Central government which has given permission May 20 to five drug companies to produce antifungal drug Amphotericin-B liposomal injections, on May 21 said it is in the process of importing a total of 6.8 lakh vials of the drug in May and June.
The import is part of all round efforts to ramp up supply and availability of Amphotericin-B liposomal injection critical for treatment of the of Mucormycosis, also called as Black Fungus disease.
The production capacity of these companies was extremely limited in the month of April 2021. As a result of the handholding by Government of India, these domestic manufactures will cumulatively produce 1,63,752 vials of Amphotericin-B in May 2021. This will be further ramped up to 2,55,114 vials in the month of June 2021.
Apart from this, efforts are being made for supplementing the domestic availability of this anti-fungal drug through imports.
At the moment five Indian companies are Bharat Serums & Vaccines (BSV), BDR Pharmaceuticals, Sun Pharma, Cipla and Life Care Innovations are manufacturing the drug, while Mylan imports the drug.
However, these companies cumulatively produce or supply 1,63,752 vials of Amphotericin-B in May 2021, and will are ramping up to 2,55,114 vials in the month of June 2021.
The production is very limited, while the cases are rising at alarming pace, pressing some states to declaring the disease as epidemic.
As on May 19 Black Fungus has affected close to 5,500 people across the country and 126 of them have died. To treat Black Fungus it would require 4-8 vials in a day, and the duration of the treatment would be 15-30 days. A patient would need minimum of 60 vials.
Please read here to know more about Black Fungus and how pharma companies are scrambling to raise capacity.
The government said in May 2021, 3,63,000 vials of Amphotericin-B will be imported, thereby resulting in total availability in the country inclusive of the domestic production of 5,26,752 vials.
Around 3,15,000 vials will be imported in June 2021. Hence, along with the domestic supply, the countrywide availability of Amphotericin-B will be enhanced to 5,70,114 vials in June 2021.
The five new companies that got permission Natco Pharma, Alembic Pharma, Gufic Biosciences, Emcure and Lyka cumulatively will be producing 1,11,000 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," the government said.
"Over and above this, Union Ministry of Health in collaboration with Ministry of External Affairs (MEA) is also actively exploring other global sources from where the Amphotericin-B drug can be imported," the government added.
Meanwhile Union Health Ministry is also trying to procure other antifungal drugs which can be used in treatment of Black Fungus.
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