Pharma. D Regulations 2008
Pharma. D Regulations 2008
Pharma. D Regulations 2008
CHAPTER-II
3. Duration of the course.
a) Pharm.D: The duration of the course shall be six academic years (five years of
study and one year of internship or residency) full time with each academic year
spread over a period of not less than two hundred working days. The period of six
years duration is divided into two phases
Phase I consisting of First, Second, Third, Fourth and Fifth academic year.
Phase II consisting of internship or residency training during sixth year
involving posting in speciality units. It is a phase of training wherein a student is
exposed to actual pharmacy practice or clinical pharmacy services and acquires
skill under supervision so that he or she may become capable of functioning
independently.
b) Pharm.D. (Post Baccalaureate): The duration of the course shall be for three
academic years (two years of study and one year internship or residency) full time
with each academic year spread over a period of not less than two hundred
working days. The period of three years duration is divided into two phases
Phase I consisting of First and Second academic year.
Phase II consisting of Internship or residency training during third year
involving posting in speciality units. It is a phase of training wherein a student is
exposed to actual pharmacy practice or clinical pharmacy services, and acquires
skill under supervision so that he or she may become capable of functioning
independently.
4. Minimum qualification for admission to.
a) Pharm.D. Part-I Course A pass in any of the following examinations (1) 10+2 examination with Physics and Chemistry as compulsory subjects along with one
of the following subjects:
Mathematics or Biology.
(2) A pass in D.Pharm course from an institution approved by the Pharmacy Council of
India under section 12 of the Pharmacy Act.
(3) Any other qualification approved by the Pharmacy Council of India as equivalent to
any of the above examinations.
Provided that a student should complete the age of 17 years on or before 31 st
December of the year of admission to the course.
Provided that there shall be reservation of seats for the students belonging to the
Scheduled Castes, Scheduled Tribes and other Backward Classes in accordance with the
instructions issued by the Central Government/State Government/Union Territory
Administration as the case may be from time to time.
b) Pharm.D. (Post Baccalaureate) Course A pass in B.Pharm from an institution approved by the Pharmacy Council of India under
section 12 of the Pharmacy Act:
Provided that there shall be reservation of seats for the students belonging to the
Scheduled Castes, Scheduled Tribes and other Backward Classes in accordance with the
instructions issued by the Central Government/State Government/Union Territory
Administration as the case may be from time to time.
5. Number of admissions in the above said programmes shall be as prescribed by the
Pharmacy Council of India from time to time and presently be restricted as below
i) Pharm.D. Programme 30 students.
ii) Pharm.D. (Post Baccalaureate) Programme 10 students.
6. Institutions running B.Pharm programme approved under section 12 of the Pharmacy
Act, will only be permitted to run Pharm.D. programme.
Pharm.D. (Post
Baccalaureate) programme will be permitted only in those institutions which are
permitted to run Pharm.D. programme.
7. Course of study. The course of study for Pharm.D. shall include the subjects as
given in the Tables below. The number of hours in a week, devoted to each subject
for its teaching in theory, practical and tutorial shall not be less than that noted against
it in columns (3), (4) and (5) below.
TABLES
First Year :
S.No. Name of Subject
(1)
No. of
hours of
Theory
(2)
No. of
hours of
Practical
(3)
No. of
hours of
Tutorial
(4)
(5)
1.1
1.2
Pharmaceutics
1.3
Medicinal Biochemistry
1.4
1.5
1.6
3*
Total hours
16
18
6 = (40)
* For Biology
Second Year:
S.No
Name of Subject
(1)
No. of
hours of
Theory
(2)
No. of
hours of
Practical
(3)
No. of
hours of
Tutorial
(4)
(5)
2.1
Pathophysiology
2.2
Pharmaceutical Microbiology
2.3
2.4
Pharmacology-I
2.5
Community Pharmacy
2.6
Pharmacotherapeutics-I
Total Hours
17
6 = 32
No. of
hours of
Theory
No. of
hours of
Practical
No. of
hours of
Tutorial
Third Year:
S.No.
Name of Subject
(1)
(2)
(3)
(4)
(5)
3.1
Pharmacology-II
3.2
Pharmaceutical Analysis
3.3
Pharmacotherapeutics-II
3.4
Pharmaceutical Jurisprudence
3.5
Medicinal Chemistry
3.6
Pharmaceutical Formulations
Total hours
16
15
5 = 36
Fourth Year:
S.No. Name of Subject
(1)
No. of
hours of
Theory
(2)
No. of
hours of
Practical/
Hospital
Posting
(3)
No. of
hours of
Tutorial
(4)
(5)
4.1
Pharmacotherapeutics-III
4.2
Hospital Pharmacy
4.3
Clinical Pharmacy
4.4
4.5
4.6
Clinical Toxicology
Total hours
15
12
6 = 33
No. of
hours of
Theory
No. of
hours of
Hospital
posting*
No. of
hours of
Seminar
Fifth Year:
S.No. Name of Subject
(1)
(2)
(3)
(4)
(5)
5.1
Clinical Research
5.2
Pharmacoepidemiology and
Pharmacoeconomics
5.3
5.4
Clerkship *
5.5
20
Total hours
20
4 = 32
Sixth Year:
Internship or residency training including postings in speciality units. Student should
independently provide the clinical pharmacy services to the allotted wards.
(i) Six months in General Medicine department, and
(ii) Two months each in three other speciality departments
8. Syllabus. The syllabus for each subject of study in the said Tables shall be as
specified in Appendix -A to these regulations.
9. Approval of the authority conducting the course of study. (1) No person, institution,
society or university shall start and conduct Pharm.D or Pharm.D. (Post
Baccalaureate) programme without the prior approval of the Pharmacy Council of
India.
(2) Any person or pharmacy college for the purpose of obtaining permission under
sub-section (1) of section 12 of the Pharmacy Act, shall submit a scheme as
prescribed by the Pharmacy Council of India.
(3) The scheme referred to in sub-regulation (2) above, shall be in such form and
contain such particulars and be preferred in such manner and be accompanied with
such fee as may be prescribed:
Provided that the Pharmacy Council of India shall not approve any institution
under these regulations unless it provides adequate arrangements for teaching in
regard to building, accommodation, labs., equipments, teaching staff, nonteaching staff, etc., as specified in Appendix-B to these regulations.
10. Examination. (1) Every year there shall be an examination to examine the students.
(2) Each examination may be held twice every year. The first examination in a year
shall be the annual examination and the second examination shall be
supplementary examination.
(3) The examinations shall be of written and practical (including oral nature) carrying
maximum marks for each part of a subject as indicated in Tables below :
TABLES
First Year examination :
S.No.
Name of Subject
1.1
1.2
1.3
1.4
1.5
1.6
Sessional
Total
Examination
Sessional
Total
70
30
100
70
30
100
70
70
70
30
30
30
100
100
100
70
70
70
30
30
30
100
100
100
70
30
100
70
30
100
70
30
100
70*
30*
100*
600
* for Biology.
