Department of Clinical Pharmacology - TNMC & Nair Charitable Hospital

About the Department

Department of Clinical Pharmacology

The Department was set up in 2000 by Dr NA Kshirsagar, then Dean of the Institute. Following her transfer as Dean to KEM hospital in 2001, Dr. Sharadini Dahanukar took charge of the department. After her unexpected demise in August 2002, Dr. Urmila Thatte, her student and ardent follower, took over the mantle and with her vision and dedication took the department to new academic heights. Presently, Dr. Renuka Munshi, who heads the Department of Clinical Pharmacology and her team continue to carry out research activities and patient care services (including newer services like Molecular Diagnostics & specialized lab tests). The motto of the Department is to conduct & promote evidence-based research in modern Medicine and Ayurveda and help in generating new knowledge and technologies for the benefit of mankind.

The Advanced Centre for Ayurveda, Research, Training & Services (ACARTS), the Ayurvedic section of the Department was set up by Dr. Sharadini Dahanukar. Following her demise, the Centre was renamed as Dr. Sharadini Dahanukar - Advanced Centre for Ayurvedic Research Training & Services (SD-ACARTS), as a tribute to her work by MCGM [MCGM CR No. 82 dated 9^th October 2003]. It is one of the few Centres in the country situated in a Modern healthcare hospital, rendering Ayurvedic services and conducting research in Ayurveda.

The Department is recognized as an ICMR Centre of Excellence for Research in Clinical Pharmacology of Traditional Medicine

The department has conducted collaborative research projects funded by the Government of India, Indian Council of Medical Research (ICMR), Dept. of AYUSH, Council of Scientific & Industrial Research (CSIR), Department of Biotechnology (DBT), Department of Technology (DST), Department of Ocean Development (DOD), various Corporate sponsored research projects and those sponsored by the World Health Organization (WHO) and Pharmaceutical Industry.

Departmental Facilities

The Department of Clinical Pharmacology thus comprises of 03 units - Clinical Research, Basic Research & Ayurvedic Therapeutic Units.

Clinical Research Unit is well equipped to conduct clinical research including clinical trials viz. vaccine studies like the COVISHIELD, vaccine study, Phase II - Phase IV studies for modern drugs as well as herbal and herbo-mineral medications.

Basic Research Unit wherein the department has standardized various bioassays and animal models which can be readily used for drug development in different therapeutic areas.

Ayurvedic Therapeutic & Panchakarma Therapy Unit was established with support by the Department of AYUSH. GOI. Various therapeutic procedures such as Swedan, Basti, Vaman, Virechan, Nasya, Shirodhara, Agni karma, Tarpan for various medical indications like obesity, asthma, arthritis, skin diseases, piles and varicose veins are offered on OPD basis. Research projects have also been done to assess the effect of Panchkarma in improving the immunological and metabolic profile of patients

The Department has the following laboratory facilities to support its research activities:

QC accredited Haematology Laboratory wherein routine and biochemical investigations required for research. Specialized lab tests are processed as part of patient care services.
Drug Assay Laboratory wherein drug levels of various anti-epileptic drugs viz., Phenytoin, Phenobarbitone, Carbamazepine, Ox-Carbamazepine, Valproate, Levetiracetam, Lamotrigine, Topiramate, Zonisamide, Lacosamide, Brivaracetam, Clobazam from biological samples are estimated as part of TDM services. Detecting steroid adulteration in herbal samples using HPTLC system is also done.
Molecular Biology Diagnostic laboratory wherein genotyping of patient samples is done to correlate genetic variations with clinical non-response to drugs.
Tissue culture laboratory with facilities for in-vitro screening for anti-cancer activity, anti-inflammatory activity, anti-ulcer and anti-diabetic potential of molecules viz. insulin secretagogue activity, adipocyte differential potential, insulin mimetic activity, apoptosis etc.
Microbiology laboratory with a Level II Biosafety cabinet for performing anti-microbial & anti-tubercular drug related studies.
Instrumentation Room wherein immunological assays, angiogenic studies and assay to test irritant activity of drugs are done.

