MEA identified new sources of Amphotericin B/ Liposomal Amphotericin B injections
New Delhi, 18 June (HS): 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, which has been seen as a post COVID complication. Through active measures to augment production, and import and ensure equitable distribution, Government 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. An inter-departmental meeting was held on 10th May, 2021 with Department of Pharmaceuticals, Ministry of Health & Family Welfare (MoHFW), Central Drugs Standard Control Organisation (CDSCO) and Directorate General of Health Services (DGHS)to take stock of the situation. A view emerged that allocation of limited stocks among the States/UTs would ensure that all States get a fair chance of accessing a share of the available supplies, till the supply demand gap is overcome.
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, alternate drugs and expeditious approvals of new manufacturing facilities. The manufacturing firms were contacted and have been sensitized about the need to increase production. The existing manufacturers have also been called upon to increase production of Liposomal Amphotericin-B. Ramping up production of alternative drugs/forms for treating the disease is also being actively pursued with the manufacturers. 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 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 Amphotericin B Liposomal Injection has increased from about 62000 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.
Regular Monitoring of production is being carried out by the Government and several meetings held with the manufacturers to identify the issues involved in the augmentation of the production. Companies manufacturing APIs have also been contacted by the Government and asked to ensure increased and continuous supplies for augmenting production.