600 = 1200
Name of Subject
2.1
2.2
2.3
2.4
2.5
2.6
Pathophysiology
Pharmaceutical
Microbiology
Pharmacognosy &
Phytopharmaceuticals
Pharmacology-I
Community Pharmacy
Pharmacotherapeutics-I
Sessional
Total
Sessional
Total
70
70
30
30
100
100
70
30
100
70
30
100
70
30
100
70
70
70
30
30
30
100
100
100
600
70
30
100
300 = 900
Name of Subject
3.1
3.2
3.3
3.4
3.5
3.6
Pharmacology-II
Pharmaceutical Analysis
Pharmacotherapeutics-II
Pharmaceutical
Jurisprudence
Medicinal Chemistry
Pharmaceutical Formulations
Sessional
Total
Sessional
70
70
70
70
30
30
30
30
100
100
100
100
70
70
70
-
30
30
30
70
70
30
30
100
100
600
70
70
30
30
Total
100
100
100
100
100
500 = 1100
Name of Subject
4.1
4.2
4.3
4.4
4.5
4.6
Pharmacotherapeutics-III
Hospital Pharmacy
Clinical Pharmacy
Biostatistics & Research
Methodology
Biopharmaceutics &
Pharmacokinetics
Clinical Toxicology
Sessional
Total
Sessional
Total
70
70
70
70
30
30
30
30
100
100
100
100
70
70
70
-
30
30
30
-
100
100
100
-
70
30
100
70
30
100
70
30
100
600
400 = 1000
Name of Subject
5.1
5.2
5.3
5.4
5.5
Clinical Research
Pharmacoepidemiology and
Pharmacoeconomics
Clinical Pharmacokinetics
& Pharmacotherapeutic Drug
Monitoring
Clerkship *
Project work (Six Months)
Sessional
Total
Sessional
Total
70
70
30
30
100
100
70
30
100
300
70
100**
30
-
100
100
200 = 500
11. Eligibility for appearing Examination. Only such students who produce certificate
from the Head of the Institution in which he or she has undergone the Pharm.D. or as
the case may be, the Pharm.D. (Post Baccalaureate) course, in proof of his or her
having regularly and satisfactorily undergone the course of study by attending not less
than 80% of the classes held both in theory and in practical separately in each subject
shall be eligible for appearing at examination.
12. Mode of examinations. (1) Theory examination shall be of three hours and practical
examination shall be of four hours duration.
(2) A Student who fails in theory or practical examination of a subject shall re-appear
both in theory and practical of the same subject.
(3) Practical examination shall also consist of a viva voce (Oral) examination.
(4) Clerkship examination Oral examination shall be conducted after the completion
of clerkship of students. An external and an internal examiner will evaluate the
student. Students may be asked to present the allotted medical cases followed by
discussion. Students capabilities in delivering clinical pharmacy services,
pharmaceutical care planning and knowledge of therapeutics shall be assessed.
13. Award of sessional marks and maintenance of records. (1) A regular record of both
theory and practical class work and examinations conducted in an institution
imparting training for Pharm.D. or as the case may be, Pharm.D. (Post Baccalaureate)
course, shall be maintained for each student in the institution and 30 marks for each
theory and 30 marks for each practical subject shall be allotted as sessional.
(2) There shall be at least two periodic sessional examinations during each academic
year and the highest aggregate of any two performances shall form the basis of
calculating sessional marks.
(3) The sessional marks in practicals shall be allotted on the following basis:(i) Actual performance in the sessional examination
(20 marks);
(ii) Day to day assessment in the practical class work,
promptness, viva-voce record maintenance, etc.
(10 marks).
10
14. Minimum marks for passing examination. A student shall not be declared to have
passed examination unless he or she secures at least 50% marks in each of the
subjects separately in the theory examinations, including sessional marks and at least
50% marks in each of the practical examinations including sessional marks. The
students securing 60% marks or above in aggregate in all subjects in a single attempt
at the Pharm.D. or as the case may be, Pharm. D. (Post Baccalaureate) course
examination shall be declared to have passed in first class. Students securing 75%
marks or above in any subject or subjects shall be declared to have passed with
distinction in the subject or those subjects provided he or she passes in all the subjects
in a single attempt.
15. Eligibility for promotion to next year. All students who have appeared for all the
subjects and passed the first year annual examination are eligible for promotion to the
second year and, so on. However, failure in more than two subjects shall debar him
or her from promotion to the next year classes.
16. Internship. (1) Internship is a phase of training wherein a student is expected to
conduct actual practice of pharmacy and health care and acquires skills under the
supervision so that he or she may become capable of functioning independently.
(2) Every student has to undergo one year internship as per Appendix-C to these
regulations.
17. Approval of examinations. Examinations mentioned in regulations 10 to12 and 14
shall be held by the examining authority hereinafter referred to as the university,
which shall be approved by the Pharmacy Council of India under sub-section (2) of
section 12 of the Pharmacy Act, 1948. Such approval shall be granted only if the
examining authority concerned fulfills the conditions as specified in AppendixD to
these regulations.
18. Certificate of passing examination. Every student who has passed the examinations
for the Pharm.D. (Doctor of Pharmacy) or Pharm.D. (Post Baccalaureate) (Doctor of
Pharmacy) as the case may be, shall be granted a certificate by the examining
authority.
11
CHAPTER-III
Practical training
19. Hospital posting. Every student shall be posted in constituent hospital for a period
of not less than fifty hours to be covered in not less than 200 working days in each of
second, third & fourth year course. Each student shall submit report duly certified by
the preceptor and duly attested by the Head of the Department or Institution as
prescribed. In the fifth year, every student shall spend half a day in the morning hours
attending ward rounds on daily basis as a part of clerkship. Theory teaching may be
scheduled in the afternoon.
20. Project work. (1) To allow the student to develop data collection and reporting
skills in the area of community, hospital and clinical pharmacy, a project work shall
be carried out under the supervision of a teacher. The project topic must be approved
by the Head of the Department or Head of the Institution. The same shall be
announced to students within one month of commencement of the fifth year classes.
Project work shall be presented in a written report and as a seminar at the end of the
year. External and the internal examiners shall do the assessment of the project work.
(2) Project work shall comprise of objectives of the work, methodology, results,
discussions and conclusions.
21. Objectives of project work. The main objectives of the project work is to
(i) show the evidence of having made accurate description of published work of
others and of having recorded the findings in an impartial manner; and
(ii) develop the students in data collection, analysis and reporting and interpretation
skills.
22. Methodology. To complete the project work following methodology shall be
adopted, namely:
(i) students shall work in groups of not less than two and not more than four under an
authorised teacher;
(ii) project topic shall be approved by the Head of the Department or Head of the
Institution;
(iii)project work chosen shall be related to the pharmacy practice in community,
hospital and clinical setup. It shall be patient and treatment (Medicine) oriented,
like drug utilisation reviews, pharmacoepidemiology, pharmacovigilance or
pharmacoeconomics;
(iv) project work shall be approved by the institutional ethics committee;
(v) student shall present at least three seminars, one in the beginning, one at middle
and one at the end of the project work; and
(vi) two-page write-up of the project indicating title, objectives, methodology
anticipated benefits and references shall be submitted to the Head of the
Department or Head of the Institution.
12
23. Reporting . (1) Student working on the project shall submit jointly to the Head of
the Department or Head of the Institution a project report of about 40-50 pages.
Project report should include a certificate issued by the authorised teacher, Head of
the Department as well as by the Head of the Institution
(2) Project report shall be computer typed in double space using Times Roman font on
A4 paper. The title shall be in bold with font size 18, sub-tiles in bold with font
size 14 and the text with font size 12. The cover page of the project report shall
contain details about the name of the student and the name of the authorised
teacher with font size 14.
(3) Submission of the project report shall be done at least one month prior to the
commencement of annual or supplementary examination.
24. Evaluation. The following methodology shall be adopted for evaluating the project
work
(i) Project work shall be evaluated by internal and external examiners.
(ii) Students shall be evaluated in groups for four hours (i.e., about half an hour for a
group of four students).
(iii)Three seminars presented by students shall be evaluated for twenty marks each
and the average of best two shall be forwarded to the university with marks of
other subjects.
