The Government of India has given license to five more manufacturers to produce Amphotericin-B, an antifungal drug used for treatment of the Black Fungus disease. 

The five new manufacturers are: NATCO Pharmaceuticals, Hyderabad; Alembic Pharmaceuticals, Vadodara; Gufic Biosciences Ltd., Gujarat; Emcure Pharmaceuticals, Pune; and Lyka, Gujarat. 

In recent days, several states and UTs have reported an increasing number of patients suffering from COVID-19 complications in the form of Mucormycosis, popularly known as Black Fungus. There is also a reported shortage of Amphotericin-B, an antifungal drug used for treatment of the Black Fungus disease. 

The Union Ministry of Health along with the Department of Pharmaceuticals and Ministry of External Affairs (MEA) are making proactive efforts for significantly ramping up domestic production of Amphotericin-B drug. The Union Government has also made effective efforts in supplementing the domestic availability through securing supply from global manufacturers. 

Presently, there are five existing manufacturers of Amphotericin-B in the country and one importer. These are: Bharat Serums & Vaccines Ltd.; BDR Pharmaceuticals Ltd.; Sun Pharma Ltd.; Cipla Ltd.; Life Care Innovations; and Mylan Labs (Importer). 

The production capacity of these companies was extremely limited in the month of April 2021. As a result of handholding by Government of India, these domestic manufactures will cumulatively produce 163,752 vials of Amphotericin-B in May 2021. This will be further ramped up to 255,114 vials in the month of June 2021. 

Apart from this, efforts are being made for supplementing the domestic availability of this antifungal drug through import. In May 2021, 363,000 vials of Amphotericin-B will be imported, thereby resulting in total availability in the country (inclusive of the domestic production) of 526,752 vials. 

315,000 vials will be imported in June 2021. Hence, along with the domestic supply, the countrywide availability of Amphotericin-B will be enhanced to 570,114 vials in June 2021.

Cumulatively, these companies will start producing 111,000 vials of Amphotericin-B per month from July 2021. The Union Health Ministry and Department of Pharmaceuticals are together trying to proactively facilitate these five manufacturers to prepone some of this production so that these additional supplies begin in June 2021.