LinkedIn You Tube Instagram

Clinical Pharmacology



About the Department

Department of Clinical Pharmacology was established in June 1995 as a super-specialty Department

Milestones

  1. CDRI Clinical Pharmacology Unit
  2. ICMR- Advanced Centre in Clinical Pharmacology [2000]
  3. DBT- Clinical Research Training Centre [2005]
  4. Regional Centre for the PvPI [2010]
  5. ICMR-Advanced centre in Clinical Pharmacology –PK PD Anti-infectives [2018]
  6. ICMR-Advanced centre for Product development [2019]
  7. Allergy OPD for testing patients referred with suspected drug allergies [2020]

Achievements

  • Addition of pharmacogenetics of azathioprine – services for TPMT
  • Addition of TDM of Voriconazole
  • Development of method for detection of hydroxyurea
  • Development of method for detection of mycophenolate mofetil
  • Selected as one of the phase 1 center of excellence by ICMR in 2023

Future outlook

  1. To develop a method for TDM of amikacin
  2. Development of method for detection of thalidomide

Events

  1. Two Pharmacovigilance ‘Advanced Level Training’ Workshops were conducted as a Regional Training Centre under the aegis of Pharmacovigilance Program of India (PvPI)

Name

Dr Nithya Gogtay

Designation

Professor & HoD

Qualification

MBBS, MD, DNB, PhD

Email id

njgogtay@hotmail.com

Teaching experience

25 years

Name

Dr Mahesh N Belhekar

Designation

Associate Professor

Qualification

MBBS, MD

Email id

belhekardrmahesh4@gmail.com

Teaching experience

12 years

Name

Dr Bhaskar Krishnamurthy

Designation

Assistant Professor

Qualification

MBBS, MD, DM

Email id

drbhaskar.kemgsmc@gmail.com

Teaching experience

3 years

    • Facilities/services available in your department
  • Pharmacogenetics laboratory
  • Therapeutic Drug Monitoring (TDM) laboratory
  • Parasitology (Malaria) laboratory
  • Biochemistry laboratory
  • Phase 1 Unit
  • ADR monitoring center
  • Allergy OPD
  • Facility Photograph/video
  • Wards – Ward 24 Second floor, New MS Building, Dept of Clinical Pharmacology
  • Special OPD/Clinic – Allergy OPD
  • Types of OPDs with timings day wise
  • TDM OPD (diagnostic OPD) run every Friday and Saturday from 8:00 am to 12:30 pm
  • Pharmacogenetics OPD daily from 9:00 am to 12:30 pm
  • Allergy OPD – every Friday from 8:00 am to 12:30 pm

  • Patient Feedback – not applicable
  • Patient Education – patients are sensitized about consumer reporting of ADRs as per the Pharmacovigilance program of India (PvPI)

  • Courses offered –
    • DM (Clinical Pharmacology)
    • PhD (Clinical Pharmacology)
    • PhD (Pharmaceutical Medicine)
    • PhD (Applied Biology)
    • MSc (Applied Biology)
    • Fellowship in Drug Development
  • Teaching schedule / Student activities
    • PG seminars every Wednesday 12:00 pm to 1:00 pm
    • Journal clubs every Thursday 12:00 pm to 1:00 pm
    • common teaching program every Saturday 12:00 pm to 1:00 pm.
  • Workshop/CME
    • Canvas of Clinical Pharmacology Workshop (CCPW) every alternate year as a National Clinical Pharmacology conference

