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{{Short description|Indian clinical pharmacologist}}
{{Use dmy dates|date=July 2021}}

{{Infobox medical person
| name = Nilima Arun Kshirsagar
| image =
| alt =
| caption =
| birth_date = {{Birth year and age|1949}}
| birth_place = [[Mumbai]], [[Maharashtra]], [[India]]
| death_date =
| death_place =
| profession = Clinical Pharmacologists
|specialism =
|research_field = Liposomal Formulations
| known_for =
| years_active =
| education = [[Doctor of Medicine]]<br />[[King Edward Memorial Hospital and Seth Gordhandas Sunderdas Medical College]]
| work_institutions =
| prizes =
| relations =
}}
'''Nilima Arun Kshirsagar''' (born 1949) is an Indian [[Clinical pharmacology|clinical pharmacologist]] who developed and patented [[Liposome|liposomal]] [[amphotericin B]] and its [[drug delivery]] system in 1993.<ref name="Liposomal drug delivery system from laboratory to clinic">{{cite journal |last1=SK Pandya, BG Kirodian, S Sanath |first1=NA Kshirsagar |title=Liposomal drug delivery system from laboratory to clinic |journal=Journal of Postgraduate Medicine |date=2005 |volume=51 |issue=5 |pages=S5-15 |pmid=16519249 |url=https://www.jpgmonline.com/article.asp?issn=0022-3859;year=2005;volume=51;issue=5;spage=5;epage=15;aulast=Kshirsagar |access-date=30 May 2021}}</ref> She is the former dean of [[King Edward Memorial Hospital and Seth Gordhandas Sunderdas Medical College]].<ref name="KEM Hospital gets private touch"/> She is the national chairperson in clinical pharmacology at [[Indian Council of Medical Research|Indian Council of Medical Research (ICMR)]] and president of the South Asian chapter of the American college of clinical pharmacology. She is a Member of the WHO Committees on Product development and Drug statistics Methodology.

Kshirsagar is a fellow of the National Academy of Sciences, India, a fellow of the Searle Research Center, England, Faculty of Pharmaceutical Medicine UK and Fellow of American College of Clinical Pharmacology, USA. She is the Chair of the core training Panel of [[Pharmacovigilance Programme of India]].<ref name=chapter>{{cite web |title=South Asian chapter of American college of clinical Pharmacology |url=http://www.sacaccp.org/team/clinical-pharmacology-dr-nilima-kshirsagar/ |website= |access-date=28 May 2021}}</ref><ref name="Drugs for Neglected Diseases initiative (DNDi).">{{cite web |title="Drugs for Neglected Diseases initiative (DNDi)." |url=https://dndi.org/our-people/nilima-kshirsagar/ |website=Drugs for Neglected Diseases initiative (DNDi). |access-date=28 May 2021 |archive-date=12 July 2021 |archive-url=https://web.archive.org/web/20210712073930/https://dndi.org/our-people/nilima-kshirsagar/ |url-status=dead }}</ref><ref name=fdc>{{cite news|date=15 December 2017|title=SC refers 349 FDC medicines to Drug Advisory Board for relook|work=Economic Times|publisher=|url=https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/sc-refers-349-fdc-medicines-to-drug-advisory-board-for-relook/articleshow/62089147.cms?from=mdr|access-date=30 May 2021}}</ref>

She established departments of Clinical Pharmacology at [[King Edward Memorial Hospital and Seth Gordhandas Sunderdas Medical College|KEM Hospital]] and at [[Topiwala National Medical College and B.Y.L. Nair Charitable Hospital, Mumbai|Nair Hospital]] Mumbai. The drug [[Liposome|Liposomal]] Amphotericin-b, used to treat the [[Black fungus (COVID-19 condition)|Indian Mucormycosis epidemic of 2021]] was developed and patented in India by Nalini Kshirsagar in 1993.<ref name="Liposomal drug delivery system from laboratory to clinic" />

== Career==
In 1977, after her doctorate she became assistant professor at [[King Edward Memorial Hospital and Seth Gordhandas Sunderdas Medical College]] and she was promoted to associate professor in 1985. In 1993 she become a Professor and a Member of the steering committee of [[World Health Organization]] and a member of the advisory commission on product development and evaluate science program at [[Haffkine Institute]]. In 1993 she become the founding Head of the Department of Clinical Pharmacology at [[King Edward Memorial Hospital and Seth Gordhandas Sunderdas Medical College|KEM]], Mumbai, India.<ref name=ref55>{{cite web |title=मराठी विश्वकोश |date=11 February 2021 |url=https://marathivishwakosh.org/48411/ |publisher=मराठी विश्वकोश |access-date=30 May 2021}}</ref>

