Mucormycosis: Amphotericin B production capacity to cross 3.75 lakh in June, says Centre

In the wake of rising cases of mucormycosis, A sudden increase in the demand has been observed in some States for Amphotericin-B, which is being actively prescribed by the physicians. So far, through active measures to augment production, and import and ensure equitable distribution, the Centre has been able to mobilise over 6.67 lakh vials of the Amphotericin B for patients in the states and UTs and Central Health Institutes, in addition to other drugs such as Amphotericin Deoxycholate and Posaconazole being used for treatment of this disease.

The Department of Pharmaceuticals (DoP) along with inputs from CDSCO has been continuously assessing the availability of drugs for treating Mucormycosis - both through domestic manufacturing and import. Since early May, 2021 the details of production, stock, supplies made and purchase orders were obtained from the manufacturers and their co-operation sought to overcome the gap between supply and demand.

In order to augment the domestic manufacture, the Centre 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, alternate drugs and expeditious approvals of new manufacturing facilities.

The existing five 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.

The domestic production capacity of the drug has increased from about 62,000 in April 2021, to 1.63 lakh vials in May 2021 and is expected to cross 3.75 lakh vials in June, which is a fivefold increase in a short time span.

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 health ministry has called upon MEA to take steps to procure Liposomal Amphotericin-B from Australia, Russia, Germany, Argentina, Belgium and China.

Besides, in order to ensure equitable distribution of the limited stocks, it was decided to make allocation of limited stocks among states, which would ensure that all states with patients of Mucormycosis would get a fair chance of accessing a share of the supplies.

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 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.

Talking about the supply, arrangements are being monitored by the National Pharmaceuticals Pricing Authority (NPPA) under the Department so as to ensure expeditious availability of the drug to the needy. NPPA has put in place a system to ensure timely supplies of allocated volumes and maintains continuous contact with States / UTs and suppliers to trouble shoot any issues in reaching the drugs to the Health Departments of states/ UTs.

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