  • Dr Ananya Rakshit (First year DM resident) presented an oral paper on ‘Status of registration and re-registration of Ethics Committee in CDSCO and DHR – evaluation of extent of Ethical oversight in the country’ at the 1st Annual Conference of National Association of Pharmacology and Therapeutics (NAPTICON) at Mangalore, Karnataka (28th – 29th October 2022).
  • Dr Dhruve Soni (Final year DM resident) presented an oral paper on ‘Evaluation of the risk of allergy to COVID-19 vaccines in people with a history of allergic diatheses at the 1st Annual Conference of National Association of Pharmacology and Therapeutics (NAPTICON) at Mangalore, Karnataka (28th – 29th October 2022).
  • Dr Sukant Pandit (First year DM resident) presented an oral paper on ‘Comparison of WHO-UMC and Naranjo scales for causality assessment of reported adverse drug reactions’ at the 1st Annual Conference of National Association of Pharmacology and Therapeutics (NAPTICON) at Mangalore, Karnataka (28th – 29th October 2022).
  • Second prize for oral presentation: Dr Bhaskar Krishnamurthy (Assistant Professor) has won the 2nd prize in the oral presentation category for the paper ‘Economic analysis of renal transplant services in a tertiary care hospital’ at the 14th Annual Conference of the ‘Indian Society for Rational Pharmacotherapeutics’ (ISRPTcon) in Hyderabad from (10th – 12th of November 2022).
  • Dr Jeffrey Pradeep Raj (Assistant Professor) presented an oral paper on ‘Can a Discrete Choice Experiment (DCE) help understand COVID-19 vaccine Hesitancy? A study from India’ at the 22nd Annual FERCAP (Forum for Ethical Review Committees in the Asian and Western Pacific Region) Conference, 2022 at Daegu, South Korea (27th – 30th November 2022).
  • Dr Palvi Kudyar (Assistant Professor) presented an oral paper on ‘Evaluation of satisfaction and reasons for participation in a COVID-19 Vaccine Clinical Trial: a single Centre observational study’ at the 22nd Annual FERCAP (Forum for Ethical Review Committees in the Asian and Western Pacific Region) Conference, 2022 at Daegu, South Korea (27th – 30th November 2022).
  • Dr Dhruve Soni (Final year DM resident) presented an oral paper on ‘Assessment of factors that motivate participants to take part in a COVID-19 vaccine study’ at the 22nd Annual FERCAP (Forum for Ethical Review Committees in the Asian and Western Pacific Region) Conference, 2022 at Daegu, South Korea (27th – 30th November 2022).

  • 11th Annual National Conference of Consortium Against Rabies, DY Patil Deemed to be University, Nerul, Navi Mumbai conducted on 8th and 9th December 2023.

    Prize: 1st prize [Rs. 2000/- cash award] in oral presentation to Dr. Vijaya Chaudhari-Gunjal, Assistant Professor for research entitled

  • "Comparison of pre-COVID-19 pandemic, lockdown and post-lockdown participant adherence in a phase IV clinical trial for the treatment of post-exposure rabies prophylaxis"

    Prize: 2nd prize [Rs. 1000/- cash award] in oral presentation to Dr.Roopa Parida [DM Student] for research entitled

  • "Pharmacoeconomic Analysis on Post-Exposure Prophylaxis (PEP) for Rabies Vaccination in Human at a Public Tertiary Care Hospital (Public Sector) in Mumbai-An Interview- Based Study"
  • "FERCICON -23"

    Prize- 1st prize- Dr Palvi Kudyar, Assistant Professor -Dr Ramalingam Sankaran Best Paper Award (Rs 5000/- )for paper titled, _"Evaluation of Satisfaction & Reasons for participation in a Covid-19 vaccine clinical trial: _a single centre study, Mumbai- at the 10th International Conference of the Forum for Ethics Review Committees in India held at PSG Institute of Medical Sciences and Research on December 8th & 9th, 2023.

