Nilima Arun Kshirsagar

Last updated

Nilima Arun Kshirsagar
Born1949 (age 73–74)
Mumbai, Maharashtra, India
Education Doctor of Medicine
King Edward Memorial Hospital and Seth Gordhandas Sunderdas Medical College
Medical career
ProfessionClinical Pharmacologists
ResearchLiposomal Formulations

Nilima Arun Kshirsagar FACCP, FRCP, FNAMS FNAS (born 1949) is an Indian clinical pharmacologist who developed and patented liposomal amphotericin B and its drug delivery system in 1993. [1] She is the former dean of King Edward Memorial Hospital and Seth Gordhandas Sunderdas Medical College. [2] 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.

Contents

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. [3] [4] [5]

She established departments of Clinical Pharmacology at KEM Hospital 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. [1]

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 KEM, Mumbai, India. [6]

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. [7]

Notable work

Bimal Kumar Bachhawat, Kshirsagar and Uttamchand Khimchand Sheth are credited with creating the research and academic structure for teaching pharmacology in India. [8]

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. [9] [10]

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. [11] 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. [1] [12]

Eye infected with mucormycosis Periorbital fungal infection of mucormycosis, or phycomycosis PHIL 2831 lores (cropped).jpg
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. [13] 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 model in India. [13] [14] Liposomal Amphotericin-b was used as the primary treatment in the Mucormycosis epidemic of 2021 in India. [15] [16]

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. [17] 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". [18]

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. [19]

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. [2]

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 of India to decide whether to regulate, restrict or prohibit the sale of over 300 fixed-dose combination drugs in India. [20] Based on a 700-page report submitted by the committee, the Supreme Court of India banned 328 fixed-dose combination drugs in September 2018. [21]

Awards

Publications

Nilima has produced over 200 publications:- [26]

Related Research Articles

<span class="mw-page-title-main">Pharmacology</span> Branch of biology concerning drugs

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 molecule which exerts a biochemical or physiological effect on the cell, tissue, organ, or organism. It is the science of drugs including their origin, composition, pharmacokinetics, therapeutic use, and toxicology. More specifically, it is the study of the interactions that occur between a living organism and chemicals that affect normal or abnormal biochemical function. If substances have medicinal properties, they are considered pharmaceuticals.

<span class="mw-page-title-main">Histoplasmosis</span> Human disease

Histoplasmosis is a fungal infection caused by Histoplasma capsulatum. Symptoms of this infection vary greatly, but the disease affects primarily the lungs. Occasionally, other organs are affected; called disseminated histoplasmosis, it can be fatal if left untreated.

<span class="mw-page-title-main">Nystatin</span> Pharmaceutical drug

Nystatin, sold under the brandname Mycostatin among others, is an antifungal medication. It is used to treat Candida infections of the skin including diaper rash, thrush, esophageal candidiasis, and vaginal yeast infections. It may also be used to prevent candidiasis in those who are at high risk. Nystatin may be used by mouth, in the vagina, or applied to the skin.

<span class="mw-page-title-main">Amphotericin B</span> Antifungal and antiparasitaric chemical compound

Amphotericin B is an antifungal medication used for serious fungal infections and leishmaniasis. The fungal infections it is used to treat include mucormycosis, aspergillosis, blastomycosis, candidiasis, coccidioidomycosis, and cryptococcosis. For certain infections it is given with flucytosine. It is typically given intravenously.

<span class="mw-page-title-main">King Edward Memorial Hospital and Seth Gordhandas Sunderdas Medical College</span> Hospital

King Edward Memorial Hospital and Seth Gordhandas Sunderdas Medical College is one of the foremost medical colleges and hospital in India, located in Mumbai, Maharashtra. It was founded in 1926; it is affiliated with Maharashtra University of Health Sciences (MUHS).

<span class="mw-page-title-main">Doxorubicin</span> Chemotherapy medication

Doxorubicin, sold under the brand name Adriamycin among others, is a chemotherapy medication used to treat cancer. This includes breast cancer, bladder cancer, Kaposi's sarcoma, lymphoma, and acute lymphocytic leukemia. It is often used together with other chemotherapy agents. Doxorubicin is given by injection into a vein.

<span class="mw-page-title-main">Anthracycline</span> Class of antibiotics

Anthracyclines are a class of drugs used in cancer chemotherapy that are extracted from Streptomyces bacterium. These compounds are used to treat many cancers, including leukemias, lymphomas, breast, stomach, uterine, ovarian, bladder cancer, and lung cancers. The first anthracycline discovered was daunorubicin, which is produced naturally by Streptomyces peucetius, a species of Actinomycetota. Clinically the most important anthracyclines are doxorubicin, daunorubicin, epirubicin and idarubicin.

