GUIDELINES FOR COMPETENCY BASED

POSTGRADUATE TRAINING PROGRAMME FOR MD IN

PHARMACOLOGY

Preamble

The purpose of PG education is to create specialists who would provide high quality
health care and advance the cause of science through research & training.

Pharmacology consists of both the experimental (basic) and clinical sciences.

Experimental pharmacology is essential to understanding of drug action in diseases as
well as for the pharmaceutical industry for drug discovery and development. Clinical
pharmacology is essential for prescribing practice in medicine, adverse drug reactions,
clinical trial and pharmacovigilance. The job prospects for a medical pharmacologist are
in academics, pharmaceutical industry/clinical research organization, government
research institutions, in regulatory bodies and as scientific writer or science manager.
Accordingly, a post graduate (MD) student in Pharmacology should be competent to
meet the job requirements at all these places.

The applied nature of the discipline, the move towards integrated course structures, the
widening of discipline boundaries and increasing number of students seeking post
graduation degree raise issues concerning maintaining and improving competency as
along with maintenance of academic standards. These issues also necessitate integration
with other biomedical and clinical disciplines. A pragmatic approach to postgraduate
pharmacology teaching in India is an important step towards addressing the aforesaid
challenges and facilitating a fresh curriculum design.

The purpose of this document is to provide teachers and learners illustrative guidelines to
achieve defined outcomes through learning and assessment. This document was prepared
by various subject-content specialists. The Reconciliation Board of the Academic
Committee has attempted to render uniformity without compromise to purpose and
content of the document. Compromise in purity of syntax has been made in order to
preserve the purpose and content. This has necessitated retention of “domains of
learning” under the heading “competencies”.

SUBJECT SPECIFIC LEARNING OBJECTIVES

At the end of the MD training programme in Pharmacology, the student should acquire
competencies in the following areas:
1. Acquisition of knowledge

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The student should be able to explain clearly concepts and principles of Pharmacology
and therapeutics. The student should also be able to explain the drug development
processes. S/he should be able to explain Drugs and Cosmetics Act, in addition to clinical
trial procedures.

2. Teaching and training

The student should be able to effectively teach undergraduate students in medicine

(MBBS) and allied health science courses (Dentistry and Nursing) so they become
competent healthcare professionals and able to contribute to training of postgraduate
trainees.

3. Research
The student should be able to carry out a research project (both basic and clinical) from
planning to publication and be able to pursue academic interests and continue life-long
learning to become more experienced in all the above areas and to eventually be able to
guide postgraduates in their thesis work.

SUBJECT SPECIFIC COMPETENCIES

The student during the training program should acquire the following
competencies:

A. Cognitive domain
1. Describe and apply pharmacological principles to explain the mechanism/s of the
effects of drugs used in diagnosis, prevention and treatment of diseases of all
systems of human body.
2. Explain pharmacodynamics and pharmacokinetics of drugs.
3. Describe mechanisms of drug-drug interactions and their clinical importance.
4. Apply and integrate knowledge of pathophysiology of diseases and its modulation
by drugs.
5. Acquire knowledge on pharmacogenetics and pharmacogenomics
6. Acquire knowledge on principles of pharmacoeconomics
7. Acquire knowledge on pharmacoepidemiology, including drug utilization
studies.
8. Aquire knowledge and understanding of principles of Good clinical practice
(GCP) and Good laboratory practice (GLP) guidelines
9. Acquire knowledge on essential medicines
10. Acquire knowledge on pharmacovigilance
11. Acquire knowledge and apply the principle of biostatistics in the evaluation and
interpretation of drug safety and efficacy studies
12. Describe how to evaluate, analyse and monitor preclinical and clinical data in
drug discovery

