Bharat Serums gets DCGI nod to covid linked black fungus drug

The firm, Bharat Serums and Vaccines Limited, has become the first company in India to receive the approval from Drug Controller General of India (DCGI) to use anti-fungal medication -- Liposomal Amphotericin B or LAmB -- as a medical intervention in patients of Mucormycosis.

With a fatality rate of up to 80 per cent, Mucormycosis is a deadly invasive fungal infection which emerged as a 'new worry' for healthcare practitioners amid the Covid-19 pandemic. While it's cases have traditionally been low in India before the pandemic hit here, the instances started to rise among the people who recovered from the Covid-19.

Lately, many hospitals in India have reported the emergence of Mucormycosis cases in Covid-19 recovered patients. More than 50 cases were reported in Delhi hospitals alone in December last year.

The health experts said that the infection can turn aggressive within two days of its onset if not diagnosed on time and many a times, the patients have to let go of the organ it infects. Mucormycosis starts in the nasal area, sinuses, and quickly spreads to the eyes and the brain. If left untreated, this can result in a brain abscess, blindness or even death.

The infection predominantly occurs to immunocompromised people like those having poorly controlled diabetes, AIDS and certain cancers.

Those on immune suppressing medications or long-term steroid use are the most vulnerable to the Mucormycosis which also includes the patients of Covid-19 as steroids are used frequently to manage cytokine storms in the patients.

Vishwanath Swarup, COO, Bharat Serums & Vaccines (BSV), said that anti-fungal medication can prevent the patients suffering from black fungus from progressing the stage of surgery.

"BSV is indigenously developing and manufacturing the formulation of Amphotericin B including Liposomal Amphotericin B and Lipid Complex Amphotericin B - the anti-fungal medications that have been recommended for use in life-threatening fungal infections such as mucormycosis. Also, BSV is the first Indian company to get the regulatory approval of Liposomal Amphotericin B," he added.

Dr Swashraya Shah, BSV's Chief Medical officer, said that evidence suggests successful clinical recovery of patients suffering from Mucormycosis following the treatment with LAmB.

"Its treatment involves a combination of surgical removal of affected tissues and use of antifungal therapy, usually intravenous Liposomal Amphotericin B (LAmB). Several international clinical guidelines have recommended LAmB in the management of various invasive fungal infections including Mucormycosis. A few recently published reports mention successful clinical recovery of patients suffering from Mucormycosis following the treatment with LAmB," he noted.