Ch. Bansi Lal University, Bhiwani · its effects, Chromophores and their interaction with EMR, Woodward-Fieser rule, Absorption spectra of organic compounds and complexes illustrating

Session: 2016-17

1

Schemes of Examinations

&

Syllabi

of

M. Pharmacy

for

Drug Regulatory Affairs

(2016-2017)

Ch. Bansi Lal University, Bhiwani

Session: 2016-17

2

Ch. Bansi Lal University, Bhiwani

Scheme of Examination for M. Pharmacy Drug Regulatory Affairs

Semester-I Credits: 34 Marks: 750

Paper Code

Subjects

Type

of

Course

Contact Hours Per Week Credits Examination Scheme Total

Theory Practical Total Theory Practical Total Internal

Assessment

Theory Practical

MDA-101 Modern Analytical and

Pharmaceutical

Techniques-I (MAT-I)

C.M.C 04 -- 04 04 -- 04 20 80 100

MDA-102 Pharmaceutical

Regulation in India

C.C 04 -- 04 04 -- 04 20 80 100

MDA-103 International

Pharmaceutical

Regulation-I

C.C 04 -- 04 04 -- 04 20 80 100

MDA-104 International

Pharmaceutical

Regulation-II

C.C 04 -- 04 04 -- 04 20 80 100

MDA-105 Biostatistics I.D.C 04 -- 04 04 -- 04 20 80 100

MDA-106 Practical (MAT-I) C.M.C - 06 (6X1) 06 -- 03 03 -- - 100 100

MDA-107 Practical (MDA- 102-104) C.C - 18 (6X3) 18 -- 09 09 -- - 100 100

MDA-108 Seminar/ Journal Club C.C 03 -- 03 -- -- 01 - -- -- 25

MDA-109 Self-study Paper C.C -- -- -- -- -- 01 -- -- -- 25

Total 23 24 47 20 12 34 100 400 200 750

Session: 2016-17

3


Semester-II Credits: 34 Marks: 750

Paper

Code

Subjects

Type

of

Course

Contact Hours Per Week Credits Examination Scheme Total

Theory Practical Total Theory Practical Total Internal

Assessment

Theory Practical

MDA-201 Modern Analytical

Techniques-II (MAT-II)

C.M.C 04 -- 04 04 -- 04 20 80 100


Regulatory Practices

C.C 04 --- 04 04 04 20 80 100

MDA-203 Pharmaceutical Quality

Management

C.C 04 -- 04 04 -- 04 20 80 100


Regulatory Management

C.C 04 -- 04 04 -- 04 20 80 100

MDA-205 Intellectual Property

Rights

C.C 04 -- 04 04 -- 04 20 80 100

MDA-206 Practical (MAT-II) C.M.C 06 (6X1) 06 -- 03 03 -- -- 100 100

MDA-207 Practical

(MDA- 202- 204)

C.C -- 18 (6X3) 18 -- 09 09 -- -- 100 100

MDA-208 Seminar/ Journal Club/

Synopsis

C.C 03 - 03 - - 01 - - - 25

MDA-209 Self-study Paper C.C -- - -- - - 01 - - 25

Total 23 24 47 20 12 34 100 400 200 750

Session: 2016-17

4


3rd

Semester Credits: 23 Marks: 225

PART-I (DISSERTATION WORK)

Paper Code Subject Contact

Hours

Credits

Examination Marks Max. Marks

Internal External

MIP-301 Pharmaceutical Entrepreneurship 04 04 20 80 100

MIP-302 Midterm Evaluation/Presentation/Viva

voce

-- -- -- 100 100

MIP-303 Journal Club (One Research Paper Per

Student) 02 01 25 - 25

MIP-304 Research Work 36 18 - - -

Total 42 23 45 180 225

4th

Semester Credits: 23 Marks: 250

PART-II (DISSERTATION WORK)

Paper Code Subject Contact

Hours

Credits

Examination Marks Max. Marks

Internal External

MIP-401 Communication Skills 04 04 20 80 100

MIP-402 Journal Club

(One Research Paper Per Student)

02 01 25 - 25

MIP-403 Research Work 36 18

MIP-404 Dissertation Evaluation by External

Examiner

- - - 100 100

MIP-405 Dissertation / Final Presentation &

Viva voce

- - - 50 50

Total 42 23 45 230 275

Duration- 02 years (04 semesters)

Total Marks- 2000

Total Credits- 114

Session: 2016-17

5

M. Pharmacy (Drug Regulatory Affairs)

Semester 1

MDA-101

Modern Analytical Techniques -I (MAT- I)

Maximum Marks: 100

Theory Examination: 80

Internal Assessment: 20

Time: 3 hrs

Note: There shall be nine questions in all. Question no. 1 shall be compulsory, consisting of

eight short answer type questions covering the entire syllabus. Two questions will be asked

from each unit. Student will have to attempt one question from each unit. Each question shall

carry equal marks.

UNIT-I

UV-Visible spectroscopy: Brief review of electromagnetic spectrum, UV-Visual range, energy-

wavelength colour relationships. Interaction of electro - magnetic radiation (UV-Vis) and matter and

its effects, Chromophores and their interaction with EMR, Woodward-Fieser rule, Absorption

spectra of organic compounds and complexes illustrating the phenomenon and its utilization in

qualitative and quantitative studies of drugs, Beer-Lambert‟s law, Shifts and their interpretation

(including solvent effects). Multi component analysis, derivative spectroscopy.