Year

Number of Publications

2023

10

2022

12

2021

18

2020

17

2019

11

2018

18

2017

17

2016

17

2015

12

2014

16

2013

13

2012

08

YEAR-2024

YEAR-2023

YEAR-2022

  1. Jeffery Pradeep Raj, Nithya J Gogtay, Avaneesh Pandey, Ashish Kumar Kakkar, Nusrat Shafiq Khan, Mekala Padmaja, Usharani Pingali, Arun Prasath Raju, Surulivelrajan Mallayasamy, Nilima Arun Kshirsagar. Population pharmacokinetics of hydroxychloroquine sulphate in healthcare workers given for prophylaxis against Corona Virus Disease 2019 (COVID-19) in India". The J Clinical Pharmacol 2022; 0(0): 1-9.
  2. Karande S, Bhavani S, Gogtay NJ, Shiledar MP, Kelkar S, Oke AS. Do school students with specific learning disabilities have lower emotional intelligence abilities? A cross-sectional questionnaire-based study in Mumbai, Maharashtra, India. J Postgrad Med 2022;68:24-30.
  3. Saha S, Gogtay NJ. Research, residents, and registrars - getting it right. Perspect Clin Res 2022; 3(2):63-64.
  4. Raj JP, Mamde A, Ganatra K, Gogtay NJ, Thatte UM. An evaluation of the minutes of subject expert committee meetings of novel COVID-19 proposals. Perspectives in Clinical Research 2022; 13(3): 172-73.
  5.  

YEAR-2021

  1. Figer BH, Lamture SS, Gandhi T, Chauhan A, Gvalani A, Gogtay NJ, et al. A survey of knowledge and variables influencing perceptions about clinical research: A cross-sectional study from Mumbai. Perspect Clin Res 2021;12:93-9
  2. Shetty NS, Salvi RA, Thatte UM, Gogtay NJ. Has mandatory prospective registration of all studies brought about a change? A 1-year audit of studies registered in the Clinical Trials Registry of India [CTRI] before and after April 1, 2018. Perspect Clin Res 2021;12:72-5.
  3. Gogtay NJ, Ranganathan P, Aggarwal R. Understanding estimands. Perspect Clin Res 2021;12:106-12.
  4. Bose D, Gogtay NJ, Rajan SK. Placing the results of the SOLIDARITY trial with regards to Remdesivir in perspective - Lung India [accepted for publication]
  5. Bavdekar SB, Saha S, Thatte UM, Gogtay NJ. An analysis of invitations for article submissions received via e mail. Accepted for publication in the Indian Jr Medical Ethics
  6. Konwar M, Maurya MM, Thatte UM, Gogtay NJ, Bose D. A systematic review and meta analysis of the safety of Hydroxychloroquine in randomized controlled trials and observational studies. Accepted for publication in Current Clinical Pharmacology
  7. Gogtay NJ, Sheth HJ, Maurya MM, Belhekar MB, Thatte UM. A literature review of consent declines and consent withdrawals in Randomized Controlled Trials (RCTs) conducted during the COVID-19 pandemic. Accepted for publication in the Journal of Postgraduate Medicine.
  8. Konwar M, Mamde A, Patankar P, Thatte UM, Gogtay NJ. An audit of safety reporting in randomized controlled trials over a five year period in a high impact factor journal. Accepted for publication in the Journal of Postgraduate Medicine.
  9. Bose D, Ravi RS, Gogtay NJ, Thatte UM, Borse T. An Audit of Interim Analyses of Randomized Controlled Trials [RCTs] Published in Three High Impact Factor Medical Journals over a seven-year period [2012-2018]. Accepted for publication in Reviews on Recent Clinical Trials.  
  10. Saxena U, Bose D, Saha S, Gogtay NJ, Thatte UM. An Audit of Warning letters [WLs] issued to Sponsors, Institutional Review Boards [IRBs], and Investigators by the United States Food and Drug Administration (US FDA) over a six-year period. Accepted for publication in the Indian Jr Medical Ethics
  11. Konwar M, Gogtay NJ, Ravi R, Thatte UM, Bose D. Evaluation of efficacy and safety of Fosfomycin versus Nitrofurantoin for the treatment of uncomplicated lower urinary tract infection (UTI) in women - A systematic review and meta – analysis. Accepted for publication in Journal of Chemotherapy. 
  12. Subash S, Gogtay NJ, Iyer KR, Gandhe P, Budania R, Thatte UM. Evaluation of vanillin as a probe drug for aldehyde oxidase and phenotyping for its activity in a Western Indian cohort. Indian J Pharmacol 2021;53:213-20.
  13. Konwar M, Maurya MR, Nishandar TB, Thatte UM, Gogtay NJ. An evaluation of drug lag for new drugs approved by the Indian regulator relative to the United States, European Union, and Japanese regulatory agencies: A 15-year analysis (2004–2018). Perspect Clin Res 2021;12:159-64.
  14. Raj Jeffery, Mamde AM, Ganatra K, Gogtay NJ & Thatte UM. An evaluation of minutes of subject expert committee [SEC] meetings of novel corona virus disease [COVID-19] proposals. Accepted for publication in Perspectives in Clinical Research.
  15.  Shukla SC, Pandit S, Soni D, Gogtay NJ. Evaluation of allergic reactions following COVID-19 vaccination in patients with documented allergies. J Assoc Phy Ind 2021; 69: 14-17.
  16. Chaudhari VL, Godbole CJ, Bendkhale SB, Desai NN, Gogtay NJ, Thatte UM. Evaluation of COVID-19 studies registered with Clinical Trials Registry of India [CTRI]- a database analysis. J Assoc Phy Ind 2021; 69: 28-31.
  17. Gogtay NJ and Bhatt AD. The clinician and the pandemic- keeping track, keeping pace and keeping the faith. J Assoc Phy Ind 2021; 69: 11-12.
  18. Karande S, Bhavani S, Gogtay NJ, Shiledar MP, Kelkar S, Oke AS. Do school students with specific learning disabilities have lower emotional intelligence abilities? A cross-sectional questionnaire-based study in Mumbai, Maharashtra, India. J Postgrad Med 2022;68:24-30.

