DM Clinical Pharmacology: Admissions, Medical Colleges, Fees, Eligibility Criteria details

Cognitive Domain: theory

A. General pharmacology

• History of development, definition and scope of clinical pharmacology
• Basic pharmacokinetic (PK) principles - ADME (Absorption, Distribution, Metabolism and Excretion) of drugs, membrane transporters
• Studies on bioavailability of drugs including novel dosage forms, drug-drug and drug food interactions, enzyme induction and inhibition,
• Therapeutic drug monitoring – drugs requiring Therapeutic drug monitoring (TDM),dosage adjustments based on physiological or pathological changes, dose optimization strategies
• Population pharmacokinetics: sources and correlates of variability in drug concentrations in patients
• Dose response relationship, PK-PD modelling and simulation
• Physiologically-based pharmacokinetic (PBPK) modeling and simulation - the effects of extrinsic factors viz. concomitant drugs, food and intrinsic factors viz. age, organ dysfunction, disease status, and genetics on drug exposures
• Basic pharmacodynamic (PD) principles – molecular basis of drug action
• Drug disease, drug host, drug environment interactions - mechanisms and clinical importance
• Drug use in special prescribing situations – in children, elderly, during pregnancy, lactation, organ dysfunction – hepatic, renal, cardiac etc., malnutrition
• Pharmacogenomics – application of pharmacogenomics in therapeutic decision making and optimization of clinical care, precision/ personalized medicine
• Animal toxicology and PK-PD data relevant to clinical evaluation of new drugs
• Nomenclature of drugs
• Pharmaco-epidemiology - basic principles of epidemiology, study designs, confounding and bias, analysis and interpretation of data, survival analysis, propensity score methods
• Pharmaco-economics-fundamental concepts and methods, terminology, role in drug development and healthcare decision making and formulary management.

B. Systemic pharmacology

• Cardiovascular system - ischemic heart disease, hypertension, heart failure, circulatory shock, cardiac arrhythmias, stroke, hyperlipidemias and pulmonary arterial hypertension and metabolic syndrome
• Central nervous system - epilepsy, psychosis, depression, mania, anxiety, sleep disorders, general and local anesthetics, opioid analgesics, neurodegenerative disorders, drug addiction.
• Pulmonary pharmacology (common bronchopulmonary diseases. like bronchial asthma, COPD, pulmonary fibrosis and pulmonary function tests)
• Genitourinary system - kidney diseases, acute kidney injury, chronic kidney disease, renal failure, urolithiasis, benign prostatic hypertrophy and prostatic carcinoma
• Gastrointestinal pharmacology – peptic ulcer, GERD, GI motility disorders, inflammatory bowel disease, irritable bowel syndrome.
• Hepatobiliary systems, viral hepatitis, nonalcoholic fatty liver disease, cirrhosis
• Hormones and hormone antagonists – thyroid, female reproductive system, male reproductive system, adrenals, pancreas including diabetes mellitus, bone mineral homeostasis, hypothalamic pituitary axis.
• Cytotoxic and targeted cancer chemotherapy, hormones and related agents in cancer therapy.
• Immuno-pharmacology- immune-suppressants – glucocorticoids, calcineurin inhibitors, antiproliferative and antimetabolic agents, biologics, immunological reactions to drugs and drug allergy.
• Ocular pharmacology – drug delivery strategies, ophthalmic uses of drugs - antimicrobials, autonomic agents, anti-inflammatory, immunomodulatory agents, drugs for retinal neovascularization and macular degeneration, ocular adverse effects of drugs.
• Dermatologic pharmacology
• Pharmacotherapy of inflammation, pain, fever
• Chemotherapy of infectious diseases- bacterial, viral, fungal, protozoal, helminthic and other infections
• Nutraceuticals
• Clinical pharmacology of drugs used in cardiovascular, CNS, renal, pulmonary, gastrointestinal tract, infective, and other disorders
• Common malignant diseases- pathophysiology, drug targets
• Drugs for neglected diseases initiatives in India

C. Use of drugs for diagnostic purposes

• Special contrast media
• Radionuclide imaging

D. Research methodology and biostatistics

• Interventional and epidemiologic study designs
• Qualitative research methods
• Data types and choice of statistical methods
• Descriptive statistics measures and graphs
• Sample size determination and power analysis
• Parametric and non-parametric tests
• Tests for comparing proportions
• Correlation and regression
• Statistics of diagnostic tests
• Logistic regression, multiple regression
• Survival analysis
• Critical interpretation of statistical outputs including P-values and confidence intervals; multiple hypothesis testing
• Principles of interim analysis of clinical trial data
• Overview of statistical software
• Basics of data management
• Role of biostatistician in protocol designing
• Principles of critical appraisal of literature, levels of evidence and quality of evidence
• Role and limitations of evidence in development of guidelines.