(iv) Evaluation shall be done on the following items:
Marks
a) Write up of the seminar
(7.5)
b) Presentation of work
(7.5)
c) Communication skills
(7.5)
d) Question and answer skills
(7.5)
Total
(30 marks)
(v) Final evaluation of project work shall be done on the following items:
a) Write up of the seminar
b) Presentation of work
c) Communication skills
d) Question and answer skills
Total
Marks
(17.5)
(17.5)
(17.5)
(17.5)
(70 marks)
Explanation. For the purposes of differentiation in the evaluation in case of topic being
the same for the group of students, the same shall be done based on item numbers b, c and
d mentioned above.
13
APPENDIX-A
(See regulation 8)
PHARM.D. SYLLABUS
First Year
1.1 HUMAN ANATOMY & PHYSIOLOGY (THEORY)
Theory : 3 Hrs. /Week
1. Scope and Objectives: This course is designed to impart a fundamental knowledge
on the structure and functions of the human body. It also helps in understanding both
homeostasis mechanisms and homeostatic imbalances of various body systems. Since
a medicament, which is produced by pharmacist, is used to correct the deviations in
human body, it enhances the understanding of how the drugs act on the various body
systems in correcting the disease state of the organs.
2. Upon completion of the course the student shall be able to:
a. describe the structure (gross and histology) and functions of various organs of the
human body;
b. describe the various homeostatic mechanisms and their imbalances of various
systems;
c. identify the various tissues and organs of the different systems of the human body;
d. perform the hematological tests and also record blood pressure, heart rate, pulse
and Respiratory volumes;
e. appreciate coordinated working pattern of different organs of each system; and
f. appreciate the interlinked mechanisms in the maintenance of normal functioning
(homeostasis) of human body
3. Course materials:
Text books
a. Tortora Gerard J. and Nicholas, P. Principles of anatomy and physiology
Publisher Harpercollins college New York.
b. Wilson, K.J.W. Ross and Wilsons foundations of anatomy and physiology.
Publisher: Churchill Livingstone, Edinburg.
Reference books
a. Guyton arthur, C. Physiology of human body. Publisher: Holtsaunders.
b. Chatterjee,C.C. Human physiology. Volume 1&11. Publisher: medical allied
agency, Calcutta.
c. Peter L. Williams, Roger Warwick, Mary Dyson and Lawrence, H.
d. Grays anatomy. Publisher:Churchill Livingstone, London.
14
15
10 Nervous system
a) Definition and classification of nervous system
b) Anatomy, physiology and functional areas of cerebrum
c) Anatomy and physiology of cerebellum
d) Anatomy and physiology of mid brain
e) Thalamus, hypothalamus and Basal Ganglia
f) Spinal card: Structure & reflexes mono-poly-planter
g) Cranial nerves names and functions
h) ANS Anatomy & functions of sympathetic & parasympathetic N.S.
11 Urinary system
a) Anatomy and physiology of urinary system
b) Formation of urine
c) Renin Angiotensin system Juxtaglomerular apparatus - acid base Balance
d) Clearance tests and micturition
12 Endocrine system
a) Pituitary gland
b) Adrenal gland
c) Thyroid and Parathyroid glands
d) Pancreas and gonads
13 Reproductive system
a) Male and female reproductive system
b) Their hormones Physiology of menstruation
c) Spermatogenesis & Oogenesis
d) Sex determination (genetic basis)
e) Pregnancy and maintenance and parturition
f) Contraceptive devices
14 Sense organs
a) Eye
b) Ear
c) Skin
d) Tongue & Nose
15 Skeletal muscles
a) Histology
b) Physiology of Muscle contraction
c) Physiological properties of skeletal muscle and their disorders (definitions)
16 Sports physiology
a) Muscles in exercise, Effect of athletic training on muscles and muscle
performance,
b) Respiration in exercise, CVS in exercise, Body heat in exercise, Body fluids
and salts in exercise,
c) Drugs and athletics
16
17
(e)
(f)
(g)
(h)
(i)
Digestive system.
Urinary system.
Nervous system.
Special senses.
Reproductive system.
Sessionals
04
04
07
03
02
20
03hrs
Annual
10
10
20
15
15
70
04hrs
Note : Total sessional marks is 30 (20 for practical sessional plus 10 marks for
regularity, promptness, viva-voce and record maintenance).
18
19
20
5. Liniments
a. Liniment of turpentine IP*
b. Liniment of camphor IP
6. Suspensions*
a. Calamine lotion
b. Magnesium Hydroxide mixture BP
7. Emulsions*
a. Cod liver oil emulsion
b. Liquid paraffin emulsion
8. Powders
a. Eutectic powder
b. Explosive powder
c. Dusting powder
d. Insufflations
9. Suppositories
a. Boric acid suppositories
b. Chloral suppositories
10. Incompatibilities
a. Mixtures with Physical
b. Chemical & Therapeutic incompatibilities
* colourless bottles required for dispensing Paper envelope (white), butter paper and
white paper required for dispensing.
Scheme of Practical Examination:
Synopsis
Major Experiment
Minor Experiment
Viva
Max Marks
Duration
Sessionals
05
10
03
02
20
03hrs
Annual
15
25
15
15
70
04hrs
Note : Total sessional marks is 30 (20 for practical sessional plus 10 marks for
regularity, promptness, viva-voce and record maintenance).
21
22
23
24
25
26
27
Annual
15
25
15
15
70
04hrs
Note : Total sessional marks is 30 (20 for practical sessional plus 10 marks for
regularity, promptness, viva-voce and record maintenance).
28
29
16
17
18
19
20
21
30
Annual
15
25
15
15
70
04hrs
Note : Total sessional marks is 30 (20 for practical sessional plus 10 marks for regularity,
promptness, viva-voce and record maintenance).
31
REMEDIAL MATHEMATICS :
1. Scope and objectives: This is an introductory course in mathematics. This subjects
deals with the introduction to matrices, determinants, trigonometry, analytical
geometry, differential calculus, integral calculus, differential equations, laplace
transform.
2. Upon completion of the course the student shall be able to :
a. Know Trignometry, Analytical geometry, Matrices, Determinant, Integration,
Differential equation, Laplace transform and their applications;
b. solve the problems of different types by applying theory; and
c. appreciate the important applications of mathematics in pharmacy.
3. Course materials:
Text books
a. Differential calculus By Shantinarayan
b. Text book of Mathematics for second year pre-university by Prof.B.M.Sreenivas
Reference books
a. Integral calculus By Shanthinarayan
b. Engineering mathematics By B.S.Grewal
c. Trigonometry Part-I By S.L.Loney
4. Lecture wise programme :
Topics
1 Algebra : Determinants, Matrices
2 Trigonometry : Sides and angles of a triangle, solution of triangles
3 Analytical Geometry :Points, Straight line, circle, parabola
4 Differential calculus: Limit of a function, Differential calculus,
Differentiation of a sum, Product, Quotient Composite, Parametric,
exponential, trigonometric and Logarithmic function. Successive
differentiation, Leibnitzs theorem, Partial differentiation, Eulers theorem
on homogeneous functions of two variables
5 Integral Calculus: Definite integrals, integration by substitution and by
parts, Properties of definite integrals.
6 Differential equations: Definition, order, degree, variable separable,
homogeneous, Linear, heterogeneous, linear, differential equation with
constant coefficient, simultaneous linear equation of second order.
7 Laplace transform: Definition, Laplace transform of elementary
functions, Properties of linearity and shifting.
32
BIOLOGY :
1. Scope and objectives: This is an introductory course in Biology, which gives detailed
study of natural sources such as plant and animal origin. This subject has been
introduces to the pharmacy course in order to make the student aware of various
naturally occurring drugs and its history, sources, classification, distribution and the
characters of the plants and animals. This subject gives basic foundation to
Pharmacognosy.
