Speed Post News Network
New Delhi : A sudden increase in the demand has been observed in some States for Amphotericin-B, 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, the 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 May 10, 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.
Production enhancement : 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 sabout the need to increase production.
The existing manufacturers have also been called upon to increase production of Liposomal Amphotericin-B. 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, according to a PIB release.
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 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.
Import facilitation : 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 were received till June 16, 2021, by M/s Mylan, the main importer. The remaining deliveries are being expedited.
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. The allocation by the Central Government is being done only in respect of Lyposomal Amphotericin-B, barring one manufacturer Bharat Serum, which produces Lyposomal, Lipid and emulsion form of the drug.
On June 7, 2021, MoHFW had circulated the advisory of the National Task Force on Covid-19 for treatment and management of Covid related Mucormycosis (CAM), which explains in detail, the manner and conditions under which various Mucormycosis drugs like Amphotericin B lipid complex, liposomal Amphotericin B, Amphotericin deoxycholate form, Posaconazole etc. are to be used.
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