Patient Care Services

Therapeutic Drug Monitoring (TDM) OPD

Every Saturday morning between 9:00 to 12 noon.

TDM blood levels of various antiepileptic drugs (AEDs) viz., Phenytoin, Phenobarbitone, Carbamazepine, Ox-Carbamazepine, Valproate, Levetiracetam, Lamotrigine, Topiramate, Zonisamide, Lacosamide, Clobazam & Brivaracetam and Lithium are carried out using HPLC & HPTLC techniques in epileptic patients & those with psychiatric disorders.

Patients are counselled regarding their drugs schedule, drug interactions & possible adverse reactions.

Ayurvedic OPD

Twice a week every Tuesday and Wednesday afternoons between 1.30 to 3.30 pm.

Patients are counselled regarding their disorders and treatment and preventive measures that can be taken to prevent disease progression.

Panchakarma therapy is also offered for various indications like obesity, asthma, arthritis, skin diseases, piles and varicose veins.

Ayurvedic medicines are given free of charge to the patients.

Molecular Biology Diagnostic services

Genotyping of patient samples is done to correlate genetic variations with clinical non-response to drugs. Genotyping for CYP2C9*2, CYP2C9*2, CYP2C9*3, VKORC1, CYP2C19*2, CYP2C19*3, HLA A*3101, HLA B*1502, MTHFR A1298C, MTHFRC677T, RFC1G80A, TPMT 2A, TPMT 3B, TPMT 3C, NUDT*15, NAT2*4, NAT2*5, NAT2*6, NAT*7, CYP3A4*1B, CYP3A5*3, Factor V Leiden and Prothrombin gene mutation is carried out as patient care service.

Specialized Investigations including Complete lipid Profile (Total Cholesterol, Triglycerides, HDL Cholesterol, LDL Cholesterol), Apo a, Apo b, CRP, Ferritin, Homocysteine, PT-INR, APTT, Fibrinogen, Protein C, Protein S, Anti-thrombin

Detection of steroid adulteration in herbal samples and heavy metal analysis is performed.

Institutional activities performed by the Department:

I] Institutional Animal Ethics Committee: Dr Renuka Munshi is the Secretary of the Institutional Animal Ethics Committee (IAEC) and coordinating the activities of the IAEC to ensure ethical approval of animal experimental projects. She also coordinates with CPCSEA New Delhi to ensure that the registration of the Central Animal House is continued as it is an essential requirement as per MCI & MUHS rules.

II] Ethics Committee for Academic Research projects (ECARP): Dr Renuka Munshi is the Member Secretary of the ECARP which meets every month to review and approve academic research projects of both UG & PG students. This Ethics Committee is registered with the CDSCO, Government of India for regulatory studies and Department of Health Research (DHR), Govt. of India for academic studies.

III] Central Animal house facility (Reg No. 407/PO/Re/S/01/CPCSEA dated 10 November 2021) The Institute has a well maintained and CPCSEA registered Central Animal House located on the 4^th Floor College Building of TNMC & BYL Nair Ch. Hospital which is under the supervision of the Department of Clinical Pharmacology. Here, various experimental models for diabetes, osteoporosis, and immunological & anti-inflammatory efficacy studies have been standardized & toxicity studies as per the OECD guidelines are conducted.

Faculty

Dr Renuka Munshi

Professor & Head, Clinical Pharmacology

Research and Publications

Publications of the last 5 years

2021

�

� � � �Munshi RP, Dhiman A, Save SU. Cost analysis of critical patient care at a pediatric intensive care unit of a tertiary care public hospital in an urban metropolis of India. Int J Basic Clin Pharmacol 2021;10:834-9.

