Nilima Arun Kshirsagar
FACCP,
FRCP, FNAMS FNAS (born 1949) is an Indian
clinical pharmacologist
Pharmacology is a branch of medicine, biology and pharmaceutical sciences concerned with drug or medication action, where a drug may be defined as any artificial, natural, or endogenous (from within the body) molecule which exerts a biochemica ...
who developed and patented
liposomal amphotericin B
Amphotericin B is an antifungal medication used for serious mycosis, fungal infections and leishmaniasis. The fungal infections it is used to treat include mucormycosis, aspergillosis, blastomycosis, candida infections, candidiasis, coccidioidomy ...
and its
drug delivery
Drug delivery refers to approaches, formulations, manufacturing techniques, storage systems, and technologies involved in transporting a pharmaceutical compound to its target site to achieve a desired therapeutic effect. Principles related to dr ...
system in 1993.
She is the former dean of
.
She is the national chairperson in clinical pharmacology at
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.
She established departments of Clinical Pharmacology at
KEM Hospital
King Edward (VII) Memorial Hospital and Seth Gordhandas Sunderdas Medical College, located in Mumbai, is one of the foremost teaching and medical care providing institution in India. It was founded in 1926; it is affiliated with Maharashtra Uni ...
and at
Nair Hospital Mumbai. The drug
Liposomal Amphotericin-b, used to treat the
Indian Mucormycosis epidemic of 2021 was developed and patented in India by Nalini Kshirsagar in 1993.
Early life and education
Kshirsagar was born in 1949.
Career
In 1977, after her doctorate she became assistant professor at
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
The World Health Organization (WHO) is a specialized agency of the United Nations responsible for international public health. The WHO Constitution states its main objective as "the attainment by all peoples of the highest possible level of ...
and a member of the advisory commission on product development and evaluate science program at
Haffkine Institute
The Haffkine Institute for Training, Research and Testing is located in Parel in Mumbai (Bombay), India. It was established on 10 August 1899 by Dr. Waldemar Mordecai Haffkine, as a bacteriology research centre called the "Plague Research Labora ...
. In 1993 she become the founding Head of the Department of Clinical Pharmacology at
KEM, Mumbai, India.
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.
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Notable work
Bimal Kumar Bachhawat, Kshirsagar and Uttamchand Khimchand Sheth are credited with creating the research and academic structure for teaching pharmacology in India.
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 KEM and at Nair Hospital Mumbai with financial help from the Brihanmumbai Municipal Corporation
The Brihanmumbai Municipal Corporation (BMC; IAST: ), also known as the Municipal Corporation of Greater Mumbai (MCGM), is the governing civic body of Mumbai, the capital city of Maharashtra. It is India's richest municipal corporation. The ...
.
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 Nephrotoxicity is toxicity in the kidneys. It is a poisonous effect of some substances, both toxic chemicals and medications, on kidney function. There are various forms, and some drugs may affect kidney function in more than one way. Nephrotoxins ...
and infusion-related reactions was a major constraint. Kshirsagar and her team improved the techniques of the production of liposomes derived from soyabean
The soybean, soy bean, or soya bean (''Glycine max'') is a species of legume native to East Asia, widely grown for its edible bean, which has numerous uses.
Traditional unfermented food uses of soybeans include soy milk, from which tofu and ...
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.
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. 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 The National Research Development Corporation (NRDC) was a non-departmental government body established by the British Government to transfer technology from the public sector to the private sector.
History
The NRDC was established by Attlee's Lab ...
(NRDC) to a pharmaceutical company for marketing. This was the first drug development initiative of a Public–private partnership model in India. Liposomal Amphotericin-b was used as the primary treatment in the Mucormycosis
Mucormycosis, also known as black fungus, is a serious fungal infection that comes under fulminant fungal sinusitis, usually in people who are immunocompromised. It is curable only when diagnosed early. Symptoms depend on where in the body the ...
epidemic of 2021 in India.