E. Clinical trials, BA/BE studies, Bioequivalence and allied topics

• Salient features of various phases of clinical trials, principles of controlled clinical trials, sequential trials, crossover trials, adaptive trials and registries
• Special considerations for Phase I studies – principles of First in Human (FIH) dose determination, pharmacokinetic studies, human pharmacodynamic studies, tolerance, single dose/ multiple dose, dose escalation, infrastructure requirements
• Phase II: Dose selection, study designs, selection of subjects, proof of concept studies, dose ranging studies
• Phase III: Study designs, multicenter trials, global trials, site selection
• Post-marketing studies: types of studies and their objectives, post-marketing surveillance, phase IV trials, Periodic safety update/assessment reports
• Principles and methods of Bioequivalence studies
• Multicentric studies: organization, standardization, quality control, training, protocol compliance, data processing, central randomization, issues
• Use of placebo: pharmacology of placebo, historical aspects, active/inert placebo, placebo reactors, ethics of placebo.
• Washouts and run-in periods: needs, ethics, duration
• Withdrawals, dropouts, and missing values: problems, handling of data
• Clinical trial designs including herbal medicines and AYUSH medicines – history, present status, standardization, preclinical evaluation, special issues and their solutions, regulatory aspects.
• Protocol design, Case Report Form (CRF ), design of standard operating procedure (SOP) development
• Adaptive designs of clinical trials, platform trials, basket trials, umbrella designs
• Interim analysis
• Randomization, blinding and other bias control measures – need, methods, issues and their solutions
• Endpoints and biomarkers (including surrogates) – selection in specific therapeutic areas.
• Stopping rules
• Superiority, inferiority, and equivalence trials
• Per-protocol and intention-to-treat analysis
• Role of monitors, inspectors, auditors, Data Safety Monitoring Board (DSMB)
• Special considerations for bioequivalence and bioavailability (BA/BE) studies.
• Specific topics: academic trials, collaborative research, compensation for participation and trial related injury, trial insurance, compliance monitoring, quality of life assessment.
• Clinical and preclinical development of vaccines
• Clinical trials of repurposed drugs.

F. Ethics in clinical practice and research, including

• Historical evolution of principles of ethics
• Principles of risk benefit assessment
• Nuremberg code, Belmont report, Declaration of Helsinki
• Indian Council of Medical Research (ICMR) ethics guidelines, ethics of pediatric research, pandemic research, research integrity and publication ethics
• Ethical dilemmas in clinical practice and research
• Role of the ethics committee, informed consent
• Vulnerable subjects in clinical research
• Ethics of clinical practice, for e.g., resource allocation in pandemics, organ transplant, euthanasia
• Audiovisual consent.

G. Preclinical studies and their assessment

• Animal pharmacology – efficacy and safety studies, assessment of adequacy of data
• Pharmacokinetics and toxicokinetic studies
• Toxicity studies: acute, subacute, chronic
• Mutagenicity, carcinogenicity, reproductive toxicity, special toxicity studies, safety pharmacology studies, QT prolongation studies
• Good laboratory practices, OECD principles.

H. Pharmaceutics and drug discovery

• Drug formulations, pharmaceutical equivalence
• Good manufacturing practices
• Bioavailability, bioequivalence and bioequivalence studies
• New drug delivery systems
• Screening of chemical compounds, high throughput screening
• Computer assisted drug designing
• General pharmacology and systematic screening.

I. Rational use of medicines, including:

• Principles of rational use of medicines
• Essential medicine lists
• Drug Formularies
• Standard treatment guidelines or protocols from Indian Council of Medical Research, Ministry of Health and Family Welfare and other professional bodies
• Rationality of fixed dose combinations
• Antibiotic policy and antimicrobial stewardship programs for respective medical institutions – role of a clinical pharmacologist – principles, methods, prospective audit and feedback, formulary restriction, educational interventions, guidelines, IV oral switching, dose optimization, timeouts, antibiotic use measures, special situations viz. intensive care, healthcare acquired infections, immuno-compromised patients etc.

J. Regulatory affairs, including

• Good Clinical Practice – role and responsibilities of stakeholders
• Good Laboratory Practice, Good Clinical Laboratory Practice and Good Manufacturing Practice, Other quality guidelines/ regulations – GxP (a collection of quality guidelines and regulations created to ensure that bio/pharmaceutical products are safe, meet their intended use, and adhere to quality processes during manufacturing, control, storage, and distribution)
• Drug laws applicable in India, new drug clinical trial Rules, 2019
• Structure and functions of drug control authority (Central Drugs Standard Control Organization), State Licensing Authorities
• Drug price control by National Pharmaceutical Pricing Authority, Government of India
• Emergency Use authorization of vaccines/ drugs in pandemic situation
• Regulation of nutraceuticals, medical devices, biologics and biosimilars
• Mutual acceptability of data across countries.
• Phytopharmaceuticals.