� � �Munshi R, Talele G & Shah R. Preparation and Standardization of Nosodes sourced from Klebsiella pneumoniae, Salmonella typhi, Neisseria gonorrhoeae and Candida albicans strains. Homeopathy 2021. DOI https://doi.org/10.1055/s-0041-1726009.

� � � �Munshi R, Talele G & Shah R. In vitro Evaluation of Antimicrobial Activities of Escherichia coli, Klebsiella pneumoniae, Salmonella typhi, Neisseria gonorrhoeae, and Candida albicans nosodes. Homeopathy: the Journal of the Faculty of Homeopathy,� 2021: 10.1055/s-0041-1727149.

�2020

� � � � Kulkarni-Munshi R, Vishwakarma J. Application of High-Performance Thin Layer Chromatography in the Quantitative estimation of� � � � � � � serum� � � � � � � Clobazam levels. J Chromatogr Sep Tech. 2020; 11:433. DOI: 10.35248/2157-7064.20.11.433

� � � Jain S, Thanage R, Panchal F, Rathi P, Munshi R, Udgirkar S, Contractor Q, Chandnani� S, Nair S, Debnath P & Singh A. Screening of Family Members of Nonalcoholic Fatty Liver Disease Patients can Detect Undiagnosed Nonalcoholic Fatty Liver Disease Among Them: Is There a Genetic Link. Journal of Clinical and Experimental Hepatology. 2020. 10.1016/j.jceh.2020.10.003.

� � � Munshi R, Talele G & Shah R. Preparation and Standardization of Escherichia coli Nosodes Sourced from Select E. coli Strains. Homeopathy 2020; 109. 10.1055/s-0040-1710044.

� � �Shetty P, Panchal F, Munshi R, Sundar U & Darole P. A Case Series of three patients presenting with Isoniazid induced Toxicity and N- acetyl transferase 2 Gene Mutation: A management conundrum for programmatic therapy of Tuberculosis in IndiaIndian J Tuberc. 2020;67(3):407-410.� � �doi: 10.1016/j.ijtb.2020.01.005.

� � � Munshi R, Panchal F, Shinde D. Inhibition of Carbohydrate Digestive Enzymes by Select Plant Extracts: Role in the Management of Diabetes mellitus EPMR 2020; 7(7):, 605-612

� � � � � �Munshi Renuka P, Kumbhar Dipti A, Munot Sonali R. A Questionnaire Based Survey To Assess The Knowledge, Attitude and Practices of Ayurvedic Practitioners Towards Masanumasik Kashayas. International Journal of Ayurveda and Pharma Research. 2020;8(9):20-26.

�2019

�� Pai, Sarayu & Munshi, Renuka & Juvekar, Archana. Partially hydrogenated vegetable oil containing 5% trans fats when combined with fructose� � � � � exacerbates obesity and non-alcoholic fatty liver disease in rats. Nutrire 2019; 45 (1): 10.1186/s41110-019-0105-6.

� � Munshi R, Kumbhar D, Panchal F, Varthakavi P. Assessing the Effectiveness of Panchatikta Ghrita, a Classical Ayurvedic Formulation as Add-on Therapy to Vitamin D3 and Calcium Supplements in Patients with Osteopenia: A Randomized, Open-Labeled, Comparative, Controlled Clinical Study. The Journal of Alternative and Complementary Medicine 2019; 25 (10): 10441053

� � �Munshi R, Joshi S, Panchal F, Kumbhar D, Chaudhari P. Does Panchatikta ghrita have anti-osteoporotic effect Assessment in an experimental model in ovariectomized rats. J Ayurveda Integr Med. 2019 Nov 7. pii: S0975-9476(19)30033-6. doi: 10.1016/j.jaim.2019.04.006.

� � Munshi R, Panchal F, Kulkarni V, Chaurasia A. Methylenetetrahydrofolate reductase polymorphism in healthy volunteers and its correlation with homocysteine levels in patients with thrombosis. Indian J Pharmacol. 2019 Jul-Aug; 51(4):248-254. doi: 10.4103/ijp.IJP_215_19. PubMed PMID: 31571711; PubMed Central PMCID: PMC6759526.