Kshirsagar was later made the Dean, the Professor and the Head of the Clinical Pharmacology department at King Edward Memorial Hospital and Seth Gordhandas Sunderdas Medical College.<ref name="ias">{{Cite web |title=Women Fellows of the Indian Academy of Sciences |url=https://www.ias.ac.in/Initiatives/Women_in_Science/Women_Fellows_of_NASI }}</ref>

== Notable work ==
[[Bimal Kumar Bachhawat]], Kshirsagar and [[Uttamchand Khimchand Sheth]] are credited with creating the research and academic structure for teaching pharmacology in India.<ref>{{Cite book|last=Patil|first=Popat N.|url=https://books.google.com/books?id=nqmEQIxqEs0C&q=nilima+Kshirsagar&pg=PA733|title=Discoveries in Pharmacological Sciences|page=733|date=2012|publisher=World Scientific|isbn=978-981-4355-07-0|language=en}}</ref>

Bachhawat encouraged Kshirsagar and Sunil Pandya to set up a liposome research laboratory. Under the leadership of Kshirsagar a new department of clinical pharmacology was set up at the [[King Edward Memorial Hospital and Seth Gordhandas Sunderdas Medical College|KEM]] and at [[Topiwala National Medical College and B.Y.L. Nair Charitable Hospital, Mumbai|Nair Hospital]] Mumbai with financial help from the [[Brihanmumbai Municipal Corporation]].<ref>Kshirsagar N A, Pandya S K, Kirodian B G, Sanath S. Liposomal drug delivery system from laboratory to clinic. J Postgrad Med [serial online] 2005 [cited 2021 May 28];51, Suppl S1:5-15. Available from: https://www.jpgmonline.com/text.asp?2005/51/5/5/19808</ref><ref name="Drug couriers">{{cite news |last1=Khanna |first1=Anjani |title=Drug couriers – Artificial fat globules called liposomes can reduce the side-effects of drugs |url=https://www.downtoearth.org.in/news/drug-couriers-27361 |access-date=28 May 2021 |publisher=Down to earth |date=15 January 1995}}</ref>

Conventional amphotericin B was developed in the 1950s and for many decades it was the only [[antifungal]] agent available for the treatment of invasive fungal diseases. It was a standard care for a range of [[pathogenic fungus]], however [[nephrotoxicity]] and infusion-related reactions was a major constraint.<ref>{{cite journal |last1=Neil RH Stone, Tihana Bicanic, Rahuman Salim, William Hop |title=Liposomal Amphotericin B (AmBisome®): A review of the pharmacokinetics, pharmacodynamics, clinical experience and future directions |journal= Drugs|year=2016 |volume=76 |issue=4 |pages=485–500 |doi=10.1007/s40265-016-0538-7 |pmid=26818726 |pmc=4856207 }}</ref> Kshirsagar and her team improved the techniques of the production of liposomes derived from [[soyabean]] [[Lecithin]] to make them usable in human beings. Liposomal amphotericin B, a lipid formulation of amphotericin B, was developed in India. Pharmacological and preclinical tests of liposomal amphotericin B drug delivery system were successful.<ref name="Liposomal drug delivery system from laboratory to clinic" /><ref name="म्युकरमायकोसिसवरील औषध उत्पादनाचे केईएमकडून प्रयत्न">{{cite news |last1=कलगुटकर |first1=शर्मिला कलगुटकर |title=म्युकरमायकोसिसवरील औषध उत्पादनाचे केईएमकडून प्रयत्न |url=https://maharashtratimes.com/maharashtra/mumbai-news/kem-hospital-has-decided-to-reproduce-the-injection-on-mucormycosis/articleshow/82928114.cms |access-date=31 May 2021 |publisher=Maharashtra Times |date=25 May 2021}}</ref>
[[File:Periorbital fungal infection of mucormycosis, or phycomycosis PHIL 2831 lores (cropped).jpg|thumb|Eye infected with mucormycosis]]
Use of liposomes as a delivery system for Amphotericin B was highly effective and less toxic as it carries the drug to the specific site and so it is required in much lower concentrations.<ref name="Case Study 2: Lipoosomal Amphotericin-b">{{cite journal |last1=Mehra |first1=Kavita |title=Case Study 2: Lipoosomal Amphotericin-b |journal=India, Science & Technology:2008 |issue=S&T Structure, Infrastructure and Public Space |url=https://www.nistads.res.in/all-html/Technology%20Transfer.html |access-date=29 May 2021}}</ref> After completion of the human trials, Kshirsagar defined the administration and dosing schedules. The product was patented and the technology was transferred through the [[National Research Development Corporation]] (NRDC) to a pharmaceutical company for marketing. This was the first drug development initiative of a [[Public–private partnership|Public–private partnership model]] in India.<ref name="Case Study 2: Lipoosomal Amphotericin-b" /><ref name="KEM doctor puts drugs, dosage under microscope">{{cite news |last1=Minwalla |first1=Shabnam |title=KEM doctor puts drugs, dosage under microscope |url=https://timesofindia.indiatimes.com/city/mumbai/kem-doctor-puts-drugs-dosage-under-microscope/articleshow/42200945.cms |access-date=29 May 2021 |publisher=Times of India |date=2 April 2003}}</ref> Liposomal Amphotericin-b was used as the primary treatment in the [[Mucormycosis]] epidemic of 2021 in India.<ref>{{cite news |last1=Varghese |first1=Anuja Susan |title=Kerala running short of medication to meet black fungus threat? Shortage of Liposomal Amphotericin B, used widely for treatment, has hit hosps across state |url=https://www.newindianexpress.com/states/kerala/2021/may/30/kerala-running-short-of-medication-to-meet-black-fungus-threat-2309322.html |access-date=30 May 2021 |publisher=The New Indian express |date=30 May 2021}}</ref><ref name="Celon Laboratories comes up with an alternative formulation of Amphotericin B">{{cite news |title=Celon Laboratories comes up with an alternative formulation of Amphotericin B |url=https://www.thehansindia.com/news/cities/hyderabad/celon-laboratories-comes-up-with-an-alternative-formulation-of-amphotericin-b-688893?infinitescroll=1 |access-date=3 June 2021 |publisher=Hans News Service |date=2 June 2021}}</ref>

