More domestic drugmakers have joined the brigade to produce Amphotericin B that is used to treat Mucormycosis (black fungus), and the shortages being reported in parts of the country are expected to ease in a fortnight.

The Centre has granted new drug approvals to five more drug companies for producing the injectable Amphotericin B in India, adding to the six companies that are already producing it. In fact, Union Minister of State for Chemicals Mansukh Mandaviya tweeted, “Black Fungus (Mucormycosis) curing drug #Amphotericin B’s shortage will be resolved soon!” Further, he added, “Indian companies have also placed orders for importing 6 lakh vials of Amphotericin B.”

The anti-fungal drug has been in short supply across the country as the patients suffering from Mucormycosis surged in numbers. “There is a shortage of this drug. This situation has arrived because hospitals are seeing more patients with diabetes and they are put on steroids for the treatment,” said J A Jayalal, President, Indian Medical Association.

Amphotericin B supplies

Earlier this week, the Centre had reviewed the supplies of Amphotericin B and prepared a strategy to ramp up domestic production and allowed direct import of the drug. Sun Pharma, Mylan Laboratories, Bharat Serums and Vaccines Ltd, BDR Pharma, Cipla and Life Care produce the drug. The five new companies that received approval to produce the drug include Emcure Pharmaceuticals, Natco Pharma, Gufic Biosciences, Alembic Pharmaceuticals and Lyca Pharmaceuticals. Companies are rushing to ensure the API (active pharmaceutical ingredient) supplies to ensure large-scale production of the drug.

BusinessLine spoke to some of the manufacturers and found that while existing players are augmenting their capacities for additional production and new players are working on the approvals, the supply crunch will take about a fortnight to a month to ease. None of the companies divulged any details about the additional capacities being planned.

A Sun Pharma spokesperson said the company had already ramped up production of Lambin 50 Injection — Liposomal Amphotericin B — to meet the additional demand and was confident of increasing production rapidly. Cipla, on the other, had ramped up production of Amphotericin B last year, “but there has been an unprecedented surge in demand and we are working towards ensuring equitable patient-access to the drug,” a company spokesperson said.

Rakesh Bamzai, President - India, Emerging Asia & Access Markets - Emerging Markets, Viatris, informed “Viatris and Gilead are closely working with the Government to accelerate supplies of AmBisome to help meet the evolving patient needs in India.”

Among new producers, Alembic Pharmaceuticals’ Managing Director Pranav Amin said, “We had developed this formulation for some of our international markets. But because of the shortage in our country now, we are looking to bring it to Indian market first.”

The brigade

More companies are likely to join the brigade as the disease is declared an epidemic. Ahmedabad-based Intas Pharmaceuticals among others are likely to apply for the approval to make this drug soon.

Industry insiders said, besides the genuine shortage arising from the lower production and higher demand, there were issues at the distribution part too. Without a central distribution mechanism in many states, hoarding and black-marketing of the drug become rampant thereby further squeezing the supply. States have opted for centralised distribution for the patients. These include Rajasthan, Maharashtra, Uttar Pradesh, Gujarat and Delhi. In order to overcome the supply crunch, Gujarat even floated a tender for the procurement of Amphotericin B injections either from manufacturers or through direct importers.

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