� � � Munshi RP, Tople GD, Munot SR. Assessment of the degree of awareness among post-graduate medical physicians and Pharmacists about look-alike, sound-alike drug and potential medication errors Int J Basic Clin Pharmacol 2019;8:1771-5.

� � Pai SA, Martis EA, Munshi RP, Gursahani MS, Mestry SN, Juvekar AR. Chrysin mitigated obesity by regulating energy intake and expenditure in rats, Journal of Traditional and Complementary Medicine. 2019 https://doi.org/10.1016/j.jtcme.2019.09.002

� �Pai SA, Munshi RP, Panchal FH, Gaur IS, Juvekar AR. Chrysin ameliorates nonalcoholic fatty liver disease in rats. Naunyn� �Schmiedebergs Arch Pharmacol. 2019 Dec;392(12):1617-1628. doi: 10.1007/s00210-019-01705-3.

� � � Pai SA, Munshi RP, Panchal FH, Gaur IS, Mestry SN, Gursahani MS, Juvekar AR. Plumbagin reduces obesity and nonalcoholic fatty liver disease induced by fructose in rats through regulation of lipid metabolism, inflammation and oxidative stress. Biomed Pharmacother 2019;111: 686-694. doi: 10.1016/j.biopha.2018.12.139.

� � � Gaikwad M, Shirsat V, Bulbule M, Kalekar S, Munshi R & Garrido G. Ethyl acetate extract of Citrullus colocyn this (Linn.) Schrad. fruit suppresses angiogenesis. Journal of Pharmacy & Pharmacognosy Research 2019; 7:331-342.

� � � Munshi R, Gawde N. Development and Validation of a HPTLC Method to Determine Serum Zonisamide levels for Therapeutic Drug Monitoring in Clinical Settings. Indian J Pharm Sci 2019;81(2):385-389

� � � �Munshi R, Joshi S, Talele G, Shah R. An In-Vitro Assay Estimating Changes in Melanin Content of Melanoma Cells due to Ultra-Dilute, Potentized Preparations. Homeopathy. 2019 Aug;108(3):183-187. doi: 10.1055/s-0039-1678541. Epub 2019 Mar 5. PubMed PMID: 30836409.

�2018

�� Chowdhury AA,, Gawali NB, Munshi R, Juvekar AR. Trigonelline insulates against oxidative stress, proinflammatory cytokines and� � � � � � � � �restores� � � � � BDNF levels in lipopolysaccharide induced cognitive impairment in adult mice. Metab Brain Dis 2018;33(3): 681-691. doi:� � � � � � � � �10.1007/s11011-� � � � � �017-0147-5.

� � �Desai S, Rathi N, Kawade A, Venkatramanan P, Kundu R, Lalwani SK, Dubey AP, Venkateswara Rao J, Narayanappa D, Ghildiyal R, Gogtay NJ, Venugopal P, Palkar S, Munshi R, Bavdekar A, Juvekar S, Ganguly N, Niyogi P, Uttam KG, Kondekar A, Kumbhar D, Mohanlal S, Agarwal MC, Shetty P, Antony K, Gunale B, Dharmadhikari A, Deshpande J, Nalavade U, Sharma D, Bansal A, Tang Y, Flores J, Kulkarni PS. Non-interference of Bovine-Human reassortant pentavalent rotavirus vaccine ROTASIIL with the immunogenicity of infant vaccines in comparison with a licensed rotavirus vaccine. Vaccine. 2018 Sep 5;36(37):5519-5523. doi: 10.1016/j.vaccine.2018.07.064. Epub 2018 Aug 10. PubMed PMID: 30104114; PubMed Central PMCID: PMC6143481.

