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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 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.
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 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 16th June by Mylan, the main importer. The remaining deliveries are being expedited.