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13. Able to integrate principles of immunology in biochemistry.
14. Demonstrate knowledge of basics of research methodology, develop a research
protocol, conduct the study, record experimental observations, analyse data using
currently available statistical software, interpret results and disseminate these
results and to have the potential ability to pursue further specializations and
eventually be competent to guide students.
15. Describe the principles of teaching - learning technology towards application and
take interactive classroom lectures, modules for problem based learning (PBL),
case discussions, small group discussions, seminars, Journal club and research
presentations
16. Demonstrate knowledge about computer assisted learning (CAL) softwares and
ability to use them efficiently to promote learning of pharmacology.
17. Demonstrate knowledge of principles of Instrumentation.
18. Demonstrate knowledge about recent advances and trends in research in the field
of pharmacology and clinical pharmacology.
19. Acquire knowledge on generic drugs and generic prescription.
20. Acquire knowledge on rational use of drugs and prescription auditing
21. Aquire knowledge about antimicrobial stewardship programs and strategies for
containment of antibiotic resistance
22. Acquire knowledge on animal toxicity studies
23. Acquire knowledge on common poisoning
24. Acquire knowledge on the legal and ethical issues involved in drug
development and research.
25. Acquire knowledge in Biostatistics including use of statistical softwares :
 Estimation Sample size for a clinical trial
 Scales of measurement, data display, measures of central tendency (mean,
median, mode)
 Dispersion of data (variance, standard deviation)
 Selection of tests (of significance) and their applicability
 Correlation and regression analysis
 Basics of systematic reviews and meta-analysis

B. Affective domain
1. Effectively explain to patients, the effects and side effects of drugs, including
the need for medication adherence.
2. Communicate effectively with pharmacological reasoning with students, peers,
staff and faculty, and other members of the health care team on rational use of
drugs and improving spontaneous reporting of adverse events.
3. Demonstrate respect in interactions with peers, and other healthcare
professionals.
4. Demonstrate ethical behavior and integrity in one’s work.

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5. Demonstrate ability to generate awareness about the use of generic drugs in
patients.
6. Acquire skills for self-directed learning to keep up with developments in the
field and to continuously build to improve on skills, expertise and perpetual
professional development.

C. Psychomotor domain
1. Able to predict efficacy and adverse effects associated with use of drugs, along
with causality assessment.
2. Demonstrate skills for prescription writing.
3. Perform major in vivo and in vitro animal experiments.
4. Observe and understand basic principles of working of important advanced
techniques, like High Performance Liquid Chromatography (HPLC).
5. Demonstrate standard operating procedures of various methods and techniques
used in clinical trials and research.
6. Determine levels of common poisons in blood
7. Demonstrate presentation skills at academic meetings, publications and writing
research projects for funding agencies.
8. Be able to analyze and evaluate a research paper

By the end of the course, the trainee should have acquired practical skills in the
following:

1. In vivo and ex vivo experiments, like organ bath, analgesiometer, physiography/

polygraph, convulsiometer, plethysmograph, learning and memory, models for
affective disorders.
2. Administration of drugs by various routes (subcutaneous, intravenous,
intraperitoneal) in experimental animals
3. Collection of blood samples and oral gavage in experimental animals
4. Preparation and administration of a drug solution in appropriate strength and
volume
5. Experiments to show dose response curve of agonists (in the presence or absence
of an antagonist) on various biological tissues, like
i) Isolated rabbit/rat/ guinea-pig intestine
ii) Isolated rat uterus

6. Determination of EC50, ED50, pD2 and pA2 values of drugs

7. Perform in vivo experiments to study effect of mydiatrics and miotics on rabbit
eye
8. Perform in vivo experiments to study effect of antiepileptic drugs using animal
models of epilepsy

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9. Perform in vivo experiments to study effect of analgesics using animal models of
analgesia
10. Perform in vivo experiments to study effects of drugs on learning, memory and
motor coordination
11. Estimate toxic drug levels using chemical and biological tests (alkaloids,
glycosides, steroids, barbiturates, salicylates) by commonly used methods)
12. Clinical pharmacology
i) Prepare protocol for a clinical trial
ii) Prepare Informed consent form and participant information sheet for
research involving human participants
iii) Report Serious Adverse Effect (SAE)
iv) Evaluate promotional drug literature
v) Prepare “Drug Information Sheet” (WHO criteria)
vi) Interpret bioavailability parameters with the help of given
pharmacokinetics data
vii) Perform causality assessment and report ADR as per
Pharmacovigilance Programme of India (PvPI)

Animal Experiments: All animal experiments must be compliant with Govt. of

India regulations, notified from time to time. Amphibian/Dog/Cat experiments
should be conducted by computer assisted simulation models/ facilities. Other
experiments should be performed as permissible by CPCSEA guidelines