YEAR-2020

  1. Chaudhari N, Ravi R, Gogtay NJ, Thatte UM. Recruitment and retention of participants in Clinical Trials: Challenges and Solutions. Accepted for Publication in Perspectives in Clinical Research
  2. Saha S, Kerkar P, Gogtay NJ. A critical analysis of the non – inferiority design of the TALENT trial. Accepted for publication in the Indian Heart Journal.
  3. Gogtay N, Kuyare M, Pai N, Mehta L, Rajapure P, Thatte U. A randomized, controlled, equivalence study of authorized versus non – authorized deception in a model of pain following third molar extraction. Accepted for publication in Clinical Ethics. SAGE publications 2020;
  4. Gogtay NJ, Thatte UM. Sampling and Sample Size in Clinical Research - A Scientific and Ethical Imperative. J Assoc Phy Ind 2020; 68: 11-12.
  5. Rajan S, Gogtay NJ, Konwar M, Thatte UM. The global initiative for asthma guidelines (2019): change in the recommendation for the management of mild asthma based on the SYGMA-2 trial - A critical appraisal. Lung India 2020; 37(2):169-173.
  6. Figer B, Gogtay NJ, Thatte UM. Compliance of Mumbai based Clinical Trial Sites with the Quality Council of India [QCI] guidelines and evaluation of the challenges faced by the investigators. Accepted for publication in Perspectives in Clinical Research.
  7. Figer BH, Sapra KP, Gogtay NJ, Thatte UM. A comparative study to evaluate quality of data documentation between investigator-initiated and pharmaceutical industry-sponsored studies. Perspect Clin Res 2020;11:13-7.
  8. Bose D, Saha S, Saxena U, Kesari H, Thatte UM, Gogtay NJ. Factors influencing recruitment and retention of participants in clinical studies conducted at a tertiary referral center: A five-year audit. Perspect Clin Res 2020;11:81-5.
  9. Chaudhari N, Ravi R, Gogtay NJ, Thatte UM. Recruitment and retention of the participants in clinical trials: Challenges and solutions. Perspect Clin Res 2020;11:64-9.
  10. Godbole C, Thaker S, Kerkar P, Nadkar M, Gogtay NJ, Thatte UM. Association of Paraoxonase 1 (PON1) gene polymorphisms and enzymatic activity on risk of coronary artery disease (CAD)" . Accepted for publication in Future Cardiology.
  11. Ranganathan P, Nair D, Gogtay NJ. Addressing challenges due to the COVID-19 pandemic – A site and investigator perspective. Perspect Clin Res 2020;11:111-4.
  12. Saxena U, Bose D, Maurya M, Gogtay NJ, Thatte UM. An audit of questions asked by participants during the informed consent process for regulatory studies at a tertiary referral centre – an analysis of consent narratives. Accepted for publication in Clinical Ethics.
  13. Figer BF, Raj JP, Thaker SP, Gogtay NJ, Thatte UM. Determination of Reference Intervals from a Laboratory Database of an Academic Clinical Research Unit Affiliated to a Tertiary Care Teaching Hospital and an Audit of Out of Range Values. Accepted for publication in Perspectives in Clinical Research [PICR].
  14. Dhuya M, Pal MM, Hazra A, Chaterjee S, Gogtay N. Cytochrome P450D6 polymorphism in eastern Indian population. Ind J Pharmacol 2020; 52: 189-95. 
  15. Bacchav SS, Dighe V, Mali N, Gogtay NJ, Thatte UM, Devarajan PV. Nose to brain delivery of diazepam from an intra nasal aqua-triggered in – situ [ATIS] gelling microemulsion: monitoring brain uptake by micro dialysis. Eur J Drug Metabolism and Pharmacokinetics. Published on line on 19 Aug 2020.
  16. Bose D, Nasta S, Ravi R, Thatte UM, Gogtay NJ. An audit of reporting of conflict of interest policies among three stakeholders in Indian biomedical journals. Perspect Clin Res 2020;11:168-73.

