The domestic production capacity of Amphotericin B Liposomal Injection to treat mucormycosis or black fungus, a post-Covid complication, has increased from about 62000 vials in April 2021, to 1.63 lakh vials in May 2021 and is expected to cross 3.75 lakh vials in June. This is an over five-fold increase in a short time span, according to an official statement issued on Thursday.
A sudden increase in the demand for Amphotericin-B has been observed in some States, which is being actively prescribed by the physicians to the patients suffering from Mucormycosis.
In order to augment the domestic manufacture, the Government is continuously engaging with the manufacturers to resolve their issues related to raw materials. Department of Pharmaceuticals and the Drug Controller General of India (DCGI) have actively coordinated with the industry for identification of manufacturers, alternative drugs and expeditious approvals of new manufacturing facilities.
The manufacturing firms were contacted and have been sensitized about the need to increase production. Various concerns of manufacturers and importers, including those related to licensing and availability of raw material issues, import license are being speedily addressed.
The existing five local manufacturers of Liposomal Amphotericin B are Bharat Serums and Vaccines Limited, Cipla, Sun Pharma, BDR Pharmaceuticals and Lifecare Innovations. The expected release by them for the month of June is about 2.63 lakh vials.
Manufacturing of liposomal formulation involves a complicated process and can only be done by industries having advanced technology. DCGI, after consultation with the association of Drugs manufacturers, has issued manufacturing / marketing permission of Amphotericin B Liposomal Injection to six firms, viz., Emcure, Gufic, Alembic, Lyka, Natco Limited and Intas Pharma. The expected release by the six new manufacturers for the month of June is about 1.13 lakh vials.
Ministry of External Affairs (MEA) is playing an important role in reaching out to various players abroad. Through its missions all over the world, MEA has identified new sources of Amphotericin B/ Liposomal Amphotericin B injections and alternative drugs for treatment of Mucormycosis. Out of the identified sources, the MoHFW has called upon MEA to take steps to procure Liposomal Amphotericin-B from Australia, Russia, Germany, Argentina, Belgium and China.
Department of Pharmaceuticals and the Indian Embassy in the USA are working continuously with the Mylan Labs for increasing import and ensuring early delivery from M/s Gilead Inc. USA. Out of total Orders placed with Gilead for 9,05,000 vials, the stocks of 5,33,971 vials have already been received till 16th June by M/s Mylan, the main importer. The remaining deliveries are being expedited.
Allocation to states
For equitable distribution, allotments are being made to the States/ UTs in accordance with the proportion of their reported case load in respect of the entire country. The number of patients in a particular State is derived from the portal of Ministry of Health and Family Welfare, in which the States themselves enter the figures of mucormycosis patient load in their respective states. This allocation regime is an interim arrangement till the supply of the drug stabilises vis a vis the demand.
Physical distribution and availability of the drug in a particular city/ hospital is managed by the State Governments concerned.