Syllabus

The course contents should cover the following broad topics:

1. Basic and molecular pharmacology

2. Drug receptors and Pharmacodynamics
3. Pharmacokinetics (Absorption, Distribution, Metabolism and Excretion)
4. Biotransformation
5. Pharmacogenomics and Pharmacogenetics
6. Autonomic Pharmacology
7. Drugs acting on Smooth muscles
8. Clinical pharmacology
9. Drug development and Regulations
10. Clinical Pharmacokinetics
11. Drugs acting on Synaptic and Neuroeffector Junctional sites
12. Drugs acting on Central Nervous System (Sedative, Hypnotics, Antiepileptics,
General Anesthetics, Local Anesthetics, Skeletal Muscle Relaxants,

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 Antipsychotic, Antidepressants, Drugs used in Parkinson’s disease and other
neurodegenerative disorders, opioid agonists and antagonists, Drugs of abuse)
13. Drugs modifying renal function
14. Drugs acting on cardiovascular system and haemostatic mechanisms
(Antihypertensives, Antianginal, Antiarrhythmics, Drugs used in heart failure,
Drugs used in Dyslipidemias, Fibrionolytics, Anticoagulants, Antiplatelets
15. Reproductive Pharmacology
16. Agents effecting calcification and bone turnover
17. Autacoids and related pharmacological agents (NSAIDs) and drugs used in
Rheumatoid arthritis and Gout
18. Gastrointestinal drugs
19. Pharmacology of drugs affecting the respiratory system (drugs used in
Bronchial Asthma and COPD)
20. Antimicrobial, antiparasitics, disinfectants, antiseptics
21. Chemotherapy of neoplastic disease
22. Antiviral drugs
23. Drugs used in Autoimmune disorder and Graft versus Host Disease)
24. Dermatological pharmacology
25. Ocular pharmacology
26. Use of drugs in pregnancy
27. Perinatal and Pediatric Pharmacology
28. Geriatric Pharmacology
29. Immunomodulators - immunosuppressants and immunostimulants
30. Pharmacology of drugs used in endocrine disorders (drugs used in diabetes
mellitus, hypothalamic and pituitary hormones, thyroid and antithyroid drugs,
adrenocorticid hormones and their antagonists, gonadal hormones and their
inhibitors)
31. Drug delivery systems
32. Heavy metal poisoning
33. Non-metallic toxicants - air pollutants, pesticides etc.
34. Research methodology and biostatistics
35. Literature search.
36. Pharmacogenomics, Pharmacovigilance (ADR reporting),
pharmacoeconomics (cost-effectiveness study) and pharmacoepidemiology
37. Over the counter drugs
38. Dietary supplements and herbal medicines
39. Pharmacometrics - methods of drug evaluation.
40. General screening and evaluation of:
 Analgesics, antipyretics, anticonvulsants, anti-inflammatory drugs,
antidepressants, antianxiety and antipsychotics, sedatives, muscle

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 relaxants, antihypertensives, hypocholesterolaemic agents, anti-
arrhythmics, diuretics, adrenergic blocking drugs
 Drugs used in peptic ulcer diseases/Prokinetic agents/ antiemetics
 Antitussives, /anti-asthma agents
 Local Anaesthetics
 Oxytocics, antifertility agents
 Antidiabetics
Behavioral pharmacology models and evaluation of drugs affecting
learning and memory
41. Bioassays
 Bioassay methods
 Animal experiments: Ethical considerations, ethical approval, applicable
regulatory Guidelines (CPCSEA), humane animal research (principles of
3Rs) and alternatives to animal experimentation. General and statistical
considerations
 Anesthetics used in laboratory animals
 Principles of EC50, ED50, pD2 and pA2 values of drugs
 Describe methods of bioassay for estimation of :
Acetylcholine, skeletal neuromuscular junction blockers, adrenaline,
noradrenaline, histamine, 5 HT, hormones, insulin, vasopressin/oxytocin,
estrogen, progestins, ACTH
 Competitive antagonism - pA2 values
 Immunoassays: Concept, types of bioassays and their application/s
 Animal experiments: Ethical consideration, ethical approval
 Regulatory Guidelines (CPCSEA) and alternatives to animal
experimentation
42. Biochemical Pharmacology

 Basic principles and applications of simple analytical methods

 Principles of quantitative estimation of drugs, endogenous compounds and
poisons using Colorimetry, Spectrophotometry, flame photometry, High
Performance Liquid Chromatography (HPLC) and enzyme-linked
immunosorbent assay (ELISA).