K. Pharmacovigilance and allied topics, including:

• Types of adverse drug reactions
• Methods of pharmacovigilance
• Causality assessment
• Signal detection and processing
• Adverse events following immunization
• Hemovigilance
• Materiovigilance
• Medication errors
• National program- PvPI, WHO program of international drug monitoring.

L. Clinical toxicology, including:

• General principles of toxicology
• Common poisons and drug toxicities
• Common environmental and occupational hazards
• Basic mechanisms of mutagenesis, teratogenesis, carcinogenesis and organ-specific toxicities
• Sources of toxicology information
• General management of poisoned patient
• Use of specific antidotes and chelating agents
• Use of specialized treatment techniques e.g. charcoal hemoperfusion, hemodialysis
• Management of envenomation e.g. scorpion or snake bites
• Aspects of analytical and forensic toxicology relevant to the poisoned patient.

M. Novel drug delivery systems and therapeutic approaches, including:

• Liposomal and nanoparticle-based drug delivery
• Inhalational drug delivery
• Monoclonal antibodies and other targeted therapies
• Gene therapy
• Stem cell therapy.

N. Miscellaneous topics, including:

• Biosimilar drug products
• Drug utilization studies
• Principles of evidence-based medicine
• Basics of bioinformatics
• Orphan drugs
• Basic and clinical contraceptive research for women and men
• Fetal medicine
• Critical appraisal of pharmaceutical promotional literature
• Clinical Trials Registry of India
• Role of government institutes, pharmaceutical industry, and academic centres in drug development collaborative efforts.
• Intellectual Property Rights and patent rights
• Setting up clinical pharmacology units – roles, infrastructure, personnel requirements.
• Drug repurposing/ repositioning
• Drug development during emergency situations viz. pandemics.

Cognitive Domain: Practical demonstrations and skills

The post graduate student should be able to perform the following procedures independently and/or interpret the results of:

A. Should be able to perform

Pharmacokinetic exercises

• Pharmacokinetics of paracetamol in healthy volunteers using HPLC method
• Pharmacokinetics of sulfonamides in healthy volunteers using spectrophotometric method
• Modification of the dosing of phenytoin based on serum phenytoin concentration
• Design and conduct a single dose study to estimate the orocecal transit time of a given drug X in a healthy subject using sulphapyridine method
• Design and conduct a single dose pharmacokinetic study and calculate the important PK parameters of the given anti-epileptic drug / immunosuppressant drug in a human subject
• To assess the pharmacogenomic variants and use this information for dose optimization of a drug
• Estimate the levels of oxidative stress markers and nitrite in a given sample
• To study the pharmacokinetics of antiepileptic drugs using HPLC method.

Pharmacodynamic exercises

• Recording blood pressure by conventional and ambulatory BP monitors
• Recording and interpretation of 12-lead ECG
• Recording and interpretation of routine lung function tests using a spirometer and assessing effects of a bronchodilator
• Effect of hand grip exercise on blood pressure and heart rate
• Hemodynamic effects of exercising on a treadmill
• Hemodynamic effects of exercising on a bicycle ergometer
• Effect of sublingual nitroglycerin on blood pressure and heart rate and exercise induced changes
• Effect of beta-blockers on isometric exercise-induced hemodynamic changes
• Effect of beta-blockers on exercise tolerance in volunteers utilizing treadmill / bicycle ergometer
• Analgesic effects of drugs in human volunteers
• Adverse effect of drugs on psychomotor performance
• Effect of diuretic on urinary volume and sodium and potassium excretion
• Effect of anticholinergic drug on salivation, pupillary size and heart rate
• Evaluation of analgesic activity of a drug using cold stress test
• Demonstration of pupillary effects of ocular drugs in healthy volunteers
• Evaluation of drug effects on cold induced hemodynamic changes.

Biostatistics exercises

• Sample size calculation for various clinical study scenarios
• Performance of basic parametric and non-parametric tests
• Performance and interpretation of one-way analysis of variance
• Performance and interpretation of statistical tests pertaining to 2 X 2 contingency tables
• Receiver operating characteristic (ROC) curve analysis
• Performance and interpretation of simple and multiple linear regression
• Performance and interpretation of binary logistic regression
• Basic survival analysis
• Interpretation of forest plots and critical assessment of meta-analysis.

Clinical trial related exercises

• Developing a clinical trial protocol
• Developing a BA/BE study protocol
• Developing informed consent / assent documents for a clinical trial
• Developing case report form (CRF) for a clinical trial
• Performance of various types of randomization, blinding and allocation concealment.