� � �Munshi R, Panchal F,� Chaurasia A, Rajadhyaksha G. Association between Paraoxonase 1(PON1) Gene Polymorphisms and PON1 Enzyme Activity in Indian Patients with Coronary Artery Disease (CAD). Current Pharmacogenomics and Personalized Medicine, 2018, 16, 219-229

� � � Mali NB, Deshpande SP, Karnik ND, Gogtay NJ, Munshi RP, Divatia JV, Wagle SC, Sridharan K, Thatte UM. A Multicentric, Prospective, Observational Antibacterial Utilization Study in Indian Tertiary Referral Centers. Indian J Crit Care Med. 2018 Oct;22(10):723-729. doi: 10.4103/ijccm.IJCCM_197_18. PubMed PMID: 30405283; PubMed Central PMCID: PMC6201646.

� � � R. Munshi, N. Gawde, S. Dalal, and D. Ganachari. Development and Validation of a High-Performance Thin-Layer Chromatographic Method for the Quantitative Assessment of Topiramate from Human Serum: Application in Therapeutic Drug Monitoring. Journal of Planar Chromatography 31 (2018) 2, 112115DOI: 10.1556/1006.2018.31.2.3

� � �Gogtay NJ, Munshi R, Ashwath Narayana DH, Mahendra BJ, Kshirsagar V, Gunale B, Moore S, Cheslock P, Thaker S, Deshpande S, Karande S, Kumbhar D, Ravish HS, Harish BR, Pisal SS, Dhere R, Parulekar V, Blackwelder WC, Molrine DC, Kulkarni PS. Comparison of a Novel Human Rabies Monoclonal Antibody to Human Rabies Immunoglobulin for Postexposure Prophylaxis: A Phase 2/3, Randomized, Single-Blind, Noninferiority, Controlled Study. Clin Infect Dis. 2018 Jan18;66(3):387-395. doi: 10.1093/cid/cix791.

� � � Chowdhury AA, Gawali NB, Shinde P, Munshi R, Juvekar AR. Imperatorin ameliorates lipopolysaccharide induced memory deficit by mitigating proinflammatory cytokines, oxidative stress and modulating brain-derived neurotropic factor. Cytokine 110; 2018; 7886

2017

� � � �Pai SA, Martis EAF, Joshi SG, Munshi RP, Juvekar AR. Plumbagin exerts antiobesity effects through inhibition of pancreatic lipase and� � � � � �adipocyte differentiation. Phytotherapy Research. 2018;15. https://doi.org/10.1002/ptr.6085

� � �Pai S, Munshi R, Nayak C. Fatal dapsone hypersensitivity syndrome with hypothyroidism and steroid-induced diabetes mellitus.� � Indian J Pharmacol 2017;49:396-8

� � �Mestry SN, Gawali NB, Pai SA, Gursahani MS, Dhodi JB, Munshi R, Juvekar AR. Punica granatum improves renal function in gentamicin-induced nephropathy in rats via attenuation of oxidative stress. J Ayurveda Integr Med 2018 Mar 16. pii: S0975-9476(17)30323-6. doi: 10.1016/j.jaim.2017.09.006.

� � �Goyal A, Singh H, Sehgal VK, Jayanthi CR, Munshi RP, Bairy KL, Kumar R, Kaushal S, Kakkar A, Ambwani S, Goyal C, Mazumdar G, Adhikari A, Das N, Stephy DJ, Thangaraju P,� Dhasmana DC, Rehman SU, Chakrabarti A, Bhandare B, Badyal DK, Kaur I, Chandrashekar K, Singh J, Dhamija P, Sarangi SC & Gupta YK.Impact of regulatory spin of pioglitazone on prescription of antidiabetic drugs among physicians in India: A multicentre questionnaire-based observational study. Indian J Med Res 146, October 2017, pp 468-475 DOI: 10.4103/ijmr.IJMR_1416_15

� � � �Munshi RP & Pai SA. Discontinuation practices of anti-platelet drugs in the peri-operative period and their outcomes on patient care.� � � � � �J. Preventive� Cardiology Vol 6 (3) 2017; 1043-1047.