TEACHING AND LEARNING METHODS

Postgraduate teaching programme

Teaching methodology
Learning in a PG program is primarily self-directed and in Pharmacology consists of
laboratory and academic work. The formal sessions are merely meant to supplement this

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core effort. Acquisition of practical competencies thus becomes the cornerstone of
postgraduate medical education in Pharmacology.

Formal teaching sessions

• In addition to laboratory work, at least 6-hr of formal teaching per week is
necessary. The departments may select a mix of the following sessions:
Journal club Once a week
Seminar Once a week
Practical Once a week
Group Discussions Once a week
Case discussions Once a month
Interdepartmental case or seminar Once a month
Note: These sessions may be organized as an institutional activity for all
postgraduates.
• Attend accredited scientific meetings (CME, symposia, and conferences).
• A postgraduate student of a postgraduate degree course in broad specialities/super
specialities would be required to present one poster presentation, to read one
paper at a national/state conference and to present one research paper which
should be published/accepted for publication/sent for publication during the
period of his postgraduate studies so as to make him eligible to appear at the
postgraduate degree examination.
• Additional sessions on basic sciences, biostatistics, research methodology,
teaching methodology, hospital waste management, health economics, medical
ethics and legal issues related to experimentation are suggested.
• There should be a training program on Research methodology for existing faculty
to build capacity to guide research and for keeping abreast with rapidly evolving
methods and techniques in related disciplines.
• The postgraduate students shall be required to participate in the teaching and
training programme of undergraduate students and interns.
• Log book: During the training period, the post graduate student should maintain a
Log Book giving details of experimentation done and skills acquired. The log
book shall be used to aid the internal evaluation of the student. The Log books
shall be checked and assessed periodically by the faculty members imparting the
training.
• Department should encourage e-learning activities.

The postgraduate student in M.D (Pharmacology) shall undergo a 3 - year (6 terms of 6

months each) training that will comprise of the following:
I Theory: (lectures, seminars, group discussion, journal club) (at least 6 hours a week,
daily 2 hours for 3 days)
II Rotation:

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Practical training in the following suggested areas: (8 hours a week, daily 4 hours for 2
days)
• Experimental Pharmacology:
In vitro (including bioassays), in vivo (including common methods of drug
evaluation) experiments, computer simulations and toxicity tests
• Chemical Pharmacology:
Identification of drug/toxin by using chemical, biological and analytical tests.
Quantitative estimation - Use of colorimeter, spectrophotometer and/or other
advanced analytical equipments
• Clinical Pharmacology:
I Evaluation of drugs in healthy volunteers as well as patients
II Critical evaluation of drug literature, pharmacoeconomics,
pharmacovigilance and pharmacoepidemiology.
III Thesis on a suitable problem
IV Training in undergraduate teaching
V Computer training

During the training programme, patient safety is of paramount importance;

therefore, skills are to be learnt initially on the models, later to be performed under
supervision followed by performing independently; for this purpose, provision of
skills laboratories in medical colleges is mandatory.

ASSESSMENT
FORMATIVE ASSESSMENT ie., assessment during the training

Formative assessment should be continual and should assess medical knowledge,

patient care, procedural & academic skills, interpersonal skills, professionalism, self
directed learning and ability to practice in the system.

General Principles

Internal Assessment should be frequent, cover all domains of learning and used to
provide feedback to improve learning; it should also cover professionalism and
communication skills. The Internal Assessment should be conducted in theory and
practical/clinical examination.

Quarterly assessment during the MD training should be based on:

1. Journal based / recent advances learning

2. Patient based /Laboratory or Skill based learning
3. Self directed learning and teaching
4. Departmental and interdepartmental learning activity
5. External and Outreach Activities / CMEs

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The student to be assessed periodically as per categories listed in postgraduate
student appraisal form (Annexure I)

SUMMATIVE ASSESSMENT, ie., assessment at the end of training

The summative examination would be carried out as per the Rules given in
POSTGRADUATE MEDICAL EDUCATION REGULATIONS, 2000.

