The government is taking various steps to enhance the availability of Amphotericin B in the country to cater to the sudden increase in demand for the medication, which is used in the treatment of Mucormycosis (black fungus), Chemicals and Fertilisers Ministry said in a release on Thursday. The government has been so far able to allot over 6.67 lakh vials of Amphotericin B to states and Union Territories (UTs) by augmenting production and initiating imports.
"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 the treatment of this disease," the ministry said. In order to boost domestic manufacturing, the government is continuously engaging with the manufacturers to resolve their issues related to raw materials, it added.
Besides, the Department of Pharmaceuticals and Drug Controller General of India (DCGI) have actively coordinated with the industry for the identification of manufacturers, alternate drugs and expeditious approvals of new manufacturing facilities, the ministry stated. The existing manufacturers have also been called upon to increase the production of Liposomal Amphotericin-B.
Various concerns of manufacturers and importers, including those related to licensing and availability of raw material issues, import license are being speedily addressed, it said. Currently, Bharat Serums and Vaccines Ltd, Cipla, Sun Pharma, BDR Pharmaceuticals and Lifecare Innovations are manufacturing Liposomal Amphotericin B and are expected to produce about 2.63 lakh vials this month.
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Besides, the DCGI, after consultation with the association of drug manufacturers, has issued manufacturing/marketing permission of Amphotericin B Liposomal Injection to additional six firms — Emcure, Gufic, Alembic, Lyka, Natco and Intas Pharma. The expected release by the six new manufacturers for June is about 1.13 lakh vials, the ministry said. The domestic production capacity of Amphotericin B Liposomal Injection has increased from about 62,000 vials in April to 1.63 lakh vials in May and is expected to cross 3.75 lakh vials in June, it added. The Department of Pharmaceuticals and the Indian Embassy in the US were working continuously for early delivery of the medication from Gilead Inc, the ministry said. Out of total orders placed with Gilead for 9,05,000 vials, the stock of 5,33,971 vials have already been received till June 16 by Mylan, the main importer, the release said.
The remaining deliveries are being expedited, it added. Besides, the Centre along with state governments continue to closely monitor the production, import, supplies and availability of the drugs required for treatment of Mucormycosis, which damages the nose, eyes, sinuses, and sometimes even the brain.
The doctors in India are documenting an alarming number of cases of mucormycosis among patients with Covid-19 and those who have recently recovered. They believe that mucormycosis may be triggered by the use of steroids, a life-saving treatment for severe and critically ill Covid-19 patients.