During the [[COVID-19 pandemic in India]] there was a large increase of cases of what was named "black fungus" or [[mucormycosis]] in affected patients. Surgeons had to remove eyes after they were infected.<ref>{{Cite journal|last=Dyer|first=Owen|date=13 May 2021|title=Covid-19: India sees record deaths as "black fungus" spreads fear|url=https://www.bmj.com/content/373/bmj.n1238|journal=BMJ|language=en|volume=373|article-number=n1238|doi=10.1136/bmj.n1238|issn=1756-1833|pmid=33985993|doi-access=free}}</ref> One treatment was a daily injection for eight weeks of anti-fungal intravenous injection of amphotericin B. The injection could be standard [[amphotericin B deoxycholate]] or the liposomal form. Kshirsagar's liposomal form cost more but it was considered "safer, more effective and [with] lesser side effects".<ref name=bfungusbbc>{{Cite news|date=19 May 2021|title=Black fungus in India: Concern over drug shortage as cases rise|language=en-GB|work=BBC News|url=https://www.bbc.com/news/world-asia-india-57167322|access-date=8 July 2021}}</ref>

The [[World Health Organization]] (WHO) launched a global program to eliminate [[Lymphatic Filariasis]] in 2000. Kshirsagar's team of Indian scientists worked in two villages, Kurzadi and Selukate in [[Wardha]], Maharashtra ensuring the safety and efficacy of the drugs.<ref>{{cite news |last1=MALIK |first1=SHIKHA T |title=SCIENTISTS DISCOVER THAT ADDITION OF DRUG ALBENDAZOLE HAS NO ADVANTAGES IN THE TREATMENT OF LYMPHATIC FILARIASIS |url=https://www.firstpost.com/tech/news-analysis/scientists-discover-addition-of-drug-albendazole-is-not-effective-against-lymphatic-filariasis-4171587.html |access-date=30 May 2021 |publisher=First post |date=24 October 2017}}</ref>

During her tenure as dean of [[King Edward Memorial Hospital and Seth Gordhandas Sunderdas Medical College]] capacity was increased from 1,800 to 2,400 beds and the capacity of [[Intensive care unit]] beds was enhanced from 160 to 300.<ref name="KEM Hospital gets private touch">{{cite news |title=KEM Hospital gets private touch |url=https://www.dnaindia.com/mumbai/report-kem-hospital-gets-private-touch-1095743 |access-date=30 May 2021 |publisher=DNA |date=9 May 2007}}</ref>