2. Course materials:
Text books
a. Text book of Biology by S.B.Gokhale
b. A Text book of Biology by Dr.Thulajappa and Dr. Seetaram.
Reference books
a. A Text book of Biology by B.V.Sreenivasa Naidu
b. A Text book of Biology by Naidu and Murthy
c. Botany for Degree students By A.C.Dutta.
d. Outlines of Zoology by M.Ekambaranatha ayyer and T.N.Ananthakrishnan.
e. A manual for pharmaceutical biology practical by S.B.Gokhale and C.K.Kokate.
3. Lecture wise programme :
Topic
PART A
01 Introduction
02 General organization of plants and its inclusions
03 Plant tissues
04 Plant kingdom and its classification
05 Morphology of plants
06 Root, Stem, Leaf and Its modifications
07 Inflorescence and Pollination of flowers
08 Morphology of fruits and seeds
09 Plant physiology
10 Taxonomy of Leguminosae, umbelliferae, Solanaceae, Lilliaceae,
Zinziberaceae, Rubiaceae
11 Study of Fungi, Yeast, Penicillin and Bacteria
01
02
03
04
05
06
PART-B
Study of Animal cell
Study animal tissues
Detailed study of frog
Study of Pisces, Raptiles, Aves
Genearal organization of mammals
Study of poisonous animals
33
Sessionals
04
04
07
03
02
20
03hrs
Annual
10
10
20
15
15
70
04hrs
Note : Total sessional marks is 30 (20 for practical sessional plus 10 marks for
regularity, promptness, viva-voce and record maintenance.
34
Second year
2.1 PATHOPHYSIOLOGY (THEORY)
Theory : 3 Hrs. /Week
1. Scope of the Subject: This course is designed to impart a thorough knowledge of the
relevant aspects of pathology of various conditions with reference to its
pharmacological applications, and understanding of basic Pathophysiological
mechanisms. Hence it will not only help to study the syllabus of pathology, but also
to get baseline knowledge of its application in other subject of pharmacy.
2. Objectives of the Subject : Upon completion of the subject student shall be able to
a. describe the etiology and pathogenesis of the selected disease states;
b. name the signs and symptoms of the diseases; and
c. mention the complications of the diseases.
Text books (Theory)
a. Pathologic basis of disease by- Cotran, Kumar, Robbins
b. Text book of Pathology- Harsh Mohan
c. Text book of Pathology- Y.M. Bhinde
Reference books (Theory)
a. Clinical Pharmacy and Therapeutics; Second edition; Roger Walker; Churchill
Livingstone publication
3. Detailed syllabus and lecture wise schedule :
Chapter
1
Basic principles of cell injury and Adaptation
a) Causes, Pathogenesis and morphology of cell injury
b) Abnormalities in lipoproteinaemia, glycogen infiltration and glycogen
infiltration and glycogen infiltration and glycogen storage diseases
2
Inflammation
a) Pathogenesis of acute inflammation, Chemical mediators in
inflammation, Types of chronic inflammation
b) Repairs of wounds in the skin, factors influencing healing of wounds
Diseases of Immunity
a) Introduction to Tand B cells
b) MHC proteins or transplantation antigens
c) Immune tolerance
- Hypersensitivity
Hypersensitivity type I, II, III, IV, Biological significance, Allergy
due to food, chemicals and drugs
- Autoimmunity
Criteria for autoimmunity, Classifications of autoimmune diseases in
man, mechanism of autoimmunity, Transplantation and immunologic
tolerance, allograft rejections, transplantation antigens, mechanism
of rejection of allograft.
- Acquired immune deficiency syndrome (AIDS)
35
- Amylodosis
4
5
6
7
4. Assignments :
Title of the Experiment
1 Chemical Mediators of inflammation
2 Drug Hypersensitivity
3 Cigarette smoking & its ill effects
4 Biological Effects of Radiation
5 Etiology and hazards of obesity
6 Complications of diabetes
7 Diagnosis of cancer
8 Disorders of vitamins
9 Methods in Pathology-Laboratory values of clinical significance
10 Pathophysiology of Dengue Hemorrhagic Fever (DHF)
Format of the assignment
1 Minimum & Maximum number of pages.
2. Reference(s) shall be included at the end.
3. Assignment can be a combined presentation at the end of the academic year
4. It shall be computer draft copy.
5. Name and signature of the student
6. Time allocated for presentation may be 8+2 Min.
36
37
38
Sessionals
05
10
03
02
20
03hrs
Annual
15
25
15
15
70
04hrs
Note : Total sessional marks is 30 (20 for practical sessional plus 10 marks for regularity,
promptness, viva-voce and record maintenance).
39
40
41
42
General Pharmacology
a) Introduction, definitions and scope of pharmacology
b) Routes of administration of drugs
c) Pharmacokinetics (absorption, distribution, metabolism and excretion)
d) Pharmacodynamics
e) Factors modifying drug effects
f) Drug toxicity - Acute, sub- acute and chronic toxicity.
g) Pre-clinical evaluations
h) Drug interactions
Note: The term Pharmacology used here refers to the classification, mechanism of
action, pharmacokinetics, pharmacodynamics, adverse effects, contraindications,
Therapeutic uses, interactions and dose and route of administration.
2.
3.
43
4.
5.
6.
7.
44
45
3
4
5
6
9
10
11
12
13
46
47
48
Annual
15
25
15
15
70
04hrs
Note : Total sessional marks is 30 (20 for practical sessional plus 10 marks for regularity,
promptness, viva-voce and record maintenance).
49
Third Year
3.1 PHARMACOLOGY II (THEORY)
Theory : 3 Hrs. /Week
1. Scope of the Subject: This subject will provide an opportunity for the student to learn
about the drug with regard to classification, pharmacodynamic and pharmacokinetic
aspects, adverse effects, uses, dose, route of administration, precautions, contraindications
and interaction with other drugs. In this subject, drugs acting on autacoids, respiratory
system, GIT, immune system and hormones, and pharmacology of autocoids and
hormones will be concentrated. In addition, pharmacology of chemotherapeutic agents,
vitamines, essential minerals and principles of toxicology are also taught. In addition to
theoretical knowledge, the basic practical knowledge relevant to therapeutics will be
imparted.
2. Objectives of the Subject Upon completion of the subject student shall be able to:
a. understand the pharmacological aspects of drugs falling under the above mentioned
chapters,
b. carry out the animal experiments confidently,
c. appreciate the importance of pharmacology subject as a basis of therapeutics, and
d. correlate and apply the knowledge therapeutically.
Text books (Theory)
a. Tripathi, K. D. Essentials of medical pharmacology. 4 th edition, 1999. Publisher:
Jaypee, Delhi.
b. Satoskar, R.S. and Bhadarkar, S.D. Pharmacology and pharmacotherapeutics. 16 th
edition (single volume), 1999. Publisher: Popular, Dubai.
c. Rang, H.P. and Dale, M.M. Pharmacology. 4 th edition, 1999. Publisher: Churchill
Living stone.
Reference books (Theory)
a. Goodman Gilman, A., Rall, T.W., Nies, A.I.S. and Taylor, P. Goodman and Gilmans
The pharmacological Basis of therapeutics. 9 th edition, 1996. Publisher: Mc Graw
Hill, Pergamon press.
b. Craig, C.R. and Stitzel, R.E. Modern Pharmacology. Latest edition. Publisher: Little
Brown and company.
c. Katzung, B.G. Basic and clinical pharmacology. Latest edition. Publisher: Prentice
Hall, International.
d. Gupta, P.K. and Salunkhe, D.K. Modern Toxicology. Volume I, II and III. Latest
edition. Publisher: B.V. Gupta, Metropolitan Book Co. (p) Ltd, New Delhi.
