Amphotericin Standards for COVID-19 associated Mucormycosis Concern in India

As of 15th July, India has reported over 45,432 cases and 4,252 deaths due to mucormycosis1. The mucormycosis, now termed COVID-19 associated mucormycosis (CAM), has been declared an epidemic and a notifiable disease in India as infections rise among COVID-19 patients. The estimated prevalence of mucormycosis is around 70 times higher in India than in other global areas, with a mortality rate of 50 percent2.

The significant spike in CAM has unleashed unprecedented and complex issues in India associated with public procurement policies and supply chain gaps. The shortages of critical COVID-19 drugs, including amphotericin B injections, resulted in increased incidences of substandard and falsified medicines, black-marketing, price manipulation, and bulk stocking.

As part of USP’s commitment to accelerate manufacturing and support access to quality COVID-19 treatments, USP offers free access to Amphotericin monographs.  Pharmacopeial monographs provide validated methods, acceptance criteria, and other information to support objective assessments of a medicine’s quality. The Amphotericin B Reference Standard can help speed development and support access to quality medicines by building consistency and reproducibility into analytical methods. These methods can assist regulators and manufacturers in helping ensure quality amphotericin B is being approved, procured, and distributed.

To access complimentary monographs, click below:

Amphotericin B (pdf attached)
Amphotericin B for Injection (pdf attached)

About USP Amphotericin B RS

USP Catalog No: 1032007
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1 https://www.livemint.com/news/india-records-over-40k-cases-of-mucormycosis-11624875874985.html
2https://onlinelibrary.wiley.com/doi/10.1111/myc.13338