Spectrofluorimerty: Fluorescence, Phosphorescence, Chemiluminescence-Theory, instrumentation

and applications. (9 Lectures)

UNIT-II

Infra-Red Spectroscopy: Nature of Infra-red radiation, Interaction of IR radiation with organic

molecules and effects on bonds, Molecular or infra-red spectra, Brief outline of classical IR

instrumentation and interpretation of spectra, including sample preparation for spectroscopy,

Qualitative interpretation of IR Spectra, Influence of substituents, ring size, hydrogen bonding

vibrational coupling and field effect on frequency, Quantitative methods, FT-NIR and applications.

Recent advances in IR Spectroscopy.

Raman spectroscopy- Principle, Instrumentation and applications.

Laser Spectroscopy: Introduction, principle, instrumentation and applications. (9 Lectures)

UNIT-III

Chromatographic Techniques: Introduction and classification.

High performance TLC – Principle, adsorbents, retention and separation parameters, detection

methods, quantitative and quantitative HPTLC.

Gas Chromatography: Introduction, Principles, Instrumentation, carrier gas, types of columns,

column selection- liquid stationary phases, column efficiency parameters, the Van Deemter

equation, Resolution, Derivatisation methods, Detectors. A critical comparison of sensitivity,

selectivity and field of applications of these detectors. Applications of GC in Pharmaceutical

sciences. (9 Lectures)

Unit-IV Liquid Chromatography: Instrumentation, columns, packing materials, column selection, mobile

phase selection, efficiency parameters, resolution and optimization of chromatographic parameters.

Detectors in HPLC: Comparison of sensitivity, selectivity and field of applications of these

detectors. Modes of HPLC-Ion pair, Ion-exchange, Size exclusion, Supercritical, Chiral, Gel-

permeation, Flash chromatography. Applications of liquid chromatography. Ultra Performance

Liquid Chromatography.

Emission Spectrometry (Atomic Absorption Spectrometry, Flame Photometry). (9 Lectures)

Session: 2016-17

6

Reference books:

1. Principles of Instrumental Analysis, 5th Ed., D.A. Skoog, F.J. Holler and T. A. Nieman.

2. "Spectrometric Identification of Organic Compounds" Silverstein, R.M., Bassler & Morril 5th

Ed., 1991.

3. Instrumental Methods of Analysis, H.H. Willard, L.L Merritt, J.A. Dean, F.A. Settle, 7th Ed.

4. Pharma Analysis, Modern Methods - (Ed) James W Munson Part-B, Vol. -2.

5. Drugs & Pharma, Sciences Series, Marcel Dekker Inc.

6. “Applications of absorption spectroscopy of organic compounds” by John R. Dyer.

7. “Contemporary practice of chromatography” by Poole, Colin F. and Sheila A. Schuette.

8. Ewing‟s Analytical Instrumentation Handbook, edited by Jack Cazes, CRC press.

9. “Practical HPLC method development” by L. R. Snyder Willey Interscience, Second Ed.

10. Aldrich FT-IR Spectral Library.

11. “Pharmaceutical Analysis” by David C. Lee Blackwell Publisher.

Session: 2016-17

7


Semester 1

MDA-102

PHARMACEUTICAL REGULATIONS IN INDIA

Maximum Marks: 100



Time: 3 hrs




carry equal marks.

UNIT-I

1. Detailed study of Drugs and Cosmetics Act 1940 and its rules 1945 including Import

License, Sale License, Manufacture License, Certificate of Pharmaceutical Product (CoPP)

(9 Lectures)

UNIT-II

2. Laws and Acts: An introduction of following laws with regard to drug product design,

manufacture and distribution in India (with latest amendments):

a) National Pharmaceutical Pricing Authority (NPPA)

b) Intellectual property rights - Indian Patents and Design Act 1970 and its

amendments, Law of Copyright and Designs, Law of Trademark and Geographical

indications

c) Patent Procedure in India (9 Lectures)

UNIT-III

3. Guidelines for drug testing in animals/ humans:

a) Animal testing: Rationale for conducting studies, CPCSEA Guidelines

b) Human testing: ICMR guidelines (Transfer of human biological material for

research commercial purpose, Good clinical laboratory practices, stem cell research

and therapy, international collaboration for research, ethical guidelines for human

participants), IRB / IEC structure and function. (9 Lectures)

UNIT-IV

4. CDSCO (Central Drug Standard Control Organization): Organization, Responsibilities,

and Registration Procedures for approval of drug products. Approval procedures (clinical

trials), timelines for approval, CDSCO guidelines (Approval of Clinical trials, Indian

Common Technical Document, Serious Adverse Events Reporting)

5. Bioavailability (BA) and Bioequivalence (BE): Bioavailability and Bioequivalence

Requirements, Bio-pharmaceutics drug classification, Documentation Requirements for

Bioequivalence study for export applications.

(9 Lectures)

Session: 2016-17

8

Books Recommended:

1. Manual of Patent Practice & Procedure, 3rd Edition, by The Patent Office of India

2. Patent Failure How Judges, Bureaucrats, and Lawyers put innovators at risk by James

Bessen and Michael J. Meurer

3. Principles and Practice of Clinical Trial Medicine by Richard Chin and Bruce Y. Lee

4. Ethical Guidelines for Biomedical Research on Human Participants by Indian Council of

Medical Research New Delhi 2006.