Text books (Practical)
Kulkarni, S. K. and Dandia, P. C. Hand book of experimental pharmacology. Latest
edition, Publisher: Vallab, Delhi.
50
2.
3.
Chemotherapy
a) Introduction
b) Sulfonamides and co-trimoxazole
c) Penicillins and Cephalosporins
d) Tetracyclins and Chloramphenicol
e) Macrolides, Aminoglycosides, Polyene & Polypeptide
antibiotics
f) Quinolines and Fluroquinolines
g) Antifungal antibiotics
h) Antiviral agents
i) Chemotherapy of tuberculosis and leprosy
j) Chemotherapy of Malaria
k) Chemotherapy of protozoal infections (amoebiasis, Giardiasis)
l) Pharmacology of Anthelmintic drugs
m) Chemotherapy of cancer (Neoplasms)
Immunopharmacology
Pharmacology of immunosuppressants and stimulants
5.
51
6.
Books:
1 Molecular Biology of the Cell by Alberts B., Bray, D., Lewis, J., Raff M., Roberts, K
and Watson, JD, 3rd edition.
2 Molecular Cell Biology By Lodish, H., Baltimore, D., Berk, A et al., 5 th edition.
3 Molecular Biology by Turner, PC., McLennan, AG., Bates, AD and White MRH 2 nd
edition.
4 Genes VIII by Lewin, B., (2004)
5 Pharmaceutical Biotechnology, by Crommelin, DJA and Sindelar RD (1997)
6 Recombinant DNA by Watson, JD., Gilman, M., et al., (1996)
7 Biopharmaceutical: Biochemistry and Biotechnology by Walsh, G., (1998)
52
53
54
3. Electrometric Methods:
Theoretical aspects, instrumentation, interpretation of data/spectra and analytical
applications be discussed on the following topics.
a. Potentiometry: Electrical potential, electrochemical cell, reference electrodes,
indicator electrodes, measurement of potential and pH, construction and working
of electrodes, Potentiometric titrations, methods of detecting end point, Karl
Fischer titration.
b. Conductometry: Introduction, conductivity cell, conductometric titrations and
applications.
c. Polarography: Instrumentation, DME, residual current, diffusion current and
limiting current, polarographic wave, Ilkovics equation, Effect of oxygen on
polarographic wave, Polarographic maxima and suppressors and applications.
d. Amperometric Titrations: Introduction, types of electrodes used, reference and
indicator electrode, instrumentation, titration procedure, advantages and
disadvantages of Amperometry over potentiometry. Pharma applications.
4. Spectroscopy:
Theoretical aspects, instrumentation, elements of interpretation of data/spectra
and application of analytical techniques be discussed on:
a.
Absorption Spectroscopy:
- Theory of electronic, atomic and molecular spectra. Fundamental laws
of photometry, Beer-Lamberts Law, application and its deviation,
limitation of Beer law, application of the law to single and multiple
component analysis, measurement of equilibrium constant and rate
constant by spectroscopy. Spectra of isolated chromophores,
auxochromes, batho-chromic shift, hypsochromic shift, hyperchromic
and hypochromic effect, effect of solvent on absorption spectra,
molecular structure and infrared spectra.
Instrumentation Photometer, U.V.-Visible spectrophotometer
sources of
U.V.-Visible radiations,
collimating
systems,
monochromators, samples cells and
following detectors-Photocell,
Barrier layer cell, Phototube, Diode array, applications of U.V.-Visible
spectroscopy in pharmacy and spectrophotometric titrations.
- Infrared Spectroscopy: Vibrational transitions, frequency structure
correlations, Infrared absorption bands, InstrumentationIR spectrometer sources of IR, Collimating systems, monochromators, sample
cells, sample handling
in IR spectroscopy and detectors
Thermocouple, Golay Cells, Thermistor, Bolometer, Pyroelectric
detector, Applications of IR in pharmacy.
55
c.
d.
e.
f.
g.
h.
i.
types of
56
57
Practicals
Title of the Experiment:
1 Study of agonistic and antagonistic effects of drugs using Guinea-pig ileum
preparation.**
2 To study the effects of drugs on intestinal motility using frogs esophagus model*
3 To study the effects of drugs using rat uterus preparation.**
4 To study the anticonvulsant property of drugs (any one model).*
5 To study antihistaminic property of drug using histamine induced anaphylactic
reaction in guinea pigs.
6 To study the apomorphine-induced compulsive behaviour (stereotypy) in mice.*
7 To study the muscle relaxant property of diazepam in mice using rotarod apparatus.*
8 To study the antiinflammatory property of indomethacin against carrageenan-induced
paw oedema.**
9 To study the anxiolytic effect of diazepam in mice using mirrored-chamber
apparatus.**
10 To demonstrate the effect of various drugs on the blood pressure and respiration of
anaesthetized dog.
11 To study the effect of anthelmintics on earthworms.
12 To study the taming effect of chlorpromazine.*
13 To study the effects of drugs on vas deferense of the male rat.**
14 To study the effect of drugs on pesticide toxicity using rats as model.
15 To study the effect of drugs on heavy metal toxicity.
** indicate major experiment & * indicate minor experiment
Scheme of Practical Examination:
Sessionals
Annual
Synopsis
05
15
Major Experiment
10
25
Minor Experiment
03
15
Viva
02
15
Max Marks
20
70
Duration
03hrs
04hrs
Note : Total sessional marks is 30 (20 for practical sessional plus 10 marks for regularity,
promptness, viva-voce and record maintenance).
58
59
60
61
4.
5.
6.
7.
8.
9.
10.
11.
12.
4. Assignments:
Format of the assignment
1. Minimum & Maximum number of pages
2. It shall be a computer draft copy
3. Reference(s) shall be included at the end.
4. Name and signature of the student
5. Assignment can be a combined presentation at the end of the academic year.
6. Time allocated for presentation may be 8+2 Min
Case studies relating to
1. Drugs and Cosmetics Act and rules along with its amendments, Dangerous Drugs
Act, Medicinal and Toilet preparation Act, New Drug Policy, Professional Ethics,
Drugs (Price control) Order, Patent and Design Act.
2. Various prescription and non-prescription products.
3. Medical and surgical accessories.
4. Diagnostic aids and appliances available in the market.
62
63
64
3.
4.
5.
6.
7.
65
Manufacture of Tablets
a. Ordinary compressed tablet-wet granulation
b. Tablets prepared by direct compression.
c. Soluble tablet.
d. Chewable tablet.
2.
3.
Manufacture of parenterals
a. Ascorbic acid injection
b. Calcium gluconate injection
c. Sodium chloride infusion.
d. Dextrose and Sodium chloride injection/ infusion.
4.
5.
6.
7.
Cosmetic preparations
a. Lipsticks
b. Cold cream and vanishing cream
c. Clear liquid shampoo
d. Tooth paste and tooth powders.
8.
66
Fourth Year
4.1 PHARMACOTHERAPEUTICS III (THEORY)
Theory : 3 Hrs. /Week
1. Scope : This course is designed to impart knowledge and skills necessary for contribution
to quality use of medicines. Chapters dealt cover briefly pathophysiology and mostly
therapeutics of various diseases. This will enable the student to understand the
pathophysiology of common diseases and their management.
