edition, Vandhana Publications, New Delhi.

2. Pharmaceutical process validation, Bernard T. L. and Robert A. Nash, Volumes 23, Marcel

Decker.

3. Good Manufacturing Practice for pharmaceuticals, Sidney H. Willing, Mercel Decker Inc.

4. Validation of Pharmaceutical Process, James Agalloco, 3rd Edition, Infroma Healthcare USA

5. Validation of Pharmaceutical Processes, Sterile Products, F.J.Carleton, Marcel Dekker Inc.

6. Guidelines on cGMP & Quality of Pharmaceutical Products, S. Iyer, D.K. Publication, Mumbai.

7. Validation in Pharmaceutical Industry (Concept, Approches & Guidelines), P.P. Sharma,

Vandhana Publications, New Delhi

8. GMP practices for pharmaceutical-James Swarbrick.

Page 41 of 47

SEMESTER-II DRUG REGULATORY AFFAIRS-II (PH820.05)



• To provide a detailed view of the pharmaceutical regulations in WHO and regulatory agencies (excluding USA & EU).

• To integrate aspects of licensing, auditing and documentation of the pharmaceutical drug product manufacturing. Students learning outcomes/objectives:

• To develop the ability to effectively apply knowledge of law related to the pharmaceutical industries and certification of the licensing and documentation.

• He/She should be able to explain and prepare documentation for the application of the drug products in accordance to regulatory agencies (excluding USA & EU). Instructional Methods and Pedagogy:

• Through lectures, discussion in a class-room.


Sr. No.

Unit

Minimum No. of Contact Hours

Approx. Weightage %

1 ICH Guidelines 15 25

2 WHO Guidelines 10 17

3 Study of regulatory agencies (excluding USA & EU)

25 42

4 Auditing of manufacturing facilities 5 8

5

Status of pharmaceutical industry with special reference to post GATT scenario. Project planning and implementation.

5 8

60 100

Page 42 of 47



1. International Conference On Harmonisation (ICH): Introduction, History, structure and

activities of ICH.

a. ICH guidelines on quality: Stability Testing of New Drug Substances and Products

Stability Testing : Photostability Testing of New Drug Substances and Products,

Stability Testing for New Dosage Forms, Bracketing and Matrixing Designs for Stability

Testing of New Drug Substances and Products, Evaluation of Stability Data, Impurities

in New Drug Substances, New Drug Products, Impurities: Guideline for Residual

Solvents

b. ICH guidelines on efficacy: ICH guidelines on clinical trial and Good Clinical Practice

c. ICH guidelines on safety: Carcinogenicity Studies - Need for Carcinogenicity Studies of

Pharmaceuticals and Testing for Carcinogenicity of Pharmaceuticals. A Standard Battery

for Genotoxicity Testing of Pharmaceuticals.

d. ICH guidelines on multidisciplinary

15

2. WHO Guidelines:

• The WHO Guidelines and their relevance in international registration.

• The WHO certification scheme on the quality of pharmaceutical product moving in

international commerce.

10

3. Detailed study of following regulatory agencies:

MCC, TGA, ANVISA, PMDA, TPDHPFBHC, AFSSAPS, BfArM, SWISSMEDIC 25

4. Auditing of manufacturing facilities by International regulatory agencies. The ISO 9000 &

14000 series of quality systems standards. 5

5. Status of pharmaceutical industry with special reference to post GATT scenario. Project

planning and implementation. 5

Page 43 of 47

Recommended books: (Latest edition of the books should be referred)

1. Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices By John J.

Tobin and Gary Walsh

2. FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, Second

Edition by Douglas J. Pisano and David S. Mantus

3. Good Drug Regulatory Practices: A Regulatory Affairs Quality Manual (Good Drug Development

Series, Vol 1) by Helene I. Dumitriu

4. Encyclopedia of Pharmaceutical Technology, Jasmes Swarbrick and James C. Boylan, Marcel

Dekker Inc., New York.

5. Guidelines for Developing National Drug Policies; WHO Publications, 1998.

6. Export Marketing by Cherian and Parab; Himalaya Publishing House, Delhi

7. The Pharmaceutical Regulatory Process, 2nd ed. – Ira R. Berry, Robert P. Martin

8. Medical Product Regulatory Affairs: Pharmaceutical , Diagnostics, Medical Devices John J. Tobin

and Gary Walsh

9. Quality Assurance of Pharmaceuticals–A Compendium of Guidelines and Related Materials, Vol.–

1; WHO Publications.

10. Good Manufacturing Practices for Pharmaceuticals-A Plan for Total Quality Control by Sidney H.

Willing & James R Stoker. (Drugs & Pharm. Sciences) Vol. 78; Marcel Dekker

Inc.