YEAR-2019

  1. Shetty PA, Gogtay NJ & Thatte UM. An audit of minutes of Subject Expert Committee [SEC] meetings as a metric to assess the clinical research roadmap of India. Perspect Clin Res 2019; 10: 15-19.
  2. Birajdar AR, Bose D, Nishandar TB, Shende AA, Thatte UM & Gogtay NJ. An audit of studies registered retrospectively with the Clinical Trials Registry of India [CTRI] – a one-year analysis. Accepted for publication. Perspect Clin Research 2019; 10: 26-30.
  3. Mukhopadhyay S, Tiwari P, Sekharan S, Shetty P, Gogtay NJ, Thatte UM. Modelling and Forecasting Indian Malaria Incidence Using Generalized Time Series Models. Accepted for publication in Communications in Statistics – Case Studies and Data Analysis.
  4. Gogtay NJ. Reporting of Randomized Controlled Trials: will it ever improve? Accepted for publication in Perspectives in Clinical Research. [Editorial].
  5. Shah I, Jadhao N, Mali N, Deshpande S, Gogtay N, Thatte U. Pharmacokinetics of isoniazid in Indian children with tuberculosis on daily treatment. Int J Tuberc Lung Dis 2019; 23 (1): 52-7.
  6. Bose D, Saha S, Saxena U, Kesari H, Thatte UM, Gogtay NJ. Factors influencing recruitment and retention of participants in clinical studies conducted at a tertiary referral center- a five year audit. Accepted for publication in Perspectives in Clinical Research. [Original article].
  7. Kannan S, Sannala CR, Mallaysamy SR, Chaturvedi A, Kadam PK, Hase NK, Shukla A, Gogtay N, Thatte UM. Population pharmacokinetics of primaquine in Indian population and effect of hepatic dysfunction- an exploratory approach.  Indian J Pharmacol 2019; 51: 17-24.
  8. Bose D, Saha S, Saxena U, Kesari H, Thatte UM, Gogtay NJ. Factors influencing recruitment and retention of participants in clinical studies conducted at a tertiary referral center: A five-year audit. Perspect Clin Res [Epub ahead of print] [cited 2019 May 4]. DOI: 10.4103/picr.PICR_198_18
  9. Sengar M, Gogtay N, Jain H. Ibrutinib Regimens in Older Patients with Untreated CLL. N Engl J Med. 2019; 25;380(17):1679.
  10. Sengar M, Gogtay N, Jain H. Ibrutinib Regimens in Older Patients with Untreated CLL. N Engl J Med. 2019; 25;380(17):1679.
  11. Shukla A, Jain A, Kahalekar V, Bendkhale S, Gogtay N, Thatte U, Bhatia S. Mutations in CYP2C9 and/or VKORC1 haplotype are associated with higher bleeding complications in patients with Budd-Chiari syndrome on warfarin. Hepatol Int 2019; 13(2):214-221.#
  12. Mali NB, Tullu MS, Wandalkar PP, Deshpande SP, Ingale VC, Deshmukh CT, Gogtay NJ, Thatte UM. Steady state pharmacokinetics of vancomycin in children admitted to the Pediatric Intensive Care Unit of a tertiary referral center. Indian Jr Critical Care Medicine 2019; 23: 497-502.