2. Objectives: At completion of this subject it is expected that students will be able to
understand
a. the pathophysiology of selected disease states and the rationale for drug therapy;
b. the therapeutic approach to management of these diseases;
c. the controversies in drug therapy;
d. the importance of preparation of individualised therapeutic plans based on diagnosis;
e. needs to identify the patient-specific parameters relevant in initiating drug therapy,
and monitoring therapy (including alternatives, time-course of clinical and laboratory
indices of therapeutic response and adverse effects);
f. describe the pathophysiology of selected disease states and explain the rationale for
drug therapy;
g. to summarize the therapeutic approach to management of these diseases including
reference to the latest available evidence;
h. to discuss the controversies in drug therapy;
i. to discuss the preparation of individualised therapeutic plans based on diagnosis; and
j. identify the patient-specific parameters relevant in initiating drug therapy, and
monitoring therapy (including alternatives, time-course of clinical and laboratory
indices of therapeutic response and adverse effects).
Text Books
a. Clinical Pharmacy and Therapeutics - Roger and Walker, Churchill Livingstone
publication
b. Pharmacotherapy: A Pathophysiologic approach - Joseph T. Dipiro et al. Appleton &
Lange
Reference Books
a. Pathologic basis of disease - Robins SL, W.B.Saunders publication
b. Pathology and therapeutics for Pharmacists: A Basis for Clinical Pharmacy Practice Green and Harris, Chapman and Hall publication
c. Clinical Pharmacy and Therapeutics - Eric T. Herfindal, Williams and Wilkins
Publication
d. Applied Therapeutics: The clinical Use of Drugs. Lloyd Young and Koda -Kimble
MA
e. Averys Drug Treatment, 4th Edn, 1997, Adis International Limited.
f. Relevant review articles from recent medical and pharmaceutical literature.
67
68
69
List of Assignments:
1. Design and Management of Hospital pharmacy department for a 300 bedded hospital.
2. Pharmacy and Therapeutics committee Organization, functions, and limitations.
3. Development of a hospital formulary for 300 bedded teaching hospital
4. Preparation of ABC analysis of drugs sold in one month from the pharmacy.
5. Different phases of clinical trials with elements to be evaluated.
6. Various sources of drug information and systematic approach to provide unbiased
drug information.
7. Evaluation of prescriptions generated in hospital for drug interactions and find out the
suitable management.
70
Special requirements:
1. Each college should sign MoU with nearby local hospital having minimum 150 beds
for providing necessary training to the students on hospital pharmacy activities.
2. Well equipped with various resources of drug information.
Scheme of Practical Examination:
Sessionals
Annual
Synopsis
05
15
Major Experiment
10
25
Minor Experiment
03
15
Viva
02
15
Max Marks
20
70
Duration
03hrs
04hrs
Note : Total sessional marks is 30 (20 for practical sessional plus 10 marks for regularity,
promptness, viva-voce and record maintenance).
71
72
73
Assignment:
Students are expected to submit THREE written assignments (1500 2000 words) on the
topics given to them covering the following areas dealt in theory class.
Drug information, Patient medication history interview, Patient medication counselling,
Critical appraisal of recently published articles in the biomedical literature which deals
with a drug or therapeutic issue.
Format of the assignment:
1. Minimum & Maximum number of pages.
2. Reference(s) shall be included at the end.
3. Assignment can be a combined presentation at the end of the academic year.
4. It shall be computer draft copy.
5. Name and signature of the student.
6. Time allocated for presentation may be 8+2 Min.
74
Research Methodology
a) Types of clinical study designs:
Case studies, observational studies, interventional studies,
b) Designing the methodology
c) Sample size determination and Power of a study
Determination of sample size for simple comparative experiments,
determination of sample size to obtain a confidence interval of specified
width, power of a study
d) Report writing and presentation of data
2 Biostatistics
2.1 a) Introduction
b) Types of data distribution
c) Measures describing the central tendency distributions- average, median,
mode
d) Measurement of the spread of data-range, variation of mean, standard
deviation, variance, coefficient of variation, standard error of mean.
2.2 Data graphics
Construction and labeling of graphs, histogram, piecharts, scatter plots,
semilogarthimic plots
2.3 Basics of testing hypothesis
a) Null hypothesis, level of significance, power of test, P value, statistical
estimation of confidence intervals.
b) Level of significance (Parametric data)- students t test (paired and unpaired),
chi Square test, Analysis of Variance (one-way and two-way)
c) Level of significance (Non-parametric data)- Sign test, Wilcoxans signed
rank test, Wilcoxan rank sum test, Mann Whitney U test, Kruskal-Wall is test
(one way ANOVA)
d) Linear regression and correlation- Introduction, Pearsonns and Spearmanns
correlation and correlation co-efficient.
e) Introduction to statistical software: SPSS, Epi Info, SAS.
75
76
77
78
8. Clinical symptoms and management of chronic poisoning with the following agents
Heavy metals: Arsenic, lead, mercury, iron, copper
9. Venomous snake bites: Families of venomous snakes, clinical effects of venoms,
general management as first aid, early manifestations, complications and snake
bite injuries.
10. Plants poisoning. Mushrooms, Mycotoxins.
11. Food poisonings
12. Envenomations Arthropod bites and stings.
Substance abuse:
Signs and symptoms of substance abuse and treatment of dependence
a) CNS stimulants :amphetamine
b) Opioids
c) CNS depressants
d) Hallucinogens: LSD
e) Cannabis group
f) Tobacco
References:
a. Matthew J Ellenhorn. ELLENHORNS MEDICAL TOXICOLOGY DIAGNOSIS
AND TREATMENT OF POISONING. Second edition. Williams and Willkins
publication, London
b. V V Pillay. HANDBOOK OF FORENSIC MEDICINE AND TOXICOLOGY.
Thirteenth edition 2003 Paras Publication, Hyderabad
79
Fifth year
5.1 CLINICAL RESEARCH (THEORY)
Theory : 3 Hrs. /Week
1. Drug development process:
Introduction
Various Approaches to drug discovery
1. Pharmacological
2. Toxicological
3. IND Application
4. Drug characterization
5. Dosage form
2. Clinical development of drug:
1. Introduction to Clinical trials
2. Various phases of clinical trial.
3. Methods of post marketing surveillance
4. Abbreviated New Drug Application submission.
5. Good Clinical Practice ICH, GCP, Central drug standard control organisation
(CDSCO) guidelines
6. Challenges in the implementation of guidelines
7. Ethical guidelines in Clinical Research
8. Composition, responsibilities, procedures of IRB / IEC
9. Overview of regulatory environment in USA, Europe and India.
10. Role and responsibilities of clinical trial personnel as per ICH GCP
a. Sponsor
b. Investigators
c. Clinical research associate
d. Auditors
e. Contract research coordinators
f. Regulatory authority
11. Designing of clinical study documents (protocol, CRF, ICF, PIC with assignment)
12. Informed consent Process
13. Data management and its components
14. Safety monitoring in clinical trials.
80
References :
a. Central Drugs Standard Control Organization. Good Clinical Practices-Guidelines for
Clinical Trials on Pharmaceutical Products in India. New Delhi: Ministry of Health;
2001.
b. International Conference on Harmonisation of Technical requirements for registration
of Pharmaceuticals for human use. ICH Harmonised Tripartite Guideline. Guideline
for Good Clinical Practice.E6; May 1996.
c. Ethical Guidelines for Biomedical Research on Human Subjects 2000. Indian Council
of Medical Research, New Delhi.
d. Textbook of Clinical Trials edited by David Machin, Simon Day and Sylvan Green,
March 2005, John Wiley and Sons.
e. Principles of Clinical Research edited by Giovanna di Ignazio, Di Giovanna and
Haynes.
f. Clinical Data Management edited by R K Rondels, S A Varley, C F Webbs. Second
Edition, Jan 2000, Wiley Publications.
g. Goodman & Gilman: JG Hardman, LE Limbard, 10th Edn. McGraw Hill
Publications, 2001.