Other clinical pharmacology and therapeutics exercises

• Reporting / interpreting a suspected adverse drug reaction / drug interaction in standard format
• Causality analysis of suspected adverse drug reactions
• Reporting medication errors in prescribed format
• Need assessment, devising and implementation plans for antimicrobial stewardship activities in the hospital
• Judging the rationality of a fixed dose combination
• Judging the rationality of a therapeutic prescription
• Drawing up essential medicine lists, standard treatment guidelines and hospital formulary for various scenario
• Critical appraisal / Peer review of a clinical study report/ randomized clinical trial/ observational studies/ diagnostic and prognostic studies/ systematic reviews
• Application of principles of evidence based medicine for solving a clinical/ therapeutic query.

Teaching exercises

• Lectures classes for medical / nursing / pharmacy / dental students
• Demonstration / tutorial classes for medical / nursing / pharmacy / dental students.

B. Should be able to interpret

• Animal toxicology data that may impact human trial of new chemical / molecular entities
• Therapeutic drug monitoring (TDM) data for various drugs e.g. antiepileptics, immunosuppressants, aminoglycosides and other antibiotics, lithium etc.
• Pharmacokinetic data for modifying drug dosing in special situations like renal impairment and hepatic impairment
• First -in-human dose (Phase I dosing) from preclinical data
• Non-conventional clinical trial designs
• Reports of adverse event following immunization (AEFI), Adverse Event of Special Interest , hemovigilance reports and materiovigilance reports
• Material safety data sheets for agricultural and industrial chemicals
• Pharmacoeconomic reports
• Data from rating scales used in clinical studies in various fields like neurology, psychopharmacology, respiratory medicine, etc.

C. Procedures to observe or perform under supervision (desirable skills)

• Analyzing hematological and biochemical parameters using semi-automated or automated analyzers
• Pharmaceutical analysis by spectrophotometric technique (e.g. UV-Visible spectrophotometry)
• Pharmaceutical analysis by chromatographic technique (e.g. HPLC)
• Pharmaceutical analysis by immunoassay technique (e.g. ELISA)
• Basics of tissue culture
• Basics of protein / DNA / RNA extraction
• Basics of PCR and RT-PCR
• Basics of flow cytometry.

Career Options

After completing a DM in Clinical Pharmacology, candidates will get employment opportunities in Government and the Private sector.

In the Government sector, candidates have various options, including Registrar, Senior Resident, Demonstrator, Tutor, etc.

In the Private sector, the options include Resident Doctor, Consultant, Visiting Consultant (Clinical Pharmacology), Junior Consultant, Senior Consultant (Clinical Pharmacology), Clinical Pharmacology Specialist, Clinical Research Associate, and Clinical Principal Investigator.

Courses After DM in Clinical Pharmacology Course

DM in Clinical Pharmacology is a specialisation course which can be pursued after finishing a Postgraduate medical course. After pursuing specialisation in DM in Clinical Pharmacology, a candidate could also pursue certificate courses and Fellowship programmes recognized by NMC and NBE, where DM in Clinical Pharmacology is a feeder qualification.

Frequently Asked Questions (FAQs) –DM in Clinical Pharmacology Course

Question: What is the full form of DM?

Answer: The full form of DM is Doctorate of Medicine

Question: What is a DM in Clinical Pharmacology?

Answer: DM Clinical Pharmacology or Doctorate of Medicine in Clinical Pharmacology, also known as DM in Clinical Pharmacology, is a super speciality level course for doctors in India that they do after completion of their postgraduate medical degree course.

Question: What is the duration of a DM in Clinical Pharmacology?

Answer: DM in Clinical Pharmacology is a super speciality programme of three years.

Question: What is the eligibility of a DM in Clinical Pharmacology?

Answer: Candidates must have a postgraduate medical Degree (MD/MS/DNB) from any college/university recognized by the Medical Council of India (now NMC)/NBE.

Question: What is the scope of a DM in Clinical Pharmacology?

Answer: DM in Clinical Pharmacology offers candidates various employment opportunities and career prospects.

Question: What is the average salary for a DM in Clinical Pharmacology candidate?

Answer: The DM in Clinical Pharmacology candidate's average salary is between Rs. 5,00,000 to Rs. 30,00,000 per year, depending on the experience.

Question: Can you teach after completing the DM Course?

Answer: The candidate can teach in a medical college/hospital after completing the DM course.

Question: Is clinical pharmacology a good career?

Answer: Clinical pharmacology can lead to a fulfilling career in medical research, drug development, and patient care. It offers a unique blend of medical expertise and pharmacological knowledge, but the path is demanding and requires a significant commitment to education and training.