5. CPCSEA Guidelines for Laboratory Animal Facility by Committee for the purpose of

control and supervision on experiments on animals (CPCSEA)

6. ICH E6 Guideline “ Good Clinical Practice” by ICH Harmonised Tripartite

7. Guidance for Industry on Submission of Clinical Trial Application for Evaluating Safety and

Efficacy by CDSCO (Central Drug Standard Control Organisation)

8. Guidance for Industry on Requirement of Chemical & Pharmaceutical Information including

Stability Study Data before approval of clinical trials / BE studies by CDSCO

9. Guidelines for Import and Manufacture of Medical Devices by CDSCO

10. Guidelines from official website of FSSAI (Food Safety Standards Authority of India)

11. Encyclopedia of Biopharmaceutical Statistics 2nd Edition, Edited by Shein- Chung Chow

12. Guidelines from official website of CDSCO

Session: 2016-17

9


Semester 1

MDA-103

INTERNATIONAL PHARMACEUTICAL REGULATIONS- I

Maximum Marks: 100



Time: 3 hrs




carry equal marks.

UNIT-I

1) A detailed study of Federal Food, Drug and Cosmetics Act of USA, restricted to human

drugs, cosmetics and biotechnological products with special emphasis on:

a) History of drug regulation in USA.

b) Organization and functions of FDA, including historical developments.

c) OTC drugs, Orphan drugs, Orange Book and Fast Track Products.

d) General penalties as applicable to drugs, cosmetics and biotechnological products

(9 Lectures)

UNIT-II



a) Drug approval process.

b) Investigational New Drug application.

c) New Drug Application (9 Lectures)

UNIT-III



a) ANDA

b) SNDA, SUPAC and BACPAC

c) Post Marketing (9 Lectures)

UNIT-IV



a) Labelling and advertising requirements for drugs, cosmetics and biotechnological

products.

Session: 2016-17

10

b) Introduction to environmental protection laws, as applicable to drugs, cosmetics and

biotechnological products, including EPA and OSHA.

c) Common Technical Document and Drug Mater Files.

d) Factory Inspection. (9 Lectures)

Books Recommended:

1. Generic Drug Product Development, Solid Oral Dosage forms, Leon Shargel and Isader

Kaufer, Marcel Dekker series, Vol. 143

2. The Pharmaceutical Regulatory Process, Edited by Ira R. Berry Marcel Dekker Series, Vol.

144

3. The Pharmaceutical Regulatory Process, Second Edition Edited by Ira R. Berry and Robert

P. Martin, Drugs and the Pharmaceutical Sciences, Vol. 185 Informa Health care Publishers.

4. New Drug Approval Process: Accelerating Global Registrations By Richard A Guarino,

MD, 5th edition, Drugs and the Pharmaceutical Sciences, Vol. 190.

5. Guidebook for drug regulatory submissions-Sandy Weinberg By John Wiley & Sons. Inc.

6. FDA regulatory affairs: a guide for prescription drugs, medical devices, and biologics

/edited by Douglas J. Pisano, David Mantus.

7. Clinical Trials and Human Research: A Practical Guide to Regulatory Compliance By Fay

A. Rozovsky and Rodney K. Adams.

8. HIPAA and Human Subjects Research: A Question and Answer Reference Guide By Mark

Barnes, JD, LLM and Jennifer Kulynych, JD, PhD.

9. Principles and Practices of Clinical Research, Second Edition Edited by John I. Gallin and

Frederick P. Ognibene.

10. Drugs: From Discovery to Approval, Second Edition By Rick Ng

11. New Drug Development: A Regulatory Overview, Eighth Edition By Mark Mathieu

12. Pharmaceutical Risk Management By Jeffrey E. F, Wayne L. Pines and Gary H. Slatko

13. Preparation and Maintenance of the IND Application in eCTD Format By William K.S

14. Medical Device Development: A Regulatory Overview By Jonathan S. Kahan

15. Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices By

John J. Tobin and Gary Walsh

16. Country Specific Guidelines from official websites.

Session: 2016-17

11


Semester 1

MDA-104

INTERNATIONAL PHARMACEUTICAL REGULATIONS- II

Maximum Marks: 100



Time: 3 hrs




carry equal marks.

UNIT-I

1. Emerging Markets: Overview, Regulatory Requirements for generic drug registration, new

drugs and post approval requirements in BRICS countries (Brazil, Russia, India, China,

South Africa) and Egypt. (9 Lectures)

UNIT-II

2. European Union: Organization of EMA & Marketing Authorization procedures in EU (CP,

DCP, MRP). Eudralex directives for human medicines, Variations & extensions.

Requirements for BA/BE studies, Compliance of European Pharmacopoeia (CEP)/

Certificate of Suitability (CoS) (9 Lectures)

UNIT-III

3. Japan, Canada, Australia and UK: Organization of the regulatory body, Drug approval

process and types of registration applications. (9 Lectures)

UNIT-IV

4. Medical Devices: Regulatory approval process for Medical Devices and In-vitro Diagnostics

in US and EU. CE certification, ISO standards for Medical devices and In-vitro diagnostics.

