Department of Clinical Pharmacology

History : Human resources : Patient Care Services : Clinical Facilities : Laboratory Facilities : Courses offered : Central Animal house facility : Training activities : Publications : Awards / Achievements : CME programmes / Conferences / Academic activities : Special activities : Research Activities :

History

  • Clinical Pharmacology evolved as a separate discipline in India in the late eighties and the early nineties. Dr Nilima Kshirsagar was the first Head of the Department of Clinical Pharmacology established at TNMC & BYL Nair Ch. Hospital in 2000. After her promotion, Dr. Sharadini Dahanukar took over the mantle as Dean & Professor & Head of the Department in July 2001. She also established an Advanced Centre for Ayurveda, Research, Training & Services (ACARTS) at the Department in 2001.
  • After the unexpected demise of Dr. Sharadini Dahanukar in August 2002, Dr. Urmila Thatte took charge of the Department. On 6th November 2004, the Centre was named the “Dr. Sharadini Dahanukar - Advanced Centre for Ayurvedic Research Training & Services”(SD-ACARTS) as a tribute to her work with formal permission from the Municipal Corporation of Greater Mumbai [Municipal Corporation of Greater Mumbai CR No 82 Dated 9th October 2003]. Shri Sharad Pawar (Hon. Union Minister for Agriculture. Food & Civil Supplies and Consumers Affairs) graced the occasion as Chief Guest.      
  • Following the transfer of Dr. Thatte to KEM Hospital, Dr. Renuka Kulkarni-Munshi now heads the Department.

Seminar on "Herbal Products : Regulatory Aspects"

Day 1 Session 1 Anand Chaudhary_rationality of AYUSH formulations
    SS Gandhi_EU regulations
    Sunil Bhaskaran_US regulations
    Vijay Chauhan_Indian_SAARC regulations
  Session 2 Adip Roy_history of safe use data generation
    Amit Agarwal_Safety data documentation
    CK Katiyar_Safety Evaluation of Ayurvedic Drugs_Regulatory Requirements, Issues and Perspectives
Day 2 Session 3 Arun Bhatt_Botanicals
    Prabodh Halde_Neutraceuticals
  Session 4 Pralhad Patki_Quality issues
    Shailesh Nadkarni_Ayurvedic Pharmacopoiea
  Session 5 N Sandu_AYUSH GCP_Industry perspective
    N Srikanth_AYUSH GCP_Ethical perspective
    YK Gupta_AYUSH GCP_Investigator perspective
    DBA Narayana_Herbals Regulations_IPR issues

 

Human resources

 

1] Teaching Faculty

Sr. No

Name

Designation

1. Dr. Renuka Kulkarni-Munshi Associate Professor & In-charge

 

2] Research faculty:

  • Dr. Supriya Bhalerao, Ayurvedic Research Officer

3] Research staff:

Designation           

No.

Medical Officers 4
Senior Research Fellows 2
Junior Research Fellows 6
Laboratory Technician -
Office Assistants 2
Research Laboratory Assistants 2
Clerk/CCT 1 Clerk
Other categories 1 Animal House Keeper

Patient Care Services


I] Therapeutic Drug Monitoring (TDM) services

  • TDM OPD is run every Friday morning wherein levels of various anti-epileptic drugs (viz. phenytoin, carbamazepine, sodium valproate, phenobarbitone, oxcarbazepine, lamotrigine and levetiracetam) and risperidone & lithium levels are estimated using High Performance Liquid Chromatography out in patients suffering from epilepsy and psychiatry disorders. Patients are also counseled regarding their drugs schedule, drug interactions, possible adverse reactions and precautions to be taken. Every year more than 1000 epileptic and 100 psychiatry patients avail this facility.
TDM clinical pharmacology

 

II] Pharmacovigilance

  • Pharmacovigilance activity for the Adverse Drug Reaction (ADR) monitoring of allopathic drugs. Adverse Drug Reactions reported from the various departments of the Institute and from private practitioners are documented at the Centre and causality analysis of the reports is carried out. Drug information on various aspects of drug use is also provided by the Department.

