MoHFW and MEA to boost production of Amphotericin-B domestically

The Health Ministry on Friday along with Department of Pharmaceuticals and the Ministry of External Affairs are making proactive efforts for significantly ramping up domestic production of Amphotericin-B drug, the Centre said on Friday.

Currently, 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, Mylan Labs (importer).

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 import. 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 5,26752 vials.

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.

As a result of the proactive efforts by Union Ministry of Health, five more manufacturers have been given the license to produce the anti-fungal drug within the country. These are:

1. NATCO Pharmaceuticals, Hyderabad
2. Alembic Pharmaceuticals, Vadodara
3. Gufic Biosciences Ltd, Gujarat
4. Emcure Pharmaceuticals, Pune
5. Lyka, Gujarat

Cumulatively, these companies will start producing 1,11,000 vials of Amphotericin-B per month from July 2021. The Union Health Ministry and Deptt. 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.

Over and above this, Union Ministry of Health in collaboration with MEA is also actively exploring other global sources from where the Amphotericin-B drug can be imported. Union Health Ministry is also trying to procure other antifungal drugs which can be used in treatment of Black Fungus.

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