GHTF/ IMDRF. (9 Lectures)

Books Recommended:

1. Generic Drug Product Development, Solid Oral Dosage forms, Leon Shargel and Isader

Kaufer, Marcel Dekker series, Vol. 143

2. The Pharmaceutical Regulatory Process, Edited by Ira R. Berry Marcel Dekker Series, Vol.

144

3. The Pharmaceutical Regulatory Process, Second Edition Edited by Ira R. Berry and Robert

P. Martin, Drugs and the Pharmaceutical Sciences, Vol. 185 Informa Health care Publishers.

4. New Drug Approval Process: Accelerating Global Registrations By Richard A Guarino,

MD, 5th edition, Drugs and the Pharmaceutical Sciences, Vol. 190.

5. Guidebook for drug regulatory submissions-Sandy Weinberg By John Wiley & Sons. Inc.

6. FDA regulatory affairs: a guide for prescription drugs, medical devices, and biologics

/edited by Douglas J. Pisano, David Mantus.

Session: 2016-17

12

7. Clinical Trials and Human Research: A Practical Guide to Regulatory Compliance By Fay

A. Rozovsky and Rodney K. Adams.

8. HIPAA and Human Subjects Research: A Question and Answer Reference Guide By Mark

Barnes, JD, LLM and Jennifer Kulynych, JD, PhD.

9. Principles and Practices of Clinical Research, Second Edition Edited by John I. Gallin and

Frederick P. Ognibene.

10. Drugs: From Discovery to Approval, Second Edition By Rick Ng

11. New Drug Development: A Regulatory Overview, Eighth Edition By Mark Mathieu

12. Pharmaceutical Risk Management By Jeffrey E. F, Wayne L. Pines and Gary H. Slatko

13. Preparation and Maintenance of the IND Application in eCTD Format By William K.S

14. Medical Device Development: A Regulatory Overview By Jonathan S. Kahan

15. Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices By

John J. Tobin and Gary Walsh

16. Country Specific Guidelines from official websites.

Session: 2016-17

13


Semester 1

MDA-105

BIOSTATISTICS

Maximum Marks: 100



Time: 3 hrs




carry equal marks.

Unit I

Probability and Descriptive Statistics Scientific notation: significant digits, rounding off, scientific

notation, Error analysis; Counting and Probability: Addition rules; Permutations; Combinations;

Inclusion-exclusion rule; Sampling with and without replacement; Conditional probability: Bayes‟

theorem; Independence; Descriptive statistics and Random variables; Measures of central tendency:

mean, median, mode; Expectation; Measures of spread: range, percentile, standard deviation;

Higher moments: kurtosis, skew, Displaying data: Histograms, Stemand-leaf plots, box plots,

frequency distributions; Discrete random variables: Bernoulli, Binomial, Poisson; Geometric

distributions; Continuous random variables: Normal; Exponential distributions; Standard normal

distribution. (9 Lectures)

Unit II

Inferential statistics and one sample hypothesis testing Samples and populations: Random,

stratified and cluster sampling; Single- and Double-blind experiments; Point and interval estimates;

Sampling distributions: t, chi-square, F distributions; Hypothesis testing: null and alternative

hypotheses, decision criteria, critical values, type I and type II errors, Meaning of statistical

significance; Power of a test; One sample hypothesis testing: Normally distributed data: z, t and chi-

square tests; Binomial proportion testing. (9 Lectures)

Unit III

Multi-sample and nonparametric hypothesis testing two sample hypothesis testing; Nonparametric

methods: signed rank test, rank sum test; Kruskal-Wallis test; Analysis of variance: One-way

ANOVA. (9 Lectures)

Unit IV

Curve fitting Regression and correlation: simple linear regression; Least squares method; Analysis

of enzyme kinetic data; Michaelis-Menten; Lineweaver-Burk and the direct linear plot; Logistic

Regression; Polynomial curve fitting.

Design of Experiments Single factor experiments; Randomized block design; Lackett-Burman

Design; Comparison of k treatment means; Factorial designs; Blocking and confounding; Response

surface methodology. (9 Lectures)

Texts/References

1. Bernard Rosner, Fundamentals of Biostatistics, 5th Edition, Thomson Brooks/Cole, 2000.

2. Richard A. Johnson, Probability and Statistics for Engineers, 6th Edition, Prentice Hall,

2000.

3. Morris H. DeGroot, Mark J. Schervish, Probability and Statistics, 3rd Rev. Edition,

Addison-Wesley, 2002.

4. E. Kreyszig, Advanced Engineering Mathematics, 9th Edition, John Wiley, 2006.

Session: 2016-17

14


Semester 1

MDA-106

Practical (MAT)

Maximum Marks: 100

Time: 06 hrs/week

1. Use of UV Vis spectrophotometer for analysis of Pharmacopoeial compounds and their

formulations.

2. Simultaneous estimation of multi component containing formulations by UV

spectrophotometry.

3. Effect of pH and solvent on UV spectrum of certain drugs.

4. Experiments on factors affecting the absorbance/fluorescence in UV spectroscopy/

Fluorimetry.

5. Interpretation of IR spectra

6. Experiments based on various chromatography techniques for separation of mixture of

compounds.

7. Any other practical based on aforementioned theory.

Reference books:

1. Principles of Instrumental Analysis, 5th

Ed., D.A. Skoog, F.J. Holler and T. A. Nieman.

2. "Spectrometric Identification of Organic Compounds" Silverstein, R.M., Bassler & Morril

5th Ed., 1991.