During the COVID-19 pandemic in India
The COVID-19 pandemic in India is a part of the worldwide pandemic of coronavirus disease 2019 () caused by severe acute respiratory syndrome coronavirus 2 (). As of , according to Indian government figures, India has the second-highest n ...
there was a large increase of cases of what was named "black fungus" or mucormycosis
Mucormycosis, also known as black fungus, is a serious fungal infection that comes under fulminant fungal sinusitis, usually in people who are immunocompromised. It is curable only when diagnosed early. Symptoms depend on where in the body the ...
in affected patients. Surgeons had to remove eyes after they were infected. 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 ith
The Ith () is a ridge in Germany's Central Uplands which is up to 439 m high. It lies about 40 km southwest of Hanover and, at 22 kilometres, is the longest line of crags in North Germany.
Geography
Location
The Ith is immediatel ...
lesser side effects".
The World Health Organization
The World Health Organization (WHO) is a specialized agency of the United Nations responsible for international public health. The WHO Constitution states its main objective as "the attainment by all peoples of the highest possible level of ...
(WHO) launched a global program to eliminate Lymphatic Filariasis
Lymphatic filariasis is a human disease caused by parasitic worms known as filarial worms. Usually acquired in childhood, it is a leading cause of permanent disability worldwide. While most cases have no symptoms, some people develop a syndrome ...
in 2000. Kshirsagar's team of Indian scientists worked in two villages, Kurzadi and Selukate in Wardha
Wardha is a city and a municipal council in Wardha district in the Indian state of Maharashtra. It is the administrative headquarters of Wardha district. Wardha gets its name from the Wardha River which flows at the north, west and south bounda ...
, Maharashtra ensuring the safety and efficacy of the drugs.
During her tenure as dean of capacity was increased from 1,800 to 2,400 beds and the capacity of Intensive care unit
220px, Intensive care unit
An intensive care unit (ICU), also known as an intensive therapy unit or intensive treatment unit (ITU) or critical care unit (CCU), is a special department of a hospital or health care facility that provides intensi ...
beds was enhanced from 160 to 300.
In 2017 Kshirsagar was appointed as chairperson of the expert committee constituted by the Drugs Controller General of India
Drugs Controller General of India (DCGI) is the head of department of the Central Drugs Standard Control Organization of the Government of India responsible for approval of licences of specified categories of drugs such as blood and blood p ...
to elaborate on the parameters set out in section 26A of the Drugs and Cosmetics Act of India to decide whether to regulate, restrict or prohibit the sale of over 300 fixed-dose combination drugs in India. Based on a 700-page report submitted by the committee, the Supreme Court of India banned 328 fixed-dose combination drugs in September 2018.
Awards
* Dr. B. C. Roy Award for her work with drugs combating malaria, epilepsy, elephantiasis and heart diseases – (2002).
* Nathaniel T. Kwit memorial Awarde – (2018).
* Professor Archana Sharma Memorial Lecture Awardees – (2018).
* VASVIK Industrial Research Award- Smt. Chandaben Mohanbhai Patel Industrial Research Award for Women Scientists – (1997).
* Mumbai Mayors award for societal contribution.
Publications
Nilima has produced over 200 publications:-
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* 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.
References
External links
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{{DEFAULTSORT:Kshirsagar, Nilima Arun
1949 births
Indian pharmacologists
Marathi people
Clinical pharmacologists
Indian medical researchers
Indian medical academics
World Health Organization officials
Indian Council of Medical Research
Dr. B. C. Roy Award winners
Fellows of the Royal College of Physicians of Edinburgh
Fellows of the National Academy of Medical Sciences
20th-century Indian biologists
Scientists from Mumbai
Scientists from Maharashtra
Medical doctors from Mumbai
Medical doctors from Maharashtra
20th-century Indian medical doctors
21st-century Indian medical doctors
University of Mumbai alumni
Living people