In 2017 Kshirsagar was appointed as chairperson of the expert committee constituted by the [[Drugs Controller General of India]] to elaborate on the parameters set out in section 26A of the [[Drugs and Cosmetics Act, 1940|Drugs and Cosmetics Act]] of India to decide whether to regulate, restrict or prohibit the sale of over 300 [[Combination drug|fixed-dose combination drugs]] in India.<ref>{{cite news |title=New committee to examine safety, rationality of over 300 drugs banned since 2016 |url=https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/new-committee-to-examine-safety-rationality-of-over-300-drugs-banned-since-2016/articleshow/63001708.cms?from=mdr |access-date=30 May 2021 |publisher=economic-times |date=20 February 2018}}</ref> Based on a 700-page report submitted by the committee, the Supreme Court of India banned 328 fixed-dose combination drugs in September 2018.<ref name="Saridon exempted from list of banned drugs by Supreme Court">{{cite news |last1=Kohli |first1=Namita |title=Saridon exempted from list of banned drugs by Supreme Court |url=https://www.theweek.in/news/biz-tech/2019/02/21/saridon-exempted-list-banned-drugs-supreme-court.html |access-date=3 June 2021 |publisher=The Week |date=22 February 2019}}</ref>

== Awards==
* [[Dr. B. C. Roy Award]] for her work with drugs combating malaria, epilepsy, elephantiasis and heart diseases – (2002).<ref name="LIST OF FELLOWS - B C Roy">{{cite web |title=LIST OF FELLOWS |url=https://www.nams-india.in/downloads/fellowsmembers/ZZ.pdf |website=www.nams-india.in |publisher=National Academy of Medical Sciences (India) |access-date=1 June 2021}}</ref><ref name="KEM doctor puts drugs, dosage under microscope" />
* Nathaniel T. Kwit memorial Awarde – (2018).<ref>https://www.hopkinsmedicine.org/pharmacology_molecular_sciences/_pdf/Hendrix_2018ACCP_Award_Winner.pdf {{dead link|date=July 2021}}</ref>
* Professor Archana Sharma Memorial Lecture Awardees – (2018).<ref name="Workshop on Trends in Healthcare Innovations in India 29th February-1st March 2020">{{cite web |title=Workshop on Trends in Healthcare Innovations in India 29th February-1st March 2020 |url=http://www.nirrh.res.in/wp-content/uploads/2020/02/Combined-programme-abstract-book.pdf |publisher=ICMR |access-date=31 May 2021 |archive-date=14 July 2021 |archive-url=https://web.archive.org/web/20210714012106/http://www.nirrh.res.in/wp-content/uploads/2020/02/Combined-programme-abstract-book.pdf |url-status=dead }}</ref>
* [[VASVIK Industrial Research Award]]- Smt. Chandaben Mohanbhai Patel Industrial Research Award for Women Scientists – (1997).<ref name="Smt. Chandaben Mohanbhai Patel Industrial Research Award for Women Scientists">{{cite web |title=Smt. Chandaben Mohanbhai Patel Industrial Research Award for Women Scientists |url=http://www.vasvik.org/Women%27s_Award.html |publisher=Vividhlaxi Audyogik Samshodhan Vikas Kendra |access-date=31 May 2021 |archive-date=26 February 2014 |archive-url=https://web.archive.org/web/20140226070926/http://www.vasvik.org/Women%27s_Award.html |url-status=dead }}</ref>
* Mumbai Mayors award for societal contribution.<ref name="Drugs for Neglected Diseases initiative (DNDi)."/>

