5 Pharma Companies Get Approval To Make Black Fungus Drug

Mumbai/ Ahmedabad, 21 May 2021:

The Drugs Controller General of India (DCGI) has cleared applications from five pharmaceutical companies to manufacture anti-fungal drug Amphotericin B, used to treat mucormycosis or black fungus.

The subject expert committee (SEC) of the health ministry on Wednesday had given its nod to proposals from drug makers to boost the availability of Amphotericin B.

These developments come amid fast spread of the disease in various states and shortage of drugs to treat them. The government, however, hopes the fresh approvals and imports will help end the drug shortage soon.

Rajasthan has already declared mucormycosis or black fungus an epidemic with over 100 cases reported in the state. The central government has also declared mucormycosis as a notifiable disease under the provisions of the Epidemic Diseases Act while the Delhi government has formed a committee to oversee the distribution of this drug. Amphotericin B, an injection, is currently sold by Abbott, Bharat Serums, Cipla, Sun Pharma and Viatris. Drug makers, including Alembic, Emcure and Natco had sought nod to manufacture the drug.

“Amphotericin B injection is manufactured using liposomal technology. The production cycle of this injection is 25-28 days. Sterility tests need to be carried out and then only can the finished product be sent for distribution. While existing manufacturers are ramping up their production, new approvals will increase availability further. The Central Drugs Standard Control Organisation is fast tracking the processes of all the drugs used for Covid-19 to ensure adequate supplies,” said a pharma industry expert.

R K Baheti, chief financial officer (CFO) of Alembic Pharmaceuticals, confirmed the SEC nod and said the company is now coordinating with third party manufacturers for supply of active pharmaceutical ingredients and packaging materials, among other things. Baheti, however, refused to divulge any timeline for production and supply of the injectable.

“We have ramped up production of Lambin B injection (Liposomal Amphotericin B) to meet the additional demand. We are confident of increasing our production rapidly because of the use of advanced technology in manufacturing,” Sun Pharma said.

Minister of state for chemicals and fertilisers, Mansukh Mandaviya, on Thursday said the fresh approvals along with the ramp up of production by existing six manufacturers and imports will help to end shortage of the drug soon.

“As a leading health care firm, we are committed to doing our part to support the public health needs amid the Covid-19 pandemic. Viatris and Gilead are closely working with the government to accelerate supplies of AmBisome to help meet the evolving patient needs in India,” said Rakesh Bamzai, president, India, emerging Asia and access markets, Viatris. Business Standard