4. Pharma Analysis, Modern Methods - (Ed) James W Munson Part-B, Vol. -2.








Session: 2016-17

15


Semester 1

MDA-107

PRACTICAL DRUG REGULATORY AFFAIRS

Maximum Marks: 100

Time: 18 hrs

Twenty Assignments to be carried out and submitted on the aforementioned theoretical aspects like:

1. Preparation of clinical trial protocol for registering trial in India

2. Registration for conducting BA/ BE studies in India

3. Import of medical devices into India

4. Import of drugs for research and developmental activities

5. Preparation of regulatory dossier as per Indian CTD format

6. Registering for different Intellectual Property Rights in India

7. Registration of a facility for conducting animal studies

8. Preparation of Product Safety Update Report (PSUR) for an approved product

9. GMP Audit Requirements as per CDSCO

10. Preparation and documentation for Indian Patent application


1. Preparation of checklist for registration of IND as per ICH CTD format.

2. Preparation of checklist for registration of NDA as per ICH CTD format.

3. Preparation of checklist for registration of ANDA as per ICH CTD format.

4. Case studies on response with scientific rationale to USFDA Warning Letter

5. Patent challenge / non infringement (Para IV) case studies.

6. Preparation of Periodic Safety Update Report (PSUR).

7. Comparison study of DMF system in US and EU

8. Preparation of an IMPD for EU submission.

9. Preparation of Clinical Trial Application (CTA) for EU submission

10. Comparison study of marketing authorization procedures in EU.

11. Checklist for registration of prescription medicines (Category I & II applications) for TGA

12. Checklist for submission of Category III applications (Post approval changes) for TGA

13. Study of DMF system in Japan

14. Preparation of submission checklist for Class I, II and III medical devices

15. Preparation of submission checklist for registration of OTC products

16. Preparation of submission checklist for registration of Herbal products

17. Comparison of Clinical Trial Application Requirements of US, EU and Japan of a dosage

form.


1. Preparation of checklist for registration of IND as per ICH CTD format.

2. Preparation of checklist for registration of NDA as per ICH CTD format.

3. Preparation of checklist for registration of ANDA as per ICH CTD format.

4. Case studies on response with scientific rationale to USFDA Warning Letter

5. Patent challenge / non infringement (Para IV) case studies.

6. Preparation of Periodic Safety Update Report (PSUR).

7. Comparison study of DMF system in US and EU

8. Preparation of an IMPD for EU submission.

Session: 2016-17

16

9. Preparation of Clinical Trial Application (CTA) for EU submission

10. Comparison study of marketing authorization procedures in EU.

11. Checklist for registration of prescription medicines (Category I & II applications) for TGA

12. Checklist for submission of Category III applications (Post approval changes) for TGA

13. Study of DMF system in Japan

14. Preparation of submission checklist for Class I, II and III medical devices

15. Preparation of submission checklist for registration of OTC products

16. Preparation of submission checklist for registration of Herbal products

17. Comparison of Clinical Trial Application Requirements of US, EU and Japan of a dosage

form.

Session: 2016-17

17


Semester 2

MDA-201

Modern Analytical Techniques-II (MAT-II)

Maximum Marks: 100



Time: 3 hrs




carry equal marks.

UNIT-I

Nuclear Magnetic Resonance Spectroscopy: Fundamental principles of NMR (Magnetic

Properties of nuclei, applied field and precession, absorption and transition frequency). Chemical

shift concept, Isotopic nuclei, Reference standards, proton magnetic spectra, their characteristics,

presentation, terms used in describing spectra and their interpretation (signal no., position,

intensity), Brief outline of instrumental arrangements and some practical details, Signal multiplicity

phenomena in high resolution PMR, Spin-spin coupling, Application of Signal Splitting and

coupling constant data to interpretation of spectra, Decoupling and shift reagent methods.

Quantitative NMR. Brief outline of principles of 13

C NMR. Introduction to 2-D NMR Techniques.

Applications of NMR technique in Pharmaceutical sciences. (9 Lectures)

UNIT-II

Mass Spectrometry: Basic principles and brief outline of instrumentation. Ion formation and types,

molecular ion, meta stable ions, fragmentation processes, Fragmentation patterns and fragment

characteristics in relation to parent structure and functional groups, Relative abundances of isotopes

and their contribution to characteristic peaks, Mass spectrum, its characteristics, presentation and

interpretation, Chemical ionisation mass spectrometry, ESI, Ion-trap. FAB mass spectroscopy.

Applications of mass spectrometry. (9 Lectures)

UNIT-III

X-Ray Diffraction Methods: Elementary crystallography, X-Ray diffraction, Bragg‟s law, X-Ray

powder diffraction, X-Ray powder diffractometer- interpretation of data.

Thermal Analysis: Principles and applications of thermogravimetric analysis (TGA), Differential

thermal analysis (DTA) and Differential scanning Calorimetry (DSC). (9 Lectures)

Unit-IV

Electrophoresis: Principle, techniques, instrumentation including detection strategies and

applications.

Hyphenated techniques: Brief introduction (LC-MS, GC-MS, GC-IR, LC-NMR and GC-NMR)

and applications.

Radioimmunoassay Assay and ELISA: Principle, instrumentation and applications. (9 Lectures)

Session: 2016-17

18

Reference books:


2. "Spectrometric Identification of Organic Compounds" Silverstein, R.M., Bassler & Morril 5th

Ed., 1991.