== Publications ==

Nilima has produced over 200 publications:-<ref>{{cite web |title=COVID-19 from Public Health Perspective |url=https://iipsindia.ac.in/sites/default/files/news_documents/Covid_Webinar_17Oct2020.pdf |publisher=International Institute for Population Sciences |access-date=30 May 2021}}</ref>
{{Refbegin|30em}}
* {{cite journal |last=Kshirsagar |first=Nilima Arun |title=Different liposomal amphotericin B formulations for visceral leishmaniasis–Author's reply |journal=The Lancet Global Health |date=August 2014 |volume=2 |issue=8 |pages=e450 |doi=10.1016/S2214-109X(14)70270-0 |pmid=25103516 |oclc=|doi-access=free }}
* {{cite journal |last=Kshirsagar |first=Nilima Arun, Shinde RR, Mehta S. |title= Floods in Mumbai: impact of public health service by hospital staff and medical students |journal=Journal of Postgraduate Medicine |date=August 2006 |volume=52 |issue=4 |pages=312–314 |pmid=17102558 }}
* {{cite journal |last1=Deshpande |first1=Aparna A |last2=Mehta |first2=Sanjay |last3=Kshirsagar |first3=Nilima A |title=Hospital management of Mumbai train blast victims |journal=The Lancet |date=24 February 2007 |volume=369 |issue=9562 |pages=639–640 |doi=10.1016/S0140-6736(07)60305-5 |pmid=17321304 |s2cid=5241646 |doi-access=free }}
* {{cite journal |doi=10.16943/ptinsa/2017/49232|title=Tropical Diseases|year=2017|last1=Kshirsagar|first1=Nilima|journal=Proceedings of the Indian National Science Academy|volume=95|doi-access=free}}
* {{cite journal |doi=10.1016/S2214-109X(14)70011-7|title=Single-dose liposomal amphotericin B for visceral leishmaniasis|year=2014|last1=Kshirsagar|first1=Nilima A.|journal=The Lancet Global Health|volume=2|issue=4|pages=e203|pmid=25103058|doi-access=free}}
* {{cite journal |doi=10.3233/JRS-130601|title=Comparative regulatory performance on introduction & withdrawal of drugs in India and EU/Internationally|year=2013|last1=Kshirsagar|first1=Nilima A.|last2=Bachhav|first2=Sagar S.|journal=International Journal of Risk & Safety in Medicine|volume=25|issue=4|pages=235–238|pmid=24305562}}
* {{cite journal |doi=10.4103/2229-3485.106410|title=Endnote: Vision of research ethics|year=2013|last1=Kshirsagar|first1=Nilimaa|journal=Perspectives in Clinical Research|volume=4|issue=1|pages=108–111|pmid=23533993|pmc=3601695 |doi-access=free }}
* {{cite journal |doi=10.4103/0253-7613.84946|title=Clinical pharmacology: Prospects and development in India|year=2011|last1=Kshirsagar|first1=Nilima|last2=Kumar|first2=Vijay|journal=Indian Journal of Pharmacology|volume=43|issue=5|pages=489–491|pmid=22021987|pmc=3195114 |doi-access=free }}
* NA, Kshirsagar. (2021). Symposium- Malaria: Antimalarial resistance and policy ramificationsand challenges. Journal of Postgraduate Medicine (ISSN: 0022-3859) Vol 52 Num 4.
* Kshirsagar, N & Sheth, U. (1977). Drug protein binding: relevance to treatment. Journal of postgraduate medicine. 23. 50-2.
{{Refend}}

== References ==
{{Reflist}}

==External links==
* {{cite news |last1=Swati |first1=Lokhande |title= मराठी किमयागार! 10 फुटांच्या खोलीत झाला Mucormycosis वरील इंजेक्शनचा शोध; पाहा VIDEO |url=https://lokmat.news18.com/maharashtra/nilima-shirsargar-invented-injection-on-black-fungus-kem-hospital-has-its-patent-557339.html |access-date=31 May 2021 |publisher=IBN lokmat TV. |date=28 May 2021 |ref=TV Report in Marathi.}}
* {{cite news |last1=Shrivastava |first1=Shreya |title=Vaccines – A Lemon and Spoon Race (Podcast with Dr Nilima Kshirsagar & Dr Dhvani Mehta) – Ep 1, Healthy Dose |url=https://soundcloud.com/vidhi-legal-policy/vaccines-a-lemon-and-spoon-race-with-dr-nilima-kshirsagar-dr-dhvani-mehta-ep-1-healthy-dose |publisher=[[Vidhi Centre for Legal Policy]]}}

{{Authority control}}

{{DEFAULTSORT:Kshirsagar, Nilima Arun}}
[[Category:1949 births]]
[[Category:Indian pharmacologists]]
[[Category:Marathi people]]
[[Category:Clinical pharmacologists]]
[[Category:Indian medical researchers]]
[[Category:Indian women medical researchers]]
[[Category:Indian medical academics]]
[[Category:World Health Organization officials]]
[[Category:Indian Council of Medical Research]]
[[Category:Dr. B. C. Roy Award winners]]
[[Category:Fellows of the Royal College of Physicians of Edinburgh]]
[[Category:Fellows of the National Academy of Medical Sciences]]
[[Category:20th-century Indian biologists]]
[[Category:Scientists from Mumbai]]
[[Category:Medical doctors from Mumbai]]
[[Category:Medical doctors from Maharashtra]]
[[Category:20th-century Indian medical doctors]]
[[Category:21st-century Indian medical doctors]]
[[Category:University of Mumbai alumni]]
[[Category:Living people]]

Nilima Arun Kshirsagar - Revision history

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