In order to facilitate the import of Amphotericin-B/ Liposomal Amphotericin-B injections and alternative drugs for the treatment of black fungus, the Ministry of External Affairs (MEA) has identified new sources of these drugs.

As per the Health Ministry statement, it has called upon the External Affairs Ministry to take steps to procure Liposomal Amphotericin-B from Australia, Russia, Germany, Argentina, Belgium and China.

The MEA has also been actively working to ensure supply of key excipients, HSPC and DSPG-NA, from sources abroad for the production of Liposomal Amphotericin-B in India.

The existing five manufacturers of Liposomal Amphotericin-B – Bharat Serums and Vaccines Limited, Cipla, Sun Pharma, BDR Pharmaceuticals and Lifecare Innovations – are expected to release 2.63 lakh vials for June to treat patients. Meanwhile, the six firms – Emcure, Gufic, Alembic, Lyka, Natco Limited and Intas Pharma – are expected to release about 1.13 lakh vials for June, as per the Health Ministry.

“Manufacturing of Liposomal formulation involves a complicated process and can only be done by industries having advanced technology. The Drug Controller General of India (DCGI), after consultation with the association of drugs manufacturers, has issued manufacturing / marketing permission of Amphotericin-B Liposomal Injection to six firms – Emcure, Gufic, Alembic, Lyka, Natco Limited and Intas Pharma.

“The expected release by the six new manufacturers for June is about 1.13 lakh vials,” said the ministry in a statement.

Domestic production

The Ministry further added that the domestic production capacity of the injection has increased from 62,000 in April to 1.63 lakh vials in May, and is likely to cross 3.75 lakh vials in June, a five-fold increase within a short time span.

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