4. Pharma Analysis, Modern Methods - (Ed) James W Munson Part-B, Vol -2.








Session: 2016-17

19


Semester II

MDA-207

Practical (MAT-II)

Maximum Marks: 100

Time: 06 hrs/week

1. Interpretation of NMR and Mass spectra.

2. Experiments Based on flame photometry.

3. Any other practical based on aforementioned theory.

Reference books:


2. "Spectrometric Identification of Organic Compounds" Silverstein, R.M., Bassler & Morril

5th Ed., 1991.


4. Pharma Analysis, Modern Methods - (Ed) James W Munson Part-B, Vol -2.

5. Drugs &Pharma, Sciences Series, Marcel Dekker Inc.







Session: 2016-17

20

M. Pharmacy Drug Regulatory Affairs (Pharmaceutics)

Semester 2

MDA-202

PHARMACEUTICAL REGULATORY PRACTICES

Maximum Marks: 100



Time: 3 hrs




carry equal marks.

UNIT-I

1. Medical Devices: Comparative study of Medical Devices and In vitro Diagnostics in India, US

and EU, Japan, China. (9 Lectures)

UNIT-II

2. ICH Guidelines: ICH guidelines to establish quality, safety, efficacy of drug substances and

products. (9 Lectures)

UNIT-III

3. WHO guidelines and its relevance in international registration.

4. Pharmacovigilance: ADR reporting and safety (9 Lectures)

UNIT-IV

5. Basics of Clinical trials and Clinical Research, Preclinical studies, Features of Clinical Trials,

Good Clinical Practices, Bioavailability studies. (9 Lectures)

Books Recommended:

1. Official websites related to various guidelines.

2. Drug & Cosmetic Act, 1940, Controller of Publications, India.

3. www.ich.org/

4. Encyclopaedia of clinical pharmacy, Edited by Joseph T. Dipiro, Marcel Dekker.

5. Preclinical Development Handbook, Toxicology, Edited by Shayne Cox Gad, Wiley

Interscience.

6. FDA regulatory affairs, Edited by, Douglas J. Pisano, CRS Press.

7. The Pharmaceutical Regulatory Process edited by Ira R. Berry, Marcel Dekker.

Session: 2016-17

21

M. Pharmacy Drug Regulatory Affairs (Pharmaceutics)

Semester 2

MDA-203

PHARMACEUTICAL QUALITY MANAGEMENT Maximum Marks: 100



Time: 3 hrs




carry equal marks.

UNIT-I

1) Drug product development: New Drug Discovery and development, Concept of generics,

Generic drug product development, in vitro and in vivo drug product performance, BA/BE

studies, Genotoxic impurities.

2) Requirements to clinical study process, GCP obligations of Investigators, sponsors & Monitors,

Importance of Quality Assurance in clinical trials, Managing and Monitoring clinical trials.

(9 Lectures)

UNIT-II

3) 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).

4) Validation: Types of Validation, Statistical Process Control (SPC), Types of Qualification,

Validation master plan (VMP), Analytical Method Validation. Validation of utilities,

[Compressed air, steam, water systems, Heat Ventilation and Air conditioning (HVAC)],

Cleaning Validation, Validation facilities in Sterile and Non-Sterile area. Validation of Tablets

and sterile products. (9 Lectures)

UNIT-III

5) Quality management: Concept of Quality, Total Quality Management, Quality by design, Six

Sigma concept, Out of Specifications (OOS), Change control

Audits and risk management: Types of Audits, Auditors, Auditing strategies and preparation

of audits, Auditing/inspection of manufacturing facilities by regulatory agencies. Conducting

and Handling of audits, Timelines for audits/inspection, Pre approval inspections, Corrective

and Preventive action (CAPA), Risk Management. (9 Lectures)

Session: 2016-17

22

UNIT-IV

6) Harmonization of regulatory requirements: Common Technical Document (CTD),

Electronic CTD, Harmonization of Pharmacopoeial standards.

The International Organization for Standardization (ISO) 9000 series of quality systems

standards, ISO 14000. (9 Lectures)

Books Recommended:

1. Good Manufacturing Practice Rationale and compliance by John Sharp

2. Pharmaceutical master validation plan: The ultimate guide to FDA, GMP and GLP

Compliance by Syed Imitiaz Haider

3. Pharmaceutical dosage forms: Parenterals Vol-2, II Edition, by Kenneth EA and Leon

Lachman

4. Packaging and Pharmaceuticals and health care products by H. Lockhart, Frank A. Paine

5. Establishing a CGMP laboratory audit system- A Practical guide by David M. Bliesner.

6. J.F.Hanlon: Hand book of package engineering :Mac-Grawhill company

7. Good manufacturing practices: A plan total quality control: S.H. Wilhing, M.M. Tuckerman,

S. Hitchings, Marcel Deckker, Inc. New York.

8. Pharmaceutical Process Validation, 3rd Edition, Edited by Robert Nash and Alfred Wachter,

Marcel Dekker

9. Good Manufacturing Practices for Pharmaceuticals: A Plan for Total Quality Control from

Manufacturer to Consumer, Sidney J. Willig, Marcel Dekker, 5th Ed.

10. Validation of Pharmaceutical Processes: Sterile Products, Frederick J. Carlton (Ed.) and

James Agalloco (Ed.), Marcel Dekker, 2nd Ed.

11. Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance

in the Pharmaceutical, Medical Device, and Biotech Industries, Syed Imtiaz Haider

12. Pharmaceutical Equipment Validation: The Ultimate Qualification Handbook, Phillip A.

Cloud, Interpharm Press

13. Pharmaceutical Quality Assurance by Manohar A. Potdhar, 2nd edition, Nirali Prakashan.

Session: 2016-17

23


Semester 2

MDA-204

PHARMACEUTICAL REGULATORY MANAGEMENT

Maximum Marks: 100



Time: 3 hrs




carry equal marks.

UNIT-I

1. Regulatory Capacity of Organisation:

Legal Basis, Organizational Structure and Authority, Human Resources, Financing Drug

Regulation

2. CMC Post-approval Regulatory Affairs

3. Licensing of Manufacturing, Distribution and Retail Sale Power and Process, Human

Resources, Paying For Licensing Performance (9 Lectures)

UNIT-II

4. Inspection and Surveillance

Power and Process: Comparing Structures And Processes, Human Resources, Paying For

Inspection, Planning, Process And Performance

5. Product Assessment and Registration

Power and Process, Human Resources, Paying For Registration Performance, Adverse Drug

Reaction Monitoring, Clinical Trials (9 Lectures)

UNIT-III

6. Control of Drug Promotion and Advertising

Power and Process: Comparing Structures and Processes, Performance

7. Drug Quality Control Laboratory

Power and Process, Human Resources, Performance

8. Assessing Regulatory Performance

Assessing Government Functions: An Essential Part of Policy-Making Monitoring and

Evaluating the Effectiveness and Efficiency of Drug Regulation, Monitoring and Evaluating

the Accountability and Transparency of Drug Regulation (9 Lectures)

Session: 2016-17

24

UNIT-IV

9. Intellectual Property Rights

a) Intellectual Property rights, TRIPS and GATT agreement, Patent, Copyright and

Trademarks, Exclusive Marketing Rights.

b) Patent systems in India: Types of patent, patent rights, claims, patent infringement,

forms & filings.

c) Patent applications in foreign countries.

d) Scientific Exchange in Genomic Research (9 Lectures)

Books Recommended:

1. Official websites related to various guidelines.

2. Drug & Cosmetic Act, 1940, Controller of Publications, India.

3. www.ICH.Org

4. International IT Regulations and compliance Quality standards in the pharmaceutical and

regulated Industries, Siri H. Segalsatd. A John Wiley and Sons. Ltd, Publication.

5. FDA regulatory affairs, Edited by, Douglas J. Pisano, CRS Press.

6. The Pharmaceutical Regulatory Process edited by Ira R. Berry, Marcel Dekker.

7. Effective drug regulation, A multi country study, Ms Sauwakon Ratanawijitrasin and Mr

Eshetu Wondemagegnehu, WHO 2002 ISBN 92 4 156206 4

Session: 2016-17

25


Semester 2

MDA-205

INTELLECTUAL PROPERTY RIGHTS

Maximum Marks: 100



Time: 3 hrs




carry equal marks.

UNIT-I

Intellectual Property Rights

Concepts and fundamentals: The emergence and growth of the concepts regarding intellectual

property (IP), intellectual property protection (IPP) and intellectual property rights (IPR); economic

importance, copyright, trademarks; role of IP in pharmaceutical industry; global ramifications and

financial implications.

Ethical issues in IPR/IPP (9 Lectures)

UNIT-II

Trade Related Aspects of Intellectual Property Rights

Intellectual property and international trade, concept behind WTO, WIPO, GATT, TRIPs, TRIMS

and GATS, status in India and other developing countries. (9 Lectures)

UNIT-III

Indian Patent Act. 1970 and its amendments: WTO and modifications under TRIPS, filing of a

patent application, precautions before patenting-disclosures/non-disclosures, publication-

article/thesis, prior art search – published patents search, internet search, patent sites, specialized

service search requests, costs, patent application forms and guidelines, fee structure, time frames,

jurisdiction aspects. (9 Lectures)

UNIT-IV

Technology Development/Transfer Commercialization Related Aspects Technology

development: Types of patent applications provisional, non-provisional, PCT and convention

patent applications, international patenting requirement procedures and costs. Patent infringement:

Meaning, scope, litigation, drug related patents infringements, case studies and examples, patenting

by research students. (9 Lectures)

Session: 2016-17

26

Reading Material Recommended

1. Treece DJ. Managing Intellectual Capital: Organizational, Strategic and Policy Dimension.

Oxford University Press, England. Latest Edition.

2. Wadedhra BL. Law Relating to Patents, Trademarks, Copyright Design and Geographical

Indications. Universal Law Publishing, New Delhi. Latest Edition.

3. Bansal P. IPR Handbook for Pharma Students and Researchers, Pharma Book Syndicate,

Hyderabad. Latest Edition.

4. Copyright Protection in India [website: http:copyright.gov.in].

5. Information on Orange Book [website: www.fda.gov/cder/ob/default.htm].

http://www.fda.gov/cder/ob/default.htm

Session: 2016-17

27


Semester 2

MDA-207

PRACTICAL DRUG REGULARITY AFFAIRS

Maximum Marks: 100

Time: 18 hrs

Twenty Assignments to be carried out and submitted on the fore mentioned theoretical aspects like:

1. Validation of equipments like HPLC, Dissolution, UV spectrophotometer, tablet press

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. Labelling comparison between brand and generics.

