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POSTGRADUATE MEDICAL EDUCATION IN PHARMACOLOGY

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    POSTGRADUATE MEDICALEDUCATION IN

    PHARMACOLOGYBy

    Professor Ranjit Roy Chaudhury**

    National Professor of Pharmacology (National Academy ofMedical Sciences) &Chairman Task Force for Research

    Apollo Hospitals Educational and Research Foundation

    Kolkata10th December 2009

    ** Former Professor and Head, Dept. of Pharmacology, Dean andActing Director

    Postgraduate Institute of Medical Education and Research, Chandigarh

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    G A P

    Pharmacological expertise needed

    and

    Availability of pharmacologists

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    G A P

    Type of specialized pharmacologicalexpertise needed

    and

    Type of pharmacological expertiseavailable

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    GLOBAL LEADERSHIP

    Drug discovery

    International health care

    Clinical trials

    Traditional medicine research

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    DRUG DISCOVERY

    New molecules coming from Indianlaboratories

    40+ molecules at different stages of clinicaltrials in India

    Interesting leads sold to the foreigncompanies

    Essential to have drug developmentexpertise in India

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    TYPES OF PHARMACOLOGICAL

    EXPERTISE NEEDEDImmunopharmacology

    Biochemical pharmacology

    Pharmacogenetics

    Molecular pharmacology

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    INTERNATIONAL HEALTH CARECost of Carrying Out

    Procedure USA India Thailand Singapore

    Coronary arterybypass surgery

    $70,000-133,000

    $7,000 $22,000 $16,300

    Bypass surgerywith heart valve

    replacement

    $75,000-140,000

    $9,500 $25,000 $22,000

    Hip replacement $33,000-57,000

    $7,200 $12,700 $12,000

    Kneereplacement

    $30,000-53,000

    $7,200 $11,500 $9,600

    Prostate surgery(TURPprocedure)

    $10,000-16,000

    $3,600 $4,400 $5,300

    Gastric bypass $35,000-52,000

    $9,300 $13,000 $16,500

    Face-lift $10,500-16,000

    $4,800 $5,000 $7,500

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    CLINICAL TRIALSWhy India?

    Availability of a large population of patients

    Large variety of diseases prevalence

    Availability of naive patients, 299 medicalcolleges, competent clinicians with fluencyin english

    Greatly reduced cost for carrying out clinicaltrials

    Relatively strong drug regulatory agency

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    CLINICAL TRIALS IN INDIA

    BOON Ethical transparent trials

    or

    BANE Unethical trials exploitingpoor and illiterate

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    PREPARATIONS BY ICMR FORDRUG DEVELOPMENT /

    CLINICAL TRIALSAdvanced Centres

    NIRRH, Mumbai Reproductive ToxicologyNIN, Hyderabad Toxicology

    JIPMER, Pondicherry Genotoxicology

    - Reverse PharmacologyRegional Research Institute, Jammu

    Standardization

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    PREPARATIONS BY ICMR FORDRUG DEVELOPMENT /

    CLINICAL TRIALSAdvanced Centres

    RMRC, Belgaum Traditional medicine

    Himalayan Institute, Palampur Cultivationof medicinal plants

    Bose Institute, Kolkata Plant genomeresearch

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    CLINICAL TRIAL CENTRES

    NIZAMs Institute, Hyderabad -Pharmacodynamics

    CMC, Vellore Centre for evidence basedmedicine

    Vivekananda Yoga Kendra Effect of yoga

    Nair Hospital, Mumbai Clinical Trials

    KEM Hospital, Mumbai Clinical Trials

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    CENTRES FOR CLINICAL TRIALSOF TRADITIONAL REMEDIES

    AIIMS, New Delhi

    PGIMER, ChandigarhBHU, Varanasi

    Medical Colleges Cuttack

    - Trivandrum

    - Chennai

    - Kottayam

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    INSTITUTE ETHICSCOMMITTEE

    To protect patient/public from exploitation

    Committee needed at all centres whereclinical trials are being carried

    No trial to be carried out till proposalcleared by Ethics Committee

    and

    Placed in Register of Clinical Trials, ICMR

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    CLINICAL PHARMACOLOGISTin Institutional Ethics

