AHMEDABAD : During the second wave of Covid, citizens had a tough time procuring Amphotericin B, the drug of first choice to treat mucormycosis or black fungus. Learning a lesson from this situation, Gujarat has granted permission to a dozen pharmaceutical companies to produce the anti-fungal drug.
The prominent among them, according to the state FDCA, are Emcure Pharmaceuticals Ltd, Intas Pharmaceuticals Ltd, Sun Pharmaceuticals Ltd, Alembic Pharmaceuticals Ltd, BDR Pharmaceuticals International, Lyka Labs Limited, Swiss Parentarals Ltd and Gufic Biosciences Ltd.
Confirming this, Gujarat FDCA commissioner H G Koshia said, “Gujarat Food and Drugs Control Administration has issued as many as 19 licences to a dozen companies since May 2021 to manufacture Amphotericin B — in the form of both liposomal and emulsion injections — in Gujarat.”
Amphotericin B is an anti-fungal drug usually injected into a vein and it is used to treat serious, possibly fatal fungal infections and leishmaniasis. In India, it is also used as a drug of choice for the treatment of mucormycosis disease (mainly a post-Covid complication). Mucormycosis is a rare but potentially fatal infection if not treated adequately.
While some of the companies have already started making this drug, few others are in the process to do so.
“Emcure has been granted a licence to make Amphotericin at its plant at Gujarat and production has already started,” said Samit Mehta, president-operations, Emcure.
“As of now, 54,000 units per month are being produced from the plant in line with the current orders. We will continue to produce the quantity as required to meet the challenges that India faces in the present pandemic scenario,” Mehta added.
Ahmedabad-based Intas Pharmaceuticals could not start production due to the short supply of a key excipient (DSPG-Na). “The delivery is now expected on August 2. Based on that, we will be able to manufacture the drug in the second week of August and deliver 1,600 units by the end of the month,” said an Intas spokesperson.
The entry of more companies will help create adequate supply of this anti-fungal drug. The rapid surge in incidence of black fungus in Covid patients during the second wave of the pandemic posed a major challenge to the country and multiple states grappled with the shortage of Amphotericin B.
The recent data tabled in Rajya Sabha on July 20 showed that India recorded 45,374 cases of Covid-19-mucormycosis infection. Maharashtra (9,348 cases) and Gujarat (6,731) alone accounted for 35% of the cases registered in India.
“Gujarat is also the largest manufacturer of the bulk drug or raw material for Amphotericin B. One company already manufactures it in the state and another pharma major has recently obtained a permission to make it,” added Koshia.