� � � Karande SP, Munshi RP, Kumbhar DA. A double blind, randomized, placebo controlled, phase IV, proof-of-concept, comparative study to evaluate the efficacy and safety of Swasawin asthaloc tablets when given as add-on therapy in patients suffering from mild to moderate persistent bronchial asthma. Int J Res Med Sci 2017;5:4929-36.

� � �Joshi Samidha, Munshi Renuka, Talele Gitanjali & Shah Rajesh. An experimental in vitro study to evaluate the antimalarial activity of select homeopathy preparations. International Journal of Medical and Health Research, Volume 3; Issue 7; July 2017; Page No. 65-68

� � �Renuka Munshi, Rima Mittra and Tanvi Patil. Comparison of 3 Different Techniques to assess Angiogenesis using the Chick Embryo Chorioallantoic Membrane Model. EJPMR, 2017,4(7), 632-636

� � �Munshi Renuka, Kumbhar Dipti, Jagasia Jairam & Parekh Aseem. An Open, Randomized, Comparative Clinical Study to assess the Analgesic & Anti-Inflammatory Efficacy of Painmukti Mj Tablets, Painmukti Cream and Painmukti-Sandhical Tablets in Patients suffering from chronic pain. International Ayurvedic Medical Journal, Issue VI (63): June 2017; pg. 1865-1876

� �Joshi Samidha, Munshi Renuka, Talele Gitanjali & Shah Rajesh. Evaluation of the Melanogenic and Anti-Vitiligo Activities of Homeopathic Preparations on Murine B16f10 Melanoma Cells. EJPMR, 2017,4(7), 718-723

�

Academic Activity

Webinar on Pharmacovigilance for Private Practitioners on 16 August 2021

Lecture on Rational Drug Use for Interns

Short Term hands-on training in research for MBBS, MSc (Biotechnology/Life Sciences) students

The department is affiliated to Mumbai University for MSc and PhD courses in Applied Biology.

Externship provision for students of various fraternities.

Awards and Achievements

The Department is recognized as an Advanced Centre for Clinical Pharmacology in Diabetes research using Traditional Medicine by ICMR.

The Department is recognized as a Pharmacovigilance Centre (AMC) for Drugs & & Medical Devices under the Pharmacovigilance Program of India

The Department has & presently conducts various collaborative research projects funded by Central Government agencies

ICMR.

Exploration of the mechanisms of action of Pterocarpus marsupium, Clinical and experimental evaluation of select herbal medicines in diarrhoea & wound healing.

A Pharmaco-genomic study to explore the impact of genetic variation on the lipid lowering response of Statins in patients with hyperlipidemia.

Government of India (GOI)

Advanced Pharmacological Testing & Early Clinical Development of Candidate Molecule/s derived from the sea.

Immunological and Metabolic effects of Panchakarma.

Validation of Ayurvedic concepts Prakriti and their correlation with biomarkers and candidate genes.

AYUSH

Assessment of prakriti and its co-relation with Cellular markers.

Experimental & clinical studies to evaluate the Anti-osteoporotic effect of Panchtikta Ghrita, a classical Ayurvedic formulation

Department of Biotechnology (DBT)

Developing new drug molecules taking leads from Ayurvedic pharmacopoeia for Tuberculosis, Cancer & Diabetes mellitus.

Department of Science & Technology (DST)

Establishing standards for various bhasmas and exploring their efficacy and safety using in-vivo models.

Assessing the Immunomodulatory effects of select herbal extracts

WHO

Surveillance of drug use and its correlation with anti-microbial resistance patterns in the Community

Gallery

Location

4th & 5th floors, G building, TN Medical College & BYL Nair Ch. Hospital

Contact Us

Tel: 91 22 2302 7205 /2301 4713

e-mail: admin@dcpnairhospital.org