  1. Evaluation of population pharmacokinetics of levetiracetam in patients with epilepsy
  2. Prediction of factors influencing Indian adults’ likelihood of accepting any Covid-19 vaccination and their willingness to pay – a Discrete Choice Experiment (DCE) study
  3. A randomized, open label, parallel, proof of concept study to evaluate efficacy and safety of topical Phenytoin cream in adult patients with Diabetic ulcers
  4. A Multi-Center, Prospective, Open-Label, Assessor-Blinded, Randomised, Controlled, Non-Inferiority, Pivotal Clinical Investigation to evaluate the Performance and Safety of 3-D Scaffold Matrix – A Class C Medical Device Bone Void Filler as a Bone Graft Substitute in Orthopaedic Surgery
  5. A prospective, randomized, double blind, placebo-controlled study of ZYBK2 to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics in patients with Rheumatoid arthritis
  6. A multinational, open-label, randomised, controlled trial to investigate efficacy and safety of NNC0365-3769 (Mim8) in adults and adolescents with haemophilia A with or without inhibitors.
  7. Safety, efficacy, and exposure of subcutaneously administered NNC0365 3769 (Mim8) prophylaxis in children with haemophilia A with or without FVIII Inhibitors
  8. A Prospective, Nonrandomized, Open Label, Single Arm, Multicenter, Phase 3 Clinical Study to Evaluate the Efficacy and Safety of Human Normal Immunoglobulin for Intravenous Administration in Adult Patients with Chronic Primary Immune Thrombocytopenia
  9. A Phase III Prospective, multicentric, clinical study in the management of pregnancy induced cholestasis to evaluate the efficacy and safety of Ursodeoxycholic acid (Udiliv) Tablets [PICTURE study]
  10. Community Activities - During the National Pharmacovigilance week in the month of September 2022, on 23rd September 2022, the Pharmacovigilance team of our department have created awareness of Adverse Drug Reactions among patients in Geriatric OPD at Kamgar Kalyan Kendra, Naigaon community centre along with Community Medicine Department.


  • Common teaching programme

    Presenters: Dr Palvi Kudyar and Dr Dhruve Soni

    Date: 16th March 2024 (Saturday)

    Time: 12.00 pm onwards


  • Journal club

    Presenters: Dr Achal Sukhdeve

    Date: 14th March 2024 (Thursday)

    Time: 3.00 pm onwards


  • DM seminar

    Presenters: Dr Ananya Rakshit

    Topic: One compartmental PK models (Intravenous)

    Date: 6th March 2024 (Wednesday)

    Time: 2.30 pm onwards


  • DM seminar

    Presenters: Dr Sourav Mondal

    Topic: Drug-drug and Drug-food interactions

    Date: 28th February 2024 (Wednesday)

    Time: 2.30 pm onwards


  • Journal Club

    Presenters: Dr Laxmi Hotkar

    Date: 23rd February 2024 (Friday)

    Time: 2.30 pm onwards


  • Causality assessment committee meeting (January 2024)

    Case: Amoxicillin / Cefpodoxime induced Fixed Drug Eruption (FDE)

    Presenters: Dr Sanjeed Athikkay and Dr Kishore Patil

    Date: 31st January (Wednesday)

    Time: 12 noon onwards


  • Journal club :

    Presenter: Dr Sanjeed Athikkay

    Date: 17th January (Wednesday)

    Time: 12 noon onwards


  • Journal club :

    Presenter: Dr Kishore Patil

    Date: 11th January(Thursday)

    Time: 12 noon onwards


Photo Gallery


Contact Us - Executive assistant – Mrs. Ujwala Parulekar Tel:91 22 24133767/24174420

Notifications & updates – regular updates on academic schedule are put up on the Department website.