The post graduate examination shall be in three parts:

1. Thesis
Every post graduate student shall carry out work on an assigned research project
under the guidance of a recognised Post Graduate Teacher, the result of which shall
be written up and submitted in the form of a Thesis. Work for writing the Thesis is
aimed at contributing to the development of a spirit of enquiry, besides exposing the
post graduate student to the techniques of research, critical analysis, acquaintance
with the latest advances in medical science and the manner of identifying and
consulting available literature.

Thesis shall be submitted at least six months before the Theory and Clinical /
Practical examination. The thesis shall be examined by a minimum of three
examiners; one internal and two external examiners, who shall not be the examiners
for Theory and Clinical examination. A post graduate student shall be allowed to
appear for the Theory and Practical/Clinical examination only after the acceptance of
the Thesis by the examiners.

2. Theory examination:
The examinations shall be organized on the basis of ‘Grading’or ‘Marking system’ to
evaluate and to certify post graduate student's level of knowledge, skill and
competence at the end of the training. Obtaining a minimum of 50% marks in
‘Theory’ as well as ‘Practical’ separately shall be mandatory for passing examination
as a whole. The examination for M.D./ MS shall be held at the end of 3rd academic
year. An academic term shall mean six month's training period.

There shall be four theory papers:

Paper I: General Pharmacology
Paper II: Clinical Pharmacology
Paper III: Systemic Pharmacology
Paper IV: Recent Advances in Pharmacology

3. Practical/clinical and Oral/viva voce examination

Practical:

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 a) Long Experiment:
Demonstrating effects of drugs/interpretation of results in anesthetized animal
Table exercise - Examples are given below:
- Calculating pharmacokinetic parameters
- Statistical exercise
- Critical appraisal of a published paper (abstract writing of a published
paper)
- Evaluation of drug literature.
- Protocol designing
- ADR reporting and causality assessment
- Assessment of preclinical toxicity data
- Analysis of rational and irrational formulations

b) Short experiment
a. Isolated tissue experiment (Bioassay of drugs) (as per Govt regulations)
Or
interpretation of results of a previous tracing

b. In vivo experiment
c) Spotting exercises: Various drug delivery systems, inhalers, insulin syringe,
drip chamber, various tablets, etc.

Oral/Viva voce Examination

Microteaching (teaching exercise)
Discussion on dissertation
Principles of general and systemic pharmacology
Recent advances in pharmacology & drug therapy

Recommended Reading Material

Books (latest edition)

1. Goodman & Gilman's The Pharmacological Basis of Therapeutics, ed. Laurence

Brunton, Bruce A. Chabner, Bjorn Knollman.
2. Essentials of Medical Pharmacology, by KD Tripathi
3. Basic and Clinical Pharmacology, by Bertram G. Katzung and Anthony J. Trevor
4. Drug Discovery and Evaluation: Pharmacological Assays Editors: Vogel, Hans
Clinical Pharmacology by Laurence, Bennett and Brown
6. Rang and Dale's Pharmacology by H.P. Rang
7. Koda Kimble and Youngs Applied Therapeutics by Brian K Alldredge and Robin
L Corelli

Journals
03-05 international Journals and 02 national (all indexed) journals

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 Annexure 1
Postgraduate Students Appraisal Form
Pre / Para /Clinical Disciplines
Name of the Department/Unit :
Name of the PG Student :
Period of Training : FROM…………………TO……………
Sr. PARTICULARS Not Satisfactory More Than Remarks
No. Satisfactory Satisfactory
1 2 3 4 5 6 7 8 9
1. Journal based / recent
advances learning
2. Patient based /Laboratory
or Skill based learning
3. Self directed learning and
teaching
4. Departmental and
interdepartmental
learning activity
5. External and Outreach
Activities / CMEs
6. Thesis / Research work
7. Log Book Maintenance

Publications Yes/ No

Remarks*______________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
________________________________________
*REMARKS: Any significant positive or negative attributes of a postgraduate student to be
mentioned. For score less than 4 in any category, remediation must be suggested. Individual
feedback to postgraduate student is strongly recommended.

SIGNATURE OF ASSESSEE SIGNATURE OF CONSULTANT SIGNATURE OF HOD

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