81
Pharmacoepidemiology :
Definition and scope:
Origin and evaluation of pharmacoepidemiology need for pharmacoepidemiology,
aims and applications.
Measurement of outcomes in pharmacoepidemiology
Outcome measure and drug use measures
Prevalence, incidence and incidence rate. Monetary units, number of prescriptions,
units of drugs dispensed, defined daily doses and prescribed daily doses, medication
adherence measurement
Concept of risk in pharmacoepidemiology
Measurement of risk, attributable risk and relative risk, time-risk relationship and
odds ratio
Pharmacoepidemiological methods
Includes theoretical aspects of various methods and practical study of various
methods with the help of case studies for individual methods
Drug utilization review, case reports, case series, surveys of drug use, cross
sectional studies, cohort studies, case control studies, case cohort studies, meta
analysis studies, spontaneous reporting, prescription event monitoring and record
linkage system.
Sources of data for pharmacoepidemiological studies
Ad Hoc data sources and automated data systems.
Selected special applications of pharmacoepidemiology
Studies of vaccine safety, hospital pharmacoepidemiology, pharmacoepidemiology
and risk management, drug induced birth defects.
2.
Phrmacoeconomics:
Definition, history, needs of pharmacoeconomic evaluations
Role in formulary management decisions
Pharmacoeconomic evaluation
Outcome assessment and types of evaluation
Includes theoretical aspects of various methods and practical study of various
methods with the help of case studies for individual methods:
Cost minimization, cost- benefit, cost effectiveness, cost utility
3.
Applications of Pharmacoeconomics
Software and case studies
82
83
APPENDIX-B
(See regulation 9)
84
Specialisation required
1.
Pharmacy Practice
2.
3.
4.
5.
6.
Pharmaceutical Inorganic
Chemistry
7.
Pharmaceutical
microbiology
Pathophysiology
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
M.Pharm in Pharmacognosy
M.Pharm in Pharmaceutical chemistry or
Pharmaceutical Analysis or Quality
assurance or Bulk Drug
M.Pharm in Pharmaceutical chemistry or
Pharmaceutical Analysis or Quality
assurance or Bulk Drug
M.Pharm
in
Pharmaceutics
or
Pharmaceutical Biotechnology
M.Pharm
Pharmacy
practice
or
Pharmacology
M.Pharm in Pharmacology or Pharmacy
practice or Pharmaceutical chemistry
M.Pharm in Pharmacology or Pharmacy
practice
M.Pharm in Pharmaceutics
85
No.
1
Asst. Professor
Lecturer
Professor
Asst. Professor
Lecturer
1
1
3
Professor
Asst. Professor
Lecturer
Department of Pharmacognosy
Professor
Asst. Professor
Lecturer
Department
of
Pharmacy Professor
Practice
Asst. Professor
Lecturer
1
1
2
1
1
1
1
2
3
Department of Pharmaceutical
Chemistry
(Including Pharmaceutical
Analysis)
Department of Pharmacology
2.
CADRE
QUALIFICATIONS
EXPERIENCE
Lecturer
i) Basic degree in
pharmacy (B.Pharm).
ii) Registration as a
pharmacist under the
Pharmacy Act.
iii) First Class Masters
degree in appropriate
branch of
specialization in
Pharmacy (M.Pharm)
No minimum requirement.
Assistant
Professor
i) Basic degree in
pharmacy (B.Pharm).
ii) Registration as a
pharmacist under the
Pharmacy Act.
iii) Masters degree in
appropriate branch of
specialization in
Pharmacy (M.Pharm)
86
iv) Ph.D. degree (with
First Class degree
either at Bachelors or
Masters level) in the
appropriate branch of
specialization in
Pharmacy.
3.
4.
Professor
Director or
Principal
or Head of
institute
i) Basic degree in
pharmacy (B.Pharm).
ii) Registration as a
pharmacist under the
Pharmacy Act.
iii) Masters degree in
appropriate branch of
specialization in
Pharmacy (M.Pharm).
iv) Ph.D. degree (with
first Class either at
Bachelors or Masters
level) in appropriate
branch of
specialization in
Pharmacy.
i) Basic degree in
pharmacy (B.Pharm).
ii) Registration as a
pharmacist under the
Pharmacy Act.
iii) Masters degree in
appropriate branch of
specialization in
Pharmacy (M.Pharm)
iv) Ph.D. degree (with
first Class degree
either at Bachelors or
Masters level in the
appropriate branch of
specialization in
Pharmacy.
87
v) Workload of Faculty :
Professor 8 hrs. per week
Assistant Professor 12 hrs. per week
Lecturers 16 hrs. per week
vi) Training of Pharmacy Practice Faculty :
a) Teaching staff will be trained as per the module prescribed by the Central
Council.
b) Duration of training
Minimum 3 months.
c) Training sites
4) NON-TEACHING STAFF :
Sl.No.
1
2
3
4
5
Designation
Laboratory
Technician
Laboratory
Assistants or
Laboratory
Attenders
Office
Superintendent
Accountant
Store keeper
Required
(Minimum)
1 for each Dept
Required
Qualification
D. Pharm
SSLC
Degree
1
1
Computer
Data Operator
7
8
9
10
Office Staff I
Office Staff II
Peon
Cleaning
personnel
Gardener
1
2
2
Adequate
Degree
D.Pharm or a
Bachelor degree
recognized by a
University or
institution.
BCA or Graduate
with Computer
Course
Degree
Degree
SSLC
---
Adequate
---
11
88
5) ACCOMMODATION :
Suitable and sufficient accommodation with adequate ventilation, lighting and other
hygienic conditions should be provided to the rooms for Principal or the Head of the
department, office, class rooms, library, staff, staff common room, students common
room, museum, laboratories, stores, etc.
At least two lecture halls alongwith eight laboratories as specified below should be
provided for:
1. Pharmaceutics and Pharmacokinetics Lab
-2
2. Life Science (Pharmacology, Physiology, Pathophysiology)
-2
3. Phytochemistry or Pharmaceutical Chemistry
-2
4. Pharmacy Practice
-2
-----Total = 8
-----In addition to the laboratories, balance room, aseptic room or cabinet, animal house
and a machine room shall also be provided.
Floor area of the laboratory should not be less than 30 square feet per student required
to work in the laboratory at any given time subject to a minimum of 750 square feet.
Laboratories should be fitted and constructed in a manner that these can be kept
reasonably clean. Gas and water fittings, shelves, fuming cupboards be provided
wherever necessary.
8
9
10
Name
Microscopes
Haemocytometer with Micropipettes
Sahlis haemocytometer
Hutchinsons spirometer
Spygmomanometer
Stethoscope
Permanent Slides for various tissues
89
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
II. Apparatus:
S.No
1
2
3
4
5
Name
Folin-Wu tubes
Dissection Tray and Boards
Haemostatic artery forceps
Hypodermic syringes and needles of
size 15,24,26G
Levers, cannulae
90
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
02
01
01
01
02
01
01
01
15
15
01
01
15
01
02
02
01
01
II. Apparatus:
S.No.
1
2
3
4
6
7
Name
Reflux flask with condenser
Water bath
Clavengers apparatus
Soxhlet apparatus
TLC chamber and sprayer
Distillation unit
Name
Hot plates
Oven
Refrigerator
Analytical Balances for demonstration
Digital balance 10mg sensitivity
Digital Balance (1mg sensitivity)
Suction pumps
Muffle Furnace
91
9
10
11
12
13
Mechanical Stirrers
Magnetic Stirrers with Thermostat
Vacuum Pump
Digital pH meter
Microwave Oven
10
10
01
01
02
II. Apparatus:
S.No.
