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How Amphotericin B Became The Hard-To-Obtain Drug For Rare Black Fungus Disease

Representative photo.

Representative photo.

Cases of black fungus are on the rise in the country and with it the demand for Amphotericin B, the injection needed to combat it

Stories of its shortage have been reported from across the country with Haryana the latest to ask the Centre for 12,000 vials of the Amphotericin-B injection as stocks available with it are just a fraction of that number and total cases of the dreaded mucormycosis, or black fungus disease, at more than 400. So, what is Amphotericin-B and why is the drug in such high demand suddenly amid the surge of Covid cases in the country.

How Is Allocation Of The Injection Being Made To States?

According to a list shared by Union minister DV Sadananda Gowda two days back, the distribution of Amphotericin B to the states is being done on the basis of the number of mucormycosis cases reported by them. Gujarat was allotted 5,800 vials of the drug, which was about 25% of the total of 23,680 additional vials that the Centre released to the states. The state accounts for a similar proportion, that is a fourth, or 2,281 cases of mucormycosis out of a total of 8,848 in the country as of May 22.

The allocations announced, the Centre said, represent 75% of the total additional doses being sent to the states with the remaining 25% to be sent out depending on further cases of black fungus reported by the states.

The Centre has also announced that approvals have been extended for more companies to produce the drug in the country while orders have been placed with overseas manufacturers to import Amphotericin B. The Centre has said that five additional firms will now join six other companies that are already working to augment their production of the drug. Further, Indian companies have also placed orders to import 6 lakh vials of Amphotericin-B.

The drug is domestically produced but given that the disease is a rare one with only a handful of cases reported in normal times, production capacities were overwhelmed by the jump in demand amid the Covid-19 second wave. Black fungus has to be dealt with aggressively and the dosage is typically 42 vials for a patient for a week, the Centre told Delhi high court. A 50mg vial of the injection can cost up to Rs 7,800 in India.

What is causing the jump in cases of black fungus?

All India Institute of Medical Science Director Dr Randeep Guleria has said that while mucormycosis was earlier seen in diabetes mellitus patients with abnormally high blood sugar levels in cancer patients undergoing chemotherapy and people taking immunosuppressants. But the Covid emergency has driven up numbers of black fungus cases.

A combination of factors is behind the alarming rise in black fungus cases in Covid-19 patients. Patients with diabetes are susceptible to catching the disease and the government has flagged excessive steroid use in Covid-19 patients as a prime factor for the sudden rise in cases of mucormycosis. Another high-risk group for the disease are severely immuno-compromised patients.

Mucormycosis is a fungal infection caused by certain types of mold known as mucormycetes, which are present commonly in nature and can be found in the soil and decaying organic matter. However, although they are found widely in nature, these molds typically don’t cause problems. But they can affect people with a weakened or compromised immune system in whom they can even lead to life-threatening infection.

Mucormycosis is commonly contracted by breathing in spores, which are minute cells that are produced by, among others, fungi and bacteria. It does not spread from person to person though there are very small instances of infection occurring due to the spores entering the body through a cut or open wound.

The infection commonly occurs as a sinus infection that is accompanied by nasal congestion and sinus pain. It can also lead to fever and headache. The infection, called black fungus because it can turn affected tissues black, can also spread outside the sinuses. If it affects the brain, it can cause lethargy, seizures, slurred speech, partial paralysis, etc.

Mucormycosis spreading to the eyes can cause swelling due to fluid accumulation and potentially lead to blindness. Pulmonary mucormycosis, caused when the infection reaches the lungs, is accompanied by fever and cough and, in rare cases, in spitting or coughing up of blood, chest pain, etc.

Cases have now also been reported of black fungus spreading to the intestines, which can happen if spores are breathed into the mouth or with the consumption of contaminated food. That can cause abdominal pain and vomiting of blood. There can also be cases of disseminated mucormycosis, especially for severely immuno-compromised people, in which the infection spreads to other areas of the body.

How to detect black fungus?

According to Dr Guleria, an X-ray or CT scan of sinuses can show if there is an infection. A biopsy through nasal endoscopy can also be done to scan for the disease and a blood test can also show if a patient has contracted it.

Dr Guleria added that patients who are recovering from Covid-19 should consult a doctor immediately if they have a persistent headache or swelling on one side of the face or if there is discoloration in the mouth and numbness in any part of the face.

Listing three factors as “very important” in monitoring for black fungus cases, Dr Guleria said that first, people must take steps to control their blood sugar levels. Further, those on steroids must monitor blood sugar levels regularly and, care has to be taken to see when to give steroids and their dosage for patients of Covid-19.

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