Health ministry panel vetting requests by six cos to make Mucormycosis drug

Development come amid fast spread of disease in various states and shortage of drugs to treat it; Rajasthan has already declared an epidemic

The government is reviewing applications from six pharmaceutical companies as it looks to boost the availability of drug Amphotericin B which is used to treat mucormycosis.

While Minister of State for Chemicals and Fertilizers, Mansukh Mandaviya, is monitoring the supplies of all the essential drugs, the subject expert committee (SEC) of the health ministry is examining proposals from drug makers to boost the availability of Amphotericin B.

The development comes amid the rapid spread of disease in various states and the shortage of drugs to treat it. Rajasthan has already declared mucormycosis or black fungus as an epidemic with over 100 cases reported in the state. The Delhi government too 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.

Six companies including Alembic, Emcure and Natco have sought the 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.

According to R K Baheti, chief financial officer of Alembic Pharmaceuticals Ltd., the company has filed an application for manufacturing of amphotericin B which it intends to produce by outsourcing to third parties. "We are now awaiting to hear from the SEC on approval of our application post which we can begin the production as early as possible," Baheti told Business Standard, while refusing to divulge further details on the same.

“We have ramped up the 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 in a statement.

According to information shared by the ministry of chemicals and fertilizers, production of Amphotericin B has been ramped up three times in a month. Around 380,000 vials are under production and 300,000 vials are being imported and thus a total of 680,000 vials will be available in the country.

"As a leading healthcare company 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 the supplies of AmBisome (Amphotericin B) to help meet the evolving patient needs in India,” said Rakesh Bamzai, president India, Emerging Asia and Access markets, Viatris.