3,75,000 vials of Amphotericin-B to be allocated to states, UTs
Hyderabad: The domestic production capacity of Amphotericin B Liposomal Injection, prescribed for patients suffering from mucormycosis, has registered a five-fold increase in a short span time, going up from about 62,000 in April to 1.63 lakh vials in May and is expected to cross 3.75 lakh vials in June.
Given the sudden surge in the demand for Amphotericin-B which is being prescribed for patients suffering from mucormycosis, the Union government while remaining engaged with the drug manufacturers has decided to make allocation of the limited stocks among the states.
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 about 2.63 lakh vials for the month of June.
The DCGI, has also 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 the month of June is about 1.13 lakh vials.
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.
Import facilitation:
The Ministry of External Affairs (MEA) through its missions all over the world, has identified new sources of Amphotericin B/ Liposomal Amphotericin B injections and alternative drugs for treatment of mucormycosis. Out of the identified sources, the steps were initiated 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 with Mylan Labs for increasing import and ensuring early delivery from 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 June 16 and the remaining deliveries are being expedited.
Making allocation:
To ensure equitable distribution of the limited stocks, the government decided to make allocation of limited stocks among states and ensure all states with patients of mucormycosis get a fair chance of accessing a share of the supplies. 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.
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