Name
1
Distillation Unit
2
Reflux flask and condenser single
necked
3
Reflux flask and condenser double/
triple necked
4
Burettes
5
Arsenic Limit Test Apparatus
6
Nesslers Cylinders
Name
Mechanical stirrers
Homogenizer
Digital balance
Microscopes
Stage and eye piece micrometers
Brookfields viscometer
Tray dryer
Ball mill
Sieve shaker with sieve set
Double cone blender
Propeller type mechanical agitator
Autoclave
Steam distillation still
Vacuum Pump
Standard sieves, sieve no. 8, 10,
12,22,24, 44, 66, 80
Tablet punching machine
Capsule filling machine
Ampoule washing machine
Ampoule filling and sealing machine
92
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
01
01
01
01
01
01
01
01
01
05 EACH
10
01
01
01
02
01
01
02
10
02
02
02
01
01
02
01
01
II. Apparatus:
S.No
1
2
3
4
5
6
7
8
9
Name
Ostwalds viscometer
Stalagmometer
Desiccator*
Suppository moulds
Buchner Funnels (Small, medium,
large)
Filtration assembly
Permeability Cups
Andreasons Pipette
Lipstick moulds
93
2
1
1
94
10
11
12
13
Autoclave sterilizer
Membrane filter
Sintered glass funnel with complete
filtering assemble
Small disposable membrane filter for
IV admixture filtration
Laminar air flow bench
Vacuum pump
Oven
Surgical dressing
Incubator
PH meter
Disintegration test apparatus
Hardness tester
Centrifuge
Magnetic stirrer
Thermostatic bath
1
1 Unit
Adequate
Adequate
14
1
15
1
16
1
17
Adequate
18
1
19
1
20
1
21
1
22
1
23
1
24
1
NOTE:
1. Computers and Internet connection (Broadband), six computers for
students with internet and staff computers as required.
2. Adequate number of glassware commonly used in the laboratory should
be provided in each laboratory and the department.
G. CENTRAL INSTRUMENTATION ROOM :
S.No.
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
Name
Colorimeter
Digital pH meter
UV- Visible Spectrophotometer
Flourimeter
Digital Balance (1mg sensitivity)
Nephelo Turbidity meter
Flame Photometer
Potentiometer
Conductivity meter
Fourier Transform Infra Red
Spectrometer (Desirable)
HPLC
HPTLC (Desirable)
Atomic Absorption and Emission
spectrophotometer (Desirable)
Biochemistry Analyzer (Desirable)
Carbon, Hydrogen, Nitrogen Analyzer
(Desirable)
Deep Freezer (Desirable)
Ion- Exchanger
Lyophilizer (Desirable)
95
APPENDIX-C
(See regulation 16)
INTERNSHIP
1) SPECIFIC OBJECTIVES :
i) to provide patient care in cooperation with patients, prescribers, and other
members of an interprofessional health care team based upon sound therapeutic
principles and evidence-based data, taking into account relevant legal, ethical,
social cultural, economic, and professional issues, emerging technologies, and
evolving biomedical, pharmaceutical, social or behavioral or administrative, and
clinical sciences that may impact therapeutic outcomes.
ii) to manage and use resources of the health care system, in cooperation with
patients, prescribers, other health care providers, and administrative and
supportive personnel, to promote health; to provide, assess, and coordinate safe,
accurate, and time-sensitive medication distribution; and to improve therapeutic
outcomes of medication use.
iii) to promote health improvement, wellness, and disease prevention in co-operation
with patients, communities, at-risk population, and other members of an
interprofessional team of health care providers.
iv) to demonstrate skills in monitoring of the National Health Programmes and
schemes, oriented to provide preventive and promotive health care services to the
community.
v) to develop leadership qualities to function effectively as a member of the health
care team organised to deliver the health and family welfare services in existing
socio-economic, political and cultural environment.
vi) to communicate effectively with patients and the community.
2) OTHER DETAILS :
i) All parts of the internship shall be done, as far as possible, in institutions in India.
In case of any difficulties, the matter may be referred to the Pharmacy Council of
India to be considered on merits.
ii) Where an intern is posted to district hospital for training, there shall be a
committee consisting of representatives of the college or university, and the
district hospital administration, who shall regulate the training of such trainee.
For such trainee a certificate of satisfactory completion of training shall be
obtained from the relevant administrative authorities which shall be countersigned
by the Principal or Dean of College.
96
iii) Every candidate shall be required, after passing the final Pharm.D. or Pharm.D.
(Post Baccalaureate) examination as the case may be to undergo compulsory
rotational internship to the satisfaction of the College authorities and University
concerned for a period of twelve months so as to be eligible for the award of the
degree of Pharm.D. or Pharm.D. (Post Baccalaureate) as the case may be.
3. ASSESSMENT OF INTERNSHIP :
i) The intern shall maintain a record of work which is to be verified and certified by
the preceptor (teacher practioner) under whom he works. Apart from scrutiny of
the record of work, assessment and evaluation of training shall be undertaken by
an objective approach using situation tests in knowledge, skills and attitude during
and at the end of the training. Based on the record of work and date of evaluation,
the Dean or Principal shall issue certificate of satisfactory completion of training,
following which the university shall award the degree or declare him eligible for
it.
ii) Satisfactory completion of internship shall be determined on the basis of the
following:(1) Proficiency of knowledge required for each case management SCORE 0-5
(2) The competency in skills expected for providing Clinical
Pharmacy Services
SCORE 0-5
(3) Responsibility, punctuality, work up of case, involvement
in patient care
SCORE 0-5
(4) Ability to work in a team (Behavior with other healthcare professionals
including medical doctors, nursing staff and colleagues).
SCORE 0-5
(5) Initiative, participation in discussions, research aptitude.
SCORE 0-5
Poor
0
Fair
1
Below Average
2
Average
3
Above Average
4
Excellent
5
97
APPENDIX-D
(See regulation 17)
CONDITIONS TO BE FULFILLED BY
THE EXAMINING AUTHORITY
1. The Examining Authority shall be a statutory Indian University constituted by the
Central Government/State Government/Union Territory Administration. It shall
ensure that discipline and decorum of the examinations are strictly observed at the
examination centers.
2. It shall permit the Inspector or Inspectors of the Pharmacy Council of India to visit
and inspect the examinations.
3. It shall provide:(a) adequate rooms with necessary furniture for holding written examinations;
(b) well-equipped laboratories for holding practical examinations;
(c) an adequate number of qualified and responsible examiners and staff to conduct
and invigilate the examinations; and
(d) such other facilities as may be necessary for efficient and proper conduct of
examinations.
4. It shall, if so required by a candidate, furnish the statement of marks secured by a
candidate in the examinations after payment of prescribed fee, if any, to the
Examining Authority.
5. It shall appoint examiners whose qualifications should be similar to those of the
teachers in the respective subjects as shown in AppendixB.
6. In pursuance of subsection (3) of section 12 of the Pharmacy Act, 1948, the
Examining Authority shall communicate to the Secretary, Pharmacy Council of India,
not less than six weeks in advance the dates fixed for examinations, the time-table for
such examinations, so as to enable the Council to arrange for inspection of the
examinations.
7. The Examining Authority shall ensure that examiners for conducting examination for
Pharm.D. and Pharm.D. (Post Baccalaureate) programmes shall be persons possessing
pharmacy qualification and are actually involved in the teaching of the Pharm.D. and
Pharm.D. (Post Baccalaureate) programmes in an approved institution.
(ARCHNA MUDGAL)
Registrar-cum-Secretary
Pharmacy Council of India
New Delhi 110002