<span class="mw-page-title-main">Drugs for Neglected Diseases Initiative</span> Non-profit organization

The Drugs for Neglected Diseases initiative (DNDi) is a collaborative, patients' needs-driven, non-profit drug research and development (R&D) organization that is developing new treatments for neglected diseases, notably leishmaniasis, sleeping sickness, Chagas disease, malaria, filarial diseases, mycetoma, paediatric HIV, cryptococcal meningitis, hepatitis C, and dengue. DNDi's malaria activities were transferred to Medicines for Malaria Venture (MMV) in 2015.

<span class="mw-page-title-main">Mucormycosis</span> Fungal infection

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 infection occurs. It most commonly infects the nose, sinuses, eyes and brain resulting in a runny nose, one-sided facial swelling and pain, headache, fever, blurred vision, bulging or displacement of the eye (proptosis), and tissue death. Other forms of disease may infect the lungs, stomach and intestines, and skin.

Saksenaea vasiformis is an infectious fungus associated with cutaneous or subcutaneous lesions following trauma. It causes opportunistic infections as the entry of the fungus is through open spaces of cutaneous barrier ranging in severity from mild to severe or fatal. It lives in soils worldwide, but is considered as a rare human pathogen since only 38 cases were reported as of 2012. Saksenaea vasiformis usually fails to sporulate on the routine culture media, creating a challenge for early diagnosis, which is essential for a good prognosis. Infections are usually treated using a combination of amphotericin B and surgery. Saksenaea vasiformis is one of the few fungi known to cause necrotizing fasciitis or "flesh-eating disease".

<i>Apophysomyces variabilis</i> Species of fungus

Apophysomyces variabilis is an emerging fungal pathogen that can cause serious and sometimes fatal infection in humans. This fungus is a soil-dwelling saprobe with tropical to subtropical distribution. It is a zygomycete that causes mucormycosis, an infection in humans brought about by fungi in the order Mucorales. Infectious cases have been reported globally in locations including the Americas, Southeast Asia, India, and Australia. Apophysomyces variabilis infections are not transmissible from person to person.

Ramniklal Kirchand Gandhi was an Indian pediatric surgeon, medical academic, writer and the president of the Association of Surgeons of India. Born in a Jain family of modest means in Khanpar, Wankaner, Gujarat in the Indian state of Gujarat on 18 January 1929, he did his schooling at Rajkot and graduated in medicine from the King Edward Memorial Hospital and Seth Gordhandas Sunderdas Medical College, Mumbai with first rank. He did his post graduation at the same institute in pediatric surgery while practicing medicine.

<span class="mw-page-title-main">Tehemton Erach Udwadia</span> Indian surgeon and gastroenterologist (1934–2023)

Tehemton Erach Udwadia was an Indian surgeon and gastroenterologist, considered by many as the father of laparoscopic surgery in India. He was a general surgeon at two Mumbai hospitals, Breach Candy Hospital and Hinduja Hospital and was the founder president of the Indian Association of Gastrointestinal Endo-Surgeons. The Government of India awarded him the fourth highest civilian honour of the Padma Shri, in 2006 and the third highest civilian honour of the Padma Bhushan in 2017 for his contributions to Indian medicine.

<span class="mw-page-title-main">Sharad Panday</span> Indian heart surgeon

Sharad Pandey was an Indian heart surgeon. He was on the team of surgeons who performed the first-ever heart transplant in India at the King Edward Memorial Hospital and Seth Gordhandas Sunderdas Medical College in Mumbai. He was a specialist in bloodless heart surgery, and was an early exponent of bloodless open heart surgery in India.

Bimal Kumar Bachhawat was an Indian neurochemist and glycobiologist, known for his discovery of HMG-CoA lyase, an intermediate in the mevalonate and ketogenesis pathway, and for the elucidation of the molecular cause of metachromatic leukodystrophy, a hereditary disease of the brain His studies on sugar-bearing liposomes led to its use as a carrier for in situ delivery of drugs and hormones to diseased organs and he pioneered the therapy of systemic fungal infections using liposomal formulations. He was a recipient of several awards including the Shanti Swarup Bhatnagar Award, the highest Indian honor in science and technology and an elected fellow of three major Indian science academies. The Government of India awarded him the third highest civilian honour of the Padma Bhushan, in 1990, for his contributions to science.

Uttamchand Khimchand Sheth (1920–2000) was an Indian clinical pharmacologist and the director of King Edward Memorial Hospital and Seth Gordhandas Sunderdas Medical College.