    CommitteesInformed Consent

    Use of Placebo

    Ownership of data

    Rights of patient after completion of trial

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    TRADITIONAL MEDICINE

    Kolkata

    Col. R. N. Chopra

    Dr. B. B. Dikshit

    Dr. B. Mukherjee

    School of tropical medicine,Kolkata

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    RESEARCH

    Resources Technology Bio-diversity

    North Yes Yes No

    South No No Yes

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    GOLD STANDARD

    For Synthetic DrugControlled

    Comparative

    Placebo

    Double-Blind

    RandomizedMulti-centred

    Clinical trial

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    OTHER DESIGNS MAY BEAPPROPRIATE FOR

    TRADITIONAL MEDICINES

    Observational pharmacology trials

    Open trials

    Single blind studies

    Sample of one trials

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    RATIONAL USE OF MEDICINESADVANTAGES

    Better therapeutics

    Reduction of side effects- Inappropriate dose

    - Inappropriate duration of treatment- Interactions

    Reduction in cost of medication- Individual- Family

    - Community

    - Country

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    THE DELHI MODEL

    Rajasthan

    Himachal Pradesh

    Uttar Pradesh

    Haryana

    Mumbai Corporation

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    OTHER ORGANIZATIONSUSING CONCEPT OF

    RATIONAL USE OF MEDICINES

    Helpage

    Family Planning Association

    National Rural Health Mission

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    NEED FOR PHARMACOLOGISTS

    Development of drug policySelection of drugs to be used in country

    Drug regulation

    Drug discoveryCarrying out clinical trials

    Corporate and government hospitals

    Research in traditional medicines

    Pharmacovigilance

    Memberships/Chair Ethics Committees

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    NEED FOR PHARMACOLOGISTS

    Traditional role as professors ofpharmacology in medical colleges

    and

    in drug research institutes

    and

    in drug regulatory agenciesand

    in pharmaceutical industry

    D M COURSE IN CLINICAL

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    D.M. COURSE IN CLINICALPHARMACOLOGY AT PGI,

    CHANDIGARHTeam: Professor Ranjit Roy Chaudhury

    Professor V. S. MathurProfessor P. L. SharmaDr. K. S. RaghavanDr. S. K. Garg

    Collaboration: Professor P. K. Devi

    Professor R. N. ChakravartyGuidance and

    Support: Professor P. N. ChhuttaniProfessor K. L. Wig

    Professor Santokh Singh Anand

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    D.M. CLINICALPHARMACOLOGY

    Open to pharmacologists and cliniciansafter receiving first advanced degree

    Two year course

    Clinical attachment

    WHERE ARE THEY 36 TILL

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    WHERE ARE THEY 36 TILLDECEMBER 2009

    India and Abroad

    Professors of clinical pharmacology

    Medical Directors/Vice-Presidents inpharmaceutical houses

    Heads of drug regulatory agencies

    Heads of divisions in research institutes

    Academic staff of medical colleges

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    D.M.S QUALIFYING EVERYYEAR

    PGIMER, Chandigarh - 2

    KEM, Mumbai - 2

    Nizams, Hyderabad - 2

    A.I.I.M.S - 1

    Others - 2

    - 10

    DNB in clinical pharmacology 4 to 5

    TOTAL 15 per year

    NEED - 100 per year

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    OTHER TRAININGPROGRAMMES

    Masters in pharmacology from collegesof pharmacy

    Masters course in pharmaceuticalmedicine run by KEM Hospital, Mumbai

    90 trainees each year

    WHY IS THERE SO MUCH

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    WHY IS THERE SO MUCHNEED?

    Healthcare IndustryAt present 20 billion dollars

    In ten years 45 to 63 billiion dollars

    + 9.00 billion dollars

    If health insurance comes in

    Clinical trial turnover

    1.0 billion dollars by 2015

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    INTERNATIONAL HEALTHPatients from Abroad

    1999 10,000

    2004 180,000Annual growth rate 25 to 30%

    ExampleApollo HospitalsIn last five years 60,000

    from 55 countries

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    M.D. COURSE OF A.I.I.M.SContains

    Molecular biology in pharmacology

    Clinical pharmacology and recent

    advancesDrug regulations

    Drug development process

    Clinical trials

    Therapeutic drug monitoring

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    AREAS WHICH COULD BEADDED

    Drug delivery systems

    - Transdermal drug delivery

    Ocular pharmacology

    Pharmacovigilance

    Regulations regarding IPRPharmacogenetics

    Genomic pharmacology

    PHARMACOLOGY

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    PHARMACOLOGYPOSTGRADUATES

    More needed- Scaling up

    Different expertise needed- Broaden curriculum horizons

    NEED tremendous

    No time to lose


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