Session: 2016-17

28


Semester 3

MDA-301

PHARMACEUTICAL ENTREPRENEURSHIP

Maximum Marks: 100



Time: 3 hrs




carry equal marks.

UNIT-I

Accounting and Finance

Taking decision on starting a venture; Assessment of feasibility of a given venture/new venture;

Approach a bank for a loan; Sources of financial assistance; Making a business proposal/Plan for

seeking loans from financial institution and Banks; Funds from bank for capital expenditure and for

working; Statutory and legal requirements for starting a company/venture; Budget planning and

cash flow management; Basics in accounting practices: concepts of balance sheet, P&L account,

and double entry bookkeeping; Estimation of income, expenditure, profit, income tax etc.

UNIT-II

Marketing

Assessment of market demand for potential product(s) of interest; Market conditions, segments;

Prediction of market changes; Identifying needs of customers including gaps in the market,

packaging the product; Market linkages, branding issues; Developing distribution channels;

Pricing/Policies/Competition; Promotion/ Advertising; Services Marketing

UNIT-III

Negotiations/Strategy With financiers, bankers etc.; With government/law enforcement authorities; With

companies/Institutions for technology transfer; Dispute resolution skills; External

environment/changes; Crisis/ Avoiding/Managing; Broader vision–Global thinking

Information Technology How to use IT for business administration; Use of IT in improving business performance; Available

software for better financial management; E-business setup, management.

UNIT-IV

Human Resource Development (HRD) Leadership skills; Managerial skills; Organization structure, pros & cons of different structures;

Team building, teamwork; Appraisal; Rewards in small scale set up.

Fundamentals of Entrepreneurship Support mechanism for entrepreneurship in India

Role of knowledge centre and R&D Knowledge centres like universities and research institutions; Role of technology and upgradation;

Assessment of scale of development of Technology; Managing Technology Transfer; Regulations

for transfer of foreign technologies; Technology transfer agencies.

Session: 2016-17

29

Case Study 1. Candidates should be made to start a „mock paper company‟, systematically following all

the procedures.

• The market analysis developed by them will be used to choose the product or services.

SEMESTER - IV 25 M.Sc (General Biotechnology)

• A product or service is created in paper and positioned in the market. As a product or

services available only in paper to be sold in the market through the existing links. At this

juncture, the pricing of the product or the service needs to be finalized, linking the

distribution system until the product or services reaches the end consumer.

• Candidates who have developed such product or service could present the same as a

project work to the Panel of Experts, including representatives from industry sector. If the

presented product or service is found to have real potential, the candidates would be exposed

to the next level of actual implementation of the project.

2. Go to any venture capital website (like sequoiacap.com) and prepare a proposal for funding

from

SUGGESTED READINGS:

1. Dynamics of Entrepreneurial Development & Management, Vasant Desai – Himalaya

Publishing House

2. Entrepreneurship Development –Poornima.M.Charantimath – Small Business Enterprises –

Pearson Education – 2006 (2 & 4)

3. Entrepreneurship Development – S.S.Khanka – S.Chand & Co

Session: 2016-17

30


Semester 4

MDA-401

COMMUNICATION SKILLS

Maximum Marks: 100



Time: 3 hrs




carry equal marks.

Unit-I Human Communication (Theoretical perspective): Its uniqueness, its nature, models of

communication, Types of Human communication, Language, non-verbal communication, logic and

reasoning, lateral thinking. The concept of facilitating: factors, barriers and filters in

communication; the seven C‟s of effective communication. Preparing for interviews, CV/Biodata.

(9 Lectures)

Unit -II

Self-communication, interpersonal communication, dyadic communication, small group

communication. Public communication. Mass Communication. Reliability of communication. Input

and Evaluation Processes (Practice): Listening (process, comprehension, evaluation). Reading

(process, comprehension, evaluation). Watching (process, comprehension, evaluation). Email Do‟s

and Don‟ts. (9 Lectures)

Unit-III Output and Interaction Processes (Practice): Speech (conversation, interview, group discussion,

public speech). Writing (spontaneous writing, guided writing, creative writing). Organizing ideas

(noting, summary, flow charts, concept maps). Correspondence (personal, business). (9 Lectures)

Unit-IV Science/ Scientific Writing (Theory and practice): Goals and Objectives. Ethics in writing. Structure

of documents. Language and grammar. Illustrations and aids. Writing proposals and instructions.

Making presentations. Formatting documents. Drafts and revisions. Editing. Writing popular

science/ journal article. (9 Lectures)

Suggested Texts and References:

1. Communicating a social and career focus, K. M. Berko, Andrew D. Wolvyn and Darlyn R.

2. Wolvyn, Houghton Mifflin Co., Boston (1977)

3. The Craft of Scientific Writing (3rd Edition), Michael Alley, Springer, New York (1996)

4. Science and Technical Writing – A Manual of Style (2nd Edition), Philip Reubens (General

editor), Routledge, New York (2001)

5. Writing Remedies – Practical Exercises for Technical Writing Edmond H. Weiss, Universities

Press (India) Ltd., Hyderabad (2000)

6. Effective Technical Communication, M. Ashraf Rizvi, Tata Mc Graw – Hill Publishing Co. Ltd.,

New Delhi (2005)

Documents

Ch. Bansi Lal University, Bhiwani · its effects, Chromophores and their interaction with EMR, Woodward-Fieser rule, Absorption spectra of organic compounds and complexes illustrating