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References

  1. 1 2 3 SK Pandya, BG Kirodian, S Sanath, NA Kshirsagar (2005). "Liposomal drug delivery system from laboratory to clinic". Journal of Postgraduate Medicine. 51 (5): S5-15. PMID   16519249 . Retrieved 30 May 2021.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  2. 1 2 "KEM Hospital gets private touch". DNA. 9 May 2007. Retrieved 30 May 2021.
  3. ↑ "South Asian chapter of American college of clinical Pharmacology" . Retrieved 28 May 2021.
  4. 1 2 ""Drugs for Neglected Diseases initiative (DNDi)."". Drugs for Neglected Diseases initiative (DNDi). Retrieved 28 May 2021.
  5. ↑ "SC refers 349 FDC medicines to Drug Advisory Board for relook". Economic Times. 15 December 2017. Retrieved 30 May 2021.
  6. ↑ "मराठी विश्वकोश". मराठी विश्वकोश. 11 February 2021. Retrieved 30 May 2021.
  7. ↑ "Women Fellows of the Indian Academy of Sciences".
  8. ↑ Patil, Popat N. (2012). Discoveries in Pharmacological Sciences. World Scientific. p. 733. ISBN   978-981-4355-07-0.
  9. ↑ 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
  10. ↑ Khanna, Anjani (15 January 1995). "Drug couriers – Artificial fat globules called liposomes can reduce the side-effects of drugs". Down to earth. Retrieved 28 May 2021.
  11. ↑ Neil RH Stone, Tihana Bicanic, Rahuman Salim, William Hop (2016). "Liposomal Amphotericin B (AmBisome®): A review of the pharmacokinetics, pharmacodynamics, clinical experience and future directions". Drugs. 76 (4): 485–500. doi:10.1007/s40265-016-0538-7. PMC   4856207 . PMID   26818726.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  12. ↑ कलगुटकर, शर्मिला कलगुटकर (25 May 2021). "म्युकरमायकोसिसवरील औषध उत्पादनाचे केईएमकडून प्रयत्न". Maharashtra Times. Retrieved 31 May 2021.
  13. 1 2 Mehra, Kavita. "Case Study 2: Lipoosomal Amphotericin-b". India, Science & Technology:2008 (S&T Structure, Infrastructure and Public Space). Retrieved 29 May 2021.
  14. 1 2 Minwalla, Shabnam (2 April 2003). "KEM doctor puts drugs, dosage under microscope". Times of India. Retrieved 29 May 2021.
  15. ↑ Varghese, Anuja Susan (30 May 2021). "Kerala running short of medication to meet black fungus threat? Shortage of Liposomal Amphotericin B, used widely for treatment, has hit hosps across state". The New Indian express. Retrieved 30 May 2021.
  16. ↑ "Celon Laboratories comes up with an alternative formulation of Amphotericin B". Hans News Service. 2 June 2021. Retrieved 3 June 2021.
  17. ↑ Dyer, Owen (13 May 2021). "Covid-19: India sees record deaths as "black fungus" spreads fear". BMJ. 373: n1238. doi: 10.1136/bmj.n1238 . ISSN   1756-1833. PMID   33985993.
  18. ↑ "Black fungus in India: Concern over drug shortage as cases rise". BBC News. 19 May 2021. Retrieved 8 July 2021.
  19. ↑ MALIK, SHIKHA T (24 October 2017). "SCIENTISTS DISCOVER THAT ADDITION OF DRUG ALBENDAZOLE HAS NO ADVANTAGES IN THE TREATMENT OF LYMPHATIC FILARIASIS". First post. Retrieved 30 May 2021.
  20. ↑ "New committee to examine safety, rationality of over 300 drugs banned since 2016". economic-times. 20 February 2018. Retrieved 30 May 2021.
  21. ↑ Kohli, Namita (22 February 2019). "Saridon exempted from list of banned drugs by Supreme Court". The Week. Retrieved 3 June 2021.
  22. ↑ "LIST OF FELLOWS" (PDF). www.nams-india.in. National Academy of Medical Sciences (India). Retrieved 1 June 2021.
  23. ↑ https://www.hopkinsmedicine.org/pharmacology_molecular_sciences/_pdf/Hendrix_2018ACCP_Award_Winner.pdf [ dead link ]
  24. ↑ "Smt. Chandaben Mohanbhai Patel Industrial Research Award for Women Scientists". Vividhlaxi Audyogik Samshodhan Vikas Kendra. Retrieved 31 May 2021.
  25. ↑ "COVID-19 from Public Health Perspective" (PDF). International Institute for Population Sciences. Retrieved 30 May 2021.
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