 

III] Ayurvedic Services

  • The services mentioned below are offered by the “Dr.    Sharadini Dahanukar - Advanced Centre for Ayurvedic Research Training & Services”(SD-ACARTS) under the Department
  • Ayurvedic OPD run by the Department serves upward of 1600 patients annually. Ayurvedic medicines are given free of charge here.

  • The Department is a recognized Pharmacovigilance Centre for the Adverse Drug Reaction Monitoring activity for Ayurveda, Siddha & Unani drugs. Adverse Drug Reactions reported from the various departments of the Institute and from private practitioners are documented at the Centre and causality analysis of the reports is carried out. Drug information on various aspects of drug use is also provided by the Department.
  • A Panchakarma (Ayurvedic therapeutic procedures) unit wherein various therapies are offered on an outpatient basis at a minimal cost. This Centre has been established with support from the Department of AYUSH, Govt. of India The Ayurvedic Panchkarma Therapy Unit supported by the Govt. of India grant, provides facilities for the various therapeutic procedures described in Ayurveda. About 100 patients are treated annually.

Ayurvedic Panchkarma

 

  • Additionally, herbal medicines are tested for heavy metal and steroid adulteration.

III] Genotyping services

  • The Department has a well equipped Molecular Diagnostic laboratory wherein wherein genotyping of patient samples are carried out to correlate genetic variations with clinical non-response to drugs. Several genes viz. CYP2C9*2/*3, RFC, UGTA1*20, VKORC1, TPMT and MTHFR have been standardized as a part of patient care activities which are beneficial to the hospital clinicians in managing the clinical strategy of the patients who are genetic variants.

Clinical Facilities

  • Clinical Pharmacology Ward situated on the 4th floor of the Department. Different phases of clinical trials (I-IV) (both for allopathic & herbal drugs) and bio-equivalence studies are conducted in the ward.
  • Human Pharmacodynamics laboratory equipped with Cardiac monitors, Treadmill & ECG machines for cardiovascular studies, Psychometry software & other instruments to evaluate different CNS functions like concentration, attention, memory, Pulse Plethysmograph to evaluate endothelial function and blood flow parameters, and Motor nerve conduction velocity recording instrument that are important tools when conducting Phase I-IV clinical studies.
Pharmacodynamics laboratory Pharmacodynamics lab

 

Laboratory Facilities

 

A fully automated & QC accredited Haematology Laboratory with 2 semi-auto & one fully automated biochemical auto-analysers and a Cell counter.

This lab is an important accessory for the various laboratory investigations (both experimental & clinical) research. 


A well-equipped Drug Assay Laboratory complete with 2 HPLC systems with autosampler, HPTLC (CAMAG) unit, Gas chromatography unit and an Electrolyte analyser for carrying out analysis of drug levels from biological samples and steroid estimation in herbal samples.

An elite Tissue culture laboratory with facilities for screening anti-cancer activity, anti-inflammatory activity, anti-ulcer and anti-diabetic potential of molecules viz. insulin secretagogue activity, adipocyte differential potential, Insulin mimetic activity, etc.

Radio Immunoassay laboratory

A Radio Immunoassay laboratoryapproved by the Board of Radiation Technology with a Micro-beta counter, a Gamma counter along with a Cell harvester and an Elisa reader with washer

Molecular Diagnostic laboratory

A Molecular Diagnostic laboratory with a PCR thermocycler, Electrophoresis Unit, Gel documentation system and other essentials wherein genotyping of patient samples are carried out to correlate genetic variations with clinical non-response to drugs.

Microbiology laboratory

A fully fledged Microbiology laboratory with a Level II Biosafety cabinet for performing anti-microbial & anti-tubercular drug related studies.

Cell Studies Laboratory

A functional Cell Studies Laboratory with facilities for evaluating immunomodulatory activity of compounds and a Platelet aggregocorder used for evaluation of anti-platelet activity.

Instrumentation Room

 A fully equipped Instrumentation Room having Ultra Centrifuge, UV-Vis Spectrophotometer and modern amenities like Image analyser software system and Stereomicroscope.