11. Text Book of Forensic Pharmacy by Mithal B. M.;Vallabh Prakashan, New Delhi.

12. Relevant articles from journals

13. Official websites of WHO, ICH and other regulatory agencies.

Page 44 of 47

SEMESTER-II DRUG REGULATORY AFFAIRS-III (PH820.06)

(THEORY)


Objectives of the Course:

• To Study the basics of the drug regulatory affairs as per the USA & EU legislation. The

primary goal of the course related to introduce the basic concepts of drug regulatory affairs

with special emphasis on the highly regulated pharmaceutical market.

Students learning outcomes/objectives:

• Students will be aware of the drug regulatory affairs.

• Students will be able to understand the pharmaceutical legislations of USA & EU.


• Through discussion in a class room, performing practicals, preparing assignments and case

studies.


Sr. No. Unit Minimum No. of Contact Hours

Approx. Weightage %

1 Pharmaceutical Regulatory Process in USA

35 60%

2 Pharmaceutical Regulatory Process in European Union

25 40%

Total 60 100 %

Detail of Syllabus

1. Pharmaceutical Regulatory Process in USA (United States of America):

I. Regulatory agency of USA: Introduction, Organization and General Guidelines.

II. A detailed study of Federal Food, Drugs and Cosmetics Act of USA, restricted to human drugs,

cosmetics, Medical Devices and biotechnological products, with special emphasis on:

o General drug approval process.

o Investigational New Drug application. (INDA)

o New Drug Application (NDA)

Page 45 of 47

o Abbreviated New Drug Application (ANDA)

o Post marketing surveillance

o Drug Master Files in US

o Supplemental New Drug Application (SNDA)

o Scale-Up and Post Approval Changes (SUPAC)

o Bulk Actives Post Approval Changes (BACPAC)

o Biologics License Applications (BLA)

o Medical Devices Development & Approval Process

III. Introduction to regulation of Orange Book, OTC drugs, Orphan drugs, herbal drugs,

neutraceuticals, Fast Track Products and Pharma excipients

IV. Case study

2. Pharmaceutical Regulatory Process in European Union (EU):

I. Regulatory authorities in EU -- Introduction, Organization and General Guidelines.

II. A detailed study of Regulation approval process, restricted to human drugs, cosmetics, Medical

Devices and biotechnological products, with special emphasis on:

o Regulatory consideration for pre-clinical testing and clinical testing in EU.

o Registration application for marketing approval (IND, NDA, ANDA) in EU.

o Drug Master Files in EU.

o Medical Devices & Biologics Development & Approval Process.

III. Introduction to regulation of OTC drugs, Orphan drugs, herbal drugs, neutraceuticals, Fast Track

Products & Pharma Excipients.

IV. Regulatory considerations for manufacturing, packaging and labeling of pharmaceuticals in EU.

V. Case study

Recommended Materials:

1. Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices By John J. Tobin and

Gary Walsh

2. FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, Second Edition

by Douglas J. Pisano and David S. Mantus

3. Good Drug Regulatory Practices: A Regulatory Affairs Quality Manual (Good Drug Development Series,

Vol. 1) by Helene I. Dumitriu

4. Official websites and regulatory guidelines of respective country.

Page 46 of 47

SEMESTER-II DRUG REGULATORY AFFAIRS PRACTICAL-III (PH820.07)



1. To perform the practicals of statistical design of experiments.

2. To illustrate the topics included under theory of GMP, QA & Validation.

SEMESTER-II DRUG REGULATORY AFFAIRS PRACTICAL-IV (PH820.08)



1. To illustrate the topics included under theory of Drug Regulatory Affairs-II.

2. To illustrate the topics included under theory of Drug Regulatory Affairs-II1.

Page 47 of 47

SEMESTER II

COMMUNITY SERVICES-II (PH824.04)

(PRACTICAL)


Course Description

• Students are undertaking a group research project. Students of each group choosing community

service projects must commit at least 3 hours/week to their projects.

• Students in this course will have an opportunity to work collaboratively with community partners to

identify needs in communities.

• Students will investigate, discuss, and plan methods of addressing identified needs within the community.

• Under the guidance of the instructor or an advisor, students will be actively involved in implementing a self-designed community service project.

Course Goals

• Promote active learning and responsible citizenship.

• Identify personal values, beliefs, attitudes, and philosophies.

• Promote collaborative learning.

• Strengthen ties between student and community; and community and college.

• Foster a commitment of service to others. Course Objectives

• Develop interpersonal skills necessary for being an active participant in a community

• Develop a learning community

• Investigate and identify needs within a community

• Develop a plan of action for responding to an identified need of the community Course Evaluation

Projects selected in Community services-II will be in continuation with Community services-I. Evaluation

will be based on final presentation and final report preparation.

The performance of every student will be evaluated as follows: Approx. Weightage (%) Final report (assignment) 25 Final Presentation 75

Documents

M.Pharm.(Pharmaceutics-Drug Regulatory Affairs)